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4

Other Factors Influencing the Development of Food Safety Policy

This session focused on other factors—international, regulatory, business, consumer, and political—that in addition to science and risk assessments, can influence the development of food safety policy. Often all of these factors are weighed against one another in managing food safety hazards and determining the most acceptable level of risk.

INTERNATIONAL CONSIDERATIONS

Presented by Fritz Käferstein, D.V.M., Ph.D.

Distinguished Visiting Scientist, Food and Drug Administration and Food Safety Inspection Service, U.S. Departments of Health and Human Services and Agriculture

The Codex Alimentarius Commission is an intergovernmental body, consisting presently of 165 member states, concerned with protecting the health of consumers and ensuring fair practices in international food trade through the development of the Codex Alimentarius. The Codex Alimentarius, or food code, is an international agreed set of food standards, recommendations, and guidelines for consumers, food producers and processors, national food control agencies, and the international food trade. The Codex Alimentarius system itself is unique in that it provides an opportunity for all its member countries to join the international community in the development of such standards, recommendations, and guidelines.

In recent years, participants at the Uruguay Round of Multilateral Trade Negotiations raised the issue that many food laws and regulations adopted by countries to protect the health and safety of their consumers could become disguised barriers to trade as well as being discriminatory. As a result, Codex standards became the international reference standards for harmonization and it became clear that deviations from Codex standards code would need to be justified. The Codex Alimentarius Commission, in anticipation of this new paradigm, realized the need to examine and evaluate the process of risk assessment methodologies on which standards were based. More challenging, the Commission is also faced with determining to what extent other legitimate factors beyond science, such as social, economic and ethical issues, should be considered in its decisions.



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Page 18 4 Other Factors Influencing the Development of Food Safety Policy This session focused on other factors—international, regulatory, business, consumer, and political—that in addition to science and risk assessments, can influence the development of food safety policy. Often all of these factors are weighed against one another in managing food safety hazards and determining the most acceptable level of risk. INTERNATIONAL CONSIDERATIONS Presented by Fritz Käferstein, D.V.M., Ph.D. Distinguished Visiting Scientist, Food and Drug Administration and Food Safety Inspection Service, U.S. Departments of Health and Human Services and Agriculture The Codex Alimentarius Commission is an intergovernmental body, consisting presently of 165 member states, concerned with protecting the health of consumers and ensuring fair practices in international food trade through the development of the Codex Alimentarius. The Codex Alimentarius, or food code, is an international agreed set of food standards, recommendations, and guidelines for consumers, food producers and processors, national food control agencies, and the international food trade. The Codex Alimentarius system itself is unique in that it provides an opportunity for all its member countries to join the international community in the development of such standards, recommendations, and guidelines. In recent years, participants at the Uruguay Round of Multilateral Trade Negotiations raised the issue that many food laws and regulations adopted by countries to protect the health and safety of their consumers could become disguised barriers to trade as well as being discriminatory. As a result, Codex standards became the international reference standards for harmonization and it became clear that deviations from Codex standards code would need to be justified. The Codex Alimentarius Commission, in anticipation of this new paradigm, realized the need to examine and evaluate the process of risk assessment methodologies on which standards were based. More challenging, the Commission is also faced with determining to what extent other legitimate factors beyond science, such as social, economic and ethical issues, should be considered in its decisions.

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Page 19 Thus in 1995, the Codex Alimentarius Commission adopted four statements of principle concerning the role of science in the Codex decision-making process and the extent to which other factors are taken into account. Of these, the first two are relevant to this discussion on international considerations influencing the development of food safety policy. First, the Commission deemed that food standards, guidelines, and other recommendations developed by the Codex Alimentarius shall be based on the principle of sound scientific analysis and evidence, involving a thorough review of all relevant information in order that the standards assure the quality and safety of the food supply. The second principle stated that when elaborating and deciding upon food standards, the Codex will have regard for other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade. Ever since, the Commission has been trying to find an answer to the question of what are the “other legitimate factors”. The decisions it has taken since are rather inconsistent. On the one hand, in 1995 the Commission adopted, after a stormy debate and with only a small majority of its votes, the standards for four growth hormones (Estradiol 17-B, Progesteron, Testosteron, Zeranol). On the other hand, it refused to adopt after another stormy debate and with only a small majority, the standard for bovine somatotrophin (BST). However, both groups of substances, the growth hormones and BST, had been dealt with in identical ways: first in the Joint FAO/WHO Expert Committee on Food Additives (JEFCA) and thereafter in the Codex Committee on Residues of Veterinary Drugs in Food. In spite of many time consuming debates over all of the years in the Commission itself and in some of its subsidiary committees, in particular in the Codex Commission on General Principles, the only agreement so far reached regarding the meaning of “other legitimate factors” was not to agree. REGULATORY CONSIDERATIONS Presented by Morris Potter, D.V.M. Director, Food Safety Initiative, Food and Drug Administration U.S. Department of Health and Human Services Current U.S. food safety policies can be considered accumulations of several decades of mainly independent efforts to address specific problems, primarily based on the concepts that equate safety with cleanliness. In general, these policies respond to obvious hazards that pose clear risks in three ways. For hazards that have straightforward technical fixes, regulations have been crafted that require the application of those technologies and establish regulatory standards at the performance limit of the technology. For hazards without solutions or technologies that mitigate the problem, two other regulatory responses are exercised. The first is to keep the hazardous food entirely out of the marketplace. An alternative response is to assume that consumers can protect themselves and, therefore, regulation is inappropriate or undesirable. This regulatory paradigm is most effective in areas of clearly defined risks when broad public concern and support for government intervention exists, and public confidence in the safety technology is high. Examples of food safety problems that have been successfully addressed by this regulatory paradigm include the application of low acid canned food regulations to control botulism; fermentation to preserve cheese, sausage, and yogurt; and the creation of water quality standards for shellfish growing waters to control shellfish-associated typhoid fever. However, in many situations, risks are not clearly defined, traditional food safety approaches and food technologies poorly address contemporary hazards, and public confidence in new

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Page 20 technologies is low. An additional barrier to successful mitigation of food safety hazards is the difficult task of identifying the point of contamination along the line of production. It is not always clear whether a pathogen was introduced during distribution, processing, packaging, preparation, or in the growing fields. Without a defined point of contamination, effective and efficient regulatory action to prevent recurrence is impossible. A traditional method for reducing food-borne illness that continues to be an important point of intervention is ensuring that safe food handling and preparation practices are used immediately prior to consumption. However, for foods prepared in a manner that can kill pathogens, the history of outbreaks associated with those foods highlights the difficulty in maintaining behaviors and practices in homes and commercial kitchens that assure an acceptable level of risk. In addition, for many foods, traditional handling in the kitchen has minimal impact on pathogens that may be present, for example, the clear water rinses that we use on fresh produce or the mild to no heating that we apply to many egg-containing dishes. Therefore, the focus is shifting towards improving the level of control of food-borne pathogens before foods reach the kitchen. Implementing practices and policies that will eliminate pathogens from the food chain before foods arrive in the kitchen presents a regulatory challenge for several reasons. Our inability to accurately predict the public health outcomes of exposure; the restricted distribution of some disease, either geographically or to a more susceptible subpopulation; and the lack of understanding of the relative risk of various food/pathogen combinations under various conditions of handling can make it difficult to mobilize consumers and industry behind a comprehensive food safety policy. Another problem arises when the food industry responds to consumer demands with product innovation that result in unanticipated hazards. Despite these complications, regulatory agencies are committed to forming the best scientific base possible to achieve food safety and public health goals. Agencies are working to achieve these goals by investing in research to develop and test new hazard elimination methods. They are also using risk assessments to identify needs, allocate resources, and characterize food-borne risks as correctly and publicly as possible. It has often been difficult to determine the best combination of guidance, regulation, public advisories, and warning labels or bans to apply while methods to assure the safety of these foods are designed and implemented. However, regulatory agencies will continue to make certain that new information to manage risks is put into practice as quickly and effectively as possible. BUSINESS CONSIDERATIONS Presented by Dane Bernard, M.S. Vice President for Food Safety Programs, National Food Processors Association It seems to some that the integration of scientific information with the relatively new discipline of risk assessment to inform food safety policy decisions is being done without full consideration of the impact of the potential policy alternatives on business. Worse, in cases where scientific knowledge is insufficient for conducting risk assessments or economic analyses, new food safety challenges are often met with a strong regulatory response (such as establishing a politically popular but ultimately self-limiting “zero tolerance”). Even when equally effective approaches are available, regulatory solutions are often chosen over other alternatives because regulations represent concrete, politically saleable solutions that are perceived as more acceptable to the public. This model of food policy establishment however, can significantly

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Page 21 impact businesses, not only in terms of daily operations but growth and profitability as well. This model also virtually ignores the fact that industry self control initiatives result in conducting more microbiological testing, chemical testing, on-site audits, field inspections, and other food safety activities, than the combined efforts of government agencies. With the recent movement toward control programs such as Hazard Analysis Critical Control Points (HACCP), in conjunction with on-going industry activities, the question arises: Should food safety issues continue to be addressed only through the existing paradigm of regulation, or is it time to consider a new framework that expands on the roles and responsibilities of industry? To fully consider this question, we should first take a brief look at the economic importance of the industry and the potential impact of new regulations. A brief look at the food service industry shows that over the past 20 years the sector has grown by a phenomenal 300 percent, a trend that continues despite industry consolidations in other areas of the food industry. In the early 1980s, almost a quarter of the private jobs in the United States were related, in some way, to the food industry, with the highest proportion in the food service sector. In the United States, 99.7 percent of all businesses are classified as small, and in this sector food-related businesses, and in particular, food service is the number one employer, both in terms of the numbers of people employed and in the rate of growth in the employment sector. This trend however, appears to be opposite of that in the manufacturing sector. New regulations directed at tightened controls on the food industry often increase the cost of doing business, and these can be felt disproportionately by small businesses. Between 1965 and 1985, consolidations of processing facilities shut down an average of about 4 percent of these locations per year resulting in industry concentration and removal of private sector jobs, often in more rural areas. This trend continues, and while consolidations create efficiencies, they can also be demanding in terms of providing employment for those that are dislocated. The increased costs of complying with regulatory requirements contribute to an increase in consolidation pressures. International food trade also creates numerous challenges and opportunities for the food industry. Trade in food and food ingredients is a global industry. While this is by no means a new trend, the amount of imports as well as the origins of these goods continues to expand. While Americans enjoy the most abundant and diverse food supply in the world, the expanding import market as well as the increase in U.S. goods that are exported place more demands on the government agencies that must set standards and for the businesses that must abide by them. Among the challenges are such questions as, What level of inspection should be devoted to determining that tolerances for agricultural chemicals are met? While chemical residues on imports have been reported to be higher than on domestic products, the actual amount of the chemicals and the percentages of products that show positive for residues are so small that the real difference in scientific terms appears inconsequential. Furthermore, it is beyond government capability to provide the quantity of inspections to give the safety net that consumers seem to expect. Other questions include, Considering that the risk involved is probably trivial, does this situation warrant a high level of official scrutiny? How should such issues be conveyed to a public that appears to be uncomfortable with the concept that risk, even a trivial risk, might be associated with foods? What are the alternatives to stricter regulations, increased domestic inspection levels, and import standards in an era of limited government resources? In lieu of absolute assurances of safety, labeling has been offered by some as one solution to consumer protection. Advocates of this approach say that warning labels for foods such as unpasteurized juices would help to protect consumers. However, a General Accounting Office

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Page 22 report indicated that, in their opinion, this is a costly option with little real benefit. Another possible measure would be to expand risk communication efforts with consumers to collect their perceptions of risk and create dialogue on the real cost of mitigation and reduction of these hazards. Too often, past attempts at risk communication have been reactive rather than proactive and have been initiated in response to each individual crisis instead of addressing the system as a whole. In the future, risk communication needs to be proactive and must, in my opinion, balance industry capability with consumer preferences in establishing appropriate levels of protection. As the number of recognized food safety hazards and the demands on regulatory agencies increases, it may be time to consider a new food safety paradigm—a paradigm that recognizes and expands upon industry's unique roles, knowledge, and resources. This paradigm should include a strong component of risk communications as well as the costs to the individual in addressing problems. Scientific details and value choices need to be separated and put into context through the risk communications process in order to elucidate those problems that can be solved by science and those that cannot. Alternatives to regulation need to be considered in order to minimize the financial and operational burdens on government, industry, and consumers. It is only through the combined efforts of industry, consumers, and regulatory agencies that the most effective means for reducing the incidence of food-borne illness can be identified and implemented. CONSUMER CONSIDERATIONS Presented by Edward Groth, III, Ph.D. Director of Technical Policy and Public Service, Consumer's Union In managing food safety hazards, in addition to relying on science and risk assessment, the costs, benefits, and rights and responsibilities of various sectors of society must also be weighed against one another to determine the most acceptable level of risk. To accomplish this, it is important that all stakeholders participate in the process and that the process be transparent. In particular, the boundaries between what can be resolved by science and what are “other factors” and value choices need to be clearly defined. Consumer participation in food safety debates is fundamental. Consumers have a right to know and to choose what they are eating and a right to participate in determining what level of food safety risk is acceptable. However, many scientists and regulators are afraid consumers might reject something that is perfectly safe for reasons that cannot be supported by science. A complex issue, this raises many questions: To what extent should industry and government paternalistically decide what level of risk consumers should accept? How much influence should consumers have in determining what products or processes they are willing to accept? And to what extent should other factors such as values be incorporated into the food safety debate? There is generally no forum to discuss such issues, and food safety debates often unduly emphasize what is scientifically known about a food safety hazard when the issue at hand is really a conflict of values. In considering scientific uncertainty, government and industry may need to accept that consumers might prefer a more precautionary approach. Consumers have diverse preferences and will differ on what they consider an acceptable level of risk, and consumer perception of the benefits associated with particular technologies or production methods is also variable. Overall, consumer preferences can be a powerful market force, guiding the use of technology. Consumers need to be informed and made aware of costs, risks, and

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Page 23 benefits and these facts should be conveyed as part of a more comprehensive communication process. Labeling is emerging as a possible solution for dealing with the boundaries between government regulations and consumer choices. In the past, this type of a solution has often been rejected because much label information relates to subjective preference values other than safety. Furthermore, defining which factors should be dealt with by labeling and which by setting standards has not yet been integrated into risk analysis discussions. The bottom line for industry and regulatory agencies is to acknowledge that consumers want to be a part of the market and have their preferences and requests expressed. Consumers want to participate in decisions about which products will be adopted and what they will put on the table. In order to achieve this, all stakeholders must continue to grapple with the issue of what is acceptable for consumers to decide in the marketplace and define those factors beyond science that should be included as part of the food safety and food quality discussion. POLITICAL CONSIDERATIONS Presented by Eric Juzenas, J.D. Professional Staff Member, U. S. Senate Agricultural, Nutrition and Forestry Committee Federal and public entities alike support a science-based regulatory system that directs its resources towards those food safety and health hazards that represent the greatest risks and that will achieve the greatest benefits in public health. Unfortunately, defining the greatest risks and best approaches for solving food safety problems is not always straightforward. More often than not, agencies must make policy decisions based on insufficient science and technology information. Additionally, all stakeholders must face the more challenging issue of determining the level of risk federal agencies should consider in making decisions despite inadequate information. To deal with these uncertainties, agencies have incorporated, often at Congress's behest, many information management techniques such as risk assessment and cost-benefit analysis to frame available information into a format that is understandable to the public and private sectors and which can contribute to decision-making. When good data and methodologies exist to drive risk-assessment and cost-benefit analyses, they can help “depoliticize” decision-making by allowing decisions to be based on objective factors. However, one of the dangers of many broad-based regulatory reform proposals is that they force agencies to base decisions on these quantitative tools when there may not be reasonable available data or methodologies to support such a heavy reliance. In essence, most regulatory reform proposals simply assume that there are sufficient data and methodologies available or that they can be developed, and all that Congress needs to do is direct federal agencies to use them more. Furthermore, even incorporating well-done analyses into regulatory decisions can be complex since the rulemaking process often becomes centered on issues such as public values, funding, and resource availability, that are very difficult to quantify precisely. In food safety this means that, even with the best quantitative analysis, it still must be decided how much is too much and how many tax dollars can be spent. In general, three main areas demonstrate the countervailing pressures that Congress faces when trying to link science and food safety policy: the pressure to demonstrate results from food safety programs, the need for enhanced harmonization and coordination of food safety activities,

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Page 24 and the need for a better understanding of how to best implement a risk-based food safety regulatory system. Presently, an effective way to illustrate the benefits and thus rank the effectiveness of food safety programs at the federal program level in a manner truly driven by objective data does not exist as traditionally these programs have not been authorized by Congress. Current surveillance and trace-back networks in food safety seem insufficient to provide the quantitative estimates necessary to accurately define the benefits (in terms of lives saved or illnesses prevented) of a given regulatory program. In fact, I do not think that people know what it would take in practical terms to develop an information infrastructure for such an analysis. Without quantitative data to link programs and outcomes, support for public health programs like food safety from the Congress and the private sector can be hard to generate. Recent efforts to alleviate this problem include PulseNet and FoodNet, two surveillance and monitoring systems that were developed to aid in tracing food-borne illness. Given adequate funding, these networks seem to have the potential to provide quality data to allow fairly accurate estimates of the national burden of food-borne illness. Another area challenging Congress is determining how to better coordinate food safety activities across the different federal agencies and identify the necessary changes in existing food safety statutes. Possible solutions thus far include establishment of a unified budget authority, creation of a single food safety agency, and/or conception of an integrated process for food safety programs. A recent attempt to address this problem was initiated in 1998 with the creation of the President's Council on Food Safety, a committee charged with the task of coordinating budgets and developing programs for food safety activities across agencies. Much remains to be resolved regarding the extent of changes necessary to make the system more effective and several different legislative programs proposing alterations to the system are being reviewed by Congress. Finally, perhaps one of the greatest challenges that Congress faces in addressing public health issues in today's environment is identifying which aspects of the regulatory system need to change to foster better decision-making practices. As mentioned above, agencies have developed many information management techniques to deal with these issues. But public and industry participation will be key in determining these changes and making this process transparent. A good example of recent efforts to create these types of solutions are Hazard Analysis Critical Control Points (HACCP) based systems—systems that identify critical hazard points along food production lines and then develop specific techniques to control these. In conclusion, there are many countervailing pressures that regulatory agencies must take into consideration when developing food safety policy. These range from identifying which products present the greatest risks to determining how to include all stakeholders in decision-making processes. Agencies are currently identifying ways to increase industry and consumer involvement in developing alternatives to command and control regulations and recent efforts to incorporate such solutions have yielded many valuable lessons. Effective navigation of these issues will determine the level of success that food safety agencies have in achieving the most cost effective risk reductions possible while sustaining a food supply that consumers can rely on.