March 17, 1999
The Honorable Jane E. Henney, M.D. Dear Commissioner Henney: During discussions last year with my staff regarding the safety of imported food, Food and Drug Administration (FDA) staff said it would not be feasible, and even impossible, to develop "real-time" tests (results within a few hours) to identify microbial and pathogenic contaminants on food. I am interested in knowing whether FDA still holds this view in light of announcements concerning progress that private research firms have recently made in developing such tests. In fact, unlike FDA, the U.S. Department of Agriculture (USDA) is working closely with at least one company to develop a real-time test to detect potentially deadly bacteria in meat. A Denver-based biotechnology company, Molecular Innovations, recently announced that, within two years, it expects to be able to "develop tests for 12 different pathogens the government is concerned with." This company expects to have its first test on the market in about a year. It is developing a test for E. coli that can identify this potentially deadly bacteria in a short period of time. The company says these tests will be simple, inexpensive, and will give a result quickly. The USDA recently awarded Molecular Innovations a grant to develop a real-time test for Listeria, a bacteria that has recently been found in hot dogs and identified as causing serious illness. The Department of Defense is also working with this company to develop a test to detect bubonic plague in the battlefield. Altogether, Molecular Innovations has received $1.2 million in grants from federal agencies, including the National Cancer Institute, to develop tests for the detection of various bacteria. Another company, New Horizons Diagnostics located in Columbia, Maryland, has developed a device that can give an instant read-out of the overall level of bacterial contamination in a particular sample. This device is currently being used to conduct food inspections by a large number of countries, including Ireland, Germany, Italy, and Poland. The USDA has conducted studies and concluded that the New Horizons device "can provide processors or meat inspectors with a rapid means to detect microbial contamination on carcasses and allow for improvements in the overall microbial quality of the carcasses before they leave the slaughter floor." While this device cannot identify the specific type of bacteria in a sample, New Horizons says that with additional development, this capability could be realized within two years. Clearly, major advances have been made in the development of real-time tests that would especially benefit FDA inspection of imported fresh fruits and vegetables for microbial contamination. Typically, FDA has access to imported food only for a matter of hours before it is sent to market and often consumed a few days later. On the other hand, FDA has "farm-to-table" access to food grown and processed in the U.S. Yet I note in FDA’s budget justification for FY 2000 that FDA will spend nothing on the development of real-time tests and instead will only conduct research on traditional, culture-type tests in an effort to shorten the week or more such tests now take to identify bacteria and other microbial contaminants. Given the work being done outside FDA, I am curious whether FDA, like USDA and other federal agencies, is making plans to shift its attention away from culture-type tests and toward the development of real-time tests. As a result, I am requesting that you provide me with your response to the following questions by close of business on Monday, April 12, 1999. (1) Does FDA still believe it is infeasible or impossible to develop real-time tests for the detection of bacteria and other pathogens on food? (2) What plans does FDA have to fund or to conduct research into the development of real-time tests, either in cooperation with outside firms or academic institutions or by FDA on its own? (3) Was FDA aware of the work being done by Molecular Innovations and New Horizons Diagnostics to develop real-time tests for detecting bacterial and pathogenic contaminants in food? Does FDA know of other private firms or research entities that are conducting research and development activities on real-time tests for pathogens? (4) Does FDA believe the kind of work being done by Molecular Innovations and New Horizons Diagnostics has any usefulness or significance for its efforts to reduce bacterial and microbial contamination through the inspection of imported food? Why, or why not? Thank you for your cooperation. I look forward to hearing from you. Sincerely,
Enclosures cc:
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