Principles and Practices

Question 1

Risk/Safety level:What is the Safety Level of Your Lab (e.g. BSL1, BSL2, other)? Do you have different spaces with different safety levels? If so, describe which activities are done in different spaces. Include a picture of your lab.

The laboratory we are going to work with during the Bio-Academy Program is KRIBS at Cochin, a Biotechnology Incubator space with well equipped laboratories supported by Rajiv Gandhi Centre for Biotechnology in Kerala. The safety level of our lab has both BSL1 and BSL2.

Question 2

Work Area: Which work areas do you use for handling biological materials? (e.g open benches, biosafety cabinet, fume hoods etc)? Include a picture of your work spaces.

The biochemicals that are not very contaminating are worked in openbenches. , For working with bacteria, fungi, viral vectors and biological toxins, the Biosafety cabinet is used. Fume hoods are used for working with exploding chemicals, which generates fumes.

Question 3

Training: Have you received, or will you receive, any ethics and/or safety training? Who provides this training? Briefly describe any topics covered.

I have received the basic training on how to deal with harmful chemicals during my graduate studies at SASTRA University. When I was selected as a Summer Research Fellow by Indian Academy of Sciences, I underwent a training on how to use the Biosafety Cabinet (BSL2) for handling bacterial cultures. I have also attended an online lecture conducted by the National Biosafety and Biocontainment Training Program, National Institutes of Health and Dartmouth College on safety measures to be taken in BSL2 and on Autoclaving. In future, I will undergo training on both BSL3 and BSL4 too.

Question 4

Rules and Regulations: Which laws and regulations (locally, nationally and internationally) apply to your lab? Include links to any oversight institutions/organizations and policies, and describe which specific rules are pertinent to your lab and project and why?

National Rules and Regulations

The guidelines for Good clinical practices developed by Indian council for Medical Research is applied nationally to all the laboratories who are working in biology such as Microbiology, Molecular Biology, Biochemistry and Clinical Diagnostics. The implementation of biosafety procedures, rules and guidelines under Environment (Protection) Act 1986 and Rules 1989 in the Department of Biotechnology (DBT- India) ensures safety from the use of Genetically Modified Organisms (GMOs). A three tier mechanism comprising Institutional Biosafety Committees (IBSC) at the Institute/ company; the Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology; and the Genetic Engineering Approval Committee (GEAC) in the Ministry of Environment & Forests (MoE&F)for granting approval for research and development activities on recombinant DNA products, environmental release of genetically engineered (GE)crops and monitoring and evaluation of research activities involving recombinant DNA technology has been established. The regulations by DBT India is given in the below link
DBT-India Regulations

International Rules and Regulations

The research involving blood and body fluids in the Biosafety cabinet should adhere to the Occupational Safety and Health administration – O.S.H.A. Blood bourne pathogen Universal standard, which is established since 1930.
For shipping via commercial carriers,

• Adherence to all DOT and IATA regulations, 49 CFR 100-185
• Shipping clinical specimens need to be crosschecked with EH&S list

Safety Regulations in our Lab

Currently we have both BSL1 and BSL2 in our lab, but is not yet fully functional. As and when we grow and have people to use the facilities, we will keep all the safety rules and regulations and ethical considerations in place. As of now, Safety regulations for working with BSL2 and for the effective use of BSL2 in our lab as we mostly work with BSC, we follow the following safety procedures

• See if BSC is certified annually
• Check air flow everytime
• Clean with a suitable disinfectant (mostly 70% EtOH
• Vacuum assisted pipette aids
• Avoid working outside the BSC (pipette buckets outside to be avoided)
• Personal Safety equipment

1. Laboratory coat covering full body
2. Shoes with toes covered
3. Gloves, heat resistant gloves will be better
4. Liquid resistant apron if autoclaving liquids
5. Goggles to protect eyes
6. Protective helmet to protect face and head

As the lab deals with potentially hazardous materials, Biohazard label should be stuck on all the below items

• Containers
• Incubators
• BSC
• Freezers
• Others as per usage

The below link gives the guidelines of Good Clinical Practises followed by ICMR.

Question 5

Organization and Practices: How do you enforce these rules? Who is responsible for ensuring safety in your lab/space? What happens when safety issues are raised?

It is a must for everyone who enters the lab to follow rules in laboratory. We have stuck some labels on the equipments, samples, etc like biohazards. We have also notice boards and caution notice boards before using any BSL2 equipment for new users. We are in the process of appointing a lab assistant to look after this for the safety and make sure students and others are following the protocol. In case of not any basic safety issue is raised, we have the capability of solving it but for major issues related to law or legal, we would like to recruit a legal team before the facilities are being used by students and public.

Question 6

Uncertainties: Are there any areas where you are uncertain about how to apply these rules, and whether they are relevant to your lab and/or work?

As of now, we are clear with the safety measures for BSL1 and 2. As and when we grow, we might be unclear about the safety protocols and during which we might also take some approporiate trainings on safety protocols.