Required Report: Required - Public Distribution

Date: December 04, 2023
Report Number:

BG2023-0020

Report Name: Agricultural Biotechnology Annual
Country: Bangladesh
Post: Dhaka
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

Tanvir Hossain

Approved By: Sarah Gilleski
Report Highlights:
Bangladesh is pursuing advanced biotechnological crop research. In June 2023, the Bangladesh
Academy of Science submitted a “Standard Operating Procedures for Research and Release of Genome
Edited Plants of Categories SDN-1 and SDN-2 in Bangladesh” to the Bangladesh Agricultural ResearchCouncil, Ministry of Agriculture. This SOP is currently under review by the Ministry of Agriculture.
Additionally in 2023, the Cotton Development Board released two bollworm resistant hybrid Bt cotton
varieties for limited cultivation. Scientists from various organizations are engaged in developing climate
resilient gene transferred and gene edited rice, eggplant, tomato, and potato varieties.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYExecutive Summary:
Bangladesh is advancing towards the recognition of innovative biotechnology. In June 2023, aBangladesh Academy of Science lead expert team submitted a “Standard Operating Procedures for
Research and Release of Genome Edited Plants of Categories SDN-1 and SDN-2 in Bangladesh” to the
Bangladesh Agricultural Research Council, Ministry of Agriculture (MOA). The MOA is currently
conducting stakeholder meetings and is reviewing the SOPs.
Ten years after releasing the first Bt Brinjal variety in Bangladesh, the Cotton Development Board
received approval for two bollworm resistant hybrid Bt cotton varieties. Bangladesh officials, regulators,
and scientists are showing strong interest in modern science-based crop research.
The public research institutions and universities of Bangladesh are making continued progress incultivating climate resilient crops through precision biotechnology. Even though the vitamin A enriched
Golden Rice has been waiting for regulatory approval for six years, rice scientists have initiated more
research to develop climate smart biotic and abiotic stress resistant rice varieties. The research for beta
carotene-fortified eggplant, and leaf curl virus resistant tomato and the confined field trials fordeveloping late blight resistant potato are progressing under the supervision of biosafety regulators.
However, no national or international life science corporations have submitted applications for theauthorization of any events for commercial use. The uncertainty of government approval for Golden
Rice, the delay in the approval process due to the limited capacity of the government’s biosafety
regulatory authority, and lack of awareness of the importance of approval and commercial use of GE
products are the main factors preventing local industry from pursuing transboundary movement andcommercial use approval. The research and development of animal and microbial biotechnology in
Bangladesh is underdeveloped.

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TABLE OF CONTENTS
CHAPTER 1: PLANT BIOTECHNOLOGYPART A: Production and Trade
PART B: Policy
PART C: Marketing
CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: Production and Trade
PART E: Policy
PART F: Marketing
CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: Production and Trade
PART H: Policy
PART I: Marketing
APPENDIX A – Bt Cotton Release Announcement

3List of Acronyms
BARI
BCC
BG
BPH
BRRI
BSO
BSTI
Bt
CDB
CFT
Codex
CPB
CS
DU
ERA
FBC
GE
GI
IBC
IPPC
JKAL/ JKAGL
LMOs
MAB
MDHAR
MOA
MOEFCC
MOFL
MOH
NBF
NIB
NTCCB
NTCFLB
NTFBB
RIB
SBE
SP
TGMS
TLS
ToLCV
USAID

Bangladesh Agriculture Research Institute
Biosafety Core Committee
Biosafety Guidelines
brown planthopper
Bangladesh Rice Research Institute
Biological Safety Officers
Bangladesh Standardization and Testing InstituteBacillus thuringiensis
Coton Development Board
Confined Field Trial
Codex Alimentarius
Cartagena Protocol on Biosafety
Certified Seed
University of Dhaka
Environmental Risk Assessment
Field Level Biosafety Committee
Genetically Engineered
Glycemic Index
Institutional Biosafety Committee
International Plant Protection Convention
JK Agri Genetics Limited
Living Modified Organisms
Marker Assisted BackcrossMonodehydroascorbate reductase
Ministry of Agriculture
Ministry of Environment, Forest, and Climate Change
Ministry of Fisheries and Livestock
Ministry of HealthNational Biosafety Framework
National Institute of Biotechnology
National Technical Committee on Crop Biotechnology
National Technical Committee on Fisheries and Livestock
Biotechnology
National Task Force on Biotechnology of Bangladesh
Refuge in Bag
Starch branching enzymes
Separate Pack
Thermo-sensitive Genic Male Sterile
Truthfully labeled seed
Tomato Leaf Curl Virus
U.S. Agency for International Development

4CHAPTER 1: PLANT BIOTECHNOLOGYPART A: PRODUCTION AND TRADEa) PRODUCT DEVELOPMENT:The Cotton Development Board (CDB), the Bangladesh Agricultural Research Institute (BARI), theBangladesh Rice Research Institute (BRRI) and National Institute of Biotechnology (NIB) are theleading advanced crop biotechnology research organizations in Bangladesh. Public universities,
including the University of Dhaka (DU), are also conducting limited genetically engineered (GE)biotechnology research.
CottonThe Cotton Development Board's (CDB) application to release the hybrid GE Bacillus thuringiensis (Bt)
Cotton hybrid varieties JKCH 1947 Bt and JKCH 1050 Bt, developed by JK Agri Genetics Ltd. (JKALor JKAGL), India, was approved by the National Committee on Biosafety (NCB) on May 31, 2023.
In crop year 2023-24, the CDB started limited cultivation for demonstration trials of two Bt cotton
varieties on 138 farmers’ plots (0.25 acres/plot) and 30 on farm research plots (0.11 acre/plot) covering a
total 37.8 acres located in 13 cotton production zones and five cotton research centers; Jashore,
Chuadanga, Kushtia, Jhenaidah Rangpur, Bogura, Rajshahi, Thakurgaon, Dhaka, Mymensingh,
Khagrachari, Bandarban, Rangamati, Gazipur, and Dinajpur districts..
After a successful confined field trial (CFT) in a single location in December 2020, the CDB received
approval in September 2021 to continue with multilocation CFTs. Based on the success of CFTs, the
CDB’s Institutional Biosafety Committee (IBC) and the National Technical Committee on Crop
Biotechnology (NTCCB) recommended the field release of JKCH 1947 Bt and JKCH 1050 Bt in 2022.
Table 1: Yield and Yield Contributing Characters of Bt cotton and Non-Bt cotton
Plant height
Boll per Plant
Individual Boll
Seed Cotton
Variety(cm)(Number)
Weight (g)Yield (g/plant)
JK 1947 Bt

105.9

4.9

4.0

19.6

JK 1050 Bt

123.2

8.7

3.15

27.4

2.75

4.07

11.2

CB-9 (non-Bt)
99.3
Source: Cotton Development Board

The official approval of Bt cotton’s limited release for cultivation at the field level was notified withconditions issued by Ministry of Environment, Forest and Climate Change (MOEFCC), on May 31,
2023 (see Appendix A).
Eggplant
BARI was the first public institute to release four GE Bacillus thuringiensis (Bt) eggplant (brinjal)(Bangla name “begun”) varieties in Bangladesh in 2013.

5

BARI and Maharashtra Hybrid Seeds Company Limited signed an agreement for technical cooperation
for the introgression of the Cry1Ac gene in two popular eggplant varieties: BARI Begun-10, and BARI
Begun-11. These two events are helping develop wilt tolerant and year-round Bt eggplant varieties.
Maharashtra Hybrid Seeds Company is currently conducting the research and there is possibility ofhanding over the seed in 2024.
In 2019, the National Institute of Biotechnology (NIB) started developing beta carotene-fortified
eggplant through genetic transformation by multiple genes. NIB obtained seven transgenic eggplantlines and second-generation research is going on.
TomatoTomatoes are one of the most important year-round vegetable crops in Bangladesh. However, tomato
leaf curl virus (ToLCV) causes serious yield loss and is the biggest threat to domestic tomato productionin the country. In response, BARI is leading an effort to develop a ToLCV-resistant tomato variety
started in 2009. Researchers inserted two reporter genes, viz. gusA and Cycle 3 gfp (gfpC3), into each of
the binary vector backbones, using potato Ubi3 and CaMV35S promoter-terminator cassettes for
optimization of the tomato transformation protocol.
PotatoBARI has been working with Michigan State University since 2021 under the Feed the Future
Biotechnology Potato Partnership project, funded by the U.S. Agency for International Development(USAID) to develop a late blight resistant 3R-gene GE potato variety truncated Rpi-mcq1, Rpi-blb2, andRpi-vnt1.1. These three genes have been isolated from wild potatoes and inserted in farmers’ preferred
Diamant variety. Based on the application submitted to NTCCB in August 2022, and the NCB approval,
BARI started CFTs at four research stations (Gazipur, Rangpur, Munshiganj and Chattogram) in 2023.
Rice
The Plant Breeding Division of BRRI completed the biosafety evaluation of Golden Rice line GR2E
BRRI dhan29 and submitted the dossier in November 2017 to the NTCCB of the Ministry of Agriculture(MOA) for the environmental and food safety assessment. The National Committee on Biosafety (NCB)
and the Biosafety Core Committee (BCC) are reviewing the dossier. The process has been delayed formore than six years without approval. For additional information on the history of Golden Ricedevelopment in Bangladesh, refer to the 2022 Agricultural Biotechnology Annual Report.
In addition to their work on Golden Rice, BRRI is advancing in developing first-generation
CRISPR/Cas9 target gene-edited rice lines with traits to effectively fight against rice blast disease,insect-like brown planthopper (BPH), and salinity intrusion.
The research division is developing salt tolerant rice by knocking out the OsRR22 gene. The division is
also applying CRISPR/Cas9-targeted mutagenesis on the fragrance gene BADH2 to develop more highyielding aromatic rice varieties.
With an aim to develop heat or temperature adaptive/tolerant rice variety, BRRI is developing thermosensitive genic male sterile (TGMS) lines employing the CRISPR/Cas9 gene editing technology tomodify the gene TMS5. BRRI is also using CRISPR/Cas9 mediated genome editing to transform the6resistant gene OsERF922 for developing a rice blast disease resistant variety. The rice transformation
research was completed in 2022 and sequencing and artificial inoculation is in progress. The scientists
are also working to knock out CYP71A1 (encoding tryptamine 5-hydroxylase) by CRISPR/Cas9 todevelop brown planthopper (BPH) resistant rice variety.
Scientists of the Biotechnology Division of BRRI are involved in upgrading the most popular rice
variety BRRI dhan29 into a saline tolerant transgenic rice variety transforming with salt tolerant genes
GlyI (Glyoxalase I) and GlyII (Glyoxalase II). They are also developing another salt tolerant transgenic
rice variety through crossed between transgenic rice plant containing salt tolerant gene AeMDHAR(Monodehydroascorbate reductase (MDHAR)) from mangrove plant (Acanthus ebracteatus) and BRRI
dhan28 and BRRI dhan29. The salt tolerant GE rice variety will be beneficial to farmers in coastal areas
where sea level rise and salinity intrusion are major threats from climate change.
The development of a saline tolerant transgenic rice variety from BRRI dhan86, BRRI dhan87 andBRRI dhan89 through the isolation and cloning of the most promising salt tolerant Vacuolar H[+] ATPase subunit c gene (PVA1) is progressing.
A research team of the Department of Biochemistry and Molecular Biology, University of Dhaka (DU)
developed some drought and salt-tolerant and high-yielding commercial rice lines from two varieties
BRRI dhan27 and BRRI dhan55 using cloning and transformation technologies. In 2022, DU signed an
MOU with the National Institute of Biotechnology (NIB) for laboratory and field support for testing theperformance of these lines following a biosafety protocol. In 2022, NIB applied to the NTCCB of the
MOA for contained trial approval (Table 2). Finally, in September 2023, BCC recommended starting thecontained trial and the application is waiting final approval from NCB.
Table 2: NIB Events Submitted for Field Trials
Event No. Name of the gene
Rice Variety

Stage

Lines

TraitsDrought and salt tolerant atseedling and reproductiveneeds half water for same yield

1

At-HRD cDNA

BRRI Dhan 27

T5

300

2

PDH-AtHRD cDNA

BRRI Dhan 27

T3

50

Drought and salt tolerant atseedling and reproductive

3

Rice SNAC1 cDNA

BRRI Dhan 55

T5

300

Drought and salt tolerant atseedling and reproductive

4

RD29-Rice SNAC1

BRRI Dhan 55

T4

300

Drought-inducible promoterdrought tolerant at seedling andreproductive

5

Rice G-protein βsubunit
cDNA

BRRI Dhan 55

T5

300

Salt and heat tolerant atseedling and reproductive

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Rice with a low Glycemic Index (GI) value and high amylose content rice is preferred by diabetic
patients to avoid a sudden rise in glucose in the bloodstream. The NIB crop biotech division isdeveloping high amylose content and resistant starch in high-yielding rice through multiplex
CRISPR/Cas9.
b. COMMERCIAL PRODUCTION:
Eggplant
The first GE crop in Bangladesh, Bt eggplant is in mass commercial production with seed production
occurring. BARI produces breeder seeds and sells them to the Bangladesh Agricultural Development
Corporation (BADC) and NGOs for distribution. BADC produces foundation seeds on its own farms
and supplies to contract growers to produce certified seeds (CS) and truthfully labeled seeds (TLS).
These seeds are then and sold to farmers. The Department of Agricultural Extension (DAE) encourages
and helps farmers cultivate Bt eggplant.
From June 2022 to July 2023, BADC produced 1019 kilograms (kg) of seed for seed dealers and farmers(Table 1). The dealer price for Bt eggplant foundation seed was BDT 1500 /kg ($14/kg) and TLS pricewas BDT 1400/kg ($13/kg). Dealers sold foundation seed to the farmers with a retail price of BDT
1700/kg ($15/kg) and TLS seeds at BDT 1600/kg ($14/kg).
In 2022-2023, based on the volume of seed sold to farmers, Bt eggplant was cultivated on 6885 acres ofland, covering about 8.1 percent of total winter season eggplant acreage (Table 3). This is a decline of
15 percent in planted area due to decreased seed supply to the farmers. DAE didn’t supply seeds tofarmers in 2022-23 due to lack of funding.
Table 3: Bt Brinjal Seed Production
Breeder Seed Produced by BARI (kg)YearWith project funds With GoB funds
2013-14
8.10
2014-1590
2015-16661
75
2016-171068
475
2017-1867450
2018-1978
2019-20
2020-21902021-2275
2022-23
498

Foundation Seed Produced by BADC (kg)With GoB funds

284
134
179
278
213
275
1019

Source: Feed the Future South Asia Eggplant Improvement Partnership, USAID
Note: BADC produced Bt Begun 4 seed for marketing

Table 4: Seed Distributed to Farmers
Year
BARI
DAE

Seed Distributed (kg)
BADC

Total

8

2013-14
2014-152015-16
2016-172017-18
2018-192019-20
2020-212021-222022-23

0.6
3.24
2.5
5.12
5.81
2.5
2
17.5
260
185

0
0
0
120
152.02141.54
178
734
0
0

0
0
0
0
194.3
134
179
277
275
274

0.6
3.24
2.5
125.12352.13278.04
359
1029
925
459

Source: Feed the Future South Asia Eggplant Improvement Partnership, USAID

Chart 1: Bt brinjal production area (acre)
18000
Cultivated Land (acres)

16000
14000
12000
10000
8000
6000

4000
2000
0
2013-14 2014-15 2015-16 2016-17 2017-18 2018-19 2019-20 2020-21 2021-22 2022-23
Years

Source: Feed the Future South Asia Eggplant Improvement Partnership, USAID
Note: Acreage is estimated on the basis of volume of seed sold and seed packet weight is 10 g recommended for 0.15 - 0.20
acres of land.

c. EXPORTS:
The GoB has not initiated any third country application process to export GE crops.
d. IMPORTS:
According to the 2012 Bangladesh Biosafety Rules, the MOEFCC must approve a GE product before it
can be imported and commercially sold or cultivated within Bangladesh (see Regulatory Framework
section below). Contacts have not reported any third country applications for importation forcommercial food, feed use or cultivation purpose.
The 2007 Biosafety Guidelines (BG) Chapter III, notes that an exporter or the country of export needs toapply for approval to export a GE product to Bangladesh. Following Article 11 of the Cartagena
Protocol on Biosafety, the 2017 User’s Guide to the Biosafety Regulatory Process for Genetically9Engineered Plants in Bangladesh, explains the process of getting import permit to import “living
modified organisms” (LMOs) (in this case analogous to seeds of GM plants) for the purpose of direct
use as food, animal feed or for processing. An applicant needs to apply for an import permit through the
NCB of MOEFCC. Based on the final decision of Biosafety Core Committee (BCC), the NCB will issue
the notification of approval for single import/multiple import/the duration of the approval.
As a signatory of the Cartagena Protocol on Biosafety (CPB), Bangladesh follows the requirement for
Advanced Informed Agreement (AIA) whenever an LMO is going to be imported from another country,with the intention of releasing the LMO into the environment in the country of import. In the case whereBangladesh is the country of import, the application may come from an exporter or from the party where
the export originates. The application for import of a biotech crop should be submitted to the MOEFCC
NCB in the then be forwarded to the MOA for review by the NTCCB.
Chart 2: AIA Procedure When Country is the Importer
Exporter/Party of Export

National Committee on Biosafety

National Technical Committeeof Crop Biotechnology

Core Committee on
Crop Biotechnology

National Committee on
Biosafety

Biosafety Core
Committee

e. FOOD AID:
Bangladesh doesn’t import GE products as food aid.
f. TRADE BARRIERS:
No life sciences companies have applied for GE product approval. The GoB is not encouraging local
private life science companies to do GE research and apply for the release and cultivation approvals.
Imported GE products require the GOB’s approval, but importers of bulk commodities are notencouraged to go through the approval process for importing or use for commercial processing or
marketing purposes. Labeling requirements and GE product certification (Non-transgenic certification)
could create challenges for importers.
PART B: POLICY

10

a. REGULATORY FRAMEWORK:The National Task Force on Biotechnology of Bangladesh (NTFBB), led by the Prime Minister, is the
apex body of five national-level biotechnology committees that provides final approval for all
biotechnology-related policies. The five national-level biotechnology technical committees coverbiodiversity, biosafety, crop biotechnology, livestock and fisheries biotechnology, and medical
biotechnology. Among other functions, these national committees receive and review biotechnology
applications.
An unofficial translation of the 2012 Bangladesh Biosafety Rules notes that: “The Ministry ofEnvironment and Forests shall follow the [Environmental Conservation] Act and other concerned rules
formulated under the Act, if any, and the provisions of the [Biosafety] Guidelines in case of issuing
approval.” Moreover, the document states, “an individual or a firm shall not import, export, buy, or sell
any genetically modified organism or products or use them [without any approval from the Ministry ofEnvironment and Forests].” Bangladesh is a signatory of the Cartagena Protocol on Biosafety), and the2007 Biosafety Guidelines (BG), closely follows the GE application approval processes contained in the
Cartagena Protocol.
MOEFCC is the lead ministry in charge of implementing the Cartagena Protocol and established the
NCB as the final decision-making body for approving biotechnology applications. The NCB includes 21
members from various ministries including the MOA, Ministry of Science and Technology (MOST),
Ministry of Fisheries and Livestock (MOFL), and heads of national research institutes and departments.
Other important committees include: Biosafety Core Committee (BCC), which provides the NCB with technical comments andrecommendations on GE applications and advises on other GE issues;
 Institutional Biosafety Committee (IBC), which evaluates and monitors research anddevelopment activities in research institutions; and Field Level Biosafety Committee (FBC), which monitors field trials for GE plants, animals, or
fish.
Information on the biotechnology approval process can be found in Section 3.1.8 of the 2007 BG,
entitled “Procedures and Guidelines for Obtaining Permission in Favor of Working with GMOs.” GE
applications are divided into three categories: 1) GE plants, animals, and fish, 2) GE products used forfood, feed, or processing, and 3) laboratory research. Each category provides information on datarequirements, field trials, or other provisions. Section 4.1.4.5 of the 2007 National Biosafety Frameworkprovides some information on how many days it will take for a decision to be made on a biotechnology
application. However, the overall timeline is unclear and could be 360 days or more.
The 2007 National Biosafety Framework and 2017 User’s Guide to Biosafety Regulatory Process for
Genetically Engineered Plants in Bangladesh provide information on the step-by-step approval
procedure for CFTs, cultivation, and importation of “living modified organisms” (LMOs) (in this caseanalogous to seeds of GE plants) for direct use as food, feed, or processing.
According to the User’s Guide, a biotech application for CFTs or experimental cultivation can besubmitted to the IBC and an application for the approval of importation can be submitted to11

NCB/MOEFCC directly. The IBC forwards the application to the national technical committee for
evaluation. Applications may be submitted at any time of the year.
The subject-oriented national technical committees review the dossiers for field trials and cultivationand submit any recommendations or concerns to the NCB. After evaluating the application, in mostcases, the NCB sends the dossier to the BCC for further review and recommends a decision. The BCC
reviews the application, analyzes, and evaluates any relevant information, including the data supplied by
the applicant. Following the technical review report, the case is presented to the NCB, which provides
the final decision.
After obtaining approval from the NCB, according to an unofficial translation of the 2012 BR, “[the]application may be filed to the Ministry of Commerce or other concerned authorities to permit importand export or use commercially under the existing import and export policies of the country.” Current
import and export policies that regulate trade and may trigger additional approvals for GE products
include: 2021-24 Import Policy Order; 2021-24 Export Policy Order; 2018 Plant Quarantine Rules; and2005 Animal Quarantine Act; and 2017 Packaged Food Labeling Regulations from the Bangladesh Food
Safety Authority (BFSA).
Table 6: Ministries Involved in Biotechnology
Ministry
Responsibility/Role
Ministry of Environment and Forest Leads the NCB. The Secretary of MOEFCC is the Chairperson
and Climate Change (MOEFCC)
of the NCB.
Leads the National Technical Committee on Biodiversity.
Houses the BCC.
Competent national authority and focal point to implement the
CPB of Biosafety.
Lead Ministry for implementing the Bangladesh Biosafety
Rules, 2012.
Ministry of Agriculture (MOA)

Ministry of Fisheries and Livestock(MOFL)

Leads the NTCCB, which evaluates and recommends a decision
on GE crop applications.
The Secretary of MOA is the chairperson of the NTCCB.
Leads the National Technical Committee on Fisheries andLivestock Biotechnology (NTCFLB), which evaluates andrecommends a decision on GE animals and animal products
applications.
The Secretary of MOFL is the chairman of the NTCFLB.

12

Ministry
Ministry of Health(MOH)

Responsibility/Role
Leads the National Technical Committee on Medical
Biotechnology (NTCMB), which evaluates and recommends
a decision on GE medical applications.
The Secretary of MOH is the chairman of the NTCMB.

Links to Bangladesh’s regulations, policies, and other documents on biotechnology are below:
 2007 National Biosafety Frameworko The National Biosafety Framework (NBF) is a combination of policy, legal,
administrative, and technical instruments to ensure an adequate level of protectionin the field of the safe transfer, handling, and use of GMOs resulting from modern
biotechnology that may have adverse effects on the conservation and sustainable
use of biological diversity, taking also into account risks to human health.
 2007 Biosafety Guidelines of Bangladesho The Biosafety Guidelines are applicable to all research and development activities
of modern biotechnology conducted in laboratories of the government research
institutes, state enterprises, universities, international organizations located in
Bangladesh, private companies, or non-governmental organizations. The
guidelines contribute to ensuring an adequate level of protection in the laboratory,
field trial, safe transfer, handling, use and trans boundary movement, transit,
handling, and use of GMOs/LMOs as part of modern biotechnology.
 2012 National Biotechnology Policy (Bangla)
 2012 National Biotechnology Action Plan
 2012 Bangladesh Biosafety Rules (Proposed for Amendments)
 2013 Bangladesh Standard for Guidelines for the Safety Assessment of Foods Derived
from Genetically Engineered Plants;
o The 2013 Guidelines for the Safety Assessment of Foods Derived from
Genetically Engineered Plants is consistent with Codex standards. The document
notes it was written to “provide technical guidance on the safety assessment
process for whole foods, food products, and foods used as ingredients, that arederived from GE plant sources.” The guideline states that the BangladeshStandardization and Testing Institute (BSTI) has the lead in assessing the safety of
GE foods derived from GE plants.
 Work Plan for the National Biotechnology Policy 2016 Guidelines for the Environmental Risk Assessment (ERA) of GeneticallyEngineered Plants (Bangla)o Used for planning and conducting an environmental risk assessment for an open
release in Bangladesh. These guidelines cover both GE plants domesticallydeveloped for cultivation and propagable forms of GE plants imported for food,feed, and processing. This will not be applicable to non-propagable GE plants for
direct use in food, feed, or processing (e.g., flour, starch, crushed meal, and oil
derived from GE plants), environmental introduction of non-plant geneticallyengineered organisms (e.g., recombinant micro-organisms), and experimental GE
plants for confined field trials.
13














2017 User’s Guide to Biosafety Regulatory Process for Genetically Engineered Plants in
Bangladesh,o Provides guidance on submitting an application for confined field trials or
importation of LMOs for direct use as food, animal feed or for processing or
cultivation.
2017 Training manual on biosafety
2018 Emergency Response Procedures for GMOs in Bangladesh
2019 Monitoring and Enforcement Manual for GMO (draft)
2019 Manual on GMO Detection and Good Laboratory Practice (draft)
2019 Harmonization of Bangladesh’s Food Safety Standards with Codex Standards andother International Best Practices (draft)
2020 Biosafety Policy of Bangladesh (draft)
2020 Biosafety Guideline of Bangladesh (draft)
2021 National Biotechnology Policy (draft)
2021 National Biotechnology Policy Action Plan (draft)
Guidelines for Monitoring Confined Field Trial (CFT) of Genetically Engineered Plants
in Bangladesh (draft)

The MOEFCC drafted a 2020 Biosafety Policy of Bangladesh, which is subject to GoB approval and theministry has published standard operating procedures (SOP) for:
 SOP -1: Transport of Genetically Engineered Plant Material
 SOP-2: Storage of Genetically Engineered Plant Material
 SOP-3: Compliance Management of Current Season Field Trials of GeneticallyEngineered Eggplant
 SOP-3: Compliance Management of Current Season Field Trials of GeneticallyEngineered GE Cotton
 SOP-4: Termination/Harvest and Disposition of Genetically Engineered Plant Material
 SOP-5: Post-Harvest Management of Field Trial Sites of Genetically Engineered
Eggplant
 SOP-5: Post-Harvest Management of Field Trial Sites of Genetically Engineered GE
Cotton SOP-6: Contents, placement, and renewal of compliance document binder
Table 7: Terms Used in Different Acts and Rules
Legal Term
Legal term
Laws and(in official language)(in English)
Regulations where
Term is Used
Cowligoto vabe
Genetically
2012 Bangladesh
poribortito gene
Modified
Biosafety Rules
Organism(Proposed forAmendments)

Legal Definition(in English)
Any creature createdthrough application of
biotechnology

14

Genetically Modified
Organism

Genetically
Modified
Organism2018 Plant Quarantine
Rules

An organism synthesized
or innovated by altering
its genetic structure using
genetic engineering

Transgenic

Transgenic

2018 Plant Quarantine
Rules

The material used tomake cells or
microorganisms of a
species by inserting one
or more genetic materialof different species’

Genetically Modified
Food

Genetically
Modified Food2017 Packaged Food
Labelling Act

If the agricultural
product is produced
through a change inhereditary traits, theexpression "Genetically
Modified Food" shouldbe mentioned on thelabel of the packaging.

b. APPROVALS/AUTHORIZATIONS:In 2013, four varieties of Bt eggplant seed were developed by the Bangladesh Agricultural ResearchInstitute (BARI) and have been approved for commercial production. The varieties include: 1) BARI Bt
begun-1 (Bt Uttara); 2) BARI Bt begun-2 (Bt Kajla); 3) BARI Bt begun-3 (Bt Nayantara); and 4) BARI
Bt begun-4 (Bt Iswardi/ISD 006).
c. STACKED or PYRAMIDED EVENT APPROVALS/AUTHORIZATIONS:No separate regulations exist, so developers need to follow the same biosafety rules for approval.
d. FIELD TESTING:
The National Technical Committee on Agriculture Biotechnology and NTCFLB provide a
recommendation to the NCB on whether to allow field testing for GE plants or animals. The FBC
monitors the field trials and collects data during the biotechnology approval process.
e. INNOVATIVE BIOTECHNOLOGIES:
Although researchers have started using genome editing tools for crop variety development, Bangladesh
has not yet decided to regulate innovative biotechnology. A Bangladesh Academy of Science lead expert
team submitted a “Standard Operating Procedures for Research and Release of Genome Edited Plants ofCategories SDN-1 and SDN-2 in Bangladesh” to the Bangladesh Agricultural Research Council,
Ministry of Agriculture in June 2023. The Ministry is following the review process by consulting withthe related research organization and experts.

15

f. COEXISTENCE:
Currently there are no specific regulations or policies that address coexistence.
g. LABELING AND TRACABILITY:
An unofficial translation of the 2012 BR states: “The box or package carrying the Genetically Modified
Organism or products shall bear the complete information of its identification on them or bear labelingthat states that the product is Genetically Modified Organism or that has been produced from
Genetically Modified Organism, and it shall be done additionally, whatever stated in other Acts on thematter.”Additional requirements are specified in Section 3.2.2.4 of the 2007 BG and the 2006 Product Labeling
Policy. These rules are not functional for GE products because there are no GoB approved packaged orprocessed commodities derived from GE raw materials. Farmers usually do not sell vegetables withlabels. Most consumers buy loose vegetables from the wet markets and Bt brinjal is sold without special
labeling.
h. MONITORING AND TESTING:
On behalf of the NCB, the Field Level Biosafety Committee monitors approved GE crops for
performance and impact on biodiversity and the environment. The country tests GE traits of plantvarieties that are imported for field trials, research, and commercial release. An applicant must submit
information on testing methodologies and reference materials supplied by the developer. The NCB
published SOPs on the transportation, storage, harvest, and compliance management of current season
monitoring, termination-harvest and disposition, and post-harvest management.
The IBC FBC and Biological Safety Officers (BSOs) ensure safe management of biosafety activities in
the laboratories and in the field. Per the 2007 BG, “the IBC and BSOs will ensure that all personnel
working on genetic engineering are well aware of the risks and hazards involved in their work and thatthe facilities and instruments governing ambient Biosafety are in order. The BSO will adopt a system ofreporting laboratory accidents, occupational hazards and the subsequent emergency measures
undertaken in dealing with such incidents.”
i. LOW LEVEL PRESENCE (LLP) POLICY:
Currently there are no regulations or policies that address low level presence.
j. ADDITIONAL REGULATORY REQUIREMENTS:
Variety registration is required for approved GE crop variety seed marketing. The 2007 BG and the2012 Bangladesh Biosafety Rules need to be followed for seed registration and marketing. According to
the 2018 Seed Policy of Bangladesh (Draft), all plant varieties need to be registered with the National
Seed Board before commercial production and marketing. Except for controlled crops (rice, wheat, jute,potato, and sugarcane), registration does not involve additional testing.
According to Section 3.2.2.3 of the 2007 BG, the country of export must certify that a GE product used
for food, processing, or feed is “fit for consumption” and either “does not contain harmful ingredients”
or “is free from all kinds of harmful germs.” Moreover, the certificate should mention the “age group forwhich the item is eligible for consumption.”16

k. INTELLECTUAL PROPERTY RIGHTS (IPR):
Bangladesh lacks effective legislation or enforcement mechanisms to protect intellectual property rights.
Due to the lack of proper enforcement, IPR infringement is very common in different product markets.
Bangladesh has the Department of Patents, Design, and Trademarks, and the Copyright Office. It has
international membership in the World Intellectual Property Organization and acceded to the Paris
Convention on Intellectual Property in 1991 and Trade-Related Aspects of Intellectual Property Rights
agreements. Bangladesh has national regulations on IP, including: 2023 Patents and Designs Act; 2015
Trademark Rules; 2009 Trademark Act; 2000 Copyright Act; and 2013 Geographical Indication(Registration and Protection) Act.
l. CARTAGENA PROTOCOL RATIFICATION:
Bangladesh is a signatory to the Cartagena Protocol. It ratified the protocol in 2004. The 2012 BR and2007 BG create a framework to implement the Cartegena Protocol.
m. INTERNATIONAL TREATIES and FORUMS:
Bangladesh is a member of the International Plant Protection Convention (IPPC) and Codex
Alimentarius (Codex). Activity in these two international bodies has been limited.
n. RELATED ISSUES: No information available.
PART C: MARKETING
a. PUBLIC/PRIVATE OPINIONS:
There is a general recognition within Bangladesh’s scientific and policy community that agricultural
biotechnology is a tool to ensure food security in light of the country’s growing population.
Nevertheless, some local advocacy groups publicly question GE technology.
b. MARKET ACCEPTANCE/STUDIES:
Bangladeshi citizens are not well informed about GE products. The quality of publicly disseminatedinformation is not always accurate or supported with sound science.
GE seeds for planting may experience difficulty gaining market acceptability unless proper knowledge
sharing and extension activities are conducted by multinational seed companies. The lack of purchasing
power in the farming sector, due to the predominance of small and marginal farmers, may also restrict
the wider use of GE seeds, which farmers believe cost more than non-GE varieties.

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CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: PRODUCTION AND TRADE
a. PRODUCT DEVELOPMENT:
Bangladesh has not conducted cloning or GE animal research. The private sector is unable to engage in
genetic engineering or cloning because of the lack of policies in place. The private sector has not
expressed interest in GE animal research to date. The Bangladesh Livestock Research Institution may, inthe future, undertake research. According to the 2012 Action Plan of the National Biotechnology Policy,
the GoB expressed interest in supporting GE animal research for Bangladesh research institutions,although it is unclear whether financing is available or not.
b. COMMERCIAL PRODUCTION: No information available.
c. EXPORTS: Bangladesh does not export any GE animals or animal products.
d. IMPORTS: Bangladesh does not import any GE animals or animal products.
e. TRADE BARRIERS: No information available.
PART E: POLICY
a. REGULATORY FRAMEWORK:The 2012 BR and 2007 BG also apply for GE animal research, commercialization, and trade. The 2006
National Guidelines for Fish and Animal Biotechnology establish objectives to promote the: 1)
acquisition of knowledge of and skills in animal and fish biotechnology; and 2) development ofbiotechnology tools in the fields of fisheries and livestock to optimize safety and acceptability. As there
are no applications submitted to the NCB for the approval of GE livestock and fisheries products, the
NTCFLB is essentially inactive.
b. APPROVALS/AUTHORIZATIONS: No information available.
c. INNOVATIVE BIOTECHNOLOGIES:
Bangladesh has not decided to regulate innovative biotechnology, such as genome editing, in animals.
d. LABELING AND TRACEABILITY: No information available.
e. INTELLECTUAL PROPERTY RIGHTS (IPR): No information available.
f. INTERNATIONAL TREATIES and FORUMS:
Bangladesh is member of the World Organization for Animal Health and Codex. Participation in these
two international bodies has been limited.
g. RELATED ISSUES: No information available.
PART F: MARKETING

18

a. PUBLIC/PRIVATE OPINIONS:
Most Bangladeshis have little or no knowledge about GE animals. For an often religiously conservative
society such as Bangladesh, public perception of animal biotechnology and cloning is likely to besensitive.
b. MARKET ACCEPTANCE/STUDIES: No information available.

19

CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: PRODUCTION AND TRADEa) COMMERCIAL PRODUCTION:
Bangladesh does not commercially produce any food ingredients derived from microbial biotechnology.
b) EXPORTS:
Bangladesh does not export GE microbes nor any product that contains microbial biotech-derived foodingredients to the United States or any other country.
c) IMPORTS:
Bangladesh imports microbial biotech-derived food ingredients, but import data is not available. Thereis no agency directly regulating biotech-derived food ingredients. A list of 88 product standards(English) is regulated and monitored by the BSTI, where there is a possibility of having microbial
biotech-derived food ingredients.
d) TRADE BARRIERS:
There are no known trade barriers that affect U.S. exports of microbial biotech-derived food ingredientsor processed food products containing microbial biotech-derived food ingredients.
PART H: POLICYa) REGULATORY FRAMEWORK:
Processed food and food ingredients for commercial production are regulated by various government
agencies based on national and international standards. BSTI (Bangla) regulates food and non-food andingredient standardizations. BFSA (Bangla) regulates food safety.
b) APPROVALS:BSTI is responsible for the clearance of imported food products based on national standards, CODEX,
and other international standards. Food ingredient imports for industrial food production are tested andcertified by the Institute of Food Science Technology Laboratory of Bangladesh Council of Scientificand Industrial Research (BCSIR). The Customs House of the National Board of Revenue sends theimported food ingredient product sample to BCSIR for certification.
To provide a “Release Letter for Imported Food Products,” BSTI follows the September 2023, List of
Bangladesh Standards on Agricultural and Food Products. BFSA is responsible for ensuring the qualityof food falls within the regulation of the 2017 Use of Food Additives Regulations (Bangla).
Documents required for customs clearance and laboratory testing:20 Updated trade license Letter of Credit
 Invoice Bill of lading (BL) Import Registration Certificate
 Radiation certificate (for powdered milk/food products)
 Attested Tax Identification number (TIN) certificate
 Certificate of Analysis (Chemical analysis)
 Health certificate
 Country of Origin
Note: Required documents may vary by productc) LABELING and TRACEBILITY:
BSTI and BFSA follow the 2017 Packaged Food Labeling Regulations (Bangla) for food products andfood ingredients used in food industry. There are no separate labeling regulations available for foodingredients derived from microbial biotechnology.
d) MONITORING AND TESTING:
Microbial biotechnology products and ingredients are tested only when imported. BCSIR is assigned totest food ingredients and the BSTI Food and Bacteriology Division performs standard tests throughfollowing laboratories:









Cereal and Bakery Lab
Processed Food products and Fruit Drinks Lab
Water and Beverages Lab
Microbiological Lab
Oils and Fats Products Lab
HPLC Lab
Instrumental Lab
GC-MS Lab

Testable products include, sugar, chilis (whole and ground), soybean oil, mustard oil, turmeric powder,honey, suji, banaspati, red flour (atta), white flour (maida), water, carbonated beverages, cake, candy,
ice cream, pasteurized milk, toffee, yoghurt, milk powders, skim milk powder, infant formula, biscuits,chanachur, noodles, instant noodles, white bread, lachsa shemai, fruit juice, fruits drinks, jam, jelly,
marmalade, pickles, sauce, tomato ketchup, tomato paste, chutney, fruit syrup, fruit cordial, edible jelly,and soft drink powders.
e) ADDITIONAL REGULATORY REQUIREMENTS:
No known additional regulatory requirements.
f) INTELLECTUAL PROPERTY RIGHTS (IPR):

21

Please refer Chapter 1, Part B, Section k of this report.
g) RELATED ISSUES: No information available.
PART I: MARKETINGa) PUBLIC and PRIVATE OPINION:
The public is generally not aware of products that use microbial biotechnology ingredients.
b) MARKET ACCEPTANCE and STUDIES:
There are no studies available related to market acceptance of microbial biotechnology.

22

Appendix A
People’s Republic of Bangladesh
Ministry of Environment, Forest and Climate Change
Environment -2 Branch
No. 22.00.0000.073.06.020.21 (Part-1)-153

Date: 31 May, 2023

In light of the 14th meeting of the National Committee on Biosafety (NCB), application from the
Bangladesh Cotton Development Board for hybrid cotton variety JKCH 1947 Bt and JKCH 1050 Bt
imported from JK Agri Genetics Limited (JKAL or JKAGL) of India to release for limited field level
cultivation is approved with the following condition:1) In accordance with the proposal of Cotton Development Board, opinion from National Instituteof Biotechnology and Department of Livestock Services and recommendation from the Ministryof Agriculture, hybrid Bt Cotton variety JKCH 1947 Bt and JKCH 1050 Bt may be released forlimited cultivation at the field level under a specific action plan;2) Before releasing on the field level, associated ministries and institutions must notify the NCB
and BCC by devising reports on the field production planning, field biosafety management
planning, emergency response planning, safety measures like: isolation distance management
planning, border row management planning, techniques for protection of local and indigenous
variety and wild plants;
3) The Cotton Development Board ought to present the NCB with the proposition to form a fieldlevel biosafety committee, so as to monitor the biosafety measures in the regions where limited
cultivation will be conducted. The committee members should be the local officer of the
Department of Agricultural Extension and Department of Livestock Services, Scientific officerof Cotton Development Board, and district and division level officer of the Department ofEnvironment;
4) In case of refuge as separate pack (SP), for purity terms of transgenics/transgenes, Bt cotton seedpack having minimum of 90% seeds positive for each transgene. Separate refuge non-Bt. Cotton
seed pack with transgene positive seeds not exceeding 5%;5) In case of refuge in bag (RIB), for purity terms of transgenics/transgenes, Bt cotton RIB seedpack having minimum of 90% and maximum of 95% seeds positive for each transgene. The RIB
seed packet shall contain minimum of 5% and maximum 10% non-Bt. Cotton seeds.
6) The non-Bt seeds provided along with Bt. Seeds either as “Refuge as Separate Pack (SP)’ or as
RIB shall be of a non-Bt hybrid that is an isogenic version of the corresponding “Bt hybrid or ofa non-Bt. Hybrid with similar flowering period and fiber traits as that of ‘Bt. Hybrid’ per thelabel claim.

237) Each packet must be labeled with the description of Bt Cotton hybrid including transgene’s
name, and NCB’s approval. Other than that, the method of sowing, pest management, suitablefor which agricultural climate should be written on the packet;
8) Bt cotton susceptibility of bollworms must be checked regularly, and the report to NCB if
resistance grows;9) The Cotton Development Board must submit the research report to NCB regarding the impact of
Bt cotton on non-target insects or crops;10) Farmers in designated areas for limited cultivation should be trained on eco-friendly cultivation
and biosafety measures. Biosafety and Bt cotton cultivation regulations guidelines or leaflets
should be distributed to the concerned farmers;11) If there is any risk created to the environment and public health due to Bt cotton cultivation, theapplicant organization and the relevant ministry must implement emergency plans withimmediate measures, so as to prevent the spread of such threats and alleviate its adverse effects.
In case of any adverse environmental impact or situation arising out of release at field level, theapplicant organization/institution shall be held liable under Biosafety Rules;
12) Annual report on Bt cotton cultivation (amount of cultivation, area covered, bollworm resistance,yield, training of farmers etc.) must be submitted to NCB by January 31 of the following year;13) As per the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (CBD),
monthly report detailing the biosafety measures taken for the environment at the point of releaseshould be submitted to the NCB and BCC for publication in the Biosafety Clearing House;
14) The committee may issue necessary directions and new conditions from time to time based on
the report submitted to the NCB and the biosafety guidelines.

Attachments:
No Attachments24