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upsetsubduedManagement

Nov 9, 2013 (3 years and 10 months ago)

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“The Role of National Biosafety
Authority and Regulatory
Framework in Kenya.”



Willy K.
Tonui
, PhD, RBP

Chief Executive Officer

Establishment of NBA


The

Biosafety

Act,

2009

established

the

National

Biosafety

Authority

(NBA)
.



The main features of the Biosafety Act include:

1.
Prohibition of anyone dealing with a GMO (
eg
. for
research, manufacture, production, commercial
release and import) unless licensed by the National
Biosafety Authority for contained use or intentional
release into the environment

2.
Establishment of a National Biosafety Authority to
implement the legislation;

3.
Establishment of the NBA Board



Mandates


The mandate of NBA is to exercise supervision
and control over the development, transfer,
handling and use of genetically modified
organisms (GMOs) with a view to ensuring
and assuring safety of human and animal
health and provision of an adequate level of
protection of the environment.


Functions

The Biosafety Act, 2009 lists the functions of NBA as follows:



To
consider

and
determine applications for approval
for the development,
transfer, handling and use of genetically modified organisms, and related;



To
co
-
ordinate, monitor and assess activities
relating to the development,
safe transfer, handling and use of genetically modified organisms in order
to ensure that such activities do not have adverse effect on human health
and the environment;



To


co
-
ordinate research and surveys
in matters relating to the safe
development, transfer, handling and use of genetically modified
organisms, and to collect, collate and disseminate information about the
findings of such research, investigation or survey;



To identify
national requirements for manpower development
and
capacity building
in biosafety;


Functions
--
2


To
advise the Government


on legislative and other measures
relating to the safe development, transfer, handling and use of
genetically modified organisms;



To
promote awareness and education among the general public
in
matters relating to biosafety;



To establish and maintain a biosafety clearing house
to serve as a
means through which information is made available facilitate the
exchange of scientific, technical, environmental and legal
information on, and experience with, living modified organisms;



To exercise and perform all other functions and powers conferred
on by the Act.


Enforcement of the Biosafety Legislation


In enforcing the Biosafety law, the National Biosafety

Authority collaborates with a number of 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).


Vision

A World Class Biosafety Agency







What Does it take to be a World
Class Biosafety Agency??

Benchmark with the Best and

Have Good Practices

Benchmarking visit to Australia and Singapore

June 1
-
6, 2012

International Best practices


To domesticate International
agreements and best practices (e.g.
WHO, UN 1540 and BTWC) in
regulations


To develop regulations that support
laboratory design and construction
are essential during certification
and accreditation of laboratories


To certify staff who handle
biological materials in Kenya


To strengthen homeland security
and the Protected Areas Act (Cap
242) should be considered
alongside Biosafety regulations

Result of the Visits


The visit influenced our position that NBA should:


Have clear roles and responsibilities of stakeholders and
other regulators in Kenya


Strengthen laboratory standards and to establish a GMO
testing laboratory in NBA


Have a strong certification and accreditation process


Improve on Risk assessment methodologies and post
release review frameworks


Employ highly skilled professionals who can do the work


Document how Institutions and Counties can
implement/enforce the Biosafety Act and Standards

Mission

To ensure and assure safe development,
transfer, handling and use of genetically
modified organisms in Kenya


Governance

The

NBA

is

managed

by

a

Board

of

Management

comprising

of
:




A

Chairperson

who

must

be

an

eminent

scientist

appointed

by

the

Minister

for

the

time

being

responsible

for

Science

and

Technology




CEOs

(or

their

Appointed

Alternates)

from

six

(
6
)

Government

agencies

whose

mandates

relates

to

biosafety

issues

Six

(
6
)

other

persons

appointed

by

the

Minister,

3

of

whom

shall

be

experts

in

biological,

environmental

and

social

sciences,

the

others

as

follows
;


One shall represent the interests of consumers,


One shall represent the interests of farmers


One shall represent the interests of the biotechnology industry.




Representative of the Permanent Secretary (PS)
-

Ministry responsible for Science and
Technology




Representative of the PS
-

Ministry of Finance




Representative of the PS
-

Ministry of Agriculture




CEO of the National Council for Science and Technology (NCST)




CEO of the NBA appointed by the Board who is also the Secretary to the Board




Establishment

Management Structure

The Authority has two divisions headed by Directors as follows:


1)
Technical Services Division headed by the Director, Technical Services


2)
Finance and Administration Division headed by the Director, Finance and Administration


Technical Services Division


Has 3 Departments namely;


Biosafety Evaluation and Clearing House


Standards and Enforcement


Monitoring and Evaluation


Finance and Administration Division


Has 4 Departments as follows;



Finance and Accounts


Human Resource and Administration


Procurement



Planning and Performance Contracting


Regulatory Framework

Handling Applications



Any person wishing to undertake any activities
using GMOs can only do so with the approval
of the NBA


Activities envisaged under the Act include
-


Research
-

contained use, confined use


introduction into the environment


Placing on the market


Import, transit, export



18

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

Risk Assessment


Risk assessment objective
“identify and
evaluate the potential adverse effects of GMO
to human health, animal and environment”


General principles
:


Scientifically sound and transparent manner



Lack of scientific knowledge or consensus does
not imply a particular level of risk


Risk of GMO must be considered in the context of
non
-
GMO

Decision Making



Based on Risk assessment report from reviewers,
submitted by applicant and available information



The Authority then prepares a decision document


The decision document will contain
-


A summary of the application including the details
of the applicant, the genes involved, the purposes
of the intended use


The risk assessment


The decision


Every decision must be reached at within 150
days of receipt of the application but not less
than 90 days




Review and Appeal Mechanisms


The Act makes provisions for a review as well
as appeal mechanism.


A review may be done by the Authority on its
own volition or upon the rquest of an
applicant


An appeal’s board has been established to
consider applications from persons aggrieved
by the decision of the Authority

Offences and Penalties


Several offences have been created under the
Act; these include
-


makes contained use of, releases into the
environment, places on the market, imports or
exports a genetically modified organism
without the approval of the Authority;


contravenes any conditions attached
toan

approval under this Act;


fails to furnish any information as required by
this Act;




Penalties and Offences


uses any confidential information for any purpose
not authorized under this Act;


uses a genetically modified organism in a manner
inconsistent with the approval granted by the
Authority or for unethical purposes;


obstructs or fails to assist the Authority or officers
of the Authority in the performance of their duties
under this Act;


The penalties range from fines of Ksh two million to
Ksh twenty million and/ or imprisonment of up to
ten years

Biosafety Regulations, 2011

Biosafety


“Avoidance of risk to human health and safety
and the conservation of the environment as
result of use of genetically modified organism”



GMO: “An organism that possesses a novel
combination of genetic material obtained
through the use of modern Biotechnology”

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 (2011)


Environmental Release (2011)



Import, Export and Transit (2011)


Regulations for Labeling (2012)

Biosafety (Contained Use)
Regulations


Context and Scope



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.


Contained Use:
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 undertake contained use
without the written approval of the Authority
(Art. 7. (1)


Such activity must be carried out within or in
collaboration with a research institution


The research institution carrying out such activity
must establish Institutional Biosafety committee





Other Provisions


Suspension/Revocation of approval (
Art. 11
)


Institutional Biosafety Committee


Classification of containment levels


Handling of New Information (
Art. 12
)


Contingency Plans/Emergency Measures (
Art.
13
)


Miscellaneous (Register of Decisions, BCH,
CBI)


Offences, Schedules





Biosafety (Environmental
Release) Regulations


Context and Scope



These regulations cover activities involving
release of GMOs into environment; placing on
market


Typically apply during commercialization

Objective (Art. 3)


The objective of these Regulations is to ensure
that potential adverse effects of genetically
modified organisms are addressed to protect
human health and the environment when
conducting environmental release.


Environmental Release:
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)


An application for environmental release/placing
on market shall be made to the Authority … (in a
prescribed manner

with KShs 850,000 as fees)


FLOW CHART
-
ENVIRONMENTAL RELEASE


Other Provisions


Suspension/Revocation of approval


Handling of New Information


Contingency measures


Miscellaneous (Register of Decisions, BCH, CBI)


Offences, Schedules


Public awareness and participation


Monitoring





Biosafety (Import, Export &
Transit) Regulations

Context and Scope




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


Import, Export & Transit:
Requirements


A person shall not conduct any activity involving
GMOs without written approval from the
Authority
(Biosafety Act, 2009, Art. 18)


A person wishing to import, export or transit a
GMO shall apply for and obtain written approval
from the Authority (
Arts. 4(1); 5(1) & 6 (1)


A person transiting shall ensure GMO is packaged
and transported as per Kenyan Laws


Transit require prior approval by the receiving
country


Labelling Regulations, 2012






“Labeling” means any written,
printed, or graphic matter that
accompanies a food or is displayed
near the food, including that for
the purpose of promoting its sale
or disposal


Definitions




Objectives of Labelling 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



Food or feed produced from
Genetically modified
organisms, placed on the
market in accordance with
the Biosafety Act.



Contains Genetically modified
food, approved by NBA

Exemptions



Where GMO is below 1%
threshold level




Highly refined foods
devoid of GMO



Food additive



Food intended for
consumption


Provisions of the labelling regulation


Labelling requirement



operators shall ensure that:

(a) for
pre
-
packaged products
, the words ‘genetically modified (name of
ingredient) ’ or ‘genetically modified (name of food)’ appear on a label;


(b) for non
-
pre
-
packaged products the words ‘genetically modified organisms’
or ‘genetically modified (name of organism(s))’ shall appear on, or in
connection with,
the display of the product
.



Monitoring inspection and compliance


10.
(1) The Authority shall liaise with the relevant regulatory agency to
monitor any genetically modified organisms for compliance with the
requirements of these Regulations.



NBA Achievements

Achievements


Approved applications within the required
period



Guidelines for certifying personnel and
laboratories being developed



Curriculum to support training in universities
being developed



Monitoring of approved projects




Achievements


IBC Forum to be initiated in 2012/2013



Roster of Experts (In Progress)



Guidelines on Commercial release developed



Enhanced partnerships and networking with local
and International agencies to prepare for release
into the market


Achievements


Establishing Entry/exit points at the Coast and
Western Kenya



Employed Biosafety Inspectors to support
inspection and testing at exit/entry points



Developing Regulations on Handling,
Transport of GMOs (In progress)


Strategic Plan 2011
-

2015

Official launch May 22, 2012

Strategic Plan

Service Charter

Presided over by Hon Margaret Kamar, EGH, MP

Minister for Higher Education Science and Technology

NBA Logo

Stands for

“Excellence in regulating potential biohazards for gene
technology and protecting the environment in Kenya and
throughout the world


Strategic Objectives

NBA
Strategy

2011
-
2015

Assure safety
during
development
of GMOs

Establish
Biosafety
Information
system

Enhance
collaboration
and
partnerships

Enhance
coordination
of
Regulations

Enhance
public
participation
and
Awareness

Capacity
Building

Public Concerns about GMOs

Concerns



Food Security


Environmental
Impact


Socio
-
economic


Intellectual property


Biological materials


Feed


Treat


Clothe


Secure

…….. The Nation

Theme 1: To build capacity at NBA
towards the fulfilment of its mandates



Undertake physical infrastructural development


Have our own Headquarters


strive to develop its own laboratory to facilitate the
detection of GMO events.




Realize competent, committed and motivated
employees


embark on a systematic effort to develop the human
resource across its functional areas in order to enhance
and sustain its intellectual capital.

Theme 2: To raise public awareness and participation
in NBA activities with respect to Biosafety


To increase the level of awareness of, and
public participation in biosafety


Navigate impartially through the debate and
facilitate the responsible development and
application of modern biotechnology for the
benefit of the people of Kenya and avoid the risk
of being undermined by either camp.


Implement Communication Strategy



Highlights of the conference

Theme: Strengthening National Capacity for
Biosafety Management


2 days of Pre
-
Conferences


2 days of Conference discussions


Biosafety recognition and Best Presenters
awards


Panel discussion on Role of Media and
Concerns on GMOs (last day)


Theme 3: To assure safety during the
development, handling and use of GMOs



To assure integrity during the development,
handling and transfer of GMOs


Establish Test laboratories



Monitor approved activities


Apply biosafety standards in development, handling,
transfer and use of GMOs


Equip the cross sectoral and dispersed inspectors with
rapid diagnostic methodologies (kits) to assist in their
work.


Implement biosafety regulations

Theme 3: To assure safety during the
development, handling and use of GMOs



Establish mechanism for regular inventory of
biosafety expertise and facilities in Kenya


Implement a registration programme of Biosafety
experts



Develop and implement a certification programme
for Biosafety experts


Apply guidelines for annual certification of equipment
and facilities conducting GMOs


To ensure transparent, predictable science based
risk assessment of applications

Theme 3: To assure safety during the
development, handling and use of GMOs



To ensure transparent, predictable science
based risk assessment of applications


To implement risk assessment SOPs


Apply clear guidelines for reviewers


Maintenance of approval database


Maintain platform for public participation


Theme 4: To establish a Biosafety
Information Management System



To establish a biosafety information management
and Exchange system


Facilitate the exchange of scientific, technical,
environmental and legal information on, and
experience with, genetically organisms.



Provide access, where possible to other international
biosafety information exchange mechanisms.



Avail summaries of risk assessments or environmental
reviews of GMOs generated by its regulatory
processes.


Theme 5: To enhance Collaboration
and partnerships


Enhance partnership and linkages at both
national and international levels


Establish collaborative relationships and strategic
partnerships.


Broaden partnerships and collaborations

Theme 6: To enhance coordination for
effective implementation of Biosafety
regulations



To improve implementation and coordination of
Biosafety regulations


Develop a harmonized biosafety regulatory regime



Establish/Strengthen Institutional Biosafety
Committees



Develop MOUs with regulatory agencies for
effective coordination of activities

Thank You

For more information:

Website:
www.biosafetykenya.go.ke

E
-
mail:
info@biosafetykenya.go.ke

ceo@biosafetykenya.go.ke