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Send to KindleFood safety law is here, and so are some of its effects
• 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 [email protected], and visit his firm's Web site at www.ericfgreenbergpc.com.
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