Skip to main content

Cover Story : Raw & Order

The nation’s food police, with their rules and regulations, work at keeping us safe


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, 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.


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 people, 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.


Since 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, several 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:


1. 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.


2. 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.


3. The Decoster’s’ 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, most 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.




Story by Dr. Darin Detwiler. Detwiler is Assistant Dean of the Northeastern University College of Professional  Studies and Director of the Master of Science in Regulatory Affairs of Food and Food Industries program.




• Pure Food and Drug Act/Meat Inspection Act prohibits interstate commerce of is branded and adulterated food, drinks, and drugs.
• Requires inspection of all meat sold across state lines.


• First certified color regulations.
• Identifies seven colors as acceptable for use in processed foods.


• Gould Amendment
• Requires accurate labeling of food packages with weight, measure, or numerical count.


• McNary-Mapes Amendment
• Authorizes FDA standards of quality and fill-ofcontainer for canned food, excluding meat and milk products.


• Food, Drug, and Cosmetic Act
• Expands the 1906 law to cover cosmetics and gives FDA authority to establish regulations and guidelines for the food industry.


• First food standards of identity
• Establish definitions and standards of composition for canned tomatoes, tomato puree, and tomato paste.


• FDA publishes guidance to industry, referred to as the “black book.”


• Food Additives Amendment / Delaney Clause
• Requires the safety of a new additive to be established before requesting an approval for its use. The first GRAS list was published, identifying nearly 200 food additives deemed “generally recognized as safe.”
• Prohibits the use of any additive in food that is found to cause cancer.


• Color Additives Amendment
• Requires the safety of any new color additive for food, drugs, or cosmetics to be established before requesting an approval for its use.


• Fair Packaging and Labeling Act 1980
• Infant Formula Act
• Establishes special FDA controls to ensure necessary nutrition content and safety.
• Requires all consumer products in interstate commerce to be honestly and informatively labeled.


• Saccharin study and labeling act.
• Stops FDA from banning the chemical sweetener but requires a label warning that saccharin has been found to cause cancer in laboratory animals.


• FDA publishes first Red Book (successor to 1949 “black book”), officially known as Toxicological Principles for the  Safety Assessment of Direct Food Additives and Color Additives Used in Food.


• Nutrition Labeling and Educations Act/Organic Foods Production Act
• Requires all packaged foods to bear nutrition labeling and all health claims to be consistent with specifically defined terms. Authorizing certain health claims.
• Standardizes the food ingredient panel serving sizes and terms such as low fat and light.


• Dietary Supplement Health and Education Act
• Defines dietary supplements, places burden of proof for safety on FDA, authorizes some health claims for dietary supplements, and establishes the office of dietary supplements.


• Rule on dietary supplements.
• Defines the type of statement that can be on labeling regarding the effect of supplements on the structure or function of the body.


• Food allergy labeling and consumer protection.
• Requires a food allergy warning on the label of food products containing a protein derived from any peanuts, soybeans, cow’s milk, eggs, fish, crustacean shellfish, tree nuts, and wheat.


• Country of origin labeling requires retailers to inform customers of the source of certain foods, including: muscle cuts of meat and ground meats; wild and farm raised fish and shellfish; fresh and frozen fruits and veggies; peanuts, peanuts, pecans, and macadamia nuts; and ginseng.


• New Food Code
• Identifies time and temp controls for serving cut greens.


• Egg Safety Rules/Food Safety Modernization
• Prescribes measures for preventing salmonella that apply to all egg producers with at least 3,000 laying hens whose shell eggs are not processed with a treatment to ensure their safety, such as pasteurization.


• Mandatory HACCP programs
• Prescribe industry food safety programs for seafood, juice, meant, and poultry. FDA provides the training.


• Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA). Establishes and reauthorizes certain programs under the Public Health Service Act and the Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response.


• FDA proposed regulations to 1) implement the mandate that all food processing firms subject to FDA oversight develop and implement a «Food Safety Plan» (January); 2) implement the safe-handling requirement for raw  agricultural commodities intended for the consumer market (January); 3) ensure safety of imported foods (July); 4) implement preventive controls for food for animals (October); and 5) implement food defense plan to protect food  against intentional adulteration, that is, the Food Defense Plan (December).


• FDA published “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)” including an appendix with guiding principles for implementation for food facilities, produce safety, and import system.


• FDA finalizes several regulations to implement the FDA Food Safety Modernization Act (FSMA).


• FDA requests input on the use of “natural” in food labeling after receiving several citizen petitions on the topic.
• Congress amends the Agriculture Marketing Act authorizing USDA AMS to establish regulations for labeling foods containing GMOs; see National Bioengineered Food Disclosure Standard.


• FDA finalized regulation for Food Defense Plan (see 21 CFR 121 Strategies to protect food against intentional adulteration) as part of implementing the Food Safety Modernization Act.