Food safety issues are once again in the news. A large outbreak of E. coli O104:H4, centered in Germany, has sickened more than 3,000 people and killed 35. After a lengthy investigation, German public health authorities believe the source of the E. coli to be bean and seed sprouts.
This recent outbreak highlights the need for strengthened national and international food safety regulation. The United States took a large step toward improving food safety earlier this year by enacting the FDA Food Safety Modernization Act (FSMA). In a recent Commentary in the Journal of the American Medical Association, O’Neill Institute Faculty Director Larry Gostin and I addressed the improvements that the FSMA will bring to the U.S.’s food safety system.
As noted in the Commentary, food safety regulation is complex and improving safety requires efforts aimed at primary prevention, surveillance, and response. The FSMA has been lauded for giving the FDA new mandatory recall authority for food, an enforcement tool it had lacked to date. Though mandatory recall authority is an enormous boon for the FDA, the current crisis in Germany highlights the importance of a comprehensive “farm-to-table” food safety system. Mandatory recalls can clearly only be applied when the source of the infection is known. For this latest outbreak, identifying the source of the outbreak proved difficult. By requiring producers to adopt preventive control plans and increasing inspections for production facilities, the FSMA moves the FDA toward a preventive approach to food safety.
The FSMA also addresses the safety of imported food, an increasingly important aspect of ensuring that the foods Americans eat are safe. Approximately 15% of the U.S. food supply is imported, making Americans vulnerable to food safety problems around the world. In the German E. coli outbreak, it appears that the contaminated sprouts were not exported from Germany, but the situation could have easily become a larger international crisis.
Global food safety requires not only the efforts of national governments to ensure the safety of their own residents, but also international efforts. The World Health Organization (WHO) plays an increasingly large role in monitoring food safety and responding to outbreaks. The International Food Safety Authorities Network (INFOSAN), a joint effort of WHO and the Food and Agricultural Organization, connects food safety authorities around the world to aid in early detection, identification, and response to food safety problems. Additionally, the overhaul of the International Health Regulations (IHR), culminating in the issuance of new Regulations in 2005, made this important international instrument applicable to food safety.
Though the FSMA is an enormous step forward for public health, realizing its potential will require additional attention to food safety from Congress. Without sufficient appropriations in the federal budget for FDA, and for food safety in particular, the FSMA’s promise will fall short. With Congress increasingly concerned with cutting the federal budget and hostile to new regulations, the FDA may be left with an impressive law it can’t implement or enforce.
UPDATE (June 20, 2011): The FDA today released a special report entitled “A Pathway to Global Product Safety and Quality.” The report highlights the changing global markets for FDA-regulated products (including food) and the agency’s commitment to “transform itself from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders.”
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.