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Food and Drug Branch

Industry Assistance: Introduction

Federal, state, and local agencies share responsibility for ensuring that food processors follow food safety laws. The goal of all of these laws is to protect the public by ensuring that food processors produce safe food. Laws and regulations are legal requirements that must be followed. "Prerequisite Programs" is the term used to describe a range of programs that enhance operational conditions and provide a foundation for food safety programs. Examples of such prerequisite programs are Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP), and Sanitation Standard Operating Procedures (SSOP). Why are prerequisite programs important? Prerequisite programs, when properly followed, help keep small problems from becoming serious problems that could eventually have an impact on food safety. Voluntary programs are completely voluntary and in many cases are developed by the food industry associations to provide guidance for their members.

Local, state and federal public health agencies may inspect food-processing facilities. Federal agencies such as the FDA have jurisdiction over products in interstate commerce that is; products that move or have moved across state lines. State agencies have jurisdiction over food produced, distributed and consumed in the state. State regulators may adopt federal requirements as their own state laws. Some states may adopt requirements that must be met in addition to federal requirements. Food processing operations must comply with all existing state and federal laws and regulations that apply to food establishments.

To view the California Health and Safety Code, Division 104, Part 5, "Sherman Food, Drug, and Cosmetic Laws", click on the link below:

Sherman Food, Drug, and Cosmetic Law

 

"The Act"

The first of these laws is the Federal Food, Drug, and Cosmetic Act which is sometimes referred to as the "F D & C Act" or simply "The Act". The Act is one of the main legal authorities for food inspection in the United States. The Act was enacted to protect public health.

The Act prohibits the interstate shipment of adulterated food, which includes any food containing a pathogen (an organism that can cause disease) such as Salmonella, E. coli O157:H7, or any other harmful substance. Foods that are spoiled or that are prepared using spoiled food or foods that are contaminated by insects, rodents, or other types of filth are also considered to be adulterated. High quality food prepared or stored under insanitary conditions, such as in a dirty environment, or handled by workers with poor personal hygiene, is also adulterated. When food is adulterated, regulatory agencies have procedures that they follow. In some cases they may ask the firm to voluntarily correct the problem. Sometimes the agency may send a warning letter to the firm. In other cases the adulterated food may be removed from commerce through the courts. Finally, in serious cases the regulators may file an injunction to stop the firm from producing adulterated food or they may initiate a criminal prosecution of the responsible persons, typically the manager and owner of the firm.

To view the entire Federal Food, Drug, and Cosmetic Act, click on the following link:

 

http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm

 

Good Manufacturing Practices (GMP)

GMP are regulations that describe how food processing plants should be designed and run to ensure food safety. GMP regulations for food production and storage facilities can be found in the Code of Federal Regulations, Title 21, Part 110 "Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food". The GMP were designed to ensure that processed food is produced under conditions that meet minimum food safety standards. GMP are a system that you can incorporate into your daily operation to ensure the safety of your product from receiving of ingredients to distribution. The standards were developed with input from the public, including the food industry.

Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (pdf)

Voluntary Programs

As mentioned previously, once GMP and Prerequisite Programs are in place, processors can develop additional food safety programs such as HACCP. HACCP (pronounced as "hassip.") H-A-C-C-P, is an acronym that stands for "Hazard Analysis and Critical Control Point". This concept is an important part of a food safety program because it builds upon the use of GMP and prerequisite programs and focuses on prevention of food safety problems. HACCP is a tool for managers and line workers to evaluate each of the firm’s operations from receiving to distribution. In HACCP, the biological, chemical, and physical hazards that are associated with each operation are identified. After identifying the hazards, Critical Control Points (CCPs) are identified. CCPs are those points in the processing where controls can be applied and where loss of control would lead to a food safety problem. Therefore, a process is put in place for each CCP to make sure that food safety problems do not occur. The process is then monitored frequently to ensure that all aspects of the product process at the CCP are in control. HACCP programs are a mandatory part of juice, meat, poultry, and seafood production, but HACCP is not currently required for all processed food products. Just as one cannot sanitize without first cleaning, HACCP cannot be properly planned and implemented without a strong foundation of GMP and prerequisite programs.

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