1. 1 Goals for EH&S Discussion  Regulatory Environment after 9/11 and impact on university EH&S and Campus Police operating procedures

2. 2 NC State Environmental Health and Public Safety

3. 3 The Threat of Bioterrorism Before September 11 th -- Predictions of Bioterrorism We were... “ at the brink of a new age—what some experts call catastrophic terrorism...I do not believe it is a question of whether a lone terrorist or terrorist group will use infectious disease agents to kill unsuspecting citizens; I’m convinced it’s really just a question of when and where.” Michael Osterholm, Former State Epidemiologist for Minnesota

4. 4 The Threat of Bioterrorism After September 11 th Reality of Bioterrorism Attack with Anthrax through the mail Fear grips the Nation Scientists become suspects

5. 5 Anthrax Attack 2001 Unknowns  Who sent the letters? –Unknown--individual yet to be apprehended –Believed to be from US--sent by someone with access to US biodefense program information  Where were the letters sent from –Certainly NJ--initially thought to be Trenton but now thought that it may have been Princeton based upon detection of spores in mailbox  Where did the anthrax come from –Ames strain originated in Texas--never in Iowa as originally thought –Forensics indicate grown in last 2 years and clearly same as the strain at USAMRIID

6. 6 Anthrax Attack 2001 Unknowns  Index case identified in individual who lived in Florida, but traveled and spent time in North Carolina  FBI contacts State of North Carolina Health Dept. and other state agencies trying to determine who in NC may have anthrax or other “select agents.”  Basically, no information available and no central or other repositories of information on possession.

7. 7 What has been the response to lack of information on possession of hazardous agents?  Primarily, regulatory at national and state level with specific mandates  NC Biological Agents Registry, 15 A NCAC 19A 0900 requires registration of biological agents  Antiterrorism and Effective Death Penalty Act of 1996 regulated the shipment and receipt of “select agents.” CDC promulgated a select agent list of bacteria, viruses, fungi and toxins considered to be threats as agents of bioterrorism. The Act did not regulate “possession.”

8. 8 What has been the response to lack of information on possession of hazardous agents? The USA Patriot Act of October 26, 2001 places restrictions on persons who may possess select agents.  Restricts aliens from countries designated as supporting terrorism from possessing select agents  Restricts persons who may not carry hand guns from possessing select agents (mental illness, drug abuse, criminal record)  Dishonorable discharge from the Armed Services  No exemptions under any circumstances  NC State has conducted background checks on persons with “access to select agents.”

9. 9 HHS SELECT AGENTS  CRIMEAN-CONGO HAEMORRHAGIC FEVER VIRUS  EBOLA VIRUSES  LASSA FEVER VIRUS  MARBURG VIRUS  RICKETTSIA PROWAZEKII  RICKETTSIA RICKETTSII  SOUTH AMERICAN HAEMORRHAGIC FEVER VIRUSES  TICK-BORNE ENCEPHALITIS COMPLEX VIRUSES  VARIOLA MAJOR VIRUS (SMALLPOX VIRUS)  VIRUSES CAUSING HANTAVIRUS PULMONARY SYNDROME  YELLOW FEVER VIRUS  YERSINIA PESTIS  ABRIN  CONOTOXINS  DIACETOXYSCIRPENOL  RICIN  SAXITOXIN  TETRODOTOXIN

10. 10 USDA HHS OVERLAP AGENTS  BACILLUS ANTHRACIS  BRUCELLA ABORTUS  BRUCELLA MELITENSIS  BRUCELLA SUIS  BURKHOLDERIA (PSEUDOMONAS) MALLEI  BURKHOLDERIA (PSEUDOMONAS) PSEUDOMALLEI  CLOSTRIDIUM BOTULINUM  COCCIDIOIDES IMMITIS  COXIELLA BURNETII  EASTERN EQUINE ENCEPHALITIS VIRUS  EQUINE MORBILLIVIRUS (HENDRA VIRUS)  FRANCISELLA TULARENSIS  RIFT VALLEY FEVER VIRUS  VENEZUELAN EQUINE ENCEPHALITIS VIRUS  AFLATOXINS  BOTULINUM TOXINS  CLOSTRIDIUM PERFRINGENS EPSILON TOXIN  SHIGATOXIN  STAPHYLOCOCCAL ENTEROTOXIN  T-2 TOXIN

11. 11 Public Health Security and Bioterrorism Act  Signed by President Bush on June 12, 2002.  Intended to improve ability of US to respond to bioterrorism and other public health emergencies  Possession of “select agents” requires registration. Agents are listed by both CDC and USDA.  Required registration for possession by September 10, 2002. NC State has registered.  Tracks acquisition, transfer, possession  Requires safeguards and security regulations be followed.

12. 12 Public Health Security and Bioterrorism Act Rules issued December 13, 2002 for developing security plans:  Security plan must be based on a vulnerability and risk assessment  Inventory control  No unrestricted access for any unauthorized persons (safety, maintenance, students) would all need background check prior to unrestricted access. –Procedures for reporting suspicious persons and –Card access or cyper locks

13. 13 Public Health Security and Bioterrorism Act  Requires registered facilities to submit names of individuals with access to select agents to the Attorney General, who will use criminal, immigration, and national security databases available to the federal government to ensure that such individuals identified as restricted are denied access to select agents and toxins  Regulations remain to be issued: –How will we notify the Attorney General? –What specific information will we need to –submit? –What will be the timeframe for notification? –Will current research have to stop?  Exempts medical uses, but not necessarily investigational products

14. 14 What does the future hold? More NC State rules:  More lab security directives  Development of biosecurity plan to comply with Dec. 13, 2002 rules on Possession, Use and Transfer of Select Agents and Toxins  More scrutiny of safety plans and biological and chemical inventories (lists need to be accurate), remember UConn!

15. 15 What Do EH&S Groups Need?  Review and/or approval of procurement  Review: –Chemicals/gases/toxins –Biological safety cabinets –Semiconductor equipment –Robotic equipment –Pressure vessels –RF Generators –Diathermy Units –Microwave heaters/dryers (not ovens)

16. 16 What Do EH&S Groups Need?  Approval –Chemicals/gases/toxins –Respirators –Fume hoods –Gas monitoring, storing, scrubbing equipment –X-ray producing –Radioactive materials –Liquid scintillation counters  Appropriate purchasing agreements –Asbestos notification –Lead notification

17. 17 UNC Purchasing Issues from EH&S Perspective Do Exist  Unauthorized procurement of cyanide compound  Wrong delivery of hazardous chemicals  Unauthorized procurement of x-ray producing equipment  Unauthorized procurement of fume hoods  Unauthorized procurement of butler building resulted in unauthorized use as a laboratory  Unauthorized equipment procurement often results in unauthorized installation

18. 18 Mission of Environmental Health and Public Safety Division  The mission of the Environmental Health and Public Safety Division is to protect life, property, and the environment. We provide leadership and service in environmental affairs; emergency planning; insurance and risk management; chemical radiation; biological safety; campus policing; and fire safety.

19. 19 Radiation Safety Reviews  Expedited approval – one week –Complete applicable forms –Submit to Radiation Safety Officer –Review by Radiation Safety Committee Chair  Regular approval – 6 weeks  Provisional approval for grant applications same day

20. 20 Biosafety/Recombinent Approval  Complete applicable paperwork online  One week review – Biosafety Officer  One week review – Chair Biosafety Committee  Two week approval unless special circumstances

21. 21 Select Agent Approval  Submit to Biosafety Officer – one week  Submission to CDC – indeterminate/3 months absolute minimum

22. 22 Waste Shipping Program