Volume 59 Issue 3
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Table of Contents
> Food Safety Oversight for the 21st Century:
The Creation of a Single, Independent Federal Food Safety Agency
by Richard J. Durbin, U.S. Senator (D-IL). Senator Durbin serves on the Oversight of Government Management Subcommittee, Committee on Governmental Affairs.
> Establishing a Single, Independent Food Standards Agency: The United Kingdom’s Experience
by John Krebs, Chairman of the Food Standards Agency, London, United Kingdom.
> Lead or React? A Game Plan for Modernizing the Food Safety System in the United States
by Michael R. Taylor, Senior Fellow at Resources for the Future, a nonprofit policy research organization based in Washington, D.C. He served formerly as Deputy Commissioner for Policy at the Food and Drug Administration and as Administrator of the Food Safety and Inspection Service in the U.S. Department of Agriculture.
> Food Security Would Be Compromised by Combining the Food and Drug Administration and the U.S. Department of Agriculture Into a Single Food Agency
by Stuart M. Pape, Partner in the FDA practice group at Patton Boggs LLP, Washington, D.C. He previously served as the Associate Chief Counsel for Food at the Food and Drug Administration (FDA) and executive assistant to FDA Commissioner Donald Kennedy.
Paul D. Rubin, Partner in the FDA practice group at Patton Boggs LLP, Washington, D.C.
Heili Kim, Associate in the FDA practice group at Patton Boggs LLP, Washington, D.C.
> Are We Cutting the GRAS? Food Safety Perceptions Are Diminished by Dysfunctional Bureaucratic Silos
by James T. O’Reilly, Visiting Professor of Law, University of Cincinnati, OH.
> It Is Time to Designate a Single Food Safety Agency
by Timothy M. Hammonds, President and Chief Executive Officer of the Food Marketing Institute (FMI), Washington, D.C.
> Rising Imports, Bioterrorism, and the Food Supply
by Caroline Smith DeWaal, Director of Food Safety at the Center for Science in the Public Interest (CSPI), Washington, D.C.
> Putting All Your Eggs in One Basket: Egg Safety and the Case for a Single Food-Safety Agency
by Sandra B. Eskin, public policy consultant in the Washington, D.C. area, specializing in Consumer Protection issues, in particular food and drug safety and labeling.
> The Single Food Safety Agency: A Modest Dialectic Dialogue
by Scott Bass, head of the Sidley Austin Brown & Wood International Food and Drug Law Practice, in Washington, D.C.
Alan Raul, head of the Sidley Austin Brown & Wood Information Law and Privacy Practice, in Washington, D.C. Formerly, he served as General Counsel of the U.S. Department of Agriculture and of the Office of Management and Budget.
Food Safety Oversight for the 21st Century:
The Creation of a Single, Independent Federal Food Safety Agency
Author: Richard J. Durbin
Issue: 59 Food and Drug Law Journal 383-386 (2004).
I have been working for the creation of a single, independent federal food safety agency in the United States since my election to the U.S. Senate in 1996, but the debate has raged for much longer. At least twelve federal agencies have authority over food safety currently, leading to confusion, duplication, and an inability to respond quickly to new challenges. Over twenty-five years ago, the Senate Committee on Governmental Affairs concluded that overlapping authority and inconsistency hampered the U.S. food regulatory system. The General Accounting Office has called for a single food safety agency in at least sixty reports over the last twenty-five years. In a comprehensive 1998 study, the National Academy of Sciences also concluded that a single official be charged with food safety regulation. It is now time to act. I propose a single food safety agency with an administrator who would oversee all food safety laws, develop safe food standards, coordinate food safety research and education, focus resources on reducing foodborne illness, and coordinate with state and local agencies to ensure the safety of the U.S. food supply.
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Establishing a Single, Independent Food Standards Agency:
The United Kingdom’s Experience
Author: John Krebs
Issue: 59 Food and Drug Law Journal 387-398 (2004).
During the 1980s and 1990s a series of food scares, culminating in the BSE crisis, badly damaged public confidence in the United Kingdom’s food supply. The government set up the Food Standards Agency (FSA) as a radical response to the climate of confusion and suspicion surrounding the handling of food safety and standards issues. The FSA is an independent public protection body governed by a board appointed to act in the public interest and put consumers first. Since its inception in April 2000, the FSA has achieved widespread public recognition and has established a reputation for the clarity of its advice and the prioritization of consumer interests. It has increased public trust in food safety by being honest about food risks and uncertainties, and by being open, transparent and inclusive in its decisionmaking. All of the FSA’s advice and information is published free of political influence.
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Lead or React? A Game Plan for Modernizing the Food Safety System in the United States
Author: Michael R. Taylor
Issue: 59 Food and Drug Law Journal 399-404 (2004).
For several years, many food safety experts and stakeholders have called for statutory and organizational reform of the U.S. food safety system to better deal with the public health problem of foodborne illness and the new food safety challenges of the global food system. Such fundamental change in government programs is difficult to achieve, however, without strong leadership from the top of the American political system. This article describes the need for modernization of the U.S. food safety system and a game plan for a White House-led initiative to achieve it, based on an inclusive, bipartisan effort to design, legislate, and implement needed change.
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Food Security Would Be Compromised by Combining the Food and Drug Administration
and the U.S. Department of Agriculture Into a Single Food Agency
Authors: Stuart M. Pape, Paul D. Rubin & Heili Kim
Issue: 59 Food and Drug Law Journal 405-416 (2004).
There is a recurring debate regarding combining certain segments of the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) into a single food agency. Although this consolidation may have made sense in a pre-September 11th context, the authors believe that post-September 11th, with increase terrorism and bioterrorism concerns, the debate should now be closed. In the current high-risk environment, food security has taken on greater importance. The extensive amount of time required to merge such large, multifaceted regulatory agencies and resolve longstanding jurisdictional and other issues would jeopardize existing safeguards and potentially compromise the food supply—particularly in the short term. FDA and the USDA have recognized the importance of food security and implemented numerous measures to secure the nation’s food supply. At the present time, there is little reason to believe that any food security benefits would result from a consolidation of FDA and the USDA.
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Are We Cutting the GRAS? Food Safety Perceptions Are Diminished by Dysfunctional
Bureaucratic Silos
Author: James T. O’Reilly
Issue: 59 Food and Drug Law Journal 417-426 (2004).
Times have changed, and the future of the inefficient silos in the United States that divide food regulation by politically-derived classes shows that the current system diminishes U.S. leverage in a global food regulatory system. This article calls for an end to artificial lines between regulatory bodies and to conflicts, including the funding of regulators by fees from applicants. Congress should modify its oversight, split the Food and Drug Administration's medical products from its food roles, and centralize federal food programs in a single food overseer with proper incentives to actually improve quality and the perception of food safety.
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It Is Time to Designate a Single Food Safety Agency
Author: Timothy M. Hammonds
Issue: 59 Food and Drug Law Journal 427-432 (2004).
The U.S. regulatory system that has served our country so well in maintaining the safety, integrity, and wholesomeness of the food supply has evolved piecemeal over a full century. Changes to this system have been made in response to problems as they have arisen one-by-one, not as part of a well-thought-out strategy. Faced with far different needs than were possible to envision when this basic system was designed and implemented, we are nearing the point at which we will no longer be able to provide the level of safety and security we have come to expect. This article presents the case for a strategic redesign and makes specific suggestions for how this might be accomplished.
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Rising Imports, Bioterrorism, and the Food Supply
Author: Caroline Smith DeWaal
Issue: 59 Food and Drug Law Journal 433-440 (2004).
Today, the food on America’s tables comes from all over the world. Innovations in transportation and refrigeration have revolutionized the food industry, leading to more centralized food production nationally and an increased reliance on imports. But with the international globalization of the food industry also come greater risks from both food-borne illness outbreaks and bioterrorism.
In the United States, there are many weaknesses in the government’s food safety infrastructure. Multiple agencies have overlapping responsibilities and share a disparate allocation of resources. New issues, like mad cow disease or genetically modified foods, do not fit neatly into the statutory framework. In addition, the growing numbers of imports, coupled with insufficient resources, make effective regulation increasingly difficult. The food safety infrastructure would be immensely strengthened by the creation of a unified food safety agency. This new agency should consolidate responsibility, authority, and resources and operate under a modern food safety statute. Improving government programs will make the food supply safer overall and also will serve as a deterrent to using food to threaten public safety.
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Putting All Your Eggs in One Basket: Egg Safety and the Case for a Single Food-Safety Agency
Author: Sandra B. Eskin
Issue: 59 Food and Drug Law Journal 441-452 (2004).
This article examines the existing approach to the regulation of egg safety in the United States as a case study in support of a single food-safety agency. It begins with a review of the history and evolution of the multiple laws, regulations, and agencies governing egg safety at both federal and state level. The emergence of Salmonella enteritidis (SE) as an egg-borne pathogen in the mid-1980s presented authorities with a significant challenge. This article chronicles both the causes and conditions that led to SE contamination in eggs, as well as the government authorities’ response to it. After reviewing the various elements that comprise a comprehensive SE-control strategy—on-farm measures, controls at packing and processing plants, refrigeration and labeling requirements—and assessing the current regulations (or lack thereof) in these areas, the article concludes by arguing that the development of a single food-safety agency governing all aspects of egg safety would be far more efficient and effective than the current bifurcated system.
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The Single Food Safety Agency: A Modest Dialectic Dialogue
Authors: Scott Bass & Alan Raul
Issue: 59 Food and Drug Law Journal 453-458 (2004).
Two food and drug practitioners engage in a spirited dialogue over the proposition that food safety responsibilities should be consolidated in one agency, based at the U.S. Department of Agriculture (USDA), with jurisdiction over all foods—not bifurcated as it is now between meat and poultry at the USDA, on one hand, and all other foods at the Food and Drug Administration (FDA), on the other. This dialectic presentation reviews the history and development of the current regulatory scheme, considers various suggestions for reform, examines the strengths and flaws of the single agency theory, and posits some possibilities for the future.
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