Context for revising the AU Model law - African Union

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1


AFRICAN UNION





UNION AFRICAINE



UNIÃO AFRICANA




AFRICAN MINISTERIAL CONFERENCE ON

SCIENCE AND TECHNOLOGY (AMCOST III)

STEERING COMMITTEE MEETING

Third Ordinary Session

6
-

7 June 2007

PRETORIA, SOUTH AFRICA




AU/EXP/

STEERING

/ST/6(Ill)







CONTEXT FOR REVI SI NG

THE AU MODEL LAW ON
SAFETY I N BI OTECHNOL
OGY

TABLE OF CONTENTS

LIST OF ACRONYMS

________________________________
________________

3

EXECUTIVE
SUMMARY

________________________________
______________

4

I. INTRODUCTION

________________________________
___________________

6

II.

KEY DEVELOPMENTS AT
THE AFRICAN UNION LE
VEL THAT
NECESSITATE REVIEW O
F THE MODEL LAW

________________________

8

III.

THE CARTAGENA PROTOC
OL AND THE AFRICAN M
ODEL LAW ON
SAFETY IN BIOTECHNOL
OGY

________________________________
____

10

A. The Cartagena Protocol

________________________________
_________

10

B. African Model Law on Safety in Biotechnology

______________________

13

C. Comparison of the Model Law and the Biosafety Protocol (BSP)

_______

14

IV.

SUB
-
REGIONAL APPROACHES
TO BIOTECHNOLOGY AND

BIOSAFETY

________________________________
____________________

16

A.

The Economic Community of Central African States (ECCAS
-
CEEAC)

__

18

B. The Common Market for Eastern and Southern Africa (COMESA)

______

18

C.

Intergovernmental Authority on Development (IGAD)

________________

19

D. Southern Africa Development Community (SADC)

__________________

21

E. Economic Community for West African States (ECOWAS)

____________

24

F.

The Model Law and Regional Efforts Towards Harmonization of
Biosafety

________________________________
_____________________

25

V. STATUS OF BIOTECH
NOLOGY AND BIOSAFETY

IN AFRICA

____________

25

A. Overview

________________________________
_____________________

25

B. Select National approaches

________________________________
______

29

1. South Africa

________________________________
________________

29

2. Kenya

________________________________
_____________________

30

3. Egypt

________________________________
______________________

32

VI.

BIOSAFETY INITIATIVE
S IN AFRICA

_______________________________

37

A.

UNEP/GEF

________________________________
____________________

37

B.

USAID Program for Biosafety Systems (PBS)

_______________________

38

C. Association for Strengthening Agricultural Resear
ch in Eastern and
Central Africa (ASARECA)

________________________________
_______

39

D. The RABESA Initiative

________________________________
__________

40

E. The AU Biosafety Project

________________________________
________

42

F. Recognition of the Need for a Regional Approach to Biotechnology
and Biosafety Policy in Eastern and Southern Africa

_________________

43

VII.

CONCLUSION AND WAY F
OR
WARD

_______________________________

44


3

LI ST OF ACRONYMS


AEC


African Economic Community

AIA
-
Advance Informed Agreement

AMCOST
-
African Ministerial Council for Science and Technology

AMU


Arab Maghareb Union

APB
-

African High Level Panel on Modern Biot
echnology

ASARECA
-
Association for Strengthening Agricultural Research in Eastern and
Central Africa

AU


African Union

BCH


Biosafety Clearing House

BSP
-
Biosafety Protocol

CBD
-
Convention on Biological Diversity

CEN
-
SAD


Community of Sahel
-
Saharan States

COMESA


Common Market for Eastern and Southern Africa

COP
-
Conference of Parties

DNA
-
Dioxiribonuclic acid

EAC


East African Community

ECCAS


Economic Community for Central African States

ECOWAS


Economic Community for West African States

EU
-
European Uni
on

FFPs
-
Food, feed and processing

FANR
-
Food Agriculture and Natural Resources

GEF


Global Environmental Facility

GMO(s)


Genetically Modified Organism(s)

GTZ
-

German Technical Cooperation

IGAD


Intergovernmental Authority on Development

IGADD


Intergov
ernmental Authority on Drought and Development

KARI
-
Kenyan Agricultural Research Institute

LMO(s)


Living Modified Organism(s)

MOP
-
Meeting of the Parties

NBC
-
National Biosafety Committee

NBF


National Biosafety Framework

NCST
-
National Council for Science

and Technology

NEPAD
-
New Economic Partnership for Africa’s Development

OAU


Organisation of African Unity

PBS
-
Program for Biosafety Systems

RABESA


Regional Approach to Biosafety in Eastern and Southern Africa

REC(s)


Regional Economic Community(s)

SAD
C


Southern African Development Community

UN


United Nations

UNEP


United Nations Environment Programme

USAID


United States Agency for International Development

WHO
-
World Health Organization

WTO


World Trade Organisation


4


EXECUTI VE SUMMARY

The Africa
n Model Law was concluded in 2001. Since then there are a number of
key developments at the international, regional, sub
-
regional and national levels
that raise the need for review of the text of the Model Law. The cropland under
biotechnology crops contin
ues to increase and we have South Africa among the
countries that are leading in this regard.

A number of developments make the review of the Model Law. At the AU level,
three key developments are worth noting. The Cairo Declaration of the
Extraordinary Co
nference of the African Ministerial Council on Science and
Technology (AMCOST)
1

which re
-
affirms that science and technology are key to
socio
-
economic development; the AU resolved to take a common approach to
address issues pertaining to modern biotechnolo
gy and biosafety by endorsing
decision EX. CL/Dec. 26(III) calling for an African common position on biosafety.
This Decision stressed the need for Member States to equip themselves with
human and institutional capacities to deal with biosafety issues with
in the
framework for the implementation of the Biosafety endorsed steps taken by the
AU Commission to put in place an Africa
-
wide biosafety system and programmes
to strengthen the abilities of Member States to deal with biosafety issues; and the

African St
rategy on Biosafety which aims at guiding modern biotechnology
developments and providing guidance to African countries in dealing with the rest
of the world where biotechnology is concerned.


Another key development that raises the need to review the Mod
el Law is the
coming into force of the Cartagena Protocol on Biosafety in 2003. Some of the
provisions of the Protocol necessitate changes to the Model Law to align it with
these provisions in light of membership to the Protocol by many African
countries.
Many African countries are in the process of domesticating the
provisions of the Cartagena Protocol which provides minimum standard for
biosafety. While the Model Law provisions are more detailed in some respects, it
is imperative that some discussion be c
anvassed around the provisions.
Examples of issues that call for alignment between the Biosafety Protocol and
the Model Law are: application of risk assessment to

transboundary movement of
living modified organisms which are pharmaceuticals for humans; the

application
of AIA procedure to LMOs intended for FFPs; liability and redress; identification
and labelling; capacity building and public awareness.


Linked to the Protocol are the numerous initiatives for biosafety capacity building
that many African co
untries have participated in or are still engaged in. The
UNEP
-
GEF project on building national biosafety frameworks deserves mention
here. It has catalysed discussions on biosafety even in countries where
biotechnology is at best nascent. The acknowledgem
ent by African countries of
biotechnology benefits raises the need to strike a balance between these
P

1


23
-
24 NOVEMBER 2006, CA
IRO, EGYPT ,EXT/AU/EXP/ST/DECL/13(II)
\
REV.1


5

benefits and risks. Indeed maximisation of benefits and minimisation of risks is
what the African Strategy on Biosafety seeks to achieve. Apart from the UN
EP
-
GEF project there are numerous other initiatives at sub
-
regional and national
levels. These can inform revision of the Model Law.


African countries have formed and organized around eight regional economic
communities (RECs) which, though not coterminou
s with the AU sub
-
regions, are
recognised by the AU. These form an important intervention point for
biotechnology and biosafety even though the RECs mandate at inception was
limited to trade and their capacity in Biosafety is limited. Five of these RECs
(C
ommon Market for Eastern and Southern Africa (COMESA), Intergovernmental
Authority on development (IGAD), the economic Community of Central African
States (ECCAS
-
CEEAC, Southern Africa Development Community (SADC) and
the Economic Community for West Africa
n States (ECOWAS)) have been
designated as the regional pillars of African Economic Community (AEC) by the
African Union. While RECs were not conceived of as biotechnology or biosafety
institutions, their mandates provide points for interfacing regional in
tegration with
the quest for harmonized approaches for biotechnology and biosafety at the sub
-
regional levels. Some of the RECs have taken on biotechnology and biosafety in
their mandates and can therefore inform the process of revising the Model Law.
Addi
tionally, security imperatives have informed the mandates of many of the
RECs. A closer look at the RECs identified as regional pillars is important here to
illustrate the potential role that these can play in biotechnology and biosafety and
hence the need

to consider them in revising the Model Law. Some of these
(SADC, COMESA and ECOWAS) have dealt explicitly with biotechnology and
biosafety.


At the national levels, African countries have invested in biotechnology. This has
happened within the context of
biosafety regulatory frameworks that pre
-
date the
Cartagena Protocol or emerging draft biosafety regulations developed under the
UNEP
-
GEF project. Countries have also had to deal with food aid and trade
issues related to GMOs and these need to be dealt wit
h in a revised Model Law.


The need for a regional approach, spelt out by the AU is also matched by sub
-
regional harmonisation initiatives. These can inform the revision of the Model
Law.


Finally,
the Model Law needs to facilitate the efforts by African

countries to invest
in biotechnology as spelt out in some sub
-
regional initiatives and at the AU level.
The revised law should be clear on scope and coverage.







6

I. I NTRODUCTI ON

The review of the African Model Law on Safety in Biotechnology (Model Law)

comes against the backdrop of increased crop land being devoted to modern
biotechnology in different parts of the world including Africa. More crop land
being devoted to GMOs and African countries joining the fray.


The global
biotechnology crop area reac
hed the 250 millionth acre in 2006, with more than
10 million farmers in 22 countries planting 102 million hectares of biotech crops,
up from 90 million hectares planted by 8.5 million farmers in 21 countries in
2005.
2

The increase of 30 million acres betw
een 2005 and 2006 was the second
highest in the last five years and equivalent to an annual growth rate of 13% in
2006.

Clive James notes that that more than half (55% or 3.6 billion people) of
the global population of 6.5 billion live in the 22 countries
where biotechnology
crops were grown in 2006 and

more than half (52% or 776 million hectares of the
1.5 billion hectares of arable land) of the cropland in the world is in the 22
countries where approved biotech crops were grown in 2006.
3

Of the countries

that grew biotechnology crops in 2006, South Africa was ranked eighth in terms
of the hectarage devoted to growing biotechnology crops
.
4

It is clear that

African
countries will generate biotechnology products and processes and will not be
mere recipients.

Looked at from this perspective, the Model Law as it currently is,
may restrict and prevent investment in biotechnology rather than being a
facilitative instrument driven and informed by science to assist countries
maximise the benefits of biotechnology w
hile minimising the risks.


The need to review thus arises from a number of key factors:



Developments at the international level



Developments at the African Union level



Sub
-
regional initiatives



National R&D and legislative and policy developments



Prolifera
tion of biosafety initiatives in Africa which have influenced the
development of national R&D infrastructure as well as laws and policies.

This paper looks at these issues with a view to providing a context for the
revision of the Model Law. It provides a
background to the revision of the Model
Law highlighting developments in the African Union that provide the impetus for
reviewing the law. It then outlines the provisions of the Cartagena Protocol on
Biosafety which came into force after the Model Law, not
ing that this in itself is a
P

2

Clive James, Global Status of Commercialized Biotech/GM Crops: 2006, ISAAA Brief 35
-
2006:
Highlights

3


Ibid.

4


Ibid.


7

reason for reviewing the Model Law given that most African countries are parties
to the Protocol. The paper then outlines the key provisions of the Model Law with
a view to highlighting its main thrust before highlighting the m
andates of Regional
Economic Communities (RECs) that provide a context for depositing
biotechnology and biosafety provisions. Apart form the RECs, the paper also
highlights key initiatives on biosafety which can inform a revision of the Model
Law. Finally,

the paper addresses the status of national biotechnology and
biosafety activities and regulatory frameworks arguing that there have been
major developments that call for a review of the Model Law.


For the purposes of the paper, biotechnology refers to te
chnological applications
that use biological systems, living organisms, or their derivatives to modify
products or processes for a specific use. It has been used by humans for a long
time in brewing, bread making, making of cheese, yoghurt and other produc
ts.
The technology has evolved with new techniques coming up using recombinant
Deoxyribonucleic acid (DNA). These processes are referred to as genetic
engineering and their products Genetically Modified Organisms (GMOS) or Living
Modified Organisms (LMOs).

Biosafety refers to all measures put in place to
ensure that the development, transfer and application of modern biotechnology is
done in a manner safe that does not endanger biological diversity, the
environment and human health. Biosafety measures requi
re interventions in
institutional, infrastructural, policy and legal, and human resource matters. The
need to ensure environmentally sound use of biotechnology was agreed upon in
1992 with the Convention on Biological Diversity calling upon parties to put
in
place or maintain mechanisms to manage or control risks associated with the use
and release of LMOs which are likely to have a negative impact on the
conservation and sustainable use of biological diversity, taking also into account
risks to human healt
h.


The precautionary principle is the cornerstone of the Biosafety Protocol and
informs all attempts at putting in place biosafety systems. Its upshot is that
“uncertainty regarding serious potential environmental harm is not a valid ground
for refrainin
g from preventive measures”.
5

In another enunciation of the principle,
it is stated that “where there are threats of serious or irreversible damage, lack of
full scientific certainty shall not be used as a reason for postponing cost
-
effective
measures to p
revent environmental degradation”.
6

This enshrined in Principle 15
of the Rio Declaration which is referred to in the Preamble and Article 1 of the
Protocol. In broad parlance, the principle enables an action whose negative
impacts are not yet known in sci
ence with the requirement that preventive
measures be put in place to mitigate such negative impacts. It is important to
point out that it was the African Group, representing like
-
minded developing
P

5

See
Principle 15 UNCED, Final Declaration of the UN Conference on Environm
ent and
Development, Rio de Janeiro (1992).


6


Hartmut Meyer, The Precautionary Principle and the Cartagena Protocol on Biosafety: Development
of a Concept, Gen

k, Norway (Forthcoming, 2007) (On file with the author).


8

countries during the negotiations on the Cartagena Protoco
l that demanded the
inclusion of the precautionary principle in the Protocol.
7

I I.

KEY DEVELOPMENTS AT
THE AFRI CAN UNI ON
LEVEL THAT NECESSI TA
TE REVI EW OF THE MOD
EL
LAW

The African Union (AU) put the Model Law in place to assist African countries in
craftin
g their national laws on biosafety. The need for that assistance as well as a
regional approach to biosafety is still valid at the AU level. Additionally, a number
of key developments raise the need to review the Model Law at this level. These
include
firs
tly
, the Cairo Declaration of the Extraordinary Conference of the
African Ministerial Council on Science and Technology (AMCOST)
8

which re
-
affirms that science and technology are key to socio
-
economic development,
economic competitiveness and the attainmen
t of the Millennium Development
Goals (MDGs).


Secondly, recognizing the need for a harmonized regional approach in dealing
with biosafety issues, the Executive council of the AU resolved to take a common
approach to address issues pertaining to modern bi
otechnology and biosafety, by
endorsing decision EX. CL/Dec. 26(III) that calls for an African common position
on biosafety. This Decision EX/CL/Dec.26 (III) stressed the need for Member
States to equip themselves with human and institutional capacities to

deal with
biosafety issues within the framework for the implementation of the Biosafety
Protocol. The decision also endorsed steps taken by the AU Commission to put
in place an Africa
-
wide biosafety system and programmes to strengthen the
abilities of Mem
ber States to deal with biosafety issues.


Thirdly
, the African Strategy on Biosafety
which was endorsed along with the
Report of the High Level African Panel on Biotechnology through the Cairo
Declaration (EXT/AU/EXP/ST/Decl/13(II)
\
Rev.1) and the AMCOST
(EXT/AU/MIN/ST/Rpt. (II)) in November 2006
aims at guiding modern
biotechnology developments and providing guidance to African countries in
dealing with the rest of the world where biotechnology is concerned. It is centred
on six pillars, namely Establishm
ent and Strengthening of Institutional
Frameworks; Awareness Raising and Biosafety Information Exchange; Capacity
Building and Preparedness for Negotiations; Policy and Legal Frameworks;
International Cooperation; and Sustainability Mechanism.
9

Each of th
e pillars
has defined actions to be undertaken for its implementation.


P

7


African Union, Directorate of Huma
n Resources, Science and Technology,
African Strategy on
Biosafety

(2006) EXT/AU/EXP/ST/4(II).


8


23
-
24 NOVEMBER 2006, CAIRO, EGYPT ,EXT/AU/EXP/ST/DECL/13(II)
\
REV.1

9


African Union, Directorate of Human Resources, Science and Technology,
African Strategy

on
Biosafety,
November 2006.


9


Review of the Model Law will contribute to the implementation of the strategic
framework to guide member states and the region in the development, handling
and use of modern biotechn
ology as laid out in the African Strategy on Biosafety
which recognises that biotechnology, though not a panacea for all challenges of
sustainable development, could play a key role in providing some useful products
in agriculture, animal industry, medicin
e, food production and processing and
environmental protection if it is applied judiciously with the necessary safety
measures and precautions. This makes biosafety a pivotal element in the
strategy, the idea being that biotechnology and biosafety are intr
insically
intertwined and neither can be effective without the other. The AU strategy seeks
to harmonise biotechnology and biosafety initiatives in the continent. This is
important given the existence of regional economic communities in the regions
whose f
ocus witin their mandate directly and indirectly includes biotechnology
and biosafety.


Fourthly,
the Model Law needs to be revised
to give effect to the
recommendations by the High Level African Panel on Modern Biotechnology
(APB) such as the one proposi
ng that countries should work together at the
regional level to scale up the development of biotechnology. APB as set up to
advise the AU on matters of Biotechnology and to provide the AU and NEPAD
with independent and strategic advice on developments in m
odern biotechnology
and its implications for agriculture, health and the environment.



Fifthly
, the African Ministers of Agriculture discussed an African position on
GMOs in Agriculture to which an Experts Meeting adopted the position at the
Conference of

African Union Ministers of Agriculture held in Libreville, Gabon
from November 27 to December 1, 2006. This pointed to the need for the AU to
guide member states in:


a)

Establishing mechanisms for public awareness

b)

Developing a sustainable African strategy
on bio
-
safety (build capacities
and task forces)

c)

Creating an enabling environment for application of biotechnology

d)

Establishing mechanisms to facilitate harmonization of regulatory systems

e)

Strengthening African capacity for effective participation in in
ternational
negotiations

f)

Facilitating effective collaboration among Policy makers, researchers,
farmers, service providers, civil society organizations, African leaders and
development partners.


Sixthly
, it is recognized that the involvement and input of

all member states and
the five sub
-
regions of Africa is necessary bringing in the pivotal role of Regional
Economic Communities which have on
-
going biosafety programs. The fact that
biotechnology has transboundary implications calls for a regional approac
h
integrating biosafety within biotechnology initiatives to maximise benefits and

10

minimise risks; develop and harmonise regional regulations of research and
development, safety from confined trials, field trials and commercialisation.

I I I.

THE CARTAGENA P
ROTOCOL AND THE AFRI
CAN
MODEL LAW ON SAFETY
I N BI OTECHNOLOGY

A.

T
HE
C
ARTAGENA
P
ROTOCOL

As a protocol to the UN Convention on Biological Diversity, the Cartagena
Protocol sets minimum standards for regulating certain aspects concerning the
safe transfer, ha
ndling and use of living modified organisms (LMOs
-

in other
legal texts defined as genetically modified organisms or GMOs) with a special
focus on the import and export of LMOs. These standards should ensure an
adequate level of protection to avoid or min
imize potential adverse effects on the
conservation and sustainable use of biological diversity, taking into account
human health.



The Protocol, which came into force in 2003, is the centre
-
piece of the emerging
global governance architecture for genetic

engineering. This emerging
governance framework has to contend with a wide range of concerns including
ecological, human health, social and ethical. The governance challenge is made
more complex by the fact that the existence, nature and manageability of
risks
remain deeply contested.


As pointed out above, the Cartagena Protocol on Biosafety is based on the
Precautionary Principle which, as used by the Protocol, is best expressed in
Article 10.6, also repeated in Article 11.8:

Lack of scientific certaint
y due to insufficient relevant scientific information
and knowledge regarding the extent of the potential adverse effects of a
living modified organism on the conservation and sustainable use of
biological diversity in the Party of import, taking also into

account risks to
human health, shall not prevent that Party from taking a decision, as
appropriate, with regard to the import of the living modified organism in
question as referred to in paragraph 3 above, in order to avoid or minimize
such potential adv
erse effects.

The statement is made in the context of the transboundary movement of LMOs.
But it applies equally in the development, handling and use of LMOs and their
products domestically since according to Article 2.2, Parties are obliged to
"ensure tha
t the development, handling, use, transfer and release of any" LMO
cause no risk. A simplified view of the Precautionary Principle is to err on the side
of caution when the existing facts do not show with certainty the LMO and its
products to be safe, and
thus to prevent its use until the information becomes
reliable.



11

Exporting corporations, or even exporting countries, are likely to pressurize a
developing country’s competent national authority into accepting that there is
indeed no risk.
I
n its preamble
of the Cartagena protocol Paragraph 8, states
that, "Taking into account the limited capabilities of many countries, particularly
developing countries, to cope with the nature and scale of known and potential
risks associated with living modified organisms
".


The socio
-
economic conditions of a developing country in this instance would
constitute a very important component in deciding whether to import a LMO or
not. But the provision on socio
-
economic considerations, Article 26, is very weak.
Most African
countries are financially constrained and therefore biosafety
measures are less likely to take a substantive budget. If a risk materializes, it will
require financial as well as human resources which is not available. Some socio
-
economic concerns voiced by

developing countries, such as adverse impacts of
traded GMOs on traditional livelihoods or increased dependence on GM seed,
may well run afoul of world trade rules, if used as a justification to restrict imports.
However, it remains contested and unclear
whether such key socio
-
economic
concerns as the lack of domestic capacity to monitor, segregate or label imported
GMOs would be acceptable reasons to restrict imports.


With the “advance informed agreement,” the Cartagena Protocol mandates that
importer de
cisions about GMO trade should be based upon scientific risk
assessment. Various groups have argued that it should be the only basis for
decision
-
making about GMO imports, with the hope that the Protocol will become
a vehicle to diffuse such a regulatory a
pproach to developing countries and
harmonize regulatory outcomes relating to GMO trade. However, at the
insistence of the European Union and developing countries, the Protocol also
allows for precautionary (trade restrictive) decisions in the face of scie
ntific
uncertainty about harm posed by a traded GMO. The Protocol permits
consideration of socio
-
economic factors in decision
-
making about GMO imports,
a demand from developing countries.


The scope of the Protocol (Art. 4) covers all LMOs that may have a
dverse effects
on the conservation and sustainable use of biodiversity, taking also into account
risks to human health. The expression, "taking also into account risks to human
health" is vague. It came into the Protocol from the CBD. While the CBD was
bei
ng negotiated, the countries leading in the development of genetic
engineering wanted to restrict any discussion on biosafety only to possible
impacts on biodiversity; they wanted human health to be disregarded by the
CBD, presumably thinking that they wou
ld have an advantage dealing with it
under other legal instruments. The other countries all wanted human health also
to be handled by the CBD. The compromise reached was this clumsy
expression.


Article 5 states that the Protocol shall not apply to the tra
nsboundary movement
of LMOs which are pharmaceuticals for human use that are handled by other

12

international agreements or organizations. In practice, the only all inclusive
arrangement that deals with pharmaceuticals for humans is the WHO’s
"Certification
Scheme on Pharmaceutical Products Moving in International
Commerce". The industrialized (OECD) countries also have "the Convention for
the Mutual Recognition of Inspections in Respect of the Manufacture of
Pharmaceutical Products". Both the Certification S
cheme and the Convention
were in place long before genetic engineering came into being. They both focus
only on the impact to human health, and not on any environmental impact.
Therefore, the prevention of risks from LMOs that are pharmaceuticals to the
co
nservation and sustainable use of biological diversity is not covered by any
international agreement, arrangement or organization other than the Cartagena
Protocol on Biosafety. To the extent of possible impact on the environment,
therefore, all LMOs that
are pharmaceuticals for humans are under the Protocol
according to Article 5 until such a time as WHO or any other international
organization develops a system for dealing with their environmental impacts as
well. It would seem logical then to subject LMOs

that are pharmaceuticals to the
AIA procedure. There would be complaint by industrialized countries that this
would slow down the importation of urgently required vaccines. This problem
however can be solved through national inter
-
institutional arrangemen
ts.


Article 5 states that a Party has the right to subject all LMOs to risk assessment.
The question of which institution will be responsible for the risk assessment in a
developing country can be settled through domestic legislation. Depending on
the out
come, the Ministry of Health can arrange for the import of the
pharmaceutical LMO after it receives a risk assessment and a suggestion for a
decision from the responsible environmental agency.


The Cartagena Protocol obliges member states to share biosafet
y information
between countries. GMO
-
exporting countries are required to provide biosafety
information to potential importing countries, either directly or via global
information clearing house. The nature and extent of information to be shared
depends upo
n intended use of a GMO in a domestic context. This right to
information is seen as critical in making the GMO trade more transparent and
hence is of key relevance for potential GMO importing countries. One particularly
contentious issue has been the exten
t of information to be shared about GM
varieties in the bulk agricultural commodity trade. Most developing countries and
the European Union are demanding clear identification and detailed information
sharing about specific GMO varieties in the commodity tr
ade. Exporting countries
and producers strongly resist these demands, arguing that they pose an unfair
burden on trade.


The Protocol in Article 2.4 allows countries to set standards higher than,

though
not inconsistent with, those set by its objective and

provisions. This is rather
difficult because when it comes to responding to the wishes of their corporations,
industrialized countries will want to pressurize developing countries away from

13

adopting higher standards. Already Civil society organizations ar
e exerting a lot
of pressure on governments which makes it more difficult to resist. Most of these
organizations are funded by the foreign genetic engineering corporations and
pose as home
-
grown pressure groups for supporting development. If the
developing

countries give in to such orchestrated pressure, they could be faced
with serious risks that will affect not only the present generations, but also
coming generations into the unknown future.

There are elements of the Cartagena Protocol that require furth
er elaboration
and negotiation such as the issue of liability and redress and labelling and
identification. The revision of the Model Law provides an opportunity for African
countries to develop common positions on those issues which will facilitate their
engagement in international negotiation forums. While the Model law already
covers these issues, it may need to be recast in light of on
-
going discussions at
the international level.

B.

A
FRICAN
M
ODEL
L
AW ON
S
AFETY I N
B
I OTECHNOLOGY

Following on the Model La
w on Rights, the AU adopted a Model Law on Safety in
Biotechnology. The Model Law
recognizes the precautionary principle as a
means of regulating any undertaking for the import, contained use, release or
placing on the market of genetically modified organi
sms and products of
genetically modified organisms.

The law adopts a number of the provisions of the
Cartagena Protocol, but in many cases transcends most of them.

The model law points out that while modern biotechnology might have much
promise for the im
provement of human well
-
being, its potential adverse effects
on the environment, biological diversity and human health are a cause for
concern and that governments have the responsibility to ensure the safety of the
people and the environment with respect
to the risks arising from GMOs and
products of GMOs resulting from modern biotechnology.

The Model law applies to the import, export, transit, contained use, release or
placing on the market of any GMO whether intended for release into the
environment, fo
r use as a pharmaceutical, for food, feed or processing or a
product of a GMO. It proposes the establishment of national institutions for the
implementation of the law namely, the National Focal Point (to be responsible for
liaison with the Secretariat of
the CPB and Clearing
-
House and facilitate the
exchange of information among the relevant bodies and authorities); the
Competent Authority (to follow up, supervise and control the implementation of
the Model law); the
National Biosafety

Committees

(NBC) com
prising
representatives of governmental and non
-
governmental organizations, and the
private sector relevant to the issues of biotechnology and biosafety (to provide
policy recommendations and guidelines to the Competent Authority); and
Institutional Biosaf
ety Committees within institutions involved in the import,
export, handling , contained use, release or placing on the market of GMOs or

14

products of GMOs (to institute and control safety mechanisms and approval
procedures at the institution level).

The Mo
del Law contains provisions on decision
-
making procedures on LMOs
requiring risk assessment and management; public participation in decision
-
making; clear labelling and identification of GMOs and their characteristics; strict
liability for harm occasioned
by importation, contained use of, release or
placement on the market a GMO or a product of a GMO; and penalties for
violations of the provisions of the law.

The Model Law is a template that the AU recommended for member states to
use in enacting national l
aws. It is an attempt to facilitate harmonization of
existing legislation in the area of biosafety and to ensure the adoption of unified
legislation in Africa. It is not binding and therefore countries are not compelled
but encouraged to adopt all or some

of its provisions. This raises the need for the
Model law to be informed by developments in the continent.


It is important to point out that the provisions of the Model Law have informed the
approach of many African countries towards biosafety. For insta
nce, a proposed
Kenya Legal Framework for safety in Biotechnology in 1999 adopted the Model
Law’s provisions on liability and redress, including strict liability, provisions for
costs of reinstatement, rehabilitation or clean
-
up and preventive measures
inc
urred. This approach was influenced by the environmental lawyers in the
group. The more recent initiative, the draft GMO bill which was generated by a
group comprising more scientists than lawyers, provides that “
liability and redress
for any damage that o
ccurs, as a result of activities subject to this Act, shall be
addressed by applicable laws”. Similarly, many African countries’ positions on
identification and labelling derive from the Model Law.
\

C
.

C
OMPARI SON OF THE
M
ODEL
L
AW AND THE
B
I OSAFETY
P
ROTOCOL

(BSP)

Here we identify some areas of incongruence between the Model Law and the
Biosafety Protocol:




Article 3
(Competent Authority) should allow for flexibility for countries
wishing to designate more than one Competent Authority



Article 5

of the BSP sta
tes that risk assessment for LMOs will not apply
to the transboundary movement of living modified organisms which are
pharmaceuticals for humans. On the contrary, Article 2 of the Model
Law states that the law will apply indiscriminately to all GMOs includ
ing
pharmaceutical products.
Provision should be included for
pharmaceuticals products that are addressed by other relevant
international agreements or organizations such as WHO.This could
avoid subjecting such products to repeated risk assessment as this
is
likely to hinder or disrupt supply and access to essential drugs in many

15

African countries
-

a region where human health and the burden of
disease is a major concern.



Article 7

of the BSP on the application of AIA procedure exempts
LMOs intended for F
FPs to AIA.
Article 2

of the Model Law requires
that AIA procedures be applied to all categories of GMOs including
those ones destined for food, feed or processing. Africa is a continent
that heavily depends on food aid from time to time.
The risk
assessme
nt (article 8) and risk management (article 9) regimes
proposed in the Model Law appear to be very cautious as opposed to
promoting a science
-
based approach to decision
-
making. If African
countries adopted a zero risk tolerance to GMOs would that hold? Is
the
legislation aimed at blocking African countries from harnessing the
potential benefits of GMOs or minimizing risks while maximizing
benefits? The two articles contradict Articles 15 and 16 of the Biosafety
Protocol which make a clear distinction betwee
n identifying risks on one
hand and managing them to minimize impacts on human health and the
environment. The articles should be carefully reviewed to ensure that R
and D activities involving GMOs are not hampered.
Biotechnology and
biosafety issues are b
est addressed with a clear picture of priorities and
constraints for the region, through a proactive approach, rather than a
purely defensive one, and focusing on pragmatic solutions that enhance
Africa’s capacity for applying biosafety and obtaining benef
its from the
use of its genetic resources in order to support sustainable
development and poverty eradication efforts.



Article 14 on Liability and Redress

is a very important regime and the
Model Law cannot exhaustively cover it. Other relevant national la
ws
should also be applicable where necessary on a case
-

by
-
case basis.



No article in the Model Law refers to the need and importance of
capacity building. This is a major omission since all discussions on
biotechnology and biosafety raise the issue as an
important one which
requires attention. Article 22 of the Biosafety Protocol places emphasis
on capacity building.



Article 11
-
Identification and labelling
:
The Model Law calls for
mandatory identification and labelling of all GMOs. In some cases this
may
not be applicable.
The third Meeting of the Parties (MOP
-
3) held in
Curitiba, Brazil made key resolutions with regard to labelling.

The Model
Law should be revised to reflect the decisions reached at COP
-
MOP 3.
The meeting resolved that any shipments conta
ining GMOs must state
and identify which events are present, what their intended use is, and
how they have been modified. Where it is not possible to identify those
GMOs, shipments must bear a label saying that they “may contain”
GMOs. In cases where the i
dentity of the LMO is known “through
means such as identity preservation systems” (a series of
documentation and storage
-
related requirements aimed at
guaranteeing that a product retains particular characteristics), the
shipment should be labelled as cont
aining LMO
-
FFPs. In cases where

16

the identity is unknown, the "may contain" label would apply. In both
cases, exporters would be required to provide the common scientific or
commercial names of the LMOs, as well as information about the
specific nature of t
he genetic modification.

I V.

SUB
-
REGI ONAL APPROACHES
TO
BI OTECHNOLOGY AND BI
OSAFETY

For administrative and other purposes, Africa is divided into five sub
-
regions
under the AU namely:

a) Eastern Africa (Djibouti, Ethiopia, Somalia, Eritrea, Kenya, Uganda,

Tanzania,
Comoros, Seychelles, Mauritius, Sudan);

b) Northern Africa (Algeria, Egypt, Libya, Morocco, Mauritania, Tunisia, Western
Sahara);

c) Western Africa (Benin, Burkina Faso, Cape Verde, Cote d’Ivoire, Liberia, Mali,
Sierra Leone, Guinea, Guinea Biss
au, The Gambia, Senegal, Ghana,
Níger,Nigeria, Togo);

d) Central Africa (Burundi, Cameroon, Chad, Central African Republic, Congo,
Congo Democratic Republic, Gabon, Equatorial Guinea, Rwanda, Sao Tome and
Principe);

e) Southern Africa (Angola, Botswana, Le
sotho, Madagascar, Mauritius, Malawi,
Mozambique, Namibia, South Africa, Swaziland, Zambia and Zimbabwe).


Each of these sub
-
regions has clear cut membership and no country belongs to
more than one sub
-
region. The African group has used these sub
-
regions
for
representation and coordination of biosafety activities beginning from the
negotiations on the biosafety protocol but more recently in the AU
-
GTZ Biosafety
Project and the African High Level Panel on Biotechnology.


The African High Level Panel on Bio
technology noted that each of the sub
-
regions could focus on a distinct area of biotechnology using
regional economic
integration as an institutional vehicle for mobilizing, sharing and using existing
scientific and technological capacities for R&D and inn
ovation. Such an approach
requires a broadly agreed to framework for biosafety which a revised Model Law
can provide. The sub
-
regions are the central focus in the establishment of the
regional centres of excellence in biotechnology and biosafety research a
nd
training. Pooling resources at a sub
-
regional level is seen as most effective in
developing biotechnology and biosafety capacity in light of differentiated
capacities in the individual countries.


African countries have formed and organized around eight

regional economic
communities (RECs) which, though not coterminous with the AU sub
-
regions, are
recognised by the AU. These form an important intervention point for
biotechnology and biosafety even though the RECs mandate at inception was
limited to trade

and their capacity in Biosafety is limited. Some countries belong
to more than one REC. Five of these RECs (Common Market for Eastern and

17

Southern Africa (COMESA), Intergovernmental Authority on development
(IGAD), the economic Community of Central Africa
n States (ECCAS
-
CEEAC,
Southern Africa Development Community (SADC) and the Economic Community
for West African States (ECOWAS)) have been designated as the regional pillars
of African Economic Community (AEC) by the African Union.


Other

RECs include:
10




The Arab Maghareb Union (AMU)
: Formed in 1964, but remained until
the late 1980s when it was revived with a membership of five countries,
namely: Algeria, Morocco, Libya, Mauritania and Tunisia. Its main
objective is to strengthen all ties among member sta
tes to ensure regional
stability and enhance policy coordination among others. The treaty names
the development of agriculture, commerce, industry and food security as
areas for cooperation. These provide an entry point for biotechnology and
biosafety init
iatives.



The Community of Sahel
-
Saharan States (CEN
-
SAD):

Established on
4th February 1998, CEN
-
SAD provides a framework for integration and
complementarity, whose objective is to work together with the other RECs
and AU

to strengthen peace, security and s
tability and achieve global
economic and social development. It has 23 member States namely
Benin, Burkina Faso, Central African Republic, Chad, Côte d'Ivoire,
Djibouti, Egypt, Eritrea, The Gambia, Ghana, Guinea Bissau, Liberia,
Libya, Mali, Morocco, Niger
, Nigeria, Senegal, Sierra Leone, Somalia,
Sudan, Togo and Tunisia. Though the primary objectives of the
community are economic in nature, the identification of the need to
harmonise and set similar standards in different spheres as well the
technical coop
eration can be used for biosafety.



The East African Community (EAC)
: The Permanent Tripartite
Commission for East African Cooperation, formed in 1967 as the East
African Community with Kenya, Tanzania and Uganda, collapsed in 1977
due to political differen
ces. It was revived in 1996 and the Secretariat of
the Permanent tripartite Commission launched at the Headquarters of the
EAC in Arusha, Tanzania. The Treaty of the East African Community
(EAC), signed on 30 November 1999, seeks to promote and strengthen
the balanced and sustainable integration of economic, social, cultural and
political aspects of the three member states: Tanzania, Kenya, and
Uganda. To this end EAC is promoting regional projects, facilitating the
movement of people and vehicles across bo
rders, harmonizing policies
and regulations for trade and investments and promoting regional
infrastructure. The objectives of the community to harmonise standards
will facilitate a regional approaching biotechnology and biosafety.


P

10


Ibid.


18

While RECs were not con
ceived of as biotechnology or biosafety institutions,
their mandates provide points for interfacing regional integration with the quest
for harmonized approaches for biotechnology and biosafety at the sub
-
regional
levels. Some of the RECs have taken on bio
technology and biosafety in their
mandates and can therefore inform the process of revising the Model Law.
Additionally, security imperatives have informed the mandates of many of the
RECs. Broadening security to include human security means that the manda
tes
encompass biotechnology and biosafety issues. A closer look at the RECs
identified as regional pillars is important here to illustrate the potential role that
these can play in biotechnology and biosafety and hence the need to consider
them in revising

the Model Law. Some of these (SADC and ECOWAS) have
explicit biotechnology and biosafety mandates.

A.

T
HE
E
CONOMIC
C
OMMUNITY OF
C
ENTRAL
A
FRICAN
S
TATES
(ECCAS
-
CEEAC)

Established in 1983 the leaders of the Central African Customs and Economic
Union (UDEAC)
agreed in principle to form a wider economic community of
Central African states. ECCAS began functioning in 1985 but was inactive
between 1992 and 1998 due to the conflict in the Great Lakes region as well as
financial difficulties occasioned by non
-
payme
nt of membership fees.
11

The state
parties agreed to the resurrection of the organisation in 1998. The aim of ECCAS
is to promote and strengthen harmonious cooperation and balanced and self
-
sustained development in all fields of economic and social activity
. These include
energy, agriculture, tourism, natural resources, and trade among others. To
achieve the set objectives, ECCAS proposes a number of interventions which
include the harmonization of national policies in order to promote Community
activities i
n industry, transport and communications, energy, agriculture, natural
resources, trade, currency and finance, human resources, tourism, education,
culture, science and technology. (Treaty establishing ECCAS, 1983). The
prevailing conflict situation in the

Great Lakes Region has greatly influenced the
working of ECCAS whose main activities so far, have been in the peace and
security realm. There is however an opportunity to integrate biotechnology and
biosafety in the work of ECCAS if one looks at a broader

definition of security to
include human security.

B.

T
HE
C
OMMON
M
ARKET FOR
E
ASTERN AND
S
OUTHERN
AFRICA

(COMESA)


COMESA was formed in December 1994 replacing the former Preferential Trade
Area (PTA). Its member states which have agreed to co
-
operate in d
eveloping
P

11


The member states are Angola, Burundi, Cameroon, Central African Republic, Chad, Congo
(Brazzaville), Democratic Republic of Congo, Equatorial Guinea, Gabon, Rwanda, Sao Tome and
Principe.


19

their natural and human resources and has 21 member states.
12

COMESA’s
objectives include cooperation in agricultural development, science and
technology, to increase agricultural production and attain regional food security.
This provides an inte
rface with biotechnology and biosafety. More specifically,
the region held a workshop to consider Regional Approaches to Biosafety in
Eastern and Southern Africa (RABESA) from 30
-
31 May 2006 with participants
drawn from the COMESA member states’ ministries

of Agriculture, Environment
and Trade. Among the recommendations that came out of this workshop were
that there was need for cooperation at regional (COMESA) level in assessment
of Risks for GMOs destined for commercial release, commercial trade and those

coming in as food aid, but leaving decision making to be done at national level, in
accordance with national law. The workshop further called for the establishment
of regional centres of excellence in biotechnology and biosafety; establishment of
a region
al panel of experts to advise on matters of biotechnology and biosafety;
capacity building in the field of biotech and biosafety at regional level to become
priority and public awareness at national level. The workshop finally called on the
COMESA secretar
iat to be more proactive regarding collaboration and
cooperation with the African Union secretariat and other regional economic
communities (and other organizations) in raising the region’s capacity in matters
of biotech and biosafety. COMESA has been work
ing closely with the
Association for Agricultural Research in Eastern and Southern Africa
(ASARECA) with regard to biosafety and biotechnology issues.


C.

I
NTERGOVERNMENTAL
A
UTHORITY ON DEVELOPM
ENT
(IGAD)

IGAD superseded the Intergovernmental Authority on

Drought and Development
(IGADD) established in 1986, it has seven members.
13

Originally conceived as
an organization to coordinate the efforts of member states, the mandate of IGAD
has extended to broader social, political and economic issues in the region
. The
new Agreement gave IGAD an expanded mandate that defines the areas of
cooperation among the Member States to include:



Enhancing cooperation and coordinating their macro
-
economic policies

Promoting sustainable agriculture development and food securi
ty.



Conserving, protecting and improving the quality of the environment.



Ensuring the prudent and rational utilization of natural resources



Promoting conflict prevention, management and resolution.



Respect of the fundamental and basic rights of the peoples

of the region
to benefit from emergency and other forms of humanitarian assistance.



Promoting trade and the gradual harmonization of trade policies and

P

12


Egypt, Sudan, Eritrea,

Djibouti, Ethiopia, Kenya, Uganda, Rwanda, Burundi, Democratic Republic of
Congo, Angola, Zambia, Namibia, Comoros, Seychelles, Mauritius, Madagascar, Malawi Swaziland,
Lesotho, and Zimbabwe.

13


Djibouti, Ethiopia, Kenya, Somalia, Sudan and Uganda. Eritre
a


20



Gradual harmonization of transport and communication policies and
development of infrastr
ucture. (IGAD Strategy, 2003).
14


While the Agreement Establishing IGAD identified some twenty areas of
cooperation among the member states, the priority areas identified as the
immediate entry points for cooperation are: Food security and environmental
pro
tection; Conflict prevention, management and resolution; and Economic
cooperation and integration. A major strength of IGAD is the political commitment
of the leadership of the Member Countries towards the idea of regional
cooperation despite differences b
etween some Member States. The IGAD
Secretariat plays an important role in enhancing efforts towards regional
coordination and working towards common positions of the Member States in
various regional and international for a such as ACP
-
EU and the World Tr
ade
Organization (WTO). It has in collaboration with the other regional co
operating
partners developed the regional programmes for cooperation with the European
Union and collaborated with other agencies such as the African Union (AU) in
coordinating new
regional initiatives and NEPAD. IGAD programs are intended to
complement the national development programs and the incapacity of Member
States to cope with development problems on their own without external inputs is
a major challenge. To address the probl
ems of food insecurity and environmental
degradation, IGAD programmes on agricultural development and food security,
natural resources management and environment protection. The agriculture and
food security programme acknowledges the fact that the region‘
s prosperity and
stability is predicated on agricultural development and improved food access
especially in the chronically food insecure areas. The programme acknowledges
the importance of building its interventions on the foundations of the national
stra
tegies of the member states and has three components, namely, boosting
agriculture, livestock and food production, improving the efficiency of agricultural
and food marketing, and strengthening the food security safety net.

P

14


The objectives of IGAD are to: a) Promote joint development strategies and gradually harmonize
macro
-
economic policies and programmes in the social, technological and scientific fields; b) Harmonize
policies with regard to trade, customs, transport,

communications, agriculture, and natural resources, and
promote free movement of goods, services, and people within the region.

c) Create an enabling environment for foreign, cross
-
border and domestic trade and

investment; d) Achieve regional food secur
ity and encourage and assist efforts of Member States to
collectively combat drought and other natural and man
-
made disasters and their natural consequences; e)
Initiate and promote programmes and projects to achieve regional food security and sustainable
development of natural resources and environment protection, and encourage and assist efforts of Member
States to collectively combat drought and other natural and man
-
made disasters and their consequences; f)
develop and improve a coordinated and compleme
ntary infrastructure, in the areas of transport,
telecommunications and energy in the region; g) Promote peace and stability in the region and create
mechanisms within the region for the prevention, management and resolution of inter
-
State and intra
-
State
conflicts through dialogue; h) Mobilize resources for the implementation of emergency, short
-
term,
medium term and long
-
term programmes within the framework of regional cooperation; i) Promote and
realize the objectives of the Common Market for Eastern and

Southern Africa (COMESA) and the African
Economic Community; j) Facilitate, promote and strengthen cooperation in research development and
application in science and technology.


21

D.

S
OUTHERN
A
FRICA
D
EVELOPMENT

C
OMMUNITY
(SADC)


SADC, the successor to the Southern African Development Co
-
ordination
Conference was established in April 1980 by Governments of Angola, Botswana,
Lesotho, Malawi, Mozambique, Swaziland, Tanzania, Zambia and Zimbabwe.
The conference was
transformed into a community in August 1992 when the
Heads of State and Government of the Southern African Development
Coordination Conference signed a Declaration and Treaty establishing the new
SADC (Southern African Development Community). The membershi
p grew to 14
member states after Seychelles, Mauritius, the Democratic Republic of Congo,
Namibia and South Africa, joined the community. SADC has developed since
then, to become an organisation that has a Programme of Action, covering
several broad econom
ic and social sectors including Environment and Land
Management, Water, Human Resource Development, Food, Agriculture and
Natural Resources, Legal Affairs and Health.



The objectives of SADC are to:

a) Achieve development and economic growth, alleviate p
overty, enhance the

standard and quality of life of the people of southern Africa and support the

socially disadvantaged through regional integration;

b) Evolve common political values, systems and institutions;

c) Promote and defend peace and security
;

d) Promote self
-
sustaining development on the basis of collective self
-
reliance,
and

the interdependence of member states;

e) Achieve complementarity between national and regional strategies and

programmes;

f) Promote and maximise productive employm
ent and utilisation of resources of
the

Region;

g) Achieve sustainable utilisation of natural resources and effective protection of
the

environment;

h) Strengthen and consolidate the long standing historical, social and cultural

affinities and links a
mong the people of the Region.


The ultimate objective of SADC, is therefore, to build a Region in which there will
be a

high degree of harmonisation and rationalisation to enable the pooling of
resources to achieve collective self
-
reliance in order to i
mprove the living
standards of the people of the region.


At a meeting of the SADC Council of Ministers for Food, Agriculture and Natural
Resources (FANR)
-

held on July 5, 2002 in Mozambique


the lack of a
harmonised regional position on GMOs was noted
to be creating serious
problems in the movement of food and non
-
food items. Consequently the council
advised member states to engage in bi
-
lateral consultations and to explore

22

mechanisms to facilitate movement of humanitarian food that may contain
GMOs. Th
e FANR Ministers approved the establishment of an Advisory
Committee to develop guidelines to safeguard Member States against potential
risks of GMOs in the areas of Trade, Food Safety, Contamination of Genetic
Resources, Ethics, and Consumer Concerns. The

committee was tasked to
provide advice to countries of the sub
-
region on issues associated with
biotechnology and propose ways of harmonizing their policies and regulations
and to enable SADC countries to develop and adopt a proactive strategy to
respond
to issues raised by biotechnology.


The SADC Advisory Committee on Biotechnology and Biosafety formulated
interim measures aimed at guiding the region on issues relating to biotechnology
and biosafety which were approved by SADC in August 2003. These incl
uded
measures addressing food aid specifically providing that there should be
harmonised transit information and management system for Genetically Modified
food aid designed to facilitate trans
-
boundary movement in a safe and
expeditious manner; Food aid s
hould be preferably sought from within the region;
Donors providing Genetically Modified food aid should comply with the Prior
Informed Consent principle and with the notification requirements in accordance
with Article 8 of the Cartagena Protocol on Biosa
fety; Food aid consignments
involving grain or any propagative plant material that may contain GMOs should
be milled or sterilized prior to distribution to beneficiary populations; and Food aid
in transit that may contain GMOs should be clearly identified
and labelled in
accordance with national legislation.


The Committee recommended that countries that did not have national legislation
(See Table 1) should make use of the requirements under the AU Model Law on
Biosafety and/or the South African Guidelines

on the handling of transit material
which may be GMO. Further Member States were to sign and ratify the
Cartagena Protocol on Biosafety to the Convention on Biological Diversity and
develop national biotechnology policies and strategies and expedite the p
rocess
of establishing national biosafety regulatory systems.


Further, the Committee recommended a harmonized policy and regulatory
system based on the African Model Law on Biosafety and the Cartagena
Protocol on Biosafety and that risk assessments shoul
d be done on a case
-
by
-
case basis and every genetic modification should be tested in the environment
under which it will be released. On capacity building, the Committee
recommended that member states should develop capacities at national and
regional leve
l in order to develop and exploit the benefits of biotechnology and
that resources should be allocated for capacity
-
building in the management of
biotechnology and bio
-
safety. The Committee also recommended that SADC
member states should commission studies

on the implications of biotechnology
and bio
-
safety on agriculture, environment, health and socio
-
economics as part
of an integrated monitoring and evaluation system and that public awareness and

23

participatory programmes on Biotechnology and Biosafety tha
t involve all
stakeholders should be developed.








Table 1. Status on the Development of Biotechnology and Biosafety Policy
and Legal Frameworks within SADC


Country

Status on development of Biotechnology & Biosafety Policy
and Legal Frameworks

Ang
ola

There is no biosafety policy or legislation

But there is a Ministerial Decree on importation of GMOs

Botswana

There is no biosafety policy or legislation in the country; but there
is a Cabinet Memo, which stipulates on obligations for
declaration o
f GMOs imports. A draft national biosafety framework
initiated in 2002 with UNEP/GEF funding is being finalised

Lesotho

There is no biosafety policy and legislation, but a Multisectoral
Task Force has been set up to develop a national biotechnology
and bi
osafety policy and legislation

Malawi

Has a legislation on Biosafety but is in the process of developing a
national biotechnology and biosafety policy

Mauritius

Has no biosafety policy but the Genetically Modified Organisms
Bill (No. 44 of 2003) was pa
ssed into law in March 2004

Mozambique

Has no biosafety policy and legislation, but has set up a National
Biosafety Working Group to develop a policy and legislation

Namibia

Has a Biotechnology and Biosafety Policy passed in 1999 but
does not have a leg
islation

Seychelles

Has no biosafety policy and legislation

South Africa

Has had a biosafety framework, the GMO Act since 1997

Swaziland

Has no biosafety policy and legislation

Tanzania

There is no biosafety policy and legislation, but there is a 2
nd

d
raft
Policy and 1
st

draft Biosafety Regulations

Zambia

There is no biosafety legislation, but has a National Biotechnology
and Biosafety Policy. A draft legislation on biosafety has been
approved in principle by Cabinet and will be presented to
Parliament

in 2006


24

Zimbabwe

Has a biosafety framework which includes a Biosafety Board and
its Secretariat and the Biosafety Regulations and Guidelines


Source: Adopted from African Centre for Biosafety

ht
tp://www.biosafetyafrica.net/south.htm


F.

E
CONOMIC
C
OMMUNITY FOR
W
EST
A
FRICAN
S
TATES
(ECOWAS)


ECOWAS treaty was signed in 1975 in Lagos actualizing the idea of a West
African community. In 1993, a revised treaty was signed to accelerate economic
integra
tion and increase political cooperation. The member states are Benin,
Burkina Faso, Cape Verde, Côte d’Ivoire, The Gambia, Ghana, Guinea, Guinea
-
Bissau, Liberia, Mali, Mauritania, Niger, Nigeria, Senegal, Sierra Leone and
Togo. ECOWAS aims at promoting eco
nomic, cultural and social cooperation,
ultimately leading to a monetary and economic union through total integration of
the economies of the member states. It also aims at raising the living standards
of its people, maintain and enhance economic stability
, foster relation among
member states and contribute to the progress and development of the African
continent.


The revised treaty (1993) provides for the achievement of a common market and
a single

currency as economic objectives, while on the political

front, it provides for a
West African Parliament, an economic and social council and an ECOWAS court
of justice, to

replace the existing tribunal and enforce community decisions. Regarding
Modern biotechnology and biosafety, ECOWAS member states held a m
inisterial
conference on biotechnology in 2005, among whose outcomes were:

Concerning the Regional Approach to Biosafety (In the short term):

a) to call on the countries that have not yet ratified the Cartagena Protocol to do it

as soon as possible, so t
hat by July 1st, 2006 all the ECOWAS country members

would have adopted their national policy and legislations on bio safety, thus,

facilitating regional harmonization of the bio safety system from now until July

2008;

b) implement the regional strateg
ic Plan on biosafety for the benefit and access
of

biotechnology in west Africa;

c) adopt a regional initiative based on:

d) the creation of a regional supporting structure for the implementation of
actions planned and the elaboration within a period of

one year of a national
regulatory framework on bio safety in each country.

In the medium term:

a) harmonize national legislations and put in place a regional regulatory
framework

on biosafety; and


25

b) raise an independent fund for the assessment of the

socio
-
economic impacts
of

the use of GMOs.

G.

T
HE
M
ODEL LAW AND REGIONA
L EFFORTS TOWARDS
HARMONIZATI ON OF BIO
SAFETY

Recent developments and trends demonstrate that RECs are pushing for
regional integration and cooperation in a wide range of issues inclu
ding matters
of biosafety. The Model Law does not contain any provisions or articles that
would facilitate regional cooperation in handling transboundary movement of
GMOs. A country may have a strong national legislation such as the one
provided by the AU
Model Law but the porous nature of borders in African
countries and informal trade (legal or illegal) makes all the countries susceptible
to transboundary movement of GMOs. While the Model Law focuses on
individual countries, it is important to include pro
visions that recognize and seek
to promote regional approaches to biosafety.


For instance, Article 14 of the Protocol states that parties may enter into bilateral,
regional or multilateral arrangements to deal with transboundary movement of
GMOs. The ar
ticle provides space for the RECS to spearhead regional
integration arrangements that in turn provide opportunities for centralized risk
assessment, capacity building and sharing of resources. Given the stringent and
precautionary nature of the Model Law,
majority of African countries lack
adequate capacity to enforce all the provisions of the law. Such countries can
benefit from regional cooperation and complementarity.

V. STATUS OF BI OTECH
NOLOGY AND BI OSAFETY

I N
AFRI CA

A.

O
VERVIEW

Countries are at dif
ferent levels of development and application of biotechnology

and are putting in place measures to build their capacity to reap the possible
benefits from modern biotechnology while avoiding the possible risks. Some
countries have moved further along than
others in terms of research and
development, research infrastructure and legal and regulatory provisions. A
process of learning from each other can be institutionalised through discussions
towards revision of the Model Law.


Only South Africa has commercia
lly released GMOs into the environment. Other
countries such as Egypt, Kenya, Burkina Faso, Uganda and Zimbabwe have
carried out or in the process of carrying out field trials of some GMOs, while

26

others are considering the options available with research s
till at laboratory and
green house stages.
15

Some African countries have started engagement in
modern biotechnological research to identify useful applications that they can
integrate in their national development programmes. In addition to South Africa
whi
ch has already released GMOs into the environment on a commercial scale,
countries like Egypt, Algeria, Kenya, Libya, Namibia, Nigeria, Tunisia, Uganda,
Zambia and Zimbabwe are in the process of carrying out modern
biotechnological research or are in the p
rocess of establishing or strengthening
their laboratory facilities
.
16


As countries have invested in biotechnology, the have developed their national
capacities in Biosafety, to be able to regulate and safely apply modern
biotechnology and its products, wh
ether internally generated or introduced into
the countries from other countries which have been doing GMO research for
much longer and have commercialised several products. This has provided them
with opportunities to test their regulatory frameworks. The
ir experiences can
inform the revision of the Model Law. For instance, South Africa was among first
AU states to develop specific legislation on GMOs and was among the leading
country globally in the hectarage of land devoted to GMOs in 2006 as pointed out

above. The South Africa Genetically Modified Organisms Act of 1997 became
effective in December 1999 and is currently undergoing review, to align it with the
Cartagena Protocol on Biosafety. Similarly, Zimbabwe in 1998 amended its
Research Act to include
biotechnology and biosafety and Malawi promulgated its
Biosafety Act in October 2002, a comprehensive piece of legislation covering
environmental risks as well as risks to human health. The purview of the Malawi
Act includes the importation, development, p
roduction, testing, release, use and
application of GMOs. The other countries are still drafting their national
legislation or are just through the drafting process, awaiting enactment by their
national parliaments.

Many African countries are in the proce
ss of drafting their national biosafety
legislation and may have looked at the provisions of the Model Law in the
Process (see Table 2). They can therefore inform the regional process of
reviewing the Model Law drawing from their national experiences.

Tabl
e 2: Available Biosafety Laws, Regulations and Guidelines of Countries
as of April 19, 2007

1

Burkina Faso

Law, Regulation or
Guideline

Summary of regulatory system

All functions pursuant t
o the Cartagena Protocol
on Biosafety

BCH
-
CP

2

Cameroon

Law, Regulation or
Guideline

Law laying down safety regulations governi
ng
modern biotechnology in Cameroon

All functions pursuant to the Cartagena Protocol
on Biosafety

BCH
-
CP

P

15


African Strategy on Biosafety,
supra
note
7
.

16


Ibid.


27

3

Côte d'Ivoire

Law, Regulation or
Guideline

DECRET N° 63
-
647 du 7 novembre 1963 fixant
les conditions d'introduction et d'exportation des
végétaux et autres matières susceptibles de
véhiculer des organismes dangereux pour les
cultures.

Transboundary movement (import/export)

BCH
-
CP


Côte d'Ivoire

Law, Regulation or
Guideline

LOI N° 64
-
490 du 21 décembre 1964 relative à
la protection des végétaux.

Tr
ansboundary movement (import/export)

BCH
-
CP


Côte d'Ivoire

Law, Regulation or
Guideline

Loi n° 96
-
766 du 3 octobre 1996 portant

Code
de l'Environnement

All functions pursuant to the Cartagena Protocol
on Biosafety

BCH
-
CP


Côte d'Ivoire

Law, Regulation or
Guideline

Décret n° 96
-
894 du 8 novembre 1996
déterminant les règles et procédures
applicables aux études relatives à l'impact
environnemental des projets de développement

All functions pursuant to the Cartagena Protocol
on Biosafety

BCH
-
CP

4

Ghana

Law, Regulation or
Guideline

Biosafety Bill

All functions pursuant to the Cartagena Protocol
on Biosafety

BCH
-
CP


Ghana

Law, Regulation or
Guideline

National Biosafety Guidelines

All functions pursuant to the Cartagena Protocol
on Biosafety

BCH
-
CP


Ghana

Law, Regulation or
Guideline

National Biosafety Framework for Ghana
-

Administrative Guidelines

All functions pursuant to the C
artagena Protocol
on Biosafety

BCH
-
CP


Ghana

Law, Regulation or
Guideline

Public Participation Guidelines

Public awareness and

participation

BCH
-
CP

5

Lesotho

Law, Regulation or
Guideline

National Biosafety Policy

All functions pursuant to the Cartagena
Protocol
on Biosafety

SCBD

6

Madagascar

Law, Regulation or
Guideline

Projet de loi relative au régime de la biosécurité

All fu
nctions pursuant to the Cartagena Protocol
on Biosafety, Handling, transport, packaging
and identification, Intentional introduction into
the environment (AIA), LMOs for use as food or
feed or for processing, Public awareness and
participation, Transbounda
ry movement
(import/export), Transit and contained use,
Contained use, Transit

BCH
-
CP


Madagascar

Law, Regulation or
Projet d'arrêté interministériel portant
réglementation de l'importation et de
BCH
-
CP


28

Guideline

l'exportation, du transit, de la commercialisation,
de la manipulation et de l'utilisation d'OGM et/ou
produits dérivés

All functions pursuant to the Cartagena Protocol
on Bios
afety, Handling, transport, packaging
and identification, Intentional introduction into
the environment (AIA), LMOs for use as food or
feed or for processing, Transboundary
movement (import/export), Transit

7

Namibia

Law, Regulation or
Guideline

Draft Biosafety Bill

All functions pursuant to the Cartagena Protocol
on Biosafety, Contained use, Handling,
transport, packaging
and identification,
Intentional introduction into the environment
(AIA), LMOs for use as food or feed or for
processing, Pharmaceuticals, Transboundary
movement (import/export), Transit and
contained use, Transit

BCH
-
CP

8

Nigeria

Law, Regulation or
Guideline

Nigeria Biosafety Guidelines

Handling, transport, packaging and
identification, Public awareness and
participation

BCH
-
CP

9

Rwanda

Law, Regulation or
Guideline

Draft GMO Regulatory Framework

All functions pursuant to the Cartagena Protocol
on Biosafety

BCH
-
CP

10

Senegal

Law, Regulation or
Guideline

Regulatory summary

All functions pursuant to the Cartagena Protocol
on Biosafet
y

BCH
-
CP

11

South Africa

Law, Regulation or
Guideline

Genetically Modified Organisms Act, 1997 (Act
No. 15 of 1997)

Intentional
introduction into the environment
(AIA), LMOs for use as food or feed or for
processing, Transit and contained use

BCH
-
CP


South Africa

Law, Regulation or
Guideline

Regulations: Genetically Modified Organisms
Act,1997

Intentional introduction into the environment
(AIA), LMOs for use as food or feed or for
processing, Transit and contained use

BCH
-
CP

Source: Biosafety Clearing House, CBD website


29

B.

S
ELECT
N
ATIONAL APPROACHES


1. South Africa

The Genetically Modified Organisms Act was passed in 1997 and implemented in
1999. The GMO Act is administered by the Ministry of A
griculture and
establishes procedures and an institutional structure for regulating transgenics in
South Africa. This structure comprises of the Executive Committee consisting of
representatives of agriculture, health, environment, science and technology a
nd
trade, as well as a Scientific Advisory Council.


The Executive Committee is mandated with deciding on approvals of
transgenics. The committee ensures that all represented government
departments can, in theory, veto particular transgenic crop approvals.

The 2001
National Biotechnology Strategy outlines a vision for biotechnology’s role in
ensuring South Africa’s technological leadership in the 21st century. It mandates
creation of regional innovation centres. It also calls for “suitable regulatory
syste
ms in order to participate as exporters and importers in the international
trade in biotechnology products.


Ratification of the Cartagena Protocol has provided an important additional
stimulus to amend the existing GMO Act. A draft amended bill is now und
er
consideration in parliament, yet it has come under sustained criticism from civil
society groups for failing to address environmental and social concerns around
transgenic crop use in South Africa and for failing to institutionalize a
precautionary appr
oach. Changes to the act directly stimulated by the Protocol
include only certain procedural adjustments to time frames in the current GMO
approval process. Discussions are also underway about how best to meet the
country’s obligations to provide informati
on about domestic GMO approvals to
the Protocol’s biosafety clearing house.


The conflict between the US and the EU, and trade imperatives in general, have
thus been less of an influence on domestic regulatory developments in South
Africa. Where internatio
nal influences have been important is on the debate in
South Africa and neighbouring countries over food aid containing genetically
modified varieties, particularly from the US. In the food aid crisis in 2002, it was
South Africa’s offer to mill maize in f
ood aid (to prevent planting as seed) at its
ports of entry before it was sent onto other countries that defused the crisis to
some extent.


Most recently, a court case brought by the environmental organization BioWatch
against the government demanded acce
ss to a wide variety of information about
domestic transgenic crop approvals. BioWatch won the case, with the Registrar
of the GMO Act who is the main repository of such information within the
Department of Agriculture now required to make such information

available.



30

In its broadest contours, South African biosafety legislation has tended to follow
the permissive regulatory approach of the United States. This is also reflected in
the recently passed labelling legislation under the Ministry of Health, which

subscribes to the notion of the substantial equivalence of GM food with non
-
GM
food. This permissive approach to GMO regulation in South Africa may also be
politically feasible in part because there is currently little widespread public
knowledge or conce
rn about transgenics. A recent survey carried out on behalf of
AfricaBIO claimed that a substantial majority of the population is unaware or
unconcerned about transgenic foods, a finding that subsequent government
surveys claim to confirm as well.


In an i
mportant development in late 2005, a policy decision was taken to halt
approvals of applications for GMO commodity imports, pending the outcome of a
study by the Department of Trade and Industry about the impacts of such imports
on South African agricultur
e and trade regionally. The position of the Ministry of
Environment in South Africa has been strengthened because of existence of the
Protocol, partly because of its role in regime negotiation and evolution, and partly
because of the increased legitimacy
conferred upon a precautionary discourse
around biosafety.

2. Kenya

The National council for science and Technology is the competent authority on
matters of biotechnology in Kenya. The council has established the national
biosafety Committee (NBC), which

receives and approves applications for
biotechnology and handles all matters pertaining to biosafety, risk assessment
and management of biotechnology. The mandate of NBC is supported by
biosafety guidelines and regulations developed in 1998. The same regu
lations
also give guidance and direction to the establishment of institutional biosafety
committees particularly in institutions such as KARI. The biosafety guidelines and
regulations were developed under the science and Technology act 1980 with the
suppor
t of the UNEP
-
GEF programme on pilot biosafety projects. Under the
leadership of the council, a draft policy for biotechnology and biosafety has been
developed by a task force made up of representatives from all the institutions
engaged in biotechnology Re
search and development in Kenya.


The need to review the biosafety guidelines and regulations and align them with
the broader provisions and stipulations of the Cartagena protocol on biosafety
was realized a few years after the protocol was adopted. This p
rompted the
review process which started in 2003 and consequently led to the publication of
revised regulations. Kenya has also been a beneficiary of the second phase of
UNEP
-
GEF project on the implementation of the National Biosafety frameworks.
The revis
ed guidelines also cover requirements for containment levels and risk
assessment for contained use, deliberate release and commercialization. The
process of drafting the bill was initiated in 2003 under the auspices of the NCST.
The bill is pending parliam
ent approval. If it goes through, it will pave way for the

31

establishment of the National biosafety Authority a full fledged and autonomous
body with a legal face and mandate to approve or reject applications for the
introduction of GMOs in Kenya. The legis
lation will protect diverse interests of
key stakeholders and cover broad aspects of biotechnology product
development. Both the biotechnology policy and biosafety bill have been
submitted to the parliamentary Committee for Science, Technology and
Environm
ent for consideration and endorsement.
17


In Kenya , unlike neighbouring countries such as Tanzania and Uganda,
approval for and research trials of genetically modified organisms moved swiftly
and so far have been undertaken in a biotechnology policy and bi
osafety
legislation vacuum. Although Kenya has draft biosafety policy and legislation
pending approval by parliament, the country has a well established and growing
biosafety system housed by the NCST. While this can be seen as a milestone in
harnessing bi
otechnology in Kenya, it is claimed that the creation of NBC and the
development of national biosafety guidelines was driven and supported by
international forces and interests to prepare Kenya for the introduction of GM
crops.


GM crops and products that
have been cleared for introduction in absence of
policy and legislation include the transgenic sweet potato, Bt.maize, rinder pest
vaccine, Bt. Cotton and transgenic cassava. While introduced to address local
problems they originated from outside, develope
d either by biotechnology
multinationals or international organizations. Transfer of such technologies has
taken the form of public
-
private partnerships between KARI and the developers
of the technologies. Other pieces of legislation such as seeds and Plan
t varieties
Act (Cap. 326) have been applied to deal with issues of plant health and approval
of GM seed varieties.


Generally, most countries in the region are at various stages of formulating
policies and legislative frameworks for governing GMOs. Uganda

and Tanzania
have gone ahead with development of regulations and guidelines for biosafety in
biotechnology based on existing laws (Table 2) pending promulgation of explicit
biotechnology policy and or biosafety laws that would be pivotal for
commercializa
tion of transgenic products. The situation remains fluid and any
standard
-
setting efforts in biotechnology will certainly wait until the draft
legislations come into force to provide latitude for full
-
fledged development of
regulatory standards enforced by

competent regulatory authorities. Thus, the
operational standards for biotechnology in the region to a large extent emanate
from international treaties and conventions to which some countries in Eastern
Africa are contracting parties.

P

17


The Authority may decline to undertake a risk assessment where it determines that sufficient
experience or information exists to conclude that GMOs or activities concerned do not pose a significant
risk to the environment.


32

3. Egypt

Biosafety
regulations and guidelines were published in draft form in January
1994.The guidelines were intended to describe the modalities of use, handling,
transfer and testing of GMOs. They address laboratory practices, greenhouse
containment and small scale field
testing. The guidelines describe the structure,
composition roles and responsibilities of NBC. Information on commercial
releases is derived from other agencies in particular the seed registration
committee.


The range of GM crops that have been approved f
or trials and the nature of
genetic engineering research conducted by the country’s institutes of scientific
research demonstrate solid evidence on the development of this front. These
crops include cotton, potato, squash, Melon, Watermelon, cucumber, toma
to,
maize, Banana, Wheat and sugar cane.


Table 3 give examples of incongruences between national laws and the Model
Law making the case for the need to review and revise the Model Law.



33

Table 3: Sample Provisions in AU Model Law, National Laws and Biosaf
ety Protocol



AU Model Law

National legislation

Biosafety protocol

Remarks

South
Africa

Includes food aid

Provides measures to promote
responsible development, production,
use and application of genetically
modified organisms’ and

‘ensure that all activi
ties involving use
of GMOs (including importation,
production, release and distribution)
are carried out in such a way as to limit
possible harmful consequences to the
environment

Deals with protection
of human health,
adverse effects on the
consernation a
nd
sustainable use of
biological diversity


Malawi



Covers environmental risks as well as
risks to human health




Zimbabwe

Provision on
financial
resources
lacking

Part VII makes provision for
establishment of a biotechnology fund

Article 28 focuses on

financial mechanisms
and resources

The Model law should
have a provision on
financial resources for
implementation

Kenya

The law covers
pharmaceuticals

The Kenya biosafety bill does not apply
to GMOs that are pharmaceuticals for
human use

The Protocol ex
cludes
pharmaceuticals that
are covered by other
international
legislation



Provision for
handling GMOs
in transit is
lacking

Makes provision for handling of GMOs
in transit (Article 17)

The Protocol has a
provision on GMOs in
transit (Article 18)

-
The
Model Law should
have a provision on
handling of GMOs in
transit


Follows the
precautionary
principle

Article 23 recognizes the concepts of
Familiarity and Substantial
equivalence
18

The Precautionary
Principle is the basis
of the Protocol


P


18

Paarlberg, R. 2006 Toward a Regional Policy on GM Crops among COMESA/ASARECA Countries. Policy Options Paper for discussion d
uring RABESA
Regional Workshop. May 2006, Nairobi, Kenya


34


AU Model Law

National legislation

Biosafety protocol

Remarks

Tanzania


The
Tanzania Environmental
Management Act provides the legal
framework for the country’s biosafety
framework. The biosafety framework
applies to all categories of GMOs as
stipulated in the Model Law.


The Model law
substantially influenced
the drafting of the
Biosafety Framework.

Ghana

Law applies to
GMO
pharmaceuticals

Section 1 on the scope of the Act
stipulates that Pharmaceutical products
for human use are not covered by the
legislation

The Protocol excludes
pharmaceuticals
covered by other
internationa
l
agreements or
organizations

Ghana legislation is
informed by the Model
Law.


No provision for
handling GMOs
in transit

Section 15 provides guidelines and
procedures for handling GMOs in
transit

Article 6 is concerned
about transit or
transhipment of GMO
s
through the territory of
a country

Provision for handling
GMOs in transit is
important especially
where trade or emergency
food aid applies.


Public
participation is
mentioned but
for the public to
effectively
participate the
element of
awareness is
cr
itical

Covers both public participation and
awareness. The aspect of public
education is also given priority

Art. 23 stipulates that
public awarness and
participation is
promoted and
facilitated. The public
should also be
involved in the
decision
-
making
pr
ocess

The revised law should
incorporate aspects of
public awareness and
education


Liability and
redress regime
is elaborate

Not elaborate and only mentions that
Act is subject to applicable laws

Liability and redress
regime is still being
negotiated

Gha
na can borrow the
liability and redress
regime from the model
law.

Ethiopia

The model law
applies to
pharmaceuticals

Section 3 on the Scope of the Draft
Proclamation covers pharmaceuticals
for human or animal use

Pharmaceutical
covered by other
internat
ional legislaton
Ethiopia has borrowed a
lot from the Model Law

GE



35


AU Model Law

National legislation

Biosafety protocol

Remarks

are exempted from the
scope


Provision on
transit of GMOs
lacking

Section 12 provides guidance for transit
of GMOs through the territory of
Ethiopia

Art. 6 relates to transit



Public
awaren
ess and
education not
specified

Procedures for public participation and
input in decision making are elaborate
as indicated in section 15. However,
mechanisms for public awareness and
education are not mentioned

Art. 23 covers this

The AU Model law can
bo
rrow some elements of
public participation from
the Ethiopian legislation


Guidelines for
inspection at the
ports of entry
and exit are not
provided

Guidelines for inspection at the ports of
entry and exit are provided

Inspection at ports of
entry and exi
t have
not been addressed

Should be taken into
consideration when
revising the Model Law

Mali

Scope includes
Pharmaceuticals
and products of
GMOs

Scope includes pharmaceuticals and
those GMOs with double
pharmaceutical and food function of
agricultural
interest. Scope also
includes products of GMOs

The Protocol excludes
pharmaceuticals
covered by other
international
agreements or
organizations


Provision should be made
for exempting those
pharmaceuticals that are
covered in international
legislation. How
ever
pharmaceuticals for
humans and animals and
those having double
functions should be
addressed


Detail liability
and redress
regime provided

Liability is strict as well as joint and
several. Liability and redress provisions
also apply to socio
-
economi
c
considerations

Liability and redress
regime is still being
negotiated

The Mailian Biosafety Bill
has significantly reflected
some of the provisions of
the Model Law


37

VI.

BI OSAFETY I NI TI ATI VE
S I N AFRI CA

Since the conclusion of the Model Law, there have b
een numerous initiatives on
biosafety in Africa. These need to inform a revised Model Law which was
concluded before many countries invested in biotechnology.

A.

UNEP/GEF

UNEP
-
GEF has impacted significantly on the development of NBFs in African
countries
through the provision of requisite funding and a follow up mechanism
for participating countries to ensure that whatever approach they take
(developing new legislation, using existing legislation or promulgating regulations
to adopt existing legislation);
mechanisms are out in place for the safe handling
of GMOs.


NBFs are defined as a combination of policy, legal, administrative and technical
instruments set in place to address safety for the environment and human health
in the context of modern biotechno
logy. These frameworks focus on living
modified organisms and vary from country to country. Despite these variations,
there are certain similar elements in the various NBFs under the UNEP
-
GEF
project. These are:



Policy on biosafety



Legal/regulatory syste
m



Administrative system to handle requests for permits. This system
includes risk assessment and management procedures to help in
decision
-
making.



Mechanism for monitoring and inspection.



System to provide information to stakeholders about National Biosaf
ety
Frameworks and for Public participation.


Ten (10) African Countries participated in the Pilot Phase of UNEP
-
GEF project
which ran from 1997. These are Cameroon, Egypt, Kenya, Malawi, Mauritania,
Mauritius, Namibia, Tunisia, Uganda, Zambia. They genera
ted draft frameworks
for biosafety. As pointed out above, Kenya has used the draft regulations and
guidelines developed during Pilot phase to consider applications for importation,
continued use and field trials of LMOs.


As a follow
-
up to the Pilot Phase,

the UNEP
-
GEF global project on the
development of NBFs began in June 2001. This was a three
-
year project aimed
at assisting up to 100 countries in developing NBFs so that they can comply with
the CPB. Using a country
-
driven process, the global project was

to help each
participating country to set up a framework for management of LMOs at the
national level. The project was also expected to promote regional and sub
-
regional cooperation on biosafety and exchange of experience on issues of
relevance to the Nat
ional Biosafety Frameworks. This was expected to facilitate

38

efficient use of financial and human resources, establish regional and sub
-
regional networks, and promote harmonization of risk assessment procedures
and regulatory instruments. The UNEP
-
GEF offic
e at UNEP was expected to
provide advice and support to countries throughout the development of their
NBFs.


At the national level, UNEP
-
GEF projects are implemented primarily through
national focal points in the relevant ministries. These have been minist
ries of
Environment, Science and Technology; Finance and office of the President in
different countries. Many African countries are currently developing their NBFs
with the assistance of UNEP GEF. These include Algeria, Angola, Benin,
Botswana, Burkina Fas
o, Burundi, CAR, Cape Verde, Congo, Comoros, Cote
D’Ivoire, DR Congo, Djibouti, Ethiopia, Eritrea, Gabon, Gambia, Ghana, Guinea,
Guinea Bissau, Lesotho, Libya, Liberia, Madagascar, Mali, Morocco,
Mozambique, Niger, Nigeria, Rwanda, Senegal, Seychelles, Sie
rra Leone, South
Africa, Sudan, Swaziland, Tanzania, Togo, and Zimbabwe.


Some countries have moved to the stage of implementing their NBFs. These
include countries that participated in the Pilot Phase (Kenya, Uganda, and
Cameroon) as well as countries tha
t have developed GMO work, developed their
NBF independently and need to align their existing laws to the Cartagena
Protocol on Biosafety (South Africa).


UNEP
-
GEF has significantly influenced the development of NBFs in the region.
Indeed for many countrie
s, NBFs would have developed at a much slower pace
absent UNE
-
GEF funding. This has two implications. On the one hand, countries
may have engaged in NBF formulation in the absence of meaningful GMO
activities and in the absence of a felt national need for
such frameworks. On the
other hand, UNEP
-
GEF assisted countries develop a framework that was needed
but for which there were no resources available.

B.

USAID

P
ROGRAM FOR
B
IOSAFETY
S
YSTEMS
(PBS)

In May 2003, the US Agency for International Development de
cided to award the
sum of USD 14.8 million to International Service for National Agriculture
Research (ISNAR) to implement the five
-
year Program for Biosafety Systems
(PBS). PBS’ work is based on the framework for biosafety implementation that
the IBS (ISN
AR Biotechnology Service) team developed over the last years
through its work in Egypt, Argentina, Kenya and other countries. The goal of PBS
is to “more effectively address biosafety within a sustainable development
strategy, anchored by agriculture
-
led e
conomic growth, trade and environment
objectives.”


Responding to this goal, activities are grouped into four components: policy
development/new models; risk assessment; facilitating regulatory approval; and
skills/strategies for communication, public outr
each and capacity building. The
systems approach to biosafety is expected to evolve through Country and

39

Regional Advisory Groups, targeting policy development through National
Biosafety Committees and national/regional policy
-
making bodies. The specific
ob
jectives of PBS are to assist participating countries to:



Establish National Biosafety Committee secretariat, equip its office, and
enhance information flows among its members



Gain advanced training for handling regulatory application dossiers
(packages) f
or NBC members, relevant Kenyan agencies and other
stakeholders



Harmonize biosafety regulatory roles, supportive policy analysis, and
identifying actions or policies to gain efficiencies



Develop mechanisms for public information and participation in biosa
fety
processes



General capacity building for biosafety.


A number of African countries including Zambia, Malawi, Kenya, Uganda and
Namibia are participating or have applied to participate in this initiative. It is
important to point out that while this ini
tiative is expected to build on what has
been achieved under UNEP
-
GEF, this objective may be difficult to achieve in the
absence of on
-
going activities that spur national legislative initiatives to further
develop through learning and use.

C.

A
SSOCI ATI ON F
OR
S
TRENGTHENING
A
GRICULTURAL
R
ESEARCH
IN
E
ASTERN AND
C
ENTRAL
A
FRICA
(ASARECA)

ASARECA is a non
-
profit, non
-
political sub
-
regional organization for the National
Agricultural Research Systems (NARS) in ten Eastern and Central African
countries. A Committee
of Directors oversees its activities and provides policy
guidance, governs ASARECA and maintains a Secretariat that services the
Committee of Directors, the regional Networks, programmes and projects.


The Committee of Directors established a Working Group

to review, analyze and
develop a potential program for biotechnology and biosafety addressing the
needs of the sub
-
region. The working group is composed of ten members (one
from each ASARECA member country), and is supported by a Coordinator and
the ASARE
CA secretariat. The working group was asked to conduct a broader
dialogue among stakeholders; identify the major thrusts and objectives of the
program and develop a fundable project proposal. In consultation with
stakeholders, the working group developed a

funding proposal for a
biotechnology and biosafety program for the ECA countries. The program will
support the existing ASARECA crop and livestock networks, but will encourage
strong linkages and partnerships with other international, regional, sub
-
region
al
and national biotechnology/biosafety initiatives. The proposed program will
address the development objectives of the ECA countries by initiating a series of
biotechnology R & D projects that clearly address the priorities of the region and
an integrate
d regional approach to biosafety.



40

Under this rubric, ASARECA has an initiative seeking to harmonise biosafety and
biotechnology policies among its member states especially around administrative
procedures (setting up of common window for the receipt and p
rocessing of
applications; establishment of a single source for the provision of information and
the dispensing of advice) and around technical standards (environmental risk
assessment procedures, information requirements and criteria for determining
unacc
eptable levels of risk and providing applicants with the opportunity to
prepare common applications).


This is informed by the belief that harmonisation of administrative regulations and
guidelines will be an easier way of developing biosafety frameworks t
han
convincing countries to copy regulations and guidelines from other countries
which is perceived as an assault on the sovereignty of a country. Like the
example of SADC above exemplifies, regional networks in Africa will continue to
be key determinants
in the development of NBFs in individual countries.

D.

T
HE
RABESA

I
NITI ATIVE

The origin of the Regional Approach to Biotechnology and Biosafety Policy in
Eastern and Southern Africa (RABESA) Initiative is traceable to concerns related
to GMOs and trade in

the COMESA region way back in 1997. Member States
were concerned that the proliferation of GMOs could impact on trade and food
security in unknown ways and COMESA was not prepared at the time to guide
the region through the anticipated eventualities.
19

On
November, 2001, the
COMESA Ministers of Agriculture meeting in Kampala, Uganda agreed on the
need for a regional policy on biotechnology, especially GM Crops and products.


The need for a regional approach to biotechnology and Biosafety was reinforced
furt
her by the realization in 2002 among SADC countries that the divergence of
national polices on GM food aid was causing undue restriction to access of food
aid by countries in the region. This divergence of national policies in the SADC
region inspired eff
orts in both SADC and COMESA to consider closer regional
policy coordination on GMOs in the region.
20


In 2003 COMESA approached ASARECA, seeking technical guidance and policy
advice on how to address biotechnology/Biosafety issues at a regional level. The
advice was given and the RABESA Initiative/project was designed to investigate
the potential impacts of GMOs on trade, food security and access to emergency
food aid. The overall objective f RABESA therefore was to generate and analyze
technical informatio
n on the potential impacts of GMOs on trade, food security
and access to emergency food aid, to inform COMESA and ASARECA Countries
in coming up with a regional approach to GMOs in the above areas.


P

19

Paarlberg R(2006) Towards a Regional Policy on GMO Crops among COMESA/A
SARECA Countries


20

Ibid 20


41

The specific objectives of the Initiative were

1.

To underta
ke a stakeholder analysis in the COMESA region with the aim
of capturing views and opinions of individuals and institutions with regard
to the impact of GMOs on trade, food security and food aid.

2.

To estimate the impacts of GMO crops on farm income in
ASARE
CA/COMESA countries

3.

To estimate the possible commercial export risks associated with planting
of GMO crops in the ASARECA and COMSA region

4.

To determine the impact of precautionary GMO approaches on access to
emergence food aid in the ASARECA and COMESA reg
ion

5.

To review a range of regional policy options and adopt a common
position towards GMO Crops for the COMESA countries


The implementation of the Initiative was endorsed at the COMESA/ECA Maize
Trade Policy Conference, held in Nairobi in September 2003

and it started in
June 2004. The initiative covered six sample countries in the
COMESA/ASARECA region namely: Egypt, Ethiopia, Kenya, Tanzania, Uganda
and Zambia.


The Initiative has been implemented in a partnership involving COMESA,
ASARECA, ECAPAPA and

PBS. It is supported by the United States Agency for
International Development (USAID)


At a regional meeting of experts and stakeholders in Nairobi (30
-
31 May 2006)
that met to discuss the findings of the RABESA Initiative and seek ways of
evolving a reg
ional position on the issue of GMOs in Eastern and Southern
African countries, the meeting recommended to the COMESA Council of
Ministers the following positions.


With regard to commercial planting of GM Crops, it was recommended that the
region adopts a
centralised regional assessment system and final approval to be
left at national level.
21

In respect of commercial trade policy, it was recommended
that advice/information be given from a central regional clearing house, with final
decision vested in nation
al authorities. In regard to food aid policy, it was agreed
that guidelines be developed at a regional level, but the decision of whether or
not to accept the aid to should be left at country level to be made on case by
case basis.


While the initiative ha
s generated a lot of useful information and is guiding the
region in evolving a regional approach to GMOs, a number of issues remain to
be addressed. First, people are concerned that the initiative places a lot of
emphasis on GMO trade issues and ignores r
isks to human health and the
environment. It is important that the findings and recommendations are based on
P



21

BIO
-
EARN 2004. Resource book for implementation of Bio Safety in East Africa. Published by the
regional Co
-
ordination Office of the East African Regional Programme and Research Network for
Biotechnology biosafety and Biotec
hnology development.


42

a holistic approach to biotechnology and biosafety issues. It is not enough to omit
considering such issues on the basis that they are being addres
sed in other
initiatives.


Secondly, the initiative does not address the question of GMOs and the farmers’
rights to save, reuse and exchange seed which is one the major concerns of
African countries in the debate on GMOs. Any discussion on food security i
n the
African context minus a debate on the farmers’ right to seed and the seed
distribution system remains incomplete.


Thirdly, the initiative seems to be shifting the COMESA countries’ focus from the
need to finalise and strengthen their NBFs to develop
ing the regional approach.
While the regional approach could be good, it should be based on national
biosafety systems which address local circumstances, needs and aspirations.
The Regional approach should build on national Biosafety systems.


E.

THE

AU

B
IOSAFETY

PROJECT

At its third ordinary session, held in July 2003 in Maputo, the Executive Council
of the AU adopted Decision EX/CL/Dec.26 (III), which stressed the need for
Member States to equip themselves with human and institutional capacities to
deal
with biosafety issues within the framework for the implementation of the
Biosafety Protocol. The decision also endorsed steps taken by the AU
Commission to put in place an Africa
-
wide biosafety system and programmes to
strengthen the abilities of Member St
ates to deal with biosafety issues.


In view of this therefore, a project on capacity building for an Africa
-
wide biosafety
system has been developed between the AU and the German government through the
German Development Cooperation (GTZ),
to provide the

AU with the necessary
capacities and effective instruments to support its Member States in
implementing the Cartagena Protocol on Biosafety and the African Model Law on
Safety in Biotechnology.
This project is currently under the Department of Human
Resou
rces Science and Technology within the AU Commission and is being
implemented as part of a broader AU

German Cooperation. The aim of this project is to
incorporate the topic biosafety into the political and institutional frameworks of the AU
and into its s
upport services for the Member States.
The implementation of the first
substantive activities of the project started in January 2006.


Among the objectives of the Project is the establishment of a Biosafety Unit that would
undertake the development of an A
frican Strategy on Biosafety to implement the
provisions of the Cartagena Protocol on Biosafety and the African Model Law on Safety
in Biotechnology and its application at national and regional levels.


In March 2006, the Project convened a Preparatory Wor
kshop for the African delegates
at the Third Conference of the Parties Serving as the meeting of the Parties (COP
-
MOP)
to the Cartagena Protocol on Biosafety in Curitiba, Brazil. This workshop supported the
AU Member States in their quest to form a well
-
pr
epared African Group at the

43

negotiations in order to strengthen their negotiation capacities and impact. The
workshop therefore provided a platform to develop a common position of the AU
Member States on the crucial issues of the negotiations.


Further a T
echnical Advisors Committee (TAC) had been established from among the
National Focal Points on Biosafety from the five sub
-
regions and key stakeholder
institutions. Two meetings of the TAC have been conducted to give technical advice to
the Project on the
various activities involved. What is more, an African Strategy on
Biosafety was developed, which was considered and adopted by the Extraordinary
Conference of African Ministers Council on Science and Technology (AMCOST) in
November 2006
22
. The revision of t
he Model Law is initiated under this Biosafety
Project which is intended to have considered the current challenges and latest
developments in the fields of biosafety and biotechnology taking the African context into
account.



A network for continuous inf
ormation exchange between the AU Biosafety Unit and the
National Biosafety Focal Points of Member States will be maintained. The network will
be used throughout the Project to ensure continuous information exchange between the
AU and the Focal Points. Regi
onal workshops would be organized to support the
Member States in using the biosafety
-
related decisions of the Heads of State and
Government Summit on the implementation of their national biosafety frameworks and
laws.


Furthermore, depending on the needs
and priorities of the AU Member States and the
outcome of the Heads of State and Government Summit, strategic options for a
coordinated approach with regard to GMO detection and identification in Africa will be
developed. It is therefore believed that the
existing technical and laboratory capacities to
identify GMOs and products thereof at regional, sub
-
regional and national levels will be
strengthened.

F
.

R
ECOGNITION OF THE
N
EED FOR A REGI ONAL A
PPROACH TO
B
I OTECHNOLOGY AND
B
I OSAFETY
P
OLICY IN
E
ASTERN AND
S
OUTHERN
A
FRICA

There are many reasons why countries in Eastern and Southern Africa are
considering adopting a regional approach to biotechnology and Biosafety. As
countries relate in regional networks, the need to develop common standards or
harmonised s
tandards and regulations in different areas of development is
increasingly becoming vital in regional cooperation. The depending regional
integration is therefore raised as one of the reasons for considering a regional
approach to biotechnology and biosafe
ty Policy in Eastern and Southern Africa.
In this context, it is worth noting that COMESA is consolidating its regional
agenda and is moving towards becoming a Customs Union and in East Africa,
there is the ongoing process of fast tracking the East African

Community (EAC)
becoming a political federation by 2011.


P

22

Report of the meeting of Ministers EXT/AU/MIN/ST/Rpt.(II)


44

Advocates for the regional approach, also argue that the regional approach will
ensure larger markets for GMO products within the region. In this context, they
observe that most of the GMOs and the
ir products that will be produced in
Eastern and Southern Africa will be traded and consumed in the region. It is also
contended that a regional approach will lead to speed and timeliness in decision
-
making processes. It can also lead to optimal utilizatio
n of available scarce
resources and reduce unnecessary duplication. The fact of the borders between
countries being porous has also been raised as a reason why it is virtually
impossible for any country to think that it can individually deal with its biosa
fety
related issues. It is also argued that a regional approach is important for forging
common positions in international meetings and therefore a means of increasing
and strengthening the region’s bargaining power in such fora.


Given the status of devel
opment of biotechnology policy and biosafety systems in
the region, it has also been argued that a regional approach could catalyse the
development of national policies and thus capacitate countries to implement their
obligations under CPB.
23

But the skepti
cs of the regional approach argue that it
could be a ploy by the GM producing countries and corporations to introduce
GMOs in the region at the most convenient and cost effective manner. They also
argue that if policy is decided at regional level, this cou
ld pose serious threats to
the sovereignty of countries and will make it difficult for individual countries to
exercise their own decisions about whether or not to accept GMOs.
24

They
further contend that biosafety issues are better addressed locally, with
an eye
towards highly specific ecosystems and ecosystem differences. These
discussions need to be canvassed within a broader level and the revision of the
Model Law provides that opportunity.

VI I.

CONCLUSI ON AND WAY F
ORWARD

Most countries in the continent

are at various stages of formulating policies and
legislative frameworks for governing GMOs. They all seem to be in agreement
that regulation of GMOs is a subject of undisputed need for oversight nationally
and regionally. There are many mechanisms for GM

regulation, some just
evolving while others are full
-
fledged internationally accepted instruments. Owing
to natural, economic and socio
-
technical disparities among countries, there is
need for policy harmonization in developing and enforcing the various G
M
regulatory standards and frameworks. While there is agreement about the need
for a GMO regulatory framework, there are differences in opinion about how strict
it should be, as this is influenced by issues such as costs, perceived risks and
benefits of GM
O release, enforceability and credibility of the regulatory
framework. In addition, as already pointed out above, the varied approaches
available for GM regulation can also have far reaching implications on inter
-
P

23

Gaia Foundation (2006) Will a Regional Approach to GMOs Threaten Sovereignty for African
Courtiers? Press Release available at www.peoplesearthdecade.org

24

Wafula D., Waitha
ka M Report of the RABESA Regional Workshop on the Regional Approach to
Biotechnology and Biosafety Policy in Eastern and Southern Africa (30
-
31 May, 2006)


45

country trade and distribution of food aid
during emergency situations.
Discussions on review of the Model Law can provide an opportunity to discuss
these issues in light of emerging evidence.


The need for policy harmonization on regulation of GMOs on the African
continent cannot be overstated giv
en that ecological, ethnic, cultural and
commercial considerations transcend the national boundaries of many nation
states. Yet it is also prudent that governments must be acknowledged for
rightfully desiring to preserve their right of handling GMO regulat
ion by setting up
appropriate regulatory systems and standards of their own before seeking ways
to harmonize regulations on regional or continental scale.
25

Discussions towards
reviewing the Model Law within the aegis of the African Union does not negate
th
e aspirations of individual states to craft their on laws. It provides an
opportunity for national laws to inform the Model Law and for exchange and
sharing of experiences from different countries.


In conclusion, though the Model Law is a comprehensive pi
ece of legislation, it is
important that the law creates an enabling environment for the environmentally
sound application of biotechnology, making it possible to derive maximum
benefits from the potential benefits while minimising risks to the environment

and
human health. The Model Law as is stands out to be more restrictive and
preventive than facilitative. The balance needs to be struck by reflecting
developments within the African Union, the sub
-
regions and the countries.





P