The Biosafety Bill, 2007: Presentation by Betty - OFAB

clatteringlippsBiotechnology

Dec 5, 2012 (4 years and 8 months ago)

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THE BIOSAFETY BILL,
2007

JACARANDA HOTEL,
26
TH

JULY
2007


BACKGROUND TO THE BILL


Research activities in the country
-

these were going on and were guided by the
Science and Technology Act,


Ratification of the Cartagena Protocol on Biosafety
-



Kenya was the first country to sign the protocol. Kenya ratified the protocol in
Sept 2003



The objectives of the Protocol were to ensure an adequate level of protection in
the field of safe transfer, handling and use of genetically modified organisms
resulting from modern biotechnology that may have an adverse effect on the
human health and environment and to establish a transparent and predictable
process to review and make decisions on such genetically modified organisms
and related activities.



Setting up of the National Biosafety Committee



Draft regulations and guidelines
-

but guidelines lacked legal basis, hence
drafting of a new law



Consultative process
-

process involved all the relevant stakeholders

JUSTIFICATION


International obligation
-

Having ratified the protocol, it
is necessary that Kenya observes its obligations
under the protocol.



Need to take research to the market
-

commercializing
products whose efficacy and safety has been proven
scientifically, would enable farmers all the present
and future options to gain higher income from
commercial adoption of GM crops




Legal framework
-

A comprehensive Biosafety legal
framework strikes a balance between ensuring the
development of biotechnology and safeguarding the
interests of consumers and the environment


PROVISIONS OF THE BILL


Preliminary provisions


Administrative provisions


Handling requests and risk assessment


Review and appeal


Role of regulatory agencies


Inspections


Financial provisions


Miscellaneous provisions

PRELIMINARY PROVISIONS


Title of the Bill
-

the Biosafety Bill


Interpretation section


biosafety


Genetically modified organisms


Scope of the Act


The Act will not cover genetically modified
pharmaceuticals as they are already covered
under the WHO guidelines and which the
Ministry of Health has adopted



ADMINISTRATIVE PROVISIONS


The Bill Establishes a National Biosafety
Authority, which shall be a body corporate



The Bill sets up a representative Board of
management comprising of regulatory offices,
consumers, industry and farmers.




the Bill also provides for the appointment of a
CEO of the Authority. The CEO will carry out
the day
-
to
-

day activities of the Authority

HANDLING REQUESTS AND RISK
ASSESSMENT


The Act requires that any one wishing to carry
out activities involving GMOs i.e. research,
introduction into the environment, importing
exporting, transiting through Kenya, placing
on the market (selling), will only do so with
the approval of the Board



Prior to making a decision on whether to
allow or reject an application, the Board will
carry out a risk assessment.


RISK ASSESSMENT


Risk assessment entails
identifying and evaluating the potential adverse
effects of genetically modified organisms on human health and the
environment. Risk assessment includes
-



an identification of any genotype and phenotypic characteristics
associated with the genetically modified organisms that may have
adverse effects on the environment and on human health



an evaluation of the likelihood of these adverse effects being realized,
taking into account the level and the kind of exposure of the likely
potential receiving environment of the genetically modified organisms,



an evaluation of the consequences should these effects be realized,



an estimation of the overall risk posed by the genetically modified
organisms based on the evaluation of the likelihood and consequences
of the identified adverse effects being realized,



REVIEW AND APPEALS


An review of a decision may be done by the Authority
at any time upon obtaining significant new scientific
information relating to Biosafety of the genetically
modified organism


A regulatory agency or an applicant may also request
the Authority to review its decision with respect to an
activity conducted by the applicant.


Any person who is aggrieved by a refusal to grant an
approval; the imposition of any conditions on an
approval; the revocation, suspension or variation of
an approval; a refusal to treat an application as
confidential, may, within thirty days of being notified
of the relevant decision of the Authority, appeal to
the Appeals Board.

REGULATORY AGENCIES


The Authority will coordinate all GMO
activities. It will be assisted by the regulatory
agencies



Regulatory agencies exist and draw their
mandates from various Acts of Parliament.


RESTORATION AND CESSATION
ORDERS


Where

the

Authority

has

good

reason

to

believe

that

an

approved

activity

is

causing

adverse

effect

to

humans

and

the

environment,

the

Authority

is

mandated

by

the

Bill

to

order

the

person

carrying

out

the

activity

to

either

restore

the

environment

to

as


near

as

it

may

be

to

the

state

in

which

it

was

before

the

release

of

a

genetically

modified

organism,

or

to

cease

the

approved

activity
.

INSPECTIONS


The Minister, in consultation with the
Authority has been mandated to appoint
Biosafety inspectors, either by name or by
title office to carry out inspections.



The Bill also gives the inspectors powers to
enter premises, take samples and
carry out
such tests and inspections


FINANCIAL PROVISIONS


The Bill sets out provisions for funding
including


Monies appropriated by parliament



Donations and gifts



such moneys or assets as may accrue to or
vest in the Authority in the course of the
exercise of its powers or the performance of
its functions under the Act;

MISCELLANEOUS


Minister’s powers to make regulations for the better
carrying out of the functions of the Act



Offences and penalties


Offence of withholding information
-

fine of Ksh
10million or 3years imprisonment



Other offences
-

1 year imprisonment and a fine of Ksh
1million.



Transitional provisions
-

applications pending before
commencement of Act, or approvals granted before
the commencement of the Act

CONCLUSION


Absence of a Biosafety law exposes the country to
regulatory gaps and could be a major weakness
undermining the legitimacy and credibility of the
national Biosafety system.



Enactment of a Biosafety law in Kenya is
fundamental to provide adequate legal authority and
enforcement. This would provide an enabling
environment for modern biotechnology R and D to
thrive and at the same time safeguard the country
from potential risks posed by the technology



THE

END



THANK YOU

QUESTIONS?, COMMENTS