Biosecurity and Research: Minimizing Adverse Impacts

摘要

Securing pathogens and toxins at research and diagnostic laboratories cannot prevent bioterrorism but can make it more difficult for potential terrorists to divert material from a legitimate facility so as to build a biological weapon (BW). The biological community would be negligent to forgo measures that reasonably protect those pathogens and toxins that would cause the greatest consequences for society if used as weapons. The question is how best to apply biosecurity without impeding biomedical and bioscience research. The current U.S. regulatory environment is based on the USA PATRIOT Act and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which aim to improve the protection of "select" agents and toxins. Three Codes of Federal Regulations (42 CFR 73, 7 CFR 331, and 9 CFR 121, or collectively "CFR") establish lists of agents and toxins that pose a threat to humans, animals, or plants. They require any laboratory that possesses one of these agents or toxins to enforce and adhere to specific security measures. These security requirements can seem daunting: facility registration, designation of a responsible official; risk assessments for individuals with access to the listed agents; biosecurity plans; agent transfer rules; safety and security training and inspections; notification after theft, loss, or release of a listed agent; record maintenance; and restrictions on some types of experiments. The CFR also leave room for wide interpretation, as was evident in discussions of variations in the inspection process at a recent symposium on biosafety and biosecurity.