1. HOMELAND SECURITY and AMERICAN COUNCIL OF INDEPENDENT LABORATORIES An Environmental Sciences Section Perspective Robert Wyeth Severn Trent Laboratories

2. ACIL ESS Past Homeland Security Activity Invited participating EPA parties to ACIL meetings Invited participating EPA parties to ACIL meetings Included CDC in ELAB Included CDC in ELAB Review and commented on both 1 st and 2 nd versions of EPA’s Sampling and Analysis Manual for Homeland Security Events Review and commented on both 1 st and 2 nd versions of EPA’s Sampling and Analysis Manual for Homeland Security Events

3. Review of Sampling & Analyses Methods Manual ACIL ESS comments and conclusions, in addition to some detailed methods suggestions, was that DHS or HHS, through whatever mechanism, did not need to fund any development relative to environment laboratory capacity as the commercial laboratory industry can provide more than adequate capacity and capability. ACIL ESS comments and conclusions, in addition to some detailed methods suggestions, was that DHS or HHS, through whatever mechanism, did not need to fund any development relative to environment laboratory capacity as the commercial laboratory industry can provide more than adequate capacity and capability.

4. In the Beginning The Laboratory Response Network (LRN) was established by the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) in accordance with Presidential Decision Directive 39, which outlined national anti- terrorism policies and assigned specific missions to federal departments and agencies The Laboratory Response Network (LRN) was established by the Department of Health and Human Services, Centers for Disease Control and Prevention (CDC) in accordance with Presidential Decision Directive 39, which outlined national anti- terrorism policies and assigned specific missions to federal departments and agencies

5. What is the LRN? Bioterrorism Bioterrorism Chemical Terrorism Chemical Terrorism

6. LRN Structure for Bioterrorism National Laboratories National Laboratories CDC, U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID), and the Naval Medical Research Center (NMRC), are responsible for specialized strain characterizations, bioforensics, select agent activity, and handling highly infectious biological agents. CDC, U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID), and the Naval Medical Research Center (NMRC), are responsible for specialized strain characterizations, bioforensics, select agent activity, and handling highly infectious biological agents. Reference Laboratories Reference Laboratories Responsible for investigation and/or referral of specimens; made up of more than 100 state and local public health, military, international, veterinary, agriculture, food, and water testing laboratories. In addition to laboratories located in the United States, facilities located in Australia, Canada, and the United Kingdom serve as reference laboratories abroad. Responsible for investigation and/or referral of specimens; made up of more than 100 state and local public health, military, international, veterinary, agriculture, food, and water testing laboratories. In addition to laboratories located in the United States, facilities located in Australia, Canada, and the United Kingdom serve as reference laboratories abroad. Sentinel Laboratories Sentinel Laboratories The LRN is currently working with the American Society for Microbiology and state public health laboratory directors to ensure that private and commercial laboratories are part of the LRN. There is an estimated 25,000 private and commercial laboratories in the United States. The majority of these laboratories are hospital- based, clinical institutions, and commercial diagnostic laboratories. The LRN is currently working with the American Society for Microbiology and state public health laboratory directors to ensure that private and commercial laboratories are part of the LRN. There is an estimated 25,000 private and commercial laboratories in the United States. The majority of these laboratories are hospital- based, clinical institutions, and commercial diagnostic laboratories.

7. LRN Structure for Chemical Terrorism Currently, 62 state, territorial and metropolitan public health laboratories are members of the chemical component of the network. A designation of Level 1, 2, or 3 defines network participation, and each level builds upon the preceding level. Currently, 62 state, territorial and metropolitan public health laboratories are members of the chemical component of the network. A designation of Level 1, 2, or 3 defines network participation, and each level builds upon the preceding level. Level 3 Laboratories Level 3 Laboratories Each chemical network member participates in Level 3 activities: Each chemical network member participates in Level 3 activities: –Working with hospitals in their jurisdiction; –Knowing how to properly collect and ship clinical specimen; –Ensuring that specimens, which can be used as evidence in a criminal investigation, are handled properly and chain-of-custody procedures are followed; –Being familiar with chemical agents and their health effects; –Training on anticipated clinical sample flow and shipping regulations; and –Working to develop a coordinated response plan for their respective state and jurisdiction.

8. LRN Structure for Chemical Terrorism (cont) Level 2 Laboratories Level 2 Laboratories Thirty-seven labs participate in Level 2 activities. At this level, laboratory personnel are trained to detect exposure to a limited number of toxic chemical agents in human blood or urine. Analysis of cyanide and toxic metals in human samples. Thirty-seven labs participate in Level 2 activities. At this level, laboratory personnel are trained to detect exposure to a limited number of toxic chemical agents in human blood or urine. Analysis of cyanide and toxic metals in human samples. Level 1 Laboratories Level 1 Laboratories Ten laboratories participate in Level 1 activities. At this level, personnel are trained to detect exposure to an expanded number of chemicals in human blood or urine, including all Level 2 laboratory analyses, plus analyses for mustard agents, nerve agents, and other toxic chemicals. Ten laboratories participate in Level 1 activities. At this level, personnel are trained to detect exposure to an expanded number of chemicals in human blood or urine, including all Level 2 laboratory analyses, plus analyses for mustard agents, nerve agents, and other toxic chemicals.

9. LRN Partners Association of Public Health Laboratories Association of Public Health Laboratories Federal Bureau of Investigation (DOJ) Federal Bureau of Investigation (DOJ) American Association of Veterinary Laboratory Diagnosticians American Association of Veterinary Laboratory Diagnosticians American Society of Microbiology American Society of Microbiology Environmental Protection Agency Environmental Protection Agency Department of Agriculture Department of Agriculture Department of Defense Department of Defense Food and Drug Administration Food and Drug Administration Department of Homeland Security Department of Homeland Security Department of Energy Department of Energy

10. Summary of LRN >150 laboratories (most are Public Health Labs) >150 laboratories (most are Public Health Labs) All specimens and all samples types for chemical, biological and radiological testing All specimens and all samples types for chemical, biological and radiological testing Domestic and International Domestic and International –All 50 states and Puerto Rico –Canada –UK –Austrailia Reportedly still building the network… commercial opportunity? Reportedly still building the network… commercial opportunity?

11. Integrated Consortium of Laboratory Networks (ICLN) To further expand and improve the LRN, the Integrated Consortium of Laboratory Networks (ICLN), a network of networks was established. To further expand and improve the LRN, the Integrated Consortium of Laboratory Networks (ICLN), a network of networks was established. –Promote collaboration –Improve communication –Advance technical acuity

12. ICLN (DHS) Food Emergency Response Network (FERN)…food Food Emergency Response Network (FERN)…food Laboratory Response Network (LRN) …human health Laboratory Response Network (LRN) …human health National Animal Health Laboratory Network…animal National Animal Health Laboratory Network…animal National Plant Diagnostic Network…plant health National Plant Diagnostic Network…plant health Environmental Laboratory Response Network… environment Environmental Laboratory Response Network… environment

13. Memorandum of Agreement ICLN operates under a MOA ICLN operates under a MOA MOA participants: MOA participants: –Department of Agriculture –Department of Defense –Department of Commerce –Department of Energy –Department of Interior –Department of Justice –Department of State –Environmental Protection Agency

14. ICLN Structure Organizational structure of ICLN includes: Joint Leadership Council Joint Leadership Council Network Coordinating Group (including Executive Secretariat) Network Coordinating Group (including Executive Secretariat) Permanent and ad hoc Technical Experts Permanent and ad hoc Technical Experts

15. Federal Government Commitment Difficult to determine actual dollars spent and/or committed to the program. Difficult to determine actual dollars spent and/or committed to the program. Regarding LRN, between 2002-2004, funding was approximately $390M for bioterrorism and approximately $95M for chemical terrorism. Regarding LRN, between 2002-2004, funding was approximately $390M for bioterrorism and approximately $95M for chemical terrorism.

16. Opportunities for ACIL Members FERN looking for private sector participation FERN looking for private sector participation As a part of HSPD-7, National Infrastructure Protection Plan (NIPP), will utilize private sector input As a part of HSPD-7, National Infrastructure Protection Plan (NIPP), will utilize private sector input ICLN progress has been slow and expensive, AOAC Research Institute has developed a partnering relationship…may be a model for ACIL ICLN progress has been slow and expensive, AOAC Research Institute has developed a partnering relationship…may be a model for ACIL ICLN is or will be looking for Technical Experts ICLN is or will be looking for Technical Experts ELRN is still developing and ESS may be able to influence ELRN is still developing and ESS may be able to influence