Food Safety 101

Government Oversight

The United States food safety system is primarily regulated by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). The FDA currently regulates approximately 80 percent of the nation’s food supply, including all domestic and imported foods that are not most meat or poultry. Seafood, dairy, produce and processed foods are all examples of FDA regulated products.

Within FDA, the Center for Food Safety and Applied Nutrition (CFSAN) is the primary body within FDA for advancing the scientific and regulatory mission of the Administration. CFSAN is responsible for (1) conducting and supporting food safety research (2) developing and enforcing food safety regulations (3) coordinating FDA’s food surveillance and compliance programs (4) coordinating state’s food safety activities (5) informing consumers and industry about food safety regulation. The Office of Regulatory Affairs (ORA) is responsible for inspection of imported and domestic food. Unfortunately, in recent years a chronic lack of funding has hindered the FDA’s ability to fulfill its vital mission. As a result, over 800 inspectors and scientists have been lost in just the past few years alone.

USDA’s Food Safety and Inspection Service regulates most domestic and imported meat in the United States. Roughly 8,000 USDA inspectors are charged with ensuring the safety of products from all cattle, sheep, swine, goats, equines, and birds. At least one federal inspector is on the line during all hours a slaughtering and/or processing plant is operating. Inspectors monitor plants’ sanitary conditions and packaging processes.

Both FDA and FSIS also work closely with state and local agencies and the food industry to ensure the safety of the food supply.

Foodborne Illness

According to the CDC, every year approximately 76 million people are afflicted with a foodborne illness. The majority of these illnesses, however, come from food consumed outside the home. In 1998, the Center for Disease Control implemented an enhanced surveillance system for identifying foodborne outbreaks. Since that time, the number of cases identified has remained relatively stable, from 26,719 in 1998 to 25, 659 in 2006 (see fig 1).

While great progress has been made in eliminating some causes of foodborne illness, emerging diseases need to be identified and neutralized to the extent possible. Advancing the science mission of the FDA is crucial to this endeavor- and enhanced funding is vital. The CDC should also continue to enhance cooperation among state and local health officials and methodology for identify the epidemiology of foodborne illness. Likewise, there are some additional common-sense new authorities FDA should be given.

History of Food Safety Law and the FDA

• In 1862, President Lincoln established the Department of Agriculture and the Bureau of Chemistry- the predecessor to the FDA
• In 1906, the original Food and Drugs Act and the Federal Meat Inspection Act were passed in response to disclosures of unsanitary conditions in meat-packing plants.
• In 1927 the Bureau of Chemistry split into two different agencies- the Food, Drug, and Insecticide Administration and the Bureau of Chemistry and Soils.
• In 1930, the Food, Drug and Insecticide Administration’s name was shortened to the Food and Drug Administration (FDA).
• In 1938, after a five year battle, the Federal Food, Drug, and Cosmetic (FDC) Act was passed by Congress, granting expanded authority for the regulation of the food supply. This law is still the basis for all FDA-regulated food law.
• In 1940, Walter Campbell was appointed first Commissioner of Food and Drugs after FDA was transferred out of USDA.
• In 1958, the FDA published the first list of substances generally recognized as safe (GRAS)
• In 1973, the first low-acid food processing regulations were issued
• In 1988, the Food and Drug Administration Act established the FDA as an agency of the Department of Health and Human Services (HHS)
• In 1990, the Nutrition Labeling and Education Act passed which required all foods to bear nutrition labels
• In 1996, the Food Quality Protection Act amends FDC for reexamination of all pesticide regulations
• In 2002, following the attacks of September 11, 2001, Congress passed the Public Health Security and Bioterrorism Preparedness Act, with enhanced regulation to prevent intentional adulteration of food
• You can visit the FDA’s website for more information about the evolution of food safety law

Commonly Used Terms:

RECALL: Once a product is in widespread use, unforeseen problems can sometimes lead to a recall. Contaminated spinach, for example, led to the recent recall of spinach products under multiple brand names. Contaminated peanut butter led to the recall of thousands of jars of two popular brands. In both cases, FDA responded immediately to minimize harm.

When an FDA-regulated product is either defective or potentially harmful, recalling that product—removing it from the market or correcting the problem—is the most effective means for protecting the public. In most cases, a recall results from an unintentional mistake by the company, rather than from an intentional disregard for the law.

Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. But in every case, FDA's role is to oversee a company's strategy and assess the adequacy of the recall.

Recall Classifications
These guidelines categorize all recalls into one of three classes, according to the level of hazard involved:

Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.

HAACP: (pronounced hassip) stands for “Harzard Analysis and Critical Control Point.” Originally developed 30 years ago for NASA as a control mechanism to ensure that astronauts would not eat contaminated food, it is a widely used tool to prevent foodborne illness. FDA has a great backgrounder on its implementation of HACCP.

CFSAN: stands for “Center for Food Safety and Applied Nutrition” and is the primary body within FDA for advancing the scientific and regulatory mission of the Administration. The Center regulates $240 billion worth of domestic food, $15 billion worth of imported foods, and $15 billion worth of cosmetics sold across state lines. This regulation takes place from the products' point of U.S. entry or processing to their point of sale, with approximately 50,000 food establishments (includes more than 30,000 U.S. food manufacturers and processors and over 20,000 food warehouses) and 3,500 cosmetic firms.

ORA: stands for “Office of Regulatory Affairs” and is the enforcement body within FDA responsible for inspections and compliance.

GRAS: “Generally Recognized as Safe” is a list FDA publishes of food additives that qualified experts generally recognize as safe for its intended use. The list is published to guide industry on what ingredients do not need FDA approval for use.

To learn more about how to prevent foodborne illness, visit http://www.fightbac.org/.