Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 1 of 19

NATIONAL BIOSAFETY AUTHORITYGUIDELINES FOR DETERMINING THE REGULATORY PROCESS OF GENOME
EDITED ORGANISMS AND PRODUCTS IN KENYAFEBRUARY 2022

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 2 of 19

TABLE OF CONTENTSFOREWORD .................................................................................................................. 3
ABBREVIATIONS ......................................................................................................... 4
CHAPTER ONE ............................................................................................................. 7
1.0 THE NATIONAL BIOSAFETY AUTHORITY ......................................................... 7
1.1 BACKGROUND ................................................................................................................... 7
1.2 VISION STATEMENT ........................................................................................................... 7
1.3 MISSION STATEMENT ........................................................................................................ 7
1.4 OUR CORE VALUES ........................................................................................................... 7
1.5 OUR OBJECTIVES ............................................................................................................... 8
1.6 OUR CORE FUNCTIONS ...................................................................................................... 8
CHAPTER TWO ............................................................................................................ 9
2.0 INTRODUCTION TO GENOME EDITING.............................................................. 9
2.1 SCOPE AND OBJECTIVE ...................................................................................................... 9
2.1.3 EXEMPTIONS .................................................................................................................. 9
2.2 BACKGROUND TO GENOME EDITING .................................................................................. 9
2.3 GENOME EDITING IN RELATION TO GENETICALLY MODIFIED ORGANISMS ...................... 11
CHAPTER 3 ................................................................................................................. 12
3.0 REGULATORY CONSIDERATIONS FOR GENOME EDITING TECHNIQUES .... 12
3.1 CONSIDERATIONS FOR REGULATION OF GENOME EDITED PLANTS, ANIMALS AND
MICROORGANISMS ................................................................................................................. 12
CHAPTER FOUR ......................................................................................................... 16
3.0 REFERENCES .......................................................................................................... 16
ANNEX ......................................................................................................................... 18

Page 2 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 3 of 19

FOREWORD
Genome editing technology has been identified as a potential new option to augment existing
interventions in pursuance of achieving the African Union Agenda 2063 and it is expected that
proposed applications for genome editing technology for basic research, conservation,
agriculture, public health and other purposes will likely continue to expand as genome editing
tools become more refined.
Genome editing has broad applications in plant and animal improvement, as well as in the
medical field. For example Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) has been used to edit the genome of rice resulting to improvements in yield-related
traits, such as dense and upright panicles and reduced plant height; development of lateflowering soybean, resulting in increased vegetative size; development of citrus plants resistantto citrus canker; generation of animals suitable for human disease modelling such as CRISPRedited cynomolgus monkeys for brain disorders that cannot be fully studied in mice; studies
for the treatment of Human Immunodeficiency Virus (HIV) among other applications.
In responding to the continuous advancement in genome editing technology, the Authority has
developed a guideline document for determining the regulatory process of genome editing
techniques through broad stakeholder consultations and review of regulatory mechanisms inother countries where such technology has been deployed.
The document incorporates the aspects of implementation, as well as essential testing pathways
and implementation strategies in the country, taking into consideration all the possible sociocultural and ethical issues. This document is not meant to detail how risk assessment and risk
management of genome edited products will be conducted.

PROF. DORINGTON O. OGOYI, PhD
CHIEF EXECUTIVE OFFICER,NATIONAL BIOSAFETY AUTHORITY

Page 3 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 4 of 19

ABBREVIATIONSCPB- Cartagena Protocol on BiosafetyDNA- Deoxyribonucleic acid

GE

- Genetically engineered

GM- Genetically modified

GMO- Genetically modified organisms

ODM- Oligonucleotide-Directed Mutagenesisr-DNA- Recombinant-DNA

RNA- Ribonucleic acidSDN

- Site –Directed Nucleases

TALENs- Transcriptional Activator Like Effector Nucleases

ZFNs- Zinc Finger Nucleases

Page 4 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 5 of 19

DEFINITION OF TERMS
Applicant: means a person submitting an application to the Authority in pursuant to theprovisions of the Biosafety Act, 2009 or those who wish to determine whether the genome
edited products or processes are regulated by NBA.
Authority: means the National Biosafety Authority established under section 5 of the
Biosafety Act, 2009;
Biosafety: means the avoidance of risk to human or animal health and safety, or theconservation of the environment;
Contained use: means any activity undertaken within a facility, installation or other physicalstructure which involves genetically modified organisms that are controlled by specificmeasures;
Conventional counterpart: means a closely related organism, its components and/or products
for which there is experience of established safety based on common use.
Environment: includes the physical factors of the surroundings of humans and animals,
including land, water, atmosphere, soil, vegetation, climate, sound, odour, aesthetics, fish andwildlife;
Foreign Genetic material: Refers to novel combination of genetic material from sexually noncompatible species through the use of modern biotechnology techniques;
Genetically modified organism: means any organism that possesses a novel combination ofgenetic material obtained through the use of modern biotechnology techniques;
Genome editing: means targeted methods to introduce new traits in organisms using various
techniques which induce breaks in the DNA that can be repaired by endogenous mechanisms
and lead to a range of changes at a targeted locus within the genome. This may be achieved bydeleting, replacing, editing organism’s own DNA or inserting a DNA sequence in theorganism’s genetic material;
Intentional introduction into the environment: means any deliberate use of geneticallymodified organisms beyond contained use;
Modern biotechnology: includes the application of—Page 5 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 6 of 19a) in-vitro nucleic acid techniques including the use of recombinant deoxyribonucleic acid
(DNA) and direct injection of nucleic acid into cells or organelles; orb) fusion of cells beyond the taxonomic family, that overcome natural physiological,
reproductive and recombination barriers and which are not techniques used in traditional
breeding and selection;
Novel combination of genetic material: means an organism whose DNA has been alteredwith the addition or substitution of foreign DNA.
Regulatory agency: means a regulatory agency as set out in the First Schedule of the Biosafety
Act, 2009 or such other agency as the Minister may, by Order in the Gazette, determine;

Page 6 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 7 of 19

CHAPTER ONE

1.0 THE NATIONAL BIOSAFETY AUTHORITY
1.1 Background
The National Biosafety Authority (NBA) is a state corporation in Kenya established pursuant
to the provisions of the Biosafety Act, 2009 to regulate all activities involving geneticallymodified organisms (GMOs) in food, feed, research, industry, trade and environmental release.
Being the national focal point on biosafety matters, NBA fulfils its mandate by ensuring andassuring safe development, transfer, handling and use of GMOs with the aim of ensuring safetyof human and animal health as well as provision of adequate protection of the environment.
NBA has made great strides in establishing a strong Biosafety regulatory framework in Kenya
by developing and publishing the implementing Biosafety Regulations namely; The Biosafety(Contained Use) Regulations, 2011; the Biosafety (Environmental Release) Regulations, 2011;
the Biosafety (Import, Export and Transit) Regulations, 2011; and the Biosafety (Labeling)
Regulations, 2012. These regulations lay down a clear procedure on handling GMOs whether
plants, animals or microorganisms. NBA is the National Focal Point for the Cartagena Protocol
on Biosafety to the Convention on Biological Diversity (CBD) and is mandated to implement
the provisions of the Cartagena Protocol on all Biosafety matters pertaining to GMOs.
1.2 Vision Statement
A World-class Biosafety Agency
1.3 Mission Statement
To ensure and assure safe development, transfer, handling and use of genetically modified
organisms (GMOs) in Kenya.
1.4 Our Core Valuesa) Integrityb) Professionalismc) Transparencyd) Accountability

Page 7 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 8 of 19

1.5 Our Objectivesa) To facilitate responsible research and minimize risks that may be posed by geneticallymodified organisms;b) To ensure adequate level of protection in the development, transfer, handling and use
of genetically modified organisms that may have an adverse effect on the health of thepeople and the environment; andc) To establish a transparent, science-based and predictable process for reviewing andmaking decisions on the development, transfer, handling and use of geneticallymodified organisms and related activities.
1.6 Our Core Functions
The Biosafety Act no.2 of 2009 lists the functions of NBA as follows:a) Consider and determine applications for approval for the development, transfer,handling and use of genetically modified organisms, and related activities in accordancewith the provisions of the Biosafety Act;b) Co-ordinate, monitor and assess activities relating to the safe development, transfer,handling and use of genetically modified organisms in order to ensure that suchactivities do not have adverse effect on human health and the environment;c) Co-ordinate research and surveys in matters relating to the safe development, transfer,handling and use of genetically modified organisms, and to collect, collate anddisseminate information about the findings of such research, investigation or survey;d) Identify national requirements for manpower development and capacity building in
biosafety;e) Advise the Government on legislative and other measures relating to the safe
development, transfer, handling and use of genetically modified organisms;f) Promote awareness and education among the general public in matters relating tobiosafety;g) Establish and maintain a Biosafety clearing house (BCH) to serve as a means throughwhich information is made available to facilitate exchange of scientific, technical,
environmental and legal information on, and experience with, genetically modified
organisms; andh) To exercise and perform all other functions and powers conferred on by the Act.

Page 8 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 9 of 19

CHAPTER TWO

2.0

INTRODUCTION TO GENOME EDITING

2.1 Scope and Objective
2.1.1 Scope
These guidelines provide clarity on which genome edited organisms and/or derived products
should be regulated under the Biosafety Act and which products would be exempted andmanaged as conventional varieties or breeds. The guidelines apply to genome edited plants,
animals and microorganisms. Determination of genome edited organisms and/or products forpossible regulation will be conducted on a case by case basis.
2.1.2 Objective
The objective is to provide technical guidance to applicants and reviewers on which genome
editing organisms and/or products are regulated under the Biosafety Act, 2009.
2.1.3 Exemptions
These guidelines shall not apply to genome edited pharmaceuticals for human use andtechniques listed in the first Schedule of the Biosafety (Contained Use) Regulations, 2011.
2.2 Background to genome editing
Modern biotechnology, involving the use of recombinant-DNA (r-DNA) technologies, also
known as genetic engineering, emerged as a powerful tool with many potential applications inagriculture and healthcare in the 1980s. Organisms modified using r-DNA techniques,commonly referred to as genetically modified organisms (GMOs), have been and are being
developed with traits intended to provide benefit to farmers, consumers, and industry. These
traits include; abiotic stress tolerances, disease resistance, herbicide tolerance, pest resistance,
improved nutrition, improved shelf life, more efficient vaccines, faster growth, production of
useful by-products, among others.
Advancements in genome sequencing and comparative analysis, functional genomics, and thegrowing knowledge about function of various genes have motivated researchers to look at new
ways to develop new traits by changing specific genes in the organism’s own DNA, or to insert
new DNA in a targeted manner. Over the last decade, researchers have developed many new
precise techniques to develop new traits in a targeted manner through genome editing (Table
1). A growing number of countries have developed or are currently developing regulatory

Page 9 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 10 of 19

policy/guidance for what genome editing products may be exempted from existing GMO
regulatory frameworks, considering that genome editing can result in variety of outcomes: fromoutcomes comparable to those achieved by conventional breeding or found in nature, tooutcomes comparable to transgenesis. Possible applications of genome editing in crops include
biofortification, resistance to diseases and abiotic stress (e.g., drought), herbicide tolerance,
male/female sterility, altering of flowering time etc. Applications in livestock include improved
productivity e.g. muscle of meat, improved quality of products e.g. reduced allergenicity inmilk, animal health and welfare e.g. resistance to diseases and hornless cows among others.
Table 1: Examples of Current Methods Used for Genome Editing
Genometechniqueediting Description

Oligonucleotide Directed Oligonucleotide Directed Mutagenesis (ODM) involves
Mutagenesis (ODM)
specific nucleotide changes and, without the use of enzymes(e.g. nucleases), result in targeted single nucleotide
polymorphisms (SNPs).
Site Directed(SDN)

Nuclease Set of techniques based on the use of nucleases that introduce
break in the DNA chain near a defined target sequence.
Depending on the type of the endogenous DNA repair
mechanism, different kind of site-directed modifications or
genome editing possibilities may involve mutagenesis, genereplacement, gene insertion, and site-directed deletions orinversions.

a) Meganuclease
Technology

Meganucleases are naturally occurring restriction enzymes
isolated from bacteria and yeasts that recognize and cleave
DNA sequence targets, typically from 12 to 40 bp.

b) Zinc Finger Nuclease Zinc finger nucleases (ZFN) are proteins composed of a zinc
Technology
finger part and a nuclease part. The zinc finger protein binds
to a specific DNA location on each side where the nucleases
perform their function in pairs. Zinc finger sequence can be
adjusted such that the nucleases can cut a target sequence inthe plant.
c) TALEN (Transcription
Activator-Like
Effector
Nuclease)
Technology

A type of site-directed nuclease that combines a customizable
array of protein modules, found in bacterial proteins called
transcription activator-like effectors, that each recognize asingle DNA base and the catalytic domain of a DNA cutting
enzyme called FokI.

Page 10 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 11 of 19d) CRISPR(Clustered
Regularly Interspaced
Short
Palindromic
Repeats)/Cas
Technology

A precise form of site-directed nuclease technology based on
CRISPR/Cas bacterial defense system against viruses. The
nuclease is coupled to an RNA molecule which then binds toa specific DNA site. With this technology, scientists can elicit
targeted DNA changes.

(The above table provides a short summary of some of the genome editing techniques currently
being applied in breeding. Examples listed are for illustrative purposes and are notexhaustive).
With the emergence of genome editing techniques, there is need to consider the appropriate
regulatory mechanisms for products of such technology. Regulators around the world havebeen developing regulations to assess and make decisions on genome editing techniques. The
Authority, in collaboration with relevant regulatory agencies, has taken the initiative to developthese guidelines to establish the regulatory mechanisms taking into consideration otherinternational guiding documents and genome editing regulations from other countries.
2.3 Genome editing in relation to Genetically Modified Organisms
The Cartagena Protocol on Biosafety (CPB) to the Convention on Biological Diversity (CBD)
is the main international reference instrument for GMO regulation and Kenya is a signatory
having signed in the year 2000 followed by ratification in 2003. Kenya’s Biosafety laws are adomestication of the CPB. Under the protocol, GMOs (referred to as LMOs) are defined tomean any organism that possesses a novel combination of genetic material obtained throughthe use of modern biotechnology techniques. Genome editing techniques may alter the genomeof organisms resulting in either a GMO or organisms that are not distinguishable from thosedeveloped from conventional breeding or natural selection. Those techniques that result to a
GMO would be subject to the provisions of the Protocol and the Biosafety Act.
A number of countries such as Argentina, Australia, Brazil, Canada, Chile, Colombia,
Honduras, Japan and the US have made progress in developing regulatory frameworks that
address regulation of genome edited products. Genome editing is an evolving technology andtherefore regulatory frameworks developed need to be continually updated to facilitate
innovation. It is in this context that these guidelines have been developed in order to provide atechnical guidance to applicants and reviewers on the criteria for determining which genome
editing techniques and/or derived end products are regulated under the Biosafety Act.

Page 11 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 12 of 19

CHAPTER 3

3.0 REGULATORY CONSIDERATIONS FOR GENOME EDITINGTECHNIQUES
3.1 Considerations for regulation of genome edited plants, animals and microorganisms
These guidelines provide a criterion to determine which genome editing processes and derived
products are subject to Biosafety Act No. 2 of 2009. The decision thereof is made on a case bycase basis (Table 2, Figure 1).
An applicant is required to submit an Early Consultation Form (Annex 1) and pay theapplicable fees to the National Biosafety Authority (NBA) providing data on the experimental
processes and end product to establish whether it should be regulated under the Biosafety Act,
2009 or not. The decision on early consultation by the NBA will be communicated to theapplicant within 30 working days. However, genome editing projects that do not have therequired data will be regulated under the Biosafety (Contained Use) Regulations 2011.
This guideline may be reviewed based on new scientific information. NBA reserves the rightto alter its decision if new scientific information previously unknown becomes available.
Table 2: Categories for regulation of genome editing techniques and derived products
Category

Considerations/scenariosi). All genome editing projects without the required data*.
ii). All cases of insertions (of foreign genes and/or regulatory
elements) from a sexually non-compatible species.
iii). All instances where foreign genetic material(s) are detectable.
iv). All instances where markers used (selectable and reporter genes)for selection are present in the end-product.
v). In cases where research and developmental phase starts with a
GMO, NBA will regulate genome edited organisms up to the stage
where GMO component is removed/segregated.
Not regulated under i). All modifications by inserting genes from sexually compatible
species and where regulatory elements (promoters and terminators)
the Biosafety Act
are also from the same species.
ii). All deletions/knock outs provided that there is no insertion offoreign genetic material in the end-product.
iii). Processed products whose inserted foreign genetic material cannot
be detected.
Regulated under the
Biosafety Act

Page 12 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 13 of 19iv). Conventional breeding methods, mutagenesis, polyploidy andhaploidy

Page 13 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 14 of 19

Figure 1: Flowchart for the Early Consultation on genome editing processes in Kenya
ApplicantNBA (review within 30 days)

Relevant
Regulatory
AgencyStart

Early consultations withNBA (Applicant fills andsubmits the prescribedform)

Check forcompleteness andaccuracy of the form

Is there integrationof foreign genetic
material?

No
Yes
Notification that the process
and/or product will not be
regulated under the
Biosafety Act, 2009

NonGMOIs the foreign
genetic materialpresent in theend product?

No

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

GMO

Page 14 of 19

Notification to
the relevant
regulatory
agencies

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 15 of 19

Figure 1: Flowchart for the early consultation on genome editing. The above chart shows thedecision process for determining whether the developmental process or products for genome
editing are regulated under the Biosafety Act, 2009.

Page 15 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 16 of 19

CHAPTER FOUR

3.0 REFERENCES
1. Biosafety Act No. 2 (2009). Laws of Kenya. Nairobi. National Council for Laws Reporting.
2. Callaway, E. (2018). CRISPR plants now subject to tough GM laws in European Union.
Nature, 560(7716), 16-17.
3. Council for Agricultural Science and Technology (CAST). (2018). Genome Editing inAgriculture: Methods, Applications, and Governance—A paper in the series on The Needfor Agricultural Innovation to Sustainably Feed the World by 2050. Issue Paper 60. CAST,
Ames, Iowa.
4. Curtin, S. J., Voytas, D. F., & Stupar, R. M. (2012). Genome engineering of crops withdesigner nucleases. The Plant Genome, 5(2), 42-50.
5. Gaj, T., Gersbach, C. A., & Barbas III, C. F. (2013). ZFN, TALEN, and CRISPR/Casbased methods for genome engineering. Trends in biotechnology, 31(7), 397-405.
6. Jones, H. D. (2015). Regulatory uncertainty over genome editing. Nat. Plants, 1(14011),
10-1038.
7. Niu, Y., Shen, B., Cui, Y., Chen, Y., Wang, J., Wang, L., ... & Xiang, A. P. (2014).
Generation of gene-modified cynomolgus monkey via Cas9/RNA-mediated gene targetingin one-cell embryos. Cell, 156(4), 836-843
8. Osakabe, Y., & Osakabe, K. (2014). Genome editing with engineered nucleases in plants.
Plant and Cell Physiology, 56(3), 389-400.
9. Pâques, F., & Duchateau, P. (2007). Meganucleases and DNA double-strand break-induced
recombination: perspectives for gene therapy. Current gene therapy, 7(1), 49-66.
10. Resolution SAGYP No. 173 in the Republic of Argentina dated 12/MAY/2015.
11. Secretariat of the Convention on Biological Diversity (2000) Cartagena Protocol on
Biosafety to the Convention on Biological Diversity: text and annexes. Montreal, Quebec,
Canada. ISBN 92-807-1924-6
12. Smith, J., Grizot, S., Arnould, S., Duclert, A., Epinat, J. C., Chames, P., ... & Montoya, G.
(2006). A combinatorial approach to create artificial homing endonucleases cleaving
chosen sequences. Nucleic acids research, 34(22), e149-e149.
13. Wang, Y., Geng, L., Yuan, M., Wei, J., Jin, C., Li, M., ... & Chai, Z. (2017). Deletion of atarget gene in Indica rice via CRISPR/Cas9. Plant cell reports, 36(8), 1333-1343.

Page 16 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 17 of 19

14. Whelan, A. I., & Lema, M. A. (2015). Regulatory framework for gene editing and othernew breeding techniques (NBTs) in Argentina. GM crops & food, 6(4), 253-265.
15. Whelan, A. I., & Lema, M. A. (2019). Regulation of Genome Editing in Plant
Biotechnology: Argentina. In Regulation of Genome Editing in Plant Biotechnology (pp.
19-62). Springer, Cham.
16. Wight, A. J. (2018). Strict EU ruling on gene-edited crops squeezes science. Nature, 563,
15-16.

Page 17 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 18 of 19

ANNEX
ANNEX 1: APPLICATION FOR EARLY CONSULTATION ON GENOME EDITINGTECHNOLOGY IN KENYA
This form will guide in determining whether genome editing organisms or their derived
products are regulated under the Biosafety Act, 2009 or not.
SECTION I: APPLICANT INFORMATION
1.1 Name of Applicant, Address, Email, Telephone

1.2. Affiliated Institution, Address Email, Telephone, Website

SECTION II: ORGANISM INFORMATION
2.1. Taxonomic description of the organism: Genus, Species (Breed/ Strain/ Variety/ Line – whereapplicable)

2.2. Rationale for genome editing
Purpose of genome editing:

Intended use: Research, Import, Environmental release, Placing in the market, etc (Tick asappropriate)

SECTION III: MOLECULAR TECHNIQUES
3.1. Give a summary of the molecular techniques used:
3.2. State the gene or DNA sequence(s) modified:
3.3. Describe the type of genome editing done (deletion, insertion, substitution, replacement) withsupporting data*;
3.4. Molecular description of the target organism’s nucleotide target sequences, before and after
genome editing with supporting data*;
3.5. Molecular description of the gene edited organisms, their functions and the affected pathways(where applicable) before and after genome editing*;
3.6. Provide the names of vectors to be used and show their genetic map(if not applicable, go to 3.7.)

Page 18 of 19

Guidelines for determining the regulatory Ref:
process of genome editing techniques in Revision No: 00
Kenya
Page 19 of 19

3.6.1 Is the vector naturally
pathogenic?

3.6.2 Is the vector
disarmed?

3.6.3 If yes, how was the vector
disarmed?

Yes
No
Yes
No
3.7. Describe delivery methods used for genome editing

SECTION IV: GENOME EDITED PRODUCT
4.1. Is the inserted foreign DNA sequence(s) present in the final product?
Yes

No

If No;
Describe the techniques used to remove the inserted genetic sequences and evidence for the same*;

Describe detection protocols used to confirm absence of inserted genetic sequences in the genome
edited end products and provide data to support this assertion*;
4.2. Has the genome edited product been exempted from respective relevant GMO legislation
anywhere in the World? If YES, where and for what purpose?

*Where the required data is not available, the application shall be subjected to the Biosafety
Act, 2009 and its enabling regulations.

SECTION V: DECLARATION OF CORRECTNESS OF INFORMATIONI certify that the above information is true to the best of my knowledge.
Principal Investigator/Applicant
Name _______________________
Signature ___________________________ Date ____________
Collaborator(s) (if applicable)
Name(s) _______________________
Signature ___________________________ Date ____________

Page 19 of 19