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On January 4, 2011 President Obama signed into law the Food Safety and Modernization Act (FMSA) also known as HR 2751 formerly known as S. 510. This law was debated on and voted on by the U.S. House of Representatives on December 19, 2010. This law amends the Federal Food, Drug and Cosmetic Act of 1938 (FFDCA).

Under FMSA producers of all domestic and imported food products except meat, poultry and some egg products that are regulated by the United States Department of Agriculture (USDA) will be required to adhere to this law. Farms, very small business owners (less than $500,000 annual sales), restaurants, or grocery stores selling within the same state will be exempt from certain provisions of this law. These operations are still covered under the local and state regulations and laws.

Effective date on these provisions varies from immediately upon enactment of the law to two years after the enactment. Certain provisions require the FDA to develop and implement regulations and guidance documents.

Key provisions in this law include:

  • Food facilities are required to register with the Food and Drug Administration (FDA) biennially
  • Food from an unregistered facility may not be imported into the U.S.
  • Food from an unregistered facility cannot be introduced into intrastate and interstate commerce
  • Registered facilities are to conduct hazard analysis and developed written preventative controls and must implement them – simply must have and enact Hazard Analysis Critical Control Point (HACCP) plans
  • Registered facilities must maintain specific records related to HACCP and have additional records for tracking and tracing high-risk foods
  • Food importers are required to implement verification programs of their suppliers and take steps to verify that the food they import is safe
  • Food facilities and food importers are subjected to new fees in regards to re-inspection of facilities because of non-conformances noted
  • Food facilities will be inspected at a higher frequency then previously done and for domestic high risk facilities will not be inspected less than once every five years initially and once every three years thereafter, low risk domestic facilities will not be inspected less than once every seven years initially and once every five years thereafter and 600 import facilities must be inspected within one year of the enactment date
  • FDA can compel a business to recall tainted food. Can issue a mandatory recall after a hearing
  • FDA can administratively detain food based only on a “reason to believe” the food is adulterated or misbranded as per the FFDCA
  • Allows the FDA to suspend a facilities registration if there is a reasonable probability that the facilities products would cause adverse health consequences or death to humans or animals
  • FDA is authorized to require that an article of food offered for import into the US be accompanied by a safety certification from an accredited third-party auditor
  • FDA is required to review relevant health data every two years and set guidance or regulations for performance standards for the most significant contaminants
  • FDA is required to establish a product tracing system within the FDA to improve the agency’s capacity to effectively and rapidly track and trace food
  • Laboratory tests to be used for regulatory purposes must be performed by either a US Federal laboratory or an accredited non-Federal laboratory, and lab test must be sent directly to the FDA

SGS is committed to inform interested parties as developments on US legislation occur. Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing, auditing, inspections and consultancy of food articles for the US and worldwide markets.

Please do not hesitate to contact us for further information:

James Cook
291 Fairfield Ave,
New Jersey 07004, USA
t: + 1 (973) 575-5252
f: + 1 (973) 575-7175

About SGS

The SGS Group is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With more than 64,000 employees, SGS operates a network of over 1,250 offices and laboratories around the world.