Bioterrorism Agent Compliance : Bioterrorism Agent Compliance
“Impact on Academia”
Cheri Hildreth Watts, Director
Department of Environmental Health & Safety
University of Louisville
A Brave New World ? For EHS and Academic Professionals Dealing with Select Agents… : A Brave New World ? For EHS and Academic Professionals Dealing with Select Agents… EHS role in the spotlight
Lots of new money for biodefense research
-- $6 Billion project “Bioshield” ($1.8B NIAID)
“Bioterrorism becomes one of the hottest US research fields” Nature Medicine, March 2002
FBI, DOJ, CDC, DHHS, UDSA officials on campuses across the country
Why?? Let me count the ways… : Why?? Let me count the ways… Because we as ROs and other individuals could go to jail and face significant penalties
Big looming questions regarding SA regulations so we’re left with interpretations while regulations are in a state of flux
“Open culture”, governance mechanisms and collaborative research will all be impediments in implementing compliance requirements i.e civil and criminal penalties for individuals and other
persons up to maximum of $250,000/$500,000 respectively
* : The Subpoena that Many
Universities Received…
Started in fall 2001 during
anthrax letter investigation
EHS played key role along
with University Counsel
Very time consuming lasting
2-4 weeks
Some asked for records
going back ten years
FBI interviewed PIs asking
40-50 questions
*
“The Forces” : “The Forces”
USA PATRIOT Act– October 26, 2001
Public Health Security and Bioterrorism Preparedness and Security Act—
June 12, 2002 _____________________________
USA PATRIOT vs. PHSBPRA : USA PATRIOT vs. PHSBPRA
USA PATRIOT Act very broad only 1 ½ pages out of 342 on Select Agents (SA) – Section 817
Covers “possession” of SA for first time
Establishes possession standards i.e. bona fide research or other peaceful purpose
Assurance that no “restricted persons” have access to SA but not prescriptive in how to accomplish
Some universities opted to do “self declaration” while others did actual background checks
PHSBPRA and 12/13 Regs : PHSBPRA and 12/13 Regs Includes a separate requirement for Attorney General’s Office (AGO) to do security risk assessment for RO, individuals that have access and any individual who owns or controls the entity
Restricted person definition is retained
Process and mechanism not yet known
Deadlines in March and April to submit information to AGO– RO and entity before individuals with access!
Doesn’t eliminate need to comply with checks for
“restricted persons” with access to SA under PATRIOT Act
Slide8 : Memory Lane: Issues
that Came Up Some
Not Resolved…. 9/10 federally mandated notification to help agency
prepare for promulgation of 12/13 SA regs– just the
beginning
Multiple forms and single geographical location issue
Isolates from naturally occurring sources
Medical use exemption versus “off-label” uses not
extensively surveyed
Academic Researchers and Faculty in the News…. : Academic Researchers and Faculty in the News…. 6/19/02- 2 Harvard researchers arrested
for allegedly stealing biological materials and scientific documents
7/16/02- Brown University former PhD student
accused of stealing biological materials and data
7/28/02- Cornell post-doc stopped at airport with
vials of biological agents in luggage and
daughter’s backpack in route to China
“Because we are a university community,we don’t want to
adversely affect university openness with draconian measures.
But of course, security is a priority.” University response
Slide10 : Charged:”Tomas Foral says the case resulted from a misunderstanding.” Science Magazine 8/2/02 UConn Grad Student
Plea Agreement 7/22/02
Details and Impact of UConn Student Plea Agreement : Details and Impact of UConn Student Plea Agreement Grad student’s work was on West Nile virus
Malfunctioning basement freezer in Pathobiology Department found to have anthrax samples from cow necropsy done in 1960’s
Grad student allegedly told by lab supervisor to “get rid” of 7 vials of anthrax– he keeps two for potential future work
Occurred sometime between October 27- November 27,2001 during the height of national anthrax investigation
Continued Details on UConn Student Plea Agreement : Continued Details on UConn Student Plea Agreement November 21,2001 a 94year old Connecticut woman dies of inhalational anthrax
Whistleblower reports Tomas Foral’s possession of two vials of anthrax
FBI and other law enforcement officials descend on campus and shut down lab building for one week
Must perform 96 hours of community service and on probation for 6 months– Foral said he couldn’t afford to fight the charges
Basis of charge was DOJ’s contention that he did not possess the anthrax for “bona fide” research
Slide13 : LSU Defends Firing Steven Hatfill 9/3/02 One of several people interviewed by FBI in fall 2001
anthrax investigation
Dismissed by LSU after DOJ identifies Hatfill as
“person of interest”
Slide14 : Accused: “Plague specialist Thomas Butler is arrested for lying about the whereabouts of samples of plague bacteria.” Science Magazine TTe Te Texas Tech Professor Arrested 1/16/03
Details of Texas Tech Arrest : Details of Texas Tech Arrest
1/16/03 Dr. Butler arrested for false information to FBI on whereabouts of ~ 30 slides/vials of Yersinia pestis aka “plague”
Per public information accounts, Dr. Butler knew this was incorrect and that in fact they had already been mistakenly destroyed—later recanted statements
University officials notified law enforcement and public health officials around 3:30pm on 1/14
Continued Details of Texas Tech Arrest : Continued Details of Texas Tech Arrest By 8:00pm on 1/14 over 60 federal, state and local
law enforcement officials including DOJ and CDC
were on campus conducting the investigation
Butler repeated false statement to FBI and later recanted on 1/15 when investigation was called off
Arrested 1/16 and remained jailed until release on 1/21
after posting $100,000 bail and is being required to wear an electronic monitoring anklet
Federal decision on indictment before end of February
The New Regulatory Environment : The New Regulatory Environment Individuals are now vulnerable to consequences of enforcement as opposed to enforcement traditionally limited to the institution
Researchers and administrators are going to have to take Select Agents (SA) rules much more seriously than anything before including human subject research
Tension between decision to get out of SA business to avoid regulation and jumping in because of the proliferation of grant money
EHS in pivotal role to help raise awareness in academic community and design compliance mechanisms
Culture Clash : Culture Clash Arrests of Asian scientists for alleged thefts of research materials and documents -- profiling?
Foreign professors and lab staff under more scrutiny than most counterparts due to “restricted persons” definition—clash between implementing the regs and
institutional policies on discrimination
Clash between traditionally “open” campus environment and the need for security and restricted access
Infringement of personal and academic freedoms are potentially counterproductive to the advancement of science
per 10/18/02 Chronicle article at least a quarter of the cases filed under
the Economic Espionage Act of 1996 have been against Asian defendants
Trend Towards Destruction of SA : Trend Towards Destruction of SA Onerous requirements have led to many investigators to decide to get out of SA work and have requested destruction of SA
OSTP (Office of Science and Technology Policy) in White House has recently pushed for the creation of a SA repository due to concern about need for SA for future research – too little too late??
Sites still being considered by feds but regulations are in state of flux so no transfers likely any time soon
Recent list serve discussion about arctic
ice samples –research vs. regulation
Surge in New Grant Monies for Biodefense Research : Surge in New Grant Monies for Biodefense Research President Bush announced $6 Billion
in funding available for “Project
Bioshield”-- $1.8B of this in NIAID
Some universities are making the decision to submit
proposals for this money despite the fact that they
have little or no experience with BSL 3 or 4 agents or
facilities
Others deciding not to because regs are too confusing,
bureaucratic and expensive
More biosafety experts will be needed
SA Compliance an “Unfunded Mandate” : SA Compliance an “Unfunded Mandate” New regulation will require significant
improvements in security
NIH response -- cover lab infrastructure improvements
out of indirect costs
Make informed decision about current or future SA
research since reallocation of resources might be
necessary
Need for “early warning” mechanism of new research
recruits that might work with SA– 9/10 notification was
just a “picture in time”
SA Regulations in a State of Flux : SA Regulations in a State of Flux Regulations effective 2/7/03 but comment period open until 2/11/03 so what’s in place now may change
ASM, ABSA, COGR, AAU, ACE, HHMI, AAMC and many universities have submitted comments to date
Significant questions surrounding definition of packages, area, access, timetable for researchers after 2/7
Registration and security clearance applications still not
available but deadlines are approaching
List of SA to be reviewed biennially Lipah virus only discovered in 1999
SA State of Flux : SA State of Flux Responsible officials will have to be constantly
vigilant in watching for changes in the
regulations
ROs and others should read SA regulation comments
and become familiar with outstanding issues for
universities
Monitoring and implementation of regulations will be
time consuming and costly so … communicate with
administrators
What’s an RO to do? When
will we know what we’re
supposed to do.. I don’t
want to go to jail
Slide24 : Off-label Use Issue Section 73.6 (b)– the “medical use”
exemption
Currently, only exempt provided their
use “is only for the approved purpose”
The BoTox example– FDA approved uses are:
- blepharospasm ( eye disorder), 1989
- strabismus ( eye disorder),1989
- cervical dystonia ( neuromuscular), 2000
- frown lines ( cosmetic), 2002
BoTox used commonly in a couple of gastrointestinal
disorders – legal for physicians to do this but technically
it is not approved by FDA for this use
Comments are being submitted on this issue by COGR and
AAMC
Raising Awareness of SA Compliance on Campus : Raising Awareness of SA Compliance on Campus Stakes are high so there is a need to go beyond traditional means of communication
Governance mechanisms make this a challenge in academic setting
Expanding the forums you address on this issue– research deans, research advisory council, research integrity task force meetings executive council/president and VPs,relevant deans staff meetings, relevant department chair meetings
PowerPoint presentations, briefing documents, web sites, newsletters, informational bulletins
Using UConn and Texas Tech arrests as way to get institution’s attention?
New Policies and Procedures : New Policies and Procedures Can’t have governance by folkfore therefore written policies are needed
Universities are developing policies to cover destruction and acquisition of SA, lab commissioning and decommissioning
Anyone trying to tackle a policy on possession for legitimate
scientific purpose aka UConn grad student plea agreement
Policy and procedure for true inventory vs. declaration of SA
--which one, frequency, how broad of a list of materials of concern i.e. more biologicals, chemical precursors,radioactive materials?
Use of New or Existing Committees : Use of New or Existing Committees Institutional Biosafety Committee and its changing role
USA PATRIOT Act and PHSBPRA compliance task forces
Laboratory security and accountability task groups
Looking for gaps and recommending new processes
Getting representation from all relevant areas
EHS Relationships : EHS Relationships Relationship between EHS and researchers
Relationship between EHS and campus police/security
Relationship between EHS and senior campus administration/ management
Ability of EHS to stay on top of our “traditional” programs while implementing new bioterrorism agent compliance requirements
Security of Compliance and Scientific Information : Security of Compliance and Scientific Information
EHS information and databases on SA– what measures
if any are being taken now?
Security of scientific information vs. traditional openness
Recent NAS decision to censor sensitive information from a report on agricultural bioterrorism
ASM has developed its position and policies on this issue
Photos credited to… : Photos credited to…
Slide31 : Additional slides from Dr. Ron Atlas’s presentation at
National ACHMM conference in Louisville,Ky.
October2, 20002
NOTE: Dr. Atlas is President of the American Society
of Microbiology. He is also Graduate Dean, Professor of
Biology, and Professor of Public Health, and Co-Director
Center for Deterrence of Biowarfare and Bioterrorism
at the University of Louisville.
Suggested Policy Mechanisms to Reduce Future Biological Weapons Threats : Suggested Policy Mechanisms to Reduce Future Biological Weapons Threats Tighten restrictions on access to dangerous pathogens
Impose restrictions on the conduct and publication of “contentious research,” i.e. fundamental biological or biomedical investigations that produce organisms or knowledge that could have immediate weapons implications
Restrict access and dissemination of “relevant information”
Controlling Biological Warfare Threats: Resolving Potential Tensions Among the Research Community, Industry, and the National Security Community. Gerald L. Epstein. Critical Reviews in Microbiology, 27 (2001)
Slide33 :
Even at the height of the Cold War era it was recognized that “greater security would be achieved by the open pursuit of scientific knowledge than by curtailing the free exchange of scientific information.”
National Academy of Sciences 1982 Corson Report
“It is the policy of this Administration that, to the maximum extent possible, the products of fundamental research remain unrestricted. It is also the policy of this Administration that, where the national security requires control, the mechanism for control of information generated during federally-funded fundamental research in science, technology and engineering at colleges, universities and laboratories is classification.”
National Security Decision Directive #189. National Policy on the Transfer of Scientific, Technical and Engineering Information. September 21, 1985.
ASM Opinion on Secrecy : ASM Opinion on Secrecy
“Terrorism feeds on fear, and fear feeds on ignorance. The best defense against anthrax or any other infectious disease is information – information in a form that can be used by scientists and by members of the public to guide rational and effective actions to ensure public safety. Placing major new barriers in the path of the flow of information between scientists and between scientists and the public is more likely to contribute to terrorism than to prevent it.”
Abigail Salyers, Past President American Society for Microbiology
Slide35 :
The US is trying to balance openness with national security concerns but is struggling with how to achieve the right balance.
“The key to maintaining U.S. technological preeminence is to encourage open and collaborative basic research. The linkage between the free exchange of ideas and scientific innovation, prosperity, and U.S. national security is undeniable…the policy on the transfer of scientific, technical, and engineering information set forth in NSDD-189 shall remain in effect, and we will ensure that this policy is followed.”
Condoleezza Rice, Special Assistant to President Bush for National Security Affairs affirmed the importance of openness of fundamental research in a letter of November, 2001
Slide36 :
Federal departments and agencies ordered to take steps to protect information regarding weapons of mass destruction as well as other information that could compromise national security
Memorandum from Andrew H. Card, Jr., Assistant to the President and Chief of Staff, for the heads of executive departments. March 19, 2002.
Departments ordered to take steps to protect sensitive but unclassified information that might reasonably be expected to assist in the development or use of weapons of mass destruction.
Memorandum from Laura Kimberly, Acting Director Information Security Oversight Office, National Archives and Records Administration, and Richard Huff and Daniel Metcalfe, Co-directors of Information and Privacy, Department of Justice. March 19, 2002.
Slide37 :
Concern about sensitive biological information and the threat of recombinant DNA technology was sparked by the publication of experiments in which IL-4 genes were inserted into mousepox viruses, resulting in near total suppression of the immune response.
Jackson RJ. et al. 2001. Expression of mouse interleukin-4 by a recombinant ectromelia virus suppresses cytolytic lymphocyte responses and overcomes genetic resistance to mousepox. J. Virology 75:1205-10.
The IL-4 mousepox study was done in Australia, beyond the reach of US government regulations.
It was, however, potentially subject to restraint, raising the question of ethical responsibility within the scientific community.
Slide38 :
Report demonstrating that artificially synthesized polio virus genome produced infective pathogenic virus
Cello, J., A. V. Paul, and E. Wimmer. 2002. Chemical synthesis of poliovirus cDNA: Generation of infectious virus in the absence of natural template. Science express. July 2002/ Page 1/ 10.1126/science.1072266.
Executive Branch called upon to “…examine all policies, including national security directives, relevant to the classification or publication of federally funded research to ensure that, although the free exchange of information is encouraged, information that could be useful in the development of chemical, biological, or nuclear weapons is not made accessible to terrorists or countries of proliferation concern.”
- House Resolution 514. Introduced by Congressman Dave Weldon (R-Fla.) and seven others on July 26, 2002
Slide39 :
Problem is that there is no clear definition of what constitutes "sensitive information" in the Life Sciences.
“the concept [of sensitive but unclassified information] is so squishy [ill defined] and fraught with danger that the only sensible thing for the research community to do is to demand [classification].”
William Wulf, President of the National Academy of Engineering, Leo, A. 2002. Science and secrets. Technology Review, June 20.
Many academic institutions, like MIT, reject classified research. A recent report recommended that MIT ban classified research on its main campus to protect its educational mission although faculty could conduct such research on MITs Lincoln campus.
In the Public Interest. Report of the ad hoc faculty committee on access to and disclosure of scientific information. Massachusetts Institute of Technology, June 12, 2002