The Impact of the Food Safety Modernization Act
As one of the last acts of the 111th Congress, President Barack Obama signed into law the Food Safety Modernization Act (FSMA) on January 4, 2011, a law which was aimed at updating and strengthening the regulatory authorities and tools of the Food and Drug Administration (FDA) that they use to protect the wholesomeness of the U.S. food supply. FDA is one of two federal agencies with the primary responsibility of overseeing the safety of food products consumed in the United States, along with USDA’s Food Safety and Inspection Service (FSIS). FSIS has jurisdiction over the meat and poultry sectors, while FDA has jurisdiction over every other type of food. FDA’s writ covers about 75 percent of the U.S. food supply.
These steps were taken in response to several serious foodborne illness outbreaks that had occurred in the U.S. food sector, such as the widespread problems with E. Coli in the spinach supply in 2006 and the salmonella cases from a single peanut processing facility in Georgia in 2008. The latter outbreak caused 700 cases of salmonella poisoning, including seven deaths, and resulted in a criminal trial for the former CEO of the company responsible in 2015. The CEO received a 28-year prison sentence for the 70 criminal counts he was found guilty of, including knowingly shipping tainted food across state lines, obstruction of justice, conspiracy and wire fraud.
Since the legislation was signed into law more than a decade ago, FDA has worked diligently to implement its major provisions. FSMA changed the mindset at FDA away from responding to outbreaks that had already occurred to taking steps to prevent them by reducing the pathogen loads and risk of cross-contamination on farms and in food processing facilities. Their rulemaking effort was complicated by the fact that Congress gave medium and small businesses and farms engaged in the agri-food sector a much longer timeline to come into compliance with the new rules, and the very smallest businesses, those with average annual food sales less than $25,000, were exempted from the new rules. Producers of food grains and specialty crops that are rarely consumed in their raw form, such as pumpkins, asparagus, and dry beans, are also exempt from compliance. While most of the rules were in place by 2015, for the smaller businesses covered by FSMA, full compliance was not required until 2018. Businesses with less than $500,000 in annual food sales and who sell primarily through direct to consumer outlets or local markets can receive qualified exemptions, which must still meet some modified requirements.
Over the last several years, FDA promulgated major rules in the following seven areas based on provisions included in FSMA:
• Preventive Controls for Human Food – Human food facilities registered with the FDA must implement a written plan that identifies hazards and outlines appropriate preventive controls
• Preventive Controls for Animal Food – Animal food facilities registered with the FDA must implement a written plan that identifies hazards and outlines appropriate preventive controls
• Produce Safety – Establishes minimum standards for growing, harvesting, packing, and storing produce
• Foreign Supplier Verification Program – Importers must verify that their global suppliers comply with FDA regulations
• Third-Party Certification – Accredits third-party certification bodies to administer voluntary consultative and regulatory audits to help companies prepare for regulatory audits or achieve certifications
• Food Defense (intentional adulteration) – Food facilities registered with the FDA must develop a plan that assesses contamination vulnerabilities and document a mitigation strategy for each vulnerability
• Sanitary Transportation – New requirements for companies that transport food, including shippers, receivers, loaders, and carriers
Violations of FSMA can result in a re-inspection of the facility in question, a food recall order if the contamination is pervasive, seizure of shipments of contaminated food, and even arrest of responsible individuals or suspension of FDA licenses of facilities, resulting in temporary or even permanent closure of operations there.
Data on reported incidence of foodborne illness in the United States as collected by the Centers for Disease Control (CDC) indicate that cases of illness due to infections from salmonella and campylobacter increased slightly between 2015 and 2019, but those pathogen exposures are known to derive primarily from consumption of meat and poultry, which are not under FDA’s jurisdiction. On the other hand, cases of foodborne illness from shigella and listeria either fell or were stable during the same period, suggesting some improvement in the food safety situation over that period.
According to preliminary CDC statistics for foodborne illnesses in 2020, the incidence of such illnesses fell by 26 percent in the United States as compared to the 2017-19 average, believed to largely be the result of changes in food consumption patterns and human behavior as a result of the COVID-19 pandemic that emerged in March of 2020. Experts point to improved hygienic practices on the parts of individuals, the mass closure of restaurants and other institutional settings such as school cafeterias, reduced international travel, and reduction of emergency room visits due to fears of contracting COVID-19 in hospitals as the major factors contributing to this marked decline.
The FSMA rulemaking process is still going on more than ten years later. On December 2nd, 2021, FDA issued a proposed rule that would require farms to conduct comprehensive assessments that would help them identify and mitigate hazards in water used to grow produce. This proposal would replace the current microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with provisions for systems-based agricultural water assessments that are designed to be more feasible to implement across the wide variety of agricultural water systems, uses, and practices. Under the Administrative Procedures Act, comments on the proposed rule are due to be submitted within 120 days of its appearance in 7the Federal Register.
