Biosecurity
“A pared-down life form might serve as a useful chassis. Bolt on the right handful of genes and you could have an ecologically friendly microbe factory to produce drugs or biofuels or artificial meat.”
-James Mitchell Crow
A combination of the probability of occurrence of harm and the severity of that harm where the source of harm is a biological agent or toxin (Source: CWA 15793) is termed a biorisk. The source of harm may be an unintentional exposure (like what happened to Hulk in the Marvel Universe XD), accidental release or loss, theft, misuse, diversion, unauthorized access or intentional unauthorized release. Biorisks include both biosafety and biosecurity risks.
Did you think only cybersecurity exists ?
Biosecurity risks are a type of biorisk based on malicious intent. These risks are primarily focused on theft of a biological agent(s), equipment, or information, and sometimes include misuse, diversion, sabotage, unauthorized access, or intentional unauthorized release. The overall biosecurity risk varies with the intent of the adversary (or threat) aiming to do the malicious act.
In order to understand the biosecurity hazards our own project poses, we performed a thorough assessment through a Biosecurity Risk Assessment Form. This enabled us to pay specific attention to the potential harms and risks associated with our project, not only to the end user, but also the institute and lab personnel.
The risk assessment showed us, while the risks associated with our project were low to moderate, proper precautions in terms of storage and handling of biological material were necessary. The nature of our project also required us to have experienced supervision at all times.
iGEM 2020 Team IISER Bhopal Biosecurity Assessment Form | |||
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Step 1 | Step 2 | Step 3 | |
1. Define the Situation | 1a. Identify the Assets | 1b. Identify the threats | 1c. Define the facility and lab security environment. |
a. E coli K12 w T3SS b. E.coli Dh5 Alpha c. HIEC6 cell line d. HEK273 cell line > Infectious dose is unknown. > Possible mode of infection is physical contact or ingestion only. > Persons with possibly weakened immunity are at risk. > Non-communicable > Exact pathology of possible infection/ ingestion has not been studied yet, however the risk is not significant. |
a. Anti-GMO activists b. Pharmaceutical companies selling diabetes medicine |
> BSL 2 Facility
> Locations: The agent is stored in a -80 freezer in the BSL2 lab. For the experiment, the agent is being grown in 5 liter volumes. These volumes are stored in a laboratory incubator. > Procedures: Cell Cultures, Purifications, Extractions > Equipments: Pipettes, Incubators, Centrifuges, PCR Machine |
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2. Define the risks | 2a. Construct a series of potential risks | ||
> Risk of accidental/ improper handling of biological material.
> Risk of an unauthorized person stealing valuable biological material. > Risk of accidental/ improper handling of biological material. > Risk of an unauthorized person stealing valuable biological material. > Percutaneous route – risk of an infection caused through compromised skin or direct injection into the bloodstream. > Mucosal route – risk of an infection caused through exposure to the mucosal membranes. > Gastrointestinal route – the risk of an infection caused by contact with the gastrointestinal tract. |
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3. Characterize the risks |
3a. Asset Assessment | 3b. Adversary Assessment | 3c. Facility Vulnerability Assessment |
> Low risk of accidents while handling material.
Consequence- Risk to the health and safety of individuals near the accident.
>There is a potential risk to immunity in case of accidental release. > Chances of theft are low. > Likelihood of infection is low >Loss of funding, societal panic, community mistrust – high risk >Consequence of the hazard causing harm? Moderate >Specific consequences to at-risk individuals? Moderate to High > Specific consequences to the work process? Low |
a. At the current stage, low risk of threat from adversaries. | a. Facility has secured access. CCTV and security personnel present in the building and the campus as well.
b. Personnel, in immediate vicinity, at potential risk of exposing themselves to pathogens if there is a spill/accidental release. c. Security is based on key management system d. Security personnel are highly reliable e. Storage of biological components within . freezers etc are not locked. f. Transport of material in/out of the facility is minimal. Triple packaging is ensured for maximum safety. Accidental release of biological material can lead to a high threat to immunity for the target individual. Designated courier is responsible for delivery. g. Material inventory is maintained for accountability and is appropriately updated. However no system of accountability is in place. h. Sensitive information includes: Laboratory research data, Location and types of pathogens, Personal identifying information. Only laboratory research data is comparatively at risk of sabotage. Sensitive electronic information is secure and encrypted. |
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3d. Overall Risk Characterisation | |||
Individual(s) inside the laboratory: >Inhalational route– Low. > Percutaneous route -Moderate. > Mucosal route – Moderate. > Gastrointestinal route– Moderate. Individual(s) outside the laboratory: >Inhalational route– Low. > Percutaneous route - Low. > Mucosal route – Low. > Gastrointestinal route– Low. > Accidental release of pathogens due to theft, displacement or improper handling could lead to unexpected immune response in targets exposed to biological agents. > Overall risk is low to moderate as the consequences are not high and possibility of them happening is very low. |
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4. Determine if the risks are acceptable |
> Reliability of personnel involved in handling biological material in the lab is high as is the reliability of security.
> Health concerns are not significant according to literature however there may be some unforeseen/ uncharacterised responses that may lead to unexpected immune response. > However, overall, the risks are manageable. |
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5. Implement mitigation measures, if needed |
> Strict inventory will be maintained, storage facilities will be secured.
> Safety equipment provided to all personnel. > Better waste handling system to reduce the risks to the environment/ community. > Experts or supervisors will be monitoring the personnel or students working in the lab to avoid accidents. > Since risks are acceptable and not high, no significant extra measures are required other than the ones already in place. |