Understanding the Food Safety System

The government sets the standards for food safety and enforces them through the licensing process. Jurisdiction over food safety regulations and licensing is divided among a few different government agencies. In general, federal regulations supersede state regulations, and state regulations supersede local regulations. States may be more restrictive, but not less restrictive than federal regulations. In the same spirit, some states have “home rule” which means designated areas may act independently, and their regulations may be more restrictive than state regulations.

At the federal level the Food & Drug Administration (FDA) and the United States Department of Agriculture (USDA) have jurisdiction, which means they have the authority to make and enforce regulations applicable to any state or territory. Within the USDA is the Food Safety Inspection Service (FSIS). FDA and FSIS have overlapping authority for making and enforcing food safety standards, which adds to the complexity and confusion in our food safety system. For example, FSIS regulates livestock and dairy farms, but FDA regulates milk pasteurization. FSIS regulates animal slaughter facilities and grades meat, but FDA regulates products that contain meat as an added ingredient, such as sausage pizza and frozen dinners. FSIS regulates eggs, but FDA regulates processed egg products.   

At the state level, each state has a department of agriculture and a department of public health, each of which must, according to federal law, adopt and enforce food safety regulations at least equal to federal standards. State standards may be more restrictive than federal standards, but not less restrictive. Federal standards are set in large, complex pieces of legislation such as the Federal Meat Inspection Act and the Pasteurized Milk Order, which may be amended or re-interpreted over the years. Therefore, most states adopt federal regulations into state legal code "by reference," meaning they don't put the federal language word-for-word into state code, they simply refer to the federal law by name only as being incorporated into state law.  In effect, this requires food processors to have working knowledge of federal regulations in order to understand and comply with state regulations.

At the local level, the food safety system becomes particularly complex, with quite a bit of variation in authority, process, interpretation, and enforcement. Each state is different, and in many states, each county or municipality may be different.  In some states, food safety inspectors work under the auspices of the department of agriculture. In other states, they work under the auspices of the department of public health. There may be different inspectors for different food products and production processes. A food safety inspector may be from the local board of health or the county health department or a regional district. And training and education for food safety inspectors varies widely. All of these things combine to make licensing and inspection of on-farm food processing complex. 

USDA and FDA share federal jurisdiction. All food in “interstate commerce” — food produced in one state and sold in another state — must meet requirements of USDA and/or FDA. Food sold retail or wholesale must come from “an approved source” as defined by government regulations. Food and the facility where it is produced, stored, and sold must be inspected unless it falls under an exemption. Some federal regulations include specific exemptions for certain foods and operators, although some states may not allow those exemptions. 

The main role of USDA is to develop and manage products and markets for U.S. agriculture (food, fiber, forest, horticulture). USDA exercises authority over on-farm processing through these programs:

Agricultural Marketing Service (AMS)

• Specific programs for dairy, poultry, fruits and vegetables (Good Agricultural Practices or GAP), livestock and seed, organic standards

Animal and Plant Health Inspection Service (APHIS)

• How animals/plants are grown, where they come from, how illnesses are treated, how identified, tagged, or labeled, NAIS

Food Safety and Inspection Service (FSIS)

• Oversees domestic and imported meat, poultry, and eggs, plus foods where they are an ingredient
• Hazard Analysis and Critical Control Point Program (HACCP)
• Regulates meat and poultry from farm to table

FDA is within the U.S. Department of Health and Human Services. Its mission is to protect the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food, cosmetics, and products that emit radiation. FDA oversees all domestic and imported food sold in interstate commerce, but not meat and poultry. The agency also has oversight for animal feed, veterinary drugs, and pesticides. It shares jurisdiction with USDA over eggs and egg products. FDA programs include: Acidified and Low Acid Canned Foods, Color Additives, Dietary Supplements, Food Ingredients and Packaging, Foodborne Illness, Food Labeling and Nutrition, Hazard Analysis and Critical Control Point (HACCP), Infant Formula, Pesticides and Chemical Contaminants, and Seafood.

USDA and FDA share jurisdiction over food quality, safety, sales, and marketing.

As a result of this overlap there is often overlap at the state level between departments of agriculture and public health.  A state department of public health is analogous to the FDA.  A state department of agriculture is analogous to the USDA. State regulations govern “intrastate” production and sale — food produced and sold within the state.  State regulations are typically customized to a state’s economy, agriculture, markets, style of government, and administrative infrastructure.  Each state has a unique approach to food safety and on-farm processing with different:

• Department and division names
• Administrative structure and staffing
• Regulations and policies
• Programs and services
• Communications and media 
• Language and nomenclature
• Culture and attitude

Local health departments are responsible for food safety regulation at the local level, including enforcement of federal and state regulations. Local authorities may be empowered to create additional local regulations appropriate to community’s specific circumstances. It is important for farmers to know a local health inspector’s interpretation of food safety regulations. Local health departments have many responsibilities in addition to food safety regulation. In small rural communities, the local health inspector may be a part-time job, however, the inspector may be very familiar with farms and farm-direct food sales. In large urban communities, the local health inspector may have more expertise in food safety for restaurants and grocery stores, and less familiarity with farms and farm-direct food sales. Regardless of their knowledge and experience, local health inspectors are on the front lines of food safety.

Food safety standards are the basis for licensing a food business. To get a license the applicant must show they meet the standards established in food safety regulations. Inspectors interpret and enforce the regulations as they apply it to actual circumstances. There are five areas where local, state, and federal governments have instituted regulations to ensure food safety, quality control, and consumer protection:  food processing, food processing facilities, food storage, package labeling, and food distribution. The licensing process is a way of setting standards in each of these areas and enforcing them to protect public health.

The effect of regulations varies widely based on the type of food being considered and the scale of the operation. Food processing, as regulators define it, can range from cutting a watermelon in half to pasteurizing milk. A facility may be as simple as your home kitchen, or as complex as a slaughterhouse. Storage ranges from an open-air basket of baby greens to a humidity-controlled walk-in freezer. Labeling may be as simple as a handwritten address on a used egg carton, or as complex as the list of ingredients and nutrition information on a jar of spaghetti sauce. Distribution may be a self-service store in a farmer’s barn or trucking food across the country.

Food processing regulations are very specific for each food and/or process. A fruit or vegetable is considered “processed” as soon as the protective outer layer of the skin or husk is broken, exposing it to pathogens. A melon cut in half is “processed” because the flesh of melon is exposed to bacteria as soon as it is cut. Cutting melon in half before it is sold must be done in an inspected food processing facility. Meat is “processed” once the animal is no longer alive. Killing and packaging of an animal as food is governed by food processing regulations.

A food processing facility is anywhere food for human consumption is processed or prepared, whether a farm, factory, slaughterhouse, packing plant, dairy, shared-use kitchen, or home kitchen. Regulations often refer only to “food processing plants.”

Facilities are licensed or permitted to handle specific types of food production and sales, such as direct-to-consumer, retail, or wholesale. The license correlates to the type of food processing the facility is designed for, the type of equipment and infrastructure required, and the processes specified in food safety regulations.

Food safety regulations specify conditions under which food may be stored before it is sold. Storage conditions are critical to avoiding contamination and spoilage. With farms, farm stands, farmers’ markets, and food buying clubs, food is often stored in more than one place before it is purchased. Storage regulations specify time and temperature, and how long temperature must be maintained. Storage regulations specify conditions for the place where the food is stored, be it a truck, cooler, warehouse, or pantry shelf. Storage regulations may also specify packaging requirements, e.g., packaging materials, or whether food is required to be packaged by machine rather than by hand.   Packaging requirements may be influenced by storage conditions. 

Labels are required for all prepared foods, including breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc.  USDA, FDA, state departments of agriculture, and state departments of health have specific labeling requirements for each type of food. Labels provide information to trace a food back to its source, identify ingredients, warn of potential health hazards, recommend storage conditions, and verify weight or volume, quality or grade, calories and nutrition.

Label requirements may be linked to how food is processed, where it is processed, how it is stored, and how it is distributed.

Regulation of food distribution — moving food from wherever it is produced to the place where it will be sold — begins with the licensing of food processing facilities 

A USDA or FDA licensed facility may distribute food anywhere in the United States. In most cases, a facility licensed by a local inspector may distribute food only via retail sales (in other words, the licensee may not wholesale) within the state. A farm-direct sale is a retail sale.