On February 23rd 2012 the FDA issued an Interim Final Rule (IFR) implementing enhanced food facility record inspection authority granted to the Agency by Congress in the Food Safety Modernization Act.[1] Under the old regulations, FDA could only demand that you immediately produce distribution records (one up-one back in the distribution chain) when it had a “reasonable belief” that a specific article of food was adulterated and presented a serious risk to human or animal health. [2], [3], [4] Under the new rule, which is effective immediately, FDA’s authority to demand the immediate production of such records has increased in three significant ways:
- FDA is no longer required to have a “reasonable belief that a food poses a risk.” FDA may now demand immediate delivery of your records if it merely “believes that there is a reasonable probability of a risk.” While the change from “reasonably believes” to “believes that there is a reasonable probability” may seem inconsequential, the legal effect is gigantic. Under the new rule, FDA may demand all of your records, even if their claimed belief of a reasonable probability of risk is a clearly unreasonable belief. Sound crazy? Just think about it for a minute or two.
- Previously, FDA could only access your distribution records if the agency reasonably believed that your food was adulterated. Now, the FDA does not need to believe that the food in question is adulterated at all. FDA must merely believe, even if unreasonably so, that there is a reasonable probability that use of or exposure to an article of food poses a risk, even if FDA is certain that the food is not adulterated.
- Previously, the FDA could only demand records relating to a specific article of food that FDA reasonably believed was adulterated and directly presented the serious health risk. Now, FDA may expand their requests to “any other article of food that FDA reasonably believes is likely to be affected in a similar manner.” Again, these “other article[s] of food” do not need to be adulterated. It only matters that FDA reasonably believes that the related food is likely to be affected in a similar manner to food FDA believes presents a risk…and that initial belief of a risk can still be unreasonable!
Even under the old law FDA could require you to make all of their applicable records available to FDA within 24 hours. Now, however, FDA may do this much more often and with much less evidence of any problems, because they may now do so even if 1) their belief of a risk is unreasonable, 2) they are certain that the food in question is not adulterated, and 3) the food for which they are requesting records is not the suspect food, but merely food that they think is likely to be similarly affected to the suspect food in question.
Put more bluntly, FDA may now demand your customer and supplier lists and all other applicable records even if FDA unreasonably believes that food that they know for sure is not adulterated represents a risk.
To be clear, Congress explicitly gave FDA the authority to do this. The language in the IFR echoes the language in the FSMA. That said, this is a perfect example of a panicked grant of expanded authority extended without careful consideration of the real-world consequences or proper input from the industry or regulatory experts. Either Congress did not consider the ramifications of the change in language they approved, or they knew about it and traded vastly increased regulation for some political expediency.
While we have our own thoughts and ideas as to how FDA may put these newly-granted powers to work, we ask our readers to consider the question for themselves.
How might FDA act now that they can demand records such as reports of your customers and suppliers even when FDA unreasonably believes that food that they know for sure is unadulterated represents a risk?
We would love to hear your thoughts on the matter. If you have any ideas, please let us know!
[1] The applicable section of the rule states that you must make your records available to FDA within 24 hours “when FDA believes that there is a reasonable probability that the use of or exposure to an article of food, and any other article of food that FDA reasonably believes is likely to be affected in a similar manner, will cause serious adverse health consequences or death to humans or animals“ Establishment, Maintenance, and Availability of Records: Amendment to Record Availability Requirements, 77 Federal Register 39 (Feb. 23, 2012) pp. 10658-10662.
[2] The recordkeeping requirements apply to persons who manufacture, process, pack, distribute, receive, hold, or import food.
[3] You must deliver your records to FDA “as soon as possible, not to exceed 24 hours from the time of receipt of the official request.”
[4] In all cases, the risk to humans or animals must constitute at least a “serious adverse health consequence.”
