Source: http://www.gmpua.com/World/FDA/Book/GMP1/gmp-1.htm
Timestamp: 2017-09-26 11:00:16
Document Index: 91462793

Matched Legal Cases: ['art 110', 'art 128', 'art 128', 'art 110', 'art 110', 'art 110']

CURRENT FOOD GOOD MANUFACTURING PRACTICES
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.
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.
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).
· 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
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.
The Bureau of Chemistry passes the 1906 Pure Food and Drugs Act, prohibiting interstate commerce in misbranded and adulterated foods, drinks, and drugs
FDA recommends revising the 1906 Pure Food and Drugs Act
FDA passes the 1938 Federal Food, Drugs, and Cosmetics Act, which provides identity and quality standards for food
FDA decides to clarify the FDCA through GMP regulations
FDA proposes food GMP regulations
FDA finalizes food GMP regulations
FDA decides to revise the general GMPs rather than adopting industry-specific GMPs
Source: Dunkelberger, 1995; FDA, 1981b
The general provisions in Subpart A of the food GMPs are divided into four sections. The first section defines much of the terminology used in describing GMPs. The terms “shall” and “should” are also defined to differentiate between when compliance is necessary (“shall”) and when procedures and practices are not directly related to insanitary conditions as specified in Section 402(4)(a) (“should”).
Section 110.37 describes the requirements for adequate sanitary facilities and controls, including the water supply, plumbing, toilet and hand-washing facilities, and rubbish and offal disposal. Some of the requirements of the section are fairly specific, such as the requirement of self-closing doors for toilet facilities, whereas others remain general, such as plumbing of adequate size and design.
The first section of Subpart E lists the general sanitation processes and controls necessary to ensure that food is suitable for human consumption. It uses more general words (e.g., “adequate,” “reasonable,” etc.) and covers many aspects not discussed in previous subparts. This section also addresses the monitoring of physical factors (critical control points), such as time, temperature, humidity, pH, flow rate, and acidification.
The last subpart of the food GMPs allows FDA to define maximum defect action levels (DALs) for a defect that is natural or unavoidable even when foods are produced under GMPs as set out in the other subparts of the regulations. Generally, these defects are not hazardous to health at low levels; they include rodent filth, insects, or mold. The DALs are defined for individual commodities and may be obtained by request from FDA, which produces a Handbook on Defect Action Levels for Food. They are also available from the FDA Web site. Table 1-3 provides examples of the maximum DALs for select food products. Manufacturers are expected to use quality control operations that reduce the level of the defect to the lowest possible levels. Those exceeding maximum DALs will be considered in violation of Section 402 (3)(a) of the FDCA.
The section bans blending of food with a defect level above a maximum DAL with other food. It also stresses that compliance with DALs does not excuse violations of Section 402(4)(a) of the FDCA or that of the other subparts of 21 CFR 110
Table 1-2: Summary of 21 CFR Part 110: Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food Section 110.3
Definitions of: • Acid foods/acidified foods • Adequate • Batter • Blanching • Critical control point • Food • Food-contact surfaces • Lot • Microorganisms • Pest • Plant • Quality control operation • Rework • Safe-moisture level • Sanitize • Shall • Should • Water activity
Section 110.5
• Criteria for determining adulteration • Food covered by specific GMPs is also covered by umbrella GMPs
Requirements for: • Disease control • Cleanliness • Education and training • Supervision of personnel with regards to these requirements
Section 110.19
• Excluded operations (raw agricultural commodities) • FDA can issue special regulations to cover excluded operations
• Description of adequate maintenance of grounds
• Plant construction and design to facilitate sanitary operations and maintenance
Section 110.35
Requirements for: • Cleaning/sanitizing of physical facilities, utensils, and equipment • Storage of cleaning and sanitizing substances • Pest control
• Sanitation of food contact surfaces
• Storage and handling of cleaned portable equipment and utensils
Requirements for: • Water supply • Plumbing • Sewage disposal • Toilet facilities
• Hand-washing facilities • Rubbish and offal disposal
Section 110.40
• Requirements for the design, construction, and maintenance of equipment and utensils
Section 110.80
Delineates processes and controls for:
Section 110.93
Storage and transportation of food must protect against contamination and deterioration of the food and its
. • FDA has established maximum defect action levels (DALs) for some natural or unavoidable defects
. • Compliance with DALs does not excuse violation of 402 (a)(4)
. • Food containing defects above DALs may not be mixed with other foods
Table 1-3: Maximum Defect Action Levels for Selected Food Products Food Product
• Average of 30 or more insect fragments per 10 grams
• Average of 1 or more rodent hairs per 10 grams
. • Average of 60 or more aphids, thrips, and/or mites per 100 grams
. • More than 4% of beans by count are moldy
. • More than 4% of beans by count are insect-infested or insect-damaged
. • More than 6% of beans by count are insect-infested or moldy (NOTE: Level differs when both filth and mold are present)
. • Average of 10 mg or more mammalian excreta per pound
Average of 1.3 percent or more by count of olives with whole pits and/or pit
fragments 2 mm or longer measured in the longest dimension
Average of 10 or more fly eggs per 500 grams 5 or more fly eggs and 1 or more maggots per 500 grams 2 or more maggots per 500 grams
Dunkelberger, Edward. 1995. The statutory basis for the FDA’s food safety assurance programs: From GMP, to emergency permit control, to HACCP. Food and Drug Law Journal 50. 357-383.
Federal Register 51. 1986. Part 110—Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food. Federal Register 51. June 19.