Registration of food facilities with the U.S. Food and Drug Administration (FDA) has been a requirement for almost a decade. Since the passage of the Public Health Security and Bioterrorism Preparedness Response Act on June 12, 2002, facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States have been required to register with FDA in order to provide the agency with information on the origin and distribution of food and feed products, thereby aiding in the detection and quick response to actual or potential threats to the U.S. food supply.
Starting next week, however, all food facilities required to register with FDA must begin biennial re-registration to comply with the provisions of the Food Safety Modernization Act (FSMA). Signed into law on January 4, 2011, FSMA now requires that food facilities re-register every 2 years with FDA, during the period beginning on October 1 and ending on December 31 in even numbered years. The first registration renewal cycle under FSMA starts and Monday, October 1 and will continue until Monday, December 31, 2012. Even if a food facility is already registered with FDA, the facility is still obligated to renew registrations during the October 1-December 1 timeframe.
When registering, it is important for food facility representatives to remember that additional information is now required to accompany the registrations under FSMA. Specifically, registrations must contain the e-mail address for the contact person of the facility, or for a foreign facility, the email address of the U.S. agent for the facility, and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Additionally, if determined necessary by FDA, registrations are required to contain information regarding other applicable food categories, as determined appropriate by FDA, for foods manufactured, processed, packed, or held at registering facilities.
On a related note, under FSMA, the FDA is now, for the first time, explicitly granted the authority to suspend the registration of a food facility in certain circumstances involving food manufactured, processed, packed, received or held by a registered facility that has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA did not previously have a process for suspending the registration of a food facility in such circumstances. If the FDA were to exercise this authority and suspend the registration of a food facility, that facility would be prohibited from introducing any food into the stream of commerce in the U.S., including importing or exporting food into the U.S.
Make sure to start submitting your registrations on Monday! To register, update, or renew a registration, food facilities must submit the paper Form 3537 by mail or fax or register online at www.fda.gov/furls. FDA encourages online registration as the least costly, quickest, and most efficient means for food facility registration.
Last week, the FDA issued its first annual report on the Reportable Food Registry (RFR). The report provides statistics on the first year of the RFR (2240 entries, 229 "primary reports," a breakdown of the report by hazards, etc.).
Beyond the statistics, the FDA report should be noted by food companies for two reasons:
- Food Safety Plans
FDA Deputy Commissioner for Foods Michael Taylor says that “[s]everal key U.S. industries are already re-evaluating their hazard and preventive controls, core principles of the Food Safety Modernization Act recently passed by Congress. We also anticipate improved reporting as we continue our vigorous outreach to food facilities through federal, state, local and foreign agencies, to help us expand the positive effect of the RFR on the safety of the U.S. food supply.”
The new hazard analysis and preventative controls requirements in the Food Safety Modernization Act (FSMA) are not effective for 18 months following passage. Deputy Commissioner Taylor's comments suggest that industry standards may already be moving in that direction . To mitigate exposure and risk, FDA enforcement actions, product liability claims, supply chain contract claims and recalls, food manufacturers may want to consider updating and/or creating food safety plans that address the hazard analysis and preventative controls prescribed by the FSMA.
- Allergen Controls
The FDA reports undeclared allergens/intolerances accounted for 34.9 percent of the primary reports. Industry experts assert that the FDA believes that the industry does not in general have good control over the issue of undeclared allergens. These experts believe that the FDA will give special attention to the issue of undeclared allergens/intolerances in promulgating regulations under the FSMA's requirements for hazard analysis and preventative controls (see point 1 above). In anticipation of the FDA's concern, manufacturers should consider now how they can change manufacturing processes to address the undeclared allergen issue.