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March 3, 2020

Key Federal Laws Affecting Food Safety Compliance

Written by SmartSense | Food Safety, HACCP, FSMA

Every organization involved with the food supply chain shares responsibility for the safety of food. Essential components of the chain include growing, processing, packaging, labeling, distributing, storing, preparing, selling, and serving food. At each of these stages of the industrial food system, food products may be exposed to various levels of risk.


The federal government oversees this system by establishing standards, legislating regulations, and enforcing their compliance. In this post, we survey the key food safety laws of the last 100 years that have culminated in the Food Safety Modernization Act of 2010, taking special notice of their historical importance and basically reactionary approach based on responding to – rather than preventing – food safety disasters.


How Are Food Safety Laws Created? 

Before the 20th century, food safety regulation was a matter of state and local politics. As the food system industrialized and supply chains began to extend across the country, public support for federal food safety laws grew as muckrakers (such as Upton Sinclair) exposed hazards in the food industry. By the 1980s, as consumers grew more concerned about the effects of nutrition and food additives on health, the federal government stepped up its authority to intervene in both inter- and intra-state food commerce.


In the U.S., the majority of food safety regulations are proposed and legislated by Congress. Twenty-eight House and Senate committees provide oversight of these regulations. The primary Congressional committees responsible for food safety are the Agriculture Committee and Commerce Committee in the House; the Agriculture, Nutrition, and Forestry Committee and the Labor and Human Resources Committee in the Senate; and the House and Senate Agriculture, Rural Development, and Related Agencies Appropriating Subcommittees.


Historically, new food safety laws have been passed in response to a problematic situation catching the attention of an alarmed public and consumer advocates. Large-scale trends that contribute to new regulations include innovations in food production and technology, evolving public attitudes about food safety, scientific concerns about the changing hazards of foodborne illnesses, threats of food terrorism, and the institution of voluntary standards by the food industry.


Watch our webinar to learn about a newly released study on foodborne illness  conducted by the FDA, and how food safety management systems are key to keeping  customers safe.


Understanding how and why food safety laws have evolved  since the early 20th century provides meaningful context for the state of federal regulations today. Although the laws developed out of very different and complex circumstances, the common foundation of all of them is how federal agencies define “adulteration.” Generally speaking, food is adulterated if it:

  • Contains a harmful substance that may pose a safety risk
  • Contains an added harmful substance that cannot be reasonably avoided but exceeds tolerance levels
  • Contains a substance that has been intentionally added to the food but has not been approved by a regulatory agency
  • Has been handled under unsanitary conditions, creating a risk of contamination with a substance that may pose a safety threat


In short, the history of food safety laws is a history of how the public, consumer advocates, and government leaders have responded to instances of food adulteration that either caused deaths, widespread disgust and fear, or revelations of corporate corruption.


Food and Drugs Act & Meat Inspection Act, 1906

In 1906, the Food and Drugs Act and the Meat Inspection Act were passed by Congress on the same day. Both were the first federal laws addressing food safety, in reaction to a series of outrageous revelations of unsanitary conditions in meat-packing plants and the adulteration of food products with toxic dyes and preservatives.


The Food and Drugs Act is the parent of all subsequent laws administered by the Food and Drug Administration (FDA), while the Meat Inspection Act and its associated laws are administered by the Food Safety and Inspection Service (FSIS) of the USDA. As set forth in the U.S. Constitution, each individual state needs to align its laws with the all new federal laws, which now prevail. The primary benefit of federal regulation is that businesses involved in interstate commerce can follow a uniform set of legal standards that make conducting business in several states easier and safer.


An important difference between these two laws is that, under the Meat Inspection Act, government inspectors must be on the premises of meat processing plants to inspect each product item, while under the Food and Drugs Act, other food businesses are subject only to periodic government inspections.


Federal Food, Drug, and Cosmetic Act (FDC), 1938

In 1937, a, a drug used to treat streptococcal infections called Sulfanilamide was adulterated with toxic antifreeze, and killed 107 people, including children. This tragedy incited Congress to strengthen FDA authority with the passage of the Federal Food, Drug, and Cosmetic Act (FDCA). This act created new provisions that:

  • Authorized food quality standards
  • Prohibited false statements about food products
  • Authorized FDA inspections of processing facilities any time during normal working hours
  • Set safe tolerances for unavoidable toxic substances
  • Required the food industry to prove the safety of food additives
  • Added court injunctions to the previous penalties of seizures and prosecutions


Over the years, several amendments were attached to the FDCA to strengthen regulations:


Miller Amendment (1948): This amendment applies to interstate commerce of food products delivered to consumers. It was the government’s first recognition of the food supply chain’s growing complexity, and that food products could become contaminated at any point from "farm-to-fork" – a concept taken up again in the 1990s.


Food Additives Amendment (1958): In reaction to worries over synthetic food additives, pesticides, and cancer, the Food Additives Amendment to the FDCA was enacted in 1958, requiring manufacturers of new food additives to establish their safety. The amendment is intended to address the safety of ingredients found in processed foods, as well as animal drug residues in meat and poultry products.


The Delaney proviso (1958): This amendment prohibits the use of any food additive scientifically proven to induce cancer in humans or animals. FDA regularly updates its list of substances generally recognized as safe (GRAS). In 1960, an amendment setting the standards for color additives was also passed under the Delaney proviso.


Food Safety Laws in the Modern Era

Since the early 1970s when the environmental and alternative food movements began to gather momentum, a variety of new consumer safety laws were passed by Congress. Some of the laws that most affected the food industry include:


Fines Enhancement Laws (1984,1987): These laws significantly increased penalties for all federal offenses involving violation of food safety regulations. The maximum fine for individuals is now $100,000 for each offense and $250,000 if the violation is a felony or causes death. For corporations, these amounts are doubled.


Pathogen Reduction Ruling (1993): An outbreak of E. coli 0157:H7 in ground beef products throughout the Northwest caused 400 illnesses and four deaths. In response, FSIS issued a rule implementing Hazard Analysis and Critical Control Point (HACCP) systems  to prevent and reduce microbial pathogens in raw food products.


Public Health Security and Bioterrorism Preparedness and Response Act (2002): The federal government responded to the threat of food terrorism following September 11, 2001, by enacting new food laws designed to improve the country's ability to prevent and respond to public health emergencies. The Act gives FDA authority to enhance controls over the imported and domestically produced commodities it regulates. Consequently, the law requires that food businesses register with the FDA and maintain records of suppliers and buyers to help trace suspect food products.


Food Allergy Labeling and Consumer Protection Act (2002): Given the rise of food allergies in the general population, especially children, this Act requires labeling all foods containing a protein from any one of the following foods that, as a group, account for the vast majority of food allergies: peanuts, tree nuts, soybeans, wheat, eggs, cow's milk, and seafood.


Food Safety Modernization Act (FSMA), 2010

Undoubtedly the most important and far-reaching food law of the 21st century, the FSMA law mandates a pro-active, scientific approach to food safety that is hoped to replace a century of reactive, ad hoc legislation that merely responds to catastrophes, rather than prevents them. Key points of the law include:

  • Expands scope of FDA's authority to issue mandatory recalls
  • Creates stricter regulations for food transportation
  • Implements testing labs, illness surveillance, and tracking technologies to improve traceability of contaminated food products
  • Establishes stringent standards for raw foods that pose high-risk for consumers


Perhaps most important for the food industry, the FSMA now requires a much larger percentage of food businesses to develop and implement a food safety management system (FSMS). Stay tuned for our upcoming post that will dive deeper into the “why, what, and how” of an effective FSMS that can help ensure compliance with the food safety laws we surveyed here.


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