Current Good Manufacturing Processes

Introduction

The Food and Drug Administration (FDA) requires all foods (excluding meat, poultry, and egg products) to meet the cgmps. The cGMP regulations are printed in Title 21 Part 110 of the Code of Federal Regulations (CFR, 2006b). The cGMP regulations are general sanitation requirements that apply to all foods. They are subdivided into specific plant requirements. Within Title 21 CFR 110, definitions of food processes and products along with the specific definition of adulteration, are stated.

Food Regulations, Keener

Specific requirements for plant personnel are found in Section 110.10 and plant and grounds in Section 110.20. In brief, these specific regulations dictate that plant personnel, plant (building), and grounds, must be constructed and managed in a sanitary manner so as not to lead to adulteration of food processed in the facility.

Section 110.35 describes sanitary operation requirements for the facility, such as required cleaning of food contact and non-food contact surfaces, cleaners, and sanitizers. Sanitary facilities and controls (Section 110.39) dictate requirements for sanitary water, plumbing, toilet and handwashing station requirements, floor drain requirements, and placement of signs instructing employees in required hygiene practices.

Design of equipment and utensils (Section 110.40) for food contact are required to be constructed of non-toxic, corrosive resistant materials. “The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants.” Each freezer and cold storage cooler is required to have a thermometer with an automatic control system or alarm system if under manual operation.

All instruments and controls must be designed and maintained so as to not adulterate food. Any gases (air, nitrogen, etc.) introduced into the food or used to clean food-contact surfaces or equipment must be appropriately treated so as to not adulterate the food. “All operations in the receiving, inspecting, transporting, segregating, preparing, manufacturing, packaging, and storing of food shall be conducted in accordance with adequate sanitation principles (Section 110.80).

Appropriate quality control operations shall be employed to ensure that food is suitable for human consumption and that food-packaging materials are safe and suitable. Overall sanitation of the plant shall be under the supervision of one or more competent individuals assigned responsibility for this function.

All reasonable precautions shall be taken to ensure that production procedures do not contribute to contamination from any source. Chemical, microbial, or extraneous-material testing procedures shall be used where necessary to identify sanitation failures or possible food contamination”(CFR, 2006b). All food that has become contaminated to the extent that it is adulterated shall be rejected, or if permissible, treated or processed to eliminate the contamination.

Finished food products should be stored and transported appropriately so as to protect against product adulteration or container damage (Section 110.93). Some foods, when processed under cGMPs, contain natural or unavoidable defects that are at low levels and are not hazardous to health. FDA establishes a maximum level of each defect in food produced under cGMPs, called the defect action level (DAL) (Section 110.110).

DAL’s are established as needed and change as new technology and processing practices become available. DAL’s do not excuse the food from being adulterated by noncompliance with cGMPs, even when its effect produces defects below the DAL. In addition, the mixing of food exceeding a DAL with food below the DAL is not allowed. Even if the final product does not exceed the DAL, it would be deemed 2: Food Regulations, Keener 23 adulterated (CFSAN, 2001).

A complete list of current DAL’s for natural or unavoidable defects in food for human use that present no health hazard may be obtained upon request from the Center for Food Safety and Applied Nutrition (HFS-565), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Note: maximum levels for pesticide residues in raw agricultural products are determined by the EPA under FIFRA. FDA’s DAL for pesticide residues are EPA’s limits unless an allowance for a higher level is made.

Many food processes concentrate food products, and thus pesticides may cause the product to be considered adulterated if the DAL of pesticide residue is exceeded in the finished product. In addition, if the product is a ready-to-eat product, it may not be blended to lower the pesticide residue. For example, the DAL for aflatoxin (a carcinogen produced by certain molds) in peanuts and peanut products is 20ppb.

A finished peanut or peanut product must contain less than 20ppb aflatoxin if it is to be sold for human consumption. If the amount of aflatoxin exceeds 20ppm in dry roasted peanuts, they cannot be sold for human consumption. Also, these dry roasted peanuts cannot be blended with dry roasted peanuts containing a lower level of aflatoxin to lower the overall level of aflatoxin. In addition, if peanuts containing less than 20ppb aflatoxin were used to produce peanut butter and the peanut butter (finished product) had an aflatoxin level above 20ppb then this product could not be sold for human consumption.

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Also, this peanut butter could not be blended with peanut butter containing less than 20ppb aflatoxin to lower the overall concentration below 20ppb.