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Lester M. Crawford, Jr., D.V.M., Ph.D. - Grocery Manufacturers of America

This text contains Dr. Crawford's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery.

Grocery Manufacturers of America
Remarks by
Lester M. Crawford, Jr., D.V.M., Ph.D.

Deputy Commissioner
U.S. Food and Drug Administration,
June 9, 2002

It's a pleasure to be here, seeing old friends and acquaintances and talking shop -- which means food safety. For most of us in this room, food safety has been the topic A for many years. In my case, I've been thinking, writing, talking, and trying to improve food safety as a scientist, an academician and an official in two food-regulatory agencies of our federal government, altogether for more than three decades.

As it happens -- in no small part, due to the tragic events of last September -- food safety is at the top of our national agenda, and I am once again an official of the United States government.

This time, my responsibilities at the Food and Drug Administration include the safety and effectiveness of all human and animal drugs, vaccines, blood products, tissues for transplantation, and medical devices, as well as the safety of animal feed, products that emit radiation, and cosmetics. But since September 11, the FDA's -- and my own -- biggest and most critical concern has been to ensure the safety and security of 80 percent of our national food supply, which means virtually everything we eat except for meat, poultry and some egg products.

And so the question that I've been asked by your organizers to address -- how can we keep our food safe now, and in the future -- is not only a subject on which I've focused throughout my professional life, but also a theme that has been and is being probed in depth by some of the best food scientists and security specialists in our agency and other parts of the federal government.

As a result, I can tell you that the answer to continued improvement of the safety and security of the American food supply is two-fold: we have to make much greater use of risk assessment; and we must put in place a strong counter-terrorism program. We're hard at work making both approaches a reality.

I'll start with risk assessment. For all of us, this is a familiar concept. In essence, risk assessment is a sophisticated approach to evaluating a hazard and the likelihood that it will cause harm. It is a technique that examines a wealth of scientific data to answer three basic questions: (1) What can go wrong? (2) How likely is it to happen? and (3) What will be the consequences if the harmful event takes place?

All of us know that risk assessment is a tool that works in many ways. It is helpful in designing Boeing's airliners as well as in decision-making about an investment in a manufacturing plant abroad. In the food area, many of us are familiar with the simplified form of risk assessment on which is based HACCP -- the Hazard Analysis and Critical Control Point system -- that helps ensure the safety of seafood, juices, meat, and poultry.

But although our agency has been assessing the risks of drugs and food additives for several decades, a full-scale scientific evaluation of microbiological hazards -- to be used as the basis for managing and communicating the risks of pathogens in food -- is a recent development. In the last 3-4 years, the four-step process of risk assessment -- hazard identification, exposure assessment, dose-response assessment and risk characterization -- has been been completed by FDA in only three cases.

Two of them focused on hazards from foodborne bacteria -- Listeria monocytogenes in ready-to-eat foods and Vibrio parahaemolyticus in raw molluscan shellfish -- and one on the risk of antimicrobial resistance due to the use of fluoroquinolones in poultry. All three projects have been productive. The draft assessment of the risks of listeriosis from eating certain ready-to-eat foods has been particularly helpful in guiding FDA's disease-prevention measures. It has been the basis of two consumer advisories and of a joint FDA-USDA plan that calls for aggressive short-term and long-term actions in eight areas.

The risk assessment of the use of fluoroquinolones in poultry has been also very useful. It has helped determine the human health impact of fluoroquinolone resistant Campylobacter infections associated with the consumption of chicken, and contributed to FDA's decision to propose to ban the use of the drugs in poultry.

And the draft assessment of public health risks linked with the consumption of raw oysters containing Vibrio parahaemolyticus has evaluated the factors that affect the prevalence of this pathogen in oysters before and after harvesting, and estimated the impact of various preventive and intervention measures.

These risk assessments have not been isolated scientific inquiries. They are part of a broad food safety agenda that in the last ten years has combined the efforts of FDA, the Centers for Disease Control and Prevention, the U.S. Department of Agriculture, and other federal and state agencies in creating new surveillance systems, improving prevention programs, and accelerating the response to outbreaks of foodborne illness. And these innovations have been effective: a month ago, the CDC issued a report showing a 23 percent overall drop in bacterial foodborne illness since 1996. Illness caused by the four common pathogens -- Salmonella, Listeria, Campylobacter, and E.coli 0157:H7 -- has declined by 21 percent.

But despite this progress, we still have to contend with many factors affecting food safety. Our skyrocketing food imports reached 4.6 million shipments last year; Americans increasingly rely on commercially prepared food rather than home-cooked meals; nearly a quarter of our population -- including those over 65, pregnant women, children, and the immunocompromised -- is at higher risk for foodborne illness; and we know of five times as many food pathogens as we did in the 1940s.

Worst of all, as we learned last September, there are people who are willing to do the ultimate to do us harm -- and our food could be one of their targets. So we have to do more -- and that brings me to the other half of our two-part assurance of continued food safety, which is an effective, adequately funded counter-terrorism program.

Together with the Department of Health and Human Services and with many other agencies, since September 11, FDA has placed measures to counter terrorism at the top of its agenda. Our greatest concern has been the safety and security of imported food, which accounts for more than half of all produce and seafood consumed in our country. Thanks to a special appropriation that FDA received after the September attacks, we are now in the process of hiring 655 new employees for our field operations, 600 of whom will reinforce our food safety program.

At least two-thirds of this total will be primarily assigned to monitor food imports. This will substantially increase FDA's presence in the U.S. ports of entry. We estimate that by the end of this year we will be able to conduct 24,000 import inspections, nearly double the total in the past. We should be able to double this number again when we have all of the new people on board and they are fully trained.

In addition to the increasing surveillance of imports, we have produced two food security guidances -- one for domestic producers, and one for importers -- that are based on a six-step process that's been long used to improve safety and reduce losses in aircraft, space vehicles, and nuclear power plants. These documents -- which I commend to your attention -- describe the preventive measures that food establishments can take to reduce the risk that their products will be intentionally contaminated.

We have been also gathering information about our food assets, their viability as potential carriers of contaminants, and -- to such extent as it is feasible -- about the capability and intent of potential aggressors to attack our food supply. And last fall, we initiated an internal and external risk assessment of various categories of food in order to examine their relative vulnerability to intentional contamination during the various stages of food production and distribution.

The focus is on the severity of the public health and economic impact if various contaminants were introduced into our food, and the likelihood that such event would take place. The involved risks are measured in the light of several dozen considerations, including the relative security of the production facility, the effect of heat or other treatment on the contaminant, the batch size, and the typical consumption of the food.

For obvious reasons, the full results of this risk assessment are classified, but we are looking for acceptable ways of releasing some portions of it that could help the industry develop its own control strategies.

Finally and most recently, Congress has passed -- and the President, we believe, is about to sign -- a bioterrorism bill that substantially strengthens FDA's power to protect consumers against foods that do not meet the U.S. standards of safety. This is a seminal law that breaks more new ground than I have time to cover, but I'll outline a few of its significant provisions in the food area, to give you a sense of the coming changes in the regulatory environment.

In the first place, the new law requires registration of domestic and foreign food facilities that sell products in the U.S., including those dealing with animal feed and dietary supplements. The law defines "facility" as any factory, warehouse, or establishment that manufactures, processes, packs or holds food destined for the U.S. market.

Next, the act authorizes FDA to have access to records relating to such activities as the manufacture, distribution, holding or importation of food if there are grounds for belief that the products have been adulterated and present a serious risk to the health of humans or animals.

As you can see, these two provisions serve a dual purpose: they will make it much easier for us to provide food firms with urgent information bearing on the security of their products, and they will enable us to track food shipments that could pose a serious health hazard to animals or the public.

The FDA's ability to keep harmful food off the market is further reinforced by a section that authorizes our investigators and other designated qualified employees to order immediate detention of food that presents a serious threat to health. We no longer have to pursue such action in court, and have up to 30 days to seek product seizure or injunction.

Another important provision calls for a thorough documentation of the origin and nature of foods and other regulated products that firms desire to import for processing and export. The additional information and certification will improve our ability to prevent the importation of suspect products, or prevent their release in the U.S. market.

Finally, the bioterrorism law will give us a better control over food offered for import by requiring prior notice of imported food shipments, and the marking of food that has been refused for entry. These two provisions should relegate port shopping in the U.S. to history. Incidentally, most of the new powers require rule-making within 18 months. That's a formidable workload, but I am confident that with the help of our stakeholders, we'll meet the deadline.

Now, I have focused a great deal on food security, because it is our Job One. But that does not mean that we are neglecting other hazards that may affect the safety of our food. Let me give you a few examples of other public health issues that are high on our food agenda.

One of them is the growing antimicrobial resistance of certain human pathogens. This phenomenon is caused by many factors, including the misuse and overuse of antibiotics in both humans and animals. Unless we succeed in containing it, antimicrobial resistance will endanger the lives of many patients, especially those with weakened immunity or chronic conditions that require antibiotic treatment.

At FDA, we're addressing this hazard with several measures, including proposed changes in the data on which we base marketing approvals for drugs to be used in livestock and poultry. We are also developing a general guidance on microbiological safety, and are preparing to propose a rule that will enable us to acquire more data on the use of antimicrobials in animals. And we're conducting a risk assessment. I have already mentioned the completed assessment of the risk of the use of fluoroquinolones in poultry.

In addition, we are investigating the potential antimicrobial consequences of the use of virginiamycin in food-producing animals. What concerns us is whether animal uses of virginiamycin promote resistance to Synercid, a drug for the treatment of patients with certain serious bacterial infections.

Another threat to our public health and economy that we're watching very closely is the possible emergence in our country of BSE -- bovine spongiform encephalitis, or the "mad cow disease." BSE is one of the most dangerous new diseases to appear in the last 50 years. It has devastated livestock in the United Kingdom, and it is regarded as the cause of variant Creutzfeld-Jakob Disease, an incurable human illness that has claimed more than 100 victims in Europe.

But although one of the more recently diagnosed European victims lives now in Florida, there is no evidence of BSE or of variant CJD in the United States. This is at least in part thanks to an FDA rule prohibiting the use of most mammalian tissues -- which are the apparent carrier of the disease -- in feed for cattle and other ruminants. We're continually strengthening our enforcement of this feed rule by inspecting thousands of renderers and feed mills, and we will be soon publishing a new proposed rule based on the seminal risk assessment by the Harvard Center for Risk Analysis that was published late last year.

The Harvard BSE risk assessment has singled out FDA's feed restrictions as a particularly effective barrier against the spread of the disease in the U.S., and our proposal will make the feed rule still more effective.

I have time for just one more food safety issue, and that's food allergy. It affects about 7 million Americans, including up to 6 percent of children less than three years old. Moreover, it's a growing hazard. Epidemiologists are telling us that food allergies are skyrocketing in all developed and developing countries. We are therefore concerned about the results of an inspection of certain food plants the FDA carried out two years ago, and which found that a quarter of the inspected products tested positive for peanut allergen, although that ingredient was not listed on the product labels.

This presents a danger we cannot ignore. Our strategy has been to heighten consumer and industry awareness of the hazard presented for some individuals by the eight most common food allergens: milk, eggs, fish, wheat, tree nuts, peanuts, soybeans, and crustaceans, such as shrimp and crabs. And in these efforts, as you know, we've received valuable and much appreciated help from your industry.

With your assistance, we've trained our own and state regulators in inspecting food plants for allergen control procedures; and we've published a guidance that encourages manufacturers to identify potential allergens even within collectively named ingredients, such as flavors and spices. We're also concentrating on long-term solutions, such as encouraging the development of test kits that would reliably detect allergenic protein in food. We will evaluate industry practices to prevent cross-contact between their products with and without allergens; and we will seek improvement in allergen labeling. Confronting food allergies is a critical part of our food safety agenda.

I am running out of time, but I hope that my remarks have given you an idea of the course that the FDA is taking to safeguard our food supply against whatever challenges we may encounter. It's a course that combines judicial use of our recently augmented powers, and our substantially increased resources, to counter risks identified with the help of the most advanced and most reliable scientific analysis -- a process that combines accurate data and intellectual rigor to cast light and understanding on all public health issues, including food security and safety.

Essentially, we're on a course that's as old as the FDA -- and yet a course that's ever new, made more perfect and relevant by advances in science, and offering the most revealing and dependable answers to the most difficult regulatory questions. It's a course that serves best our public, industry and the economy becuse it enhances FDA's effectiveness, objectivity, and success in performing its public health mission. It's a course to which we're committed, and we'll continue to follow.