November 15, 2010

A New Role for the FDA in Food Safety

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I. Introduction

On March 14, 2009, President Obama remarked, "There are certain things that only a government can do. And one of those is ensuring that the foods we eat are safe and don‘t cause us harm."1 This is a widespread opinion and has been the prevailing opinion for over 100 years. Beginning in the 1870s and ‘80s, there were multiple bills in Congress to get the federal government heavily involved in food safety to effect—as one writer put it—a "dramatic expansion of the federal government‘s role in promoting the health and safety of American consumers."2 At the time, many of problems associated with food safety could be readily classified as a market failure. Pathogenic contamination was rampant, from insanitary plants and poor processing, and there were many compounds added to food that had no business in anyone‘s diet. There was generally no judicial remedy as there was almost no way to trace harm to offending products. The government‘s role in protecting consumers from risk has increased steadily right through today and, initially, the creation of the FDA saw some early successes in this area.

Yet early successes inevitably have given way to increasing stagnation and inefficiency. At the FDA, institutional arteries defined by informal relationships with stakeholders have hardened, and the supply of readily available science and technological solutions for obvious problems have been replaced by greater uncertainty and inefficiency. The FDA has continued to use the same tools as it did over 100 years ago to try and make food safer but, eventually, it will become obvious to even the most dedicated supporters of food-safety regulation that we cannot make food safer by continuing centuries-old practices. In order to reduce risk, the FDA must take on a new role.

But virtually all recent efforts to make food safer have been headed in the direction of giving the FDA more resources and more authority to continue in the same direction exercising greater control over industry. The FDA has offered a new plan issued under the Bush administration in their "Food Protection Plan: An Integrated Strategy for Protecting the Nation‘s Food Supply."3 This plan is composed of three core elements: prevention, intervention, and response. Central to the plan is an attempt to address the GAO‘s criticism of the lack of coordination between federal, state, and industry partners.4 Such coordination, coupled with risk-based inspections, would in principle allow the FDA to operate more effectively without having full responsibility for all enforcement activities. A more elaborate version than the FDA‘s plan is offered in a report entitled, "Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation‘s Food Safety System."5 Both of these documents suggest that a greater role is necessary at all government levels for food safety, with a primary emphasis on the central role of the federal government. But the history of the FDA suggests that this is the wrong direction. This discussion will begin with the early history of successes that the FDA enjoyed with early regulations. Next, there will be a discussion of how early successes evolved into diminishing regulatory effectiveness. Following that there will be a discussion of the complex world that the FDA now tries to regulate and inspect and what the modern approach has been to try and deal with this universe. Finally, there will be a discussion of new directions that are likely to be more effective at reducing food-borne disease.

ENDNOTES

1. Barack Obama, “Weekly Address: Reversing a Troubling Trend in Food Safety,” March 14, 2009. http://www.whitehouse.gov/blog/09/03/14/Food-Safety/.

2. Anthony Gaughan and Peter Barton Hutt, “Harvey Wiley, Theodore Roosevelt, and the Federal Regulation of Food and Drugs,” Harvard Law School, Winter 2004, p.3. http://leda.law.harvard.edu/leda/data/654/Gaughan.pdf.

3. Department of Health and Human Services and Food and Drug Administration, FDA Food Protection Plan: An Integrated Strategy for Protecting the Nation’s Food Supply, November 2007, http://www.nap.edu/openbook.php?record_id=12892&page=419.

4.GAO, Federal Oversight of Food Safety: FDA’s Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical, January 29, 2008.

5. Michael R. Taylor and Stephanie David, “Stronger Partnerships for Safer Food: An Agenda for Strengthening State and Local Roles in the Nation’s Food Safety System.” Department of Health Policy, School of Public Health and Health Services, George Washington University, http://www.scribd.com/doc/14519426/Stronger-Partnerships-forSafer-Food-Report-by-Michael-R-Taylor-and-Stephanie-D-David.