Food Safety Magazine

REGULATIONS | August/September 2011

Understanding the Ancestry of the Food Safety Modernization Act

By Marc C. Sanchez

Understanding the Ancestry of the Food Safety Modernization Act

As I sit at the keyboard, I’m exchanging keystrokes for bites of ice cream. I take for granted that I live in a time when I can turn to the container and read what ingredients are in my ice cream. Not only do I have a label to read, but also significant confidence that the food I’m eating is safe. It was only a little over 100 years ago that consumers didn’t enjoy that luxury. Beginning with the Industrial Revolution, food production was the wild frontier—a lawless range where unsanitary conditions combined with harmful additives and deceptive labeling.

The U.S. Food and Drug Administration (FDA) is working quickly to implement the Food Safety Modernization Act (FSMA) signed into law in January 2011. The FMSA is hailed as the biggest change to the nation’s food production system in 50 years. To understand how FSMA has changed the food production landscape—and the shortcomings left by the act—it’s important to understand its place in history.

In the Beginning: Processed Foods with No Regulation
The U.S.’s experiment with food regulation grew out of the Industrial Revolution. It was then that food left the farm for the processing plant. Absent any regulations, manufacturers were free to add whatever they liked to their products. Not only could they add whatever they liked, but no labeling law required them to report it on the product’s label. Horrible stories emerged of lead salts being added to candies and cheeses, textile inks used as coloring agents and other additives unthinkable today.[1]

The 1880s brought the genesis of change to food production. In New York City, women’s groups protested the conditions of slaughterhouses. They also protested against the adulteration of processed foods, which is the cheapening of products through the addition of inferior ingredients. At that time, producers used inks, dust, lead and other additives. In 1883, Harvey Wiley, M.D., chief chemist for the Bureau of Chemistry at the U.S. Department of Agriculture (USDA), began researching the use of untested chemicals as food preservatives. His research formed the basic elements of current food laws and regulations: regulation, testing and disclosure.

This is also the time of Upton Sinclair’s The Jungle. His graphic descriptions of the poor hygiene and deplorable conditions in meatpacking plants drew national attention when it was published in 1906. Sinclair’s book also led to an outcry from foreign governments, demanding foods imported from the U.S. be pure and wholesome.

President Roosevelt and the First Federal Regulation
President Theodore Roosevelt acted with Congress to pass two pieces of legislation in 1906. The first was the Pure Food and Drug Act, and the other was the Meat Inspection Act. The passage of these two stand-alone bills marks the birth of the bifurcation of food monitoring and safety.

The Pure Food and Drug Act prohibited adulterated food, drink and drugs in interstate commerce. The law was enforced by Wiley’s Bureau of Chemistry, which in later years would become the Food, Drug and Insecticide Administration in 1927 and eventually in 1931, the name was shortened to the FDA. The Bureau of Chemistry exercised authority to regulate the misbranding and adulteration of food, drink and drugs other than meat and poultry.

The Meat Inspection Act was passed on the same day as the Pure Food and Drug Act. The Meat Inspection Act provided a much simpler mandate—it expanded federal meat regulation to provide continuous inspection of all red meat in interstate commerce. The law also established sanitary standards for slaughterhouses and processing plants and mandated ante- and postmortem inspection of livestock.

The Pure Food and Drug Act advanced food safety, but was subject to intense lobbying that led to many shortcomings. For example, it included an exemption for “distinctive names.” Take a product called “Bred-Spred,” which was basically a jelly. It was exempt from the adulteration provisions of the Pure Food and Drug Act because it didn’t claim to be jam or jelly, but was instead a distinctively named product. Thus, it could be legally made from “coal tar, artificial pectin, artificial flavors and grass seeds.” The Pure Food and Drug Act only applied once a product was on the market; there was no premarket approval system for food additives or drugs. The passage of these two acts, with the benefit of hindsight, can be seen as another shortcoming in the regulation of the food production system.

These two acts were amended and replaced to form the modern food safety system. In 1913, the Pure Food and Drug Act was amended to require the contents be plainly marked on the outside of the food package. Prompted by the death of 107 people in 1938 from the consumption of a poisonous ingredient, Congress superseded the Pure Food and Drug Act with the Food, Drug and Cosmetics Act (FD&C). Still in effect today, the FD&C authorizes three kinds of food standards: identity, quality and fill of container. By 1957, product standards for most manufactured foods were set and enforced.

A number of smaller acts and amendments were passed over the next 40 years. A few examples include the Delaney Amendments in 1958, which gave FDA regulatory powers over pesticides; the Fair Packaging and Labeling Act in 1966 and the Food Quality Protection Act in 1996, which aimed to reduce the number of foodborne illnesses. From 1906 to 1996, food production became cleaner and more transparent. In that 90-year period, the consumer was brought more or less out of the dark.

In January 2011, President Barack Obama signed the FSMA into law. Prompted by a Salmonella outbreak linked to peanut butter in 2009 and a string of high-profile outbreaks that followed, the new law emphasizes prevention. Distinct from its predecessors, the FSMA focuses on harmful bacteria, parasites and viruses, not the old concerns of adulteration through inks and sawdust.

There are several noteworthy provisions in the sweeping update of the nation’s food safety system. One particularly noteworthy provision is the mandatory recall authority given to FDA. For the first time, FDA can demand and punish a manufacturer for not promptly removing a harmful product from the market. At no time in its history has a U.S. food agency been given this authority. Up to this point, FDA was often left negotiating with manufacturers about removing tainted products.

The law is an amendment that brings stricter standards and expanded powers to current law. The FSMA builds on existing law, instead of creating or replacing old laws. It expands inspectors’ powers to evaluate hazards in seafood, juice, fruits and countless other products. It allows inspectors to place stricter standards on imported foods and to block foods from facilities or countries that refuse inspections. The food importation provisions will most heavily affect fresh fruits and seafood, which represent 60 and 80% of imports, respectively.

The law amends only the FD&C. There are two tracks to the nation’s food safety system—those arising from the Pure Food and Drug Act, which became the FD&C, and the Meat Inspection Act. The FSMA did not amend the latter, meaning the new law generally will not apply to meat, poultry or egg products. The secretary of agriculture has stated that USDA is reviewing the Meat Inspection Act and will possibly apply FSMA reforms.

Going Forward
Going forward, several regulatory trends will continue to impact food safety.

Outside of the FSMA, changes are occurring on a global scale. Perhaps more than at any other time, food production is global, leading to a trend for global food safety certification programs and consensus on safety criteria. Certification programs would require traceability components to improve recalls. The FSMA contains a traceability requirement that is still to be implemented. New technologies may lead to safer food, but their cost remains unclear. Certification programs also include elements such as qualified import and foreign supplier verification programs. The foreign supplier programs place the onus on importers to conduct risk-based analysis of foreign manufacturers, while the qualified import programs require those countries where food production is known to be troubled to certify their exports are safe. As more nations adopt these programs, look for a global consensus on criteria establishing food safety standards.

The largest change in the U.S. will be over the next 3 years as FDA implements the FSMA. The agency in a letter to stakeholders forecast the creation of 50 new rules and guidance documents over the next 3 years. It will begin first with rules that affect imports and then traverse the entire food production system. One of the major aims will be building an integrated food safety system, supported by the FSMA. Section 209 directs FDA to set standards and administer training at every level of government. It also gives FDA the authority, albeit not the budget, to issue grants to local, state and tribal governments to build the infrastructure necessary to conduct inspections and investigations. Within this integrated food system, new criteria and preventative controls will be built. It will be important for food and beverage companies to closely monitor and implement these changes.

What remains to be seen is how USDA and FDA will integrate food safety programs. The two-track model presents a shortcoming to food safety, a problem produced by the legislation’s history. Although the passage of the FSMA represents a milestone in food safety, it highlights a problem with the U.S. approach, which relies on one agency to monitor the meat, poultry and egg portion of food production and another to monitor everything else. Not only is there bound to be duplicate oversight, but with FDA implementing the FSMA, two different sets of standards are now likely to apply.

The two-track model can be traced back to the first federal regulation in 1906. One hundred five years later, it may be time to reevaluate the wisdom of a divided food safety system. No doubt, the next big leap in food safety regulation will be the unification of the food safety net. The question is whether it will take another 90 years.

Marc C. Sanchez began his own law practice in Seattle in 2010. He has a special expertise in food law and began consulting with a range of clients on FDA and USDA compliance, recall readiness, import protocols and employee privacy.

1. Borzelleca, J. 1997. Foodborne health risks: Food additives, pesticides, and microbes. In Nutrition policy in public health, ed. F. Bronner, 33-67. New York: Springer Publishing Company.

Categories: Regulatory: FSMA