Food Safety Modernization Act Expands FDA Authority

A curious hole in the Food and Drug Administration's (FDA) authority over food recalls became apparent during the national peanut recalls of 2009. The agency announced it was serving Westco Fruit and Nuts Inc. with an investigation warrant after the company declined to initiate a recall of its peanut products despite FDA recommendations--this in the midst of a peanut-borne salmonella outbreak.

The situation was possible because under the existing law, the agency had the ability to suggest that a company recall a product, but it had no recall authority without a court order.

That will change with enactment of the FDA Food Safety Modernization Act, a sweeping update that gives the FDA increased authority and resources.

The bill, which covers all foods except meat and poultry regulated by the U.S. Department of Agriculture (USDA), contains rules that will continue the recent push to increase food safety, inspired in part by a wave of high-profile food recalls. Even major food companies are backing the bill, in the hopes that better inspections will lessen outbreaks of foodborne illnesses and costly untargeted recalls.

"An unprecedented, multifaceted coalition has been pushing for additional FDA funding on food safety for several years, and has already succeeded in getting FDA additional funding," says Eric Greenberg, a Chicago-based food and drug lawyer. "That coalition brought together an unlikely mix of former FDA and [Heath and Human Services] leaders, consumer advocates, but also major industry representatives--that's a testament to how serious the problem of declining emphasis on food safety was seen to be."

At press time, the bill was headed to President Obama's desk after a rather circuitous journey through Congress. It passed in the Senate on Nov. 30, 2010, moved on for reconciliation with a parallel House bill--and came face to face with a rare Constitutional snafu. The House deemed a fee-collection provision in the Senate bill a tax provision, which under the Constitution must originate in the House. The bill was sent back to the Senate, by then deep into the tax debate, where it gained new threats of filibuster from one of its harshest critics, Sen. Tom Coburn, R-Okla., who said he'd fight the bill if it was attached to a continuing resolution that replaced an omnibus spending bill. Then late on the Sunday before Christmas, Senate leaders reached a deal and the bill passed easily in the House on Jan. 4. After years of legislative limbo, Congress had finally approved a measure to refortify the FDA's authority over food safety.

Recall Rules

Although it has gotten a lot of attention and is a centerpiece of the legislation, some experts question what the recall authority will really change.

"Only a handful of companies in the 20 years I've done this has ever refused a recall, but consumer groups really wanted to have recall authority, so that's in there," says William Marler, managing partner of Marler Clark, which represents plaintiffs in litigation related to foodborne illnesses. Marler worked with legislators to draft the Senate bill. "I don't think it makes a whip's bit of difference to companies because most companies, if asked to do a recall, would do it."

The law also seeks to better inform customers of food recalls. That provision was taken from a bill first introduced by Sen. Kirsten Gillibrand, D-N.Y. Under the new law, companies notify consumers directly at grocery stores with a poster or notification by the cash register, or with a more targeted solution--store loyalty/membership cards, for example, now allow retailers to track their customers' purchases and inform them of relevant recalls.

"There's very little public notification right now, and when it does occur it's usually a press release to the Associated Press," says Richard Frank, a senior principal attorney at Olsson Frank Weeda Terman Bode Matz.

Increased Inspections

Of more impact on food companies is increased inspections of facilities by FDA inspectors as well as state and local authorities acting in cooperation with the FDA.

"Right now even high-risk food facilities may get inspected once every five years," Marler says.

Under the new law, facilities deemed high-risk by the FDA will be subject to even more frequent inspections.

"With the added funding and the intensified inspect, if you're in a higher-risk product category, you might be inspected two or maybe four times a year," Frank says. "The better companies are always prepared anyway, but they are going to face the threat of having the FDA show up unannounced more frequently."

The new law also requires food facilities to adhere to what amounts to a Hazard Analysis & Critical Control Points (HACCP) food safety management system. Currently HACCP requirements only apply to meat and poultry, seafood and juice facilities, but under the new law almost all food facilities will have to evaluate hazards, implement preventive controls, monitor those controls and maintain records of that monitoring.

"[The requirements] put a burden on most companies to change their everyday operations if they don't already have an equivalent system in place," Greenberg says. "These HACCP plans are things larger and mid-size companies are probably already doing. Smaller companies, which might be great with basic sanitation and have a good handle on their processes but don't document what they do, will have a lot of work to do."

Right Direction

The bill has not gone without criticism, both for what it includes and what it lacks. Marler, for instance, says the bill leaves its own funding to another day. Sen. Tom Coburn, R-Okla., has criticized the bill for too much spending and not enough impact on food safety. The Tester amendment, which was introduced by Sen. Jon Tester, D-Mont., to lessen the bill's impact on small and family farms, is being criticized by larger food companies that worry less-regulated products from smaller facilities could migrate into the larger stream of commerce. And advocates pushing for a single food agency to oversee food safety, nutrition and inspection--driven in part by miscommunications between the USDA and FDA during the egg recall in 2010--were left disappointed.

Greenberg emphasizes that the effects of the law will depend on how it's implemented--both in terms of how regulations are formulated and how the FDA exercises its authority. But the overall view is that it's a step in the right direction.

"The bill is certainly an improvement over what they have right now," says Mark Mansour, a partner in the health industry practice at Akin Gump. "If you're a large company it gives you some predictability; if you're a small company it will impose more regulations on you to be able to achieve compliance. Like all legislation, it's a compromise, some of it good and some of it not so good. But I'd rather have this bill than no bill at all."

Contributing Author

Melissa Maleske

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