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Food Safety Modernization Act (FMSA)

Friday, August 16, 2013

The Food Safety Modernization Act (FMSA) is intended to improve the safety and security of the nation’s food supply, focusing on prevention of foodborne illness.

The FSMA gives the U.S. Food and Drug Administration (FDA) greater authority to establish prevention-based controls across the food supply and conduct inspections of food producers.

The FDA has said the FMSA is needed because foodborne illness is a significant public health burden that is largely preventable by improvements to the nation’s food safety system. According to the Centers for Disease Control and Prevention, approximately 48 million people are sickened due to foodborne diseases, 128,000 are hospitalized and 3,000 die each year.

There has been opposition to the law by groups that consider it a costly and burdensome intrusion into the food industry. Some concerns of small business owners were addressed by exemptions from some rules for facilities that qualify as small businesses under the law, although those exemptions may not apply if the business is linked to a foodborne illness outbreak.

The FSMA focuses on:

  • Implementing controls to prevent the occurrence of foodborne illnesses;
  • Conducting inspections to ensure that the industry is producing safe food;
  • Expanding oversight of imported food products;
  • Improving the FDA’s response to food safety problems; and
  • Enhancing collaboration between food safety agencies to improve public health and state and local food safety programs.


  • Food facilities must develop a written hazard analysis to evaluate potential hazards that could affect food manufactured, processed, packed or held by the facility, including biological and chemical hazards, natural toxins, pesticides and drug residues.
  • Food facilities must identify and implement preventive controls to provide assurances that any hazards identified will be significantly minimized or prevented. The controls must be documented in writing, and records must be kept for at least two years.
  • The FDA must establish science-based standards for the safe production and harvesting of fruits and vegetables. These standards must consider not only man-made risks to fresh produce safety, but also naturally-occurring hazards—such as those posed by the soil, animals and water in the growing area.

 The FDA must implement measures to protect against the intentional contamination of food by conducting a vulnerability of the food system, considering the costs and benefits associated with guarding against intentional contamination at vulnerable points and determining the types of science-based mitigation strategies that are necessary to protect against these acts.

  • FDA must conduct a study of the safe transportation of food for consumption, including transportation by air, that includes an examination of the unique needs of rural and frontier areas related to the delivery of safe food, and must issue regulations accordingly.


  • The FDA must increase the frequency of inspections on all facilities.
  • The FDA must identify high-risk facilities and allocate resources to inspect them according to their known safety risks.
  • High-risk domestic facilities must receive an initial inspection within five years of Jan. 2010 and no less than every three years after that. The FDA may work with other agencies in conducting the inspections.
  • During the next year, the FDA must inspect at least 600 foreign food facilities and double the number of those inspections every year for the next five years.
  • The FDA must work with the Department of Homeland Security to allocate resources for inspecting imported food according to the known safety risks of the food.


  • The FDA is authorized to mandate a recall of unsafe food if the food company fails to do it voluntarily. In conducting a recall, the FDA will ensure that the public is notified of the recall through press releases, alerts and public notices. It will also update its website to include a searchable database of food articles that are the subjects of a recall.
  • The FDA must improve tracking and tracing of high-risk foods and has greater flexibility in ordering administration detention, which keeps suspect food from being moved.
  • The FDA may suspend the registration of any food facility if it determines that the food has a reasonable probability of causing illness or death in humans or animals. The law requires a corrective action plan for facilities seeking to regain registration.
  • The FDA may require access to all records regarding an article of food that has a reasonable probability of causing illness or death in humans or animals. Any person (excluding farms and restaurants) that manufactures, processes, packs, distributes, receives, holds or imports the potentially dangerous food must comply with the FDA’s access request.
  • Various federal agencies, including the Environmental Protection Agency (EPA) and the Department of Health and Human Services, will work with state, local and tribal governments in preparing for, assessing, decontaminating and recovering from and agricultural or food emergency. The FDA will also provide training and education programs for state, local, territorial and tribal food safety officials.


  • The FSMA requires importers to perform risk-based foreign supplier verification activities to verify that the imported food is produced in accordance with food safety requirements and is not contaminated or misbranded.
  • The FDA must establish the Voluntary Qualified Importer Program to provide for the expedited review and importation of food by participating importers. Eligibility in the program is limited to certified importers and will be based on factors like the risks of the food to be imported and the importers safety practices and compliance history.
  • The FDA must also implement a strategy to better identify smuggled food and prevent its entry into the United States. If it identifies smuggled food that is unsafe, it must notify the Department of Homeland Security and warn consumers and vendors of the potential threat.


The FDA plans to issue regulations implementing many provisions of the FSMA, along with guidance documents and small business compliance guides. The Horton Group, Inc.  will continue to monitor developments related to the new law.

For additional information in the meantime, visit the FDA’s Consumer Updates website:
For a copy of the Final Rule, see

Material posted on this website is for informational purposes only and does not constitute a legal opinion or medical advice. Contact your legal representative or medical professional for information specific to your legal or medical needs.

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