Executive Summary

The revelation in 2007 of an initially unreported incident from 2006 at Texas A&M University, in which a laboratory researcher was accidentally infected with Brucella, a pathogen that infects both humans and animals, and which was formerly weaponized by the Soviet Union, spurred a series of inquiries by Congress and the Executive Branch.  Their focus was on the safety regulations and physical security of high-containment laboratories working on select agents (pathogens and toxins itemized by the U.S. Departments of Health and Human Services (HHS) and Agriculture (USDA) that pose significant risks to human, animal, and/or plant health organizations (42 CFR 73)). By February 2009, 336 entities were registered with the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS) to work with select agents, and 14,612 laboratory researchers and support staff were registered to work with these agents. Along with the expansion of biodefense research on select agents and high-containment laboratories to accommodate that research came increased concern about pathogen security and laboratory safety. To address this concern, HHS established  the Trans-Federal Task Force on Optimizing Biosafety and Biocontainment Oversight to consider oversight of research conducted in high-containment laboratories, including but not limited to certification and training of scientists and appropriate non-scientists on biosafety. In 2008, the Commission on the Prevention for WMD Proliferation and Terrorism recommended in its report, World at Risk, that biosafety training for all life scientists should be mandatory. With the allegation against Bruce Ivins, a researcher at the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the U.S. government became concerned about the "insider threat" and vetting personnel seeking access to select agents, termed "personnel reliability." In January 2009, President George W. Bush issued an Executive Order (EO 13486), which called for an interagency review of laboratory biosecurity, including personnel reliability. Biosafety training is a cornerstone to preparing anyone entering a high-containment laboratory, and biosafety professionals generally act as gate-keepers to those laboratories.

Two units of AAAS—the Center for Science, Technology and Security Policy and the Program on Scientific Freedom, Responsibility and Law – have conducted a study of existing biosafety training programs. The goals of this study were:

• to document and describe existing educational programs and materials on biosafety training programs (information provided by course instructors);
• to provide recommendations for developing an educational program on biosafety; and
• to highlight major challenges in developing and implementing educational initiatives on biosafety and access to high-containment laboratories.

To address these goals, we convened a group of experts in biosafety, the life sciences, biosecurity, and relevant stakeholders (e.g., architects and engineers), on March 17, 2009 at AAAS to review biosafety training programs and to provide recommendations on how best to design and implement similar programs. With the help of workshop participants, we identified twenty biosafety training programs.

This workshop is one of four workshops on biosecurity education; the first workshop, held on November 21, 2008, addressed education on dual use research for scientists, and the next two workshops will address public health preparedness and biodefense policy.

Workshop Summary

At the workshop, participants discussed similarities and differences in infrastructure, oversight and personnel training between biosafety level 3 (BSL-3) and biosafety level 4 (BSL-4) laboratories. There was clear consensus among the participants that hands-on proficiency training, mentorship, and didactic training are critical for establishing and evaluating the researcher's ability to work in a high-containment laboratory; a variety of individuals, from researchers to administrators and support staff to equipment service personnel, require some level of training before gaining access to high-containment laboratories; biosafety training programs have to be flexible to account for the research (one size does not fit all), model systems, facilities, and job function; and the average cost of personnel training varies from $4000-$7000 for researchers to hundreds of dollars to $4000 for training non-scientists, like administrators. There were differing views on the validity of programs on personnel reliability and the need for additional high-containment facilities.  In addition, participants noted that there is a wide variation of appropriate levels of protective equipment depending on the risks of the research conducted.

Workshop participants identified several gaps and challenges in designing and implementing biosafety training programs and building trust between the scientific community and the public (including policymakers):

• There is a need to conduct applied biosafety research, which includes efficacy of personal protective equipment and determining the actual risk to the researcher and environment posed by working with a biological agent in modern biocontainment laboratories.
• There is a need to determine the total number hours worked in high-containment laboratories (the common denominator) to quantify the risks of research conducted in those laboratories to personnel and the surrounding community and environment.
• There is a need for databases of personnel information to help administrative staff track personnel training, potential exposures, and any health issues that may affect prevention or treatment against the agents being researched.
• There is a need for a national anonymous database, accessible by research institutions, to catalogue possible exposures and how they were handled.
• There is a shortage of knowledgeable and skilled facility and equipment operators and service professionals who can and are allowed to work in high-containment laboratories.
• There is a need to establish and sustain good training and confidential reporting of exposures for all laboratory safety levels, from BSL-1 to BSL-4 because all biosafety levels can contain hazards.
• There is a need for standardized, performance-based core competencies for training and evaluating the readiness of individuals before granting them access to a BSL-3 or BSL-4 laboratory
• There is a need to recognize that current employment and biosafety practices in academia, independent research institutes, and private industry may already address concerns over personnel reliability and that implementation of a personnel reliability program, as employed by USAMRIID or Lawrence Livermore National Laboratory, may be too costly for the non-governmental sector.
• There is a need for rational business plans and federal funding of indirect costs for operations and maintenance of high-containment facilities.

Recommendations

Based on the workshop discussion, we formulated several recommendations for the federal government, research institutions, and scientific organizations to address different aspects of biosafety training.

1. The U.S. government should allocate funds to research institutions for initial and ongoing biosafety training (potentially including topics of scientific integrity and biosecurity), applied biosafety research, and maintenance of high-containment laboratories. Research institutions receiving these funds would be held accountable for their use.
1. Additional funds need to be provided to maintain ongoing training of laboratory personnel.
2. High-containment facilities should develop a business plan and the U.S. government should provide funds for indirect costs for facility operations and maintenance.
3. Funds should be allocated to conduct applied biosafety research to understand better how to define biosafety training and protection standards as well as emergency procedures.

2. The biosafety community needs to create a national, anonymous database of exposures, including lessons learned, from which biosafety professionals and relevant administrative personnel can benefit.

3. When considering personnel reliability programs for non-governmental research institutions, the federal government should consider existing employment and biosafety training practices before granting access to high-containment laboratories, as they may already contribute to vetting of personnel.

A variety of audiences, from researchers to emergency response personnel, require some biosafety training before gaining access to high-containment laboratories. The training may be more rigorous for some, such as researchers, than others, such as administrators or the public. The following recommendations are framed with the acknowledgement that the training content requirements differ for personnel with different responsibilities but that anyone who might seek access to a BSL-3 or BSL-4 laboratory should be properly trained by knowledgeable trainers.

4. All BSL-3 and BSL-4 biosafety training programs should incorporate proficiency (i.e., competency-based) training and testing.

5. Senior scientists should continually mentor their laboratory personnel to work safely in high-containment laboratories by helping them improve their laboratory skills and be aware of current biosecurity and biosafety issues.

6. Research institutions should provide realistic information about the hazards that exist in the high-containment facility to emergency responders and appropriate members of their community to help guide their response(s) in an emergency.

7. Programs should include performance-based training standards developed from a set of core competencies that are critical for working in high-containment laboratories.  These standards should be included in the Biosafety for Microbiological and Biomedical Laboratories manual.  Standards will change over time given evolving political, health, and scientific environment and some information will be facility-specific.

8. Animal accreditation organizations in cooperation with scientific societies, the USDA, and HHS should develop content for large and small animal biosafety training.

9. The federal government should involve researchers and biosafety professionals in reviewing and improving biosafety standards.

10. Biosafety professionals should ensure that biosecurity issues along with biosafety concepts are addressed in training programs and incorporated into the conduct of hazardous research.

11. Recognizing that there is a need to keep some information confidential (e.g., proprietary information or security information), research institutions and the scientific community should openly communicate with the each other, their occupational health providers, policymakers, and the public about the safety and security features and procedures institutions employ to protect personnel, the surrounding community, and the environment against accidental exposure to any harmful biological agents housed in high-containment laboratories. Institutions should inform local and state public health departments of the biological agents being researched in the facilities.