WASHINGTON — The most effective way to prevent the deliberate misuse of biological select agents and toxins (BSATs) — agents housed in laboratories across the U.S. considered to potentially pose a threat to human health — is to instill a culture of trust and responsibility in the laboratory, says a new report from the National Research Council. Focusing on the laboratory environment will be critical for identifying and reducing concerns about facilities or personnel.
Mechanisms for fostering a safe and secure laboratory environment include engaged management, risk-based security measures, and appropriate monitoring and management of personnel, as well as training for all researchers in scientific ethics and understanding “dual-use” research that could be misused. Other methods of screening and oversight are incomplete without including the laboratory community in minimizing potential security risks, the report says. Policies and procedures that make select agent research more difficult to conduct, as opposed to more secure, diminish overall security rather than strengthen it.
Individuals cleared for access to select agents and toxins are certified for five years. Many changes can occur during this time, however, including those that impact whether an individual poses a security risk. Therefore, efforts to ensure reliable personnel should come from within the laboratories, the report says, through increased engagement and monitoring by managers and staff. The goal should be that individuals watch out for each other and take responsibility for their own performance and that of others. In a laboratory context, some security measures can also improve safety, if there is involvement of researchers in the process.
BSAT research is presently defined by a list of more than 80 select agents and toxins, developed and jointly regulated by the Centers for Disease Control and Prevention (CDC) and the Animal and Plant Health Inspection Service (APHIS). According to the committee that wrote the report, the list should be ordered based on the potential of an agent to be used as a biothreat, and a graded series of security procedures should be applied so that the greatest resources and scrutiny go to securing agents that pose maximum risk.
Personnel issues are often the most controversial and difficult aspects of maintaining security for BSATs. Security programs can be generally divided into two categories: screening individuals to determine whether they are eligible for access, and monitoring the behavior and performance of employees working with these agents. The current Security Risk Assessment screening process, which relies on screening more than 20 criminal, immigration, and terrorist databases to identify disqualifying behavior or activities, is appropriate, the report says. However, a change that should be considered is expanding the appeal process beyond a simple determination of factual errors to include the opportunity to consider circumstances surrounding otherwise disqualifying factors, such as the length of time since an offense occurred. Currently, any discovery of disqualifying factors or behaviors automatically and permanently denies an individual’s access.
Improved communication is needed among those funding research on select agents, those administering the Select Agent Program, and those conducting the research, the report says. An advisory committee with members drawn from research institutions and the private sector should be established to provide continued engagement of stakeholders. Representatives from federal agencies would serve in an EX OFFICIO capacity. Rigorous and continuing evaluation of the Select Agent Program is needed to ensure that it is running efficiently and also to consider any intended and unintended consequences of operation.
The committee concludes that, because biological select agents can replicate, an undue reliance on accounting techniques, such as counting vials, to monitor whether a biological agent has been removed from a laboratory offers a false sense of security and is counterproductive. Instead, accountability is best achieved by controlling access to archived stocks and working materials and recording which agents are present, where they are stored, who has access to them, when that access is available, their intended use, and where they are transported, if moved to another off-site location.
Physical security is required of all facilities housing select agents, with broad regulatory guidance provided by CDC and APHIS. The variation in implementing these requirements and regulations can lead to inconsistencies and confusion as facility operators, contractors, and inspectors attempt to determine whether a facility has met the necessary security guidelines. The report calls upon the Select Agent Program to define minimum physical security requirements to assist facilities in meeting their regulatory obligations. The report also recommends laboratory inspectors have scientific and laboratory knowledge and experience, as well as appropriate training specific to BSAT research and that the inspections should be harmonized across agencies. Due to the considerable security and compliance costs involved in working with select agents, a separate category of federal funding should be made available to ensure that facilities always operate with appropriate security measures in place.
This study was sponsored by the National Institutes of Health. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies. They are independent, nonprofit institutions that provide science, technology, and health policy advice under an 1863 congressional charter. Committee members, who serve pro bono as volunteers, are chosen by the Academies for each study based on their expertise and experience and must satisfy the Academies’ conflict-of-interest standards. The resulting consensus reports undergo external peer review before completion. A committee roster follows.
Copies of RESPONSIBLE RESEARCH WITH BIOLOGICAL SELECT AGENTS AND TOXINS are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at HTTP://WWW.NAP.EDU. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
[ This news release and report are available at HTTP://NATIONAL-ACADEMIES.ORG ]
NATIONAL RESEARCH COUNCIL
Division on Earth and Life Studies
Board on Life Sciences
COMMITTEE ON LABORATORY SECURITY AND PERSONNEL RELIABILITY ASSURANCE SYSTEMS FOR
LABORATORIES CONDUCTING RESEARCH ON BIOLOGICAL SELECT AGENTS AND TOXINS
RITA R. COLWELL*(CHAIR)
President and CEO
CosmosID, Inc.; and
Distinguished University Professor
University of Maryland
College Park, and
Distinguished University Professor
Bloomberg School of Public Health
Johns Hopkins University
RONALD M. ATLAS
Professor of Biology and Public Health, and
Center for Health Hazards Preparedness
University of Louisville
JOHN D. CLEMENTS
Professor and Chair of Microbiology and Immunology, and
Center for Infectious Diseases
JOSEPH A. DIZINNO
Homeland Security and Law Enforcement
Professor of Microbiology, and
Fischberg Chair and Professor
Department of Medicine, and
Global Health and Emerging Pathogens Institute
Mount Sinai School of Medicine
New York City
MICHAEL G. GELLES
Deloitte Consulting LLP
ROBERT J. HAWLEY
Senior Adviser of Science
Midwest Research Institute
Executive Managing Director
The Podesta Group
TODD R. LA PORTE
Professor Emeritus of Political Sciences
Department of Political Science
University of California
Director of Laboratory Design
Merrick and Co., and
Merrick Canada ULC
STEPHEN S. MORSE
Professor of Clinical Epidemiology, and
Center for Public Health Preparedness
Mailman School of Public Health
New York City
KATHRYN E. NEWCOMER
Professor and Director
Trachtenberg School of Public Policy and Public Administration, and
Midge Smith Center for Evaluation Effectiveness
George Washington University
ELIZABETH RINDSKOPF PARKER
McGeorge School of Law
University of the Pacific
PAUL R. SACKETT
Beverly and Richard Fink Distinguished Professor of Psychology and Liberal Arts
Department of Psychology
University of Minnesota
ADAM P. FAGEN
JO L. HUSBANDS
Senior Project Director
* Member, National Academy of Sciences