A complex web of federal and state agencies and regulations governs the food industry. According to the Centers for Disease Control and Prevention, foodborne illnesses cause thousands of deaths and nearly 50 million illnesses each year in the US, while costing billions of dollars. This makes enforcement of food safety rules a critical public concern. The US has enacted some of the tightest food safety standards in the world, but regulations must continue to keep up with evolving types of infections. Nationwide and global distribution of food can spread these illnesses more rapidly and broadly than in the past. Media attention to health hazards caused by contaminated food often spurs lawmakers to tighten rules.
At the federal level, the main agencies responsible for regulating food safety are the Food and Drug Administration and the Food Safety and Inspection Service in the US Department of Agriculture. The FDA establishes standards for most foods other than meat, poultry, and eggs, which fall under FSIS authority. (The FSIS also holds authority over products that contain more than small amounts of those foods.) Food products overseen by the FDA do not need agency approval before they can be marketed, whereas meat and poultry require prior FSIS approval. FDA inspections happen far less frequently than FSIS inspections, due in part to limits on budget and staff.
Dual Agency Authority
Some types of products or facilities fall under the authority of both agencies. For example, a pizza or sandwich chain may sell some products regulated by the FSIS and others regulated by the FDA.
Food Safety Standards
Under federal law, food must not be "adulterated" when it reaches the market. This usually means one of four things:
It contains a harmful and potentially hazardous substance
It contains a harmful substance that is added during production (or cannot be reasonably avoided) and exceeds tolerance levels
It contains an intentionally added substance that was not approved or accepted for use by a federal regulatory agency or federal law
It may be contaminated by a hazardous substance due to unsanitary handling
Specific rules apply to additives in processed foods. Additives generally consist of substances that are intended or reasonably expected to become a component of a food product or affect a characteristic of a food product. Under the Food Additives Amendment of 1958, an additive usually must be reviewed by the FDA before a food product containing it is released to the market. The FDA will consider whether the additive is safe for consumption under the specific circumstances after reviewing safety data provided by the company that seeks to use the additive.
Substances that are generally recognized as safe (GRAS) are not subject to the requirements for food additives. A substance can receive a GRAS exemption if qualified experts have determined that it is safe under the circumstances surrounding its intended use.
Some substances are eligible for a GRAS self-affirmation process, in which a company can determine on its own that a novel ingredient would meet the requirements of the exemption. This allows a company to market a product containing the ingredient without waiting for government approval.
Consequences for Violating Food Safety Standards
Violations of food safety standards may result in recalls of food products. While FSIS recalls are voluntary, FDA recalls may be mandatory under federal law. However, FSIS products likely will be recalled in response to agency action to avoid more serious consequences. Other methods of enforcement in the food industry include warning letters, injunctions, product retention, or seizure. The FSIS also can punish a violation with withdrawal of inspection, although it must pursue this sanction through an administrative proceeding. Withdrawal of inspection is a relatively extreme measure because it may force a company to go out of business. (This is because FSIS inspections are mandatory for certain products under its authority.)
For severe violations of food safety standards, the FDA or FSIS may pursue criminal penalties. These violations may be charged as misdemeanors or felonies, potentially resulting in fines and imprisonment. Corporate officials charged as individuals under federal food safety laws are subject to strict liability. This means that they may be responsible for a violation by their company even if they did not actually know about the violation.