SAM and the U.S. Centers for Disease Control and Prevention (CDC) Laboratory Response Network (LRN)
EPA’s Selected Analytical Methods for Environmental Remediation and Recovery (SAM) includes several biotoxins and pathogens that are considered to be select agents. The Laboratory Response Network (LRN) was created in accordance with the 1995 Presidential Directive 39, Policy on Counterterrorism, which established terrorism preparedness responsibilities for federal agencies. The LRN is primarily a national network of local, state, federal, military, food, agricultural, veterinary and environmental laboratories; however, additional LRN laboratories are located in strategic international locations. The U.S. Centers for Disease Control and Prevention (CDC) provides technical and scientific support to member laboratories as well as secure access to standardized procedures and reagents for rapid (4 – 6 hours) presumptive detection of biothreat agents and emerging infectious disease agents. The algorithm for a confirmed result is often a combination of one or more presumptive positive results from a rapid assay in combination with a positive result from one of the “gold standard” methods, such as culture. The standardized procedures, reagents and agent-specific algorithms are considered to be sensitive and are available only to LRN member laboratories. Thus, these procedures are not available to the general public and are not discussed in this document.
Biotoxins: Many of the biotoxins listed in Selected Analytical Methods for Environmental Remediation and Recovery (SAM) are select agents. Additional information on select agents and regulations may be obtained at the National Select Agent Registry Web site. Relevant to the purposes of analytical methods, SAM users should note that some of these agents are not regulated if the amount under the control of a principal investigator does not exceed, at any time, the amounts indicated in the Permissible Toxin Amounts table.
Pathogens: It is important to note that, in some cases, the procedures may not be fully developed or validated for each environmental sample type/pathogen combination listed in Appendix C, nor are all LRN member laboratories necessarily capable of analyzing all of the sample type/pathogen combinations. Except for Coxiella burnetii, culture methods are available for all of these pathogens as American Society for Microbiology’s (ASM) Sentinel Laboratory Guidelines. See: American Society for Microbiology’s (ASM) Sentinel Laboratory Guidelines. Exit
The agents identified below and listed in Appendix C are included in the U.S. Health and Human Services (HHS)/U.S. Department of Agriculture (USDA) select agent list and should be analyzed in accordance with appropriate regulatory compliance (42 CFR parts 72 and 73, and 9 CFR part 121) and safety and BSL requirements. See: CDC’s BMBL, 5th Edition.
Select Agents Listed in Appendix C
Pathogen(s) [Disease] |
Agent Category |
---|---|
Bacillus anthracis [Anthrax] |
Bacteria |
Brucella spp. [Brucellosis] |
Bacteria |
Burkholderia mallei [Glanders] |
Bacteria |
Burkholderia pseudomallei [Melioidosis] |
Bacteria |
Coxiella burnetii [Q-fever] |
Bacteria |
Francisella tularensis [Tularemia] |
Bacteria |
Yersinia pestis [Plague] |
Bacteria |
For additional information on the LRN, including selection of a laboratory capable of receiving and processing the specified sample type/pathogen, please use the contact information provided below or visit The Laboratory Response Network Partners in Preparedness. See: Laboratory Response Network Partners in Preparedness.
Centers for Disease Control and Prevention
Laboratory Response Branch
Division of Bioterrorism Preparedness and Response (DBPR)
National Center for the Prevention, Detection, and Control of Infectious Diseases (NCPDCID)
Coordinating Center for Infectious Diseases (CCID)
CDC
1600 Clifton Road NE, Mailstop C-18
Atlanta, GA 30333
Telephone: (866) 576-5227
E-mail: Laboratory Response Branch (lrn@cdc.gov)
Local public health laboratories, private laboratories, and commercial laboratories with questions about the LRN should contact their state public health laboratory director or the Association of Public Health Laboratories (APHL) (contact information provided below).
Association of Public Health Laboratories Exit
8515 Georgia Avenue, Suite 700
Silver Spring, MD, 20910
Telephone: (240) 485-2745
Fax: (240) 485-2700
E-mail: Association of Public Health Laboratories (info@aphl.org)
The following references and information sources provide additional information regarding Select Agents Culture Methods – LRN Sentinel Labs (website references for individual pathogens are included in their respective summaries):
- Avian Influenzae (PDF) (12 pp, 108 K, About PDF) Exit
- Brucella (PDF) (19 pp, 270 K, About PDF) Exit
- Burkholderia mallei and B. pseudomallei (PDF) (27 pp, 832 K, About PDF) Exit
- Coxiella burnetii (PDF) (14 pp, 277 K, About PDF) Exit
- Fransicella tularensis (PDF) (17 pp, 327 K, About PDF) Exit
- Yersinia pestis (PDF) (18 pp, 570 K, About PDF) Exit
Sources:
ASM. 2018. Sentinel Level Clinical Microbiology Laboratory Guidelines for Suspected Agents of Bioterrorism and Emerging Infectious Diseases. (54 pp, 368 K, About PDF) Exit
CDC. 2009. Biosafety in Microbiological and Biomedical Laboratories (BMBL), 5th Edition.