Michael A. Friedman, M.D.

to

Worldwide Food Expo

National Food Processors Association

McCormick Place

Chicago, Illinois

Nov. 1, 1997

Good morning.

Thank you for the opportunity to discuss the Food and Drug Administration's role in the President’s Food Safety Initiative and some of our actions to improve the safety of the nation’s food supply. In my allocated time, I offer the briefest of overviews of this high priority activity. Then, I too will be happy to answer any questions you might have.

First, the reason for the increased emphasis on this issue: While you recognize that the American food supply is among the safest in the world, you also read the paper and watch the news. Each year, there is a handful of spectacular outbreaks of food-borne illnesses. As our oversight becomes more diligent and acute, this incidence may paradoxically appear to actually increase. Altogether, these outbreaks sicken millions of people and kill thousands and cost the food industry millions of dollars. This is a serious public health problem, especially because many of the illnesses can be prevented.

This background level of food-borne illnesses is bad enough, but public health experts are afraid things may get worse. The problem arises from several factors. A key concern is the emergence of novel pathogens. Examples include the E. coli O157:H7 strain that recently led to the recall of millions of pounds of hamburger and caused last year’s problems with apple juice. We’re also concerned because some of the new microorganisms are multi-drug resistant, such as a form of Salmonella called DT104.

What’s more, America’s demographics and dietary habits have changed. As a nation, we eat out more, reducing the control individuals have over how carefully the food is prepared. We eat more imported foods shipped in from all over the world. And lastly, an aging population is less resistant to the pathogens that spread in food, increasing the risk of serious illnesses.

Fortunately, we can do something as a nation to prevent these food-related problems. That’s why the President launched his Food Safety Initiative earlier this year. I presume most of you know the broad outlines. The essential components include improved early warning systems and surveillance, enhanced inspections, research into food-borne pathogens and techniques to prevent food contamination, risk assessment, public education and greater coordination among public health agencies at the federal, state, and local level.

In my agency alone, we have a number of new efforts underway. Just a month ago, on Oct. 2, President Clinton announced that he will ask Congress to give FDA the authority to ensure that fruits and vegetables coming from overseas are as safe as those produced in the United States. Under the proposed legislation now being developed, FDA would be required to halt imports of fruits, vegetables, and other foods produced in countries that do not meet U.S. food safety requirements. USDA already has similar authority over imported beef and poultry.

To ensure that this new import program works, the President committed to providing additional funds, in fiscal year 1999, for FDA to dramatically expand its international food inspection force.

What’s more, it looks like the agency will get an additional $24 million (roughly) in this fiscal year for its part of the President’s Food Safety Initiative, even though FDA’s final appropriations bill has yet to pass. Most of the money will be used for increased surveillance, especially through the FoodNet sites to improve coordination during an outbreak, research, new technology, risk assessment, and education.

Some of that money will also go to hiring an additional 80 seafood inspectors to help fully implement the new Seafood HACCP regulations that go into effect next month [December]. HACCP, or Hazard Analysis and Critical Control Point, as you know, is a scientifically designed program that identifies the critical steps in food preparation where contamination is most likely to occur and then puts in place preventive measures.

Early next year, we anticipate the administration will be seeking congressional authority to transfer to FDA the Seafood Inspection Division that is now part of the National Marine Fisheries Service in NOAA, the National Oceanographic and Atmospheric Administration in the Department of Commerce. Our goal is that all of their inspectors will move over to FDA as a performance based organization to continue their fee-for-service, voluntary inspection program. This consolidates seafood inspection within one agency, making it easier for the industry and giving FDA – for the first time – its own government inspection stamp or mark, like USDA has on beef. The inspections provided by this staff will be "counted" as if they were FDA inspections and will be a part of the seafood HACCP program.

In addition to HACCP for seafood, FDA is currently working on proposed HACCP regulations for fruit and vegetable juices and, with USDA, is considering farm-to-table, HACCP-like controls for eggs and egg products. FDA also is developing a regulation to put warning labels on unpasteurized juices, as well as, working on Good Agricultural and Manufacturing Practice guidelines both for fruits and vegetables produced here in the United States and for any products we import.

I know that while everyone here supports efforts to enhance food safety, some are concerned that the federal government will over-regulate the industry or that new regulations will drive up costs. I want to assure you that regulation is only a small part of the initiative, and, I would argue, the initiative will save industry money in the long run by ensuring safer products and improving consumer confidence.

And I want you to consider the price of not taking these actions. Consider the serious damage to the market for California strawberries after imported fruit spread hepatitis or the impact on apple juice sales when unpasteurized Odwalla, Inc., apple juice became contaminated with E. coli last year.

Most of the public doesn’t differentiate between lot numbers and, often, even brands. If there is a problem with a batch of strawberries or apple juice, then all strawberries and apple juice are suspect – yours and theirs – because the public can’t tell the difference.

Every food-borne outbreak can be an economic disaster costing millions of dollars to an entire industry, not just the company that produced the products associated with the outbreak. And it causes untold worry and fear among consumers and real sickness to those affected.

So yes, this administration – led by the President -- has increased the amount of attention being paid to the safety of the nation’s food supply. Collectively we need to critically examine all our practices. We need to apply efficient and effective scientific public health measures to your practices and procedures.

The enemy is the microorganisms. Speaking for FDA, I can say that we are allies in this struggle. We want you to continue to produce some of the best and safest food products in the world, and we want to help you make it even better and safer.

In the last few years, FDA learned dramatic lessons in its drug regulation activities. Under a program launched by Congress in 1992, FDA transformed the way it manages its drug review and approval program and created closer ties with industry. That allowed companies to better understand what FDA expected and allowed our reviewers to help companies identify problems early in the process. As a result, we now review drugs at record speeds, and we are as fast or faster than any other country in getting new drugs on the market.

I am not calling for user fees. But I would like to look at how this experience can be applied to foods.

Working together, finding better ways to form more effective partnerships, we can prevent food-borne disease. FDA and USDA want to promote and protect the public health; producers have the additional interest in selling their products and protecting their markets. We have a shared aim: we all want the food supply to be safe.

When we fail and there is an outbreak of some food-borne illness, everyone is harmed. It can only be prevented with good science, good sense, good practices -- a proper balance of regulatory oversight and self-imposed quality control and assurance. The challenge is immense -- the rewards even greater.

Thank you.