Frank Maisano The Center is a graduate studies program that manages the Ceres Conferences. In these five or six major conferences per year, government, industry, academia, and consumer groups constructively discuss issues in food and nutrition policy.
During ten years at the Food and Drug Administration and U.S. Department of Agriculture, Crawford played major roles in mandatory nutrition labeling, the General Agreement on Tariffs and Trade (GATT), and the control of chemicals and microorganisms in the food supply.
Outside government, Crawford has held leadership posts at the University of Georgia, the National Food Processors Association, and the Association of American Veterinary Medical Colleges. He presently serves on the Expert Advisory Panel on Food Safety at the World Health Organization and on the Committee on Scientific Freedom and Responsibility of the American Association for the Advancement of Science.
Crawford holds a doctorate degree in veterinary medicine from Auburn University, a Ph.D. from Georgetown, and an honorary doctorate from the University of Budapest.
Maisano: From your experiences as an FDA food safety expert, what would you say are the strengths and weaknesses of the FDA’s food inspection process?
Crawford: The process’s strength is that FDA inspection personnel are well-trained and experienced. This leads to thorough inspections and a mature approach to the correction of violations. The approach is generally firm, but fair.
The weakness lies in the infrequency of inspection. Theoretically, the inspection schedule is based on the degree of risk inherent in certain plant operations and in the foodstuffs produced in those plants. In reality, the schedule is in large part driven by inadequate resources and administrative delays.
The cure for this is better and more targeted resources, as well as the institution of a quantitative risk management model for categorizing risks and guiding the frequency of inspection.
Maisano: Do regular citizens have a voice in the food inspection/safety debate, or can they reach the debate through their members of Congress?
Crawford: The interested public is encouraged to attend FDA and FSIS (the USDA’s Food Safety and Inspection Service) hearings on food safety. Moreover, the general public is invite to submit comment on regulatory proposals by both agencies. Notices of both types of opportunities for involvement are listed in the Federal Register or by regularly visiting the Web site of both agencies.
From time to time, Congress holds hearings on new food safety laws or on the implementation of previously passed legislation. Unfortunately, in these hearings there is little or no opportunity for public interaction.
Maisano: During the debate over the Hazard Analysis and Critical Control Point (HACCP) program, what interesting problems or hurdles occurred and how did you overcome them?
Crawford: The principal impediment to the implementation of HACCP was the Office of Management and Budget, which waged a campaign against FSIS based on slowing down implementation. The negative interpretation of OMB’s actions would be that the agency was responding to external political pressure; the positive interpretation would be that OMB did not have the expertise to adequately evaluate HACCP.
Actually, I cannot take credit for overcoming them. I left government in September of 1991. Implementation of HACCP was placed in abeyance and was not revived until the E. coli deaths of 1993.
Maisano: Do you wish you had had any “tools in the toolbox” that would have made the process easier?
Crawford: Yes. In the best of all possible worlds, there would be a standard means of communicating scientific analysis to OMB that would be transparent and publicly available. A matrix for decision-making that included risk assessment and perhaps cost/benefit analysis might have convinced OMB either of the merits of HACCP or the political folly of blocking this life-saving system of food inspection.
Maisano: But opponents of such regulatory improvement measures say they would slow the process of food inspection to a crawl, actually jeopardizing safety. You don’t agree with that criticism?
Crawford: No. I find that position untenable, because it is based on the premise that rigorous design of the inspection program will delay inspection. In fact, regulatory reform as envisaged in The Regulatory Improvement Act of 1999 [S. 746] would speed up the process by causing the implementation of a risk-based regulatory plan that would lead to more and better inspections with increased frequency.
Maisano: One of the more controversial elements of regulatory improvement proposals is risk assessment. Why is risk assessment so important to this process?
Crawford: Risk assessment has become the international language of the science of regulation. It is as fundamental to public health programs as the stethoscope is to cardiology. There is no way risk assessment can be abandoned in today’s world because it represents state-of-the art science.
Risk assessment is not at all controversial. It is part and parcel to public health protection programs throughout the world. Failure to incorporate risk assessment into the U.S. regulatory process would make this country an outlier, perhaps a pariah, in the world community and, specifically, in the scientific and medical communities.
Maisano: As a food safety expert, what are your thoughts about the claims made by those who have been affected by tainted meats, juices, or fruits? Are their concerns being addressed? How will S. 746 make things better?
Crawford: Food safety is a big problem today throughout the world, in countries of all kinds. It has always been a problem and always will be, but it is getting marginally better.
The reason for the improvement in food safety in the U.S. is because of the scientific research and the application of that research to both medicine and regulation. S. 746 would materially improve the regulatory process in the food safety area.
Since its inception, the Office of Management and Budget has applied a political or quasi-political calculus to its control of the regulatory process. S. 746 would require the imposition of a transparent approval process to food safety decisions, wherein the relevant science would provide the basis for decision-making. The result would be improved public health protection and a more expeditious approval of breakthrough food safety measures.
Maisano: What is the value of benefit/cost analysis for food safety?
For about 20 years, benefit/cost analysis has been an important part of the regulatory approval process. It is important to know, for example, how much food safety regulations will cost the consumer. If a measure that offers little or no public health protection would double the price of chicken, then that ought to be made known.
Beneficial public health regulations will always prevail under a system that uses benefit/cost analysis because of the enormous health costs associated with lost days of work, hospitalizations, and chronic illness. Spurious measures that address food fads and not food safety probably would not always prevail.
Maisano: How important do you think the general public perceives this issue to be? How important is regulatory improvement to everyday American families and businesses?
Crawford: I think by now the America public realizes it was over-regulated about 20 years ago, when airline deregulation presaged the modern era of regulatory evaluation. And I believe that both families and businesses understand that there are bad regulations and there are good regulations.
Maisano: What do you expect will happen with this debate in Congress this year and in the future?
Crawford: America is a nation of fairness, and it is a nation that believes in progress as well as in the benefits of science. Eventually, the people will demand that formal, publicly available assessments of public health proposals serve as the basis of decision-making and not politics. I trust and hope that this will happen yet this year.
Maisano: With our current technologies, is food safety as big a concern as it was say 10, 25, or 50 years ago?
Crawford: It is a far bigger issue than ever before. The American public now knows how to pronounce salmonella, and an informed citizen is a powerful force. Demands that food be safe will now begin to take on a structured approach, moving beyond mere rhetoric. The government must be prepared to respond in kind.
Maisano: Where will we go from here? What is the next major breakthrough on the horizon?
Crawford: A recent scientific publication discussed the paradox of increasing cases of food-borne disease in spite of HACCP. The conclusion was that with increasing populations, antibiotic resistance, evolution of disease-causing organisms, and contamination of fields and streams with human and animal sewage, food-borne disease will continue to increase.
HACCP is making a tremendous difference, but it is not a fail-safe system. The next step will be what is now being referred to as “Beyond HACCP.” This will be a systematic approach to eliminating food-borne disease, involving emergent technologies of the most innovative kinds.
Dr. Crawford can be reached by e-mail at [email protected].More information about his work, and that of The Center for Food and Nutrition Policy, can be found at the group’s Web site, http://www.ceresnet.org.