IMPACT OF THE SELECT AGENT REGULATIONS ON THE SAFETY AND SECURITY OF BIOLOGICAL SELECT AGENTS AND TOXINS IN THE UNITED STATES

The use of chemical and biological warfare to terrorize individuals or opposing armies dates back to early civilization. After the 2001 Anthrax attacks, Congress significantly increased the oversight of biological select agents and toxins (BSAT) by passing the Select Agent Regulations (SARs). The SARs give the federal government the authority to specify conditions that must be met by all organizations to possess, use, and transfer BSAT lawfully. The SARs were developed to protect the public from inadvertent exposure to BSAT while ensuring the safe and appropriate use of these agents for research involving the development of diagnostic tests and medical countermeasures.The purpose of this study was to assess how the SARs have improved the safety of laboratorians and the security of BSAT in laboratories that work with BSAT. This question was answered through a quantitative analysis of the Federal Select Agent Program inspection departures from 2018-2020 and a qualitative analysis of a survey sent to registered entities. The results of the quantitative analysis of inspection departures determined that, although not statistically significant, from 2018-2020, the average number of inspection departures decreased over time for each entity type. Throughout the study period, the study showed a decrease in departures for all parts of the regulations. Over 75% of the departures from the study fall into the low severity category. Additionally, the entity’s risk score showed statistical significance when predicting the average number of departures. Several common themes were identified from the entity survey responses, highlighting the impact of the regulations: improved biosafety, security, training, and inventory control. 75% of respondents indicated they had the infrastructure required to support compliance; however, 85.4% indicated their entity experienced additional burdens beyond financial support, support from management, or too much responsibility placed upon one individual. Based on the entity’s responses, the SARs have improved the safety and security of BSAT, training, and other areas to protect the public. Based on the inspection departures and survey results, it was concluded that the SARs have improved the safety and security of BSAT through improved safety, security, training, and oversight at entities that work with BSAT.

INDEX WORDS: Select Agent Regulations (SARs), Biological Select Agents and Toxins (BSAT), inspections, biosafety, security