Food Safety Modernization Act: Putting the Focus on Prevention

Posted by Margaret A. Hamburg, M.D. on January 03, 2011 at 04:53 PM EDT

Cross posted from

Even before the President signs the Food Safety Modernization Act (FSMA), the passage of this legislation set in motion sweeping improvements to the security and safety of our nation’s food supply.

Each year, foodborne illness strikes 48 million Americans, hospitalizing a hundred thousand and killing thousands.  I thank the President and members of Congress for recognizing that the burden that foodborne illness places on the American people is too great, and for taking this action.

The historic legislation the President will sign tomorrow directs the Food and Drug Administration, working with a wide range of public and private partners, to build a new system of food safety oversight – one focused on applying, more comprehensively than ever, the best available science and good common sense to prevent the problems that can make people sick.

The idea of prevention is not new.  FDA has established prevention-oriented standards and rules for seafood, juice, and eggs, as has the U.S. Department of Agriculture for meat and poultry, and many in the food industry have pioneered “best practices” for prevention. What’s new is the recognition that, for all the strengths of the American food system, a breakdown at any point on the farm-to-table spectrum can cause catastrophic harm to the health of consumers and great disruption and economic loss to the food industry.

So, we need to look at the food system as a whole, be clear about the food safety responsibility of all of its participants, and strengthen accountability for prevention throughout the entire food system – domestically and internationally.  The new law meets these needs in numerous ways.

For example, processors of all types of food will now be required to evaluate the hazards in their operations, implement and monitor effective measures to prevent contamination, and have a plan in place to take any corrective actions that are necessary.  Also, FDA will have much more effective enforcement tools for ensuring those plans are adequate and properly implemented, including mandatory recall authority when needed to swiftly remove contaminated food from the market.

We will, in accordance with the law, establish science-based standards for the safe production and harvesting of fruits and vegetables to minimize the risk of serious illnesses or death, and we will set standards for the safe transportation of food.

Moreover, with the signing of the law, FDA will for the first time have a congressional mandate for risk-based inspection of food processing facilities.   For example, all high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter.

The legislation significantly enhances FDA’s ability to oversee the millions of food products coming into the United States from other countries each year.

Among the improvements is the requirement that importers verify the safety of food from their suppliers and the authority for the FDA to block foods from facilities or countries that refuse our inspection.  FDA will also be working more closely with foreign governments and increasing its inspection of foreign food facilities.  FDA’s new import tool kit will have a huge impact on food safety given that an estimated 15 percent of the U.S. food supply is imported, including 60 percent of fresh fruits and vegetables and 80 percent of seafood.

Very importantly, the FSMA calls for the strengthening of existing collaboration among all food safety agencies whether they are Federal, state, local, territorial, tribal, or foreign. Among other provisions, the legislation directs the Secretary of Health and Human Services to improve training of state, local, territorial and tribal food safety officials and authorizes grants for training, conducting inspections, building capacity of labs and food safety programs, and other food safety activities.  Building and leveraging the capacity of these food safety partners is how we can have a well-integrated, national food safety system that is as effective and efficient as it can be.

Now, the task falls to the FDA to carry out the direction we’ve been given.  We are hard at work planning how we will put this law into effect.  As we look to make the improvements called for in the legislation, we must ask ourselves many questions.  What resources do we already have?  What resources will we need?  Where will those resources come from?  Already we know that the legislation did not include sufficient fee resources to cover the costs of the new requirements. In that, we will look to Congress to work with us to ensure that FDA has what’s needed to achieve our shared food safety and food defense goals.

This law represents a sea change for food safety in America, bringing a new focus on prevention, and I expect that in the coming years it will have a dramatic and positive effect on the safety of the food supply.

Margaret A. Hamburg, M.D. is the Commissioner of Food and Drugs