Enhancing Food Safety The Role of the Food and Drug Administration (2010) / Chapter Skim
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4 Sharing the Responsibility for a Risk-Based System: Models of Governance and Oversight
4 Sharing the Responsibility for a Risk-Based System: Models of Governance and Oversight
Pages 121-144
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From page 121... ...
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
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Examples are presented in Box 4-1. These examples illustrate that developing criteria for selecting a governance approach, making the selection, and evaluating performance outcomes are essential activities for regulatory agencies.
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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 regulatory philosophy, as well as choosing policy interventions and assigning responsibility.
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A major plank of its prevention strategy is a call for promoting increased corporate responsibility to prevent foodborne illness. The plan notes that examples of enhanced corporate responsibility might include "evaluating safety and security vulnerabilities and possible impacts; when appropriate, implementing preventive measures --
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. The plan states that an increased emphasis on prevention "will require close interaction with growers, manufacturers, distributors, retailers and food service providers, and importers.
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A poor reputation for proper food handling can drive a company to bankruptcy. Promoting increased corporate responsibility is key in shifting FDA's food protection effort to a proactive rather than a reactive one.
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Finally, incentive-based No government regulation NO INTERVENTION Private controls Voluntary private codes of practice Farm assurance schemes LEVEL OF GOVERNMENT INTERVENTION SELF-REGULATION Retailers' proprietary quality assurance schemes Government assembles and publishes evidence and INFORMATION provides information/advice to consumers AND "Naming and shaming" EDUCATION Government–private partnership in regulation COREGULATION Statutory or government-backed codes of practice or action plans Government rewards desirable behavior by private or INCENTIVE-BASED voluntary sector STRUCTURES Creation of market incentives for food safety investments Liability rules Prohibition requirement for certain actions, products, DIRECT and/or processes REGULATION Prescription process standards, labeling Sanctions and penalties FIGURE 4-1 Options for assigning private–public responsibility to ensure food safety. SOURCE: Adapted from Garcia-Martinez et al.
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ENHANCING FOOD SAFETY structures vary the amount and type of regulatory oversight based on how well a company performs; this is frequently referred to as a performance approach and also includes the setting of liability rules and related concepts, such as due diligence. The nature of shared responsibility for the management of food safety risks will evolve over time as legislation is passed, new circumstances arise, knowledge grows, stakeholders express different priorities, and constraints BOX 4-4 Managing the Safety of Produce: An Example of Evolving Shared Responsibility An example of how the U.S.
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SHARING THE RESPONSIBILITY FOR A RISKBASED SYSTEM shift. Based on outcomes, the mix of responsibility chosen initially may prove to be too reliant on voluntary action, at one end of the spectrum, or too focused on prescriptive government regulations, at the other end.
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, regulatory agencies benefit from having a risk-based road map for identifying and selecting interventions. Once policy interventions have been selected, assigning responsibility to different parties in the system is an important aspect of their implementation.
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Road Maps forigure 4-1 Policy Interventions F Choosing new R01720 Deciding what policy interventions to use in different situations and color determining the associated assignment of responsibilities is facilitated by having a road map of factors to consider in the selection process. It is common for multiple interventions to be in place simultaneously.
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The benefits identified as flowing from the use of this framework are Assigning/Sharing Responsibility The FDA or any agency charged with managing food safety must have mechanisms for overseeing food safety both domestically and internationally (for imported foods)
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tor, third-party or other accrediting organizations, governments of other countries, and the states. The Priate Sector A regulatory agency needs to set clear food safety standards and enforce those standards.
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Tort law, tax incentives, subsidies, other incentive-based interventions, and direct regulation are other strategies for producing the desired level of food safety. As noted above, the preferred choice of interventions and related assignment of responsibility evolve over time.
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Collaboration of this type can move systems forward to meet both societal and industry needs. aPublic Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bio terrorism Act)
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The FDA has been exploring this issue. For example, as noted earlier, the FPP calls for new legislative authority to authorize the agency to accredit highly qualified third parties for voluntary food inspections.
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committee since 2005, and their role in the process of public standards setting is under discussion at the Codex Alimentarius Commission, where a position on the matter has not yet been taken. During its last meeting in 2009, Codex decided to conduct an in-depth evaluation of the role and impact of such standards, based on comments about the negative impact of private standards on economies and questions about the science and transparency of the process (Henson and Humphrey, 2009)
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The committee found that the FPP does not articulate a clear approach to the roles of private parties and other governments in ensuring food safety for products imported into the United States. As discussed in Appendix E, the United States maintains that its approach to imported foods stands on the same general principles as its approach to domestic foods.
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As with the assignment of responsibility to industry, third parties, and other countries, the FDA needs an overall strategic vision for when it is desirable to rely on or partner with the states to ensure food safety as well as what allocation of appropriate areas and levels of responsibility is optimal. The committee found that the FDA lacks an overall regulatory philosophy or road map for these choices.
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The FDA conducted a pilot study to evaluate voluntary third-party certification programs for imported aquaculture shrimp. The FDA envisioned that such a program could help the agency make decisions about the safety of imported foods, such as prioritizing inspections and sampling.
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In essence, this road map should also serve to assign shared responsibility among the federal government, the private sector, third parties, the governments of other countries, the states, and consumers. The design of novel approaches to governance to achieve food safety is currently the subject of experimentation by other governments and debate by scholars.
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2004. Produce Safety from Production to Con sumption: 00 Action Plan to Minimize Foodborne Illness Associated with Fresh Produce Consumption.
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Washington, DC: The National Academies Press. LGMA (California Leafy Green Products Handler Marketing Agreement)
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