safety system, as well as its interventions. The FDA should include these metrics, and plans for any related data collection, as part of stra- tegic planning. The metrics should have a clearly defined link to public health outcomes.
Recommendation 3-4: The FDA should identify expertise needed to implement a risk-based approach. This includes training current and/or hiring new personnel in the areas of strategic planning; management of data; development of biomathematical models and other tools for risk ranking, prioritization, intervention analysis, and evaluation; and risk communication.
REFERENCES
Adak, G. K., S. M. Meakins, H. Yip, B. A. Lopman, and S. J. O’Brien. 2005. Disease risks from foods, England and Wales: 1996–2000. Emerging Infectious Diseases 11(3):365–372.
Batz, M. B., S. A. Hoffmann, A. J. Krupnick, J. G. Morris, D. M. Sherman, M. R. Taylor, and J. S. Tick. 2004. Identifying the Most Significant Microbiological Foodborne Hazards to Public Health: A New Risk Ranking Model. Food Safety Research Consortium Discus- sion Paper No. 1. Resources for the Future, Washington, DC. http://www.rff.org/RFF/
Documents/FRSC-DP-01.pdf (accessed February 6, 2009).
Batz, M. B., M. P. Doyle, G. Morris, Jr., J. Painter, R. Singh, R. V. Tauxe, M. R. Taylor, and D. M. Lo Fo Wong. 2005. Attributing illness to food. Emerging Infectious Diseases 11(7):993–999.
Becker, G. S. 2008. U.S. Food and Agricultural Imports: Safeguards and Selected Issues.
Washington, DC: Congressional Research Service.
Becker, G. S. 2009. Food Safety on the Farm: Federal Programs and Selected Proposals. Wash- ington, DC: Congressional Research Service.
Behn, R. D. 2003. Why measure performance? Different purposes require different measures.
Public Administration Reiew 63(5):586–606.
Bell, J. W. 2009. The USFDA and Ensuring Food Safety Perspectie of a Seafood Scientist. Pa- per presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.
Belton, V., and T. J. Stewart. 2002. Multiple Criteria Decision Analysis: An Integrated Approach. Boston, MA: Kluwer Academic Publishers.
Bevan, G., and C. Hood. 2006. Have targets improved performance in the English NHS?
British Medical Journal 332(7538):419–422.
Bird, S., C. S. David, V. T. Farewell, H. Goldstein,T. Holt, and P. C. Smith. 2005. Perfor- mance indicators: Good, bad, and ugly. Journal of the Royal Statistical Society Series A 168(Part 1):1–27.
Brougher, C., and G. S. Becker. 2008. CRS Report for Congress: The USDA’s Authority to Recall Meat and Poultry Products. Washington, DC: Congressional Research Service.
Brownson, R. C., E. A. Baker, T. L. Leet, and K. N. Gillespie. 2003. Chapter 1: The need for evidence-based public health. In EidenceBased Public Health, edited by R. C.
Brownson, E. A. Baker, T. L. Leet and K. N. Gillespie. Oxford, UK: Oxford University Press.
CAST (Council for Agricultural Science and Technology). 2006. Using Risk Analysis to Inform Microbial Food Safety Decisions. CAST Issue Paper Number 31. Ames, IA: Council for Agricultural Science and Technology.
Cavalluzzo, K. S., and C. D. Ittner. 2004. Implementing performance measurement innovations:
Evidence from government. Accounting, Organizations, and Society 29(3–4):243–267.
CFSAN (Center for Food Safety and Applied Nutrition). 2008. Sec. .0 Listeria Mono- cytogenes Draft Guidance. F. C. ORA. Rockville, MD: FDA CFSAN. http://www.fda.
gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm136694.htm (accessed March 15, 2010).
CFSAN/FSIS (Food Safety Inspection Service). 2003. Quantitatie Assessment of Relatie Risk to Public Health from Foodborne Listeria Monocytogenes Among Selected Categories of ReadytoEat Foods. Washington, DC: CFSAN/FSIS. http://www.fda.gov/ohrms/dockets/
dailys/03/oct03/103003/99n-1168-ra00001-002-Assessment-vol24.doc (accessed Febru- ary 9, 2009).
Charlebois, S., and C. Yost. 2008. Food Safety Performance World Ranking 00.
Saskatchewan, Canada: Research Network in Food Systems, University of Regina. http://
www.ontraceagrifood.com/admincp/uploadedfiles/Food%20Safety%20Performance%20 World%20Ranking%202008.pdf (accessed on March 13, 2010).
Consumers Union. 2008. Increased Inspections Needed for Produce, Processing Plants to Protect Consumers from Unsafe Food. http://www.consumersunion.org/pub/core_food_
safety/005732.html (accessed January 25, 2010).
DeWaal, C. S., H. Giselle, K. Barlow, L. Alderton, and L. Vegosen. 2006. Foods associated with foodborne illness outbreaks from 1990 through 2003. Food Protection Trends 26(7):466–473.
EFSA (European Food Safety Authority). 2008. Overview of methods for source attribution for human illness from foodborne microbiological hazards: Scientific opinion of the Panel on Biological Hazards. The EFSA Journal 764:1–43. http://www.efsa.europa.eu/cs/BlobServer/
Scientific_Opinion/biohaz_op_ej764_source_attribution_en.pdf?ssbinary=true (accessed February 6, 2009).
Engeljohn, D. 2009. USDA’s Approach to Ensuring Food Safety. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, May 28, 2009.
Evers, E. G., H. J. Van Der Fels-Klerx, M. J. Nauta, J. F. Schijven, and A. H. Havelaar. 2008.2008.
Campylobacter source attribution by exposure assessment. International Journal of Risk Assessment and Management 8(1/2):174–190.
FAO/WHO (Food and Agriculture Organization/World Health Organization). 2006. Food. 2006. Food safety risk analysis. A guide for national food safety authorities. FAO Food and Nutri
tion Series 87. ftp://ftp.fao.org/docrep/fao/009/a0822e/a0822e00.pdf (accessed March 5, 2009).
Fazil, A., A. Rajic, J. Sanchez, and S. McEwen. 2008. Choices, choices: The application of multi-criteria decision analysis to a food safety decision-making problem. Journal of Food Protection 71(11):2323–2333.
FDA (U.S. Food and Drug Administration). 2005. Pathogenic Vibrio Parahaemolyticus in Raw Oysters: Quantitatie Risk Assessment on the Public Health Impact of Pathogenic Vibrio Parahaemolyticus in Raw Oysters. http://www.fda.gov/Food/ScienceResearch/
ResearchAreas/RiskAssessmentSafetyAssessment/ucm050421.htm (accessed January 26, 2010).
FDA. 2009. Office of the Commissioner reorganization; statement of organizations, functions, and delegations of authority: Action notice. Federal Register 74(158):41713–41734.
Friedman, C. R., R. M.Hoekstra, M. Samuel, R. Marcus, J. Bender, B. Shiferaw, S. Reddy, S.
Ahuja, D. L. Helfrick, F. Hardnett, M. Carter, B. Anderson, and R. V. Tauxe. 2004. Risk factors for sporadic Campylobacter infection in the United States: A case-control study in FoodNet sites. Clinical Infectious Diseases 38(Suppl. 3):S285–S296.–S296.296.
GAO (U.S. Government Accountability Office). 2004a. Federal Food Safety and Security System: Fundamental Restructuring Is Needed to Address Fragmentation and Oerlap.
Washington, DC: GAO.
GAO. 2004b. Food Safety: FDA’s Imported Seafood Safety Program Shows Some Progress, but Further Improements Are Needed. Washington, DC: GAO.
GAO. 2004c. Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe Food. Washington, DC: GAO.
GAO. 2005. Oerseeing the U.S. Food Supply: Steps Should Be Taken to Reduce Oerlapping Inspections and Related Actiities. Washington, DC: GAO.
GAO. 2007. Federal Oersight of Food Safety: HighRisk Designation Can Bring Needed Attention to Fragmented System. Washington, DC: GAO.
GAO. 2008. Food Safety: Improements Needed in FDA Oersight of Fresh Produce.
Washington, DC: GAO.
GAO. 2009a. Agencies Need to Address Gaps in Enforcement and Collaboration to Enhance Safety of Imported Food. Washington, DC: GAO.
GAO. 2009b. Information Technology: FDA Needs to Establish Key Plans and Processes for Guiding Systems Modernization Efforts. Washington, DC: GAO.
Givens, J. M. 2009. Reiew of FDA’s Role in Ensuring Safe Food (FDA’s Approach to Risk Ba
sed Inspections—A Field Perspectie). Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Mee- ting, Washington, DC, March 24, 2009.
Gombas, D. E. 2009. FDA’s Role in Food Safety: A Produce Industry Perspectie. Paper pre-Paper pre- sented at Institute of Medicine/National Research Council Committee on Review of theInstitute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.
Gueorguieva, V., J. Accius, C. Apaza, L. Bennett, C. Brownley, S. Cronin, and P. Preechyanud.
2009. The Program Assessment Rating Tool and the Government Performance and Results Act: Evaluating conflicts and disconnections. American Reiew of Public Admin
istration 39(3):225–245.
Hald, T., D. Vose, H. C. Wegener, and T. Koupeev. 2004. A Bayesian approach to quan- tify the contribution of animal-food sources to human salmonellosis. Risk Analsyis 24(1):255–269.
Hald, T., D. M. Lo Fo Wong, and F. M. Aarestrup. 2007. The attribution of human infections with antibiotic resistant Salmonella bacteria in Denmark to sources of animal origin.
Foodborne Pathogens and Disease 4(3):313–326.
Hammond, J. S., R. L. Keeney, and H. Raiffa. 1999. Smart Choices: A Practical Guide to Better Decision Making. Boston, MA: Harvard Business Publishing.
Hartogensis, M. 2009. Feed and Pet Food Safety at the Center for Veterinary Medicine. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, May 28, 2009.
Havelaar, A. H., J. Braunig, K. Christiansen, M. Cornu, T. Hald, M. J. Mangen, K. Molbak, A. Pielaat, E. Snary, M. Van Boven, W. Van Pelt, A. Velthuis, and H. Wahlstrom. 2006.2006.
Towards an integrated approach in supporting microbiological food safety decisions.
Zoonoses Public Health 54(3–4):103–117.
Havelaar, A. H., A. V. Galindo, D. Kurowicka, and R. M. Cooke. 2008. Attribution of food- borne pathogens using structured expert elicitation. Foodborne Pathogens and Disease 5(5):649–659.
Henson, S. J., J. A. Caswell, J. A. Cranfield, A. Fazil, V. J. Davidson, S. M. Anders, and C.
Schmidt. 2007. A multi-factorial risk prioritization framework for food-borne pathogens.
In Department of Resource Economics: Working Paper 00. http://people.umass.edu/
resec/workingpapers/documents/ResEcWorkingPaper2007-8.pdf (accessed January 26, 2010).
Hoffmann, S., P. Fischbeck, A. Krupnick, and M. McWilliams. 2007a. Using expert elicita- tion to link foodborne illnesses in the United States to foods. Journal of Food Protection 70(5):1220–1229.
Hoffmann, S., P. Fischbeck, A. Krupnick, and M. McWilliams. 2007b. Elicitation from large, heterogeneous expert panels: Using multiple uncertainty measures to characterize infor- mation quality for decision analysis. Decision Analysis 4(2):91–109.
IOM/NRC (Institute of Medicine/National Research Council). 1998.. 1998. Ensuring Safe Food:
From Production to Consumption. Washington, DC: National Academy Press.
IOM/NRC. 2003. Scientific Criteria to Ensure Safe Food. Washington, DC: The National Academies Press.
IPCS (International Programme on Chemical Safety). 2004. IPCS Risk Assessment Terminol
ogy. Geneva, Switzerland: World Health Organization.
IRGC (International Risk Governance Council). 2005. White Paper on Risk Goernance:
Towards an Integratie Approach. Geneva, Switzerland: IRGC. www.irgc.org (accessed May 14, 2010).
IRGC. 2009. Risk Goernance Deficits. An Analysis and Illustration of the Most Common Deficits in Risk Goernance. Geneva, Switzerland: IRGC. www.irgc.org (accessed May 14, 2010).
Johnsen, A. 2005. What does 25 years of experience tell us about the state of perfor- mance measurement in public policy and management? Public Money and Management 25(1):9–17.
Lynn, L. E. 1998. Requiring Bureaucracies to Perform: What Hae We Learned from the U.S.
Goernment Performance and Results Act (GPRA)? Second Revised Draft. The Univer- sity of Chicago Harris School Working Papers, September 1, 1998. http://harrisschool.
uchicago.edu/about/publications/working-papers/ (accessed March 9, 2010).
Maczka, C. 2009. FSIS DataDrien Inspection. Paper presented at Institute of Medicine/
National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, May 28, 2009.
Mangen, M. J., M. B. Batz, A. Kasbohrer, T. Hald, J. G. Morris Jr., M. Taylor, and A. H.
Havelaar. 2009. Integrated approaches for the public health prioritization of foodborne2009. Integrated approaches for the public health prioritization of foodborne and zoonotic pathogens. Risk Analysis 30:702–797.
Marcus, R., J. K. Varma, C. Medus, E. J. Boothe, B. J. Anderson, T. Crume, K. E. Fullerton, M. R. Moore, P. L. White, E. Lyszkowicz, A. C. Voetsch, and F. J. Angula. 2007.
Re-assessment of risk factors for sporadic Salmonella serotype Enteritidis infections:
A case-control study in five FoodNet Sites, 2002–2003. Epidemiology and Infection 135(1):84–92.
Morgan, M. G., B. Fischhoff, A. Bostrom, L. Lave, and C. J. Atman. 1992. Communicating risk to the public. Enironmental Science and Technology 26(11):2048–2056.–2056.2056.
NRC (National Research Council). 2009a. Informing Decisions in a Changing Climate. Wash- ington, DC: The National Academies Press.
NRC. 2009b.. 2009b. Letter Report on the Reiew of the Food Safety and Inspection Serice Proposed RiskBased Approach to and Application of PublicHealth Attribution. Washington, DC:
The National Academies Press.
NRC/IOM (Institute of Medicine). 2009.. 2009. Letter Report on the Deelopment of a Model for Ranking FDA Product Categories on the Basis of Health Risks. Washington, DC: The National Academies Press.
Radin, B. 2006. Challenging the Performance Moement: Accountability, Complexity and Democratic Values. Washington, DC: Georgetown University Press.
Ruzante, J. M., V. J. Davidson, J. Caswell, A. Fazil, J. A. L. Cranfield, S. J. Henson, S. M.
Anders, C. Schmidt, and J. Farber. 2009. A multi-factorial risk prioritization framework for foodborne pathogens. Risk Analysis 30(5):724–742.
Scallan, E. 2007. Activities, achievements, and lessons learned during the first 10 years of the Foodborne Diseases Active Surveillance Network: 1996–2005. Clinical Infectious Diseases 44(5):718–725.
Scott, J. 2009. GMA Perspectie on FDA’s Role in Ensuring Safe Food. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.
Solomon, S. 2009. Regulating in the Global Enironment. Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensur- ing Safe Food Meeting, Washington, DC, March 24, 2009.
Taylor, J. 2009. Strengthening the link between performance measurement and decision making. Public Administration 87(4):853–871.
Taylor, M. R. 2002. Reforming Food Safety: A Model for the Future. Washington, DC:
Resources for the Future. http://www.rff.org/rff/Documents/RFF-IB-02-02.pdf (accessed (accessed January 25, 2010).
Taylor, M. R., and S. A. Hoffman. 2001. Redesigning Food Safety: Using Risk Analysis to Build a Better Food Safety System. Washington, DC: Resources for the Future. http://
www.rff.org/documents/RFF-DP-01-24.pdf (accessed January 26, 2010).
Treasury Board of Canada Secretariat. 2007. Assessing, Selecting, and Implementing Instru
ments for Goernment Action. Secretariat: Her Majesty the Queen in Right of Canada.
http://www.tbs-sct.gc.ca (accessed January 26, 2010).
Tucker-Foreman, C. L. 2009. Testimony of Carol L. TuckerForeman, Distinguished Fellow, The Food Policy Institute, Consumer Federation of America, before the Committee on Agriculture, U.S. House of Representaties. Agriculture. Washington, DC.
USDA (U.S. Department of Agriculture). 2010. FSIS National Residue Program for Cattle.
http://www.usda.gov/oig/webdocs/24601-08-KC.pdf (accessed on May 12, 2010).
van Pelt, W., M. A. de Wit, W. J. Wannet, E. J. Ligtvoet, M. A. Widdowson. and Y. T. van Duynhoven. 2003. Laboratory surveillance of bacterial gastroenteric pathogens in the2003. Laboratory surveillance of bacterial gastroenteric pathogens in the Netherlands, 1991–2001. Epidemiology and Infection 130(3):431–441.
Varma, J. K., M. C. Samuel, R. Marcus, R. M. Hoekstra, C. Medua, S. Segler, B. J. Anderson, T. F. Jones, B. Shiferaw, N. Haubert, M. Megginson, P. V. McCarthy, L. Graves, T. Van Gilder, and F. J. Angula. 2007. Listeria monocytogenes infection from foods prepared in a commercial establishment: A case-control study of potential sources of sporadic illness in the United States. Clinical Infectious Diseases 44(15):521–528.–528.528.
Wagner, R. 2009. FDA’S Current Approach to Risk Based Domestic Inspection Planning.
Paper presented at Institute of Medicine/National Research Council Committee on Review of the FDA’s Role in Ensuring Safe Food Meeting, Washington, DC, March 24, 2009.
4
Sharing the Responsibility for a Risk-Based System:
Models of Governance and Oversight
T
he safety of the U.S. domestic and imported food system is a responsi- bility shared by suppliers, farmers, food handlers, processors, whole- salers and retailers, food service companies, consumers, third-party organizations, and government (federal and state) agencies in the United States and abroad. Given the size and scope of the system, it is unrealistic to expect the U.S. Food and Drug Administration (FDA), or any agency at the federal level, to be everywhere and to do everything necessary to ensure food safety through surveillance and inspection without the help of those who share this responsibility.The design of approaches to governance to achieve society’s goals has been the subject of much debate and experimentation in a wide range of areas, from the financial system to public safety. The published literature on the subject addresses the pros and cons of various approaches to shar- ing responsibility, factors to be considered, and lessons learned from the implementation of these approaches. Models of governance that deviate from the traditional enforcement of rules through the imposition of penal- ties include voluntary approaches whereby regulators work with industry to develop codes of practice, third-party audits, management-based systems in which firms are responsible for adhering to plans that limit harms, and performance-based approaches that emphasize results rather than the use of specific technologies or actions. These alternatives may serve to distribute accountability across all parties that might affect outcomes.
Innovative governance approaches have already been applied to the environment, building safety, consumer product safety, nuclear power plant safety, transportation safety, and health care, among many other areas, with
BOX 4-1
Examples of the Use of Alternative Governance Approaches Nuclear Power Safety
Before the Nuclear Regulatory Commission (NRC) focused atten- tion on issues essential to protecting public health, the Atomic Energy Commission was often criticized for its dual role in protecting public health while also avoiding imposing requirements that would inhibit the growth of the industry. With respect to nuclear reactors, the NRC took the traditional approach of creating standards and requirements to pro- tect public health, eventually giving operators the sense that accidents would be prevented as long as compliance with these standards and requirements was verified by an inspector. This traditional prescriptive approach, however, was criticized as being unable to promote uniform levels of safety. The NRC then moved toward a risk-based system, whereby accountability is placed on the operator’s side. However, the Government Accountability Office has noted major challenges to the suc- cess of this system, including the need to encourage a shift to a culture of safety, significant human capital needs and costs, and methodological challenges (GAO, 2006).
British Railway System
Potential limitations of implementing novel governance approaches in the health and safety arena may be evident in the experience of the British railway system. Hutter (2001) suggests that such a move may have led to breaches in public safety. Often, a self-regulatory regime is seen as a superior governance model in that it relies not only on govern- ment accountability, but also on the capacity of corporations to regulate themselves and develop systems tailored to their specific operations.
Innovation is encouraged, and companies are more likely to follow their own rules than rules imposed on them. Hutter argues that in the case of the railway industry in Britain, enforced self-regulation was not appro- priately monitored and ended up being itself the source of risk. In fact, the self-regulation was more procedural than substantive; although rules were in place, they were not well understood. Lack of communication was a major explanation for the failure of the system in a company that was fragmented functionally and geographically.
both failure and success. Examples are presented in Box 4-1. These exam- ples illustrate that developing criteria for selecting a governance approach, making the selection, and evaluating performance outcomes are essential activities for regulatory agencies. These two examples are but a small sam- pling of the many models of regulation and oversight that exist, and the
selection of the most appropriate model for specific circumstances is a sub- ject of active debate. Even within the area of food safety, several different models of governance are evolving worldwide (Batz et al., 2005; Garcia- Martinez et al., 2007; Treasury Board of Canada Secretariat, 2007).
Chapter 3 describes the elements that are essential to the operation of a risk-based food safety system, as concluded by the committee. A governance model for the FDA must articulate criteria for deciding who is responsible for overseeing the various elements, for choosing and implementing policy interventions, and for evaluating the performance of the system. Defining the nature and range of shared responsibility is central to implementing several of these elements. This need for clearly reasoned models for shared responsibility and oversight is the subject of this chapter. The chapter reviews approaches to making governance decisions and developing a regu- latory philosophy, as well as choosing policy interventions and assigning responsibility. The discussion includes the committee’s observations on how the FDA selects models of governance.
OVERALL APPROACH TO MAKING GOVERNANCE DECISIONS AND DEVELOPING A REGULATORY PHILOSOPHY
The Food Protection Plan (FPP), written in 2007 under the leadership of the Office of Food Protection, contains the FDA’s general philosophy with respect to food safety and focuses on what the agency considers to be the core elements of food safety: prevention, intervention, and response (see Box 4-2). The FPP also outlines the following four cross-cutting principles for a comprehensive food protection approach: (1) focus on risks over a product’s life cycle from production to consumption, (2) target resources to achieve maximum risk reduction, (3) address both unintentional and delib- erate contamination, and (4) use science and modern technology systems.
To operationalize these elements and principles and to strengthen its ability to protect Americans from foodborne illnesses, the FDA proposes internal administrative changes and recognizes the need to make legislative changes (Box 4-3). The FPP is a platform for initiating a transformation at the FDA, whereby policy decisions are based on prevention and risk. However, it does not provide detail on how the principles it outlines will be achieved.
The committee supports the findings of the U.S. Government Accountability Office (GAO) (GAO, 2008a,b) that the plan does not offer specific strategies for many of the actions proposed. For example, although it refers to risk- based inspections, detail on analytical risk models or even factors that will be considered in developing such models is absent. The terms “risk” and “risk- based approaches” are understood in different ways, underlining the impor- tance of detailed articulation of such factors. Indeed, Chapter 3 explains the importance of a regulatory agency’s delineating in detail a broad strategic