President Barack Obama signed the FDA Food Safety Modernization Act (FSMA) into law on January 4, 2011. The primary driving force in the creation of this legislation was the recognition that more needed to be done to prevent food contamination.
Previously, significant resources had been allocated to respond to, rather than avert, the contamination of food. The passage of the FSMA attempts to correct this imbalance.
Notably, the FSMA is the first major piece of legislation to address the issue of food safety since 1938. The range of powers granted to food regulators under the act are the most extensive since the passage of the federal Food, Drug, and Cosmetic Act, legislation that laid the foundation for the governmental oversight of various consumer products.
Concentrating on Prevention
The proliferation of foodborne illness incidents between 2000 and 2010 prompted government officials to shift to a more preventive focus. Not only were these cases a threat to public safety, but they resulted in significant monetary losses. The food industry alone paid billions of dollars for product recalls and legal expenses. In addition, the industry had to account for billions in lost sales. The cumulative concerns from both public and private stakeholders re-emphasized the need for an inclusive and preventive food safety framework.
Prior to the enactment of the FSMA, the Food and Drug Administration (FDA) regulatory authority was mostly limited to the inspection and approval of foodstuffs. The FSMA broadened the FDA’s powers by granting the agency recall authority, a cause toward which the FDA had devoted its lobbying efforts for years. The new regulatory authority allows the FDA to work directly with public and private entities to ensure safe food practices. In addition, the FDA earned the authority to remove contaminated food from the market.
Furthermore, the FSMA revamped the oversight capabilities of the FDA, implementing a framework “focused on applying, more comprehensively than ever, the best available science and good common sense to prevent the problems that can make people sick.” Specifically, the FDA was given the authority to regulate the very processes involved in food production, which included growing, harvesting, processing, and transporting food products.
SMA statutes are intended to boost accountability from various stakeholders. For example, food processors are required to more closely evaluate and monitor internal operations, to implement comprehensive measures for corrective action, and to have detailed contingency plans in place in the event that food becomes contaminated. The FSMA allows for FDA oversight and enforcement of such accountability directives.
Overall, the legislation grants the FDA broad food safety powers in a number of areas. Four jurisdictional areas encompass the majority of significant provisions within the FSMA: prevention, response, imports, and inspection/compliance.
Preventive statues within the FSMA include both produce safety standards, as well as specified safety controls for food facilities. Under the FSMA, food facilities are required to document and implement a safety control plan that evaluates, specifies, maintains, and accounts for potential food safety hazards. Mandatory produce safety standards require the FDA to establish minimum scientifically based standards for the safe production and harvesting of fruits and vegetables. Moreover, the FDA is required to issue a series of science-based regulations against the intentional adulteration of food.
The FSMA also enhances the FDA’s response capabilities. A comprehensive food tracking and tracing system of domestic and imported goods is required under the law. Also included is a mandate for an augmented recordkeeping mechanism for facilities that process, hold, pack, or manufacture foods deemed to be high risk.
Enforcement statues include the FDA’s ability to issue mandatory recalls to companies that fail to voluntarily remove unsafe food products. In addition, the FDA now has the authority to administratively detain potentially harmful foodstuffs — effectively halting the transport of such products. Finally, the FDA may suspend a facility’s registration upon determining that its food products pose a risk to public health.
FSMA import statues require the formation of a voluntary “qualified importer program.” The program is intended to allow for the expedited review and entry of approved food products from importers. Also required is the establishment of a program wherein approved third parties can certify that foreign facilities comply with set standards of food safety.
Oversight measures require that importers verify adequate preventive control methods of their suppliers. Parties that fail to provide proof may be denied entry into the U.S. Furthermore, foreign facilities that refuse or deny the FDA’s request for access can be denied entry in accordance with FSMA law.
In addition, inspection and compliance responsibilities — the FDA’s primary roles — were further augmented under the FSMA. Inspection and compliance statutes include full access to industry records (including food plans), mandated inspection frequency of high-risk facilities, and the creation of accreditation standards for food testing laboratories. Furthermore, all future food testing must be conducted at an accredited food testing laboratory.