Pondering Public Disclosure & FSMA Records
Remember last month when we said to DOCUMENT EVERYTHING under the Food Safety Modernization Act (FSMA)? Well, here’s some more context for that recommendation.
For one, FSMA adds a substantial amount of documentation and record-keeping requirements for food companies that are covered by any one or more of FSMA’s new regulations. For example:
- Food facilities—those that manufacture, process, pack, and/or hold food for consumption in the United States—are required to have a written food safety plan (and to document the implementation of said plan), a written recall plan, and a written food defense plan to account for potential intentional adulteration of food in their facilities.
- There also are record-keeping requirements that are triggered depending on the types of ingredients a food facility receives, the kind of processing and/or manufacturing the food facility does, and type of customers the food facility has (and what those customers do to the food).
- Companies involved in the transportation of food—shippers, receivers, loaders, and carriers—are required to keep records explaining their procedures and compliance with those procedures for the safe transportation of food.
- Farms that grow produce must keep records, for example, of employee training, agricultural water testing, and use of biological soil amendments of animal origin.
- Importers of food are required, among other things, to document their supplier-approval and verification processes.
There is more, but you get the picture.
On top of that, the twist to the record-keeping requirements is this: in most instances, FSMA states that records required to be kept under FSMA are subject to the FDA’s public disclosure requirements (found in 21 C.F.R. pt. 20). The public disclosure requirements apply only to records that a company gives to the FDA, in response to an inspection or otherwise. That means that if a member of the public wants to get a copy of a record kept under FSMA that has been submitted to the FDA, that person has the right to request and, subject to some exemptions, get a copy of that record. Records that contain trade secrets and commercial or financial information which is privileged or confidential are subject to an exemption.
In order to claim an exemption, the food company submitting the records must designate at that time the records are submitted to the FDA what information in the records falls under the trade secret and commercial or financial information exemption. When a member of the public requests records required to be kept under FSMA, the FDA “will make reasonable efforts to notify the submitter” at which time the submitter of the records has five (5) working days to object to the disclosure and state the bases for its objection.
These disclosure provisions are significant for a couple of reasons. First, although food companies likely have already been keeping many of these records—for example, to monitor the food safety of their operations and/or to comply with a third-party audit—this is the first time that the government has required that companies keep such records. Because the government had not required food companies to keep most of these records, food companies had not been subject to the possibility of public disclosure of those records. Second, the records now required under FSMA include some new documents that food companies may not have been keeping previously and that, together, encompass a broad swath, if not all, of a food company’s food safety operations.
It is unclear at this time how often members of the public will request disclosure of a food company’s records, but we imagine it will happen. We raise the issue now because we think food companies should build this possibility into their internal procedures—ask: “how will we handle a request for public disclosure of our documents?” and “what information is in our documents that we consider to be trade secrets and/or commercial or financial information which is privileged or confidential?”
The latter question is important to consider now as food companies begin to keep these records under FSMA. Identifying ahead of time the information food companies consider to be proprietary and confidential (as defined by the regulations) is critical and will facilitate the process later if a public records request is made for a food company’s records after they have been submitted to the FDA.
FSMA is often talked about as being the most significant overhaul of the nation’s food safety system in over seventy years; these record-keeping and disclosure requirements represent a shift in the industry and contribute to the significance of that overhaul.