In accordance with the Rules for the use and storage of hazardous microorganisms/ genetically engineered organism/plants/cells, Government of India, Under the Environment Protection Act, 1986, has enforced rules and regulations on the biosafety and biocontainment of hazardous, recombinant DNA, synthetic nucleic acids and use of hazardous biomaterials of any kind. Under the guidelines of this act, JSS Academy of Higher Education & Research, Mysuru, has constituted - Institutional Biosafety Committee (IBSC) as per DBT, Government of India guidelines.
The primary mission of the IBSC is to ensure the safety of faculty, and the researchers involved in the biological research at our institute and to protect the general public and the environment from adverse consequences of the proposed research.
The IBSC is responsible for reviewing projects that involve, but are not limited to, recombinant DNA, RNAi, pathogens, human materials (specimen's repositories) and other potentially infectious material, as well as transgenic animals, genetically modified plants and seeds, CRISPER and Gene knockouts, bacterial and viral vectors based transfections. The IBSC provides recommendations in matters pertaining to the control of biohazards associated with the use of microbiological agents and their vectors and related research.
The IBSC will determine approval or recommendations of the proposed experiments through review of the application submitted by the principal investigator along with supporting materials. This review and oversight involves independent assessment of the biosafety containment level proposed for the work and through coordination with the biological safety officer, assessment of facilities, procedures, practices, training and expertise of personnel involved in the research.
Specifically, the IBSC will review research proposals with the following potentially hazardous biological agents and experiments
IBSC Members | ||
---|---|---|
Dr. Basavangowdappa H, Chairman, IBSC, JSS AHER | hbgowda@gmail.com | |
Dr. Sumana M N, Biosafety Officer, IBSC, JSS AHER | mnsumana@jssuni.edu.in | |
Dr. Asha Srinivasan, Member Secretary, IBSC, JSS AHER | Asha.srinivasan@jssuni.edu.in | |
IBSC Internal Members and Research Staff | ||
Prof. SubbaRao MVSST, Internal Member, JSS AHER | ||
Dr. Saravanababu C, Internal Member, JSS AHER | ||
Dr. Ashish D Wadhwani, Internal Member, JSS AHER | ||
Dr. Mohan T C Internal Member, JSS AHER | ||
Dr. Divya P Kumar, IBSC Research Staff, JSS AHER | ||
Dr. Akila Prashanth, IBSC Research Staff, JSS AHER | ||
Dr. Devananda Devegowda, IBSC Research Staff, JSS AHER | ||
Dr. Muthukumar S P, External Member, CFTRI, Mysuru | ||
Dr. Ramachandra Kini, External Member, University of Mysore, Mysuru | ||
Dr. Ravindra P V, External Member, CFTRI, Mysuru | ||
DBT Nominees | ||
Dr. Manjuntha H B DBT Nominee, University of Mysore, Mysuru | ||
Dr. Shylaja R DBT Nominee, DFRL, Mysuru | ||
Dr. Nandini C D DBT Nominee, CFTRI, Mysuru |
The IBSC has to meet at least twice a year to review the status of projects involving biohazardous, human materials, recombinant DNA. It is important that the Chairman and Member Secretary ensure that regular meetings take place. More than two meetings may be held as per requirement of the projects. The IBSC members are expected to look into the following during the meetings
The role of IBSC assumes major importance in the regulatory framework since it is a Statutory Committee that operates from the premises of the institution and hence is in a position to conduct onsite evaluation, assessment and monitoring of adherence to the biosafety guidelines. The functions in the IBSC of the head of the organization, members, DBT nominees, Principal Investigator and Member Secretary are explained below
The chairman of IBSC has the responsibility to ensure the biosafety guidelines are followed in accordance with the DBT regulations for the use and disposal of biohazardous materials. Conduct regular meetings with the internal/ external, and DBT nominated members. It is important that the Chairman and Member Secretary ensure that regular meetings take place. More than two meetings may be held as per requirement of the projects.
Advise on risk assessment for all proposed work with biological agents. Advise on biohazard waste disposal arrangements. The biosafety officer must ensure that the facilities at the institution are sufficient to meet the containment levels stipulated for biohazardous work and disposal.
The IBSC has a nominee from DBT who oversees the activities to ensure that safety aspects are being fully adhered to by the organization. The DBT nominee serves as the link between the department and the respective IBSC. In addition to the responsibilities as an IBSC member, the duty of the DBT nominee is to ensure that
Works in accordance with the Chairman, Biosafety officer and DBT nominees for smooth conduct of IBSC activities. Schedules meetings, IBSC training and coordinate all activities of IBSC. Meetings will be conducted once in 6 months or on the basis of received proposals. Member secretary will be responsible for getting confidentiality agreement signed from the external members and DBT nominees.
All recombinant research projects carried out by an organization have a Principal Investigator (PI) and it is the duty of the PI to apprise the IBSC about the nature of the experiments being carried out. Depending upon the risk category, the PI has to inform the IBSC, seek permission of IBSC before starting the experiments or seek permission of the RCGM through its IBSC.
The PI is primarily responsible for ensuring compliance with biosafety standards. The PI functions as a project manager as well as a researcher, communicating with the IBSC and bearing responsibility for training and supervising personnel.
Based on the nature of the GMO or the infectious agent, the PI determines the proper containment level for the project and, in accordance with the DBT Guidelines, develops the necessary experimental protocols. This information is then submitted to IBSC for review.
The responsibilities of PI to IBSC are summarized below:
THE Laboratory personnel must
Follow all safety guidelines and establish good laboratory practices. They must work within the assigned biological safety containment level and use personal protective equipment as recommended.
The purpose of these guidelines is to provide guidance to organisations that have Institutional Biosafety Committees (IBSCs) or intend to set up an IBSC in compliance with “Rules for the manufacture, use/import/export and storage of hazardous microorganisms/ genetically engineered organisms or cells, 1989” (hereinafter referred as Rules, 1989) notified by the Ministry of Environment and Forests (MoEF), Government of India under the Environment (Protection) Act, 1986.
The current scope of the IBSC covers research involving
Submit a hard copy of the application to the office of the Member Secretary, IBSC. A soft copy of the application should also be submitted via email: ibsc@jssuni.edu.in
The application form can be downloaded from the following links:
Please note that the IBSC normally meets every SIX months (November and May), therefore the application should be submitted at least 30 days in advance (i.e., by September 30 for the November meeting, and by March 31 for the May meeting).
It is the duty of the primary investigator (PI) to apprise the IBSC about experiments involving biohazardous materials, use of recombinant DNA (rDNA) technology, genetically modified organisms (GMOs) or living modified organisms (LMOs) through the application as stated above. This should be done prior to submission of a grant application to a funding agency.
While preparing the application please note the following:
Please go through the guidelines provided by DBT in the following document to understand the responsibilities of the PI
IBSC Guidelines Handbook - 2020
STEP 1: The application will be evaluated by the committee (and subject expert if required) and the applicant may be asked to provide other documents if required.
STEP 2: A meeting of IBSC will be scheduled and the date will be communicating to the applicant at least 20 days in advance. The applicant may be asked to present his/her proposal to the committee and a decision will be communicated to applicant within a week
All applicants are advised to go through the Indian Biosafety Rules & Regulations
The code of practice for a basic laboratory applies as follows except where modified
Follow these procedures for cleaning-up spills of blood and blood products. The same procedures can be used for cleaning up other body fluids. For any assistance call IBSC. Prior to beginning the clean-up, wear personal protecting equipment (PPE) i.e. rubber, latex, PVC or similar type gloves, lab coat etc.
As per Section 6, 8 and 25 of the Environment (Protection) Act, 1986 of the Central Government the waste must be disposed-off in the following manner
Cat. No. | Type of Waste | Examples | Treatment & Disposal |
---|---|---|---|
1 | Human anatomical waste | human tissues, organs, body parts | Incineration@/deep burial* |
2 | Animal waste | animal tissues, organs, body parts, carcasses, bleeding parts, fluid, blood and experimental animals used in research, waste generated by veterinary hospitals colleges, discharge mfrom hospitals, animal houses | Incineration@/deep burial* |
3 | Microbiology & Biotechnology waste | wastes from laboratory cultures, stocks or specimens of micro-organisms, live or attenuated vaccines, human and animal cell culture used in research and infectious agents from research laboratories, wastes from production of biologicals, toxins, dishes and devices used for transfer of cultures | local autoclaving/micro-waving/incineration@ |
4 | Sharps contaminated with biological waste | needles, syringes, scalpels, blades, glass, etc. that may cause puncture and cuts. This includes both used and unused sharps | disinfection (chemical treatment@ /autoclaving /micro- waving and mutilation/shredding## |
5 | Discarded medicine & cytotoxic drugs | wastes comprising of outdated, contaminated and discarded medicines | incineration@/ destruction and drugs disposal in secured landfills |
6 | Solid waste contaminated with biological sample | Items contaminated with blood, and body fluids including cotton, dressings, soiled plaster casts, lines, beddings, other material contaminated with blood | Incineration@ / autoclaving / microwaving |
7 | Solid waste | wastes generated from disposable items other than the waste sharps such as tubings, catheters, intravenous sets etc. | treatment@@ /autoclaving / microwaving and mutilation/shredding## |
8 | Liquid waste | waste generated from laboratory and washing, cleaning, house-keeping and disinfecting activities | disinfection by chemical treatment@@ and discharge into drains |
9 | Incineration ash | ash from incineration of any bio-medical waste | disposal in municipal landfill |
10 | Chemical waste | chemicals used in production of biologicals, chemicals used in chemical disinfection, as insecticides, etc. | chemical treatment@@ and discharge into drains for fluids and secured landfill for solids |
Note
Chemicals treatment using at least 1% hypochlorite solution or any other equivalent chemical reagent. It must be ensured that chemical treatment ensures disinfection.
Mutilation/shredding must be such so as to prevent unauthorized reuse.
There will be no chemical pretreatment before incineration. Chlorinated plastics shall not be incinerated.
Deep burial shall be an option available only in towns with population less than five lakhs and in rural areas.
IMPORATANT: This is very important to keep in mind to make sure that you or your staff are disposing off the biomedical and biohazardous waste in a correct manner.
It is the responsibility of the PI to make appropriate notifications in the wake of an occupational exposure, laboratory accident, loss of potential containment. PI should maintain a document accessible to all lab personnel, with a list of procedures to be followed in case of an accident such as a spill, injection, ingestion, aerosolization, splash, etc. The document should have the information on agent specific actions, known first aid procedures, effective disinfectants / neutralizing agents (include location in lab), and known symptoms associated with exposures to the agent(s). In case of emergency, please call Principal Investigator, Security, emergency medical personnel etc., and inform the IBSC.
The IBSC should be notified of incidents or adverse events involving biological agents or toxins.
In case of accidental exposure to infectious material e.g., infected body fluid, pathogenic strains etc., prophylaxis measures should be initiated as follows