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U.S. Department of Health and Human Services

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

Remarks by:
Jane E. Henney, M.D.





JULY 12, 1999

Good morning. This is a very exciting time for the Food and Drug Administration. Modern science and technology are providing new breakthrough products every day. These new developments present opportunities and challenges that must be continually met with the greatest scientific expertise, cutting edge knowledge--and an open mind. Since my return to the Agency as Commissioner last fall, I have spent a great deal of time considering the areas where the Agency should devote the most time, energy, and resources. During this examination, one area needing focus clearly emerged-- the enhancement and revitalization of the Agency's science base.

The reasoning behind this is somewhat simple-we are a science-based regulatory Agency. Therefore, we cannot afford not to have the best science underpinning all of our decisions. I know that often when I mention this issue, a "scientist" in a lab coat doing bench research comes to mind. However, my vision of where the Agency should be headed goes far beyond that. From the researcher in our food labs, to the reviewer in our drug divisions, the inspectors out in the field, or any employee articulating a new policy-all decisions should be based on the most recent scientific developments and knowledge. A certain confidence comes from knowing that the correct decision has been made, because it was grounded in scientific data.

One of the most obvious areas where we must have the most up-to-date information and rigorously apply our scientific skill is in the area of product reviews. High-tech industries are expanding at an exponential rate. Billions of dollars are being poured into research and development for new products-biotechnology, food additives, pharmaceuticals, and devices-to name a few, and we cannot afford to constrain or slow the process to get safe and effective new products to patients and consumers. The Food and Drug Administration reviews and makes judgements regarding new products that are the result of cutting-edge science. We must have the capability to keep up with these scientific developments because the judgments they render depend upon it.

A concrete example of where enhancement of the science base will provide tangible results is in the Agency's food safety program. Currently, we are working together with our partners in the President's Food Safety Initiative-within the Federal government, the Centers for Disease Control, the Department of Agriculture, and the Environmental Protection Agency. Together, we are enhancing the science that underpins all our food safety activities by pursuing research and development in new food pathogen detection techniques. We are working diligently to enhance our surveillance capabilities, which helps us stop foodborne disease outbreaks before they become widespread, and helps us develop the knowledge to prevent future outbreaks. We are doing increasingly more of this work in collaboration with our State and local partners as well. We are continuing to work with the food and agricultural community to develop guidelines, such as the good agricultural practices for fresh produce, that will do even more to prevent problems and to ensure an ever-safer food supply.

Specifically, in the past year, we have made tremendous strides in enhancing surveillance of foodborne disease, building an early warning system, enhancing responses to foodborne outbreaks, and improving risk assessment. These efforts have had a real impact on the development of preventive control and containment systems, and new technologies to stop microbial contamination.

Let me give you a "real world" example-in conjunction with the Centers for Disease Control, we have developed PulseNet, a computerized database of bacterial DNA subtypes. Through the use of PulseNet, two seemingly independent E.coli outbreaks in Michigan were traced back to a common source-alfalfa sprouts. Similarly, in another instance, PulseNet helped confirm that about 50 cases of E.coli in Wisconsin were attributable to cheese curds from a single facility, even after initial investigations did not reveal the source of the contamination. Through the use of science and technology, some of our traditional surveillance tools are being enhanced, to the ultimate benefit of the public health.

Within the past year, we have also awarded new research and risk assessment grants, and established new procedures to better plan and coordinate research among Federal partners. The necessity of scientific progress is clear as new pathogens in food and animal feed will continue to be identified, and new methods for control of pathogens will need to be developed. New research grant projects in the food safety area included studies on: methods to prevent E.coli, Salmonella, and Listeria contamination of fruits and vegetables; antimicrobial treatments for sprouts and sprout seeds; dose-response models for foodborne Cryptosporidium parvuum, Listeria, and Vibrio; the pathogen-related DNA structure of E.coli, and how consumer food preparation practices can be enhanced to reduce the risk of foodborne illness.

We have also funded seven cooperative agreements totaling $1 million with outside research organizations to study the microbiological hazards associated with the food animal production environment, which includes animal feeds. The projects include studies of on-farm risk factors for zoonotic enteropathogens associated with cattle feed and water, waterborne dissemination of E.coli, Salmonella virulence and antibiotic resistance in cattle and feed, factors affecting numbers of acid-resistant E.coli in cattle, a survey of antimicrobial resistant Enterococci in animals, control of EHEC in cattle by probiotic bacteria, and evaluation and use of rapid methods for on-farm survey.

I would like to take a moment and thank Dr. Ken Olden and the NIEHS for their assistance and support of studies that we are doing at our National Center for Toxicological Research (NCTR) on numerous chemicals of specific interest to the FDA, including: human and veterinary drugs, food contaminants, and food components. These research and testing efforts demonstrate the success that can be achieved when government agencies work together and seek help from our colleagues in academia and industry. Let me give you a couple of examples of the work being accomplished at NCTR through this interagency agreement between the NIEHS and the FDA. The Center for Food Safety and Applied Nutrition nominated fumonisin B1 for carcinogenesis testing by the NTP. As you know, fumonisins are mycotoxins produced by the fungus Fusarium moniliforme, one of the major species found in corn and corn products. By bringing experts together from NIEHS, USDA, Health Canada, industry and universities, studies were designed to not only evaluate the carcinogenicity of fumonisin B1, but also to provide data on the mode of action of toxicity and carcinogenicity to facilitate the process of risk assessment.

The cancer bioassays, conducted at NCTR, showed clear evidence of carcinogenic activity in rats and mice. These results, along with data from other studies and other laboratories within and outside of the FDA, will now form the basis for setting standards for exposure based on risk assessments. These studies are an excellent example of FDA scientists working with experts from several different sectors-including those in other countries-to protect the health of the public.

Other studies being done under this agreement between NIEHS and FDA include evaluations of the carcinogenicity of chloral hydrate, primarily because of its use as a sedative in children; malachite green, because of its use as an anti-fungal agent in the aquaculture industry; and the combination of ethanol and urethane, because of the presence of small amounts of urethane in alcoholic beverages. Several compounds with hormonal properties, including genistein and ethinyl estradiol, are being evaluated for adverse reproductive effects and other toxicities over multiple generations as part of a larger study of endocrine disruptors.

There are numerous other research projects on food safety questions in progress throughout the FDA centers. For example, the use of antimicribial agents in parts of the food-animal industry has raised considerable concern about the potential emergence and spread of fluroquinolone resistance among Salmonella and Campylobacter strains, which has potentially serious consequences relative to food safety, as well as the treatment of human and veterinary health disorders. To address this issue, scientists from NCTR and the Center for Veterinary Medicine are developing new methods for routine surveillance of flouroquinoline resistant Salmonella and Campylobacter strains in the poultry industry. These FDA scientists, together with colleagues from USDA, have started to monitor poultry farms in the state of Arkansas for the development of antibiotic resistance.

In the context of our fight against foodborne pathogens, microbiologists and others are working diligently to develop better methods to detect pathogens in foods. NCTR scientists have developed a rapid screen for a dozen foodborne pathogens simultaneously, including Salmonella, Shigella., and E.coli 0157H7. NCTR scientists have also developed new protein-based mass spectral techniques to investigate properties of bacteria such as antibiotic resistance and acid or heat resistance. Some FDA research leads to the development of important commercial products-NCTR scientists have developed and are collaborating with a private company to produce a chemical "freshness indicator" (FRESH TAG), based on a food dye that changes color as a fish product becomes stale or rancid. Consumers will be able to look for the color change when buying or preparing the product for consumption. Insertion of these indicators in fish products at the point of origin will help FDA inspectors rapidly identify fish products with declining freshness.

By using these types of agreements and collaborations with scientists outside of the FDA, we are effectively leveraging the resources and expertise of other outside entities. This allows us not only to enable our limited resources to go further, but also to harness a greater breadth of experience within the scientific community. By working in cooperation with those outside the Agency, we are able to attain a wide range of perspectives, while still being able to have all of our decisions grounded in good science.

One last area that I would like to touch upon involves how we lure the top scientists in the country to our Agency-- and keep them with us. It is critical that we invest wisely in those that we recruit and retain for these tasks that are so fundamental to effective protection of the public health. Since I have come back to the Agency, I have been constantly searching for new opportunities for our scientific staff. This includes measures such as ensuring that more training opportunities, research grants, cooperative agreements, and fellowships are made available to our employees.

Training and retraining of our scientists to have state-of-the-art knowledge of new scientific developments and new product technology is essential for us to remain a credible, science-based agency. Through use of our own facilities, such as NCTR, and by reaching out to institutions outside the FDA, such as yours, our regulatory scientists should go on sabbaticals where they spend time shoulder-to-shoulder with laboratory scientists. The enhancement of the science base at the Agency depends upon our ability to keep up with knowledge that is state-of-the-art-including areas of new product technology and new science.

Since I have come back to the Agency, I have spent some time traveling around the country, giving speeches and attending meetings. However, as I travel, I also have a couple of thinly-veiled ulterior motives. First, as I go to academic or industrial sectors, I want to remind scientists that there are extremely rewarding careers available in government agencies such as ours. At the same time, I have been trying to seek out opportunities for our scientists to do sabbaticals in research and technology in other settings, such as with industry, academia and other governmental agencies. By having these sort of educational opportunities open to our scientists, we ultimately enable them to bring back to the Agency deeper knowledge that translates into better and more efficient performance of regulatory tasks.

By enhancing our scientific infrastructure in the many ways that I have mentioned, we are truly bringing the Agency into the twenty-first century. I look forward to the exciting future of this Agency, and the role that science and technology will play in it. Thank you very much.