Ryan Burnette, Ph.D. Director, Alliance Biosciences Global perception of the industry The Offense Existing legislation Legislative update Trans Federal Task Force Biodefense Policy Coordinating Committee NSABB The Defense Role of bio program accreditation standards CEN Workshop Update Potential impacts to EHS departments Getting and staying prepared Increasing global awareness of infectious diseases and epidemics SARS Avian influenza HIV H1N1 swine flu Increasing public awareness and concern over high-containment labs High-profile incidents Increase in biosafety & biosecurity headlines in the media Similar to GMOs Current focus is on infectious disease research labs But eyes are wandering 1
Global Perception of the Industry (cont.) Rise in proposed legislation surrounding biosafety and biosecurity S.3127 (U.S.) Call for minimum standards Program managers frustrations with laboratory design/ operational ambiguity Facilities still being designed incorrectly Inadequately-trained personnel Funding shortages to address deficiencies Incidents and accidents on the rise (?) Varying opinions on how to deal with all of this More legislation? Government oversight? Industry-driven voluntary accreditation? Will minimum standards help simplify programs for end-users? Will this trickle down into related areas, outside of SAP, BSL3/4 labs? Biosafety & Biosecurity Issues Reaching New Audiences Other industries are being impacted by biosafety & biosecurity issues Healthcare (hospitals, autopsy suites) Traditional manufacturing (GMP meets BSL3) Insurance (reputational risk) Venture capital (financial risk) Legal industry (public policy) Transportation The job of the biosafety and EHS professional is expanding Government/ agency scrutiny Press Administrators at own institution U.S. Action Incidents and Public Perception Existing Legislation Proposed Legislation Trans-Federal Task Force 2
Incidents in the U.S. Texas A&M CDC Lightning Strike Anthrax Letters Missing USAMRIID samples Etc. Texas A&M Incident reporting failure leads to stone-lifting Worker infected with Brucella Reported to RO and Biosafety Officer TAMU failed to report to CDC for several months CDC implemented university-wide shut down of select agent research NIH cut-off research funds Federal lawsuit TAMU settled for $1 million It isn t great Legislation? Accreditation? 3
Public Laws Public Health Security and Bioterrorism Preparedness and Response Act of 2002 USA Patriot Act of 2002 21 USC 151-159- Viruses, Serums, Toxins, Antitoxins, and Analogous Products 21 USC 301-Federal Food, Drug, and Cosmetic Act 42 USC 262-Licensing of biological products and Clinical laboratories. Subpart 1--Biological Products 7 USC 136-Insecticides and Environmental Pesticide Control. Subchapter II--Environmental Pesticide Control Federal Regulations Select Agent Regulations, 42 CFR 73, HHS Final Rule Select Agent Regulations, 7 CFR 331 and 9 CFR 121 USDA Final Rule 15 CFR-Commerce and Foreign Trade 29 CFR 1910.1200-Hazard Communication 29 CFR 1910.1450-Occupational Exposure to Hazardous Chemicals in the Laboratory 49 CFR 171-180-Transportation Select Agent Program The Centers for Disease Control and Prevention (CDC) regulates possession, use and transfer of select agents and toxins that have the potential to pose a severe threat to public health and safety. 10.26.2001: Bush signs U.S. PATRIOT Act into law places restrictions on persons who possess select agents and provides criminal penalties for possession of such agents that cannot be justified for specified peaceful purposes. 6.12.2002: Bush signs Public Health Security and Bioterrorism Preparedness Response Act of 2002 into law The law is designed to improve the ability of the United States to prevent, prepare for, and respond to bioterrorism and other public health emergencies. Section 202(a) of the Law requires that all persons possessing biological agents or toxins deemed a threat to public health to notify the Secretary, Department of Health and Human Services (HHS). Section 213(b) of Law requires all persons possessing biological agents or toxins deemed a threat to animal or plant health and to animal or plant products notify the Secretary, United States Department of Agriculture (USDA). 3.18.2005: 42 CFR Parts 72 and 73, Federal Register Vol. 70, No. 52 SAP Entity Requirements Register for each select agent + Designation of Responsible Official (RO) + Get govt. approval of entity and individuals with access to select agents + Provide for CDC inspections + Maintain all records for 3 years + Develop and implement safety, security, incident response plan, test annually + Conduct annual training + Immediate notification of theft, loss, release + Annual verification of BSL-3/4 facility design and operational parameters + Biosafety cabinet certification + Experimental protocol approval from CDC/APHIS + = Full-time Headache 4
How All This Works Now BMBL (guideline, voluntary) OSHA Blood Borne Pathogens (regulatory) Select Agent Program (regulatory) Recombinant DNA NIH Guidelines (guideline, NIH funding) Transportation of Infectious Agents (regulatory) What All This Means Tremendous amount of laws, regulations and guidelines Lack of oversight and guidance Steep penalties Administrative actions (5 cases): Denial of application Revocation or suspension of application Civil monetary penalties (37 cases, $800K in fines): Up to $250K for an individual for each violation Up to $500K for an entity for each violation Criminal actions (8 cases referred to FBI): Up to 5 years in prison, and/or fine This is a huge undertaking and involves tremendous risk and responsibility Increase in Audits and Inspections 2006 HHS Inspector General audit of 15 institutions found 11 with serious weaknesses Unlocked doors and freezers Lax inventory records 8 universities had inventory/ records weaknesses 6 universities had weak access controls 6 universities had weak security plans 3 universities had not provided training to one or more individuals with access to select agents 3 universities had insufficient emergency plans 5
High-profile incidents + Public concern = New Legislation Remember GMOs? More to come Talk of moratorium on BSL3 and BSL4 construction Current Efforts to Fortify Policy (The Pipeline) Executive Order 13486 Strengthening Laboratory Biosecurity in the U.S. Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight Biodefense Policy Coordinating Committee (PCC) National Science Advisory Board for Biosecurity (NSABB) The Offense: Executive Order 13486 Strengthening Laboratory Biosecurity in the U.S. January 9, 2009 Resulted in working group to assess U.S. biosecurity HHS and DOD major contributors Report due back in early July Included in the report will be recommendations for new legislation 6
Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight... established to undertake an intensive analysis of the current framework of biosafety and biocontainment oversight of research activities involving infectious agents and toxins in high- and maximum-containment research facilities with the goal of exploring strategies to address concerns voiced by Congress and the general public. Chaired by U.S. Dept. HHS and USDA officials Representatives from other Federal agencies and departments DOC DOE DOD DHS DOL EPA NSF Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight Select Agent Program spans several agencies (CDC, USDA, HHS) and Many other agencies involved at different levels (EPA, DOT) Therefore, the TFTFOBBO is essentially a master Gap Analysis Overall mission: Streamline the oversight process for biosafety 7
Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight Public hearing held outside of Washington D.C. December 8-9, 2008 Report from Task Force due to HHS and USDA officials early 2009 Findings & Conclusions? Report has not been yet released Biodefense Policy Coordinating Committee Joint committee of Office of Science and Technology Policy (OSTP) and Homeland Security Council (HSC) Charged to review policy in Federal labs with respect to safety, security and personnel reliability Recommend policy upgrades for areas of discontinuity Biodefense Policy Coordinating Committee 7 departments and agencies polled, and about 50 regulatory and policy documents reviewed 5 major areas considered: Registration Security Transfer of agents Inspections Personnel Policy review ONLY, not an implementation strategy Overall assessment: Not bad. Areas that need improvement: Personnel reliability Transfer of biological select agents and toxins 8
National Science Advisory Board for Biosecurity Focused more on Personnel Reliability programs Big consideration: how can we fortfy personnel reliability programs without hindering the process of research? Existing vs. Improved PR systems? How to monitor? The Defense: CEN Workshop ABSA Accreditation European Committee for Standardization (CEN) Multi-organizational effort to provide standardization for best practices of high-containment labs and operations American Biological Safety Association (ABSA) Asia-Pacific Biosafety Association (APBA) European Biosafety Association (EBSA) World Health Organization (WHO) Det Norske Veritas (DNV) 9
CEN Workshop Agreement (CWA) Proposed Objectives: Establish a biosafety and biosecurity management system to minimize risk to employees, the community and the environment that may be exposed to biological materials as a consequence of its activities; Implement, maintain and continually improve biosafety and biosecurity management; Assure itself of conformance with its stated biosafety and biosecurity policy; Demonstrate such conformance to others; Make a self-determination and declaration of conformance; Seek internationally recognized third party certification of its biosafety and biosecurity management system. CEN Workshop Agreement (CWA 15793) Management system integration This laboratory biorisk management standard is compatible with the EN ISO 9001:2000 (Quality), EN ISO 14001:2004 (Environmental) and OHSAS 18001:2007 (Occupational Health and Safety) management systems standards, in order to facilitate the integration of all such management systems of an organization. NOT a design guide Like ISO standards, the CEN program is a management system Proposes what you have to have, not how to do it Voluntary Nothing to drive adherence Minimum standards for the design of high-containment labs: Not included yet May not ever be a consideration DNV involved in audit program development (?) However, promotes lab design through biorisk assessments 10
CEN Biorisk Assessment/ Management CEN Position on Laboratory Design (cont.) Who is involved? Scientific personnel Biorisk management team A&E Construction team Commissioning agents Etc. Do we need accreditation standards? Many countries/ institutions now investing and constructing high-containment labs Access to/ knowledge and expertise? Tight budgets Result = incorrect labs + poor operations May help partially quench negative perception of high-containment labs and operations Documented excellence for research institutions Accredited lab may be more likely to receive research funding Minimum accreditation standards accepted internationally ultimately geared toward the overall safety and security of the lab staff and public health 11
Do we need accreditation standards? End-user perspectives Frustration with ambiguity of guidelines How near the exit does the sink need to be? Which checklist do I use to evaluate my facility? Which is it: my lab can never go positive, or my lab can go positive for a few seconds? We re hiring a new faculty member who needs level 3 space, and we re not sure we even want to get into it. What are we in for? We sent the agency all of our SOPs for review- after six months, we called them back and they said you re good. Are we really okay? Inspectors have been making the rounds here for years- why should I be worried now? Vast majority were in favor of minimum standards Primary concerns: More hoops to jump through? How much will it cost? Accreditation and Business The world is a marketplace Each country must remain competitive to do business with other countries Quality of lab/ operations reflects quality of the product Reputational Risk can affect business Media is paying attention to high-containment operations Small or large incident- doesn t matter What face are high-containment operations and institutions presenting to public? What are the consequences/ impacts of an incident? You may escape financial and criminal penalties BUT you can get killed in the media Funding? Insurance? Damage control/ reputational risk assessments Accreditation and Research It s all about Documented Excellence in Research Practices Acceptability of the research facility draws some relevance to research practices Peer review process of scientific validity Compatibility between collaborators Research funding is based on sound approach and approved methods A lab with a clean bill of health is more likely to receive funding 12
Potential Pros of Accreditation Standards Happy end-users Financial ramifications Achieving accreditation standard may impart some advantage when seeking research funding Companies with accredited labs seeking capital may have some advantage over companies that don t meet minimum standards of design Lower risk for facility failure = safer investment Same applies for insuring your facility and products Lessen interaction/ inspections/ evaluations from Agencies Safer labs (?) BIG question Potential Cons of Accreditation Standards Decrease in design flexibility (?) Many design guidelines were designed intentionally flexible (i.e. BMBL) This vagueness accommodates experimental protocol variety, experimental conditions, organisms being researched, etc. Financial ramifications Can everyone afford to design their lab to a certain set of minimum standards? Will it cost money to go through accreditation process? Training Operations Personnel ABSA- Position and Action on Accreditation Development/ process in its infancy Templates: CWA 15793 BMBL WHO Biosafety Manual NIH Guidelines on Recombinant DNA Molecules Believes that independent accreditation will be more effective and less costly than government regulation Proposes to lead a process to develop an accreditation program with major stakeholders: AAALAC AALAS CDC Intended for U.S. use only 13
ABSA s Key Factors for Accreditation of High-Containment Labs Like CEN Proposal, ABSA Favors independent 3 rd party evaluations Believes that accreditation is voluntary Proposes to develop minimum standards Result = ABSA really does house majority of biosafety expertise in the U.S. BUT ABSA needs more than just a good accreditation program on paper to push this through ABSA needs solid representation and interfacing with U.S. legislative representatives What are the Impacts to EHS Offices? Any passed legislation will likely affect: Public labs/ operations Academic labs/ operations Private institutions Government labs Big Ticket Items: Inventory of infectious agents/ Select Agents Personnel reliability programs Documented excellence in training, updated operations, facilities What Issues Have Caused the Most Trouble? Inventory management Poor documentation Not meeting training requirements IBC not meeting regularly Inadequate facilities Unapproved experimental protocols Improper packing and shipping procedures 14
Recommendations Keep your risk assessments current Or do your fist one Keep your biosafety manual current Beef up on training Implement a solid inventory system 3 rd party evaluation of facilities annually Explore funding options through granting opportunities Explore the functionality of personnel reliability programs Define biosecurity as it pertains to your institution Be proactive, not reactionary! Thank You? 15