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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

Bangladesh as a party to the Cartagena Protocol

Bangladesh signed the Protocol on 24 May 2000 andratified it on 5 February 2004.

The Protocol came into force for Bangladesh on 5May 2004, on the ninetieth day after the date ofdeposit of the instrument of ratification.

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

Biosafety Guidelines of Bangladesh

Biosafety Guidelines of Bangladesh was earlier formulatedby the Ministry of Science and Technology in 1999 andpublished in 2000.

Considering the obligation of the protocol, the Guidelineshave been updated by the Ministry of Environment andForest in the line with the protocol during 2004-2006.

Updating of the Guidelines took into account the NationalPolicy on Biotechnology into consideration and recastedvarious aspects of Risk Assessment and Risk Management inthe light of Cartegena Protocol.

Developments of Biosafety Guidelines

Scope of biosafety guidelines Biosafety guidelines are applicable to all research and

development activities of modern biotechnologyconducted in the laboratories of the governmentresearch institutes, state enterprises, universities,international organizations located in Bangladesh,private companies and non-governmentalorganizations.

It applies to laboratory and field trial, trans-boundarymovement, transit, handling and use of allGMOs/LMOs that may have adverse effects on theconservation and sustainable use of biologicaldiversity, taking also into account risks to humanhealth.

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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

Different Committees under the BiosafetyGuidelines of Bangladesh

National committee on Biosafety (NCB) Biosafety core committee (BCC) Institutional Biosafety committee (IBC) Field level Biosafety committee (FBC)

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:1. The Secretary, Ministry of Environment and Forest

(MOEF) 2. Member Secretary-DD, DOE is nominated by MOEF Members:

Secretary, Ministry of Science, Information and Communication Technology.

Secretary, Ministry of Agriculture Secretary, Ministry of Fisheries an Livestock Secretary, Ministry of Health

Executive Chairman, Bangladesh Agricultural Research CouncilMember (relevant), National Board of Revenue Director General, Directorate of FoodDirector General, Department of EnvironmentChairman, Bangladesh Atomic Energy CommissionDirector General, Fisheries Research InstituteDirector General, Bangladesh Livestock Research InstituteDirector General, Bangladesh Agriculture Research InstituteDirector General, Bangladesh Rice Research InstituteDirector General, Bangladesh Jute Research InstituteDirector, Bangladesh Forest Research InstituteDG, Bangladesh Institute for Nuclear AgricultureDirector, National Institute of BiotechnologyOne 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)

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 riskassessment, risk management and the implementation activities.

Review all existing bilateral and multilateral projects, all researchundertaken by NGO/Private/Public organization.

Review, Monitor and Recommend measures to minimizepotential risks that may result from, import, contained use, fieldtrial and release or introduction of new species, strains or varietiesof GMOs.

Facilitate the institutes/faculties/companies working with GMOsto obtain necessary permission/clearance in favor of theiractivities.

NCB to examine the applications on case-by-case basis.MOEF will notify the decision of NCB to the applicant.

Biosafety Core Committee (BCC)

The biosafety core committee is composed of 8members. 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.

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 releaseand forward recommendations to the NCB for itsconsideration.

Provide technical comments or recommendations to NCB orthe government on policy, legal and technical issues ofBiosafety as and when requested for.

BCC will meet, as and when necessary, preferably onquarterly basis.

BCC shall arrange annual inspection and evaluation ofperformance of all the laboratory engaged in research,development and demonstration (R&DD) of GMOs/LMOs.

BCC may co-opt experts related to specific issues regardingBiosafety as and when required

Institutional Biosafety Committee (IBC)

All institutions engaged in genetic engineering shall have anInstitutional Biosafety Committee (IBC) to evaluate andmonitor the Biosafety aspects of their research.

Where an institution intends to become involved in plannedfield release, members of the IBC should collectively have therange of expertise necessary to supervise and assess theprogram.

Composition of IBCA senior knowledgeable person with adequate experience inbiosafety shall be appointed as the Chairperson. The committeewill be composed of 4 members from amongst the high caliberand experienced scientist of the institute to be appointed by theChairperson according to their expertise in biosafety of thecorresponding modern biotechnological activities, they should beable to evaluate, assess and advise precautionary measures forgenetic engineering work. The IBC represent the most importantcomponent in the domain of biosafely supervising all geneticengineering work in the institute.

Functions of IBCReview 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 ofalternative approaches to attain the purposes/objectives ofthe proposed genetic engineering products/or servicesFormulate and adopt emergency plans covering accidental

spills and personnel contamination resulting from lab andfieldworkReport immediately to the appropriate official in the

concerned organization and to the NCB any significantproblems with the implementation of the guidelines andany significant research-related accidents or illness.Maintain close liaison with the BCC.

Biological Safety Officers

Each institution shall designate at least one scientist asBiosafety Officer (BSO). The Biosafety Officer shouldhave considerable experience on Biosafety issues andemergency counter measures and is expected to haverigorous training on biosafeguards.

BSO monitors the compliance of the guidelines at theinstitution level. BSO has to report regularly to theChairperson of IBC on any matter regarding Biosafetyapplications in the institution.

Honorarium may be paid to the BSO shall bedetermined by the head of the institute.

Field level biosafety committee (FBC)

Field level biosafety committee (FBC) is formed byMoEF when permission for field trial ofGMOs/LMOs is given. NCB will appoint threescientists from relevant institutions onerepresentative from the MoEF to constitute theFBC.

National Biosafety Framework (NBF) of Bangladesh

The National Biosafety Framework (NBF) hasbeen developed following an extensiveassessment of biotechnology and biosafety inBangladesh.

Surveys were conducted on the current use ofmodern biotechnology, existing relevant polices,laws and regulations, capacity building activitiesand existing expertise within the country.

The Framework provides the basis for futureregulation for the management of GMOs inBangladesh.

Elements of the NBF

National Policy and Guidelines on Biosafety Legal Regime Administrative Systems Monitoring and Enforcement Systems Public Participation, Education and

Awareness procedures

Biosafety Administrative System under NBF

Ministry of Environment and ForestsNFP & NCA

BCC

IBC

FBC

BSO

NCB

Concerned Ministries

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

Biosafety Rules of Bangladesh 

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

The Biosafety Rules has been enacted by theMinistry of Environment and Forests on 29August 2012.

As per the gazette notification the Rules istitled as the ʺBangladesh Biosafety Rules,2012ʺ.

The Rules has altogether 13 main Rulesincluding the Title of the Rules.

The Rule ʺ2ʺ describes the definitions ofdifferent ʺTermsʺ as mentioned in the Rules,namely, ʺDirectorateʺ, ʺActʺ, ʺCommitteeʺ,ʺGMOʺ, ʺGuidelinesʺ, Biotechnologyʺ,ʺPollutionʺ, ʺEnvironmentʺ, ʺDirectorGeneralʺ, etc.

In ʺRule 3ʺ, there are three ʺSub‐rulesʺ which describedvarious aspects on the ʺRestrictions of import or exportetc. on genetically modified organism and productsʺ.

ʺSub‐rule 1ʺ described that no person or organizationcan import, export, buy, sell or commercially use anygenetically modified organism or products withoutobtaining permission from the Ministry ofEnvironment and Forests.

However, in order to conduct research or takingresearch project and implementation of the project ongenetically modified organism or products wouldfollow the instructions described in the biosafetyguidelines.

It is also stated in the rules that beforecommercialization of research results, permissionshave to be obtained from the relevant ministries,directorates, if any, etc. upon getting approval from theMinistry of Environment and Forests.

ʺSub‐rule 2ʺ described that subjected to obtainapproval under sub‐rule (1),

the notifier could apply to the Ministry ofCommerce or related other authorities underexisting import‐export policy rules for import,export or other commercial uses of GMOs.

ʺSub‐rule 3ʺ reinforced that in case of approvalas per sub‐rule (2), Ministry of Environmentand Forest has to follow the Act (EnvironmentConservastion Act, 1995); and the rules underthe act, if any, and the guidelines, etc.

ʺRule 4ʺ described the Implementation of guidelines,etc. to control genetically modified organism andproducts and to control its detrimental and adverseeffects; etc. on environment. However, there is aprerogative that ‐ if there is any contradiction orincoherence with any part of the rules or that ofguidelines then related Act would prevail.

ʺRule 5ʺ described that labeling would be requiredthe on the container or cover thereon used for carryinggenetically modified organism or products. Theprovision of labeling under this rule is additional tosuch requirement stated whatsoever in any otherrules.

ʺRule 6ʺ described the provision on receiving supportsfrom various organizations, etc. whenever the committeeor Director General would ask for the assistance andsupport from any ministry, organization, directorate forany emergency response or sometimes, facing thesituation of any risk to environment, biodiversity,human health, or dangerous situation or environmentalpollution or any kind of accident or probability of anaccident caused by genetically modified organism orproducts developed from this. The Rules authorized thatrelevant ministry, division, organization or directoratewill be bound to come forward for the assistance asrequested by the committee or Director General.

ʺRule 7ʺ described the provisions on Informing about theaccident, negligence in duty, administrative fines, etc.

The Rule described that if there is any risk on environment,biodiversity, human health or dangerous situation orenvironmental pollution or any kind of accident caused bygenetically modified organism or products, relevant personor organization has to take measures to control it and detailreport of such measures have to be submitted to BiosafetyCore Committee (BCC) and National Committee onBiosafety (NCB), immediately.

If any dangerous situation or accident arose due to thenegligence of any person or organization then the person ororganization will be held responsible for such situation.

With serving notice with appropriate cause, NationalCommittee on Biosafety (NCB) will be able to take any kindof legal measures including administrative fines rational tothe gravity of the damage caused by the responsible personor organization.

ʺRule 8ʺ described the provision on Plan foraddressing the emergency situation.

Under this rule the approved person ororganization will have to prepare for facing anypossible accident at the site of field trial or anypossible accident or emergency situation awayfrom the site and to inform the Field LevelBiosafety Committee (FBC) for its implantationand supervision.

ʺRule 9ʺ described the provision on Offence ofenvironmental pollution or damagingneighbourhood management.

This rule described that if geneticallymodified organism or products causeenvironmental pollution or damage toneighbourhood management then everyone ofproducing organization, exporter, importer,store, supplier, retailer of the producingorganism or products ‐ will be liable unlessthey can prove that they do not have directrelationship in that pollution.

ʺRule 10ʺ described the provision of Offenceand Penalty.

That any person or organization breach therule 3 or 5 or causes pollution as described insection 9 will be considered as an offenceunder this rules and for breaching thesubsection 2 of section 15 of the Act, apenalty of 2 (two) years imprisonment orpenalty of taka ten thousand or both wouldbe applicable for committing this kind ofoffence,

ʺRule 11ʺ described the provision of Appealwhere it has been mentioned that if notsatisfied by the rule 7, as per section 14 of theact and rules 9, 10 and 11 of EnvironmentConservation Rules, 1997, the person couldmove ahead for appeal.

ʺRule 12ʺ described the provision on Review –This rule indicated that if anyone is notsatisfied by rule 3 then they may be able tosubmit application to the Ministry ofEnvironment and Forests or to appropriateauthorities for review within 30 (thirty) days oforder.

ʺRule 13ʺ described that the Director General ora committee formed by the Director General orunder the guidelines will submit a half yearlyreport to the government about the activitiesdone under this rules.

The Rules is available at: http://www.doe‐bd.orgin Bangla. An English version is underpreparation to be posted into the website.

Documents Developed to Support BiosafetyRegulations:

SOPs for Confined Field Trial Inspectors Manual for Confined Field Trial Data Recording Formats Guidelines for the safety Assessment of Food

derived from GE CropsBSTI adopted this guidelines as BSTI

standards for GE food safety assessment

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.

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•Biosafety Booklet in Bangla•Biosafety Leaflet in Bangla•Biosafety Posters

Education and Awareness Materials Developed

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

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 andmanagement

Full Implementation of NBF is vital

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THANK YOU ALL!!!!!!!