Food CGMPs, or Current Good Manufacturing Practices, are federal regulations enforced by the U.S. Food and Drug Administration (FDA) that apply to all human foods regulated by the FDA. These regulations, entitled “Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food” are found in Part 110 of Title 21 of the Code of Federal Regulations. Good manufacturing practices are the procedures and actions that are necessary to protect foods from becoming contaminated with filth, harmful substances or microorganisms, and also to prevent foods from becoming unfit for consumption through spoilage or decomposition. These regulations include the most important practices for protecting the food supply from contamination or spoilage during manufacturing, packing and storage.
It is necessary to periodically reexamine these regulations to determine whether or not they should be revised to incorporate control practices based on new knowledge about food safety risks and/or new technology. Recently, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) began the process of reevaluating the CGMP regulations to identify control practices that should be incorporated into the regulation and to identify current requirements that can be improved. On Nov. 2, 2005, CFSAN published a working group report that identified opportunities for the modernization of food CGMPs.[1]
The Relationship Between CGMPs and HACCP
CGMPs are preventive controls that work with other preventive control programs, such as Hazard Analysis Critical Control Point (HACCP) systems, to assure the safety and integrity of the food supply. CGMP controls differ from HACCP controls in several fundamental ways. CGMPs can be applied to any food manufacturing, packing or storage operation, regardless of the type of food or manufacturing process. In contrast, each HACCP control plan is specifically designed for a particular food or a related group of foods or food processes. CGMP controls address not only food safety but the prevention of contamination of food with filth and food decomposition or spoilage as well, while HACCP controls are focused on food safety. CGMP controls address the general design, construction and operation of food manufacturing and storage facilities, equipment sanitation, and employee hygienic practices and require that foods do not become adulterated as defined in Section 402 of the Federal Food, Drug and Cosmetic Act. In contrast, HACCP systems identify specific food hazards that are unique to a particular food or food manufacturing processes, and then specify critical controls that reduce or eliminate these food safety hazards. Each HACCP critical control requires monitoring, recordkeeping and verification activities that ensure the successful implementation of the critical control.
Both CGMPs and HACCP assure the safety of foods. For those food processes where food safety is controlled by HACCP systems, CGMPs are essential to a successful implementation of HACCP. CGMPs are often referred to as prerequisite programs for HACCP. HACCP preventive controls alone cannot assure the safety and wholesomeness of the food supply.
Why Do the CGMPs Need to be Revised Now?
CFSAN last revised the CGMP regulations in 1986. The primary purpose of the 1986 revision was to establish new, updated, or more detailed provisions concerning food industry personnel; plants and grounds, sanitary facilities, controls, and operations; equipment and utensils, warehousing, and distribution, and natural or unavoidable defect levels.[2] Although these regulations have not been updated in many years, they are broad enough to apply to many situations that could not be envisioned at their inception in 1969. The Center understands the importance of preserving the flexibility of the CGMP regulations, yet believes that there have been significant developments in our understanding of food safety hazards and in the control of these hazards to warrant a reexamination of the CGMP regulations.
Since 1986, new foodborne pathogens and food vehicles for pathogens have been identified. In 1986, Listeria monocytogenes had only recently been recognized as a foodborne pathogen and very little was known about the importance of controlling this organism in the food processing plant environment. Similarly, the significance of pathogens such as Escherichia coli O157:H7, Campylobacter jejuni, Cryptosporidium parvum, Cyclospora cayetanensis and Norovirus were not as well understood in 1986 as they are today. In addition to these new pathogens, familiar pathogens such as Salmonella are causing outbreaks in foods where they were previously not thought to be a problem. For example, Table 1 lists recent outbreaks involving fresh produce items. Modern good manufacturing practices can play a role in reducing the risk of these pathogens.
Table 1 Source: Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, Emergency Coordination and Response Team