1.Legislative and Regulatory Changes
In 2018, Taiwan CDC completed editing, revision, and announcement of the “Guideline for Governing Management of Select Agents and Toxins”, “Guidance on the Inventory of Select Agents and Toxins”, “Security Guidance for Select Agent or Toxin Facilities”, “Guidance for Suitability Assessments”, “Drills and Exercise Guidance”, and “Select Agents or Toxins Biosafety/ Biocontainment Plan Guidance”. We also accomplished the amendment of the “Regulations Governing Management of Infectious Biological Materials” on January 31, 2019, categorizing select agents and toxins as a special section.
2.Biosafety Mechanism Registration
By December 2018, 502 entities reported biosafety management units to Taiwan CDC, of which 496 entities established biosafety committees and 6 entities designated a biosafety specialist staff. These included 20 government agencies, 153 medical institutions, 54 academic research institutions and 275 other groups.
3.Biosafety Inspections of High-Containment Laboratories
Since 2006, Taiwan CDC has routinely inspected BSL-3 and above laboratories to monitor operations and ensure safety. In 2009, TB-containment laboratories, which process culture manipulation for identification and drug-susceptibility tests, were added to inspections. In 2019, Taiwan CDC completed the annual routine laboratory biosafety and biosecurity inspecting of 22 high-containment laboratories (refers to Level 3 and Level 4 biosafety and animal biosafety laboratories.) and RG3 pathogens storage facilities. In addition, Taiwan CDC supervised the local government health bureaus to complete the laboratory inspecting of 75 BSL-2 microbiology laboratories of biotechnology industries. In order to strengthen biosafety and biosecurity of the entities that possess or use select agents and toxins, Taiwan CDC has counselled and visited the facilities of 7 entities in 2018.
4.Laboratory Biosafety Education and Training
In 2018, 4 e-learning courses on laboratory biosafety were recorded. Taiwan CDC also organized 3 biorisk management and 3 select agents and toxins training course sessions, with a total attendance of 429 laboratory workers. Taiwan CDC developed “Laboratory biosafety management information system” (ver. 2.0) which helps to conduct and oversee the condition of management of storage and transformation of infectious biological material. We held 10 operation training and 2 systematic data maintenance symposiums to help all entities getting familiar with the system, and 508 laboratory workers attended.
5.Laboratory Biorisk Management
In 2018, the bio-risk management system using CWA 15793 standard was introduced to 17 biotechnology-relatived microbiology laboratories. By focusing on continuous improvement and the Plan-Do-Check-Act (PDCA) cycle, this system will identify and monitor all aspects of laboratory biosafety and biosecurity.
Taiwan CDC has participated in the Global Health Security Agenda (GHSA) for several years and realized the international concern of Biological Select Agents and Toxins (BSAT). In 2016, we applied JEE Tool (Joint External Evaluation Tool) published by WHO to assess the epidemic prevention system of our nation which includes reviewing the level of BSAT management. For the JEE Tool, the highest score for each indicator is score 5-sustaninable. Taiwan was scored 3-developed capacity in BSAT management. As a result, by 2018, Taiwan CDC has improved the insufficiency of BSAT management and has made a great progress on it. We believe by the time of 2020, we will reach a higher score on BSAT management on JEE tool, to prove the nation’s ability of managing BSAT can be as well as other advanced countries.