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U.S. Department of Health and Human Services

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Volume IV - 2.7 Select Agents

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Orientation and Training

Food and Drug Administration

DOCUMENT NO.:

IV-02
VERSION NO.: 1.5

Section 2 - Microbiology

EFFECTIVE DATE:
10-01-03
REVISED:
02-14-13

Select agents are biological organisms or chemical toxins capable of causing great harm or potentially lethal disease.  In contrast to traditional foodborne pathogens that typically cause self-limiting gastrointestinal illness, exposure to microbiological select agents can result in serious illness or death. 

A. Objective

  1. To become familiar with factors associated with the analysis of select agents in foods.

    The website:  http://www.cdc.gov/od/sap/docs/salist.pdf lists the select agents and toxins covered by federal regulation.  FDA laboratories have received specialized training on working with microbiological select agents focusing on those microorganisms thought to have the most potential to be used as deliberate food contaminants.  This specialized training is based on the guidelines presented in the current edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL) written by the Centers for Disease Control and Prevention and the National Institutes of Health and covers several components critical to the safe and secure handling of select agents including:
    • Physical containment - Laboratory facilities must effectively contain select agents and the aerosols that could be produced during analytical manipulations.  This is accomplished through design specifications of the facility and use of specialized equipment such as Biological Safety Cabinets; sealed centrifuge rotors and buckets and transport boxes.
    • Personal Protective Equipment (PPE) includes closed front laboratory gowns or jump suits, double gloves, shoe and hair covers and respiratory protection (N95 respirators or PAPRs).
    • Biosafety practices are designed to contain aerosols and prevent release of the select agents.
    • Methods to Identify Select Agents in various food matrices.  Recovering select agents from foods can present unique challenges depending on the food type.  Care must be exercised to contain aerosols during processing of the food prior to enrichment or biochemical analyses including preparation of nucleic acid templates for use in PCR and qPCR analyses.
  2. To become familiar with the federal regulations governing select agents.

    The Centers for Disease Control and Prevention (CDC) regulates the possession, use, and transfer of select agents and toxins that pose a severe health threat to the public.  Laboratories must obtain a Select Agent Permit (SAP) from the CDC to handle these organisms.  Laboratories planning on working with or transferring microorganisms that are considered plant or animal pathogens must obtain a permit from the USDA Animal and Plant Health Inspection Service (APHIS).  All laboratories must comply with federal regulations (42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121) regarding biosafety and security if they anticipate working with select agents.

B. Assignment/exercise

Refer to the following websites and C.F.R. sections for more information on select agents.

www.cdc.gov/od/sap/
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm
       42 C.F.R. Part 73,
       7 C.F.R. Part 331
       9 C.F.R. Part 121  

C. Questions

  1. What is a select agent?
  2. Name four areas of training necessary before handling select agents.
  3. Which agency regulates the use, possession and transfer of select agents capable of posing a serious public health threat?
  4. List the PPE required to work with select agents.