Transcript No Slide Title

Goals for EH&S Discussion
 Regulatory Environment after
9/11 and impact on university
EH&S and Campus Police
operating procedures
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NC State Environmental Health
and Public Safety
ASSOCIATE VICE CHANCELLOR
HEALTH AND SAFETY, BIOSAFETY
ENVIRONMENTAL AFFAIRS
INDUSTRIAL HYGIENE
RADIATION SAFETY
RISK MANAGEMENT
CAMPUS POLICE
FIRE PROTECTION
BUSINESS CONTINUITY
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The Threat of Bioterrorism
Before September 11th -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
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The Threat of Bioterrorism
After September 11th
Reality of Bioterrorism
Attack with Anthrax through the mail
Fear grips the Nation
Scientists become suspects
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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
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strain at USAMRIID
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.
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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.”
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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.”
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HHS SELECT AGENTS
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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
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USDA HHS OVERLAP AGENTS
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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)
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FRANCISELLA TULARENSIS
RIFT VALLEY FEVER VIRUS
VENEZUELAN EQUINE ENCEPHALITIS VIRUS
AFLATOXINS
BOTULINUM TOXINS
CLOSTRIDIUM PERFRINGENS EPSILON
TOXIN
SHIGATOXIN
STAPHYLOCOCCAL ENTEROTOXIN
T-2 TOXIN
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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.
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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
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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
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products
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!
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What Do EH&S Groups Need?
 Review and/or approval of procurement
 Review:
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Chemicals/gases/toxins
Biological safety cabinets
Semiconductor equipment
Robotic equipment
Pressure vessels
RF Generators
Diathermy Units
Microwave heaters/dryers (not ovens)
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What Do EH&S Groups Need?
 Approval
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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
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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
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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.
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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
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Biosafety/Recombinent Approval
 Complete applicable paperwork online
 One week review – Biosafety Officer
 One week review – Chair Biosafety
Committee
 Two week approval unless special
circumstances
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Select Agent Approval
 Submit to Biosafety Officer – one week
 Submission to CDC – indeterminate/3
months absolute minimum
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Waste Shipping Program
450000
400000
350000
300000
250000
Waste Shipped (lbs.)
200000
Waste Disposal Cost
150000
100000
50000
0
FY 92-93
FY 93-94
FY 94-95
FY 95-96
FY 96-97
FY 97-98
FY 98-99
FY 99-00
FY 00-01
FY 01-02
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