It’s a significant new burden on companies that adds a new legal obligation to food companies, one that can create some pragmatic difficulties for the companies. We’ll talk about the significance of this big new change to your business in a moment, but first a review of the basic facts:
• Only FDA-regulated foods are included (so not meat and poultry, which U.S. Department of Agriculture regulates). However, dietary supplements aren’t included (they have their own separate reporting obligation), and infant formulas aren’t included either;
• The one who has to report is the ‘responsible party,’ defined as the entity who submitted the food facility registration to FDA under the Bioterror Act provision requiring food facilities to be registered. That means both domestic and foreign facilities have this new reporting obligation;
• It also means food additive makers, because their facilities are registered, would have to report. Food-contact substance makers, (i.e., food packaging) who aren’t required to register, do not therefore have this new reporting obligation for Reportable Foods;
• You have to report to FDA within 24 hours of determining the food is reportable;
• Moreover, state and local health officials, if they discover a Reportable Food, can voluntarily report it to FDA;
• The food you report need not be yours—it could be an ingredient sent to you by a supplier, for example;
• Only if ALL THREE of these facts are true would a responsible party not have to report a Reportable Food: [1] If the adulteration originated with that responsible party; [2] that responsible party detected it before the food was transferred to another person; AND [3] that responsible party corrected the adulteration or destroyed the food, or caused its destruction;
• FDA is setting up an Internet portal, the Reportable Food Registry, for responsible parties to submit reportable food reports, detailing all the requisite information. That’s how you have to report;
• Once you report, you also have to investigate the cause, if it may have originated with you, and you have to submit supplemental reports afterwards;
• FDA may require those who report a Reportable Food to also notify one level up and one level down, that is, their immediate suppliers and immediate recipients;
• Failure to report a Reportable Food as required by law is a new “prohibited act” under the Federal Food, Drug and Cosmetic Act, which means it subjects your company (and maybe even you individually) to all potential FDA penalties;
• Reportable Food Registry reports are not publicly available and won’t be seen by other submitters. Members of the public can get some of the information about the reports under the Freedom of Information Act, with appropriate information redacted (such as confidential business information, for example). FDA will soon provide more details about what information will and won’t be made public via FOIA.
• Reporters have to keep records of their reports for 2 years;
• Making a report is NOT a legal admission of liability on the reporter’s part of any kind, and the law says so specifically.
As was pointed out in this space when this provision was first passed, this reporting obligation gets mighty close to being a mandatory recall obligation, but it isn’t one. Clearly, though, most companies won’t feel like they have much choice (most won’t think it’s even an issue) but to recall a potentially dangerous food they report to FDA, and maybe also to their suppliers and customers. FDA says recall procedures, such as communications with local FDA district offices, are not avoided by the new reporting obligation and should proceed as before even after a report is made.
This new program is required by Congress, which included provision for it in 2007’s FDA Amendments Act. FDA officials said at an August public meeting that the intent of the program was to get bad food out of commerce sooner, and to try to narrow the focus of remedial measures sooner so that publicity and concerns don’t extend beyond foods that are actually involved.
If you think that reporting to FDA within 24 hours of determining a food may be a danger sounds like a headache, what with the pressures of ambiguous information, difficulties of investigation, and, you know, weekends, you are correct. Companies are going to have to implement policies, if they don’t already have them, for rapid flow of information about potential food safety concerns within their operation. Companies are also going to have to face the fact that this obligation will put them into unavoidable, awkward positions with suppliers and customers, especially when one has to report to FDA about a potentially dangerous ingredient you got from a supplier, or product you sent to a customer.
Remember, too, that if the food safety law that the House passed in late July becomes law later this year, some of its provisions could affect the registry’s operation. For example, if FDA gets new authority to order food recalls, how will that affect the operation of the registry? Also, if Congress changes the universe of food companies that have to register with FDA, how will that be reconciled with the registry’s requirements falling on those who registered pursuant to the Bioterror Act?
Further clarifications and more guidance from FDA can be expected. The agency appears reluctant to say out loud that they will go easy at first on reporters who fail to report or don’t report within 24 hours, so the good advice is to get familiar with this requirement and be ready to comply, right now.
