Presented by Doris Wangari, Program for Biosafety Systems (PBS), Kenya, at the Workshop on Animal Genetic Research for Africa (Biosciences for Farming in Africa), Nairobi, 10-11 September 2015

1. Program for Biosafety Systems – http://pbs.ifpri.info/
Biosafety Regulatory Framework in Kenya
Doris Wangari
Program for Biosafety Systems (PBS), Kenya
Animal Genetic Research for Africa
(Biosciences for Farming in Africa), Nairobi,
10-11 September 2015

2. Program for Biosafety Systems – http://pbs.ifpri.info/
Biosafety Act, 2009
 Sets up the National Biosafety Authority as the
National focal point of all Biosafety matters in Kenya.
 Makes provision for the establishment of a legal
framework for the safe handling, use and transfer of
Genetically modified organisms
 NBA to exercise general supervision and control over
dealings in GMO with a view to ensuring safety to
human and animal health and protection of the
environment

3. Program for Biosafety Systems – http://pbs.ifpri.info/
Objects of the Act
• To facilitate responsible research into and
minimize the risks that may be posed by GMOs
• To ensure an adequate level of protection for safe
transfer, handling and use of GMOs that may have an
adverse effect on the health of the people and the
environment
• To establish a transparent, science‐based and
predictable process for reviewing and making
decisions on transfer, handling and use of GMOs

4. Program for Biosafety Systems – http://pbs.ifpri.info/
Mandate of the NBA
• To consider and determine applications for approval
for the development, transfer, handling and use
• To co-ordinate, monitor and assess activities relating
to the development, safe transfer, handling and use of
GMOs
• To co-ordinate research and monitor activities on all
GMO work in the country
• Strengthen national technical capacities and
capabilities for biosafety
• Develop regulations to operationalize the Biosafety
Act.

5. Program for Biosafety Systems – http://pbs.ifpri.info/
Cont…
• Establish and maintain a biosafety clearing house
(BCH) mechanism- web based information sharing
of national database linked to the international
BCH;
• Promote public awareness on biosafety and
biotechnology
• Enforce the provisions of the Biosafety Act
• Provide advisory services on matters of biosafety.

6. Program for Biosafety Systems – http://pbs.ifpri.info/
Regulatory Agencies
In enforcing the Biosafety law, the NBA collaborates with 8 regulatory
agencies as specified in the Biosafety Act.
These agencies include:
• Department of Public Health.
• Department of Veterinary Services (DVS).
• Kenya Bureau of Standards (KEBS).
• Pest Control Products Board (PCPB).
• Kenya Plant Health Inspectorate Service (KEPHIS).
• National Environmental Management Authority (NEMA).
• Kenya Wildlife Service (KWS).
• Kenya Industrial Property Institute (KIPI).

7. Program for Biosafety Systems – http://pbs.ifpri.info/
Role of Regulatory Agencies
• Monitor approved GMO activity to ensure
compliance with the conditions of approval
• Inform the Authority of any significant new
scientific information indicating that an approved
activity pose biosafety risk not previously known
• Inform the authority of unintentional or
unapproved introduction of a GMO into the
environment and propose mitigation measures

8. 8
Prepare and submit application to NBA
Communicate to
Applicant
Approved?
Start
Is dossier
complete?
Communicate
to Applicant
Yes
complete?
Yes
complete?
Not complete
Not complete
Communicate to Relevant Regulatory Agency(s)
and selected experts for review
Approval with/ without relevant conditions
The end
Submit review report to NBA
Communicate to
Applicant and Relevant
Regulatory agency(s)
Monitoring for adherence to approval conditions and
provisions of the Biosafety Law

9. Program for Biosafety Systems – http://pbs.ifpri.info/
BIOSAFETY REGULATIONS
The Law provided for gazettement of regulations that would
be important for the implementation of the Biosafety Act
2009;
To date 4 regulations have been gazetted: Regulations for;
• Contained Use (August 2011)
• Environmental Release (August 2011)
• Import, Export and Transit (August 2011)
• Regulations for Labeling (2012) e.g Foods and Feeds

10. Program for Biosafety Systems – http://pbs.ifpri.info/
1. Contained Use regulations
• These regulations cover activities involving GMOs
under containment and confinement
• They are typically applied during research on GMOs
(LAB, Green house, Screen, house CFT)
Objective (Art. 3)
• The objective of this Regulation is to ensure that
potential adverse effects of genetically modified
organism are addressed to protect human health and
the environment when conducting contained use.

11. Program for Biosafety Systems – http://pbs.ifpri.info/
2. Environmental Release Regulations
• This regulation covers activities involving release of
GMOs into the environment; placing on the market; etc
• Typically apply during commercialization
Requirements:
• A person shall not conduct any activity involving GMOs
without written approval from the Authority (Biosafety
Act, 2009, Art. 18)
• A person shall not make an environmental release or
place on market a GMO without the written approval of
the Authority.(Art. 5(1); 6 (1)

12. Program for Biosafety Systems – http://pbs.ifpri.info/
3. Import, Export & Transit Regulations
• These regulations cover activities involving importation
into, exportation out of and movement of GMOs through
Kenya
• Could touch on aspects of release or placing on market in
which case Regulations on Release apply
Objective (Art. 3)
• The objective of these Regulations is to ensure safe
movement of genetically modified organisms into and out
of Kenya while protecting human health and the
environment

13. Program for Biosafety Systems – http://pbs.ifpri.info/
4. Labeling Regulations
• To ensure that consumers are aware that food/feed or
product is GMO for informed choice
• To facilitate traceability of GMO products towards
enforcement of appropriate management measures
• Application: Foods consisting of GMO or derived from
GMO
• Exemptions: Where GMO is below 1% threshold level,
Highly refined foods devoid of GMO, Food additives,
Food intended for consumption

14. Program for Biosafety Systems – http://pbs.ifpri.info/
Food/ Feed Safety Assessment

15. Program for Biosafety Systems – http://pbs.ifpri.info/
PROJECT INSTITUTION DATE APPROVED
Bt Cotton Project KALRO 14th April, 2007
Drought tolerant maize (Event MON
87460)- WEMA Project
KALRO 18th August, 2010
African Bio-fortified Sorghum
(ABS ) Project
KALRO 18th August, 2011
Bt Maize (MON 810) Project KALRO 30th Oct., 2012
Bio-‐fortified
Cassava (B-‐Plus Project)
18th August, 2011
Approved CFTs

16. Program for Biosafety Systems – http://pbs.ifpri.info/
PROJECT INSTITUTION DATE APPROVED
Cassava Mosaic virus
Resistant cassava( VIRCA
Project)
KALRO 18th Jan., 2011
Cassava Brown Streak
Disease Resistance
(VIRCA Project)
KALRO 26th Sept., 2013
Gypsophila Project for Pink
Colour flower stability
KALRO 3rd Dec., 2013
Transgenic cassava expressing
African cassava
Mosaic virus (ACMV) and cassava
brown streak virus (CBSV)
resistance
Masinde Muliro
University of Science
and Technology
(MMUST)
6th March, 2014

17. Program for Biosafety Systems – http://pbs.ifpri.info/
PROJECT INSTITUTION DATE
APPROVED
Confined Field Trial (CFT) to evaluate
sweet potato containing genetic
elements conferring siRNA resistance
to sweet potato virus disease.
KALRO 21st July,
2014
Trials of transgenic sorghum
containing pro-‐vitamin A and
enhanced iron and zinc bio-
availability
KALRO 4th March,
2015

18. Program for Biosafety Systems – http://pbs.ifpri.info/
Thank you!