Required Report: Required - Public Distribution

Date: December 01, 2023
Report Number:

KE2023-0007

Report Name: Agricultural Biotechnology Annual
Country: Kenya
Post: Nairobi
Report Category: Biotechnology and Other New Production Technologies

Prepared By:

Carol Kamau and Matthew Snyder

Approved By: Ryan Scott
Report Highlights:
On October 3, 2022, Kenya’s newly elected president, Dr. William Ruto, lifted the 10-year ban on
importation and cultivation of genetically engineered (GE) agricultural products. Kenya’s Cabinet citedthe need to provide the agricultural sector with pest and drought-resistant crops and to adapt to climatechange as motivating factors for lifting the ban. On October 28, 2022, Kenya’s High Court blocked
trade and production of GE products while the court considers a case challenging the removal of
Kenya’s 10-year ban on agricultural biotechnology. The High Court case is still ongoing. Importationand cultivation of GE products are currently halted due to the court case.

THIS REPORT CONTAINS ASSESSMENTS OF COMMODITY AND TRADE ISSUES MADE BY USDA STAFF AND NOT NECESSARILYSTATEMENTS OF OFFICIAL U.S. GOVERNMENT POLICYEXECUTIVE SUMMARY
On October 3, 2022, President Ruto lifted the 10-year ban on importation and open cultivation of GE
and GE-derived products. The ban prohibited the import and sale of all GE products, including
processed and unprocessed goods, seeds, and food assistance commodities, citing a now-discredited
study linking GE products to cancer. Lifting the ban provides a way-forward for GE imports to enter
Kenya and for GE crops to be cultivated domestically, subject to Kenya’s approval process. However,removal of the ban has been halted due to a legal challenge.
On October 28, 2022, Kenya’s High Court stopped the implementation of the Cabinet dispatch from the
Executive Office of the President of Kenya that permitted the import and cultivation of GE crops andfood into Kenya. This court order effectively blocks importation and cultivation of GE products until thecase brought before the High Court is concluded. At time of publication, the High Court case is ongoing
and trade and production of GE products are prohibited. The High Court case is one of several broughtby plaintiffs seeking to block GE products. In 2023, six cases were brought against the decision to lift
the ban. These cases have been reduced to two through merging and dismissals.
Kenya has a well-defined approval process for GE products. For imports, shipments of GE products
must apply to the National Biosafety Authority (NBA) as part of their single-window entry process
through KenTrade. According to the NBA, GE import applications will be approved if the reported GE
traits are permitted in the origin country. For cultivation, Kenya requires local field trials andenvironmental impact assessments. To date, insect-resistant bacillus thuringiensis (Bt.) cotton is the only
product that has been commercialized in Kenya. On December 19, 2019, Kenya’s Cabinet approved
cultivation of Bt. cotton and allowed importation of Bt. cottonseeds. Since then, planting of Bt. cotton
has continued, and Bt. cotton has entered Kenya’s textile value chain.
Sources note that Bt. corn will likely be the first GE food crop to be commercially released andcultivated by Kenya farmers once the court cases are finalized. Research field trials for Bt. corn werecompleted in March 2021 at six national performance trial (NPT) sites. A necessary follow-on report
was submitted to the National Performance Trial Committee (NPTC) to recommend best varieties forrelease to the National Variety Release Committee (NVRC). Commercialization of Bt. corn requires
publication of approved varieties in the national gazette, which has not yet occurred.
In March 2022, Kenya published regulatory guidelines for genome-edited products. Under theseguidelines, products derived through genome editing would not be subject to Kenya’s GE approval
process if the end product contains no foreign genetic material. If the genome-edited product has foreignmaterial, then it must follow Kenya’s full risk assessment and biosafety approval process. To date, theNBA has approved 10 genome editing research applications under the Biosafety Act of 2009.

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Contents
EXECUTIVE SUMMARY...................................................................................................................................... 2
On October 3, 2022, President Ruto lifted the 10-year ban on importation and open cultivation of GE and GEderived products. The ban prohibited the import and sale of all GE products, including processed and unprocessed
goods, seeds, and food assistance commodities, citing a now-discredited study linking GE products to cancer.
Lifting the ban provides a way-forward for GE imports to enter Kenya and for GE crops to be cultivateddomestically, subject to Kenya’s approval process. However, removal of the ban has been halted due to a legal
challenge. ................................................................................................................................................................... 2
On October 28, 2022, Kenya’s High Court stopped the implementation of the Cabinet dispatch from the
Executive Office of the President of Kenya that permitted the import and cultivation of GE crops and food into
Kenya. This court order effectively blocks importation and cultivation of GE products until the case brought
before the High Court is concluded. At time of publication, the High Court case is ongoing and trade andproduction of GE products are prohibited. The High Court case is one of several brought by plaintiffs seeking toblock GE products. In 2023, six cases were brought against the decision to lift the ban. These cases have been
reduced to two through merging and dismissals. ....................................................................................................... 2
Kenya has a well-defined approval process for GE products. For imports, shipments of GE products must apply to
the National Biosafety Authority (NBA) as part of their single-window entry process through KenTrade.
According to the NBA, GE import applications will be approved if the reported GE traits are permitted in theorigin country. For cultivation, Kenya requires local field trials and environmental impact assessments. To date,insect-resistant bacillus thuringiensis (Bt.) cotton is the only product that has been commercialized in Kenya. On
December 19, 2019, Kenya’s Cabinet approved cultivation of Bt. cotton and allowed importation of Bt.
cottonseeds. Since then, planting of Bt. cotton has continued, and Bt. cotton has entered Kenya’s textile value
chain. .......................................................................................................................................................................... 2
Sources note that Bt. corn will likely be the first GE food crop to be commercially released and cultivated by
Kenya farmers once the court cases are finalized. Research field trials for Bt. corn were completed in March 2021
at six national performance trial (NPT) sites. A necessary follow-on report was submitted to the National
Performance Trial Committee (NPTC) to recommend best varieties for release to the National Variety Release
Committee (NVRC). Commercialization of Bt. corn requires publication of approved varieties in the nationalgazette, which has not yet occurred. .......................................................................................................................... 2
CHAPTER 1: PLANT BIOTECHNOLOGY ....................................................................................................... 4
PART A: PRODUCTION AND TRADE ............................................................................................. 4
PART B: POLICY .................................................................................................................................. 7
PART C: MARKETING ..................................................................................................................... 15
CHAPTER 2: ANIMAL BIOTECHNOLOGY ................................................................................................... 16
PART D: PRODUCTION AND TRADE ............................................................................................ 16
PART E: POLICY ................................................................................................................................ 18
PART F: MARKETING ...................................................................................................................... 183CHAPTER 3: MICROBIAL BIOTECHNOLOGY ........................................................................................... 19
PART G: PRODUCTION AND TRADE ........................................................................................... 19
PART H: POLICY ................................................................................................................................ 20
PART I: MARKETING ....................................................................................................................... 20

CHAPTER 1: PLANT BIOTECHNOLOGYPART A: PRODUCTION AND TRADE RESEARCH AND PRODUCT DEVELOPMENT
Research and development of GE crops and/or plants remain unaffected by the ongoing biotech court
cases. The following table presents GE crops that Kenya may commercialize in the next five years.

Crop

Trait

Corn

Insect resistance(MON 810)

Developers

Stage of Development

Estimated
Date ofCommercial
ReleaseKALRO1NPTs were completed at six sites: (Alupe; 2024
AATF/TELA Kibos; Kakamega; Embu; Thika, and4

Project2
CIMMYT3

Corn

Stacked maize event KALRO
for insect resistance AATF
(MON810) and
CIMMYTdrought tolerance(MON87460)
Stacked event with
two insect resistancetraits (MON810
and/or MON89034)
and drought tolerance(MON87460)

Cassava Cassava Brown
Streak Disease(CBSD) resistance;
research ongoing in
Kenya, Uganda, andNigeria

KALRO
DDPSC4
IITA5
NARO6
ARCN7
UON8
ISAAA9Sorghum Enhanced vitamin A KALRO
levels, bioavailable AHBFI10
zinc, and iron
Corteva
Agriscience
PotatoLate Blight resistance KALRO(3 R-gene LBR)
CIP11
MSU12

Mwea). The National Performance Trials
Committee (NPTC) of KEPHIS in June
2021 approved three insect-resistant Bt.
maize varieties for release. The NVRC has
yet to gazette the varieties forcommercialization.
Confined field trials (CFTs) have been
2024
completed in three seasons at two sites.
KALRO scientists positively assessed thestacked maize event’s ability to withstand
Fall Army Worm (FAW), an invasive pest
which attacks corn and sorghum.
Plans are underway to conduct CFTs forMON 89034, which better withstands
FAW than MON810 and MON87460.
KALRO’s Bt. corn researchers havesubmitted a dossier to the Institutional
Biosafety
Committee (IBC) for review before
submission to the NBA.
On June 15, 2021, the NBA approved
environmental release of disease-resistant 2024/2025
GE cassava in Kenya. The cassava iscurrently undergoing national
performance trials (NPTs) at seven sites ineastern, western, and coastal Kenya.
Eighth seasonal CFT is complete.
Awaiting NPTs, pending availability offunds.

TBD, pending
fundingavailability

CFTs are ongoing at KALRO, Muguga
Center. First planting was done in May
2022.

2024/2025

Notes: 1Kenya Agricultural and Livestock Research Organization; 2African Agricultural Technology
Foundation; 3International Maize and Wheat Improvement Center; 4Donald Danforth Plant Science
Center: 5International Institute of Tropical Agriculture; 6National Agricultural Research Organization,
Uganda;7Agricultural Research Council of Nigeria; 8University of Nairobi; 9International Service for theAcquisition of Agri-biotech Applications (ISAA Africenter); 10Africa Harvest Biotechnology
Foundation International; 11International Potato Center (CIP); 12Michigan State University.
Sources: International Service for the Acquisition of Agri-biotech Applications (ISAAA) Report, 2023;

5

FAS/Nairobi field visits, interviews, and meetings with key biotech stakeholders.
Additional information on approved GE projects is available at the Biosafety Clearing House Kenya:
http://ke.biosafetyclearinghouse.net/.
 COMMERCIAL PRODUCTION
Bt. cotton is the first GE crop approved for cultivation in Kenya. In public announcements andmeetings, the Government of Kenya (GOK) has stated that it plans to increase current cultivation from10,000 acres to 40,000 acres by 2024. The GOK has set a target to increase overall cotton production
from 29,000 bales of lint to 113,500 bales by 2025.
The first planting of Bt. cotton occurred on March 9, 2020, at the Alupe University College farm in
Busia County. Bt. cotton was then planted in five counties (Busia, Kisumu, Baringo, Kwale and Tana
River) as demonstration plots for farmers during the March/April 2020 long rains season before fullcommercialization in the October/November 2020 short rain season. Positive results for Bt. cotton wereobserved in the 700 demonstration plots including high germination rates (95%), strong boll formation,
resistance to African bollworm, and yields over 2.5 times greater than conventional cotton.
 EXPORTS
Kenya does not export GE crops or products that contain GE materials. An application for GE
Gypsophila cut flowers would likely have resulted in exports, but this application was rejected overconcerns that approval could cut off Kenya’s access to the EU cut-flower market.
 IMPORTS
With the removal of the ban, GE products can be imported into Kenya if the traits associated with the
product are approved in the country of origin. However, due to a legal challenge to the decision to lift
Kenya’s 2012 ban on GE products, GE imports and cultivation of GE products are currently not
permitted.
Section 28 of Kenya’s Biosafety Act of 2009 provides for expedited clearance of imported agriculturalcommodities subject to compliance with Kenya’s import requirements. The Kenya Plant HealthInspectorate Service (KEPHIS) requires imported GE plant products to have:

A declaration from the country of origin that states the import’s GE status; andA phytosanitary certificate.

The NBA is responsible for the approval process to import shipments of GE products. Importers canrequest approval from NBA by completing the:

Application Form for Importation of GE Products found at:https://www.biosafetykenya.go.ke/index.php?option=com_content&view=article&id=29&Itemi
d=131 at a fee of Kshs. 25,000 (about $208).
Import Declaration Form (IDF) found at the Kenya Revenue Authority (KRA) iCMS system.
Depending on the product, other regulatory agencies will evaluate the application and may
apply other fees.
6 FOOD AID
Kenya is a food aid recipient country. Prior to the GE import ban, the NBA approved imports of GE
corn soy blend for humanitarian assistance through the World Food Program (WFP). Details of past GE
food import approvals are available at: http://ke.biosafetyclearinghouse.net/importandtransit.shtml.
 TRADE BARRIERSAll foods containing GE ingredients are subject to mandatory labeling requirements. Violation oflabeling provisions can result in a fine of up to $230,000 and/or imprisonment up to 10 years. For moredetails, visit: https://www.biosafetykenya.go.ke/images/conferencetwotwo/Biosafety%20LabelingRegulations-2012.pdf.
PART B: POLICYREGULATORY FRAMEWORK

Below is a table of common terms used in Kenya’s biotechnology laws and regulations. These terms arereferenced in the following laws and regulations:






Biosafety Act, No. 2 of 2009;
Contained Use Regulation, 2011;
Environmental Release Regulation, 2011;
Import, Export, and Transit Regulation, 2011;
Labeling Regulation, 2012.

Legal Term in English/Official
Language
Genetically Modified Organism

Legal Definition in English
Any organism that possesses a novel
combination of genetic material obtained throughthe use of modern biotechnology techniques.

7Modern Biotechnology

Genome Editing

Biosafety

Contained Use

Includes the application of(a) in-vitro nucleic acid techniques including
the use of recombinant deoxyribonucleic
acid (DNA) and direct injection of
nucleic acid into cells or organelles;(b) fusion of cells beyond the taxonomic
family, that overcome natural
physiological, reproductive, andrecombination barriers and which are nottechniques used in traditional breeding
and selection.
Targeted methods to introduce new traits inorganisms using various techniques which induce
breaks in DNA that can be repaired byendogenous mechanisms and lead to a range ofchanges at a targeted locus within the gene. Thismay be achieved by deleting, replacing, editing
the organism’s DNA or inserting a DNA
sequence.
The avoidance of risk to human health and safety
and the conservation of the environment as aresult of the use of genetically modified
organisms.
Any activity undertaken within a facility,
installation, or other physical structure which
involves genetically modified organisms that arecontrolled by specific measures.

Environment

Includes the physical factors of the surroundingsof human beings, including land, water,
atmosphere, soil, vegetation, climate, sound,odor, aesthetics, fish, and wildlife.

Placing in the Market

Making a genetically modified organism
available for sale.

Authority

Usually refers to the National Biosafety
Authority established under Section 5 of the
Biosafety Act.

8

Regulatory Agency

A regulatory agency as set out in the First
Schedule of the Biosafety Act, or such otheragency as the Cabinet Secretary of Agricultureand Livestock Development may, by order in thegazette, determine.

ApplicantAn individual submitting an application pursuant
to the provisions of the Biosafety Act.

The NBA, established by the Biosafety Act No.2 of 2009, is an agency within the Ministry ofAgriculture, and Livestock Development. The NBA is the main regulatory agency that oversees GErelated regulations and policies, and has general supervision and control over the transfer, handling, anduse of GE products. Following the Biosafety Act of 2009, the NBA developed the following four GE
implementing regulations:Contained Use Regulation, 2011;
Environmental Release Regulation, 2011;
Import, Export, and Transit Regulation, 2011; andLabeling Regulation, 2012.

These four regulations were issued to meet the following goals:
 To address potential adverse effects to human and animal health and the environment associatedwith open cultivation of GE crops;
 To ensure safe movement of GE materials in and out of the country;
 To confirm research on GE products is done under appropriate experimental conditions; and To establish effective tracking of GE products in the food supply chain and provide information
to consumers.
The GOK has developed an additional draft regulation on the handling, transport, packaging, andidentification of GE products. Additional information on Kenya’s regulations is available at the NBA
website.
The NBA works closely with eight other regulatory agencies to achieve its mandate:






The Kenya Plant Health Inspectorate Service (KEPHIS) under the Ministry of Agriculture, andLivestock oversees the introduction, testing and use of biotechnology plants and seeds;
The Department of Public Health, under the Ministry of Health, safeguards consumers’ healththrough food safety and quality control, surveillance, prevention, and control of foodborne diseases;
The Kenya Bureau of Standards, (KEBS) under the Ministry of Trade, Investment and Industry
develops food standards and rules regarding quality assurance and testing;
The National Environment Management Authority (NEMA), under the Ministry of Environment andForestry oversees environmental safety issues and conducts environmental impact assessments.
NEMA issues licenses that permit NPTs for GE crops;
The Pest Control Products Board (PCPB), under the Ministry of Agriculture and Livestock regulates

9






the import, export, manufacture, distribution, and use of products used for the control of pests;
The Kenya Wildlife Service (KWS), under the Ministry of Tourism, Wildlife, and Heritage
undertakes and coordinates research and monitoring through its Biodiversity Research andMonitoring Division. This division provides scientific information that is used in the conservationand management of Kenya's tourism-generating biodiversity;
The Kenya Industrial Property Institute (KIPI), under the Ministry of Trade, Investment, andIndustry administers intellectual property rights; and,The Department of Veterinary Services (DVS) under the Ministry of Agriculture and Livestock
protects against the spread of animal diseases and pests to safeguard human health, improve animal
welfare, and increase livestock productivity.

The following figures describe Kenya’s approval and trial processes for GE crops.

Figure 1: Kenya Approval Process for GE Crops

Source: NBA
Figure 2: Kenya Trial Procedure for GE Crops

10

Source: NBA
Figure 3: Kenya Procedure for GE Environmental Release

Source: NBA*Regulatory Agencies (RA); Social Economic Considerations (SEC); Institutional Technical Committee(ITC)


APPROVALS/AUTHORIZATIONS

11

Kenya approved Bt. cotton (cotton resistant to the African bollworm) for cultivation and use in 2020. Bt.
maize research trials are complete and awaiting final approval for use in Kenya subject to the conclusionof ongoing biotech court cases.
GE cassava is approved for open field trials and environmental release. GE cassava is currently
undergoing NPTs at seven sites in eastern, western, and coastal regions.
 STACKED OR PYRAMIDED EVENT APPROVALS
Stacked corn event testing for insect resistance and drought tolerance is ongoing. The NBA conducts
risk assessments for each trait individually to approve a stacked product.
 FIELD TESTING
Kenya has conducted CFTs for sorghum, sweet potato, and banana, and NPTs are ongoing for cassava.
For security reasons, only KALRO test centers are used as trial sites (for both CFTs and NPTs). These
trials are usually conducted at a plot smaller than one acre. Additionally, NEMA conducts anenvironmental impact assessment (EIA) on trial sites before NPTs commence and performs anenvironmental social impact assessment before commercialization.
KEPHIS, NBA, and KALRO have developed NPT guidelines on GE crop processes in Kenya, which
address control of gene flow and the number and size of confined field trials.
KALRO has 16 research institutes spread across different agroecological zones, providing an ample
supply of field test sites in different environments.
 INNOVATIVE BIOTECHNOLOGIESGenome Editing
Kenya’s local and international research institutions (including local universities, KALRO, ILRI, IITA,
and CIMMYT) are testing genome editing and RNA interference techniques at the laboratory level as a
proof of concept. The NBA has published genome editing guidelines to inform applicants and reviewers
how to submit applications for consideration of projects for research, trials, and commercial release of
genome-edited products. The guidelines align with Africa Union’s (AU) genome editing guideline
document. Details on the Kenyan guidelines can be found at:https://www.biosafetykenya.go.ke/images/GENOME-EDITING-GUIDELINES-FINAL-VERSION25th-Feb-2022-03.pdf. Under the NBA’s guidelines, only genome-edited products with foreign DNA
sequences in the final end product must go through Kenya’s full approval process under the Biosafety
Act of 2009.

Figure 4: Flowchart for Early Genome Editing Consultation

12

Applicant

NBA (review within 15 days)

Relevant Regulatory Agency

Start

Early consultations withNBA (Applicant fills andsubmits the prescribedform)

Check forcompleteness andaccuracy of the form

Is there integration offoreign DNA sequence

Yes

No

Notification that thetechnique and/or product will
not be regulated under the
Biosafety Act, 2009

Non-GMOIs the foreign
DNA sequence
present in theend product?

No

Yes
Notification that thetechnique and/or product will
be regulated under the
Biosafety Act, 2009

GMO

Notification to relevant
regulatory agencies

Source: NBA
NBA has received two genome editing applications to conduct trials:
1. Gene-edited corn lines with increased tolerance to Maize Lethal Necrosis (MLN) in Kenya –2022;
2. Kosakonia sacchari and Klebsiella variicola bacteria species with enhanced nitrogen fixing
capabilities – 2022.
Kenya has approved laboratory research for the following seven plant-based applications:








Genome-edited yams for resistance to yam mosaic virus and Anthracnose disease as well as
enhanced Vitamin A, approved in January 2018;
Banana edited for resistance against nanoviruses, caulimoviruses and aphids, approved in June 2015;
Grass pea edited for nutritional and other agronomic practices, approved in November 2019;
Genome-edited sorghum for striga weed resistance, approved in October 2020;
Cassava with an induced early flowering trait by ILRI/IITA and nutritional enhancement;
Banana for fungal and bacterial resistance; andPotato for potato virus Y resistance.

Synthetic Biology
13

Kenyan researchers have expressed interest in synthetic biology (SB) to find new techniques to improveanimal and human health, the agricultural industry, and the environment. In June 2019, policymakers
and researchers from Kenya and the United Kingdom held a workshop at Imperial College, London. The
workshop considered development of SB research and applications in the context of East Africa,
specifically Kenya.
Kenya’s first foray into SB is a research project using the technology to detect cassava brown streak
disease and cholera. The project aims to develop biosensors and diagnostic kits for these two diseases.
The GOK, through the National Research Fund (NRF), has awarded $110,650 (Ksh 12 million) to the
National Council for Science, Technology, and Innovation (NACOSTI) to initiate this research. To
facilitate this technology, NACOSTI is reviewing Kenya’s existing legal framework to assess if it
sufficiently covers SB products. ISAAA-AfriCenter, Kenyatta University, University of Nairobi, and
NACOSTI are partner institutions for this project.
 COEXISTENCEThe NBA has drafted policy guidance on coexistence between GE and conventional crops.
 LABELINGThe GOK requires mandatory labeling of foods and feed containing at least 1 percent GE content by
weight. No labeling is required if the GE content is less than 1 percent of the total weight and the
product has been approved by the NBA as safe.
 MONITORING AND TESTING
The NBA is responsible for approving imports of GE products, while KEPHIS, KEBS, and Port HealthServices (under the Department of Public Health) monitor and test agricultural commodities and foodproduct imports at ports of entry for compliance to Kenya’s standards and GE requirements. Multiple
public and private institutions in Kenya currently have the capacity to test for GE content, mainly using
protein ELISA and PCR methods. While there is currently no formal monitoring regime to test imports
in the market, Kenya may test imported commodities on an ad-hoc basis.
Additionally, the NBA inspects facilities that conduct GE research to ensure compliance to the
Biosafety Law of 2009 and relevant regulations.
 LOW LEVEL PRESENCE (LLP) POLICYThe NBA has a draft policy on managing low-level presence of GE traits not approved in Kenya forgrain and seed imports. The draft policy sets the LLP threshold level at 1 percent (0.01); meaning thatany product with GE traces over 1 percent by weight is treated as a GE product and must be labeled assuch. The converse is true. Any product with GE traces of less than 1 percent is allowed into the Kenya
market and treated as a non-GE product. Kenya has a zero-tolerance policy for adventitious presence.


ADDITIONAL REGULATORY REQUIREMENTS

Any person who undertakes any “GMO-related” activity without the approval of the NBA
commits an offence as provided for by the Biosafety Act, 2009; Section 52.
The Biosafety Act gives the NBA powers to halt and resume GE-related activities.
Existing civil judicial mechanisms are able to offer redress for damage to affected persons on a14

case-by-case basis.
 INTELLECTUAL PROPERTY RIGHTS (IPR)
KIPI is the government institution that administers and protects intellectual property rights that may
pertain to genetic engineering, including patents, trademarks, utility models, industrial designs, andtechnological innovations.
Kenya is a signatory to the Trade Related Intellectual Property Rights (TRIPS) agreement as a memberof the World Trade Organization (WTO). The Seeds and Plant Varieties Act (Plant Breeders Rights) andrelated regulations offer protection to patent owners.
 CARTAGENA PROTOCOL RATIFICATION
Kenya was the first country to sign the Cartagena Protocol on Biosafety (CPB) during the 5th
Conference of Parties at UNEP headquarters, Nairobi in May 2000. Kenya ratified the Protocol in 2002
and it entered into force on September 11, 2003. The Cartagena Protocol requires countries to protect
environmental safety and human health by ensuring safe handling, transport, and use of GE products.
The NBA is Kenya’s focal point for the Cartagena Protocol and shares data with the Biosafety Clearing
House, a mechanism set up by the Cartagena Protocol to facilitate information exchange on GE productdevelopment and to assist member countries in complying with their obligations. More details on the
protocol can be found at: https://bch.cbd.int/protocol/.
Kenya adopted the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the
Cartagena Protocol on October 15, 2010. The protocol gives Kenya additional flexibility under the
Cartagena Protocol to implement legislative, administrative, or judicial rules and procedures relevant toliability and redress issues.
Kenya actively participates and sends a delegation to the Cartagena Protocol biannual Conference ofParties serving as the Meeting of Parties (COP-MOP).
 INTERNATIONAL TREATIES/FORUMS
Kenya is a member of several international organizations that deal with plant protection and plant
health, including the International Plant Protection Convention (IPPC), Codex Alimentarius (Codex),
the World Trade Organization (WTO), and the Cartagena Protocol. Generally, these internationalframeworks seek to protect the environment and human health without unduly hindering international
trade, aim to be transparent and in harmony with international trade regulations, and are science-based.
 RELATED ISSUES
Not applicable.
PART C: MARKETING PUBLIC/PRIVATE OPINIONS
Debate on biotech crops and bioengineered foods in Kenya remains contentious, political, emotional,
and occasionally sensational. Some non-governmental organizations engage in well-funded advertisingtargeting Kenyan consumers with negative messaging that often lacks a scientific basis. On the other15

hand, Kenyan agricultural research scientists, farmers, university professors, seed companies, and otherpro-biotech non-governmental organizations continue to provide science-based messaging.
In February 2023, Alliance for Science conducted a quantitative study of “GMO” media articles
published in the Kenyan media between October 2022 and January 2023. They found that 40% (151 outof 376 articles) contained unchallenged negative misinformation about “GMOs”. Only 3% of articles
contained “pro – GMO” misinformation. More details from this study are available athttps://allianceforscience.org/wp-content/uploads/2023/02/GMO-misinformation-in-the-Kenyan-media1.pdf.
 MARKET ACCEPTANCE/STUDIESOn November 3rd and 4th, 2022, GeoPoll, a remote mobile research company, conducted a rapid survey
to assess Kenyans awareness and perceptions on “GMO” foods after the government lifted the 2012
import ban. The sample size was 708, composed of random users between ages 18 and 60. Since thesurvey was randomly distributed, the results are slightly skewed towards younger, male respondents
according to GeoPoll. According to the survey:
 86 percent of the respondents are aware of “GMOs” compared to 65 percent of respondents in asimilar study conducted in 2014;
 91 percent of the 86 percent were aware of the government’ decision to lift the ban;
 51 percent agreed with the government’s decision to approve “GMOs”; 35 percent disagreed;and 16 percent neither agreed nor disagreed with the government;
 51 percent believed that “GMOs” are unsafe for human consumption;
 60 percent believed that there is not enough information on “GMOs”; 30 percent believed that
there is; and 10 percent were unsure.
Find more details of the report at:https://www.geopoll.com/blog/gmo-foods-kenya-report/#About_this_GeoPoll_survey.

CHAPTER 2: ANIMAL BIOTECHNOLOGYPART D: PRODUCTION AND TRADE PRODUCT DEVELOPMENT
Kenya scientists at the International Livestock Research Institute (ILRI) have conducted research todevelop trypanosome-resistant cattle and goats, vaccines against animal diseases, and diagnostic test
kits.

16

Product/Animal

Trait

Developers

Rift Valley Fever
Vaccine

ChAdOxl-GnGc vaccine International
against Rift Valley Fever Livestock
for sheep, goats, cattle, Researchand dromedary camels. Institute (ILRI)

Stage ofDevelopment
CFT approved on
November 25, 2016.
Research trials are
ongoing.

Recombinant Viral
VaccineVaccine against
ILRI
Contained
Mycoplasma mycoides
use/laboratory stage
cluster.
Disease Diagnostic Test Diagnostic tests for
ILRI
Research ongoingKits
several diseases, forpending availability
example a latex
of funds
agglutination test kit for
CCPP (CAPRITESTR)
CattleResistance to
ILRI; KALRO; Research has stalled
Trypanosomes
and Institute of for the last two
Primate Research years due to lack of(IPR)
funds. Researchersplan to restart the
project using a newcow.
Source: NBA
ILRI research scientists plan to develop disease-resistant cattle for Africa using technologies such as
cloning, GE, and genome editing. The aim is to reduce cattle disease across the continent and improve
livelihoods for African farmers through increased cattle productivity.
Trypanosomiasis is a zoonotic disease (also known as Nagana) in cattle and sleeping sickness inhumans. It has a widespread impact on human health and livestock production across Africa. ILRI
scientists estimate its impact exceeds $1 billion in losses annually to the African continent, reportedly
affecting more than 70 percent of reared cattle. The prevalence of trypanosomiasis effectively limits
animal agriculture across Sub-Saharan Africa, depriving many communities of high-quality protein
sources and draft animals.
ILRI scientists have developed a cloned Boran calf named “Tumaini” as a first step towards producing
trypanosomiasis-resistant cattle. In the second phase of the project, ILRI scientists plan to develop a
trypanosome resistant Boran cow (“Mzima”) with a gene that produces a protein that may confer
immunity to trypanosomes (Apolipoprotein) using genome editing technology.
Key institutions involved in livestock biotechnology research and development include ILRI, KALRO,and IPR. The NBA regulates the application of biotechnology in livestock. Find more information on
NBA-approved livestock projects at Approved Contained Use Research Activities including Livestock
Biotechnology.

17 COMMERCIAL PRODUCTION
No animal biotechnology products have been approved for commercial production.
 EXPORTS
Kenya does not export animal biotechnology products.
 IMPORTS
To produce a trypanosome-resistant cow, Kenya will need to import transgenic products such as cow
fibroblasts, blastocysts, sperm, and possibly transgenic live animals.
 TRADE BARRIERS
Not applicable.
PART E: POLICY REGULATORY FRAMEWORKThe NBA’s regulatory mandate covers both plants and livestock. The NBA is currently preparing
regulations specific to animal biotechnology. Animal science researchers use the NBA’s
protocols/guidelines on experiments under contained use and CFTs.
 INNOVATIVE BIOTECHNOLOGIESILRI plans to develop a Trypanosome-resistant cow using CRISPR-Cas9 genome editing technology.
The transgenic trait used will be subject to NBA regulations. The NBA’s published genome-editing
guidelines include research in animal biotechnology.
In addition, the NBA approved research trials for an African Swine fever vaccine and development of
Trypanosome-resistant goats using genome editing in 2018 and 2019, respectively.
 LABELING AND TRACEABILITY
No specific requirements for animal biotechnology products currently exist.
 INTELLECTUAL PROPERTY RIGHTS (IPR)
Animal biotechnology products are subject to the same IPR protections as plant biotechnology products.
 INTERNATIONAL TREATIES/FORUMSTo date, Kenya has not taken a position on animal biotechnologies in international forums such as
Codex Alimentarius and the World Organization for Animal Health (OIE). Kenya research on animal
biotechnologies remains at an early stage of development.
 RELATED ISSUES
Not ApplicablePART F: MARKETING

PUBLIC/PRIVATE OPINIONS18

No information available.
 MARKET ACCEPTANCE/STUDIES
No information available
CHAPTER 3: MICROBIAL BIOTECHNOLOGYPART G: PRODUCTION AND TRADE COMMERCIAL PRODUCTION
Kenya does not commercially produce food ingredients derived from microbial biotechnology.
 EXPORTS
Kenya does not export GE microbes or any products that contain microbial biotech-derived foodingredients such as protease, lactase, steviol glycosides, or asparaginase to any country.
 IMPORTS
Kenya imports microbial biotech-derived food ingredients such as enzymes, vitamins, food flavoring,colorings, additives, and food preparations.1 The following chart shows the import value of traditionaluse products that may contain microbial derived products in calendar year 2022, totaling $231 million.
The United States supplied 3.3 percent of these products. Other major suppliers include India (17.4
percent), the United Kingdom (10.4 percent), France (9.5 percent), and South Africa (8.6 percent).

Figure 5: Kenya Imports That May Contain Microbial-Derived Products (CY 2022, $US
Millions).
$153,646,626

Value of Import s in $US$160,000,000$140,000,000$120,000,000$100,000,000$ 75,893,194$80,000,000$60,000,000$40,000,000$20,000,000$ 1,093,602$ 777,584$0
Enzymes

Food
AlcoholicPreparations Beverages

Cheese &YoghurtProduct Groups

1

Food preparations includes baking inputs, mixes and doughs, flavorings, vegetable saps and extracts, protein concentrates,
thickeners, and other processed food ingredients.

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Source: Trade Data Monitor, LLC
 TRADE BARRIERSCurrently, there are no known trade barriers that negatively affect U.S. exports of microbial biotechderived food ingredients or processed food products containing microbial biotech-derived food products.
PART H: POLICY REGULATORY FRAMEWORKNo specific regulation exists for microbial biotech derived food ingredients, which are largely imported.
Local production is non-existent. Microbial biotech-derived foods are subject to general regulations
applicable to all food products such as food safety and labeling requirements which are implemented
through KEBS and the Department of Health through the Certificate of Conformity (CoC).
 APPROVALSNone.
 LABELING AND TRACEABILITY
None.
 MONITORING AND TESTING
See Part A on imports.
 ADDITIONAL REGULATORY REQUIREMENTS
None.
 INTELLECTUAL PROPERTY RIGHTS (IPR)
No information available.
 RELATED ISSUESNone.
PART I: MARKETING PUBLIC/PRIVATE OPINIONS
Generally, Kenya food processors are aware of food ingredients produced through microbial
biotechnology and their inclusion in imported products.
 MARKET ACCEPTANCE/STUDIES
No information available.

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