Food Safety Modernization Act

In March 2009, President Obama established the Food Safety Working Group to advise him on how to upgrade US food safety laws, foster coordinating of government-regulated food safety efforts, and ensure the enforcement of laws to keep people safe from foodborne illness.  The group subsequently recommended prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery.

            Less than two years later, President Obama signed into law the Food Safety Modernization Act.  According to the FDA, this law “aims to ensure the US food supply is safe by shifting the focus of federal regulators from responding to preventing contamination.  Foodborne illness is largely preventable, especially when, each year, 1 in 6 Americans get sick and 3,000 die from foodborne diseases.  Focusing on prevention, the FDA will be able to make substantial steps towards food safety.  For the first time, the FDA has a legislative mandate to require comprehensive, preventive-based controls across the food supply chain.  Additionally, this law will give the FDA greater oversight of the millions of imported food products each year.

Main Themes of the Legislation

• Prevention

            Priorities – Mandatory Preventive Controls for Food Facilities, Mandatory Produce Safety Standards, and Authority to Prevent Intentional Contamination

• Inspections, Compliance

            Priorities – Mandated Inspection Frequency, Records Access, and Testing by Accredited Laboratories

• Response

            Priorities – Mandatory Recall, Expanded Administrative Detention, Suspension of Registration, Enhanced Product Tracing Abilities, and Additional Recordkeeping for High Risk Foods

• Import Safety

            Priorities – Importer Accountability, Third Party Certification, Certification for High Risk Foods, Voluntary Qualified Importer Program, and Authority to Deny Entry

• Enhanced Partnerships

            Priorities – State and Local Capacity Building, Foreign Capacity Building, and Reliance on Inspections by Other Agencies

Under this Act, registered food and feed companies must evaluate known safety hazards that could occur as their products are made, processed, packed, transported and stored (i.e. cross-contamination, pest infestation and dirty equipment).  Considering the preventive-controls requirement to be extremely important, the FDA is now asking the public for comments that will inform the development of guidance on the following: (1) Hazard identification (biological, chemical, radiological, and physical) and (2) control measures associated with specific types of food or specific methods of manufacturing, processing, packing, or holding food. In particular, the FDA is interested in preventive controls practices that are practical for small and very small businesses to implement.

Ø  Conducting a hazard analysis

Ø  Validating allergen and food/feed safety controls

Ø  Implementing process, sanitation and supplier controls

Ø  Environmental monitoring for Salmonella and for Listeria monocytogenes

Ø  Microbiological and other testing used to help ensure safety

Ø  Preventive control approaches and practices

Ø  Specific biological, chemical, radiological, and physical hazards and controls for food types such as spices, nuts, ready-to-eat food, bakery products, fresh-cut produce, milk products, and medical food.

 You can submit your comments online here or write to:

            The Division of Dockets Management (HFA-305)

            Food and Drug Administration

            5630 Fishers Lane, Rm. 1061

            Rockville, MD 20852

To read more on the Food Safety Modernization Act, head on over to http://www.fda.gov/Food/FoodSafety/FSMA/default.htm

For a full text of the law, please click here.