Developments on Biosafety Regulatory Regime in Bangladesh 2013


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Developments on Biosafety Regulatory Regime in Bangladesh 2013

  1. 1. 1 9/30/2013
  2. 2. Biosafety and Bangladesh  Protecting human and animal health and biodiversity from the possible adverse effects of the products of modern biotechnology, Bangladesh started working on Biosafety in the 90s’  Biosafety Regulatory System is gradually taking the shape to address R&D on modern biotech in Bangladesh  Administrative System is functional under the Biosafety Guidelines, National Biosafety Framework and Biosafety Rules
  3. 3. Bangladesh as a party to the Cartagena Protocol  Bangladesh signed the Protocol on 24 May 2000 and ratified it on 5 February 2004.  The Protocol came into force for Bangladesh on 5 May 2004, on the ninetieth day after the date of deposit of the instrument of ratification.
  4. 4. Biosafety Regime in Bangladesh: Chronology of Advancement             1999- Biosafety Guidelines (MoSICT) 2000- Signing the CPB 2004- Ratification of the CPB 2004- DNBF project 2006- Updated Biosafety Guidelines (MoEF) 2006- NBF developed 2007- Updated Guidelines gazetted 2008- NBF published 2008- BCH Web-system has been developed that is interconnected with the BCH Central Portal 2010- Drafted Bangladesh Biosafety Rules 2012- Bangladesh Biosafety Rules Gazetted 2012-Prepared NBF Implementation (INBF) Project
  5. 5. Biosafety Guidelines of Bangladesh
  6. 6. Developments of Biosafety Guidelines  Biosafety Guidelines of Bangladesh was earlier formulated by the Ministry of Science and Technology in 1999 and published in 2000.  Considering the obligation of the protocol, the Guidelines have been updated by the Ministry of Environment and Forest in the line with the protocol during 2004-2006.  Updating of the Guidelines took into account the National Policy on Biotechnology into consideration and recasted various aspects of Risk Assessment and Risk Management in the light of Cartegena Protocol.
  7. 7. Scope of biosafety guidelines   Biosafety guidelines are applicable to all research and development activities of modern biotechnology conducted in the laboratories of the government research institutes, state enterprises, universities, international organizations located in Bangladesh, private companies and non-governmental organizations. It applies to laboratory and field trial, trans-boundary movement, transit, handling and use of all GMOs/LMOs that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health.
  8. 8. Contents of the Guidelines Chapter‐I  :  Scopes and Objectives of   Biosafety   Guidelines Chapter‐II :  Institutional Arrangements  Chapter‐III:  General Provisions on  Biosafety  (risk assessment and risk   management) Chapter‐IV:  Physico‐chemical and Biological  Containments: Procedures and  Facilities 9/30/2013 8
  9. 9. Different Committees under the Biosafety Guidelines of Bangladesh  National committee on Biosafety (NCB)  Biosafety core committee (BCC)  Institutional Biosafety committee (IBC)  Field level Biosafety committee (FBC)
  10. 10. National committee on biosafety (NCB)  Composition of NCB: The NCB composed of members as shown below. The scientists and or experts will be nominated by the ministry of environment and forest. The structure of the committee will be as follows:  Chairperson: The Secretary, Ministry of Environment and Forest (MOEF) Member Secretary-DD, DOE is nominated by MOEF 1. 2.  Members:     Secretary, Ministry of Science, Information and Communication Technology. Secretary, Ministry of Agriculture Secretary, Ministry of Fisheries an Livestock Secretary, Ministry of Health
  11. 11. 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 DG, Bangladesh Institute for Nuclear Agriculture Director, National Institute of Biotechnology One representative from NGO working with environment related issues (to be nominated by NGO affairs bureau) One representative from NGO working with legal aspects related to environment (to be nominated by affairs NGO bureau)
  12. 12. Powers, Functions and Responsibilities of the NCB Regulation and Monitoring of GMOs  Formulation and review policies, guidelines, acts and rules standards and manuals on Biosafety and shall supervise risk assessment, risk management and the implementation activities.  Review all existing bilateral and multilateral projects, all research undertaken by NGO/Private/Public organization.  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.  Facilitate the institutes/faculties/companies working with GMOs to obtain necessary permission/clearance in favor of their activities.  NCB to examine the applications on case-by-case basis.  MOEF will notify the decision of NCB to the applicant. 
  13. 13. Biosafety Core Committee (BCC) The biosafety core committee is composed of 8 members. The structure of BCC shall be as follows Director general, department of environment, convener.  Director (technical), department of environment, member secretary  4 bio-scientists to be maintained by MOEF  1 medical scientist (knowledgeable and experienced in human health aspects)  1 scientist specialized in biosafety affairs. 
  14. 14. Functions of BCC       Monitor the implementation of Biosafety guidelines, policies, acts and rules as complementary to the NCB 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. Provide technical comments or recommendations to NCB or the government on policy, legal and technical issues of Biosafety as and when requested for. BCC will meet, as and when necessary, preferably on quarterly basis. BCC shall arrange annual inspection and evaluation of performance of all the laboratory engaged in research, development and demonstration (R&DD) of GMOs/LMOs. BCC may co-opt experts related to specific issues regarding Biosafety as and when required
  15. 15. 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.
  16. 16. 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 scientist 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 represent the most important component in the domain of biosafely supervising all genetic engineering work in the institute.
  17. 17. Functions of IBC  Review works conducted by the institutions and recommends research proposals for considerations by NCB.  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  Formulate and adopt emergency plans covering accidental spills and personnel contamination resulting from lab and fieldwork  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.  Maintain close liaison with the BCC.
  18. 18. Biological Safety Officers    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. BSO monitors 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. Honorarium may be paid to the BSO shall be determined by the head of the institute.
  19. 19. Field level biosafety committee (FBC)  Field level biosafety committee (FBC) is formed by MoEF when permission for field trial of GMOs/LMOs is given. NCB will appoint three scientists from relevant institutions one representative from the MoEF to constitute the FBC.
  20. 20. National Biosafety Framework (NBF) of Bangladesh
  21. 21.  The National Biosafety Framework (NBF) has been developed following an extensive assessment of biotechnology and biosafety in Bangladesh.  Surveys were conducted on the current use of modern biotechnology, existing relevant polices, laws and regulations, capacity building activities and existing expertise within the country.  The Framework provides the basis for future regulation for the management of GMOs in Bangladesh.
  22. 22. Elements of the NBF      National Policy and Guidelines on Biosafety Legal Regime Administrative Systems Monitoring and Enforcement Systems Public Participation, Education and Awareness procedures
  23. 23. Biosafety Administrative System under NBF NCB Ministry of Environment and Forests NFP & NCA BCC IBC FBC BSO Concerned Ministries
  24. 24. GM Crop Approval Process for Confined Field Trials (NBF) Application Approval by the IBC of the Respective  Organization (public or private)  Submission of application through the respective ministry (Through the National Technical Committee)  The technical committee evaluates the applications and  forwards it to MOEF (NCB)   Evaluation by the BCC & Respective Experts  BCC forwards recommendation to the NCB  Approval/Rejection by NCB
  25. 25. Biosafety Rules of Bangladesh 
  26. 26. Main Feature of BD Biosafety Rules       Restriction on import, export or any other kind of uses of GMOs without obtaining permission of NCB Notification for transbounday movement or any other uses through the respective ministries Biosafety Guidelines of Bangladesh has been appended as part of the Rules Risk Management is assigned to various committees already formed Overall coordination in implementation of the Rule is assigned to DOE Crucial Decision and Policy Making Job assigned to MOEF
  27. 27. The Biosafety Rules has been enacted by the Ministry of Environment and Forests on 29 August 2012.  As per the gazette notification the Rules is titled as the ʺBangladesh Biosafety Rules, 2012ʺ.  The Rules has altogether 13 main Rules including the Title of the Rules.  The Rule ʺ2ʺ describes the definitions of different ʺTermsʺ as mentioned in the Rules, namely, ʺDirectorateʺ, ʺActʺ, ʺCommitteeʺ, ʺGMOʺ, ʺGuidelinesʺ, Biotechnologyʺ, ʺPollutionʺ, ʺEnvironmentʺ, ʺDirector Generalʺ, etc.
  28. 28. In ʺRule 3ʺ, there are three ʺSub‐rulesʺ which described various aspects on the ʺRestrictions of import or export etc. on genetically modified organism and productsʺ.  ʺSub‐rule 1ʺ described that no person or organization can import, export, buy, sell or commercially use any genetically modified organism or products without obtaining permission from the Ministry of Environment and Forests.  However, in order to conduct research or taking research project and implementation of the project on genetically modified organism or products would follow the instructions described in the biosafety guidelines.  It is also stated in the rules that before commercialization of research results, permissions have to be obtained from the relevant ministries, directorates, if any, etc. upon getting approval from the Ministry of Environment and Forests.
  29. 29. ʺSub‐rule 2ʺ described that subjected to obtain approval under sub‐rule (1),  the notifier could apply to the Ministry of Commerce or related other authorities under existing import‐export policy rules for import, export or other commercial uses of GMOs.  ʺSub‐rule 3ʺ reinforced that in case of approval as per sub‐rule (2), Ministry of Environment and Forest has to follow the Act (Environment Conservastion Act, 1995); and the rules under the act, if any, and the guidelines, etc.
  30. 30.  ʺRule 4ʺ described the Implementation of guidelines, etc. to control genetically modified organism and products and to control its detrimental and adverse effects; etc. on environment. However, there is a prerogative that ‐ if there is any contradiction or incoherence with any part of the rules or that of guidelines then related Act would prevail.  ʺRule 5ʺ described that labeling would be required the on the container or cover thereon used for carrying genetically modified organism or products. The provision of labeling under this rule is additional to such requirement stated whatsoever in any other rules.
  31. 31. ʺRule 6ʺ described the provision on receiving supports from various organizations, etc. whenever the committee or Director General would ask for the assistance and support from any ministry, organization, directorate for any emergency response or sometimes, facing the situation of any risk to environment, biodiversity, human health, or dangerous situation or environmental pollution or any kind of accident or probability of an accident caused by genetically modified organism or products developed from this. The Rules authorized that relevant ministry, division, organization or directorate will be bound to come forward for the assistance as requested by the committee or Director General.
  32. 32. ʺRule 7ʺ described the provisions on Informing about the accident, negligence in duty, administrative fines, etc.  The Rule described that if there is any risk on environment, biodiversity, human health or dangerous situation or environmental pollution or any kind of accident caused by genetically modified organism or products, relevant person or organization has to take measures to control it and detail report of such measures have to be submitted to Biosafety Core Committee (BCC) and National Committee on Biosafety (NCB), immediately.  If any dangerous situation or accident arose due to the negligence of any person or organization then the person or organization will be held responsible for such situation.  With serving notice with appropriate cause, National Committee on Biosafety (NCB) will be able to take any kind of legal measures including administrative fines rational to the gravity of the damage caused by the responsible person or organization.
  33. 33. ʺRule 8ʺ described the provision on Plan for addressing the emergency situation.  Under this rule the approved person or organization will have to prepare for facing any possible accident at the site of field trial or any possible accident or emergency situation away from the site and to inform the Field Level Biosafety Committee (FBC) for its implantation and supervision.
  34. 34. ʺRule 9ʺ described the provision on Offence of environmental pollution or damaging neighbourhood management.  This rule described that if genetically modified organism or products cause environmental pollution or damage to neighbourhood management then everyone of producing organization, exporter, importer, store, supplier, retailer of the producing organism or products ‐ will be liable unless they can prove that they do not have direct relationship in that pollution.
  35. 35. ʺRule 10ʺ described the provision of Offence and Penalty.  That any person or organization breach the rule 3 or 5 or causes pollution as described in section 9 will be considered as an offence under this rules and for breaching the subsection 2 of section 15 of the Act, a penalty of 2 (two) years imprisonment or penalty of taka ten thousand or both would be applicable for committing this kind of offence,
  36. 36.  ʺRule 11ʺ described the provision of Appeal where it has been mentioned that if not satisfied by the rule 7, as per section 14 of the act and rules 9, 10 and 11 of Environment Conservation Rules, 1997, the person could move ahead for appeal.  ʺRule 12ʺ described the provision on Review – This rule indicated that if anyone is not satisfied by rule 3 then they may be able to submit application to the Ministry of Environment and Forests or to appropriate authorities for review within 30 (thirty) days of order.
  37. 37. ʺRule 13ʺ described that the Director General or a committee formed by the Director General or under the guidelines will submit a half yearly report to the government about the activities done under this rules. The Rules is available at: http://www.doe‐ in Bangla. An English version is under preparation to be posted into the website.
  38. 38. Documents Developed to Support Biosafety Regulations: SOPs for Confined Field Trial Inspectors Manual for Confined Field Trial Data Recording Formats Guidelines for the safety Assessment of Food derived from GE Crops  BSTI adopted this guidelines as BSTI standards for GE food safety assessment    
  39. 39. Public Education, Awareness and Participation on Decision Making of GMOs       Public Participation has been included in the NBF of Bangladesh as one of the important elements. For Public Education and Awareness on Risks of GMOs, Biosafety Booklet and Leaflet and Posters have been published in Bangla. Modes of Public Consultation has been detailed in NBF A number of Workshop, Seminar on Biosafety have been organized up to divisional level of the country Relevant Department of the Universities and Research Institutes are incorporating Biosafety in their educational courses. NBF implementation project would further strengthen Public Education, Awareness and Public Participation through various activities. 39
  40. 40. Education and Awareness Materials Developed •Biosafety Booklet in Bangla •Biosafety Leaflet in Bangla •Biosafety Posters
  41. 41. R&D endorsed by NCB, so far       TPSP Plasmid for Developing Salinity and Drought Resistant IR-64 (RICE) -Greenhouse Experiment at BRRI Late Blight Resistant Plasmid- pCLD 04541 ( R&D in Lab and Greenhouse) in BARI Confined Field Trial of Bt Eggplant at BARI research stations Confined Field Trial of Late Blight Resistant Potato at BARI research stations Confined Glasshouse Test of Golden Rice at BRRI Edible Vaccine Producing Transgenic Rice in the net house of Biochemistry and Molecular Biology Department, DU
  42. 42. Ways Ahead     Strengthening Monitoring and Enforcement of Biosafety Rules Strengthening relevant government agencies such as border control (customs), quarantine and inspection facilities, and set-up data collection and management facilities Development /Assignment of Reference/ Accredited Laboratories for wide range of safety analysis Establishment of Inter-institutional networks for risk analysis, reporting, communication and management  Full Implementation of NBF is vital
  43. 43. THANK YOU ALL !!!!!!! 50 9/30/2013