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  • Writer's pictureSwaha Chakraborty

Issues With Current BSL Laboratory System

Biosafety refers to human exposure to pathogens or inadvertent contamination of viral samples. Traditionally, biosafety legislation has been focused on minimizing human exposure for the scientists/laboratory researchers and any human subjects involved in the research. However, GOFROC experiments introduce an additional group:individuals who are unaffiliated with the research but are at risk of a laboratory leak. This group includes anyone in the general population, regardless of their absence of knowledge on the GOFROC experiment in question and lack of informed consent. Unfortunately, such breaches are not uncommon.

Examples of Biosafety breaches: Foot-and-mouth (FMD) disease, Institute of Animal Health at Pirbright, 2007 from Biosafety Level 3 Agriculture laboratory. Infected wastewater from a laboratory led to infections in local firms. SARS 2004, Beijing, BSL3 laboratory. Two researchers who were working with the virus in a Beijing lab became infected with the virus in two separate incidents. 1977 H1N1 flu – most scientists believe that the virus was released from a Chinese or Russian laboratory– Called the Russian flu, it broke out in China and Russia almost simultaneously in 1977. Many researchers have suggested that the virus leaked from a laboratory. More than half a million people died worldwide as a result of the virus. Accidental infections without transmissions:

● SARS, Taiwan 2003 : a single male laboratory worker was infected. It was an isolated incident6.

● Ebola Virus, Novosibirsk 2004 : A Russian scientist who was doing research on Ebola virus died after accidentally injecting herself with the virus7.

● SARS-contaminated West Nile Virus, Singapore 2003 : A 27-old researcher was infected with SARS due to accidental contamination. The researcher was conducting research on West Nile Virus in a laboratory that was also conducting research on SARs. Cross- contamination of samples resulted in the SARS infection8.

● Marburg Novosibirsk 1988. A single researcher accidentally contracted the Marburg virus and died9.

● USA BSL3 2002 – 2008: At least 13 Lab-acquired infections occurred. For example:

○ 2004: Two incidents of foot-and-mouth disease outbreak at Plum Island.

○ 2005: H2N2 influenza virus was included in standard testing kits sent to over 5,000 laboratories10.

○ 2006: Three Texas A&M University biodefense researchers were infected with the biological weapons agent Q Fever11. Biosafety is a critical aspect of GOFROC legislation, as a breach could potentially result in a global pandemic. Despite its low probability, the high severity of a pandemic requires regulations that are designed to specifically alleviate this risk.

Experiments must be performed in BSL-4 Laboratories Currently, laboratories are required to follow biocontainment procedures based on the nature of the organism they were experimenting with. The Centers for Disease Control and Prevention (CDC) defined four Biosafety Levels, ranging from BSL-1 to BSL-4 (1 classifying innocuous viruses, 4 classifying high-risk microbes)13. Each level builds on the regulations of the previous level. For example, a BSL-3 lab will have to follow laws specific to BSL-3, but also the laws governing BSL-1 and BSL-2 labs. BSL-1: Microbes used in this lab are not known to consistently cause disease in healthy adults and present minimal potential hazard to researchers and the environment. An example would be a nonpathogenic strain of E. Coli. Coats, gloves, and eye protection can work if necessary and experiments can be conducted on a table or open lab bench. The lab is required to have doors sectioning it off from the rest of the building and there must be a sink located in the work area. A nonpathogenic strain of E. coli bacteria would be an example of an organism used in a BSL-1 laboratory.

BSL-2: Microbes in BSL-2 labs pose a moderate threat to both their environment and researchers working with it, they tend to be indigenous and vary in severity. Protective equipment (eyewear, coats, gloves, face shields, etc.) is required, experiments with a risk of infection from splashes or aerosol are conducted in a biological safety cabinet (BSC). There must also be a method of decontamination available for waste disposal (ex. Autoclave). The lab has automatic closing doors, alongside an eyewash station. Staphylococcus aureus is an example of an organism that could be found in a BSL-2 laboratory.

BSL-3: Organisms in this lab may be exotic and are at high risk of causing lethal illness through respiratory transmission. Immunizations may be provided to workers in the laboratory, and they will be under medical surveillance as well. The lab entrance, two sets of self-locking doors, must be monitored with access always restricted. The laboratory is not allowed to recirculate exhaust air, with the building’s airflow designed for air to flow from clean areas to contaminated ones. Mycobacterium tuberculosis is an organism that may be found in a BSL-3 laboratory.

BSL-4: BSL-4 labs provide the highest level of biological safety, and their regulations are designed to contain dangerous, exotic, and high-risk pathogens. Laboratory workers are expected to change clothing upon entrance, decontaminate all materials used in experimentation before exiting, and shower before leaving the lab. Furthermore, they also have to wear an air supplied, full body suit. BSL-4 labs are either physically isolated in a separate building or are in a restricted zone of a larger building. The lab must include vacuum lines and decontamination systems. The Ebola virus is an example of a microbe experimented on in a BSL-4 laboratory.

The primary challenge with this system is that biocontainment regulations depend on the original pathogen being edited, rather than the end goal of the experiment. For example, one of the most notorious GOFROC experiments, used an avian influenza virus14. The original virus, found in birds, was used to create a highly pathogenic strain of the virus that was airborne transmissible between ferrets. This was especially concerning, as ferrets provide the most accurate animal model for influenza found in humans. In the event of a laboratory leak, there would be a risk of the virus evolving to become airborne transmissible between humans, effectively creating a lethal pandemic. Ron Fouchier, one of the researchers who created this strain of H5N1, claimed that his experiment resulted in “probably one of the most dangerous viruses you can make ''. Despite the high risk of the engineered strain of H5N1, the experiments were conducted in a BSL-3 enhanced laboratory rather than BSL-4 lab. The nature of this experiment sparked a debate on how biosafety should be managed regarding similar experiments in the future. The safest way to conduct this research would be requiring all laboratories conducting GOFROC to adhere to the standards of a BSL-4 lab16. While some scientists argue that this would decrease the efficiency of research and generate unnecessary expenses from the maintenance of a BSL-4 lab, risking the lives of the general population in the name of science is unnecessary in and of itself. It is important to note that by increasing the biosafety standards for GOFROC, research conducted in less wealthy countries will suffer (see below). However, we must ask ourselves if a country without the necessary infrastructure and weaker research oversight should be conducting such high-risk research in the first place.

However, ensuring GOFROC takes place only in BSL-4 laboratories may not be sufficient. Medical science is advancing at a rapid pace, and the number of BSL-4 labs worldwide has increased dramatically over the last decade (Chart 1). This highlights that the risk from biosafety is only increasing over time and the policies governing BSL-4 laboratories in different countries should be made stringent and enforced.


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