The Food Safety Modernization Act (FSMA) represents a fundamental change in the manner in which the U.S. Government intends to police food safety. Reactive is out; preventive is in. In that regard, the FSMA directs the U.S. Food and Drug Administration (FDA) to step up efforts to register, and collect additional information, regarding companies that manufacture, process, pack or store food for human or animal consumption in the United States.
Does your company need to register with the FDA? If in doubt, it is imperative that your company determine immediately whether it falls within the registration requirement. The current registration period remains open only until December 31, 2012. A company’s failure to register could lead to adverse government action against it.
Frankly, registering with the FDA is not a new concept. Given bioterrorism concerns, both U.S.- and international-based food companies have been required to register with FDA since the passage of the Public Health Security and Bioterrorism Preparedness and Response Act a decade ago. Now, the FSMA requires that food companies register, or reregister as the case may be, their food facilities every even-numbered year, starting in 2012.
The FSMA, however, casts a wider net than that of the Bioterrorism Act. Now, a food company must notify the FDA both of the primary and secondary products with which the company is involved. A company also must provide additional contact information. Additionally, a company must represent in the registration itself that FDA will be able to inspect the company’s facilities, consistent with the FSMA
What precisely does this new registration process entail? Recently, FDA issued a draft guidance to help food companies answer that question. That guidance differs from others that FDA has issued. Once final, the requirements of the registration guidance will be mandatory. The guidance is found at; the registration forms are found at
In addition to providing information the FSMA requires, FDA also hopes that food companies will volunteer additional profile information about themselves for the FDA’s records. That information may include, among other things, data regarding:
• Facility type
• Products
• Hazards associated with facility, production and products
• Preventative control measures
FDA posits that a company’s voluntary provision of the additional information will assist FDA in its oversight of that company, including notification of the company in the event the relevant food supply is contaminated; determination of whether the company’s facility is high-risk; establishment of the frequency with which to inspect the facility; better preparation for an inspection; and, hopefully as a result, a reduction of the time it takes to complete an inspection. In other words, information a company volunteers may influence the manner in which FDA interacts with the company for purposes of the FSMA and other regulatory compliance.
Jason R. Klinowski and John T. Shapiro are attorneys and members of the Food Industry Team at Freeborn & Peters LLP (Chicago).