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 DHHS

OSHA

USDA DOT

FDA

• BMBL • CDC … NIOSH, Import

Permits • NIH … rDNA Guidelines

• General Duty Clause • Bloodborne Pathogens

Standard • Infectious Disease Standard

(proposed

• Federal Aviation Administration

• Pipeline and Hazardous Materials Safety Administration

• APHIS … Import Permit • National Animal

Diseases Center

• Medical Devices • In Vitro Diagnostic

Devices

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.

• 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

Report of the Federal Experts Security Advisory Panel December 2014

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

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

https://ghsagenda.org/packages/p3-biosafety-biosecurity.html, Accessed Sept. 19, 2016

Global Health Security Agenda Biosafety and Biosecurity Action Package Prevent-3

https://www.cdc.gov/globalhealth/security/ Accessed Sept. 19, 2016 https://ghsagenda.org/assessments.html, 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-biosafety-in-microbiological-and-biomedical-laboratories-bmbl Accessed Sept. 19, 2016

• 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

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), 1st 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 (CBS) 2nd 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), 1st 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

• Revision of BMBL, 5th 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

• “The CBS, 2nd 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

Biosafety in Microbiological and Biomedical Laboratories, 6th edition (20xx)

Canadian Biosafety Guidelines, 2nd edition (2015)

http://canadianbiosafetystandards.collaboration.gc.ca/faq-eng.php Accessed Sept. 19, 2016

https://www.nap.edu/catalog/23585/soliciting-stakeholder-input-for-a-revision-of-biosafety-in-microbiological-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/