Animal Health Institute Annual Meeting

Remarks by

Lester M. Crawford, Jr., D.V.M., Ph.D.
Deputy Commissioner
U.S. Food and Drug Administration,

April 21, 2002

I want to start with two compliments. I want to congratulate Congressman Kasich on his moving and inspiring message. The great success of our society -- and let us not be timid about it, the United States is a highly successful society -- has been driven by a myriad of acts of the kind he described: acts of individual excellence, and courage, and tolerance, and good will. There is no doubt in my mind that these qualities will prevail, whatever our challenges.

And I must compliment the organizers of this conference on choosing the theme "Managing in Uncertain Times." Certainty, of course, is a goal that's never been achieved in human affairs, and in that sense we've always been managing -- setting priorities and bringing order out of disorder -- in uncertain times. None of us, however, has ever experienced a situation with uncertainties as palpable and potentially far-reaching as those we've been faced with since last September 11.

This is very much the case with the Food and Drug Administration, an agency that is responsible for the protection of public health -- and public health, inevitably, is a potential target of those who do not wish us well. It might therefore surprise you when I say that at the FDA, uncertainty about our major objectives -- and how to achieve them -- is not as much of a problem as it may seem to be. On the contrary: the attacks last September have made some of our most important managerial decisions easier than they had been in the past.

The reason for this seeming paradox is that even while raising many questions and dilemmas, September 11 also ushered in certain priorities that are beyond dispute. In the case of our agency, the FDA is responsible for the safety, or the safety and effectiveness, of a trillion dollars' worth of regulated products that include human and animal drugs, vaccines, the blood supply, medical devices, animal feed and cosmetics.

Many of these products are essential for our life and good health. But there is no consumer product that's as prodigiously and universally used, as vital for survival, and as potentially vulnerable to terrorist interference as our food supply -- 80 percent of which (practically all but meat and poultry) is in FDA's purview.

At the FDA, it's therefore been obvious since September 11 that our foremost duty is to ensure the safety and security of our food supply. Now, food safety has been a special FDA priority already since the early 1990s --when, as many of you will remember, there was a significant upsurge in the occurrence of foodborne disease. One important reason for that was an escalation of imports of fresh produce and other perishable foreign foods. These shipments frequently were underway for many days without adequate refrigeration, and their numbers were skyrocketing -- they've gone up from less than one million in 1985 to 4.5 million last year.

In addition, our consumers were increasingly eating out, which means that their food was handled by many more hands than it would be at home; there was an emergence of new foodborne pathogens; and we had an aging population and many people with compromised immune systems, all of whom are especially susceptible to foodborne disease.

In the 1990s FDA, together with other federal, state and local health authorities countered this growing public health problem by creating a nationwide protective network that included new surveillance systems; better outbreak prevention programs; coordinated research and risk assessment; a food safety campaign; and other measures designed to accelerate the response to foodborne outbreaks.

Incidentally, the effectiveness of this system was confirmed last week by two reports of the Centers for Disease Control and Prevention. One of them is highly positive: it shows 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. The CDC report attributes this significant progress in part to our programs to prevent foodborne illness.

The second report, which also indicates that the food safety-associated surveillance system works, and works well, is much more somber: we have the first reported case of the variant Creutzfeld-Jakob Disease in the United States. The disease, which is apparently caused by the consumption of meat from animals with BSE -- bovine spongiform encephalopathy, or "mad cow disease" -- has claimed more than 100 lives in the United Kingdom, where -- as you will remember -- BSE was epidemic in the 1980s.

The Florida resident who was diagnosed with vCJD was born 23 years ago in the United Kingdom, lived there until about 5-6 years ago, and belongs to that country's highest risk category for the disease. All the indications are that her disease originated in the UK.

These surveillance systems and protections against accidental contamination were in place, and keeping our food supply the world's safest, on September 11; and since then, they have become the basis on which we're building a still more robust system to secure our food against intentional contamination by terrorists. We have devised a three-point counter-terrorism strategy consisting of anticipation, deterrence, and response.

• In order to better anticipate a potential threat, we are gathering information about our food assets and their viability as carriers of possible contaminants. In addition, we're very interested in whatever the intelligence community can tell us about the capability and intent of potential aggressors who could target our food supply.
  
  
• To strengthen our capacity for deterrence, we have developed together with industry two security guidances: one for domestic food producers, processors, transporters, and retailers; and one for importers, brokers and others involved in importing products to this country. Both guidances outline measures that these firms can take to reduce the potential risk of a terrorist attack on food under their control.

But our main deterrence comes from strengthening the FDA's capacity for vigilance, which is mainly directed at imports and involves more inspections, more laboratory analyses, and greater emphasis on compliance and enforcement of public health rules. Congress has authorized us to spend on counter-terrorism programs $151 million, $97 million of which we're using to improve the safety and security of food.

The FDA is now in the process of hiring 655 new employees for our field operations, 600 of whom will reinforce our food program. At least two-thirds of this total -- 400 new employees -- will be primarily assigned to monitor imports. They will enable us to conduct 24,000 import inspections a year, nearly double the present total, and that number will double again once the additional staff is trained and on the job.

Our plans also include the hiring of 30 specialists who will perform risk assessments and develop rapid methods for the detection of a variety of pathogens in many types of products.

• In addition, the Department of Health and Human Services has proposed a bill that would strengthen FDA's response potential by improving our ability to rapidly trace back and remove from distribution contaminated imported food. Congress is currently considering two bills including similar measures.

As could be expected, the heightened focus on security following last year's attacks has also increased concerns about other public health hazards, some of which could be vulnerable to hostile intervention. We are therefore increasing our vigilance and protective or preventive activities on several fronts:

• We're examining our measures to protect our country's livestock from BSE -- bovine spongiform encephalopathy, or "mad cow disease" -- which, as you know, destroyed 180,000 heads of cattle in the United Kingdom,and is believed to have caused in Europe more than 100 cases of an incurable human disease called variant Creutzfeldt-Jakob Disease, or vCJD.

There is no evidence of BSE in the United States, at least in part thanks to an FDA rule prohibiting the use of most mammalian tissues in feed for cattle, but this regulation is now five years old and we believe it's time to take another look at it.

We've held a public hearing to ask stakeholders what, if anything, needs to be done to make the rule still more effective. So far, we've developed an advanced notice of proposed rulemaking that should be published shortly. And while contemplating other possible actions, we will continue to do our best to enforce the mammalian tissue rule,as the livestock feed industry and many other stakeholders have urged.

• Another important food safety challenge we're confronting is the growing problem of antimicrobial resistance to our antimicrobial armamentarium, which is caused in part by certain uses of antimicrobials in livestock and poultry. We're addressing this hazard with several vigorous measures, including proposed changes in the information FDA needs to approve drugs for use in livestock and poultry.

Currently, we are developing a general guidance on microbiological safety that will present a single plan incorporating various strategies for helping assure that animal antimicrobials do not pose a hazard for humans. In addition, we are drafting a proposed rulethat would enable our Center for Veterinary Medicine to gather more information about the use of antimicrobials in animals.

• We're concerned that dioxins could be getting into the food supply through feed for food-producing animals. Over the past two years, we've collected almost a hundred samples of animal fats, animal meals, mollasses, milk products and other feed ingredients whose analysis for dioxins should be finished by this fall.

In the meantime, we're expecting the Environmental Protection Agency to issue a report in June that will suggest that food will be a significant source of human exposure to dioxin, compared to exposure through air, water, and other sources. We continue to be concerned about dioxins from all sources, and the additional sampling of foods will help us focus on the most significant sources of exposure. We have also asked the Institute of Medicine to convene a group of experts to advise us on the safety concerns related to dioxins in food and feed. So dioxins may become an FDA feed issue.

We're keeping an eye on novel technologies that may involve public health issues.

• One of them is genetic engineering in animals. Biotechnology is moving from the lab to the farm in two general directions, both of which have implications for human and animal health. One of them is bio-pharming -- spelled with a "ph" instead of an "f" -- which uses animals as a bioreactor to produce such products as tissues to be harvested and used in human medicine. The other direction is ag-biotechnology, which is focused on improving animal health or productivity by, for example, enhancing the yield of salmon with a growth hormone.

We already regulate genetically modified animals as new animal drugs, which means that they must meet the following requirements: safety to the animal, safety of any food it produces, and safety to the environment; plus effectiveness by achieving the sponsor's purpose.

• But there is another new technology -- the nuclear transfer of somatic cells --that is increasingly used to clone animals. Our veterinary experts have been gathering data from firms conducting research and producing cloned cattle, hogs, sheep, goats and chickens. We have learned about these firms' business models and about the quantities of animals likely to be produced, and we have encouraged these pioneering entrepreneurs to publish all available information about the safety of clones and their progeny when used in food production.

We've also contracted with the National Academy of Sciences/National Research Council to examine risks and risk assessment methods for animal biotech products. The report is expected to be released around Memorial Day, and we plan to give everyone a chance to comment by holding a public meeting later in the year. Depending on the risk we find through all these activities for the public health, for the environment, and for the animals themselves, we will decide on the level, if any, of FDA's regulatory involvement.

• Finally, I want to touch on an issue that's been brought home to us so dramatically by the spread of BSE in Europe. Countries can no longer develop animal health and production policiesin isolation. There are important international rules addressing animal production and public health being developed right now, and our agency is making sure that our views, our experience, and our scientific expertise are reflected in the final documents.

FDA is part of the U.S. delegation to the Animal Feed Task Force of the Codex Alimentarius Commission, which sets international food standards under the auspices of the World Health and Food and Agriculture Organizations of the United Nations. Our delegation has been very effective -- for example, we've been asked to develop a Codex Code of Practice for minimizing antimicrobial residues, and to redraft guidelines for the control of drug residues in milk and milk products.

And the entire Task Force has been effective --for example, it has established definitions for feed, including ingredients, additives, medicated feeds, and undesirable substances in feed, and it has agreed on several guidelines, including for feed labeling. But there have been disagreements on such issues as the need for labeling of genetically modified animals and derived products, which we regard as unnecessary pending a decision by a Codex committee.

I can assure you that whenever differences arise, the U.S. position is made very clear, and we vigorously seek mutually acceptable solutions.

I would like to end on a personal note. As many of you know, I am very close to the subjects we're discussing at this conference. Animal health and public health have been my professional focus and specialty as far back as I can remember. They have been never more important to me than they are now, when my daily agenda at the FDA is replete with questions that must be answered in a way that is scientifically and legally sound, principled and consistent --answered in a way that brings certainty into issues that abound in uncertainties.

This is a great challenge, professionally and personally. Providing the best public health protection for our country and the fine folks Congressman Kasich spoke about is a big job, which we all want to be managed with expertise, vision, and a steady purpose. It is a source of strength, for the FDA as well as myself, to know we can count on the support and cooperation of such important organizations as the Animal Health Institute.

Thank you.

FDAWebsite Management Staff
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