Team:Ecuador/Safety
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Description
Model
Experiments
Engineering
Safety
Implementation
Hardware
Safety
Our safety standards have identified different tasks and their possible risks, and their probability of occurrence. Also we have considered the control measures that the person in charge has to take and the level of residual risk.
Biosafety Risk Assessment
The organisms we used are Escherichia coli strains HT115 and DH5alpha and we planned to work with Fusarium oxysporum f. sp. cubense race 1 (Foc TR1). The two strains of E. coli belong to risk group 1, i.e. these organisms do not cause serious diseases in humans, nor would they cause any damage to the environment. According to the FAO, the fungus Foc TR1 is a high-risk plant pathogen. In humans they do not cause damage, however, we could be a vector of propagation for different crops.
We have defined as control measures, the use of exclusive clothing for the laboratory and disinfection of footwear when entering and leaving the facilities. In addition, general biosafety measures are applied in the laboratory, including the sterilization of cultures and work supplies, and the correct handling of residues according to national regulations. These measures are applied by all students assigned to laboratory work and allow the level of residual risk to be insignificant.
A MODERATE risk of contact with hazardous reagents has been defined including: ethidium bromide, glacial acetic acid, phenol, chloroform, isopropyl alcohol, lactophenol blue solution. Some of these materials fall into the categories of carcinogens, mutagens, acids, corrosive chemicals and other controlled chemicals. We have defined as control measures the use of personal protective equipment that includes gloves, gown, masks and glasses, depending on the case. These procedures should be performed inside the biosafety cabinet Class II type A1 available in the lab, depending on the reagent. These measures are applied by all students assigned for laboratory work and allow the level of residual risk to be LOW.
A MODERATE risk of contamination in the environment due to the generation of aerosols in the laboratory has been determined based on the experiments that we will conduct. The laboratory is small and oftentimes several members of the iGEM team want to work at the same time. To mitigate this risk, we have defined specific spaces for each task. The availability of a biosafety cabinet Class II type A1 helps to counteract these risks. In addition, strict schedules have been defined to avoid overcrowding the lab. These measures allow the level of residual risk to be LOW.
Biosecurity Risk Assessment
To perform a rigorous biosecurity risk assessment, we decided to apply a guide designed by the International Federation of Biosafety Associations [2]. This document recommended that a biosecurity risk assessment should follow a structured and repeatable process which defines the likelihood of targeting assets from the laboratory, the likelihood of an adversary (also referred to as the threat) successfully acquiring the target, the institutional environment, and the consequence of a successful acquisition, misuse or destruction of the asset.
In addition, with the goal to understand the issue of dual-use in the case of dsRNA technology, we attended the Malice Analysis Workshop, organized by the Engineering Biology Research Consortium (EBRC). The workshop aimed to train graduate students and postdoctoral fellows to evaluate their own work for potentially malicious utility.
As a result of this work, we present below the biosecurity risk assessment for our project.
1. Define the Situation
a. Identify the assets
Biological assets:
Escherichia coli strains HT115 and DH5alpha
Foc R1
Other assets:
Freezers, incubators, centrifuges, other standard laboratory equipment
Research data
b. Identify the threats
Insider Adversary – laboratory personnel; specifically, one
staff member in particular is disgruntled.
Outsider Adversary – criminals looking to sell lab equipment, any potential
terrorist.
c. Define the facility and laboratory security environment?
Physical Security
Room security – The lab is locked when not in use. Only lab PI and lab technician
have keys
Asset security – Freezers can’t be locked.
Building security – The lab is equipped with a video security camera system.
Personnel Reliability – Interns are not formally screened prior to laboratory
access, only interviewed by PIs to determine if they are competent to perform job
duties, no background checks or formal on-going behavioral assessments.
Information Security - Staff receive or had safety and security formation
Material Control and Accountability – Staff receive introductory inventory
management training.
Transport Security – No information is given
2. Define the risks
Risk of an authorized person stealing valuable biological material for malicious use
e.g. a trainee who deliberately wishes to hand over biological material to other
researchers, or intends to misuse it
Risk of an unauthorized person stealing valuable biological material for personal
gain
e.g. a criminal intending to steal and sell a biological material or equipment which
contains biological material
Risk of an unauthorized person stealing equipment
e.g. a criminal intending to steal and sell an incubator
Risk of an authorized person stealing equipment
e.g. an employee stealing a freezer for personal
use
Risk of an unauthorized person stealing confidential information of the project
e.g. a company or researcher aiming to produce a competitive biopesticide
Risk of an authorized person stealing institution intellectual property (in the form
of information) or confidential information
e.g. a disgruntled employee desiring to sabotage project by leaking confidential
information
3. Characterize the risks and Control measures
a. Likelihood of targeting the asset for misuse or theft by the adversary, and the likelihood of successful acquisition of these assets?
Foc R1 and E. coli strains
Likelihood of targeting the asset by the threat? MODERATE
Likelihood of the adversary interest or desire to attempt to acquire the asset? LOW
Likelihood of successful acquisition of these assets? MODERATE
Overall likelihood of this occurring? MODERATE
b. Combine the consequence of misuse of the asset.
Foc R1 and E. coli strains
Consequence of the misuse causing harm? MODERATE
Institution Consequences? LOW
In summary, we define the following risks and their control measures:
| Risk | Initial Risk Level | Control Measures | How to Implement |
|---|---|---|---|
| Risk of an authorized person stealing valuable biological material for malicious use | LOW | Verify personnel reliability | Background checks for laboratory employees with access to the agent |
| Risk of an unauthorized person stealing valuable biological material for personal gain | MODERATE | Additional access control types | Adapting the freezer to block and save all samples prior to the entry of maintenance personnel |
| Risk of an unauthorized person stealing equipment | MODERATE | Acceptable risk considering the cost of improving the physical security of the laboratory | None |
| Risk of an authorized person stealing equipment | MODERATE | Additional access control types | Background checks or formal on-going behavioral assessments |
| Risk of an unauthorized person stealing confidential information of the project | LOW | The risk is not significant | None |
| Risk of an authorized person stealing institution intellectual property (in the form of information) or confidential information | HIGH | Improve information security | Sharing project results only among team members |
References
[1] World Health Organization, Laboratory Biosafety Manual. World Health Organization, 2004.
[2] L. F. Pérez-Vicente, M. Dita, and E. Martinez-De La Parte, “Technical Manual: Prevention and diagnostic of Fusarium Wilt (Panama disease) of banana caused by Fusarium oxysporum f. sp. cubense Tropical Race 4 (TR4),” Rome, Italy, Apr. 2014, p. 74.
[3] L. M. Astuto-Gribble and S. A. Caskey, “Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document,” International Biological Threat Reduction, Sandia National Laboratories and The International Federation of Biosafety Associations, US, 2014. doi: 10.2172/1171429.
[4] World Health Organization, Biorisk management: Laboratory biosecurity guidance, no. WHO/CDS/EPR/2006.6. World Health Organization, 2006.
