Understanding the Basics of Food Safety Regulations

Darin Detwiler, assistant dean of Northeastern University’s Regulatory Affairs program, describes why food safety regulations exist and how they are created.

Food safety regulations affect all participants in the food supply chain, from farm to table. With 48 million Americans becoming ill and 3,000 dying from foodborne pathogens, food safety regulations are paramount for public health. For all in the food industry, managing food safety risks and adhering to food safety regulations should be regarded as more than economic and legal imperatives.

Regulatory agencies in the U.S. include federal, state, and local boards of health. The Government Accountability Office (GAO) has identified as many as 15 federal agencies, with the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) serving as the major players and policy entities in food safety. The USDA regulates meat and poultry products—only about 20 percent of foods—while the FDA regulates the remaining 80 percent.

In January 2018, the heads of the USDA and FDA announced a formal agreement aimed at making the oversight of food safety more efficient and effective by bolstering coordination between the two agencies.

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How Food Safety Regulations Are Created

In the U.S., food safety regulations may be declared by legislative bodies, such as Congress, while state and local regulatory agencies handle the retail food segment and other food safety issues through state legislative bodies or local town ordinances and bylaws. State and local regulatory agencies may adopt or modify the federal standards. If they adopt the minimum federal standards with changes, however, these changes must be more stringent than the federal minimum standards.

The USDA and FDA, as mandated by Acts of Congress, regulate food safety interstate under their respective statutory authorities, codified in the Code of Federal Regulations. Both the FDA and USDA have provisions written into the acts that regulate their segment of the food supply individually, yet they also have cooperative inspection programs that work together. State Food Protection Programs, such as a state’s department of agriculture or public health, are responsible for the enforcement of regulations adopted by state legislation.

Why Food Safety Regulations Are Created

Regulations are created by documented need through scientific-based studies and data. The history of modern food safety regulations can be traced back to the Pure Food and Drug Act and Meat Inspection Act, both passed in 1906 by Theodore Roosevelt into law.

The earliest days of U.S. food regulation were in direct response to public outcry from Upton Sinclair’s 1906 publication of The Jungle, which described the horrific conditions and practices of the meat packing industry. While published as fiction, Roosevelt’s investigative team reported back to the president that the conditions noted in the book were sadly accurate. Roosevelt—alarmed to the point of considering vegetarianism—signed the acts signifying the first modern regulations for food safety.

Legal losses due to interpretations of the Pure Foods Act identified weaknesses in the laws that allowed unsafe practices to occur without penalty. After a mass poisoning of patients treated with an untested medication killed 100, including 34 children, in 1937, President Franklin Roosevelt signed the 1938 Food, Drug, and Cosmetic Act to replace the Pure Foods Act and provide:

Legally mandated quality and identity standards for foods, prohibition of false therapeutic claims for drugs, coverage of cosmetics and medical devices, clarification of the FDA’s right to conduct factory inspections, and control of product advertising, among other items.

The USDA made significant policy and inspection changes after the landmark 1993 “Jack in the Box” E. coli outbreak. Referred to as “the most infamous food poison outbreak in contemporary history” and the “9/11 of the meat industry,” this outbreak involved 73 fast food restaurants in California, Idaho, Washington, and Nevada, and resulted in nearly 750 reported cases of foodborne pathogen from contaminated beef patties. Worse, the outbreak left four children dead and another 178 young victims with permanent injuries, including kidney and brain damage.

Within a year, the USDA initiated research into new inspection policies and proposed establishing a Pathogen Reduction Program in federally inspected meat-processing facilities. These specific policy changes would require a radical change in how the USDA viewed pathogens.

Knowing time was required to make these changes, former USDA Secretary Mike Espy proclaimed that— in the absence of a way to detect or prevent the presence of E.coli bacteria—the USDA must do “everything [it] can do to help inform consumers about proper preparation and storage of not-ready-to-eat meat and poultry.” That announcement initiated a public education program that included placing food safe handling labels on all packages of raw meat and poultry.

Because the USDA only regulates food safety of meat and poultry, changes in FDA policies would come later, after there were outbreaks of foodborne pathogens tied to produce and ready-to-eat foods. In 2006, the California vegetable industry experienced a multi-state food poisoning incident, which resulted in 205 people becoming ill and three dying after consuming bagged spinach tainted with E. coli.

The first major overhaul of FDA food regulation since 1938 came with the 2010 Food Safety Modernization Act (FSMA). The act is important because it signifies a shift in the FDA’s focus on food safety regulation from reactive to proactive; the agency began mandating a series of risk-based preventive controls.

Before the FSMA implemented new rules, a number of high-profile foodborne illness cases tested the FDA’s ability to coordinate with the U.S. Department of Justice to handle large-scale outbreaks, including:

• The Jensen Farms of Listeria outbreak of 2011 involving cantaloupe, which resulted in 150 infected persons from 28 states and at least 33 deaths. In their subsequent federal trial, the owners received $3 million in fines and five years of probation.
• The Peanut Corporation of America’s Salmonella outbreak of 2008-2009 led to more than 700 infected persons from 46 states and nine deaths. This incident involved a massive recall of more than 3,900 different types of products from 350 companies. Though the scale and economic losses of the outbreak were notable, more so were the outcomes of the trial. The court found PCA’s owner and his brother guilty on a combined 97 federal criminal charges. The judge sentenced the CEO to 28 years in federal prison, his brother to 20, and three other quality assurance and plant managers to three to six years.
• The DeCosters’ Egg 2012 Salmonella outbreak resulted in nearly 2,000 infected persons reported to the CDC, although the CDC estimates that up to 56,000 people may have been affected. In the subsequent federal trial, the owners were sentenced to three months in prison.

While these failures might show that not everyone follows food safety regulations, there is a faster-growing number of food policy experts, regulatory authorities, and policymakers who are dedicated to making a positive change. What’s more, the vast majority of companies and individuals behind the foods we eat go above and beyond what is ethical and right to do. Food safety regulations help ensure this.