Document Type



Harvard Journal on Legislation




Recent efforts to regulate the safety of U.S. food imports have not kept up with the complexity of global trade and the risks that accompany globalization. Congress drafted the Food Safety Modernization Act of 2011 ("FSMA") in response to heightened food safety risks, surging imports, and an outdated food import safety system. While the FSMA provides the Food and Drug Administration ("FDA") additional authority to regulate food facilities, establish standards for safe produce, recall contaminated foods, and oversee imported foods, vulnerabilities still exist.

This article exposes problems with the old system of food import rules and significant challenges facing the FDA as it implements the new FSMA rules. Using a hypothetical, the author compares food import risks before and after the FSMA rules to determine which vulnerabilities are likely to remain despite the new rules. She concludes that the growing number of trading partners will further complicate supply chains, and rising trade obligations will exert downward pressure on the United States' heightened standards.

This article discusses the new FSMA rules, identifies specific challenges, and offers tangible solutions to guide final rulemaking. In light of pressure by the World Trade Organization ("WTO"), Regional Trade Agreements ("RTA"), and Mega-regionals, U.S. food safety regulators need to ensure that the higher food safety standard is not compromised. If the FSMA rules are able to withstand global challenges, these rules have the potential to serve as the global standard for food safety.