Required Report: Required - Public Distribution

Date: November 20, 2023
Report Number:

PK2023-0016

Report Name: Agricultural Biotechnology Annual
Country: Pakistan
Post: Islamabad
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

Waqas Farooq Sheikh

Approved By: Christopher Rittgers
Report Highlights:
The Department of Plant Protection (DPP) stopped imports of genetically engineered (GE) soybeans andcanola in late October 2022. DPP said that importers needed an import license from the Ministry of
Climate Change (MOCC). However, MOCC had no system to process import licenses for GE
commodities destined for food, feed, or processing (FFP). Despite attempts to amend the National
Biosafety Rules and Guidelines to create a system for importers to obtain a license, as of November
2023, the GE commodity import ban remains. Prior to the ban, Pakistan had been annually importing 2.5
to 3 million tons of GE oilseeds for FFP.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYEXECUTIVE SUMMARY
In late October 2022, without providing trading partners any prior notice, Pakistan’s Department ofPlant Protection (DPP) began requiring importers to present an import license from the Ministry of
Climate Change (MOCC) as a condition for releasing genetically engineered (GE) soybean and canolaarrivals. However, MOCC had no system for receiving and/or processing import licenses for oilseeds
destined for food, feed, and processing (FFP). As a result, since October 2022, DPP has banned GE
oilseed imports. The National Biosafety Committee (NBC) has completed draft amendments to the
Pakistan Biosafety Rules (PBR) that would potentially create a system for importers to obtain an importlicense for GE oilseeds destined to FFP. However, as of October 2023, the Federal Cabinet had still not
approved the amendment. MOCC is unlikely to implement a functioning licensing system for GE
oilseed imports before second-half 2024.
Pakistan’s agricultural biotechnology regulatory framework consists of four key laws, the PBR of 2005;
the Intellectual Property Organization of Pakistan Act of 2012; the Seed Amendment Act of 2015; andthe Plant Breeders Rights Act (PBRA) of 2016. However, many of the corresponding implementing
regulations have yet to be developed, and front-line Ministries lack sufficient technical staff to enforce
existing regulations. First generation genetically engineered GE cotton events have been approved for
cultivation and use since 2010. About 95 percent of cotton crop area is BT cotton. Weak intellectual
property enforcement hinders GE cotton seed development beyond the available first-generation traits.
Citing sufficient domestic production using conventional non-GE varieties, regulatory authorities halted
GE corn commercialization in 2019. Meanwhile, lack of regulatory clarity prevents life science
companies from investing in and pursuing GE field crop research and development. In the absence of IP
protection, breeders lack incentive to invest in the seed business.

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
Annex 1: Biotech Approval Process
Annex 2: Approved GE Cotton Events
Annex 3: Pakistan’s legal framework regulating the Seed Sector
Annex 4: Biotech Product Imports
References

CHAPTER 1: PLANT BIOTECHNOLOGYPART A: PRODUCTION AND TRADE
Product Development
In March 2019, the Ministry of National Food Security and Research (MNFSR), in conjunction with
NBC, suspended research and commercialization of GE hybrid corn. MNFSR determined that GE corn
seed was unnecessary to meet domestic demand.
In 2023, NBC approved both public and private sector entities to do laboratory work using a variety ofbiotechnology techniques, including genome editing, CRISPR and genetic engineering. This laboratory
work includes trait development on potatoes, wheat, soybeans, sesame, and cotton. The NBC approved
confined field trials for GE cotton (stacked traits) and sugarcane. In 2023, the only new GE events NBC
approved for commercialization were GE cotton varieties with multiple traits.
Several GE cottons seed varieties are approved every year. Cotton is an important cash crop in Pakistan
and exports of cotton products account for 60 percent of all foreign exchange earnings. Cotton serves as
the raw material for the textile industry, which employs 17 percent of the labor force, earns precious
foreign exchange, and contributes 8.5 percent to the gross domestic product.
The MNFSR and MOCC are the two main ministries involved in the approval and regulation of GE
products. The MNFSR approves GE seed for cultivation and issues GE product import permits. The
NBC, under MOCC, reviews and approves laboratory procedures, monitors field trials, and regulates GE
product trade and commercialization. When/if amendments to the PBR are approved, MOCC will be
responsible for reviewing and issuing import licenses for GE commodities for FFP.
Institutional Biosafety Committees (IBCs) from public and private sector entities regularly communicate
with regulatory authorities to track the status of approvals. NBC’s preference for technology providers
to conduct all their basic and primary research in-country, even if it has already been done previously inanother country, leads multinational seed companies to be reluctant to invest in GE seed development.
The approval status of various GE traits is shown below:
Table1: Development of Biotech Crops in Pakistan
Crop

Cotton1

Trait
Diamondback mothresistance with Bt
gene
Virus (CLCV)
resistance with Tr AC
gene
Virus (CLCV)
resistance with RNA

Approval Stage
Field trials

Applicant
CEMB

Status1
In process

Field trials/readyto release

CEMB

In process

Field trials

CEMB &NIBGE

In process

GE trials on all crops, except for cotton, were put on hold in March 2019.

interference (RNAi)
AVP1-H+ for salt anddrought tolerance
Cry1Ac and Cry2Ab

Wheat

Rice

Maize

Sugarcane

Field trials
Field trials

NIBGE

CEMB/NIBGE+ 4 Domestic
Seed
Companies
Cry1Ac + Cry2Ab
Field Trials
CEMB/NIBGE
and Glyphosate+ 4 Domestic
Seed
Companies
Fiber improvement
Experimental
CEMB
Rust, drought, and salt Experimental/Field NIBGE
tolerance
Trial
Bio-fortified wheat for Field Trial
FCCU/AARI
increased iron andzinc bioavailability
Increased phosphorus Field Trial
FCCU+ 1use efficiency
Domestic Seed
Company
Rust resistanceExperimental
AARI
markers
Bacterial blightExperimental
NIBGE
resistance with Xa21
gene (throughmolecular assisted
breeding)
Insect resistance with Experimental
CEMB
Cry1Ac & Cry2A
IIUI
genes
IBGE, IIUI,
Insect ResistanceField trials
CEMB/ NIGAB(Cry1Ac+Cry2A)
CEMB-GTGene
Field trials
CEMB
CEMB-AFP
Field trials
CEMB
cry2Ab2 & cry1A.105 Field trials
Pioneerand cp4epsps
cry1F, cry1Ab andField trials
Pioneer
cp4epsps
cry1Ab x mESPSPS
Field trials
Syngenta
mESPSPS
Field trials
Syngenta
Insect resistance with Experimental
NIBGE
Cry gene
Chloroplast
Experimental
CEMB
transformation
Drought tolerance
Experimental
AARI

In process
In process

In process

In process
On hold
On hold

On hold

On hold
On hold

On hold

On hold
On hold
On hold
On hold
On hold
On hold
On hold
On hold
On hold
On hold

Chickpeas

TobaccoPotato

SIG1+SIG2+SIG3
CHiA+CHiB+CHiC
Insect resistance with
VIP3+ASAL
Herbicide tolerantsugarcane
Biotic stress tolerantsugarcane using
SUGARWIN 2 gene
Abiotic stress tolerantsugarcane using scdr1
gene
Antifungal sugarcane
virus resistance
Insect resistance (Btgene)
Insect(Helicoverpaarmigera
andHeliothesisvericens)
resistance with anovel synthetic spider
venom geneSalt tolerance withyeast, Arabidopsis
Na+/H+ antiporter
genes
Salt tolerance with
ArDH chloroplasttransformation(Biosafe GM)
Non-edible vaccine
development against
Bursal and Newcastle
diseases of poultry
Virus (PLRV, PLXV,
PVY) resistance,
Chitinase gene forfungal disease
resistance
Insect-resistanttransplastomic potato– chloroplasttransformation
Fungal resistanceusing glucanase gene

Experimental
Experimental
Experimental

CEMB
CEMB
CEMB

On hold
On hold
On hold

Experimental

CABB

On hold

Experimental

CABB

On hold

Experimental

CABB

On hold

Experimental

CEMB, IBGE

On hold

Experimental

CEMB/NIGAB

On hold

Experimental

NIBGE

On hold

Experimental

NIBGE

On hold

Experimental

CABB

On hold

Experimental

CABB

On hold

Experimental

NIBGE

On hold

Experimental

CABB

On hold

Experimental

CABB

On hold

Peanut

Brassica

Herbicide resistance,
Tikka disease
resistance
Glyphosate resistance,
FAEI gene for
reduced erucic acidand MAX1 gene for
maximum axillarybranches to enhanceyield

Experimental

NIGAB

On hold

Experimental

AARI
IBGE

On hold

CEMB Centre of Excellence in Molecular Biology, University of the Punjab, Lahore
NIBGE National Institute for Biotechnology and Genetic Engineering, Faisalabad
FCCU Forman Christian College University, Lahore
AARI Ayub Agriculture Research Institute, Faisalabad
NARC National Agriculture Research Center, Islamabad
CABB Centre of Agricultural Biochemistry and Biotechnology, University of Agriculture, Faisalabad
NIGAB National Institute for Genomics and Advanced Biotechnology, NARC, Islamabad
IBGE
Institute of Biotechnology and Genetic Engineering, Ag. Univ. Peshawar
IIUIInternational Islamic University, Islamabad
Commercial Production
GE cotton is the only crop currently approved for planting. In 2023, GE cotton accounted for about 95
percent of the 2.6 million hectares in cotton area. Most of the approved biotech cotton seed varieties
contain one of the two first generation events: MON 531 (Cry1Ac gene) or (Cry1Ab gene). Varieties
with these events protect cotton from the larvae of lepidopterans (i.e., butterflies, moths). The CEMB
developed five double gene transgenic cotton varieties that are now being marketed commercially. Seedcompanies are very interested in marketing GE corn varieties, but MNFSR’s current policy of no GE
corn production prevents that.
Exports
Pakistan exports a small volume of GE cotton. During marketing year (August/July) 2022/23, Pakistan
exported 50,000 bales (480 lbs./bale) of raw cotton. Pakistan also exports cotton yarn, cotton fabric, andother items derived from both domestic and imported GE cotton. The textile sector comprises a major
share of the economy, with textiles accounting for more than 60 percent of total exports.
Imports
In October 2022, Pakistan banned imports of GE oilseeds. Prior to that, Pakistan had been importing 2.5
to 3 million tons of GE oilseeds annually. In 2022/23, Pakistan imported over 1 million tons of cotton,
mostly from the United States and Brazil.
Food Aid
There are no known issues or restrictions affecting the importation of food aid.

Trade Barriers
In late October 2022, without providing trading partners any prior notice, the DPP began requiring thatimporters present an import license from MOCC as a condition for releasing genetically engineeredsoybean and canola arrivals. However, MOCC had no system for receiving and/or processing importlicenses for oilseeds destined to FFP. As a result, GE oilseed imports have been effectively banned since
October 2022. From 2015 until DPP began enforcing the MOCC import license requirement last
October, DPP approved and cleared nearly 14 million tons of GE soybean imports; importers did nothave MOCC import licenses for any of those imports.
Since the GE import ban went into effect last October, the NBC has considered ways to amend the PBR
and Guidelines to create a system for importers to obtain MOCC import permits for GE oilseeds
destined to FFP. NBC took several months to finalize proposed changes to existing regulations due todisagreements on whether in-country risk analysis should be required or if original research conducted
where an event was originally developed could be used. The question of who should submit the importlicense request (developer or commodity importer) was also a point of contention. Also, MNFSR
leadership, which holds an influential position on the NBC, publicly announced opposition to GE
commodity imports.
In mid-2023, NBC completed draft amendments to the Rules that would allow import license applicants
to provide existing risk analysis information from third countries, rather than requiring new research to
be done in Pakistan. However, the amended guidelines still require the importer to submit the importlicense request through a third-party Institutional Biosafety Committee. This means that the commodity
importer would still need to obtain risk analysis data from life science companies who developed theindividual events. This type of coordination between the life science companies and commodity
importers, including sharing of proprietary information, will likely be difficult.
MOCC still must submit the amended rules to the federal Cabinet for approval, and it is uncertain whenthat will happen. Even if the cabinet would approve the amended rules allowing for third country risk
assessments, it will still take some time for MOCC to implement a workable import licensing system.
Due this uncertainty, it will likely be no sooner than second-half 2024 before GE oilseed imports
resume.

PART B: POLICY
Regulatory Framework
In 2005, Pakistan established its federal biotechnology regulatory structure for approving newtechnologies under the provisions of the Environmental Protection Act of 1997. Under this Act, Pakistan
created the PBR in April 2005. The PBR is the first of four foundational laws of the country’s
agricultural biotechnology framework and govern the following:The manufacture, import and storage of micro-organisms and gene technological products forteaching and research at development institutes and/or private companies involved in the uses
and applications of “genetically modified organisms” and products thereof.
All work involved in field trials of genetically manipulated plants, animals (including poultry
and marine life), micro-organisms, and cells.
The import, export, sale, and purchase of “living modified organisms,” substances, or cells, andproducts thereof, for commercial purposes.

The PBR is supposed to be consistent with the Cartagena Protocol of Biosafety, which Pakistan
ratified the (CPB) in 2009.
The PBR also established the following entities:

The NBC, which reviews and approves laboratory procedures, monitors field trials, regulates
trade and commercialization of GE crops and products. The NBC is located within theEnvironmental Protection Agency (EPA) under the MOCC. There are fifteen members of theNBC, which include representatives from the Ministries of National Food Security and Research(1), Health (2), Education (3), Science and Technology (4), Commerce and Textiles, (5),Planning and Development (6), the Pakistan Agricultural Research Council (7); the Pakistan
Atomic Energy Commission (8); and representatives from Pakistan’s four provinces (9-12) andthree territories (13-15).



The Technical Advisory Committee (TAC), which reviews applications for new GE crops andorganisms and makes recommendations to the NBC on technical matters related to laboratory
and field activities, and on placing GE crops and organisms on the market. The EPA’s Director
General chairs the TAC and committee members include representatives from Pakistan’s
provinces and territories.



Institutional Biosafety Committees (IBC), which conduct risk assessments, implement
safeguards, and monitor and inspect all regulated research and product development that has
been authorized by the NBC. The IBCs’ findings are forwarded to the TAC for review and toformulate recommendations to the NBC.



According to the draft PBR amendments on imports of GE commodities for FFP, importers must
apply for import licenses through a public sector IBC.

The Intellectual Property Organization of Pakistan Act (IPOP) of 2012 is the second of four
foundational laws of the country’s agricultural biotechnology framework. Intellectual property laws ofPakistan include the copyright laws, patent laws and trademark laws. This law is supposed to protect the
proprietary work of individuals and businesses from unauthorized use or exploitation by third parties.
By utilizing intellectual property laws, seed developers are supposed to be able to protect and recoup
their investment in GE products.
The Seed Amendment Act of 2015 is the third of four foundational laws of the country’s agricultural
biotechnology framework. This amended act allowed the private sector to import new seed technologies.
It’s regulations also helped to organize the seed industry and facilitated opportunities for all stakeholders
to expand knowledge and resources on new technology.
The Plant Breeders Rights Act (PBRA) of 2016 is the fourth of four foundational laws of the country’s
agricultural biotechnology framework. The PBRA was passed in 2016, MNSFR finalized theimplementing rules in May 2018, and established the seed registry in October 2018. The eventual
complete implementation of this Act will establish Pakistan’s first-ever intellectual property protection
for seeds and plant varieties and should attract investment in seed development and marketing. The
PBRA will provide 20 to 25 years of legal protection to firms who register their seeds, granting themexclusive rights to conduct all facets of seed production and commercialization. Pakistan’s public sector
research institutes will be able to sell intellectual property rights to agricultural firms to raise funds fortheir research and development. In addition, plant breeders in public research facilities will have a muchgreater incentive to develop innovative seed technologies. So, when fully implemented, this Act should
accelerate agricultural biotechnology development in Pakistan, and incentivize seed research anddevelopment in both the public and private sector.
Approvals
The TAC and NBC meet irregularly. During the past two years, based on TAC recommendations, theNBC approved several GE applications, mainly involving cotton events.
The committees are currently reviewing results of many cottons variety trials, including some with triple
and double stacked traits. The following are details of NBC approved events for commercialization:
Table 2: Approvals for Commercialization
S.
No
1

2
3
4

2

Trait

Status2

Institute

Crop

CEMB
NIBGE
NARC
Cotton Research Institute(CRI) Faisalabad
Auriga, Lahore
Bayer Pakistan

Cotton More than 40 cases of Bt cotton
approved

Commercialized

Cotton Bt cotton variety FH- Lalazar, MNH988, BH-184
Cotton Bt cotton Variety Sayban -202
Maize Roundup Ready corn® (NK603
Genuity VT Double Pro(MON89034XNK603)

Commercialized

GE approvals on all crops, except for cotton, were put on hold in March 2019

Commercialized
On hold5Corteva Pakistan

Maize

Maize 1507xNK603; MON
810xNK603

On hold

The PBR specifies a timeline for the approval process (i.e., laboratory work, field trial or forcommercialization) for each event. Once regulatory officials receive an application for any event, a final
decision is supposed to be communicated to the applicant within: 60 days for work bearing either low or considerable level of risk for laboratory work, green
house, and field testing.
 90 days for experimental release; or 120 days for commercialization.
Stacked Or Pyramided Event Approvals
The PBR states that single or multiple gene transformations will be treated as a single, separate event. A
seed with multiple GE genes would be treated as a single event in the approval process. With thepassage of the IPOP in 2012 and the PBRA in 2016, Pakistan’s regulatory officials have confirmed thateach new genetic trait will be protected separately.
Table 3: Details for commercial approvals and field trials for stacked events are as follows:
Genes
cp4epsps
cry2Ab2 & cry1A.105 andcp4epsps
cry1F, cry1Ab and cp4epsps
Cry1Ac + Cry2Ab + Glyphosate
Insect Resistancecry1F, cry1Ab and cp4epsps
cry1Ab x mESPSPSmESPSPS

Crop
Maize
Maize

Approval Stage
Commercial
Commercial

Company
Bayer
Bayer

Status3
On hold
On hold

Maize
Cotton
Maize
Maize
Maize
Maize

Commercial
Commercial
Field trials
Field trials
Field trials
Field trials

Corteva
CEMB
CEMB, NIGAB
Corteva
Syngenta
Syngenta

On hold
In useOn hold
On hold
On hold
On hold

Field Testing
Research institutes are only doing cotton and sugar cane field trials. There are more than 50 public
sector research institutes doing laboratory work in agriculture biotechnology, but NBC has approved
only a few of them do field trials.

3

GE approvals on all crops, except for cotton, were put on hold in March 2019

Table 4: Approvals for Field Trials
S.
No
1
2

Institute

Crop

Trial

Status4

NIBGE
NIBGE

Wheat
CottonOn hold
In process

3
4
5
6
7
8
9

NIBGE
CEMB
CEMB
CEMB
AARI
AARI
FCCU

CottonCottonCottonPotatoCottonCotton
Wheat

10
11

FCCU
CRI
Faisalabad
CRI
Faisalabad
CABB, UAF
CABB, UAF

Wheat
CottonIncreased salinity and heat tolerance
Abiotic stress tolerance, insect resistance(IR-NIBGE+8)
NIAB Bt-1 +NIAB Bt2
CEMB Klean Cotton
CEMB-77, CEMB-88
By transmission of Multiple genes
Bt cotton variety 181
Synthetic Bt gene Cry 1Ac & Cry 2Ab
Bio fortified wheat for increased
bioavailability of iron and zinc
Increased phosphorus use efficiency
Bt cotton CIM 600 &616; Cyto-177

CottonBt cotton Variety Eagle1-6

In process

Wheat
Sugarcane

Salinity and drought tolerance
Herbicide tolerance and borer-resistance

On hold
On hold

12
13
14

In process
In process
In process
On hold
In process
In process
On hold
On hold
In process

Innovative Biotechnologies
A few Pakistani academic and research institutions have been working on gene editing technology, suchas CRISPR-Cas. Biotechnology research funding is very limited.
Coexistence
At present, Pakistan has not developed a policy governing how GE and non-GE crops will coexist in
cultivation.
Labeling And Traceability
Pakistan has no labeling requirements for bulk imports of foods, seeds, fibers, oils, or feeds that arederived from GE crops.
Monitoring And Testing
Although monitoring and testing requirements are outlined in the PBR, neither is occurring. However,
the amended guidelines on GE imports might contain monitoring and testing protocols.

Low Level Presence (LLP) Policy
Pakistan does not yet have an LLP policy.

Additional Regulatory Requirements
Once a GE seed is approved by the NBC, the applicant must register the product with the Federal Seed
Certification and Registration Department (FSC&RD) of MNFSR before it can be commercialized inline with the requirements of the Seed Amendment Act of 2015. Similarly, provincial seed councils andall national research funding agencies require NBC approval prior to providing funding for any GEresearch.
Intellectual Property Rights (IPR)
The IPOP, the PBRA, and their implementing regulations, once finalized, should establish Pakistan’s
first-ever intellectual property protection for seeds and plant varieties. Enforcement of the IPOP and its
implementing regulations falls under the Ministry of Commerce. The FSC&RD of MNFSR finalized the
PBRA implementing regulations and established the plant registry in 2018, but enforcement remains lax.
Cartagena Protocol Ratification
Pakistan ratified the Cartagena Protocol on Biosafety on March 2, 2009.
International Treaties and Forums
Pakistan is a member of the International Plant Protection Convention and the Codex Alimentarius(Codex). Pakistan is a founding member of the World Trade Organization (WTO) and has a permanent
representative in Geneva.
Related Issues
Pakistan’s agricultural biotechnology framework is dependent on four key laws: the 2005 PBR, the
IPOP Act of 2012, the Seed Amendment Act of 2015, and the 2016 PBRA. None of these laws have thefull suite of implementing regulations or the deep bench of technical staff needed to make them fully
operational.
PART C: MARKETING
Public/Private Opinions
The previous MNFSR leadership was opposed to GE commodities. MOCC and the ministries of Health,
Education, Science and Technology, Commerce and Textiles, Planning and Development, as well as
Pakistan’s agricultural industry are generally supportive of GE technology. The ban on GE imports for
FFP and the moratorium on GE corn commercialization are making multinational technology providers
reluctant to invest in GE seed development. Patent laws were modified in 2001 to be consistent with
WTO guidelines, but enforcement, especially on agricultural products (e.g., seeds, cuttings), is weak.
Piracy and imitation are common.
Consumer attitudes on GE technology are mixed, but they are nonetheless generally accepting of GE
products in the marketplace. Consumers are generally unaware of the regulatory landscape.
Market Acceptance/ Studies
There are two PhD thesis on Bt cotton in Pakistan from the University of Melbourne in Australia and the
University of Guelph in Canada. The Australian study focused on the commercialization of GE cotton in
Pakistan; while the Canadian one focused on farmers’ well-being in Pakistan. In addition, theInternational Food Policy Research Institute and International Life Sciences Institute and Agricultureuniversities / Research Institute have published papers on the development of agriculture biotechnology
in Pakistan.
CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: PRODUCTION AND TRADE
Product Development
There is no commercial production or sale of animals derived from biotechnology.
There has been research on developing a recombinant vaccine for Newcastle disease in Pakistan’s
poultry industry. Research and development work on producing this vaccine is occurring at NARC’s
NIBGE in Faisalabad and Islamabad, CABB, and the University of Agriculture in Faisalabad.
Commercial Production
None.
Exports
None.
Imports
None
Trade Barriers
While there is no regulatory framework for animal biotechnology, GE animals and related productimports would likely be restricted. Imports must first receive a “No Objection Certificate” from therelevant ministry, where officials would likely raise concerns if the products were significantly uniqueor substantially different from conventional animals or their products.
PART E: POLICY
Regulatory Framework
The PBR mentions organisms (e.g., animal, plants, insects, fungi, and microbes) and it includes separate
chapters on animals and plants. These rules would be the basis for any regulation of GE animals,
livestock clones, or their products, with the NBC the likely entity to be charged with the responsibilityof reviewing any new product applications.
Approvals
The approval process has not yet started on a commercial scale as no production or trade of GE animals
or activity in animal cloning is taking place in Pakistan. Only in-vitro experiments are occurring at someresearch institutes.
Innovative Biotechnologies
Mice embryo cloning was done in the University of Veterinary and Animal Sciences (UVAS) in Lahore
as an academic model for animal cloning in milking cattle especially buffalo, goats, and sheep.
Labeling And Traceability
There is currently no labeling policy.

Additional Regulatory Requirements
None.
Intellectual Property Rights (IPR)
There are no existing IPR provisions for animal biotechnology.
International Treaties and Forums
Pakistan is a member of the WTO member and, as such, participates in WTO fora and relevant
associated bodies such as the World Organization for Animal Health and Codex.
Related Issues
None.
PART F: MARKETING
Public/Private Opinions
General awareness is limited.
Market Acceptance/Studies
There is no production or sale of GE animals in Pakistan.

CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: PRODUCTION AND TRADE
Not applicable.
PART H: POLICY
Not applicable.
PART I: MARKETING
Not applicableAnnex I
BIOTECH APPROVAL PROCESS IN PAKISTAN:
1.Regulatory Framework for Biotech Crops:

2.Timeline for Biotech Approval Process:Annex - II
Approved GE Cotton Events
The following are the genes currently approved for commercial use; they are only in cotton cropvarieties. Approval for commercialization (deregulation) was granted by the National Biosafety
Committee in the Ministry of Climate Change.
1. Cry 1Ac---- maximum cases
2. Cry 1Ac+ Cry 2A
3. Cry1Ac+ Cry 2A+ GTG (local equivalent to glyphosate).

Annex-III
Pakistan’s legal framework regulating the Seed Sector Evolution and Amendment
S.No
StatuteYear
1The Seed Act
1976
2,
The Seed (Amendment) Act
2015
3,
The Plant Breeders’ Rights Act
2016
4
The Seed (Business Regulation) Rules,
2016
5
The Plant Breeders’ Rights Rules,
2018
6
The Seed (Registration) Rules 1987 amended in
1998
7
The Seed (Truth-in-Labeling) Rules 1991, amended in 1993 and 1998
8
The Pakistan Fruit Plants Certification Rules
1998
9
Pakistan Environmental Protection Act (PEPA)
1997
10
Pakistan Plant Quarantine Act
1976
11
Plant Quarantine Rules
1967
12
Pakistan Biosafety Rules
2005
13
Patent Ordinance 2000 as amended up to2016
Source – FSC&RD

Annex – IV
Cotton Imports (1000 MT)
Marketing Year
United States
BrazilAustralia
Cote d'Ivoire
Afghanistan
Argentina
TurkeyTanzania
Benin
GreeceTogo
EU 27 External Trade
Others
Total
Source: (Trade Data Monitor LLC)

August - July
2021/2022
351
190
24
126
74
33
28
27
14
14
13
13
64
982

August -July
2022/23
426
187
91
55
46
13
52
18
6
15
8
49
12
978

Soybean Import (1000 MT)
Marketing Year
2020/21(Oct-Sep)
United States
700
Brazil
1,600
Total
2,300
Source: (Trade Data Monitor LLC)

2021/222022/23(Oct-Sep)
770
1,240
2,010

(Oct-Sep)
70
57
127

REFERENCES:
1.Pakistan Biosafety Rules, 2005
https://environment.gov.pk/Detail/MDUzMDI1OGItYWYzZC00NzQ0LTlhZWItZjYzY2RkOTkyZGVh
2.Pakistan Biosafety Guidelines,2005
https://environment.gov.pk/Detail/Nzk4N2ZhMmQtM2VlYy00NWNjLWE4NzUtOTZkYmMyMmIyY
2E2
3.Seed Act 1976
http://extwprlegs1.fao.org/docs/pdf/pak16066.pdf
4. Seed (Amendment) Act 2015
https://pakistanlawyer.com/2016/07/03/seed-amendment-act-2015/
5. Plant Breeders Rights Act 2016
http://www.na.gov.pk/uploads/documents/1485437584_777.pdf
6. Pakistan Intellectual Rights Act 2012
http://www.na.gov.pk/uploads/documents/1355912657_971.pdf

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