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The Institute of Medicine's (IOM's) Food Forum was established in 1993 to allow science and technology leaders in the food industry, top administrators in the federal government, representatives from consumer interest groups, and academicians to discuss and debate food and food safety issues openly and in a neutral setting. The Forum provides a mechanism for these diverse groups to identify possible approaches for addressing food and food safety problems and issues surrounding the often complex interactions among industry, academia, regulatory agencies, and consumers. On May 6-7, 1997, the Forum convened a workshop titled Enhancing the Regulatory Decision-Making Process for Direct Food Ingredient Technologies. Workshop speakers and participants discussed legal aspects of the direct food additive approval process, changes in science and technology, and opportunities for reform. Two background papers, which can be found in Appendix A and B, were shared with the participants prior to the workshop. The first paper provided a description and history of the legal framework of the food ingredient approval process and the second paper focused on changes in science and technology practices with emphasis placed on lessons learned from case studies. This document presents a summary of the workshop.
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
For many Americans who live at or below the poverty threshold, access to healthy foods at a reasonable price is a challenge that often places a strain on already limited resources and may compel them to make food choices that are contrary to current nutritional guidance. To help alleviate this problem, the U.S. Department of Agriculture (USDA) administers a number of nutrition assistance programs designed to improve access to healthy foods for low-income individuals and households. The largest of these programs is the Supplemental Nutrition Assistance Program (SNAP), formerly called the Food Stamp Program, which today serves more than 46 million Americans with a program cost in excess of $75 billion annually. The goals of SNAP include raising the level of nutrition among low-income households and maintaining adequate levels of nutrition by increasing the food purchasing power of low-income families. In response to questions about whether there are different ways to define the adequacy of SNAP allotments consistent with the program goals of improving food security and access to a healthy diet, USDA's Food and Nutrition Service (FNS) asked the Institute of Medicine (IOM) to conduct a study to examine the feasibility of defining the adequacy of SNAP allotments, specifically: the feasibility of establishing an objective, evidence-based, science-driven definition of the adequacy of SNAP allotments consistent with the program goals of improving food security and access to a healthy diet, as well as other relevant dimensions of adequacy; and data and analyses needed to support an evidence-based assessment of the adequacy of SNAP allotments. Supplemental Nutrition Assistance Program: Examining the Evidence to Define Benefit Adequacy reviews the current evidence, including the peer-reviewed published literature and peer-reviewed government reports. Although not given equal weight with peer-reviewed publications, some non-peer-reviewed publications from nongovernmental organizations and stakeholder groups also were considered because they provided additional insight into the behavioral aspects of participation in nutrition assistance programs. In addition to its evidence review, the committee held a data gathering workshop that tapped a range of expertise relevant to its task.
In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.