On December 21st, the House passed the Senate-passed FDA Food Safety Modernization Act (HR 2751) by a vote of 215 to 144. President Obama signed the legislation into law on January 4, 2011.

Each year, 76 million Americans are sickened from consuming contaminated food, more than 300,000 people are hospitalized, and 5,000 of these people die.  In just the last few years, there has been a string of food-borne illness outbreaks in foods consumed by millions of Americans each day – from contaminated spinach to peanut butter to cookie dough.      

This landmark bill is a sweeping overhaul of the nation’s food safety system – fundamentally changing the way we protect the safety of our food supply.  The bill puts a new focus on preventing contamination before it occurs – a departure from the current system that is more focused on responding after a food-borne illness outbreak.  Specifically, the measure requires food producers to come up with strategies to prevent contamination and then continually test to make sure these strategies are working.

The bill requires importers of foreign food to verify that products grown and processed overseas meet U.S. safety standards.  Public health experts say that this is urgently needed, given the increase in imported foods.  The FDA has been inspecting only about 1 percent of imported food products.

The bill has numerous other key provisions, including greatly increasing the number of inspections of food processing plants that the FDA must conduct, with an emphasis on the foods that are considered most high risk, and giving FDA the authority to recall food (currently, it must rely on food companies to voluntarily pull products off the shelves.)

The bill reduces the burden on small farms and food manufacturers that sell no more than $500,000 a year by exempting them from certain requirements in the bill.  However, the bill also includes a “one-strike” provision that provides that FDA can revoke such exemption if the small farm or manufacturer has food safety violations.

This bipartisan, landmark bill is supported by a very broad range of organizations, including the Consumer Federation of America, American Public Health Association, Trust for America’s Health, Center for Science in the Public Interest, The Pew Charitable Trusts, U.S. Chamber of Commerce, NAM and the Grocery Manufacturers Association. 

Key Provisions:

Improves Our Capacity to Prevent Food Safety Problems
The bill puts a new focus on preventing food contamination before it occurs – putting new responsibilities on food producers and requiring them to develop a food safety plan and ensure the plan is working.

• Hazard analysis and preventive controls.   Facilities must identify, evaluate, and address hazards and prevent adulteration via a food safety plan.  Gives FDA access to these plans and relevant documentation. 
• Access to facility records. Expands FDA access to a registered facility’s records in a food emergency.  
• Third party testing.  Provides for laboratory accreditation bodies to ensure U.S. food testing labs meet high quality standards and, in certain circumstances, requires food testing performed by these labs to be reported to the FDA.  Allows FDA to enable qualified third parties to certify that foreign food facilities comply with U.S. food safety standards.Imports.  Requires importers to verify the safety of foreign suppliers and imported food.  Allows FDA to require certification for high-risk foods, and to deny entry to a food that lacks certification or that is from a foreign facility that has refused U.S. inspectors.

Improves Our Capacity to Detect and Respond to Food-Borne Illness Outbreaks
The bill is also designed to accelerate our capacity to detect and respond to food-borne illness outbreaks.

• Inspection.  Increases the number of FDA inspections at all food facilities.
• Surveillance.  Enhances food-borne illness surveillance systems to improve the collection, analysis, reporting, and usefulness of data on food-borne illness.
• Traceability.  Enhances the tracking and tracing of high-risk foods and directs FDA to establish a pilot project to test and evaluate new methods for rapidly and effectively tracking and tracing food in the event of a food-borne illness outbreak.
• Mandatory Recall.  Allows FDA to initiate a mandatory recall of a food product when a company fails to voluntarily recall the contaminated product upon FDA’s request.
• Suspension of Registration.  Allows FDA to suspend a food facility’s registration if there is a reasonable probability that food from the facility will cause serious adverse health consequences or death.

Other Provisions

• Enhances U.S. food defense capabilities.  Directs FDA to help food companies protect their products from intentional contamination, and calls for a national strategy to protect our food supply from terrorist threats and rapidly respond to food emergencies.
• Increases FDA resources.  Authorizes increased funding for FDA’s food safety activities, such as hiring personnel, and includes targeted non-compliance fees for domestic and foreign facilities.
• Provides regulatory flexibility.  Modernizes our food safety system without being burdensome.  Provides training for facilities to comply with the new safety requirements and includes special accommodations for small businesses and farms.  Exempts small businesses from certain aspects of the produce standards and preventive control requirements.