2.1 Introduction

A. Discussion

The FDA microbiologist is well termed a regulatory microbiologist because everything he or she does is related to the regulation of products and manufacturers under the jurisdiction of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Related Acts. Thus, results of his or her work impacts directly on those products regulated, and therefore on the consumer. 

B. Training Purpose

FDA regulatory microbiologists examine products under the purview of the Act for pathogenic and non-pathogenic microorganisms, conduct method development research, and participate in team establishment inspections.

Analyses range from the relatively simple to the most complex. In recent years, microbiologists have transitioned from sole use of conventional methods to a coupling of state of the art rapid methods with the traditional.

The overall purpose of the training program is to:

1. Train the analyst to think as a regulatory microbiologist.
2. Introduce typical analytical procedures a regulatory microbiologist is to know and understand.
3. Show where and how the work performed fits into the regulatory framework.

This regulatory framework includes:

1. The reasons for sample collection.
2. The procedures of inspection and sample collection.
3. The sample analysis procedures.
4. Regulatory follow up actions and relationship of items to the FD&C Act.

C. Training Period

This training program is divided into different modules. If all modules are completed, the microbiologist will be competent in many procedures in FDA microbiology. The modules represent a basic, intermediate, and advanced curriculum; basic-sections 2.5 to 2.5.9 and 2.7, intermediate-sections 2.5.10 to 2.6 and 2.9, advanced – sections 2.8 and 2.10 to 2.13.3.

During the first year, there will be several basic training courses offered by ORA. Training will also be supplemented by computer based modules provided online by ORA U. However, most instruction will come from the laboratory.

Microbiology methodology is an ever-improving science. Training will be a continuing process throughout the microbiologist’s career. Future training will reinforce and amplify what the trainee has learned. 

D. Exercise

1. Objective
   Introductory exercises demonstrating the trainee is proficient in basic microbiology techniques
2. Assignment
   The trainee will discuss and demonstrate basic microbiology skills such as the following:
   • gram staining
   • aseptic techniques
   • hanging drop motility
   • quadrant streak
   • ELISA tes