Toward Safer Food

Perspectives on Risk and Priority Setting

Sandra Hoffmann, Michael R. Taylor, Sandra Professor Hoffmann, Michael R. Professor Taylor

• Publisher: Routledge
• Year: 2010
• eBook ISBN: 9781136524516
• Topic: Law
• Subtopic: Environmental Law
• Index: Law

In 1998, a National Academy of Sciences panel called for an integrated, risk-based food safety system. This goal is widely embraced, but there has been little advance in thinking about how to integrate knowledge about food safety risks into a system- wide risk analysis framework. Such a framework is the essential scientific basis for better priority setting and resource allocation to improve food safety. Sandra Hoffmann and Michael Taylor bring together leading scientists, risk analysts, and economists, as well as experienced regulators and policy analysts, to better define the priority setting problem and focus on the scientific and intellectual resources available to construct a risk analysis framework for improving food safety. Toward Safer Food provides a common starting point for discussions about how to construct this framework. The book includes a multi-disciplinary introduction to the existing data, research, and methodological and conceptual approaches on which a system-wide risk analysis framework must draw. It also recognizes that efforts to improve food safety will be influenced by the current institutional context, and provides an overview of the ways in which food safety law and administration affect priority setting. Hoffman and Taylor intend their book to be accessible to people from a wide variety of backgrounds. At the same time, they retain the core conceptual sophistication needed to understand the challenges that are inherent in improving food safety. The editors hope that this book will help the U.S. move beyond a call for an integrated, risk-based system toward its actual construction.

PART I

Framing the Design Problem

1

Getting to Risk-Based Food Safety Regulatory Management: Lessons from Federal Environmental Policy

SANDRA A. HOFFMANN^*

For the past 20 to 30 years the central theme in federal food safety policy has been a call for modernization. This call comes despite an impressive record of achievement. It reflects the fact that changes in food production, processing, and distribution, as well as in consumption patterns, have raised new challenges that existing policy appears ill equipped to meet. Coupled with this is the recognition that new technological developments, particularly in information technology and microbiology, provide new policy opportunities that have yet to be fully exploited.

This call for modernization has coalesced around demands for development of a more integrated, system-wide approach to managing food safety risk that uses science-based standards and decision criteria. Policy makers in such a system would rely on risk analysis and the supporting development of scientific data it requires to inform their decisions. Authors in this book at times use both the terms science-based and risk-based to talk about aspects of this approach to food safety regulation.

Advances have been made in response to this call for modernization. Over the past 20 years, significant improvements have been made in food safety data collection systems, particularly for pathogen hazards. A new science of microbial risk assessment is being developed by federal food safety agencies based in part on these data. Along with this has grown the recognition of the need for a means of integrating this new information in ways that can guide more effective resource use. This book is an effort to assess where we are in this process of better data collection, analysis, and integration of knowledge and management and to identify next steps toward a system of science-based decision analysis that can use this information to guide more effective use of federal food safety regulatory resources.

Since the early 1970s, federal agencies have demonstrated an ongoing interest in the use of quantitative risk analysis to inform more effective management of health and environmental risks (Andrews 1984; McGarity 1991; Anderson 1996). Food safety policy has been part of this reorientation of federal regulatory efforts around a risk paradigm. Comparative risk assessment and comparative risk rankings are an intuitively appealing model for thinking about use of risk information in regulatory decision analysis. In recent years, there has been increasing interest in use of comparative risk assessment among professionals concerned about food safety policy. Under circumstances very similar to those faced by food safety regulatory decision makers, environmental policy makers pursued this approach during the 1980s and 1990s. Those concerned about food safety should be interested in what this experience teaches about what comparative risk assessment has and has not been able to provide by way of assistance to regulatory decision makers.

A reasonable conclusion to draw from experience with the use of comparative risk assessment in the environmental policy arena is that although comparative risk assessment provides a first cut of information for effective resource allocation, it is only a first step. As one prominent group of risk analysis researchers noted, “Ranking risk does not solve the management problem and … may not translate directly into budgetary priorities” (Morgan et al. 1996). In this chapter, I argue that scientists, managers, and policy makers working on food safety during the past 30 years have developed risk analysis tools that provide an important complement to comparative risk assessment. These tools have been used primarily at the firm level in the private sector. I contend that they can also be drawn on to develop a framework for providing a sound scientific basis for future food safety resource allocation within government.

This chapter begins by providing a historical background on the current interest in risk-based priority setting in the food safety arena. It looks briefly at the development of microbial risk assessment, efforts to improve data collection to support it, and interest in comparative risk assessment as a framework to inform regulatory priority setting. It then examines EPA’s experience with use of comparative risk assessment in the 1980s and 1990s as a means of informing and shaping regulatory priorities. Finally, it examines development of risk-based process control, particularly Hazard Analysis Critical Control Point (HACCP), for use by firms in ensuring food safety. It then suggests how the concepts behind HACCP might provide the basis for strengthening the contributions that comparative risk assessment can make to better food safety resource allocation. The chapter ends with an overview of the book and the contributions each chapter makes to an assessment of where we are and where we need to go in developing a sound scientific basis for food safety regulatory decisions.

Toward More Effective Food Safety Regulation

In 1998, the National Academy of Sciences (NAS) committee, in drafting “Ensuring Safe Food from Production to Consumption,” defined the mission of an effective food safety system as protecting and improving public health “by ensuring that foods meet science-based safety standards through the integrated activities of the public and private sectors.” The committee focused on risk as an organizing principle for an effective food safety regulatory system. The committee noted that system should be “science-based,” with “a strong emphasis on risk analysis and prevention.” “Risk analysis provides a science-based approach to address food safety issues” (NAS 1998, 5). According to the NAS report, use of regulatory resources should be prioritized on the basis of actual impact on public health risk rather than public perception of risk. Similar risks should receive similar levels of effort. Legal standards and regulatory mechanisms should be based on scientific evidence and should be responsive to risk rather than determined by fixed, non–risk based protocols. Such a system would be preventive and anticipatory, rather than reactive, in nature. Most fundamentally, such a system is supported by “a reliable and accurate system of data collection, processing, evaluation and transfer.”

Developments in management of pathogen-related foodborne hazards provide a clearer understanding of the motivation behind food safety policy makers’ interest in such a risk-based system. Concerns about pathogen-related food safety hazards have focused on modernization of the federal meat inspection system. The basic structure of U.S. meat safety regulation has remained largely unchanged since adoption of its original enabling legislation in 1906. The 1906 Meat Inspection Act focused on critical risks of the time: zoonotic diseases such as tuberculosis, trichinosis, and brucellosis; grossly unsanitary slaughter and processing conditions; and purposeful adulteration of processed foods. The antemortem examination of animals, postmortem examination of carcasses and vital organs, and continuous inspection of slaughter and processing facilities were effective methods of detecting many of these zoonotic diseases and reflected control methods available before development of modern statistical quality control methods and modern microbial testing.

By the early 1970s, animal disease eradication programs and improved animal husbandry practices had effectively controlled many of these zoonotic hazards on-farm. Other foodborne pathogen hazards such as E. coli O157:H7, which were not necessarily animal health problems and were not detectable by sensory inspection, had emerged as significant human health hazards (Altekruse et al. 1997). At the same time, a tightening federal budget in the wake of the first oil embargo and slowing of the post–World War II economic expansion increased pressure to improve the cost-effectiveness of meat inspection programs. The result was a push for modernization of federal meat and poultry regulatory programs. Modernization ultimately meant refocusing on current risks and using new scientific and analytical methods of detecting, evaluating, and controlling hazards.

In the 1970s and 1980s, a series of government studies, culminating in the 1985 NAS report, An Evaluation of the Role of Microbiological Criteria for Foods and Food Ingredients, developed the theme that modernization of federal food safety programs—in particular meat, poultry, egg, and seafood safety—should involve movement toward risk-based performance standards, flexible allocation of both private and public resources in accordance with public health risk, and development of the scientific knowledge base for doing this. In 1976, USDA’s Food Safety Inspection Service (FSIS) commissioned a study of cost-effectiveness in meat inspection (Booz, Allen and Hamilton 1976). The report reiterated the recommendation to move toward risk-based performance standards, as well as to shift primary responsibility for food safety assurance to the private sector, to transform the role of inspector to that of verifier; and to recognize that food safety is jointly produced by actors from farm to consumer. In the early 1980s, FSIS adopted a total quality control (TQC) approach to federal meat inspection in response to U.S. General Accounting Office (U.S. GAO) recommendations (U.S. GAO 1977). Although TQC was later criticized by NAS (1985) as being improperly focused on non-risk (marketability) concerns, it marked a movement toward adoption of modern statistical approaches to quality control. In 1985, the NAS committee on microbiological criteria recommended that federal agencies ultimately adopt the HACCP approach to controlling microbial hazards in foods, which the World Health Organization had been advocating since the mid-1970s (WHO 1976; WHO/ICMSF 1982). But the committee found its evaluation of the scientific basis for HACCP programs frustrated by a lack of comprehensive quantitative risk analysis of foodborne human health hazards (NAS 1985, 154). The NAS emphasized use of quantitative risk assessment and formal risk analysis as the principal tools for managing federal food safety programs.

The recommendations of the 1985 NAS report were picked up by GAO. In a long series of reports, GAO has attempted to draw Congressional attention to the need to reform federal food safety programs to make them more able to respond to changing health risks. GAO pointed out inconsistencies in the frequency of inspections of similar establishments under Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and Department of Commerce (DoC) jurisdiction and lack of relationship between inspection frequency and risk (U.S. GAO 1992). (A description of the federal agencies’ major food safety responsibilities is provided in Appendix A.) GAO argued that the intensity and type of inspection of food processing establishments should be based on the health risk posed by specific foods and production processes and establishments’ histories of compliance (U.S. GAO 1992, 1993). It highlighted the need for better data collection on foodborne illness (U.S. GAO 1996a, 2001). GAO recognized the value of using statistical quality control procedures and microbial testing and the value of comprehensive risk assessment in guiding agency policy (U.S. GAO 1996b, 1997). Although GAO’s analysis has focused on the ways legislatively created agency structure and mandates could be reformed to promote a more risk-based system, the underlying understanding is that an effective, modern food safety system operates on a factual foundation of sound scientific assessment of the human health risks posed by food products and on analysis of how those risks enter the food chain.

Together, the policy debates and recommendations of the past 20 years outline the basic components of a modern, science-based food safety system. Such a system is responsive to changing risk profiles, bases regulatory requirements and administrative resource allocation on risk, and is preventive rather than reactive in orientation. Implementation of such a system requires effective data collection, scientific methods for assessing risks, risk responsive regulatory mechanisms, and the analytical and administrative capacity to use risk information in program management.

Risk-Based Decision Analysis in the Federal Government

Efforts to modernize food safety regulation organized around the concept of risk reduction were not taking place in a vacuum. The 1985 NAS committee on microbial criteria was well aware of the increasing use of risk analysis in the management of other federal administrative programs. The committee was operating in an environment in which the science of risk assessment and the management tools of risk analysis were gaining prominent use in federal regulatory agencies.

In the early 1970s, the federal government was taking on increasing responsibility for environmental quality. Federal environmental legislation governing toxic chemical hazards was adopted in the early 1970s (FIFRA Amendments Pub. L. 91-601 Dec. 30, 1970; TSCA 15 U.S.C. secs. 2601 et seq. (1976); RCRA 42 U.S.C. secs. 6901 et seq. (1976)). These statutes implicitly or explicitly relied on risk criteria. Implementation of these statutes fostered development of scientific methods and administrative capacity, both in the government and in industry, to base regulatory decisions on risk criteria (Hornstein 1993, note 10). Explicit use of quantitative risk assessment to support regulatory decisions expanded significantly.

During the 1980s, the role of risk in federal environmental and public health regulation developed in two directions. First, the methodology of risk assessment and of risk management was improved and institutionalized within EPA, OSHA, and the Consumer Products Safety Commission (CPSC). Second, by the end of the decade the concept of comparative risk assessment and the goal of risk reduction had taken a prominent place in debates about environmental policy priority setting. Throughout the decade, risk pervaded the discussion and administration of environmental policy. As one observer noted, “By the end of the 1980s, risk assessment was established as the primary language of analysis and management at EPA” (Andrews 1994, 217). Both external and internal forces drove this policy innovation.

In 1980, the Supreme Court ruled that OSHA could...

Table of contents

• Cover
• Title
• Copyright
• Contents
• Preface
• Contributors
• PART I. Framing the Design Problem
• PART II. Risks and Resources to Reduce Them
• PART III. Tools for Risk-Based Assessment of Food Safety Policy Priorities
• PART IV. Assessing Opportunities
• Appendix A. Responsibilities of Federal Agencies Involved with Food Safety*
• Index