FSMA logoThe numerous food recalls, challenges involving imported food, and market disruptions in recent years have amplified both consumer and industry awareness regarding the importance of food safety. As a result of this increased awareness, food safety legislation—such as the Food Safety Modernization Act (FSMA)—has gained strong and widespread support, along with subsequent enactment as jurisprudence.

Americans nearly universally have high food safety expectations. Similarly, they are overwhelming in agreement that there should be enhanced government regulation of food products. In 2014, 73 percent of the 2,236 American adults polled were in favor of “more government oversight of food safety.” It is noteworthy that this poll was taken three years after the passage of the FSMA, which is widely considered the strongest food safety legislation in over 70 years.

Elected officials have seemingly shifted their efforts toward ensuring the effective administration of the nation’s food safety organizations. Specifically, they want to ensure that these apparatuses have the necessary authority, structural organization, and resources “to safeguard the health of American consumers against foodborne illness.”

According to the U.S. Government Accountability Office, 15 federal agencies administer a minimum of 30 food safety laws. The following outlines the primary responsibilities of two key organizations: the Center for Food Safety and Applied Nutrition (CFSAN) within the Food and Drug Administration (FDA) and the Food Safety and Inspection Service within the United States Department of Agriculture (USDA).


Focused on food safety, CFSAN “in conjunction with the agency’s field staff, is responsible for promoting and protecting the public’s health by ensuring that the nation’s food supply is safe, sanitary, and honestly labeled.” It is estimated that CFSAN regulates approximately $470 million in domestic and imported foods. FDA regulatory authority includes all foodstuffs that are not classified as eggs, meat, or poultry, which are under the jurisdiction of the USDA.

One of the primary goals of the FSMA blueprint was the allocation of additional resources toward the prevention of foodborne illness. In order to accomplish this, certain statutes contained within the FSMA grant the FDA expanded regulatory authority, including statues that allow preventive capabilities for the first time.

As previously mentioned, FSMA legislation grants the FDA preventive controls to combat foodborne illnesses. In doing so, FSMA essentially realigned the FDA’s operational framework to one that emphasizes prevention. The legislation spells out no fewer than 50 specific deliverables for which the FDA must be accountable.

First, in order to appease public concern associated with food imports, the FSMA grants the FDA the authority to align imported foodstuffs with U.S food safety standards. In order to successfully meet such standards, food importers are required to provide sufficient documentation verifying and detailing the preventative controls of all foreign suppliers. Additionally, the FDA is able to provide accreditation to third-party safety auditors, who are responsible for the inspection and certification of foreign food facilities in conjunction with U.S. food safety standards.

Second, the FSMA gave the FDA authority to issue a mandatory food recall for the first time. The FSMA also boosted the FDA’s authority over the administrative detention of potentially harmful products, an action taken to prevent the sale of harmful products. Furthermore, the FSMA grants the FSA authority in the suspension or revocation of a facility’s registration.


The food safety mission of the USDA is “(ensuring) that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and properly labeled and packaged.” The organization’s food safety branch, FSIS, executes the USDA’s food safety authorizations. Together with the FDA, the two agencies comprise the majority of the nation’s food safety operations.

As it relates to the complex FSMA legislation, the USDA serves in more of an advisory, educational, and supplementary role. Accordingly, the agency’s inherent partnership with the FDA was further expanded.

One example of this expanded partnership is FSMA section 104, which requires the FDA—in conjunction with the USDA—to “implement performance standards to determine the most significant food contaminants.” As such, the USDA supports the FDA’s efforts in conducting science-based research to promote additional safeguards that “reduce the risk of serious illness or death, prevent adulteration of food, or prevent the spread of a communicable disease by food.” Any subsequent findings are often included within amendments to FSMA law.

Similarly, FSMA section 105 details additional collaborative functions of the USDA. Coordinating with the FDA, USDA officials are responsible for community education and outreach efforts. The rationale behind the USDA’s extensive activity in this regard is two-fold: a wide variance of scale between food production facilities (such as small farms and large plants) and the education of food producers is vital to the successful enactment of FSMA.

The USDA and FDA must provide sufficient and demonstrable feedback from communities, as such evidence is crucial to both amend and implement FSMA law. The feedback is then used to construct the “final rules” of the FSMA—or amended, executable law.