Seven Opportunities for Effective Biosafety and Biosecurity Governance

Introduction

The political climate in the United States is hyperfocused on how to address biosafety and biosecurity concerns stemming from the COVID-19 pandemic. Issues that provoked particular animosity were the requirement for wearing masks in public, the closing of private and public institutions, stay-at-home orders, vaccine mandates, and the origins of the virus. While these issues are important, we believe there are other gaps that deserve attention to improve biosafety and biosecurity in all laboratories across all sectors.

Together, we work at 4 very different institutions: public and private, large and small, medical and nonmedical, well-funded and less well-funded. As professionals, we have varying types and levels of expertise, with 2 of us having an extensive background in implementing safeguards for research involving enhanced potential pandemic pathogens. ¹ All of us have experience with implementing various US government biosafety and biosecurity policies, such as those focused on research with recombinant and synthetic nucleic acid molecules and biological dual use research of concern.^2,3 Each of us also has experience working with federal biosafety and biosecurity regulations, including the Federal Select Agent Program's US select agent regulations ⁴ and the US Occupational Safety and Health Administration's bloodborne pathogen standard. ⁵

As professionals with nearly 100 years of combined experience working in the biosafety and biosecurity industries, as biosafety officers, microbiology and virology laboratorians, public health experts, and elected officers of an international biosafety organization, we believe there is an opportunity to improve the quality and effectiveness of current biosafety and biosecurity governance mechanisms in the United States. In this commentary, we propose 7 areas where new legislation, regulation, guidelines, and standards could impact policy conversations taking place in government deliberations: (1) a single, transparent biological incident reporting system; (2) design and construction requirements for high-containment laboratories; (3) mandated licenses for life sciences entities; (4) institutional biosafety committee oversight of high-containment laboratories; (5) minimum education and training requirements for personnel in high-containment laboratories; (6) personnel suitability requirements for high-containment laboratories; and (7) standards of competency for biosafety and biosecurity practitioners. By focusing on these 7 strategies, the policymaking community could help mitigate risks to life sciences research and take proactive steps toward addressing significant challenges to biosafety and biosecurity.

We argue that now is an opportune time to advocate for biosafety and biosecurity practitioners to be part of the policy development life cycle. These individuals are uniquely positioned to inform policymakers about issues facing the life sciences community, and they can assist in the rollout and adoption of new requirements.

As background, biosafety and biosecurity practitioners are professionals who protect the welfare of humans, animals, plants, and the environment from possible harm from biological hazards. Historically, these practitioners have had limited representation, if any, in biosafety and biosecurity policy discussions. Instead, they operate within the policy implementation phase of governance. Because of their unique experience in understanding the challenges and opportunities in the life sciences enterprise, there is a critical need to include these practitioners in the policy creation life cycle, from agenda setting to interpretation to implementation and continuous reevaluation. By including them in the policy development process, there is an opportunity to get ahead of the myriad issues facing biosafety and biosecurity practitioners.

1. A Single, Transparent Biological Incident Reporting System

Biological incident reporting is fragmented and only required in certain circumstances, such as needlesticks in a workplace, potential exposures to recombinant or synthetic nucleic acids, or incidents involving a biological select agent or toxin.^2,4,5 Institutions have different processes for responding, handling, and reporting biological incidents (eg, accidents, releases, theft, loss of an agent). Except in rare circumstances (eg, when required by regulation), these incidents can be shielded from public view. Fears that the COVID-19 pandemic emerged from a high-containment laboratory have raised community right-to-know questions about consequential incidents that occur in laboratories. However, when considering the total amount of time personnel spend working in the numerous types of biological laboratories (eg, research, clinical, diagnostic), the overall occurrence of incidents is rare. Of those incidents, most do not result in a potential exposure or release. However, there are exceptions, as noted in the American Biological Safety Association's international laboratory acquired infection database, which compiles and analyzes known, published incidents.^6,7 With biological research, all incidents could be perceived as dangerous, but in actuality, there are multiple layers of protection to mitigate hazards and minimize the risks.

The concept of a voluntary, anonymous, no fault biological incident reporting system is not new. ⁸ We argue that to improve safety, increase transparency, and better understand the frequency of incidents and their impacts, as well as ways to prevent recurrence, such an incident reporting system is essential to improving biosafety and biosecurity in the United States. To encourage reporting, we strongly recommend that the data should be secure and not subjected to state and federal Sunshine Laws ⁹ and Freedom of Information Act ¹⁰ requests. A clear definition of what is reportable is also critical for the integrity of the reporting process.

By exploring the reporting mechanisms of other industries, such as healthcare, aviation, and nuclear energy,^11-13 we believe it is possible to protect individuals and institutions from reputational and legal harms while also providing a real-time system to collect and report biological incident data. The system should be seated at the federal level with autonomous oversight responsibility to streamline existing requirements to report incidents to the US National Institutes of Health, Centers for Disease Control and Prevention, and other government or state agencies to reduce the regulatory and administrative burden for reporting. To encourage buy-in and protect institution-specific sensitive information, the name of the entity and the people involved should not be included in any public-facing websites or databases.

The advantages of developing such a system could include improved trend analysis, simplified sharing of best practices, and minimization of future adverse incidents. Also, by examining the totality of incident data, a denominator would help determine the safety and risk of specific experiments. Disadvantages include negative publicity from misrepresentation of an incident, release of sensitive personal identifiable information, and false entries into the system. Challenges include finding a funding source and identifying capabilities to set up the integrated infrastructure and systems to collect, analyze, report the data, and manage and enforce compliance. The agency that houses the system should be a nonresearch agency to avoid possible conflicts of interest and include a diverse mix of expertise and experience in managing biological incidents.

2. Design and Construction Requirements for High-Containment Laboratories

With the publication of experiments that increased the transmissibility of airborne pathogens,^14,15 ongoing debates about the origins of SARS-CoV-2,^16,17 and growing public distrust of scientists, ¹⁸ there is a push for increased oversight of high-containment laboratories, commonly referred to as biosafety level 3 (BSL-3) and biosafety level 4 (BSL-4) laboratories.^19,20

BSL-3 and BSL-4 laboratories have special engineering and design features to increase safety and security. Yet, high-containment laboratories are not required to adhere to baseline design and construction standards unless they receive funding from the National Institutes of Health to build the laboratory. ²¹ The Department of Health and Human Services' Biosafety in Microbiological and Biomedical Laboratories manual does provide best practices for administrative and engineering controls ²² ; however, it is incumbent upon each entity to adhere to the recommended best practices.

Due to the risks posed by the biological agents being used and the activities being conducted within high-containment laboratories, it is prudent to have verified, commissioned laboratories that achieve minimal baseline standards to ensure the protection of workers, the community, and the environment. In addition, there needs to be published, standardized guidance on how to operate and maintain high-containment laboratories.

The advantages of these standards include having infrastructure and systems that are designed and built to prevent possible releases of agents that could cause serious or lethal disease. The disadvantages include increased costs, extended timelines to build facilities, and potential bureaucracy over the interpretation of standards.

3. Mandated Licenses for Life Sciences Entities

The recent discovery of an unknown Chinese biological laboratory in California has raised concerns that self-governance of the life sciences is insufficient. The fear is that it may be possible to conduct pathogenic experiments in any community without the knowledge of neighbors, local officials, or regulators. The discovery has ignited calls to action for entities conducting life sciences experiments to register and be licensed with the government. ²³

One approach to managing all biological laboratories could be similar to how organizations using chemicals must adhere to the Emergency Planning and Community Right-to-Know Act.^24,25 This law requires organizations using certain substances to submit hazardous chemical inventory reports on an annual basis. A license for life sciences entities could include the name and address of the organization, emergency point of contact and other administrative details, as well as the different types of biosafety laboratories and categories of biohazards present at the entity.

Outside of those laboratories registered with the Federal Select Agent Program, ⁴ only a few jurisdictions have enacted regulations to oversee biological laboratories. Some local municipalities, such as the Cambridge Biosafety Committee and the Boston Biological Safety Program in Massachusetts, review biological research regardless of the funding source. ²⁶ A similar registration process has also been established in Canada. ²⁷

An advantage of requiring entity licenses for life science laboratories is the ability to track and understand where biological experiments are taking place for public awareness and accountability. Disadvantages include the complexity of setting up the oversight structure and compliance enforcement, especially with the rise of do-it-yourself home biology in garages and kitchens. The license would not prevent bad actors from setting up laboratories, but it would make it harder to do so openly, with penalties for noncompliance.

4. Institutional Biosafety Committee Oversight of High-Containment Laboratories

Only federally funded institutions that conduct recombinant or synthetic nucleic acid research are required to have an institutional biosafety committee; privately funded institutions do not have to comply. ²⁸ Similarly, experiments with wild-type pathogens do not require review by an institutional biosafety committee, although some committees also review pathogen research. A dedicated biosafety officer is required only in certain circumstances, such as when research involves recombinant or synthetic nucleic acid molecules in BSL-3 and BSL-4 laboratories. Therefore, regulatory oversight is needed to ensure that organizations conducting activities in high-containment laboratories have the required institutional biosafety committee with representation from at least 2 community members.

It is neither fair nor appropriate to have an environment where some institutions are required to comply with the rules, whereas others (often conducting similar activities) are not. Leveling the playing field is essential in helping to ensure that experiments with risky pathogens adhere to the same level of review and oversight at all institutions. Having a universal requirement for a local oversight body could help prevent future laboratory acquired infections, biological incidents, and potential releases.

The advantages of requiring institutional biosafety committee oversight for all high-containment laboratories means there would be a minimal level of review and approval at the local level. It could also help alleviate concerns from members of the public that risky research is being performed in their backyards without oversight or input from the local community. The disadvantages include additional bureaucracy for organizations that are currently not required to have institutional biosafety committees and the need to learn how to organize and operate them. Another disadvantage is the potential release of sensitive information through Freedom of Information Act requests.

5. Minimum Education and Training Requirements for Personnel in High-Containment Laboratories

In BSL-3 and BSL-4 laboratories, people work with indigenous or exotic agents that can cause serious or lethal disease. Personnel working in these spaces must receive specific training in how to handle extremely dangerous pathogens and be supervised by scientists competent in handling infectious agents. The amount and frequency of education and training varies from institution to institution. However, it is our collective experience that individuals working in these laboratories are highly trained and care about the health of themselves and their families, friends, and communities.

Because there is not a minimum standard to assess and determine the proficiency of personnel in these spaces, guidance is needed. There needs to be a system in place to ensure that people working in high-containment laboratories are well trained, fully understand the risks associated with their work, and know how to manage and report incidents. Any new requirements must also recognize the need to train students and future workers to ensure that a baseline standard of knowledge and expertise is achieved.

The advantages of having minimum education and training requirements for personnel in high-containment laboratories is that it will instill confidence and trust that the people working in BSL-3 and BSL-4 facilities are highly qualified. Disadvantages include trying to adopt and enforce new rules for an entire workforce already working in vastly different research operations.

6. Personnel Suitability Requirements for High-Containment Laboratories

An additional area that deserves attention in high-containment laboratories is personnel suitability. The aim of personnel suitability is to keep pathogens away from those who might intend to misuse them. This is often described as trying to prevent insider threats as well as threats from beyond the laboratory. ²⁹ Personnel suitability programs vary by institution but can include previous employment verification, education and reference checks, financial and credit reviews, fingerprint and criminal conviction history, drug screening, psychological testing, and polygraph exams. ³⁰

We acknowledge that personnel suitability programs have challenges. For example, one of the difficulties in implementing personnel suitability programs is that bias is often implicit in the review process. There are also longstanding views about academic, personal, and professional freedom, especially at colleges and universities that have high-containment laboratories. Therefore, we recommended a multipronged, layered approach to help assess the risk of an individual. It is essential that suitability programs are administered as fairly and equitably as possible and that results are evaluated through a lens acknowledging the data may be biased, inaccurate, and incomplete. As part of a personnel suitability program, it is beneficial to implement systems for self- and peer-reporting concerns and to encourage individuals to opt out when necessary.

Although there are challenges to implementing personnel suitability programs, it is important to introduce the concept of personnel suitability in all high-containment laboratories where such programs do not already exist. The goal should be to raise awareness while simultaneously aiming to prevent potential misuse of biological materials from these laboratories.

The advantages of requiring personnel suitability for high-containment laboratories include having a baseline to attempt to identify potential risks of individuals working with dangerous biological material. Disadvantages include perceptions of bias, discrimination, retaliation, increased cost, and several other issues that are inherent in trying to assess a person's reliability and trustworthiness.

7. Standards of Competency for Biosafety and Biosecurity Practitioners

The concept of what it means to be a biosafety or biosecurity practitioner is not well defined. The roles and responsibilities of these individuals have evolved over the past several decades, often after a new biosafety and biosecurity regulation, policy, or guideline is introduced. The methodology for how someone becomes proficient in biosafety and biosecurity is often through education, training, and on-the-job learning. ³¹

There is no single path or educational degree program for someone to become a biosafety and biosecurity practitioner. Expanding the number of institutions conducting life sciences research and expanding the breadth of research activities creates a need to sustain a talent pool of highly qualified biosafety professionals. Now is an ideal time to reevaluate core competencies for biosafety and biosecurity practitioners.

The advantages of establishing minimum standards of competency for biosafety and biosecurity practitioners include creating a workforce with the same foundation to be able to understand the complexities of modern life sciences research and make difficult risk-based decisions about the safety and security of those experiments. Challenges include the potential costs of obtaining and maintaining core competencies, figuring out who should formalize the criteria for the competencies, and ensuring that the existing workforce achieves the requisite experience. Therefore, regulations aimed at addressing core competencies should address institutional support for biosafety and biosecurity practitioners.

Conclusion

We identify 7 possible areas to enhance and harmonize biosafety and biosecurity in the United States. The implementation of these recommendations could be achieved through legislation under new or existing statutes, administrative action through federal agencies under existing authority, executive orders, or funding requirements. We acknowledge that adding layers of security to a system or process will, almost without exception, lead to additional burden. From our vantage point as experts in the biosafety and biosecurity field, we believe it is important to consider possible avenues for efficient oversight. As discussed in this article, it is our intent to provide informed guidance to the policymaking community.

We recognize that many of these recommendations may be unpopular with others in our own profession, and we foresee possible pushback from scientists against these suggestions. Therefore, we have provided both advantages and disadvantages for each proposed strategy and we welcome additional discussion on these topics. We also acknowledge that these proposed strategies could place additional burdens on the biosafety and biosecurity community. Our stance is that in order to have more standardized yet adaptable protection against accidental or deliberate misuse, it is better to be proactive and create sensible biosafety and biosecurity measures instead of waiting for draconian and ineffective measures to be placed upon researchers, institutions, and compliance personnel. ³²

It is our sincerest hope that with the creation of any future biosafety and biosecurity governance mechanism, legislators and policymakers will consider these recommendations to address current safety and security concerns associated with high-containment laboratories.