In past Produce and the Law articles, we have provided brief overviews of the development and implementation of the Reportable Food Registry (the "Registry"). This week, we revisit the Registry and the developments that have occurred since our last update on this topic in 2015.
The Registry is an electronic portal established by the Food and Drug Administration ("FDA") under the Food and Drug Administration Amendments Act of 2007 (the "Act"). Its purpose is to provide a reliable mechanism for the FDA to track and inspect adulterated foods in order to protect and promote public health. The Registry covers all categories of food and drink, including pet food, animal feed and, interestingly enough, chewing gum. Dietary supplements are not "food" for purposes of the Act and therefore, are not subject to the requirements of the Registry.
The FDA's goal, in part, is to track foods that were physically transferred to persons or entities by a "responsible party," regardless of whether ownership of the food changed hands. A "responsible party" is defined as the person who submits the registration information for a facility where food for human or animal consumption is manufactured, processed, packed or held. Responsible parties are owners, operators or agents in charge of such facilities. Thus, for purposes of the Act, a "person" may be an individual, partnership, corporation or association. Foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States are required to register. Farms are exempt from the reporting requirements.
A responsible party is required to submit a report to the FDA through the Registry within 24 hours of becoming aware that food could pose a serious health risk to humans or animals. Foods that could pose a serious health risk are referred to under the Act as "reportable foods." However, a responsible party is not required to file a report if: ``(A) the adulteration originated with the responsible party; (B) the responsible party detected the adulteration prior to any transfer to another person of such article of food; and, (C) the responsible party (i) corrected such adulteration; or (ii) destroyed or caused the destruction of such article of food."
The reporting requirements for the Registry became mandatory as of December 8, 2009. In 2010, the FDA and the National Institutes of Health launched the Safety Reporting Portal (
), which was designed to streamline the reporting process to both agencies. The FDA utilizes the information to generate annual reports, which can be accessed at
. The most recent annual report was released in May, 2014, covering the period September 8, 2012, through September 7, 2013. It does not appear that an annual report was generated in 2015, but the website provides useful information for past years.
Should you have any questions regarding the Registry or any other topic, please feel free to contact