Regulated facilities should be prepared for their next inspection, including having a plan in place for employees to follow should FDA arrive for an inspection, identifying (in advance) those responsible to work with FDA during an inspection, knowing where the relevant documents are kept, and having a plan in place as to how to respond to any issues FDA identifies.
Another important component of FSMA is a newly established series of “whistle-blower” provisions. These provisions prohibit companies from terminating or discriminating against employees who engage in certain protected activities, such as reporting violations of food safety regulations. This type of whistle blowing provision is new to this industry. In order to ensure compliance, companies should review their current policies and practices, including discipline and discharge policies, as well as provide training to managers and employees, as needed.
Reportable Food Registry
The detection and response provisions of the FSMA also included some updates to the Reportable Food Registry (RFR). The RFR was launched by FDA in 2009 as a type of early warning system related to foodborne illnesses. The RFR applies equally to the human and animal food industries, yet there appears to be some confusion regarding the application of the RFR on the animal feed side. Generally, if you are required to register with the FDA, then you are subject to the RFR requirements.
Anytime a company becomes aware of the reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals, it is required to make a report to the RFR. For example, swine feed with elevated levels of selenium or sheep feed with elevated levels of copper would likely be considered reportable foods. If a company (the party responsible for filing the report) determines that it has a reportable food in its possession, it is required to file a report within 24 hours.
The only time a report need not be made is if the company can satisfy three criteria: (1) The adulteration originated with the responsible party; and (2) the responsible party detected the adulteration prior to the food article changing custody; and (3) the responsible party corrected the adulteration or destroyed the food article. If all three criteria are satisfied, then a report does not need to be filed.
Two key questions come up in relation to the RFR — how do I determine if I have a reportable food and when do I need to report it? The second question is somewhat easier to answer. Once a reportable food has been identified, the report must be filed by the responsible party within 24 hours. If it turns out to be a false alarm, or if you don’t have all the necessary information, reports can be modified at a later date to reflect more recent developments.
In order to determine when that 24-hour period begins to run through, it is important to know how to identify a reportable food. The general rule is better safe than sorry. For example, a confirmatory test related to a contaminant will automatically trigger the 24-hour reporting requirement. A presumptive test for a contaminant may trigger the reporting requirement, depending on the reliability of the test. In addition, the mere presence of a contaminant may not trigger the need to file a report, as it may be at such insignificant levels that it would not cause serious adverse health consequences or death. Each potential situation will require a thorough, timely review of the testing procedures, reliability, and other related factors before a reporting determination is made.
Traceability can also be a concern for the grain industry when it comes to the RFR. After filing a report, you may be required to notify the parties above and below you in the stream of commerce. Record keeping is a key component of this requirement, and companies need to ensure that records are adequate to, at a minimum, help narrow the focus of this notification.
While FSMA does not require traceability, it does require that FDA test pilot programs in this area. Good record keeping practices and at least minimal traceability procedures at your facilities will help ensure you are prepared to file a report with the RFR or in the case of a recall.