Current food good manufacturing practices (GMPs) are published in Title 21 of the Code of Federal Regulations, Part 110 (21 CFR 110). GMPs describe the methods, equipment, facilities, and controls for producing processed food. As the minimum sanitary and processing requirements for producing safe and wholesome food, they are an important part of regulatory control over the safety of the nation's food supply. GMPs also serve as one basis for FDA inspections.
The current GMPs are the result of an extended rulemaking process that spanned decades. The following section (Section 1.1) describes when, why, and how the food GMPs were developed and some of the obstacles that were overcome. Table 1-1 summarizes the major events that led to the development of GMPs as they are today. Section 1.2 provides a detailed discussion of the requirements in each of the five subparts of the GMP regulation, and concludes with a table (Table 1-2) outlining the main requirements.
1.1 The Development of Food GMPs
Food safety has been regulated since the mid-1800s and was mostly the responsibility of local and state regulators. However, the Pure Food and Drugs Act, passed by Congress in 1906, marked the first major federal consumer protection law with respect to food processing. The 1906 law prevented interstate and foreign commerce in misbranded or adulterated foods, drinks, or drugs. The intent of the Act was to prevent poisoning and consumer fraud. As more food products were manufactured in subsequent years, however, poor-quality food products and deceptive packaging continued to be produced due to loopholes in the law. Consumers were often unaware of what they were buying until products were opened. Therefore, in 1933, the FDA decided to overhaul the 1906 Act.
In 1938, after a battle about USDA jurisdictions with respect to the Act's enforcement, the Food Drug, and Cosmetic Act (FDCA) replaced the 1906 Act. The FDCA provided the necessary identity and quality standards to protect consumers from fraud. The FDCA provides the regulatory basis for today's food GMPs. Two sections of the FDCA are directly related to conditions in a facility where food has been manufactured.
Section 402 (a)(3) specifies that food has been manufactured under such conditions that it is unfit for consumption.
Section 402 (a)(4) considers that food may be adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.
These provisions are unlike other parts of Section 402, in that they relate to the conditions of a facility where food is produced or stored. Thus, instead of having to prove that the food is adulterated, insanitary conditions are considered sufficient to show that the food might have become adulterated.
Given the FDCA's vagueness in establishing violations and thus, the difficulty of enforcing it, FDA began working on draft GMP regulations by the mid-1960s (although others had made the suggestion to do so as early as 1948). The objective of the GMP regulations was to describe general rules for maintaining sanitary conditions that must be followed by all food processing facilities to ensure that the statutory requirements of Section 402(a)(3) and (4) were met. After much industry involvement, including much debate about FDA's authority to adopt rules to carry out the provisions of the FDCA, the GMP regulations for food processing facilities were finally proposed in 1968 (see Table 1-1).
Three broad categories of interrelated issues arose during the development of the GMPs (Dunkelberger, 1995):
Concern that the regulations were unduly stringent and especially burdensome for small food companies without necessarily improving the quality or safety of foods.
Contention that the GMP regulations must prescribe conditions that "reasonably" relate to insanitary conditions that may contaminate food and render it injurious to health.
Assertions that the regulations did not have the force of law.
These first two issues were resolved mostly through the use of more general terms, such as "adequate," "sufficient," and "suitable," rather than hard-line standards. FDA also used "shall" when the agency felt compliance was necessary and "should" when practices in the rule were less obviously related to the statutory requirements of the Act. The third issue became inconsequential when it was proved that FDA did have the statutory authority to promulgate the GMP regulations. The GMP regulations were finalized in April of 1969 and published as Part 128 of the Code of Federal Regulations (CFR). In 1977, Part 128 was recodified and published as Part 110 of the CFR.
The final GMP regulations were very broad, not specifying what exactly a facility must do to comply. This naturally created enforcement problems for the FDA. To address the ambiguity created by the umbrella GMPs, FDA next tried to develop industry-specific GMPs through the mid-1970s. By the late 1970s, however, FDA decided to improve the umbrella GMPs rather than adopting industry-specific GMPs. The revisions were finalized in 1986 and printed in 21 CFR 110. Specific GMPs were also included and printed in 21 CFR Parts 100 through 169 for:
Quality control procedures for nutrient content of infant formula (21 CFR 106).
Thermally processed low-acid canned foods in hermetically sealed containers (21 CFR 113).
Acidified foods (21 CFR 114).
Bottled drinking water (21 CFR 129).
In July of 2002, FDA formed a Food GMP Modernization Working Group to examine the effectiveness of current food GMPs given the many changes that have occurred in the food industry since 1986. The Working Group has been researching the impact of food GMPs on food safety, as well as on the impact (including economic consequences) of revised regulations. Part of the group's current effort, as of June 2004, is to find out which elements of the food GMPs are critical to retain and which should be improved. FDA is now holding public meetings to obtain the public comments to assist in this effort.
