1. National Committee on Biosafety (NCB)
The structure of the NCB is as follows:
- The Secretary, Ministry of Environment and Forests
- Secretary, Ministry of Science, Information and Communication Technology
- Secretary, Ministry of Agriculture
- Secretary, Ministry of Fisheries and Livestock
- Secretary, Ministry of Health
- Executive Chairman, Bangladesh Agricultural Research Council
- Member (relevant), National Board of Revenue
- Director General, Directorate of Food
- Director General, Department of Environment
- Chairman, Bangladesh Atomic Energy Commission
- Director General, Fisheries Research Institute
- Director General, Bangladesh Livestock Research Institute
- Director General, Bangladesh Agriculture Research Institute
- Director General, Bangladesh Rice Research Institute
- Director General, Bangladesh Jute Research Institute
- Director, Bangladesh Forest Research Institute
- Director General, Bangladesh Institute for Nuclear Agriculture
- Director, National Institute of Biotechnology
- One representative from NGO working with environment related issues (to be nominated by NGO bureau).
- One representative from NGO working with legal aspects related to environment (to be nominated by NGO bureau).
21. Full time Member Secretary to be nominated by MOEF.
Powers of NCB
The NCB will have the powers to draft and adopt legislation/measures to ensure safety of human and environment; to stop a project/program through the relevant authority after establishing that further continuation of such work is unsafe to the personnel, community and the environment and to approve deregulation of regulated materials for free movement and commercial use upon recommendation of relevant committees.
Functions of NCB
a. Formulate, review, update or amend national policies, guidelines, acts and rules on Biosafety and shall supervise risk assessment, risk management and the implementation activities thereof.
b. Review all existing bilateral and multilateral projects, and all research that are now being undertaken under private arrangements among universities, research organizations and NGOs.
c. Review, monitor and recommend measures to minimize potential risks that may result from, import, contained use, field trial and release or introduction of new species, strains or varieties of GMOs/LMOs.
d. Facilitate the institutes/faculties/companies already working with GMOs/LMOs to obtain necessary permission or clearance in favor of their activities.
e. NCB shall examine the application submitted by any university, department and division of a research institute or a private company within a specified time frame and shall approve or disapprove the application on case-by-case basis. MOEF will notify the decision of NCB to the applicant.
f. Instruct the respective authority to ensure implementation of Biosafety measures at on-site (field), laboratory, during trans-boundary movement, use, handling and release in the market.
g. Prepare different forms e.g. project proposal forms for permission to undertake laboratory genetic manipulation work; for field trial; and for commercial release of GMOs with adequate instructions for filling up of such forms for permission. At the same time forms for assessment and evaluation with adequate instruction will be prepared for various committees overseeing such work.
h. Publish the results of internal deliberations and agency reviews of the Committee.
i. Hold public deliberations on proposed national policies, guidelines and other Biosafety issues.
j. Review the appointment of the members of the Institutional Biosafety Committee (IBC) upon recommendation of respective heads of institutions/Universities.
k. Hold discussions on the comparative ecological, economic and social impacts of alternative approaches to attain the purposes/objectives of the proposed genetic modification products and/or services.
l. Assess and identify priorities in human resource development in Biosafety and in the related capacity building (including infrastructural) requirements.
m. Coordinate the activities of institutional and field level Biosafety committees.
n. NCB can co-opt relevant experts/officers as and when it will be required for.
Responsibilities of NCB
a. Shall consider only those applications where the origin of biological materials used in research is clearly stated.
b. Advise relevant authorities to develop adequate technical, legal and institutional capacity on provisions of all pertinent internationals agreements.
c. Provide advice and assistance to the IBC and FBC and other relevant committees on the risk and safety aspects of their work.
d. Suggest practical alternatives, if any to high-risk laboratory works.
e. Provide various forms/formats for application, assessment and evaluation, Biosafety Guideline and other documents to relevant committees in different organizations.
f. Inform the various institutions engaged in GMO work about new developments in biosafety to avoid unnecessary risk.
g. Coordinate biosafety aspects in public private sector partnership to ensure safety level in all biotechnological work being carried out under such partnership.
h. Maintain confidentiality of information of commercial importance upon request from the researcher.
i. Inspect and certify all laboratories and facilities engaged in high-risk genetic manipulation work.
h. Consult with other national bodies and institutions dealing with the safety of human being and the environment and inform these bodies all conceivable developments in the field of modern biotechnology.
k. Cooperate with other national authorities dealing with import of live organisms, to formulate uniform guidelines for identification, inspection and regulation of transgenic species, exotic organisms and others.
l. Advise various research institutions and regulatory agencies in setting up appropriate experimental conditions for genetic manipulation work avoiding potential hazard.
2. Biosafety Core Committee (BCC)
2.2.1 Composition of BCC:
The Biosafety Core Committee (BCC) shall be composed of eight members. The structure of BCC is as follows:
- Director General, Department of Environment, Convener
- Director (Technical) Department of Environment, Member Secretary
- Four Bio-scientists to be nominated by MOEF
- One Medical Scientists (Knowledgeable and experienced in human health aspects)
- One Scientist specialized in Biosafety affairs
Note: Bio-scientists will be chosen from the following areas: Persons knowledgeable in Biotechnology in the Field of Molecular Biology, rDNA, Immunology, Tissue Culture, Plant and Animal Breeding, Microbiology, Entomology, Biochemistry, Plant Pathology, Food Science and Nutrition
Functions of BCC:
The BCC shall perform the following functions:
a. Monitor the implementation of Biosafety guidelines, policies, acts and rules as complementary to the NCB
b. Examine application for any permit/license of import of GMOs/LMOs for contained use, field trial and field release and forward recommendations to the NCB for its consideration.
c. Provide technical comments or recommendations to NCB or the government on policy, legal and technical issues of Biosafety as and when requested for.
d. BCC will meet, as and when necessary, preferably on quarterly basis.
e. BCC shall arrange annual inspection and evaluation of performance of all the laboratory engaged in research, development and demonstration (R&DD) of GMOs/LMOs.
f. BCC may co-opt experts related to specific issues regarding Biosafety as and when required
3. Institutional Biosafety Committee (IBC)
All institutions engaged in genetic engineering shall have an Institutional Biosafety Committee (IBC) to evaluate and monitor the Biosafety aspects of their research. Where an institution intends to become involved in planned field release, members of the IBC should collectively have the range of expertise necessary to supervise and assess the program.
Composition of IBC
A senior knowledgeable person with adequate experience in Biosafety shall be appointed as the Chairperson. The committee will be composed of 4 members from amongst the high caliber and experienced scientists of the Institute to be appointed by the Chairperson according to their expertise in Biosafety of the corresponding modern biotechnological activities. They should be able to evaluate, assess and advise precautionary measures for genetic engineering work. The IBC represents the most important component in the domain of Biosafety supervising all genetic engineering work in the Institute.
Powers of IBC
The IBC is empowered to enforce all Biosafety regulations in the institute; report infractions to the Institutional head and recommend to the authority to stop a project if its continuation is considered a threat to laboratory personnel, public or environment
a. Review works conducted by the institutions and recommends research proposals for considerations by NCB. The review shall cover:
b. The containment levels required by the guidelines for the proposed research.
c. The facilities, procedures and practices and the training and expertise of personnel assigned to the work.
d. Hold discussions or public consultations on the comparative ecological, economic and social impacts of alternative approaches to attain the purposes/objectives of the proposed genetic engineering products/or services.
e. Notify the project chief/proponents/investigator about the results of the review.
f. Review at least once in every year, the work or assessment reports on potential risks being conducted at the institution as well as review laboratory records on regular basis to ensure that requirements of the guidelines are being fulfilled.
g. Formulate and adopt emergency plans covering accidental spills and personnel contamination resulting from lab and fieldwork.
h. Report immediately to the appropriate official in the concerned organization and to the NCB any significant problems with the implementation of the guidelines and any significant research-related accidents or illness.
i. Maintain close liaison with the BCC.
j. Perform such other functions as may be delegated by the NCB
Responsibilities of IBC
a. Ensure that laboratory genetic manipulation work within the institution conforms to the regulations of the Biosafety Guidelines.
b. Assess the projects submitted for approval and based on information provided and anticipated risks determine under which category of work the proposal falls and whether to endorse the work proposed.
c. Maintain records of approved project proposals for genetic manipulation work and the Committee’s assessment
d. Undertake risk assessment in cooperation with research teams if necessary to determine the appropriate containment and Biosafety conditions
e. Prepare specific contingency plan after undertaking risk assessments and reviewing project proposal.
f. Monitor the containment features and working conditions within the laboratories, plant glass houses and animal houses of the institute to ensure that various facilities are maintained at the required standard.
Biological Safety Officer (s) (BSO)
Each institution shall designate at least one scientist as Biosafety Officer (BSO). The Biosafety Officer should have considerable experience on Biosafety issues and emergency counter measures and is expected to have rigorous training on biosafeguards. It shall be the duty of the BSO to monitor the compliance of the guidelines at the institution level. BSO has to report regularly to the Chairperson of IBC on any matter regarding Biosafety applications in the institution.
4. Field level Biosafety Committee (FBC)
Provisions for constitution of Field level Biosafety Committee (FBC) shall be made in due course when permission for field trial of GMOs/LMOs is given. NCB will appoint three scientists from relevant institutions and one representative from the Ministry of Environment and Forest to constitute the field level Biosafety committee.