It seemed toward the end of 2010 that those events were uncertain to occur, though the law had been worked on and touted as just-around-the-corner for over a year. (We looked at that phenomenon, and some important issues raised by the law, in last month's column, packworld.com/article-31132).
But here it is, the Food and Drug Administration Food Safety Modernization Act, changing FDA's powers over many of the food companies it regulates and adding burdens, uh, responsibilities, to food companies. Meat and poultry companies aren't affected, since they are regulated by the U.S. Department of Agriculture, about which this law does nada.
The theme of the new and multifaceted law is prevention. That is, its many new provisions are intended to prevent unsafe food from being created or reaching the market in the first place whenever possible, and to make it easier to keep such foods from consumers when they do.
Well, life being more complicated than we often acknowledge, there are two primary complications to the scene that need considering. One is that some of the provisions of the law require new funding for FDA, and the new Congress is already sending signals it won't fund them. Implementing all the law's provisions will cost an estimated $1.4 billion over the 2011-2015 period. No new funding means no new inspectors and inspections, among other things, unless money is squeezed out of other FDA functions.
The other complication is that some of the law's provisions kicked in on January 4 when President Obama signed the law, but many others require FDA to make regulations to make them effective, such as the new HACCP plans for food makers (coming in 18 months).
Examples of immediate effects are increased inspections (though that will be tough for FDA to fully implement if they don't get full funding for it). Other key examples of provisions effective right now are:
• FDA's new power to order recalls of potentially dangerous foods, which is mentioned in virtually every explanation of the law's contents. FDA can exercise this power if the agency thinks there is a ‘reasonable probability' the food is adulterated or misbranded and that it might cause serious adverse health consequences or death, after first giving the responsible party a chance to recall voluntarily and then affording them a hearing within 2 days of issuing the order.
• FDA's new powers to have expanded access to food company records relating to manufacture, packing, distribution, and other activities during inspections whenever FDA thinks there's a ‘reasonable probability' the food will cause serious adverse health consequences or death. Right now, they can see food facility records when they have a ‘reasonable belief' that the food presents such danger and is adulterated, but this expands it to also cover records about “any other article of food” that FDA reasonably thinks is similarly dangerous.
FDA's important new power to suspend a food facility's registration—effectively putting them out of business—if they suspect food made or held there has that reasonable probability of causing serious adverse health consequences or death is administrative. That is, FDA need not ask a judge to order it. This provision becomes effective either 1) when the implementing regulations are issued; or 2) within 180 days of enactment of the FSMA, whichever is earlier.
Note that these recall, document inspection, and suspension powers kick in only when FDA finds there's a reasonable probability the food will cause serious adverse health consequences or death. That means FDA could inspect, declare your food adulterated or misbranded and a potential danger, and then they could use one of these powers.
If they think the food's in violation but not a potential danger, FDA still could of course use all its other powers, including applying pressure by threatening you with seizure, injunction or prosecution, or publicizing your food's allegedly sub-optimal condition, to try to persuade you to stop making and shipping it and to recall what's out there voluntarily, and follow up with seizure, injunction, or prosecution as they saw fit.
Also, FDA has a new important change in its power to detain suspect foods that aren't suspected of being dangerous, and this is a biggie. Whereas FDA had the power, thanks to the post-9/11 Bioterror Act, to temporarily order food detained if it had credible evidence or information indicating it presented a threat of serious adverse health consequences or death, now FDA needs only reason to believe the food is adulterated or misbranded, and need not even suspect it of being a danger to health. This provision kicks in once regulations about it are in place, but FDA has to issue those in 4 months. Other provisions requiring further implementation, and FDA's deadlines, include these (see the full list at packworld.com/article-31215): 120 days to implement the new administrative detention provision; and 1 year to make rules for the elaborate new foreign supplier verification program.
But don't let these various regulatory ships sail without your help to steer them. Any packager whose business might be affected by any of these rules can participate in the process by submitting comments to FDA on the proposed rules once they issue.
Eric Greenberg can be reach at greenberg@efg-law.com, and visit his firm's Web site at www.ericfgreenbergpc.com.
