Many governmental agencies regulate food. It is often confusing to try to understand the laws governing the processing, packaging, and distribution of food products. Persons starting their own food business often call the local health authority to find information about getting started. As often as not, they are referred to another agency, then finally to the North Carolina Cooperative Extension Service.

The type of food and how it is prepared or processed will determine which agency has the regulatory jurisdiction. Federal, state, and county regulations require that foods be produced and maintained in a safe and wholesome manner. Each agency has a set of specific rules for products prepared or produced under its jurisdiction.

Individual county health departments regulate ready-to-eat foods (foods served to the consumer for immediate consumption) and meals prepared on-site. County health departments use North Carolina food service rules as guidelines for regulating food service operations. These foods, whether served in a food service establishment, a food stand, or by a caterer, must be prepared in a permitted establishment. They must be served in or from a permitted establishment except for catering. The permit must be obtained in advance. Construction rules for facilities are strict. Plans must be submitted to the county health department in North Carolina before construction. A home kitchen is not permitted except in the case of a bed & breakfast inn. Foodservice questions can be addressed to the environmental health section of your county health department.

Packaged foods, wrapped and labeled for consumer purchase, are regulated by state agencies, usually under federal authority. In North Carolina, most packaged foods are regulated by the North Carolina Department of Agriculture (NCDA). Meat and poultry products to be sold only in N.C. are regulated by the NCDA Meat and Poultry Inspection branch. Meat and poultry products to be sold in interstate commerce are regulated by the Food Safety and Inspection Service (FSIS) of the USDA. Other processed foods are regulated by NCDA’s Food & Drug Protection Division. Fluid milk products and shellfish products are regulated by the N.C. Department of the Environment, Health and Natural Resources (DEHNR) Environmental Health Services Section.

Meat and poultry products not to be shipped in interstate commerce must be processed in an establishment inspected and approved by the Meat and Poultry Inspection Branch of the NCDA. The USDA has jurisdiction over those products shipped to another state. Interstate commerce would include any operation that transports food across state borders. Slaughtering and processing facilities require buildings and equipment designed to predetermined standards and require prior approval. The operation has many other requirements, such as inspection of the individual animals’ health and labeling. In certain situations, on-site inspectors are required. Home processing facilities are not likely to be approved.

Rules adopted by individual states regulate fluid milk products. The Grade A Pasteurized Milk Ordinance has been adopted by all states. It regulates the production, processing, and sale of products such as fluid milk, yogurt, and cottage cheese. These rules not only cover milk from the cow to the consumer but also the cow and its health.

Milk for manufacturing purposes, such as in the production of cheese, butter, and nonfat dry milk, is regulated as processed food under the rules of the USDA. These rules are, in turn, enforced by the NCDA. In both instances, raw milk must come from inspected and approved dairy farms. Raw milk may not be sold to the consumer

Shellfish (oysters, clams, mussels, scallops, etc.) harvesting and processing are regulated by the Shellfish Sanitation Branch (SSB) of DEHNR. The SSB also has jurisdiction over the crustacea, i.e., processing, packaging, and distributing cooked, ready-to-eat crab meat. Harvesting is regulated by DEHNR’s Division of Marine Fisheries acting upon the recommendations of SSB. Shellfish shall be harvested from approved waters and require shipping documentation (tag). Regulation of other seafood products is covered by rules adopted by the Food and Drug Administration (FDA) for producing safe and wholesome foods. In addition, FDA will require written HACCP plans for producing and processing seafood products by December 1997. NCDA Food and Drug Protection Division will carry out these rules in North Carolina.

The FDA regulates processed and packaged foods. The Food and Drug Protection Division of the NCDA enforces these rules in North Carolina. Regulations governing these foods are in Title 21 of the Code of Federal Regulations. These regulations consist of Sections 100 and 101 concerning labeling and Section 110, which covers Good Manufacturing Practices, along with other sections that contain Standards of Identity, acceptable ingredients, and other rules. In special cases where foods are preserved with added acid or low-acid foods are canned (pH at 4.6 and above), Sections 114 and 113 apply, respectively. These sections have special requirements, such as establishment registration under Section 108, filing of a scheduled process, and processing and packaging under the operating control of a certified supervisor.

Products held under constant refrigeration or determined to be naturally acidic foods with a pH of 4.6 or water activity (aw) of 0.85 are not covered by 21 CFR 113 or 114 provisions. However, Good Manufacturing Practices (21CFR 110) requires adequate controls to ensure the products continue to meet these parameters.

Food regulations can be confusing and often complicated. In many cases, a single food product or production facility may be covered by multiple jurisdictions. Almost all food processing requires prior notification to the regulatory agency.

Across all jurisdictions, food must be produced, processed, and held to prevent spoilage and contamination to keep it wholesome. Processing establishments must submit to unannounced inspections of the building and grounds. Unhealthy or ill persons must not be allowed to handle food, and pets are not allowed. Home kitchens are not usually considered appropriate for processing purposes for these reasons and others.

Because of the many rules for processing and preparing food for sale, entrepreneurs are advised to consult an expert prior to investing in a food processing venture. As in any business venture, know and understand the rules before you get started.