strengthening the culture of biosafety, biosecurity,...

STRENGTHENING THE CULTURE OF BIOSAFETY,

BIOSECURITY, AND RESPONSIBLE CONDUCT

IN THE LIFE SCIENCES

Dana Perkins, PhD

7th Annual International Symposium

Biosecurity and Biosafety: Future Trends and Solutions

Milan, Italy, 22-24 March 2017

Resilient People. Healthy Communities. A Nation Prepared.

Life Sciences Research

Crucial to the long term health

security and wellness of the

public, animals, plants,

environment, and the economy

Instrumental in developing

national capabilities to mitigate

the risks of infectious diseases

and environmental risks,

whether naturally occurring,

deliberate, or accidental


Laboratory-Acquired Infections (LAIs)

Pike & Sulkin (1978): 4,079 LAIs resulting in 168 deaths occurring

between 1930 and 1978 Many labs chose not to report overt cases or conduct surveillance programs to identify sub-clinical

or asymptomatic infections.

No distinguishable accidents or exposure events identified in more than 80% of reported LAIs.

Harding & Byers (2000): 1,267 overt infections with 22 deaths Additional 663 cases that presented as sub-clinical infections

Only a small number of the LAI involved a specific incident.

Improvements in containment equipment, engineering controls, and

greater emphasis on safety training may be contributing factors to the

apparent reduction in LAIs over two decades.

However, due to the lack of information on the actual numbers of

infections and the population at risk, it is difficult to determine the

true incidence of LAIs with any degree of certainty.

https://www.cdc.gov/biosafety/publications/bmbl5/bmbl5_sect_i.pdf


Human Salmonella typhimurium Infections

Associated with Exposure in Clinical and

Teaching Microbiology Laboratories

https://www.cdc.gov/salmonella/2011/lab-exposure-1-17-2012.html

August 20, 2010 - June 29, 2011

Persons infected with the outbreak strain

of Salmonella typhimurium, by state (n=109)


Case Studies: Student LAIs

Laboratory-acquired Vibrio cholerae O1 infection in Austria

(Huhulescu et al, 2008): Microbiology student had been working with V. cholerae for 4 weeks in a practical laboratory

course. Two days before onset of symptoms an open 300 mL Erlenmeyer flask with approx.

30 mL of overnight V. cholerae culture tipped over and spilled into a laboratory shaker near

the student’s working place. Wearing gloves and protective gowns, the student and her

supervisor immediately cleaned and decontaminated the shaker. As a consequence of this

laboratory incident, the institution in question replaced the clamp-less shaker plate by a

traditional shaker plate with mechanical clamps.

Laboratory-Acquired Severe Acute Respiratory Syndrome (Lim

et al, 2004): A 27-year-old graduate student in Microbiology at a local university was admitted to

Singapore General Hospital on September 3, 2003, with fever. In July and August 2003, he

had worked with a non-attenuated strain of West Nile virus in a BSL-3 lab at Institute A,

where research on SARS-CoV was also conducted. SARS-CoV contamination occurred in

the sample of West Nile virus with which he had been working three days before his illness

began.


Laboratory Practices: Pathogen Inactivation

In May 2015, the US Department of Defense (DOD) discovered that one of its labs

inadvertently sent live Bacillus anthracis to almost 200 labs worldwide over the course of 12

years. The lab believed that the samples had been inactivated, that is, the hazardous effects

of the pathogen had been destroyed while retaining characteristics of interest for future use.

Samples were shipped to support research on the detection, identification, and

characterization of biological threats.

Investigative report : senior management “allowed a culture of complacency to flourish at

the facility, resulting in laboratory personnel who did not always follow rules, regulations,

and procedures.”

http://www.gao.gov/assets/680/679392.pdf


Federal Experts Security Advisory Panel

The Federal Experts Security Advisory Panel

(FESAP) was established on July 2, 2010 by

Executive Order 13546 to provide

recommendations related to the security of

biological select agents and toxins (BSAT) to

the Secretaries of Health and Human Services

and Agriculture and the Attorney General.

The FESAP successfully completed the tasks

enumerated by Executive Order 13546 and

released the FESAP Recommendations

Concerning the Select Agent Program

report on November 2, 2010.

http://www.phe.gov/Preparedness/legal/boards/fesap


Federal Experts Security Advisory Panel

In Sep 2014, National Security Council

tasked FESAP to make recommendations

to enhance biosafety and biosecurity

Report published in Dec 2014 contains:

8 recommendations on actions and regulatory

changes to improve biosafety and biosecurity;

8 recommendations on optimizing biosafety,

biosecurity, oversight, inventory management,

and control of BSAT; and

An approach to determine the appropriate

number of high containment labs required to

possess, use, or transfer BSAT.

http://www.phe.gov/Preparedness/legal/boards/fesap


Identification of Needs and Gaps, and

Recommendations to Optimize Biosafety, Biosecurity,

Oversight, & BSAT Inventory Management & Control

- FESAP 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.


Implementation Plan

1) Develop and incorporate bioethics modules

and quality system training into laboratory

biosafety and biosecurity training and/or

research design.

2) Promote bioethics and quality system

training.

3) Develop semi-quantitative methods to

evaluate the efficacy of training, education,

codes of conduct, and similar interventions

to reduce risk and improve safety in research

laboratories housing infectious agents and

toxins.

http://www.phe.gov/s3/Documents/fesap-ftac-ip.pdf


FESAP 1.1. Working Group

U.S. Department of Health and Human Services (ASPR, CDC, NIH, FDA)

U.S. Department of Agriculture (OSEC, APHIS, ARS, FSIS, NIFA)

U.S. Department of Defense (USAMRIID, USUHS)

U.S. Department of Homeland Security

Environmental Protection Agency

Federal Bureau of Investigation

National Science Foundation

Sandia National Laboratories

Co-Chairs: Dana Perkins, PhD (HHS/ASPR) and Eilyn Fabregas, PhD (USDA/APHIS)

Non-governmental experts participated in deliberations and provided feedback (AALAS, ABSA, APHL, ASM, Behavioral-Based Improvement Solutions, Elizabeth R. Griffin Foundation, Colorado State University, UTMB National Biocontainment Training Center, University of Georgia/CITS, National Academies of Sciences, North Carolina State University/CHSEMA, Emory University, Gryphon Scientific, Chrome Biological Risk Management Consulting, etc.)


Working Definition of a Culture of Biosafety,

Biosecurity, and Responsible Conduct in

Life Sciences

An assembly of beliefs, attitudes, and patterns of

behavior of individuals and organizations that can

support, complement or enhance operating procedures,

rules, and practices as well as professional standards

and ethics designed to prevent the loss, theft, misuse,

and diversion of biological agents, related materials,

technology or equipment, and the unintentional or

intentional exposure to (or release of) biological agents.


Working Group - Developed

Educational Materials Fact Sheet

In Hindsight: Scenarios that Illustrate the

Importance of a Culture of Biosafety,

Biosecurity, and Responsible Conduct in

the Life Sciences Research

Slide deck template for training / outreach

Guiding Principles to Promote a Culture of

Biosafety, Biosecurity, and Responsible

Conduct in the Life Sciences in the context

of bioethics and laboratory quality

management training

Crossword puzzlehttps://www.absa.org/ttMiscHandoutsPosters.html


Culture Change is Goal-Directed

Reductions in laboratory-acquired infections, incidents, and near

misses

Ensuring that biosafety, biosecurity, and responsible conduct receive

appropriate attention

Ensuring that organizational members share the same beliefs and

attitudes about risks, laboratory-acquired infections, incidents, and

near misses

Increasing people’s commitment to biosafety and biosecurity

Determining the breadth and strength of a biosafety and biosecurity

program

Adapted from Cooper D., Professional Safety, 2002


Operationalizing the Concept of a Culture

of Biosafety, Biosecurity, and

Responsible Conduct in Life Sciences

Currently, there is no internationally-accepted model to enable the profession to quantify and analyze the culture of biosafety, biosecurity, and responsible conduct

A conceptual model is required in order to develop the required measurement tools

IAEA advancements in conceptualizing a model and an assessment methodology for nuclear safety and security culture provide the foundation for similar activities in life sciences


What elements should we consider targeting in

order to strengthen the organizational culture?

Management systems which

prioritize biosafety,

biosecurity, and responsible

conduct

Behavior of leadership and

personnel that fosters more

effective biosafety and

biosecurity

Principles for guiding

decisions and behavior as

they relate to biorisk

management

Beliefs and attitudes on

biosafety and biosecurity

Culture ofbiosafety, biosecurity,

and responsible conductM

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Principles for guiding decisions & behaviors

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Beliefs and attitudes


Culture Characteristics and Indicators

for Self-Assessment

Adapted from IAEA Self-Assessment of Nuclear Security Culture in Facilities and Activities that Use Nuclear and/or Radioactive Material, 2008

Example of indicators for self-assessment:

I. Management Systems

a) Visible biosafety and biosecurity policy

Policy documents state the organization’s commitment to biosafety, biosecurity, and responsible conduct; these documents establish the highest expectations for decision making and conduct, and are supported by an environment of professionalism, bioethics, and research excellence.

1. Biosafety and biosecurity policy is posted in labs and offices and is familiar to staff

2. Biosafety and biosecurity are clearly recognized values in the organization, and management invests adequate resources in biosafety/biosecurity arrangements

3. Regularly held management meetings at the organization adequately cover significant biosafety/biosecurity issues.

4. Etc.

Visible biosafety and biosecurity policy

Clear roles and responsibilities

Performance measurement

Work environment

Training and qualification

Work management

Information security

Operation and maintenance

Personnel reliability program

Quality assurance

Change management

Feedback process

Contingency plans and drills

Self-assessment

Interface with regulators

Coordination with off-site organizations

Record keeping

Professional conduct

Personal accountability

Adherence to procedures

Teamwork and cooperation

Vigilance

Motivation

Leadership

Commitment and responsibility

Professionalism and competence

Learning and improvement

Credible biorisksand threats exist

Biosafety and biosecurity are

important

Management Systems

Expectations

Use of authority

Decision making

Management oversight

Involvement of staff

Effective communications

Improving performance

Motivation

Culture of biosafety, biosecurity, and responsible conduct


Specific Criteria for Developing

Indicators

The indicator is cost-effective and reliable.

The indicator is relevant and measures what it is intended to

measure.

The necessary data are available or can be generated.

The indicator is not susceptible to bias or manipulation.

The indicator is easily and accurately communicated.

The indicator is interpreted by different groups in the same

way.

The indicator is broadly applicable across the organization’s

operations.

The indicator can be validated.

IAEA Self-Assessment of Nuclear Security Culture in Facilities and Activities that Use Nuclear and/or Radioactive Material, 2008


Management Systems & the IHR JEE Tool

- Biosafety and biosecurity practices at facilities housing or

working with dangerous pathogens -

i. Are site-specific biosafety and biosecurity management programs and

supporting documents (manuals, SOPs, job aides, records) available to include

biosafety, biosecurity, incident response and emergency plans (e.g. in case of

explosion, fire, flood, worker exposure, accident or illness, major spillage)?

ii. Are roles and responsibilities related to biosafety and biosecurity management

defined and documented (biosafety officer, security manager)?

iii. Have the biosafety and biosecurity risks been assessed and categorized?

iv. Are biosafety and biosecurity control measures described in an action plan?

v. Are there mechanisms to ensure that personnel is suitable and competent (e.g.

best practices) in human resources management (e.g., verification of prior

education and employment, periodic performance reviews), successful

completion of training, mentorship programs, ability to work unsupervised)?


Leadership Behavior:

examples from CWA 15793

Top management takes ultimate responsibility for the organization’s

biorisk management system

Top management ensures that roles, responsibilities and authorities

related to biorisk management are defined, documented and

communicated to those who manage, perform and verify work

associated with the control of biological agents and toxins

Senior management provides appropriate resources to ensure adequate

provision of personnel, facilities and other resources deemed necessary

for the safe and secure operation of the facility

Senior management ensures promotion of the biorisk management

system throughout the organization

Scientific management ensures only competent and authorized

personnel can enter and work in the facility


Personnel Behavior & WHO self-

assessment questionnaire (excerpts)

Research excellence

Education and/or training is offered on dual-use issues

Junior researchers are nurtured and supported

Bioethics

Researchers are competent to assess the potential

societal impact of research

Researchers know how to assess whether the risk

outweighs the benefit of continuing with their research

or activities

Biosafety and biosecurity

Researchers have somewhere to turn to get competent

advice if they have safety or security questions relating

to their research

Staff are required to report laboratory accidents,

incidents and near misses

http://apps.who.int/iris/bitstream/10665/70507/1/WHO_HSE_GAR_BDP_2010.2_eng.pdf


Organizational Culture Self-Assessment Process


START: DECISION to carry out initial

or subsequent self-assessment

Stage 5. Develop the Three-Tiered

Outcome Model(Green-for strengths, Red &

Yellow - for weaknesses)

Stage 4. Analyze Data and Consolidate

Assessment Results

Stage 6. Discuss Results, Submit Final

Report, and help Development of an

Action Plan

Stage 3. Start the Data Collection

PhaseSurvey, Interview, Document

Review, and Observation

Stage 1. Launch an Outreach Campaign and Establish a Self-

Assessment Team

Stage 2. Draft a Self-Assessment Plan and

Prepare for its Implementation


Use of Quantitative and Qualitative

Data for Analysis of Findings

Survey Data

Findings

Quantitative Analysis

Interview Data

Findings

Qualitative Analysis

Three-Tiered Model of Self-Assessment outcome:

Red, Yellow, and Green

Supplementary Sources: Document Review and

Observations

Comparison and Consolidation



Senior management may use assessment results to

determine how to reshape knowledge and traits that are

incompatible with an effective culture of biosafety,

biosecurity, and responsible conduct


A Kill-the-Messenger-of-Bad-News, Low-candor, Low-confrontation

Attitude

Failure of Senior Management to Act

as Role Models

Complacency

Absence of Biosafety/Biosecurity

-related Crises

Low Priority of Biosafety/Biosecurity Operational Activities

Scarcity of ResourcesOrganizational

Structure That Focuses Employees on Narrow

Functional Goals

Human Nature with Its Capacity for Denial and

Skepticism

A Lack of Sufficient Biosafety/Biosecurity

Feedback from External Sources

Too Much Smooth Talk from Senior Management


Benefits from self-assessments

Deeper understanding of the human factor and biosafety/biosecurity

culture;

Clearer understanding of employees’ concerns, needs, aspirations, and

motives;

Identification of barriers to and incentives for improvements to

biosafety/biosecurity performance;

Identification of barriers to and motives for change;

Clarification of employees’ opinions about biosafety/biosecurity-related

topics;

Improved capacity to self-assess the organization’s biosafety/biosecurity

performance, conducting trend analysis within the site or to monitor

progress;

High priority on initiatives that strengthen the overall organizational

culture in areas like internal communication and human resource

management.



Regulations or guidelines alone cannot ensure safe, secure, and responsible practices in the laboratory.

A strong culture of biosafety,

biosecurity, and responsible conduct

includes willingness to report

concerns, response to incidents, and

communication of risks.

CWA 15793: “The organization shall

establish and maintain a programme to

address risk associated with human

behaviour, including the management

of how workers interact with the facility

and its equipment”.

Culture matters !


Intergovernmental agreements

The G7 Statement on Non-Proliferation and

Disarmament calls for additional emphasis on

outreach to industry and academia and other

stakeholders in order to raise awareness and help

establish a culture of responsibility to impede efforts

by proliferators to obtain WMD-sensitive technology

and know-how (2015, 2016).

At the 8th Review Conference of BWC, Member

States noted the the value of national

implementation measures… to implement voluntary

management standards on biosafety and

biosecurity, and to encourage the promotion of a

culture of responsibility amongst relevant national

professionals and the voluntary development,

adoption and promulgation of codes of conduct

(2016).


Conclusion

Various assessment tools (CWA15793; IHR Joint External

Evaluation Tool; WHO Laboratory Quality Management

Handbook; etc) already incorporate considerations of human

behavior but are not focused on organizational culture.

We are currently reviewing existing IAEA nuclear

safety/security culture and biorisk assessment resources in

order to develop a self-assessment tool and practical guidance

for an organizational culture of biosafety, biosecurity, and

responsible conduct in life sciences.

We also seek to identify, collect, analyze, and disseminate

lessons, and best practices in strengthening the organizational

culture of life sciences research laboratories.

Dana Perkins, PhD

Senior Science Advisor

U.S. Department of Health and Human Services

Office of the Assistant Secretary

for Preparedness and Response

Tel.: +1 202-260-1880

E-mail: [email protected]

Fact Sheet on United States Government Culture of Biosafety, Biosecurity, and Responsible Conduct in the Life Sciences

The United States Government conducts and funds life sciences research which is crucial to the long term health security and wellness of the public, animals, plants, the environment, and our economy. Federal departments and agencies are committed to fostering progress in the life sciences to include responsible research involving biological agents and toxins, conducted in a safe and secure manner. Basic and applied life science research are instrumental in developing national capabilities to mitigate the risks of infectious diseases and environmental risks, whether naturally occurring, deliberate, or accidental.

Reinforcing norms of safe and responsible conduct is one of the objectives of the National Strategy for Countering Biological Threats which highlights actions that should be taken to reinforce a culture of responsibility, awareness, and vigilance among all who utilize and benefit from the life sciences. Reinforcing these norms is critical to counteracting diversion of the life sciences for harmful purposes.

The Federal Experts Security Advisory Panel (FESAP) was established by Executive Order 13546 on July 2, 2010 to provide recommendations regarding the security of biological select agents and toxins (BSAT) to the Secretaries of Health and Human Services and Agriculture and the Attorney General. The White House National Security Council staff tasked the FESAP, in September 2014, to undertake a comprehensive review and identify specific recommendations to strengthen the Government's biosafety and biosecurity practices and oversight of federally-funded activities involving (but not limited to) BSAT, consistent with the need to realize such activities’ public health and security benefits. While directed at the federal research system, FESAP recommendations have broad applications and may also inform biological risk management practices in non-federal life sciences research.

FESAP recommended several actions to strengthen and sustain the culture of biosafety, biosecurity, and the responsible conduct of science at the federal level such as promoting bioethics training that addresses the fundamental safety and security responsibilities expected of all life scientists; development and incorporation of bioethics modules into laboratory biosafety and laboratory biosecurity training and/or research design; and the development of semi-quantitative methods to evaluate the efficacy of training, education, codes of conduct, and similar interventions to reduce risk and improve safety in domestic research laboratories housing infectious agents and toxins. FESAP also emphasized that training should include discussions of ethical and legal considerations, as well as the social relevance of life science research, and the range of dual-use conundrums and dilemmas that may arise. FESAP’s recommended discussions would emphasize the impact of science and technology on society, health, and national security, and highlight efforts that should be undertaken to encourage institutional leadership to support and implement bioethics components within their institution’s training programs. FESAP also generated several interagency working groups to address these recommendations.

In order to advance the implementation of FESAP’s recommendation on the culture of biosafety, biosecurity, and responsible conduct of life sciences, the United States Government established an interagency working group with representation from 15 offices and organizations across five federal departments and agencies. This interagency working group is co-chaired by the US Department of Health and Human Services / Office of the Assistant Secretary for Preparedness and Response and US Department of Agriculture / Animal and Plant Health Inspection Service. As part of its tasking, this working group refined training goals and objectives; identified the role of “culture” as it relates to biorisk management, emphasizing principles for guiding decisions and behaviors as they related to biorisk management (i.e. motivation, leadership, commitment and responsibility, professionalism and competence, learning and improvement, maintaining public trust); conducted an inventory of existing federal and non-federal training and education programs addressing the culture of biosafety, biosecurity and responsible conduct of life sciences; and consulted with experts from academia and professional organizations on best practices and lessons learned. This working group conceptualized training and educational materials to be used by federal departments and agencies in their internal outreach or in conjunction with non-governmental organizations; refined these materials to create, strengthen, and sustain a culture of biosafety, laboratory biosecurity, and responsible conduct in the life sciences research; compiled resources to enhance individual and collective responsibility; and identified resources to reinforce the biological risk management framework of laws, regulations, and policies.

In Hindsight: Scenarios that Illustrate the Importance of a Culture of Biosafety, Biosecurity, and Responsible Conduct in the

Life Sciences Research

The purpose of these case studies is to raise awareness and promote understanding of the importance of a culture of biosafety, biosecurity, and responsible conduct in life sciences research, to build on individual and collective responsibility, and to reinforce the biological risk management framework of laws, regulations, and policies. These case studies have been prepared by a United States Government interagency working group co-chaired by the US Department of Health and Human Services / Office of the Assistant Secretary for Preparedness and Response and the US Department of Agriculture / Animal and Plant Health Inspection Service.

These case studies should be used and adapted by Federal Department and Agencies for their individual biorisk management or bioethics training needs. They cases studies will be publicly available for use by non-governmental organizations in their training programs, as appropriate.

1

Case Study #1 (reference: CDC Report on the Potential Exposure to Anthrax, 2014)

A laboratory scientist in a US Government laboratory is preparing extracts from a panel of multiple bacterial select agents, including Bacillus anthracis (B. anthracis), under biosafety level (BSL) 3 containment conditions. These samples were being prepared for analysis using matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry, a technology that can be used for rapid bacterial species identification. This technology is faster and less expensive than conventional species-identification methods, which require culture of organisms on selective bacterial media or extraction and characterization of bacterial nucleic acids. After chemical treatment for 10 minutes and extraction, the samples were checked for sterility by plating portions of them on bacterial growth media. When no growth was observed on sterility plates after 24 hours, the remaining samples, which had been held in the chemical solution for 24 hours, were moved to an adjoining BSL-2 laboratory. A week later, a fellow scientist observed unexpected growth on the anthrax sterility plate in the BSL-3 laboratory, raising concerns that the B. anthracis sample extract may not have been sterile when transferred to BSL-2 and potential anthrax exposure may have occurred.

Questions for discussion:

Q1. What does it mean to have a strong culture of biosafety, biosecurity, and responsible conduct in life sciences research? Does this incident illustrate a strong culture of responsible conduct?

A1. No. “Culture” as it relates to biorisk management is broadly defined as an assembly of beliefs, attitudes, and patterns of behavior of individuals and organizations that can support, complement or enhance operating procedures, rules, and practices as well as professional standards and ethics designed to prevent the loss, theft, misuse, and diversion of biological agents, related materials, technology or equipment, and the unintentional or intentional exposure to (or release of) biological agents.

Q2. Considering an organizational culture model1 including the following main elements:

• Management systems which prioritize biosafety, biosecurity, and responsible conduct; • Behavior of leadership and personnel to foster more effective biosafety and biosecurity; • Principles for guiding decisions and behavior as they relate to biorisk management; & • Beliefs and attitudes on biosafety and biosecurity,

how could we have prevented this incident?

1 Adapted from IAEA Nuclear Security Culture Model, 2008

2

http://www.cdc.gov/about/pdf/lab-safety/Final_Anthrax_Report.pdf

A2. Each element of the organizational culture model could have been assessed periodically and strengthened as needed:

• Management systems (i.e. processes, procedures and programs in the organization which prioritize biorisk management and have an important impact on the biosafety/biosecurity functions) should have included, at a minimum, approved/validated research protocols, including validated sterility testing procedures; quality assurance; clear roles and responsibilities; contingency plans and drills; continual determination of trustworthiness; and training and qualification;

• Leadership behavior (i.e. specific patterns of behavior and actions which are designed to foster more effective biorisk management) should have emphasized inter alia expectations, decision making, management/supervisory oversight, effective communication, and motivation. Personnel behavior (the desired outcomes of the leadership efforts and the operation of the management systems) should have emphasized inter alia professional conduct, adherence to approved/validated procedures and research protocols, team work and cooperation, and vigilance;

• Emphasis should have been placed on principles for guiding decisions and behaviors as they related to biorisk management (i.e. motivation, leadership, commitment and responsibility, professionalism and competence, learning and improvement, and maintaining public trust);

• Beliefs and attitudes on biosafety and biosecurity should have been assessed periodically and reinforced through training and education aiming to: raise awareness on the risks associated with working in a laboratory with biological materials (e.g., accidental exposure, infection or release; intentional theft and/or misuse; others such as radiological/chemical/physical safety), the potential ramifications if such risk events were to occur (e.g., injury, death, epidemics, pandemics, economic consequences, etc.), and risk mitigation strategies; raise awareness and increase understanding of the ethical, legal, and societal issues and consequences concerning life sciences research, development, and associated technologies; raise awareness and place emphasis on the importance of quality systems and practices in laboratory biosafety and biosecurity training and research design; review codes of ethics and social responsibility guidelines in life sciences research; and review biosafety, biosecurity, and dual use research of concern (DURC) regulations, guidelines, policies and procedures, and any other specified training requirements.

Q3. Review the CDC Report on the Potential Exposure to Anthrax and identify actions which addressed post-incident specific elements of the organizational culture in order to reduce the risk of a similar event happening in the future.

A3. The following elements of the organizational culture were addressed via specific actions:

• Management systems: ceased laboratory operations pending investigation, decontaminated potentially affected laboratory spaces, undertook research to refine understanding of potential exposures and optimize preventive treatment, and

3

http://www.cdc.gov/about/pdf/lab-safety/Final_Anthrax_Report.pdf

conducted a review of the event to identify key recommendations. Planned actions include an assessment and appropriate follow-up actions for all laboratory staff to determine level of skills, training, supervision, knowledge, and expertise at all levels of the organization; also planned is an external advisory committee to provide ongoing advice and direction for laboratory quality and safety;

• Leadership behavior: A single point of accountability for laboratory safety was established for the organization. The report notes that, “The creation of a single point of accountability does not reduce the responsibility of people at every level of the organization, including center, division, and branch directors, chiefs, supervisors, and all laboratory scientists to strengthen the culture of safety”;

• Personnel behavior: appropriate personnel actions have been taken with regard to individuals who contributed to or were in a position to prevent this incident;

• Principles for guiding decisions and behaviors: emphasis was placed on using approved techniques and standard operating procedures, and requiring a written study plan reviewed by senior staff or scientific leadership to ensure that the research design was appropriate and met all laboratory requirements. As part of these guidance efforts, the FSAP released its policy statement on inactivated B. anthracis in November 2015. Early in 2016, the FSAP also offered the regulatory community an opportunity to provide written comments regarding the “Inactivated Bacillus anthracis” policy. The FSAP requested these comments in order to improve its policy’s clarity and to minimize unintended consequences that would result from its implementation;

• Beliefs and attitudes on biosafety and biosecurity: inadequacies in this area included the instructions provided by a supervisor to the scientists to use virulent instead of avirulent strains (even though the instrument manufacturer states that the system identifies bacteria to only the species level and would not distinguish strains of the same species) and the lack of due diligence in reviewing available literature which would have provided knowledge on minimizing risk using appropriate filtration methods to inactivate B. anthracis. A culture of responsible conduct of science should minimize the risk whenever possible. A lapse in biosafety and biosecurity culture is also illustrated by the practice described in the report as “piggy backing” (obtaining entrance to a secured area by following a colleague rather than by having all individuals swipe their own card key as should be done) which posed challenges to identifying potentially exposed personnel. Beliefs and attitudes may be reinforced through training and education including the review and monitoring of training policies and procedures for new and existing staff by the newly created lead laboratory science position as a single point of accountability for safety; establishing and enforcing agency-wide policies that require formal review and approval of new select agent research or program protocols and provide oversight for ongoing research and program projects (e.g., yearly reviews); ensuring adherence to laboratory quality and safety protocols; and creating effective and redundant systems and controls for protocols and procedures including, but not limited to, inactivation and access to laboratories (e.g., “piggybacking” and visitor access). Arguably, the most notable follow up action which has the potential to influence attitudes and beliefs in biosafety and biosecurity is to identify the points in any

4

http://www.selectagents.gov/policystatement_bacillus.html

http://www.selectagents.gov/resources/Draft_B_anthracis_inactivation_policy.pdf

project where potential mistakes would have the most serious consequences and provide specific actions to avoid these mistakes. Examples of these critical points and associated preventive actions include requiring protocols to be reviewed by supervisors before they are implemented, having standard and clear procedures to inactivate infectious agents and specify how they will be transferred to other labs, having formal incident response plans in place, controlling laboratory access, and instituting regular review of laboratory processes to ensure proper safety, quality management, and compliance with the Select Agent Regulations.

Case Study #2 (reference: Framework for Conducting Risk and Benefit Assessments of Gain-of-Function Research Recommendations of the National Science Advisory Board for Biosecurity)

In recent years, the federal government re-assessed the risk/benefit calculus underpinning funding decisions for a certain subset of gain-of-function research involving agents that pose a significant risk to public health. Gain-of-function research refers to any modification of a biological agent — like viruses or bacteria — that gives it new or enhanced activity, such as the ability to infect a different host. While research on factors that could increase transmission or infection can be important for informing prevention strategies, some information from these studies might also be misused for harmful purposes. Gain-of-function research came to public attention in 2010, in the context of studies on the transmission dynamics of highly pathogenic avian influenza (HPAI) H5N1 conducted by the University of Wisconsin in the US and Erasmus Medical Center in the Netherlands. These studies involved the mutation of two H5N1 strains through multiple passaging and identification of specific amino acid changes that enhanced airborne transmissibility of the virus between ferrets—a standard animal influenza model that exhibits a natural history and pathology similar to what is observed in humans. The potential translation from ferrets to humans raised concerns among funders (i.e. the US National Institutes of Health (NIH)) and the broader biosecurity policy community that the research could be used for intentionally harmful purposes or result in an accidental release from the laboratory into the general population2,3

2 IDSA and Gain-of-Function Experiments with Pathogens having Pandemic Potential, Frank et al, 2015.

3 Gain-of-Function Research and the Relevance to Clinical Practice, Kilianski et al, 2015.

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. Gain-of-function research may fall into the category of DURC which is defined as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security” and is subject to several US Government policies intended to

http://osp.od.nih.gov/sites/default/files/resources/NSABB_Framework_for_Risk_and_Benefit_Assessments_of_GOF_Research-APPROVED.pdf



http://jid.oxfordjournals.org/content/early/2015/09/25/infdis.jiv474.short

http://jid.oxfordjournals.org/content/early/2015/09/25/infdis.jiv473.short

raise awareness and to limit the potential for misuse of scientific information derived from life sciences research4.

4 S3:Science Safety Security website.

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Q1. How are gain-of-function research or more broadly, the dual use research of concern (DURC) policies, relevant to the goal of strengthening the culture of biosafety, biosecurity, and responsible conduct in life sciences research?

A1. The aim of the US Government policies related to DURC and gain-of-function research are similar to efforts designed to strengthen the culture of biosafety, biosecurity, and responsible conduct in life sciences research, namely to prevent the loss, theft, misuse, and diversion of biological agents, related materials, technology or equipment, and the unintentional or intentional exposure to (or release of) biological agents.

Q2. How are the risk mitigation strategies and analysis associated with gain-of-function research relevant to the goal of strengthening the culture of biosafety, biosecurity, and responsible conduct in life sciences research?

A2. The National Science Advisory Board for Biosecurity (NSABB) recommended considering alternative experimental approaches to gain-of-function experiments that may provide the same or similar outcomes or additional/different benefits, without the same risks. These alternative approaches should be identified and their relative risks, benefits, and limitations thoroughly and impartially analyzed. NSABB also recommended that the effects of adequate or inadequate occupational medicine/medical surveillance programs, training, standard operating procedures, and administrative controls be examined and incorporated into the analysis. In addition, the impact of risk mitigation strategies and practices, the effect of public health interventions, and whether or not countermeasures are effective against novel strains, as well as how these strategies are actually employed (which may involve human error, crisis conditions, or other factors that decrease their effectiveness) should also be examined. In this context, strengthening the culture of biosafety, biosecurity, and responsible conduct in life sciences research through training, education, and awareness raising may be considered one of the risk mitigation strategies for gain-of-function research. The evaluation of such culture at the organizational level may enhance the risk/benefit analysis associated with gain-of-function research.

Q3. Did NSABB ever make recommendations to the US Government on strengthening the culture of responsibility?

http://www.phe.gov/s3/dualuse/Pages/default.aspx

A3. Yes, in the 2011 NSABBGuidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility5. NSABB notes that, “above all, good management practices are the foundation that underpins the development of a culture of responsibility, integrity, trust, and effective biosecurity. In addition, strong institutional and laboratory leadership, clear articulation of priorities and expectations, and an institutional framework that provides relevant education, training, performance review, and employee support will facilitate responsible practices, personnel reliability, safety, and security, while allowing research on biological select agents and toxins (BSAT) to flourish”. In this Guidance, NSABB provided recommendations for encouraging biosecurity awareness and promoting responsible conduct as well as a recommendation for assessing the effectiveness of practices aimed at enhancing personnel reliability and the culture of responsibility. NSABB also notes that, “all scientists—especially those working in the life sciences—are called to cultivate among themselves a culture of responsibility with regard to the conduct and the achievements of their research”. NSABB emphasized with regard to all scientists—especially those working in the life sciences—that, “their goal remains that of the generation and advancement of knowledge, but, in some cases, such knowledge may be applied for both beneficial and harmful purposes; their beliefs, attitudes, and values must reflect a heightened consciousness of the implications of their research, especially of any potential for the deliberate misuse of the information, products, and technologies generated from their research; they must consciously live and demonstrate these beliefs, attitudes, and values through day-to-day practices of mindful research. With transparency, they must examine their own research with consideration of its potential for misuse, and they must conduct and communicate their research in ways that mitigate any risks of misuse. Finally, in cultivating and sustaining a culture of responsibility, scientists who conduct research must recognize that they engage in a continuous, reciprocal process of promoting and bearing mutual responsibility for their work: They must hold themselves and their peers accountable—collegially and with a shared commitment to advancing science and maintaining public trust.”

)

5 Guidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility, NSABB, 2011.

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Case Study #3 (reference: The Cooperative Biological Engagement Program Research Strategic Plan: Addressing Biological Threat Reduction Through Research


The US Government is funding programs supporting collaborative research projects abroad aimed at reducing risks associated with infectious diseases. An example of such a program is the Defense Threat Reduction Agency’s (DTRA) Cooperative Biological Engagement Program (CBEP). The scope of CBEP’s engagement activities increasingly intersects with major US Government and international program areas, including national security, force health

http://www.dtra.mil/Portals/61/Documents/Missions/CBEP%20Research%20Strategy_FINAL_July%202015.pdf

http://www.dtra.mil/Portals/61/Documents/Missions/CBEP%20Research%20Strategy_FINAL_July%202015.pdf

http://osp.od.nih.gov/sites/default/files/resources/CRWG_Report_final.pdf


protection, global health security, science, and development and engagement. CBEP consciously engages and partners with other Department of Defense (DoD) and US Government entities (e.g., Army, Navy, Armed Forces Health Surveillance Center [AFHSC], Chemical and Biological Defense Program [CBDP], Department of Homeland Security [DHS], Department of Health and Human Services [HHS], Department of Agriculture [USDA], Federal Bureau of Investigation [FBI], United States Agency for International Development [USAID]); non-governmental organizations (e.g., World Bank, Foundation Merieux); and international programs (e.g., Food and Agricultural Organization of the United Nations [FAO], World Health Organization [WHO], World Organisation for Animal Health [OIE], and International Criminal Police (INTERPOL). For instance, CBEP projects at the Richard G. Lugar Center for Public Health Research in Tbilisi, Georgia, include research on emerging antibiotic resistance, epidemiology of human and environmental pathogens associated with vector borne diseases, and the impact of zoonotic pathogens on human health and veterinary practice, among other topics.

Q1. Whose responsibility is it to create, strengthen, and sustain a culture of biosafety, biosecurity, and responsible conduct of science at an international location where US Government-funded projects are being implemented? Consider as an example CBEP projects at the Richard G. Lugar Center for Public Health Research in Tbilisi, Georgia.

A1. Biosafety, biosecurity, and responsible conduct constitute a shared responsibility of the respective host organization, individual researchers, and the funding department or agency. They should work cooperatively to foster an assembly of beliefs, attitudes, and patterns of behavior of individuals and organizations that can support, complement or enhance operating procedures, rules, and practices as well as professional standards and ethics designed to prevent the loss, theft, misuse, and diversion of biological agents, related materials, technology or equipment, and the unintentional or intentional exposure to (or release of) biological agents.

Q2. Should the US Government research programs abroad [involving (but not limited to) BSAT] include (explicitly or implicitly) as an objective strengthening the culture of biosafety, biosecurity, and responsible conduct in life sciences?

A2. Yes. The CBEP Research Strategy mentions fostering a culture of responsible scientific practice and specifies as one of its objectives the institutionalization of a culture of responsible and ethical conduct in biological research through thoughtful experimental design, competitive laboratory capabilities, and implementation of biorisk management practices that result in high-quality data, and active participation in professional societies and the peer-review process. Not all federal programs mention specifically such a culture.

Q3. Are the Federal Experts Security Advisory Panel (FESAP) recommendations (including the recommendation to create, strengthen, and sustain a culture of biosafety, biosecurity, and responsible conduct in life sciences research) applicable to federally-funded research abroad?

A3. Yes. The White House National Security Council (NSC) staff tasked the FESAP, in September 2014, to undertake a comprehensive federal review and identify specific recommendations to strengthen the US Government's biosafety and biosecurity practices and oversight system for

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federally-funded activities involving (but not limited to) BSAT, consistent with the need to realize the public health and security benefits of such work. There is no waiver for federally-funded research abroad.

Q4. Is “responsible conduct” a new concept for federally-funded activities?

A4. No. The 2009 National Strategy for Countering Biological Threats, which articulates a vision of shared commitment wherein the US Government works with domestic and international partners to advance the health security of all people, includes as one of its objectives reinforcing of norms of safe and responsible conduct and highlights activities that should be taken to reinforce a culture of responsibility, awareness, and vigilance among all who utilize and benefit from the life sciences to ensure that biological materials and related knowledge, equipment, and technology are not diverted to harmful purposes. Such activities include: “encouraging the constituencies of the global life sciences community to engage in a robust and sustained dialogue as to the development of behavioral norms and options for their codification; encouraging professional societies in the life sciences to develop and communicate codes of ethics and consider how their membership policies can best reflect community norms; assisting professional societies and other representatives of the life sciences community in the development of relevant educational and training materials; ensuring the availability of tools and resources needed to document, communicate, and reinforce norms during the education and throughout the career of life scientists in academia, industry, or government; and supporting efforts by life scientists to explore community-based approaches for identifying and addressing irresponsible conduct”. Federal departments and agencies report annually their Strategy implementation plans to the NSC.

Q5. Outside the FESAP recommendations, are there any other international fora that address the culture of responsibility?

A5. Yes. A culture of biosafety, biosecurity, and responsible conduct in life sciences research has been addressed in various multilateral fora. For example:

• WHO Guidance on Responsible life sciences research for global health security6 promotes a culture of scientific integrity and excellence, distinguished by openness, honesty, accountability and responsibility and specifies that such a culture is the best protection against the possibility of accidents and deliberate misuse, and the best guarantee of scientific progress and development;

6 Responsible life sciences research for global health security- A guidance document, WHO, 2010.

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• At the 7th Review Conference of Biological Weapons Convention (BWC), States Parties noted that implementation of BWC includes measures to “… ensure the safety and security of microbial or other biological agents or toxins in laboratories, facilities, and during transportation, to prevent unauthorized access to and removal of such agents or


toxins…”, “implement voluntary management standards on biosafety and biosecurity; …promote amongst those working in the biological sciences awareness of the obligations of States Parties under the Convention, as well as relevant national legislation & guidelines; promote the development of training and education programs for those granted access to biological agents … and encourage the promotion of a culture of responsibility amongst relevant national professionals and the voluntary development, adoption and promulgation of codes of conduct…”;

• The Executive Summary from OIE’s Global Conference on Biological Threat Reduction, 20157, notes inter alia that, “Veterinary education establishments have significant potential to positively influence the attitudes of future professionals in terms of ethics, responsible science, and in developing an international perspective” and that ”The OIE should continue its efforts, in collaboration with veterinary education establishments, to refine the day one competencies, consider ethics as integral to education curricula, and develop on-line continuing education and learning tools, making them available to all Member Countries”;

7 Executive Summary from OIE’s Global Conference on Biological Threat Reduction.

• The G7 Global Partnership against the Spread of Weapons and Materials of Mass Destruction is addressing the CBRN Security Culture in the context of its Centers of Excellence (CoE) and CBRN Security Sub-Working Group (SWG). Since its establishment in 2012, the CoE and CBRN Security SWG also looked at the vulnerability nexus of CBRN domains: the human factor in interrelated functional areas including security of relevant materials and associated facilities, strategic trade controls, and knowledge management. Under the Germany Chairmanship of the Global Partnership (GP), on 24 April 2015, the U.S. with support from the United Nations Office for Disarmament Affairs (UNODA), organized at the U.S. Consulate in Munich a side event on “Comprehensive CBRN Security Culture: Moving Forward to Address New Challenges” on the margins of the GP meeting. This side event sought broader stakeholders’ input into how the CBRN Security Culture could contribute to the GP objectives of achieving international peace and security by preventing the proliferation of weapons of mass destruction and their means of delivery as well as effectively combating international terrorism. Participants agreed that the concept of CBRN Security Culture is inherently linked to promoting the responsible conduct of science in particular where issues of dual use research arise; as security is viewed differently across C, B, and R/N domains, a customizable approach should be developed to address domain-specific challenges; and a mechanism is needed to share lessons learned from outreach and education in support of strengthening the CBRN Security Culture as well as tools for assessing, evaluating, monitoring and improving the organizational culture in C,B, and R/N domains, with participation from a broad range of stakeholders8.

8 CBRN Security Culture Discussion at the Global Partnership: Moving Forward, Ambassador Bonnie Jenkins,1540 Compass journal vol. 8, pp 12-17, 2015.

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http://www.oie.int/eng/BIOTHREAT2015/recommendations/BTR_Conference_Final_report_7_8_2015.pdf

http://cits.uga.edu/uploads/1540compass/1540PDFs/Compass_Magazine_8_web.pdf

http://cits.uga.edu/uploads/1540compass/1540PDFs/Compass_Magazine_8_web.pdf

Template for Outreach to USG Internal and External Stakeholders

Strengthening an organizational culture that emphasizes biosafety, biosecurity, and

responsible conduct in the life sciences- Outreach Strategy -

Objectives Summarize policy context and strategic guidance

underlying the process of strengthening the organizational culture that emphasizes biosafety, biosecurity, and responsible conduct in the life sciences

Promote discussion and reflection on the elements of such an organizational culture and the path forward for assessment and sustainment

Why do we need to optimize biosafety and biosecurity?

“In 2014 and 2015, two federal departments reported multiple lapses in laboratory safety that could have exposed personnel and other individuals to hazardous biological agents.

For example, within the Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) reported an incident in June 2014 that had the potential to expose laboratory personnel to live anthrax bacteria, and in July 2014, boxes containing decades-old vials of smallpox - some of which contained live virus - and other hazardous biological agents were found in a storage space of a Food and Drug Administration (FDA) laboratory on the National Institutes of Health (NIH) campus.

In May 2015, the Department of Defense (DOD) reported safety lapses at one of its high-containment laboratories stemming from inadequate procedures to fully inactivate anthrax that resulted in DOD shipping live anthrax to other laboratories.”

Why the emphasis on the culture of safety?

“The hearings and reports show a pattern of recurring issues, of complacency, and a lax culture of safety. The lesson learned from past reviews is that Federal agencies must address cultural factors in addition to its policy and management efforts to ensure the effectiveness of its lab safety programs”.

“While specific corrective actions were taken in response to individual incidents in the past years, the broader pattern of inadequate laboratory safety was not addressed effectively. Addressing that broader pattern and our safety culture is what we are doing now.”

What about the culture of security?

“Administrative and investigative steps taken in the past year toward closure of the investigation confirm the conclusion that Dr. Ivins perpetrated the anthrax letter attacks”.

“The single overarching finding of this investigation is that a determined adversary cannot be prevented from obtaining very dangerous biological materials intended for nefarious purposes, if not from DoD laboratories, then from other sources”.

Recommendations include making “changes to monitoring activities to improve effectiveness without introducing overly intrusive measures. Hold periodic meetings with laboratory personnel to reinforce values, moral obligations, and observations that should be reported”.

Beyond the culture of safety and security- example for consideration -

Yes. DURC policies emphasize a culture of responsibility by reminding all involved parties of the shared duty to uphold the integrity of science and prevent its misuse

Is the individual and institutional oversight of DURC (which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable) an example of area where cultural factors are important?

“All scientists—especially those working in the life sciences—are called to cultivate among themselves a culture of responsibility with regard to the conduct and the achievements of their research” - 2011 NSABB Guidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility

“Recent incidents involving BSAT have raised serious safety and security policy issues. The White House National Security Council (NSC) staff tasked the FESAP, in September 2014, to 1) identify needs and gaps and make recommendations to optimize biosafety, biosecurity, oversight, and inventory management and control for BSAT; 2) identify actions and any regulatory changes to improve biosafety and biosecurity; and 3) identify an approach to determine the appropriate number of high-containment U.S. laboratories required to possess, use, or transfer BSAT”.

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”.

Culture in context

Definition of culture as it relates to biorisk management

An assembly of beliefs, attitudes, and patterns of behavior of individuals and organizations that can support, complement or enhance operating procedures, rules, and practices as well as professional standards and ethics designed to prevent the loss, theft, misuse, and diversion of biological agents, related materials, technology or equipment, and the unintentional or intentional exposure to (or release of) biological agents.

What elements should we consider for strengthening the organizational culture?

Management systems which prioritize biosafety, biosecurity, and responsible conduct

Processes, procedures and programs in the organization which prioritize biorisk management and have an important impact on the biosafety/biosecurity functions

Behavior of leadership and personnel to foster more effective biosafety and biosecurity

Leadership behavior (i.e. specific patterns of behavior and actions which are designed to foster more effective biorisk management) should emphasize inter alia expectations, decision making, management/ supervisory oversight, effective communication, and motivation. Personnel behavior (the desired outcomes of the leadership efforts and the operation of the management systems) should emphasize inter alia professional conduct, adherence to approved/validated procedures and research protocols, team work and cooperation, and vigilance.

Principles for guiding decisions and behavior as they relate to biorisk management

Emphasis should be placed on principles for guiding decisions and behaviors as they related to biorisk management (i.e. motivation, leadership, commitment and responsibility, professionalism and competence, learning and improvement, maintaining public trust)

Beliefs and attitudes on biosafety and biosecurity Beliefs and attitudes on biosafety and biosecurity should be assessed periodically and reinforced through training and education aiming to: raise awareness on the risks associated with working in a laboratory with biological materials (e.g., accidental exposure, infection or release; intentional theft and/or misuse; others such as radiological/chemical/physical safety), the potential ramifications if such risk events were to occur and risk mitigation strategies; raise awareness and increase understanding of the ethical, legal, and societal issues and consequences concerning life sciences research, development, and associated technologies; raise awareness and place emphasis on the importance of quality systems and practices in lab biosafety and biosecurity training and research design; review codes of ethics and social responsibility guidelines in life sciences research; and review biosafety, biosecurity, and dual use research of concern regulations, guidelines, policies and procedures, and any other specified training requirements.

“Above all, good management practices are the foundation that underpins the development of a culture of responsibility, integrity, trust, and effective biosecurity. In addition, strong institutional and laboratory leadership, clear articulation of priorities and expectations, and an institutional framework that provides relevant education, training, performance review, and employee support will facilitate responsible practices, personnel reliability, safety, and security, while allowing research on biological select agents and toxins (BSAT) to flourish”.

The scientists’ “goal remains that of the generation and advancement of knowledge, but, in some cases, such knowledge may be applied for both beneficial and harmful purposes; their beliefs, attitudes, and values must reflect a heightened consciousness of the implications of their research, especially of any potential for the deliberate misuse of the information, products, and technologies generated from their research; they must consciously live and demonstrate these beliefs, attitudes, and values through day-to-day practices of mindful research.

With transparency, they must examine their own research with consideration of its potential for misuse, and they must conduct and communicate their research in ways that mitigate any risks of misuse.

Finally, in cultivating and sustaining a culture of responsibility, scientists who conduct research must recognize that they engage in a continuous, reciprocal process of promoting and bearing mutual responsibility for their work: They must hold themselves and their peers accountable—collegially and with a shared commitment to advancing science and maintaining public trust.”

Foundational values of an organizational culture that emphasizes biosafety, biosecurity, and responsible conduct

• Research excellence: foster quality in life sciences activities, which is the basis for developing new treatments and therapeutics, strengthening health research systems, and promoting public health surveillance and response activities. These elements are essential to protecting and improving the health and well-being of all people.

• Bioethics –promote responsible and good research practices, the provision of tools and practices to scientists and institutions that allow them to discuss, analyze and resolve in an open atmosphere the potential dilemmas they may face in their research, including those related to dual use research of concern, the possibility of accidents or misuse of the life sciences.

• Biosafety and biosecurity –implement and strengthen of measures and procedures to: minimize the risk of worker exposure to pathogens and infections; protect the environment and the community; and protect, control and account for biological materials within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional release. Such measures reinforce good research practices and are aimed at ensuring a safe and secure laboratory environment, thereby reducing any potential risks of accidents or deliberate misuse.

Assessment of the organizational culture that emphasizes biosafety, biosecurity, and responsible conduct in the life sciences

• Organizations / laboratories are encouraged to develop methods for outcome measurement (i.e. systematic determination and evaluation of their training and oversight systems aiming to strengthen the culture of biosafety, biosecurity, and responsible conduct, and comparison with the strategic goals and intended or projected results)

• Outcome measurement has become increasingly important given the complexity of biosafety/biosecurity oversight systems, the need for evidence-based decision-making (e.g. on staffing, areas for improvement, choice of training programs), and the ability to detect changes associated with a particular intervention

• Such a systematic assessment (conducted periodically) is critical to understanding the efficiency/effectiveness of the biorisk management framework, causality of system breakdowns or analysis of incidents, sources of human error or breaches of biosafety/biosecurity, efficiency/effectiveness of training, etc.

Methods of assessment of the organizational culture that emphasizes biosafety, biosecurity, and responsible conduct in the life sciences

• Basic (based on statistical methods and information derived mostly from document review, observations, and other sources- i.e. percentage of employees who have received safety/security refresher training during the previous quarter or year; percentage of safety/security improvement proposals submitted, considered, or implemented during previous quarter or year; number of laboratory safety/security incidents or near-misses, etc);

• Intermediate (based on managers’ own “yes” or “no” judgment regarding the evolving structure and functionality of the biosafety/biosecurity framework; areas assessed requiring a “yes” or “no” response may include: information on the availability of safety/security policies, regularly held management meetings covering significant safety and security issues, professional rewards or recognition are associated with the achievement of safety/security goals, etc.) or

• Comprehensive (multi-stage process comprising both non-interactive and interactive assessment tools focusing on management and behavior characteristics of the biorisk management culture). Methods to be included in the plan may include: 1) non-interactive methods (surveys, document review, and observations) and 2) interactive methods (individual interviews and focus-group discussions).

Aim to develop a continuous improvement system that provides feedback, reassessment, and on-going training and learning opportunities

International perspectives

WHO “promotes a culture of scientific integrity and excellence, distinguished by openness, honesty, accountability and responsibility. Such a culture is the best protection against the possibility of accidents and deliberate misuse, and the best guarantee of scientific progress and development”.

States Parties noted that implementation of BWC includes inter alia measures to “… ensure the safety and security of microbial or other biological agents or toxins in laboratories, facilities, and during transportation, to prevent unauthorized access to and removal of such agents or toxins…”, “implement voluntary management standards on biosafety and biosecurity; promote the development of training and education programs for those granted access to biological agents … encourage the promotion of a culture of responsibility amongst relevant national professionals and the voluntary development, adoption and promulgation of codes of conduct…”

References

• Report of the Federal Experts Security Advisory Panel, December 2014, http://www.phe.gov/s3/Documents/fesap.pdf• Implementation Plan for Recommendations of the Federal Experts Security Advisory Panel and the Fast Track Action Committee

on Select Agent Regulations, October 2015, http://www.phe.gov/s3/Documents/fesap-ftac-ip.pdf• S3 - Science, Safety, and Security website, http://www.phe.gov/s3• High Containment Laboratories: Comprehensive and Up-to-Date Policies and Stronger Oversight Mechanisms Needed to Improve

Safety, March 2016, http://gao.gov/assets/680/675925.pdf• U.S. House of Representatives Committee on Energy and Commerce, Subcommittee on Oversight and Investigations,

Supplemental Memorandum: Committee Investigation on the 2014 Discovery of Smallpox Vials at the National Institutes of Health, Bethesda, Maryland Campus, April 2016, http://docs.house.gov/meetings/IF/IF02/20160420/104823/HHRG-114-IF02-20160420-SD003.pdf

• Thomas Frieden, MD, MPH, Director, Centers for Disease Control and Prevention, US Department of Health and Human Services, Testimony before the Subcommittee on Oversight and Investigations Committee on Energy and Commerce U.S. House of Representatives, July 16, 2014, http://docs.house.gov/meetings/IF/IF02/20140716/102479/HHRG-113-IF02-Wstate-FriedenT-20140716.pdf

• US Department of Justice, AMERITHRAX Investigative Summary, February 19, 2010, https://www.justice.gov/archive/amerithrax/docs/amx-investigative-summary.pdf

• Report of the Defense Science Board, Task Force on Department of Defense Biological Safety and Security Program, May 2009, http://www.acq.osd.mil/dsb/reports/ADA499977.pdf

• Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern – A Companion Guide to the United States Government Policies for Oversight of Life Sciences Dual Use Research of Concern, September 2014, http://www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf

• Guidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility A Report of the National Science Advisory Board for Biosecurity, September 2011, http://osp.od.nih.gov/sites/default/files/resources/CRWG_Report_final.pdf

• The Human Dimension of Security for Radioactive Sources, University of Georgia Center for International Trade and Security and Indonesia’s National Nuclear Energy Agency (BATAN), 2014, http://cits.uga.edu/uploads/documents/radreport.pdf

• Responsible life sciences research for global health security: a guidance document, World Health Organization, 2010, http://apps.who.int/iris/bitstream/10665/70507/1/WHO_HSE_GAR_BDP_2010.2_eng.pdf

• Seventh Review Conference of the States Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, Geneva, 5–22 December 2011, Final Document of the Seventh Review Conference, http://www.unog.ch/80256EDD006B8954/(httpAssets)/3E2A1AA4CF86184BC1257D960032AA4E/$file/BWC_CONF.VII_07+(E).pdf

• A guide to implementing a SAFETY CULTURE in our universities, APLU, 2016, http://www.aplu.org/projects-and-initiatives/research-science-and-technology/task-force-laboratory-safety/

Questions?

Culture of Biosafety, Biosecurity, and Responsible Conduct 1 2 3 4

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ACROSS

1 A principle, plan, or course of action that the Executive branch of the Federal Government can establish it through the use of both regulations and guidance documents

3 Biosafety cabinet 5 Systematic investigation aimed at the discovery or interpretation of

facts, revisions of accepted theories or laws in the light of new facts, or practical application of such new or revised theories or laws, including the processes of experimentation, development, testing, and evaluation

7 Security Risk Assessment 9 Recombinant DNA

12 Such agents include any microorganism (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or any naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance, capable of causing death, disease, or other biological malfunction in a human, an animal, a plant, or another living organism; deterioration of food, water, equipment, supplies, or material of any kind; or deleterious alteration of the environment

14 Presidential Policy Directive 16 "biological" and "hazard" combined 17 Public Health Emergency Medical Countermeasures Enterprise 18 A rule based on a statute 19 Select agent regulations 20 The ethics of medical and biological research 24 A type of research that is meant to increase our scientific knowledge

base with regard to certain phenomena or behavior 26 The application of combinations of laboratory practices and procedures,

laboratory facilities, safety equipment, and appropriate occupational health programs when working with potentially infectious microorganisms and other biohazards

27 The toxic material or product of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substances, or a recombinant or synthesized molecule, whatever their origin and method of production, and includes any poisonous substance or biological product that may be engineered as a result of biotechnology, produced by a living organism; or any poisonous isomer or biological product, homolog, or derivative of such a substance

29 An infection resulting from exposure to an infectious agent in a laboratory

30 Responsible Official 31 When applied to risk, it is a process used to identify the hazardous

characteristics of a known infectious agent or potentially infectious agent or material, the activities that can result in exposure to such an agent, the likelihood that such exposure will cause a laboratory-acquired infection (LAI), and the probable consequences of such an infection

34 The Biosafety Review …. or a group of individuals affiliated with a facility whose functions typically extend beyond those of the "institutional biosafety committee" (IBC) as described in the NIH Guidelines

35 For all high and maximum containment facilities, it refers to the physical containment barriers in a facility such as contained dressing and shower rooms, sealed service penetrations, specialized doors, entry and exit avenues to prevent cross-contamination, specialized air handling systems for contamination control, personal protective equipment, biosafety cabinets, etc.

38 The individual designated by a research entity to direct a project or program, and who is responsible to the entity for the scientific and technical direction of that project or program

39 Specialized clothing or equipment worn by an employee for protection against a hazard

40 The protection of hazardous biological agents, including toxins, from loss, theft, diversion, or intentional misuse

45 The effective … of risks posed by working with hazardous biological agents in laboratories; it includes a range of practices and procedures to ensure the biosecurity, biosafety, and biocontainment of high- consequence pathogens

47 A body of rules of conduct of binding legal force and effect, for instance the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

50 Biosafety level 51 Likely to spread infection 53 A laboratory event that may include exposure of staff or the public to an

infectious, potentially infectious, or zoonotic agent; environmental release of a biological hazard; escape of infected animals or vectors; spill of a biohazard outside of a primary containment device; loss or theft of biohazardous agents and other loss of containment; or equipment failure in conjunction with a biohazard (e.g., centrifuge accident) that may lead to a release of a hazardous agent within the laboratory environment or outside the laboratory environment

54 National Plant Diagnostic Network 55 Laboratory Response Network

DOWN

2 Chemical, biological, radiological, and nuclear 3 Biosafety in Microbiological and Biomedical Laboratories 4 Biological Select Agents and Toxins 5 An assurance that individuals with access to dangerous pathogens are

trustworthy, reliable, and physically and mentally competent 6 This type of conduct in research is simply good citizenship applied to

professional life 8 An objective assessment of an institution's biosafety/biocontainment or

biorisk management program by an independent body 10 Designations of laboratories for work with biohazards used in a vivarium

that include zoonotic or human pathogens 11 When referring to containment is BSL-3 13 Select Agents Program 15 Validating the expertise and credentials of an individual or an

engineering control and in some cases a laboratory facility 21 Institutional Biosafety Committee 22 A microscopic organism, such as a bacterium, fungus, protozoan, or

virus 23 When referring to containment is BSL-4 25 An assumed truth which is part of the organizational culture (plural) 28 Deoxyribonucleic acid 32 Subject Matter Expert 33 The combination of the probability of the occurrence of harm and the

severity of that harm where the source of harm is a biological agent or toxin (adapted from ISO/IEC Guide 51:1999)

36 Code of Federal Regulations 37 … biosafety and biocontainment research - Research designed to

generate science-based practices and procedures, engineering controls, personal protective equipment, and risk-assessment methodologies necessary to optimize the safety of research facilities; and to keep safety equipment, practices, and procedures up to date

38 A microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion) that can cause disease in humans, animals, or plants

41 Standards or principles written by an organization to assist in the effectiveness of an operation, or to recommend a course of action

42 The action of teaching someone a particular skill or type of behavior 43 The process of a multi-tiered, often-overlapping system-from principal

investigators at individual laboratories to agencies of the Federal Government-seeking to ensure the safety of biological laboratories and their activities through compliance with existing laws, regulations, policies, standards, and guidelines on biosafety and biocontainment

44 A type of laboratory where diagnostic or other screening procedures are performed on blood or other potentially infectious materials

46 A manner of thinking, feeling, or behaving that reflects a state of mind or disposition and is fundamental to the culture of biosafety, biosecurity, and responsible conduct

48 An assembly of beliefs, attitudes, and patterns of behavior of individuals and organizations that can support, complement or enhance operating procedures, rules, and practices as well as professional standards and ethics designed to prevent the loss, theft, misuse, diversion, of biological agents, related materials, technology or equipment, and the unintentional or intentional exposure to (or release of) biological agents.

49 National Registry of Certified Microbiologists 50 Biosafety officer or biological safety officer 52 Federal Experts Security Advisory Panel

Culture of Biosafety, Biosecurity, and Responsible Conduct Solution:

P O L I C Y B S C B B M R E S E A R C H

S R A R D N A B H E A E C N B I O L O G I C A L T S

S C S G I P P D A R C L B I O H A Z A R D O P H E M C E B N

D R R E G U L A T I O N S A R B I O E T H I C S L I M

T I B M I B A S I C B A F C B I O S A F E T Y L C E T O X I N D X Y E R L A I C N I R O I O A A S S E S S M E N T S B B E N T U C O M M I T T E E F B I O C O N T A I N M E N T E O S O F P R

P I N R P P E B I O S E C U R I T Y A G T L O S T U R I V C K H I M A N A G E M E N T L A W C O D T I D R N I U G E T N S R N B S L E L I I I N F E C T I O U S T

I N C I D E N T N G E M C O U N U G H S A R E N P D N T A L R N E S E P

1

Bioethics Training:

Guiding Principles to Promote a Culture of Biosafety, Biosecurity, and

Responsible Conduct in the Life Sciences

Life sciences research is crucial to the development of national capabilities to mitigate

the risks posed by infectious diseases and environmental risks, whether naturally

occurring, deliberate, or unintentional. As such, life sciences research fosters the long

term health, security, and wellness of the public, animals, plants, the environment, and

our economy when conducted in a safe and secure manner.

Laboratory incidents may put individuals, communities, and the environment at risk,

undermine public confidence in the research enterprise, and must be addressed to help

minimize the probability of occurrence and mitigate any potential impacts.

Reinforcing the norms of safe and responsible conduct in

life sciences is critical to counteracting the diversion of

biological materials, equipment, or technologies for

harmful purposes.

Bioethics: The study of the moral

principles or values governing, or

distinctive of, life sciences research

and the moral or societal implications

of certain biological research

procedures, technologies, or

treatments.

Culture: An assembly of beliefs,

attitudes, and patterns of behavior of

individuals and organizations that

can support, complement or enhance

operating procedures, rules, and

practices as well as professional

standards and ethics designed to

prevent the loss, theft, misuse, and

diversion of biological agents,

related materials, technology or

equipment, and the unintentional or

intentional exposure to (or release

of) biological agents.

Facilities undertaking research or performing diagnostics

that involve biological agents and toxins, as well as

professional organizations, and academic institutions

provide bioethics training and education addressing a

broad range of issues including ethical theories, ethical

concerns embodied in life sciences’ practice, emerging technologies, dual use dilemmas,

ethical research, and research integrity.

Such training should also include considerations about

how bioethical dilemmas are shaped by life sciences

professionals’ cultural values and beliefs about the

concepts of biosafety, biosecurity, and responsible

conduct of research.

Bioethics training should promote responsible, safe, and

secure research and diagnostic practices, provide tools and

guidance to scientists and institutions that facilitate open

discussion and analysis of potential challenges and

dilemmas associated with their work, including weighing

potential risks and benefits, dual use concerns, and the

possibility of accidents or misuse of life sciences research.

Training should be supplemented with primary source

materials to further examine the U.S. Government policies

regarding life sciences dual use research of concern, the National Strategy for Countering

Biological Threats (which highlights actions that should be taken to reinforce

2

a culture of responsibility, awareness, and vigilance among all who utilize and benefit

from the life sciences), case studies on bioethical dilemmas and historical examples of

scientists or biomedical professionals involved in bioterrorism or biocrimes, and

guidance and training materials developed by the National Science Advisory Board for

Biosecurity and the Federal Experts Security Advisory Panel working group on

strengthening the culture of biosafety, biosecurity, and responsible conduct.

When addressing ethical considerations related to laboratory biosafety and biosecurity,

bioterrorism or biocrimes perpetrated by biomedical professionals, emerging

technologies or dual use research dilemmas, additional questions to be raised may

include: is there a difference between common morality and professional ethics?; is there

a difference between applied ethics and professional ethics?

Analyzing and providing examples of

ethical and decision making

frameworks (decision theory,

precautionary principle, rights-based

approach, deontological ethics,

principle-based frameworks, etc.) will

serve to promote dialogue and raise

awareness on approaches for weighing

ethical and societal responsibility

issues pertinent to the life sciences.

Life sciences bioethics training may also include discussions on whether a pan-

professional ethics code is needed for the life sciences professions or the equivalent of a

Hippocratic oath to "do no harm".

.

Code of conduct: A formal statement of values and

professional practices of a group of individuals with

a common focus (either an occupation, academic

field, or social doctrine) which defines the

expectations and directs the actions of the group, and

is a persistent reminder of moral and ethical

responsibilities.

Select references:

1. Federal Experts Security Advisory Panel working group’s training materials on

strengthening the culture of biosafety, biosecurity, and responsible conduct,

American Biosafety Association (ABSA) website.

2. Dual Use Research of Concern (DURC) information, policies, and training

materials

3. Enhancing Responsible Science: Development of Codes of Conduct for Dual Use

Research, National Science Advisory Board for Biosecurity 2010.

4. Guidance for Enhancing Personnel Reliability and Strengthening the Culture of

Responsibility, National Science Advisory Board for Biosecurity 2011.

5. Responsible life sciences research for global health security: a guidance

document, World Health Organization, 2010.

6. Ethics: A Weapon to Counter Bioterrorism, Margaret A. Somerville and Ronald

M. Atlas, Science, Vol 307, Issue 5717, 1881-1882, 25 March 2005.

7. Code of ethics, American Society of Microbiology (ASM), 2005.

8. Gain-of-Function Research: Ethical Analysis, Michael J Selgelid, 2016, Sci Eng

Ethics. 2016; 22(4): 923–964.

https://www.absa.org/ttMiscHandoutsPosters.html




http://osp.od.nih.gov/sites/default/files/resources/COMBINED_Codes_PDFs.pdf

http://osp.od.nih.gov/sites/default/files/resources/COMBINED_Codes_PDFs.pdf





http://www.ieb-eib.org/en/pdf/somervilleetude-somerville-ethics-a-weapon-to-cou.pdf

http://www.asm.org/ccLibraryFiles/FILENAME/000000001596/ASMCodeofEthics05.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4996883/

3

9. New Directions: The Ethics of Synthetic Biology and Emerging Technologies,

Presidential Commission for the Study of Bioethical Issues, 2010.

10. Competency Guidelines for Public Health Laboratory Professionals, CDC and the

Association of Public Health Laboratories, MMWR Supplements

May 15, 2015 / 64(01);1-81.

11. Guidelines for Safe Work Practices in Human and Animal Medical Diagnostic

Laboratories, Recommendations of a CDC-convened, Biosafety Blue Ribbon

Panel, 2012.

12. Guidelines for Biosafety Laboratory Competencies (Culture of Safety), CDC and

the Association of Public Health Laboratories, 2011.

These guiding principles were developed by the Federal Experts Security Advisory Panel

(FESAP) Working Group established to implement FESAP recommendation to

strengthen the culture of biosafety, biosecurity, and responsible conduct in the life

sciences, with support from experts from professional organizations and academia. For

more information, contact the working group co-chairs Dana Perkins

[email protected] and Eilyn Fabregas [email protected].

http://bioethics.gov/sites/default/files/PCSBI-Synthetic-Biology-Report-12.16.10_0.pdf

http://www.cdc.gov/mmwr/preview/mmwrhtml/su6401a1.htm

http://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm?s_cid=su6101a1_w

http://www.cdc.gov/mmwr/preview/mmwrhtml/su6101a1.htm?s_cid=su6101a1_w


mailto:[email protected]


1

Laboratory Quality Management Training:

Guiding Principles to Promote a Culture of Biosafety, Biosecurity, and

Responsible Conduct in the Life Sciences

An organizational culture of biosafety, biosecurity, and responsible conduct in the life

sciences fosters quality activities that aim to develop new treatments and therapeutics,

strengthen health research systems, and promote public, animal, and environmental

health surveillance and response activities. These elements are essential to protecting and

improving health security and wellness of people, animals, and the environment.

Quality Management System:

Coordinated activities (including

policies, processes, and procedures) on

all aspects of a laboratory operation

(including organization, personnel, and

equipment) to direct and control the

quality of research and results which are

accurate, reliable, and timely.

Culture of Biosafety, Biosecurity, and

Responsible Conduct: An assembly of beliefs,

attitudes, and patterns of behavior of individuals

and organizations that can support, complement or

enhance operating procedures, rules, and practices

as well as professional standards and ethics

designed to prevent the loss, theft, misuse, and

diversion of biological agents, related materials,

technology or equipment, and the unintentional or

intentional exposure to (or release of) biological

agents.

Laboratories working with biological agents and toxins operate under rigorous

regulations and requirements to provide the appropriate levels of protection for public

and agricultural health through personnel training on biosafety and biosecurity, bioethics,

occupational health, and quality management. Such training is designed to meet quality

and regulatory objectives and to provide individuals with the knowledge, skills, and

abilities necessary to be competent in their assigned duties and responsibilities. The

training should also emphasize the need to exercise a general duty of care to protect the

health and safety of individuals as well as the

environment.

Laboratory incidents may lead to significant costs in

time, personnel efforts, and patient outcomes as well

as potential risks to the heath security of individuals,

communities, animals, plants, and the environment. A

vigorous quality management system does not

guarantee an incident-free organization but it can

rapidly identify issues when they occur and help

prevent them from reoccurring.

Strengthening an organizational culture of biosafety, biosecurity, and responsible conduct

in the life sciences is an intrinsic part of a quality management system and it implies

devoting training resources and consideration to: management systems (organization and

leadership); leadership and personnel behavior; principles for guiding decisions and

behavior; and beliefs and attitudes on biosafety, biosecurity and responsible conduct of

research.

Performing assigned duties and

responsibilities in a safe, secure, and

responsible manner is a core competency

and must be emphasized during the

competency assessment (which affirms that

training is effective and personnel

competently apply knowledge, skills, and

abilities to meet the standards of their

professional practice).

2

The organizational culture of biosafety, biosecurity, and responsible conduct in the life

sciences may be addressed as part of the safety and security training component of

laboratory quality management systems while taking into account that laboratory training

and competency assessment approaches will vary with local context, including

requirements (organizational, regulatory, accreditation), quality management systems,

path of workflow processes and procedures, and composition of personnel.

Select references:

1. Federal Experts Security Advisory Panel working group training materials on

strengthening the culture of biosafety, biosecurity, and responsible conduct,

American Biosafety Association (ABSA) website.

2. Responsible life sciences research for global health security: a guidance

document, World Health Organization, 2010.

3. Competency Guidelines for Public Health Laboratory Professionals, CDC and the

Association of Public Health Laboratories, MMWR Supplements May 15, 2015:

64(01);1-81.

4. Guidelines for Biosafety Laboratory Competency, CDC and the Association of

Public Health Laboratories MMWR Supplements April 15, 2011 / 60(02);1-6.

5. WHO Laboratory Quality Management System Training Toolkit.

6. Laboratory Accreditation or ISO 9001 Certification?, International Laboratory

Accreditation Cooperation.

These guiding principles were developed by the Federal Experts Security Advisory Panel

(FESAP) Working Group established to implement FESAP recommendation to

strengthen the culture of biosafety, biosecurity, and responsible conduct in the life

sciences, with support from experts from professional organizations and academia. For

more information, contact the working group co-chairs Dana Perkins

[email protected] and Eilyn Fabregas [email protected].






https://www.cdc.gov/mmwr/preview/mmwrhtml/su6002a1.htm

http://www.who.int/ihr/training/laboratory_quality/doc/en/

https://www.a2la.org/ilac/laboratory_accred_or_cert.PDF

