Food Safety Modernization Act

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The Food Safety Modernization Act (FSMA), which became effective January 4, 2011, is the most significant change to U.S. food supply regulations since 1938. FSMA creates a comprehensive risk-based approach to food safety, giving the FDA new enforcement authority and tools.  Some of the FDA’s key new authorities and mandates are provided below:

  • Food Facility Registration Revalidation:  Section 102 of the FSMA requires all food facilities -- domestic and foreign -- to re-register between October 1 and January 31 of each even-numbered year, beginning in 2012.  The FSMA further authorizes the FDA to cancel the registration numbers for those food facilities that do not re-register in this period.  Food imports from foreign facilities that fail to re-register will be detained or refused.  
  • Increased Liability for U.S. Agents: Under Section 107 of the FSMA, all foreign food facilities must designate a U.S. Agent upon registration and re-registration.  Whereas the role of the U.S. Agent has been minimal since the enactment of the Bioterrorism Act (BTA) in 2002, the FSMA drastically changes this; holding the U.S. Agent financially liable for the payment of user fees assessed against the registered facility, as well as increasing the U.S. Agent's responsibilities to the registered facility.
  • Collection of User Fees:  Section 107 of the FSMA authorizes FDA to assess and collect fees related to food recall activities, as well as certain domestic food facility, foreign food facility, and importer reinspections.  
  • Mandated Inspection Frequency: One significant step toward increasing food safety, is the FSMA's inspection mandate (Section 306), which directs the FDA significantly increase the frequency of food facility inspections -- all "high-risk" domestic facilities must be inspected within five years of enactment and again no less than every three years thereafter,   and  at least 600 foreign facilities must be inspected within one year of enactment and double those inspections every year for the next five years.
  • Authority to deny entry:  Under Section 304 of the FSMA, FDA can refuse entry into the U.S. of food being imported from a foreign facility if FDA is denied access to the facility by the registrant or the government of the country where the facility is located.
  • Mandatory Recalls:  Section 206 of the FSMA provides FDA with authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to by FDA.
  • Expanded Administrative Detention Section 207 of the FSMA provides FDA with a more flexible standard for administratively detaining products that are potentially in violation of the law (administrative detention is the procedure FDA uses to keep suspect food from being moved).

Our food and beverage consultants have quickly become recognized experts in FSMA, serving on advisory committees to the FDA, presenting at industry conferences on panels with FDA and lecturing to groups across the globe on the impact of this new legislation.