9.1: Food Safety

The Regulation of Food

FDA authority over food comes from the FD&C Act, which defines food as "articles used for food or drink for man or another animal, chewing gum and articles used for components of any such article." (Federal Food, Drug and Cosmetic Act, 1938). The FDA is responsible for the safety of all food, including individual components of food, animal and pet food, and food ingredients. Their mission is to prevent food adulteration and ensure foods are safe, wholesome, and sanitary in addition to providing accurately labeled food. (FDA, FDA.gov, 2016) https://www.fda.gov/food

Figure \(\PageIndex{1}\): Plant-based foods. Food, by Wikimedia, public Domain.

Center for Food Safety and Applied Nutrition (CFSAN)

The regulatory Center for food in the FDA is the Center for Food Safety and Applied Nutrition (CFSAN), which oversees food safety and purity. It has the power to regulate all domestic and imported food except for meat, poultry, and eggs (those are regulated by USDA). They oversee the safety of food ingredients developed through biotechnology, dietary supplements, food additives, and proper labeling of food. CFSAN is also concerned with food contamination, such as biological pathogens and naturally occurring toxins. They are also responsible for the regulation and safety of cosmetics ingredients and finished products.

Collaboration With Other Regulatory Bodies

FDA regulates food and cosmetic products sold in interstate commerce. However, products made and sold entirely within a state are governed by that state. This means, the FDA maintains close communications and interagency agreements with other regulatory bodies including the U.S. Department of Commerce's National Marine Fisheries Service, the Centers for Disease Control and Prevention (CDC), the U.S. Department of Treasury's U.S. Customs and Border Protection, the Federal Trade Commission (FTC), the U.S. Department of Transportation (DoT), the Consumer Product Safety Commission (CPSC), and the U.S. Department of Justice (DoJ) (FDA.gov).

Collaboration With Academia and Industry

CFSAN is actively involved in several academic projects through its Centers of Excellence (COE) program. CFSAN has four COEs:

1. the National Center for Food Safety and Technology (NCFST) with the Illinois Institute of Technology
2. the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) at the University of Maryland
3. the FDA COE for Botanical Dietary Supplement Research at the National Center for Natural Products Research (NCNPR), University of Mississippi
4. the Western Center for Food Safety (WCFS) with the University of California at UC, Davis

USDA

The FDA is not responsible for meat, poultry, and eggs, that purview belongs to the United States Department of Agriculture (USDA) (www.usda.gov). The USDA also contributes to nutrition research and public health education. A division of the USDA, the Animal and Plant Health Inspection Service (APHIS), regulates genetically engineered food plants.

EPA

The Environmental Protection Agency (EPA) (www.epa.gov) regulates pesticides and their use on food crops. It sets tolerance limits for pesticide residues in foods (which the FDA enforces), publishes “safe use” directives, and establishes quality standards for drinking water. The EPA also has some regulatory authority over the release of genetically modified organisms into the environment.

Maintaining a Safe Food Supply

Although the U.S. food supply is among the world's safest, we do not have to go too far back in the news to realize our supply is not fallible. (FDA Food Recall, 2016). See the many FDA publications on Listeria outbreaks in food just in the last year! Read more here on the Listeria outbreak in Texas's favorite Blue Bell ice-cream. The food industry and manufacturing practices are widely varied, and therefore the possible potential areas of contamination are many, including pre-harvest, processing, packaging, and storage! Check out the FDA’s Bad Bug Book to learn more! www.fda.gov/food/foodbornepathogens/bad-bug-book-second-edition

Some of CFSAN's current areas of food safety concern are:

• pathogens such as bacteria and viruses
• naturally occurring toxins such as mycotoxins
• dietary supplements
• pesticide residues
• toxic metals including lead
• particulate matter
• food allergens including wheat, nuts, and dairy
• added nutrient concerns
• dietary components and labeling
• Transmissible Spongiform Encephalopathy-type diseases
• product tampering

Figure \(\PageIndex{1}\): Listeria (L) colorized micrograph (R) grown on selective media. Image by James Folsom, public domain.

Food Safety

There are three major issues related to food safety that are the most common causes of regulatory enforcement actions, which are the most closely monitored:

1. Contamination by pathogens (e.g., E. coli, Listeria monocytogenes).
2. Adverse effects of additives such as food coloring and sweeteners.
3. Unintentional additives (e.g. pesticide residues).

The FDA has the authority to inspect any facility where food is manufactured, packaged, or handled in any way. Contamination by pathogens is one of the most significant problems faced in the United States according to the Centers for Disease Control (CDC). It is estimated that foodborne illnesses affect 1 out of every 6 Americans at some point in their lives. Forty-Eight million people become sick due to foodborne pathogens each year, of which approximately 128,000 are hospitalized, and 3,000 died (FDA.gov). The USDA and FDA have active consumer education programs targeted towards preventing such illnesses by teaching consumers about safe handling and preparation of foods, the shelf life of various kinds of food, and other common-sense tips.

Explore!

Explore these resources on foodborne statistics in the US. What germ is responsible for most foodborne illnesses? Deaths? Why?

• https://www.cdc.gov/foodborneburden/index.html
• https://www.cdc.gov/foodborneburden/burden/index.html
• https://www.cdc.gov/foodnet/reports/prelim-data-intro-2018.html

Legislative Acts That Regulate Food and Agriculture

The FD&C Act sets out broad regulations of both the food and drug industries. There are additional, specific acts that regulate food beyond the FD&C Act, which includes:

• The Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) of 1910
• The Federal Import Milk Act (1927)
• The Public Health Service Act (1944)
• Federal Meat Inspection Act and the Poultry Products Inspection Act of 1957
• The Federal Plant Act (FPPA)
• The Fair Packaging and Labeling Act (1966)
• Toxic Substances Control Act (TSCA) of 1976
• The Infant Formula Act of 1980, as amended
• The Nutrition Labeling and Education Act of 1990
• The Dietary Supplement Health and Education Act of 1994
• Food Allergen Labeling and Consumer Protection Act of 2004
• Food and Drug Administration Amendments Act of 2007
• Food Safety Modernization Act (FSMA) of 2011

Food Safety Modernization Act

Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, enables FDA to better protect public health by strengthening food safety measures. Under the new law, FDA now has much more effective enforcement tools to protect the food supply, including the authority to issue a mandatory recall order. To learn more about FSMA regulatory implications, see the FSMA Q&A factsheet. www.fda.gov/food/food-safety-modernization-act-fsma/frequently-askedquestions-fsma

In short, here are the main elements of FSMA:

1. Preventive controls - Provides FDA legislative mandate to require comprehensive, preventionbased controls across the food supply to minimize the likelihood of contamination occurring.
2. Inspection and Compliance – Allows FDA to enforce compliance through inspection.
3. Imported Food Safety - Importers must verify that their suppliers have adequate preventive controls in place to ensure the safety of imported food products.
4. Response - FDA is given mandatory recall authority for all food products as well as expanded administrative detention of products that are potentially in violation of the law, and suspension of a food facility’s registration.
5. Enhanced Partnerships - The legislation encourages strengthening the existing collaboration among all food safety agencies.

Food Defense

Food Defense is an effort to protect food from acts of intentional adulteration. In May 2016, FDA issued the final rule on Mitigation Strategies to Protect Food Against Intentional Adulteration with requirements for covered facilities to prepare and implement food defense plans.

FDA works with the private sector and other government agencies on activities related to food defense, including conducting research and analysis, developing and delivering training and outreach, and conducting exercises. Also, FDA has developed several tools and resources to help food facilities prevent, prepare for, respond to, and recover from acts of intentional adulteration of the food supply.

Explore!

To read more about Food Defense Guidelines:

1. www.fda.gov/food/guidance-documents-regulatory-information-topic-food-anddietary-supplements/food-defense-guidance-documents-regulatory-information
2. www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rulemitigation-strategies-protect-food-against-intentional-adulteration
3. What’s new in FSMA: www.fda.gov/food/food-safety...whats-new-fsma