Safety Culture in Life Sciences Laboratories: Time for Action. Donald R. Callihan

Safety Culture in Life Sciences Laboratories: Time for Action Donald R. Callihan

Safety Culture in Life Sciences Laboratories: Time for Action Discuss personal and cultural safety ethics that support biorisk management systems Review some of the responses to White House Memoranda of August 18, 2014 and October 29, 2015 Examine recent calls for improved safety culture APLU Council on Research Taskforce on Laboratory Safety Discuss processes for developing standards and guidelines Challenge thinking on the need for a rigorous regulatory framework for all work with potentially infectious agents and novel replicative life forms.

Safety Culture = Safety Ethics What is an ethical code? Does unethical action have consequences? Do standards and guidelines imply that natural consequences will follow? Is an effective culture of responsibility possible without accountability (penalties}? The culture of any organization is shaped by the worst behavior the leader is willing to tolerate. -- Steve Gruenert and Todd Whitaker, School Culture Rewired, ch. 3 (2015)

Evolution of US Biosafety and Biosecurity Regulations Selected examples: Asilomar Conference rdna Guidelines (law) NIH Laboratory Safety Monograph (1989) BMBL1 (1984) BMBL4 (1999) BMBL5 (2007/2009) BMBL6 (2017?) Select Agent Regulation: transfer only (1997) possession, use and transfer (2003) General Duty Clause, Section 5(a)(1) of the Occupational Safety and Health Act (OSHA) of 1970 Clinical Laboratory Improvement Amendments of 1988 (CLIA) [42 CFR 493] OSHA s Occupational Exposure to Hazardous Chemicals in Laboratories standard [29 CFR 1910.1450] (1990) OSHA Bloodborne Pathogens standard [29 CFR 1910.1030] (1991, 2001) OSHA Infectious Disease Standard (RFI 2010, Stakeholder Meeting 2011, publication 20??)

US Safety Culture and Regulation Medical Devices In Vitro Diagnostic Devices FDA DOT Federal Aviation Administration Pipeline and Hazardous Materials Safety Administration DHHS BMBL CDC NIOSH, Import Permits NIH rdna Guidelines OSHA General Duty Clause Bloodborne Pathogens Standard Infectious Disease Standard (proposed USDA APHIS Import Permit National Animal Diseases Center

Reactive Response to Federal Agency Incidents Feb 2003: Select Agent Regulations, Final Rule 7/2/2010: Optimizing the Security of Biological Select Agents and Toxins (Executive Order 13546) Created Federal Experts Security Advisory Panel (FESAP) 2014 Incidents at CDC/DoD laboratories Moratorium on transfer at 52 federal BSL-2 and BSL-3 facilities, Oct 2014 Report of the Federal Experts Security Advisory Panel, December 2014 2015 Series of reports and updates on improvements Last progress report: November 2015 https://www.cdc.gov/about/lab-safety/reports-updates.html. Accessed 9/27/2016

Report of the Federal Experts Security Advisory Panel December 2014 Charge To strengthen USG oversight for work with infectious agents and toxins, including (but not limited to) BSAT, the White House NSC requested that the FESAP undertake a comprehensive federal review and identify specific recommendations to strengthen the Government's biosafety and biosecurity practices and oversight system for federally-funded activities, consistent with the need to realize the public health and security benefits of such work. More specifically, with respect to federally-funded activities, the FESAP was asked to identify needs and gaps, and to provide recommendations to optimize biosafety, biosecurity, oversight, and inventory management and control for BSAT. Scope The scope of activities considered by the FESAP for this section of the report includes life science laboratory research activities in all sectors utilizing BSAT. However, the majority of the FESAP s recommendations have broader applicability to non-bsat agents.

Report of the Federal Experts Security Advisory Panel December 2014 Recommendation 1.1: Create and strengthen a culture that emphasizes biosafety, laboratory biosecurity, and responsible conduct in the life sciences. This culture of responsibility should be characterized by individual and institutional compliance with biosafety and laboratory biosecurity regulations, guidelines, standards, policies and procedures, and enhanced by effective training in biorisk management.

Report of the Federal Experts Security Advisory Panel December 2014 Other Proposed Regulatory Tools for Expanded Federal Oversight Beyond BSAT Recommendation 2.8 Support U.S. OSHA Infectious Diseases Standard. OSHA is currently drafting an Infectious Diseases standard that would address the hazards unique to working with infectious materials in laboratory and healthcare settings (Appendix D). This standard would complement current OSHA standards and regulations (e.g., Bloodborne Pathogens Standard, Personal Protective Equipment Standard, Laboratory Standard) and would apply the biosafety concepts of guidance documents such as the BMBL and NIH Guidelines to the broader U.S. workforce that may have occupational exposure to infectious diseases transmitted through contact, droplet and airborne routes. This effort should be considered for support by NSC and OSTP, and its development and implementation should be a high priority. Proposed in 2010 Hearings and RFI held No Action as of September 2015

OSHA Infectious Disease Standard (Proposed Rule Making) https://www.osha.gov/dsg/id/ Accessed 9/28/2016

CDC Biosafety Guidance for Diagnostic Laboratories Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic Laboratories, CDC convened Biosafety Blue Ribbon Panel, 2012 Guidelines for Biosafety Laboratory Competency, CDC/APHL, 2011 Competency Guidelines for Public Health Laboratory Professionals, CDC/APHL, 2015

Non-Government Publications on Safety Culture Improvement Creating Safety Cultures in Academic Institutions. American Chemical Society, 2012 A Guide to Implementing a Safety Culture in Our Universities. Association of Public & Land-Grant Universities, 2016 A More Systematic Approach to Biological Risk. Palmer, MJ, et al. Science 350: 1471, 2015 Rethink Biosafety. Trevan, T. Nature 527: 155,, 2016

https://ghsagenda.org/packages/p3-biosafety-biosecurity.html, Accessed Sept. 19, 2016 Desired National Impact: Implementation of a comprehensive, sustainable and legally embedded national oversight program for biosafety and biosecurity, including the safe and secure use, storage, disposal, and containment of pathogens found in laboratories and a minimal number of holdings across the country, including research, diagnostic and biotechnology facilities. A cadre of biological risk management experts possesses the skillset to train others within their respective institutions. Strengthened, sustainable biological risk management best practices are in place using common educational materials. Rapid and culture-free diagnostics are promoted as a facet of biological risk management. The transport of infectious substances will also be taken into account. Country Commitments to Action Package: Leading countries: Canada, Denmark, Kenya, Peru, Portugal, Spain Contributing countries: Azerbaijan, Germany, India (to be confirmed), Jordan, Republic of Korea, United Kingdom, United States Contributing international organizations: FAO, IAEA, INTERPOL, OIE, WHO

Global Health Security Agenda Biosafety and Biosecurity Action Package Prevent-3 https://ghsagenda.org/assessments.html, Accessed Sept. 19,2016 https://www.cdc.gov/globalhealth/security/ Accessed Sept. 19, 2016

Should the BMBL remain performance based or should it be more prescriptive, be more regulatory in nature? * Soliciting Stakeholder Input for a Revision of BMBL Steering Committee appointed by the National Academies of Sciences, Engineering, and Medicine. Virtual Town Hall Meeting held April 4 to May 20, 2016 Online workshop on May 12, 2016 Deborah Wilson (NIH) Co-editor for BMBL6 Wilson said she is interested in hearing comments about a couple of areas, most importantly, she said she hopes the following questions will be addressed. (1) * (1) The Virtual Town Hall commentators were not asked to specifically address these questions. Others on Steering Committee commented that they think BMBL should remain performance based. https://www.nap.edu/catalog/23585/soliciting-stakeholder-input-for-a-revision-of-biosafetyin-microbiological-and-biomedical-laboratories-bmbl Accessed Sept. 19, 2016

Report of the Federal Experts Security Advisory Panel December 2014 Recommendation 1.1: Create and strengthen a culture that emphasizes biosafety, laboratory biosecurity, and responsible conduct in the life sciences. This culture of responsibility should be characterized by individual and institutional compliance with biosafety and laboratory biosecurity regulations, guidelines, standards, policies and procedures, and enhanced by effective training in biorisk management.

Canadian Biosafety Standards and Guidelines Human Pathogens and Toxins Act (HPTA), [SC 2009, c. 24, 6/23/2009] Human Pathogens and Toxins Regulations (HPTR) Canadian Biosafety Standards and Guidelines (CBSG), 1 st Edition, 2013 Canadian Biosafety Standard (CBS), 2 nd edition, 2015 Requirements to implement HPTA and HPTR Biosafety Directives, Advisories, and Notifications Canadian Biosafety Handbook (CBH), 2016 Canadian Biosafety Guidelines CBS Biosafety App http://canadianbiosafetystandards.collaboration.gc.ca/ Accessed Sept. 19, 2016

Canadian Biosafety Standards (CBS) 2 nd edition, 2015 Joint collaboration of Public Health Agency Canada (PHAC) and Canadian Food Inspection Agency (CFIA) CBSG Expert Working Group consisting of representatives from Health Sciences Research (7), Laboratory (4), Industry (7), and Government (3) Published March 11, 2015 75-day consultation period on CBS and draft HPTR started on June 1, 2015 Solicited stakeholder input (regional, face-to-face) Effective December 1, 2015 http://canadianbiosafetystandards.collaboration.gc.ca/ Accessed Sept. 19, 2016

Canadian Biosafety Standards and Guidelines Human Pathogens and Toxins Act (HPTA), [SC 2009, c. 24, 6/23/2009] Human Pathogens and Toxins Regulations (HPTR) Canadian Biosafety Standards and Guidelines (CBSG), 1 st Edition, 2013 Canadian Biosafety Standard (CBS), 2nd edition, 2015 Requirements to implement HPTA and HPTR Biosafety Directives, Advisories, and Notifications Canadian Biosafety Handbook (CBH), 2016 Canadian Biosafety Guidelines CBS Biosafety App http://canadianbiosafetystandards.collaboration.gc.ca/ Accessed Sept. 19, 2016

Canadian Biosafety Standards and Guidelines and HPTA Performance-based standards for Containment Levels (CL1 CL4) Human Pathogens and Toxins Act Lists Risk Groups for each pathogen or toxin SCHEDULE 1 Toxins SCHEDULE 2 Risk Group 2 Human Pathogens SCHEDULE 3 Risk Group 3 Human Pathogens SCHEDULE 4 Risk Group 4 Human Pathogens SCHEDULE 5 Prohibited Human Pathogens and Toxins Also provide Pathogen Safety Data Sheets for each

Canadian vs. US Approach to Revising Biosafety/Biosecurity Guidelines Canadian Biosafety Guidelines, 2 nd edition (2015) The CBS, 2 nd Edition [updates] several requirements in a risk-, performance-, and evidence-based approach, but to allow facilities more versatility in compliance. Based on national law Draft based on review by broad stakeholder panel of experts Stakeholder comments solicited during a 75-day period Nine (9) months from draft to implementation http://canadianbiosafetystandards.collaboration.gc.ca/fa q-eng.php Accessed Sept. 19, 2016 Biosafety in Microbiological and Biomedical Laboratories, 6 th edition (20xx) Revision of BMBL, 5 th edition. A code of practice for biosafety (no compliance authority) Edited by a closed committee of government agency stakeholders (HHS, USDA) Public comment solicited through National Academies Virtual Town Hall Meeting (limited stakeholder input) Unknown publication date No established effective date https://www.nap.edu/catalog/23585/solicitingstakeholder-input-for-a-revision-of-biosafety-inmicrobiological-and-biomedical-laboratories-bmbl Accessed Sept. 19, 2016

Is it time to develop National Biorisk Management Consensus Standards? Example: Clinical and Laboratory Standards Institute Develops and publishes standards and guidelines for the global laboratory community Accredited by the American National Standards Institute (ANSI) ANSI is the US representative of the International Organization for Standardization (ISO) Adheres to a rigorous Standards Development Process based on input from and consensus among industry, government, and health care professionals Protection of Laboratory Workers From Occupationally Acquired Infections, 4th Edition, 2014 Standard for inspections College of American Pathologists voluntary Laboratory Accreditation Program (CMS CLIA) http://clsi.org/about-clsi/

Ideas for a Way Forward Short Term Follow Canadian model by drafting BMBL6 as collaborative effort involving stakeholder input APHL and ASM Biosafety and Biosecurity Partners Forum (ABSA is represented) Include others to represent academia and life sciences industry (e.g., APLU) Establish a rigorous schedule for publication of BMBL6 Draft for stakeholder input 75- to 90-day consultation period 60-day final publication period Effective date

Ideas for a Way Forward Long Term Negotiate with government, academic, and industry organizations to adopt ABSA International s voluntary ABSA Laboratory Accreditation Program for BSL 2, ABSL 2, BSL-3, and ABSL-3 laboratories For biomedical labs not under the jurisdiction of the U.S. Select Agent and Toxins Regulations. Investigate initiating or joining an ANSI standards development organization e.g., ATCC Standards Development Organization Follow a Standards Development Process based on input from and consensus among life sciences research, industry, government, and biosafety professionals http://standards.atcc.org/kwspub/home/