Embedded Files
of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) Agriculture Select Agent Services. In addition, the National Institutes of Health (NIH) conducts oversight and provides guidelines for pathogens that contain recombinant or synthetic nucleic 3 For the purpose of this report, incidents involving incomplete inactivation include incidents in which researchers had intended to inactivate samples before removing them from containment but failed to do so due to an issue with the inactivation method, a mix-up of samples, or another unforeseen event. 4 Laboratories that handle pathogens are classified into four biological safety levels (BSL) based on the risk imposed by the pathogens. Laboratories classified as BSL-1 or 2 are suitable for work involving pathogens that pose minimal to moderate hazard to laboratory personnel and the environment whereas high-containment laboratories—BSL-3 and 4 for the purpose of this report—are designed with additional safety measures to protect those working with dangerous pathogens that may cause serious and potentially lethal infection. Each level of containment describes the laboratory practices, safety equipment, and facility safeguards for the level of risk associated with handling particular pathogens. BSL3 laboratories work with indigenous or exotic pathogens with known potential for airborne transmission or those pathogens that may cause serious and potentially lethal infections. BSL-4 laboratories work with exotic pathogens that pose a high individual risk of lifethreatening disease by airborne transmission and for which treatment may not be available. 5 As of August 2016, 65 select agents or toxins have been determined to have the potential to pose a severe threat to human, animal, or plant health and safety, or to animal or plant products. For the purpose of this report, the term “select agents” encompasses both select agents and toxins and the term “nonviable” refers to the rendering of select agents nonviable and toxins nonfunctional. Page 3 GAO-16-642 Inactivation of Pathogens acid molecules.6 For the purpose of this report, “recombinant pathogens” refers to pathogens that contain molecules that are constructed by joining different nucleic acid molecules together (recombinant) or completely new nucleic acid molecules (synthetic). Researchers routinely generate pathogens containing recombinant or synthetic nucleic acid molecules for a variety of purposes, including the creation of vaccines using recombinant material. A number of concerns have been raised in recent years surrounding the biological safety and security of pathogens in high-containment laboratories. For example, we previously reported on steps the CDC and other agencies have taken to address issues identified by reviews of past safety incidents.7 Additionally, we reported on issues related to oversight of high-containment laboratories, finding that laboratories that do not work with select agents are subject to limited federal oversight and that existing oversight of high-containment laboratories is duplicative, fragmented, and relies on self-policing.8 We have also reported on issues associated with the proliferation of high-containment laboratories in the United States, 6 Department of Health and Human Services, National Institutes of Health, NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Bethesda, Md.: April 2016). NIH defines recombinant or synthetic nucleic acid molecules as either (1) molecules that are constructed by joining nucleic acid molecules and can replicate in a living cell, or (2) nucleic acid molecules that are synthesized chemically or by other means. 7 See, for example, GAO, High-Containment Laboratories: Comprehensive and Up-to-Date Policies and Stronger Oversight Mechanisms Needed to Improve Safety, GAO-16-305 (Washington, D.C.: Mar. 21, 2016), High-Containment Laboratories: Preliminary Observations on Federal Efforts to Address Weaknesses Exposed by Recent Safety Lapses, GAO-15-792T (Washington, D.C.: July 28, 2015), and High-Containment Laboratories: Recent Incidents of Biosafety Lapses, GAO-14-785T (Washington, D.C.: July 16, 2014). 8 GAO, Overlap and Duplication: Federal Inspections of Entities Registered with the Select Agent Program, GAO-13-154 (Washington, D.C.: Jan. 31, 2013); High-Containment Laboratories: National Strategy for Oversight is Needed, GAO-09-574 (Washington, D.C.: Sept. 21, 2009); and High-Containment Biosafety Laboratories: Preliminary Observations on the Oversight of the Proliferation of BSL-3 and BSL-4 Laboratories in the United States, GAO-08-108T (Washington, D.C.: Oct. 4, 2007). In October 2015, a White House report highlighted the need for a transparent U.S. laboratory system. If carried out, recommendations made in that report may, in part, effectively implement some of our past recommendations related to the oversight of high-containment laboratories. We did not examine the status of efforts to implement the White House’s recommendations in this review. The White House, Next Steps to Enhance Biosafety and Biosecurity in the United States (Washington, D.C.: Oct. 29, 2015). Page 4 GAO-16-642 Inactivation of Pathogens including risks posed by past biological safety incidents.9 We have made numerous recommendations, including recommending in 2016 that agencies update
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