Difference between revisions of "Team:CSMU Taiwan/Safety"

Biosafety

Labsafety

Regulations

Biosafety

Our team complies to the third edition of Laboratory Biosafety Manual released by World Health Organization.

Moreover, according to Taiwan Centers for Disease Control(Taiwan CDC), some of the current status for Biosafety are stated as bellow:

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.

What our team did to comply with it

Although no select agents or toxins on the list are involved in our experiment, we still looked through the guidance carefully.

Nucleoprotein and hemagglutinin of Influenza A and Influenza B virus are our target protein for SELEX, meanwhile whole influenza viruses are used to test the inhibition ability of our selected aptamers. In addition, in the Charactization and Improvement section, we improved the water solubility of HA1(Hemagglutinin for H1N1). The subtypes we chose are classified as seasonal influenza, which are surprisingly potential select agents too.

Apart from complying to the Biosafety manual for Level 2 labs, we also took some effort looking through Dual Use Research of Concern, DURC. After discussing with our instructor, we drafted a Risk mitigation plan.

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.

What our team did to comply with it

We are proud to announce that our institution, Chung-Shan Medical University, is one of the registered entity! We have applied for agreement to use virus in our experiment at the safety committee of CSMU, and the safety committee checked our facility, gave us a quiz regarding associated operations before permitting us. In addition, CDC tracks our usage regarding all contagious agents including influenza virus.

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.

What our team did to comply with it

All of our experiments regarding virus were conducted in the Biosafety Level-2 laboratories. Under the supervision of CDC, our instructor manages the lab strictly and obeys to all guidance written in the manual. For example, we were never allowed to enter the lab before putting on gloves, masks and lab coats. The wastes were always carefully collected and dispensed. Most importantly, our instructor seldom leaves us alone when performing experiments that could infect disease accidentally.

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.

 What our team did to comply with it

We have organized to watch these videos when facing the same situations the videos focused on.

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.

Future Prospects

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.

What our team did to comply with it

Not only did our team complied with the rules, we aimed to contribute to elevate the biosafety of lab and public health. In the section of design, we developed an AI system that is able to predict the spread of influenza.

To sum up, since our experiment involves in virus experiments, we paid special attention towards this issue to secure the safety for both the researchers and public.

As an additional safety measure we use SYBR Safe instead of Eidium bromide. Its use is identical in all the protocols but without carcinogenic risks.

Access to the laboratory

As we are a multidisciplinary team formed by biotechnologists, engineers and artists, not everybody knows how to behaviour in a laboratory. That is why we did several seminars directed by Alejandro Vignoni and Yadira Boada to teach the basics of their laboratory. However, as a security measure, they decided that not everybody would be allowed to work in the lab alone, only biotechlogists and biomedical engineers could be there without surveillance due to their experience and knowledge adquiered during their degree.

Over the course of these seminars we were informed about the evacuation protocols, waste management and our rights and liabilities as UPV staff. These information can be seen in the information sheets they gave us and that you can download through these buttons:

Strains

Printeria uses E.coli and V.natriegens as chassis. Both are classified as risk 1 so the harm which can cause to people is minimal. The E.coli are from strains DB3.1, 10G and TOP10, for V.natriegens we use the strain ATCC 1404 from CECT (Colección Española de Cultivos Tipo). To do constructions we use biobricks and parts supplied by IDT prepared with the Golden Gate grammar.

Regulations

Science without ethics is cruel, and ethics without science is empty. Ethics become really important when a project is being thought. For this reason we wanted to pass the UPV (Polytechnic University of Valencia) ethics committee. Here you can download the document we sent them to approve and the positive veredict of the committee.