Opening Session - Ivan Parkin Lecture

Sunday, July 22, 2012: 6:00 PM-7:30 PM
Ballroom (Rhode Island Convention Center)
Jenny Scott, Senior Advisor, Office of Food Safety, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, Maryland, USA

Working for an industry trade association and for FDA has given me the opportunity to see how the industry and government carry out their roles in ensuring the safety of food in a complementary way. I also better see how we have become more proactive over the years and how we can work more cooperatively to enhance food safety. Both industry and government must assess the risk of illness or injury from food. Industry generally assesses this qualitatively by identifying and evaluating the hazards associated with the food being produced. Industry uses information from a variety of sources, including government. Recently there has been more emphasis on doing quantitative microbial risk assessments. Industry rarely does a quantitative risk assessment, since this is not needed to determine appropriate control measures for a hazard, but industry is beginning to see how conducting such risk assessments can benefit them, e.g., to support labeling a product “pasteurized.” Government is more likely to conduct quantitative risk assessments to describe the risk to consumers, which then become resources for industry in assessing hazards in, or risk from, specific food products. To conduct such risk assessments, the government must often rely on industry data. Although industry and government need data from each other to assess the risk from foods, both industry and government have issues related to data sharing, especially availability of data and timeliness. Implementation of control measures is industry’s role, but government regulations are often needed to establish the standards that industry as a whole must follow. In the absence of government regulations or guidance, industry must establish its own standards, but in the absence of regulations these may not be uniformly applied. Industry often recognizes a need and takes action well before the government can develop regulations and/or guidance (a slow process, even when government uses “expedited” approaches, because of the many layers of approvals needed). There are many examples in which industry has been proactive and moved much more quickly than government, including guidance on pathogens in refrigerated foods and low moisture foods. The government is willing to participate in the development of industry guidance documents, which can lead to a common understanding of the issues to be addressed and help ensure industry guidance will be acceptable to the relevant government agency. Sharing guidance documents with government can lead to disseminating them on a government website and to the development of agency guidance via a shortened process. Such sharing also has an advantage for industry in that government guidance is more likely to be practical for industry. Recently much more emphasis has been placed on validating that control measures can achieve desired outcomes. Validation of control measures is primarily the role of industry, but government has much to offer in support of validation. Cooperative approaches can ensure acceptance of specific control measures by both industry and government. The passage of the Food Safety Modernization Act is providing many opportunities for industry and government to work together to share food safety data and information, e.g., in the development of training and education materials and guidance documents. Industry and government should not waste these opportunities to work together to enhance the safety of the food supply.

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