The Bacteriological Analytical Manual (BAM), published by the U.S. Food and Drug Administration (FDA), is a collection of procedures preferred by FDA laboratories for the detection of pathogens (bacterial, viral, parasitic, as well as yeast and mold) and microbial toxins in food and cosmetic products.
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The FDA Bacteriological Analytical Manual (BAM) consists of the following headings:
The methods described in these sections are the methods preferred by FDA for the microbiological analysis of foods, beverages, and cosmetics and their containers, contact materials, and manufacturing environments.
To test for an organism or microbial toxin not included in BAM, or to analyze a sample that may require special handling or processing, the user is referred to other official analysis methods. FDA works closely with the Environmental Protection Agency (EPA), the International Dairy Federation, and the International Organization for Standardization (ISO) through participation in Codex Alimentarius.
The FDA Food Safety Modernization Act is based on preventing problems before they occur, rather than simply responding to foodborne illness outbreaks. But developing prevention-based systems requires data and other information to help identify and address hazards. That’s why sampling is a key part of this preventive approach, and FDA is developing a new microbiological surveillance sampling model designed to identify patterns that can help predict and prevent future contamination from disease-causing bacteria.
This new proactive and preventive approach is part of FDA’s efforts to further protect the food supply by preventing contaminated food from reaching consumers. FDA shares data from this approach with the public and engages with stakeholders throughout the process.
Surveillance sampling is just one type of sampling that is important for food safety. There are different types of sampling, and the methods FDA uses fall into three broad categories: environmental sampling, product sampling, and emergency response and emerging issues sampling.
For example, FDA BAM Chapter 23 covers microbiological methods for cosmetics. The ability of microorganisms to grow and multiply in cosmetic products has been known for many years. Microorganisms can cause spoilage or chemical changes in cosmetic products and harm the user. Methods used to isolate microorganisms from cosmetic products are direct colony counting and enrichment culture. Water-insoluble products are first processed to make them mixable before isolation procedures are carried out. Dilution and coating media are used, which partially inactivate the preservative systems commonly found in cosmetic products. Isolated microorganisms are identified by routine microbiological methods or commercial identification kits.
It is important to analyze the samples as soon as possible, if necessary to store them at room temperature, and not to incubate, refrigerate or freeze the samples before or after analysis. Samples should be carefully examined before opening, and irregularities in the sample container should be noted. The surface of the sample container should be disinfected with an aqueous mixture of 70 percent ethanol and 1 percent hydrochloric acid or other disinfectant before opening and removing the contents. The surface should be dried with sterile gauze before opening. A representative portion of the contents should be used for microbial analysis.
For products weighing less than 1 g (ml), the entire contents must be analyzed. If only one sample unit is available and multiple analyses are requested, i.e. microbial, toxicological and chemical analyses are required, a subsample for microbiological examination must be taken before those for other analyses. In this case, the amount of subsample used for microbial analysis depends on the other analyses to be performed. For example, if the total sample content is 5 ml, 1 or 2 ml should be used for microbial analyses.
Among the numerous testing, measurement, analysis and evaluation studies that our organization has provided for businesses in various sectors, it also provides FDA Bacteriological Analytical Manual (BAM) analysis services with its trained and expert staff and advanced technological equipment.
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