The Food Safety Modernization Act (FSMA), signed into law on Jan. 4, 2011, expands the power of the Food and Drug Administration (FDA) to oversee food safety with a focus on prevention. Each year, about 48 million people get sick, 128,000 are hospitalized and 3,000 die—all from foodborne diseases that are preventable.
The FSMA is designed to reduce those numbers by radically updating industry practices to ensure food safety and defense in an evolving global economy. Because of how vast and interconnected food supply has become, these regulations will impact a number of industries.
The FDA divides the elements of the FSMA into five key areas:
- Preventive Controls: Rather than simply reacting to problems in the food supply, the FSMA gives the FDA authority to institute proactive measures to significantly minimize or prevent problems before they occur.
- Inspection and Compliance: Both inspection and compliance are key tools for determining risks and enforcing that proper safety measures are taken. The FSMA allocates inspection and compliance resources in a risk-based manner.
- Imported Food Safety: In an increasingly globalized marketplace with rising consumer demand, food imports have risen drastically. The FSMA makes sure that imported foods meet U.S. safety standards.
- Response: The FSMA gives the FDA mandatory recall authority for the first time ever. While it anticipates the FDA needing to use this authority infrequently, it nonetheless offers the agency this tool, as well as others, to ensure a rapid response to serious problems.
- Enhanced Partnerships: Prevention and rapid response aren’t possible without close partnerships with other agencies at all levels of government. As such, the FSMA directs the FDA to improve training of state, local, territorial and tribal food safety officials.
In order to make the provisions more manageable and to give all affected parties time to prepare, the FDA staggered provisions over the course of several years. Many of these have already been implemented, but there are two important deadlines coming up.
- The Sanitary Transportation of Human and Animal Food Rule – March 31, 2016
The FSMA requires the FDA to institute transportation practices that ensure food—both for humans and animals—that is transported by motor vehicle or rail is done under conditions that will not adulterate or contaminate the food.
To serve that end, the Sanitary Transportation of Human and Animal Food Rule, which goes into effect March 31, 2016, contains the following provisions:
- Vehicles: Any vehicle and transportation equipment will have to be designed and maintained in a way that ensures the food it carries won’t become contaminated.
- Transportation Operations: Procedures and practices employed during the transportation of food—such as temperature controls and the separation of food items from non-food items—will need to ensure that it is not contaminated.
- Information Exchange: Shippers, carriers and receivers will need to follow proper procedures for the exchange of information about prior cargo, the cleaning of transportation equipment and temperature control.
- Training: Carriers will need to implement and document training for all carrier personnel in sanitary transportation practices.
- Records: Carriers and shippers will need to maintain written procedures and records related to equipment cleaning, prior cargo and temperature control.
More information on sanitary transportation, including guidance and regulatory documents, can be found through the FDA’s website here.
- The Intentional Adulteration Rule – May 31, 2016
The Intentional Adulteration Rule, which goes into effect on May 31, 2016, seeks to defend the food supply from the intentional introduction of biological, chemical and radiological hazards. To achieve that end, the Intentional Adulteration Rule requires facilities to take the following measures:
- Conduct a self-assessment of vulnerabilities, specifically those related to the following:
- Bulk liquid receiving and holding
- Liquid storage and handling
- Secondary ingredient handling
- Mixing and similar activities
- Identify actionable processes, which are points, steps or procedures in a food process that will require focused mitigation strategies
- Create and document a written food defense plan, with specific mitigation strategies designed to combat the identified actionable processes
The FDA has tools and resources related to food defense available through its website, which can be found here.
Which Industries Are Affected?
Specifics on the FDA’s regulations and implementations to FSMA can be found on the FDA’s website. Rely on the Horton Group for updates, as well as for other compliance and risk management information.
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.