Genetically Modified Organisms (GMO) Impact on Environment and Health Risk Assessment Training Workshop NamPower Convention Centre Windhoek 17-19 November 2003

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Oct 23, 2013 (3 years and 9 months ago)

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Genetically Modified Organisms (GMO) Impact on
Environment and Health Risk Assessment Training
Workshop


NamPower Convention Centre

Windhoek

17
-
19 November 2003

























Workshop proceedings compiled by Desert Research Foundati
on of Namibia on behalf of the
Namibian Biotechnology Alliance (NABA) ,



Table of Content


ABBREVIATIONS

................................
................................
................................
......

3

WELCOMING AND OPENIN
G REMARKS

................................
..........................

4

“The purpose of an Act and regulation is to protect your biodiversity, so in the
absence of an Act, there is no protection. It is important to remember that if a law
does not prohibit
-

it permits. The sooner the Namibian Biosafety Bill gets
approved; the sooner protection can be provided. The law does not stop
criminals
-

it only identi
fies criminals”
-

Dr Desmond Mahon, Office of Biosafety
Environment, Canada
-

participant of workshop (17 November 2003).




2

M
AIN POINTS OF
B
IO
-
SAFETY
B
ILL
,

N
ATIONAL NEEDS AND
I
NTERNATIONAL
OBLIGATIONS
,

S
EM
S
HIKONGO
,

M
INISTRY OF
E
NVIRONMENT AND
T
OURISM

.............

4

O
VERVIEW OF THE
N
AMIBIAN
B
IO
-
SAFETY
B
ILL

J
OHANN
M
ALAN
,

M
INISTRY OF
E
NVIRONMENT AND
T
OURISM
................................
................................
.....................

5

C
ONCEPTS AND
P
RINCIPLES OF
F
OOD
S
AFETY
A
SSESSMENT OF
GM

FOODS
-

D
ESMOND
M
AHON
,

O
FFICE OF
B
IO
-
SAFETY
E
N
VIRONMENT
,

C
ANADA

.......................

6

GM

F
OOD
S
AFETY ISSUES OF CONC
ERN
-
D
R
A
RPAD
P
UTSZTAI
,

A
BERDEEN
,

UK

........

7

I
NTRODUCTION TO ASSES
SING THE ENVIRONMENT
AL
IMPACT OF
GMO
S
-

M
RS
M
UFFY
K
OCH
,

G
OLDEN
G
ENOMICS
,

S
OUTH
A
FRICA
.

................................
..............................

8

S
OCIO
-
ECONOMIC AND ETHICAL

ASPECTS OF
GMO
S
M
S
H
ARUKO
O
KUSU
,

U
NIVERSITY OF
S
HEFFIELD
,

UK
................................
................................
..................

9

A
CQUISITION OF SCIENT
IFIC BASED INFORMATI
ON
-

D
R
A
NDRE DE
K
ATHEN
,

M
INISTRY OF
H
IGHER
E
DUCATION
,

T
RAINING AND
E
MPLOYMENT
C
REATION
..........

10

INTRODUCTION OF CASE

STUDIES/APPLICATI
ONS

................................
..

10

FIELD TRAIL CASE STU
DY INTRODUCTION (HR
MAIZE) AND
COMMERCIAL RELEASE C
ASE STUDY INTRODUCTI
ON (BT MAIZE)
-

MR VINCENT VOLCKAERT

, SYNGENTA
-

SOUTH AFRICA
.......................

10

ENVIRONMENTAL ASSESS
MENT ISSUES OF CONCE
RN
-

DR DESMOND
MAHON, OFFICE OF BIO
-
SAFETY ENVIRONMENT,
CANADA

.................

11

WORKING GROUPS

................................
................................
...............................

13

W
ORKING GROUP REPORT
BACK

................................
................................
...............

13

G
ROUP
1:

G
ENERAL RELEASE
:

E
NVIRONMENT

................................
..........................

13

G
ROUP
2:

F
OOD AND
F
EED SAFETY

................................
................................
............

14

G
ROUP
3:

E
NVIRONMENTAL
A
SSESSMENTS

................................
................................
..

15

G
ROUP
4:

S
OCIO
-
ECONOMIC IMPACT
................................
................................
..........

15

SPECI
AL INSERT: PRESS CON
FERENCE
................................
.........................

18

REPORT BACK OF DECIS
ION MAKING COMMITTEE

................................

19

GAPS FROM WORKING GR
OUPS

................................
................................
......

19

GAPS IN EVALUATION A
ND AUDIT OF RA

................................
....................

20

IDENTIFICATION OF FU
TURE TRAINING NEEDS
................................
........

20

WAY FORWARD
................................
................................
................................
......

20

WORKSHOP EVALUATION

................................
................................
.................

20

ANNEXES
................................
................................
................................
...................

22









3

Abbreviations


BD


Biodiveristy

CBD


Convention on Biodiversty

FAO


Food and Agriculture Organisation

GMO


Genetically Modified Organisms

LMO


Living Modified Organisms

NABA


Namibian Biotechnology Alliance

OAU


Organisation for African Unity

RA


Risk Assessment

SPS


Sanitary and Phytosanitary Measures

TBT


Technical

Barriers to Trade

WHO


World Health Organisation
















































4

Welcoming and opening remarks


The
Hon. Minister Nahas Angula, Minis
ter

of Higher Education, Training, and Employment Creation

o
fficially opened the
workshop
.
He greeted and welcomed the participants to the workshop.

He further
defined ‘
Biotechnology
’,
for
the

lay person,

as being “
manipulation of life
”. He mentioned a recent
case he had come to hear of on US news, of the creation of a new virus. He urged that
in such cases
there should be serious

consideration for consequences
. He further r
eferred to an incident of
agricultural and environmental concern,
stating
how science can help to unravel secrets of biodiversity
for better understanding.
He advised the pa
rticipants to b
egin
with

understanding what biotech
nology

is,
and considering
whether it is good or bad for the country. If it is bad,
we should look at
how it can
be positioned to prevent negative effects.

The Hon. Minister stated that


Biotech
nology

is
here to stay,
but
it is
important to learn how to
use it in the
best

way

for the improvement of mankind and to best
prevent its usage for human
and animal health
destruction

.

With those few words he
wished for a
successful discussion

in the coming worksho
p
.



Aims and objectives of workshop
-

Mr Van Kent, Ministry of Higher Education, Training and
Employment Creation


The overall objective of the workshop was to
develop national capacity to deal with technology
impacts
.


Areas of focus were:

-

GMO Impact on
environment and health
-

potential risks and their assessment

-

The new FAO/WHO Codex Alimentarius guidelines on how to assess the risks to consumers
from foods derived from biotechnology including genetically modified foods

-

GMO food/feed risk assessment
-
gene
ral principles and current methodologies

-

Socio
-
economic and ethical aspects related to GMOs

-

Processing of GMO applications
-

case studies

-

Identifying gaps in the bio
-
safety draft bill and regulations

-

Identifying future training needs


Outcomes or expecte
d outputs:

-

Identification of knowledge gaps in GMO risk assessment and information on how to approach
the problem as a whole complex

-

Training
-

criteria for GMO safety checks

-

Building national capacity to deal with technology
-

future Bio
-
safety Board memb
ers and ad
-
hoc bio
-
safety experts.





Information sharing session
:


Main points of Bio
-
safety Bill, National needs and International obligations, Sem
Shikongo, Ministry of Environment and Tourism


Mr. Shikongo

introduced the Cartagena Protocol

and

the
his
torical background on the development
of
the

Protocol
,

particularly concentrating on the CBD mandates on biotechnology (Article 8g and Article
19 para.3). He introduced definitions
of some
of the key concepts, such as biotechnology, bio
-
safety,
the
precau
tionary principle,
and
GMO/LMOs.
He also focused on the m
ain features of the Protocol,
including capacity
-
building

and
public awareness.

Refer to Annex 1 for detailed presentation.


Discussion


After the presentation, the workshop participants sought cla
rification on the definition of the
Precautionary Principle. The workshop agreed that the principle refers to taking precaution before the
action/event occurs.


It was also mentioned that Living Modified Organisms needed clarification because it does not h
ave to
be living to be included in risk assessment.


5


Overview of the Namibian Bio
-
safety Bill

Johann Malan, Ministry of
Environment and Tourism


Mr. Malan

gave a short synopsis of the proposed Bio
-
safety bill,
highlighting
its

objectives as:





Providing
an adequate level of protection for conservation and sustainable use of Biodiversity
(BD)



Providing a framework for research development and the use of genetic engineering through
regulation of GMO’s or derived products



Providing guideline for the safe use

of biotechnology in line with adopted policy



Fulfilling obligations undertaken under the Cartagena Protocol


The overall scope of the bill includes issues such as import, export, release into the environment,
contained use, handling use, transport, placin
g on the market and placing in transit of all GMOs
including mixtures of GMOs and certain derived products (as prescribed in the bio
-
safety regulations).
Yet, it excludes pharmaceuticals covered under other legislation.

Institutions created by the Bill
in
clude the
B
io
-
safety
B
oard,
B
io
-
safety
U
nit/registrar,
B
io
-
safety inspectors, and the
B
io
-
safety fund.
Procedures for d
ecision
-
making
,

revocation of approval
,

emergency measures
,

accidental releases
,

handling, transport, packaging,
labelling

and
identific
ation,

and other related matters were summarised

(see Annex 2).



Discussion


The issue of public participation in drafting the bill was discussed. The fact that the person on the street
does not understand these issues should be addressed and efforts shou
ld be made to incorporate public
concerns. The response on this issue was that most stakeholders were involved, but due to time
limitations only identified people were involved in the process and other experts were approached to
make comments. Public invol
vement should only take place in the beginning to assess if an act is
needed or not, but once that has been established it is the Parliamentarians who deal with drafting the
bill or act. The public is not involved during that stage. However, the public can

and should be
involved in the risk assessment.
Whether
,

and how to involve the public at different levels

in

policy
-
making, development of laws and regulations, and
in

decision
-
making of each application was also
discussed.


The Ministry of Higher Educati
on, Training and Employment Creation is the lead institution drafting of
the Bio
-
safety Bill. It was further mentioned that the Parliament, as well as donor funds and grants
would contribute to the Bio
-
safety fund.


During the discussion a comment and wo
rd off caution was made about excluding pharmaceuticals as
part of active agents as presented by Mr. Malan. It is important to consider environmental impacts
together with health hazards, thus the inclusion of
human pharmaceuticals for environmental
assess
ment

should be considered
.


Another comment made was that it is important to keep in mind the crossover between the Cartagena
Protocol and the National framework and the fact that human pharmaceuticals are not exempted in the
protocol. It is important th
at each country decides what is relevant for their conditions, even if it
appears in the international agreements. There should be a difference between international and
national requirements.
Participants were reminded of the difference between the countr
y

s obligation to
the Protocol and to the CBD to develop the national bio
-
safety framework, and the importance of
considering
what

is necessary for the national bio
-
safety framework within the context of this
workshop
.


Regulations of Proposed Bill
-

Martha

Kandawa
-
Schulz, University of Namibia/ Namibian
Biotechnology Alliance (NABA)


Dr Kandawa
-
Schulz

introduced the proposed bio
-
safety regulations. In the background to the
development of the regulations, she noted that the process progressed from the natio
nal policy to the
framework of the bill, which led to the need to
develop

the regulations. She revisited the components

6

of the national bio
-
safety framework, which
included

the national policy on bio
-
safety, regulatory
regime, system to handle requests, m
onitoring and inspection systems, and public information. She
also clarified the responsibilities for various roles within the national framework. The main elements
of
the
draft bio
-
safety regulations and procedures for each type of regulated activity we
re outlined

(see
Annex 3)
.


Discussion


Discussion
was based
on how to progress with the development of regulations with the presumption
that the knowledge and expertise of officers, public,
and others are needed
.
It was mentioned that a
testing period of
at least three human generations is needed for us to presume that knowledge on this
subject exists. There was a general agreement that knowledge is lacking, but time is pressing for
ratification of the Cartagena Protocol on Biosafety and putting measures i
n place at National level. The
board aims at a deadline of February 2004 to have entry considerations. It was emphasised that the
deadline is only to work on draft regulations not to have all regulations in place.


Other issues that were discussed were h
o
w to control illegal field trials, how long the trial releases need
to be continued before general releases can be approved
,

and the criteria of the level of the risks.
Participants were assured that there are measures and rules in place for field trials.

It is important to do
field trial tests so that authorities know conditions before they approve field trials, and that they are
based on set criteria. Everything starts in the laboratory, for example in a greenhouse, and after it has
been tested it is the
n taken to field. Audits then need to be done based on information provided by the
applicant. It was mentioned that applicants should provide the information, and describe what type of
field trials they want to do. There are different risk levels to be con
sidered based on the host organism.
There is always a certain level of uncertainty, therefore, when there are doubts, it is necessary to rate it
at a higher level just to be on the safe side.


Questions were also raised about NABA’s involvement in the pro
cess. The participants were informed
that NABA started as an interim group, which lead to the establishment of a working group. They were
then given the mandate to draft a policy and conduct a countrywide study and through the policy were
further mandated
to take work forward through funding from UNEP/GEF and the Namibian
Government.


Some of the participants felt strongly that economic risk should be considered separately from social
risks. The definition of socio
-
economic should also be explicit in the Bi
ll.



Concepts and Principles of Food Safety Assessment of GM foods
-

Desmond
Mahon, Office of Bio
-
safety Environment, Canada


Desmond Mahon described the concepts and principles of food safety assessment of GM foods.
He
noted

that there were no countries
that had safety regulations for food itself
,

only for food additives and
contaminants,
perhaps
under the assumption that people knew what was safe to eat already. There
were no new foods,
it was
rather
that different
foods
were
eaten by people in differen
t parts
of the

country. Food safety for whole foods was developed with the emergence of novel foods, such as those
of the products of GM. He described the development of the food safety assessment, which began in
the form of guidelines and international
scientific principles, which gradually developed into more
detailed assessment procedures. In the strict sense, evaluation
on whether

the food is safe or harmful is
distinguished from nutrient contents and food quality (whether it tastes good), but they a
ll affect the
decision
-
making on food safety. Various concepts and procedures behind food safety assessment were
described, including the process for qualifying substantial equivalence, evaluation of toxicity levels,
dietary exposure, changes in other nut
rient components of that food, and allergenicity

(Annex 4)
.

For
further details refer to: www.rse.ca or
www.hc
-
sc.gc.ca/food
-
aliment



Discussion



Due to numerous questions on

Codex Alimentarius

it was
explained that it is an officially recognised
body of WHO with the important function of providing guidelines to governments for looking at the
safety of novel foods, in scientific matters and in providing advice on GM food matters.


7


The issue of

allergen
icity w
as
raised,
focusing on
whether foods with toxic relatives (e
.
g.
tomatoes
)
were more prone to toxicity upon genetic modification.
The response was that the question should be at
what level does toxicity make an impact. Food cannot be amended to be no
n
-
allergenic, but you can
identify to what level it can cause toxicity. It is up to the respective government to identify if a
particular food is an allergenic and at which level it is allowed. However, this process should always be
done with the precautio
nary principle in mind.


Another issue that was raised is whether certain crops, such as tomatoes and potatoes, are more prone
to toxins. In this regard it is important to know the family of plants so as to establish the potential for
plants to produce tox
ins. Potatoes have different varieties; therefore knowing the species will indicate
the toxicity level of plant. The tomato family includes toxic plants and poses a higher risk. However it
depends on the biology of the species, and so it is necessary to fi
nd out if a particular plant have toxic
family relatives.


Concerns were raised in terms of anti
-
biotic resistance with regards to Bt
-

maize and if it is safe to
consume in huge amounts. Bt, as an insecticide, has been used in grocery shops to spray on foo
ds, thus
there is no limit for Bt application. According to toxicologists looking at Bt insecticides, the current
assessment indicates that there has not been a problem in consuming Bt maize. In terms of making an
evaluation of Bt consumption in huge amoun
ts, an institution such as the Bio
-
safety board has to
consider evaluation of this. For example if 20% of Bt
-

protein is consumed then they have to evaluate if
it is a safe or good nutritional intake. They also have to consider which elements are mostly at

risk. It is
up to the authorities to created conditions to keep people protected.


The participants started a discussion on labelling

requirements
. The fact was stressed that

labelling

is a
large issue at the moment
,

with some industries or countries resi
sting mandatory
labelling

requirements
. However,

it might become a different issue when the next
generation of GM foods, with
added nutritional value is

introduced, and the presence of GM would be a selling point of the product.

However, in Canada they do
not label their food as being GM or not, it only labelled for safety,
nutrition, and allergenicity. It is considered inappropriate to label GM derived products, however, since
Canada has a voluntary system it depends on the response of public pressure to k
now. Thus it is a
choice and not a safety issue. According to the Free Trade Agreement, labelling is not a requirement,
because all food on the shelf in shops is or should be safe to eat, whether it’s GM or non
-
GM.


The ‘life’ of seeds also formed a disc
ussion point. Seeds only produce one crop, then they are infertile,
meaning that farmers are forced to buy seed again. This situation controls what they can plant or eat.
Response on this issue was that constraining available foods is not only true for GM
foods, but it’s the
same as for hybrid food in which the quality decreases, and it really is a question of governance.



GM Food Safety issues of concern
-
Dr Arpad Putsztai, Aberdeen, UK


Dr. Putsztai

gave an overview on the GM food safety issues of concer
n, particularly on what the gaps
are in the issue
s

being considered. He highlighted that there are differences in how this is addressed,
depending

on perspectives determined by the person

s expertise and level of concern.
He highlighted

difficulties for
predicting possible harmful effects fully, and the large effect
that
the consumption of
harmful agents might have on human health. He described his research on a number of GM foods and
its toxic effects to health using
laboratory

animals.
He also mention
ed the i
mportance of consequences
of potentially harmful events, such as survival of inserted genes in the gastrointestinal trac
t
.
He
c
oncluded by
stating

that
the
most informative data on GM food safety has so far come from studies of
their biological
ef
fects

on the digestive tract, and that the best way to counter
the
biotech
nology

propaganda is to enlarge this database by demanding more work to be done transparently and
independently of industry. Some of the current studies being done are
based on the
tracing
of

GM
DNA through the digestive syste
m
, transfer of GM DNA into the systemic circulation and other body

organs, and whether GM DNA pass into the placenta and the
foetus (Annex 5)
.







8

Discussion


Discussion

was on

why

there has only been one res
earch
study
done on humans
. The response was that
a
distinction
should be made
between research on GM DNA and non
-
GM but potentially harmful DNA
fragments in food
. Nevertheless, the research is fairly complicated and expensive.


There were queries on how o
ld his (Dr Putsztai’s) results were. The study was done in 1998, but was
only published in 1999. He mentioned that there is no data base
-

no collective set of data
-

that is
relevant and general and thus lack of data is a huge problem.


Participants raised
concerns such as why the facts related to health are downplayed. Since Bt is a
pesticide, what are the risks involved and how serious is it in counties where BT maize is consumed in
huge amounts
-

whether it could lead to or be related to cancer needs to be

looked at. Dr Putzstai
responded that the Coliform is a strong mosaic model and it indicates that the immune system becomes
depressed due to herbicides and pesticides. However, the consequences of Bt accumulation in the
human body are unknown. Another pro
blem he mentioned was unlabelled food. This makes it difficult
to monitor what the causes of death may have been and whether it was caused by GMO related food or
not. However, statistical reports show a doubling of gut disease incidences over the last 8 y
ears, which
is the approximate time when commercial GM products was introduced in the market, but there is no
evidence and information that it’s related to GM crops.


A follow
-
up question posed was: if Bt is found to be harmful, why there is a continuatio
n of such food
production. Dr Putsztai replied that most of the lipid
-
like fats accumulate in your body and it takes a
long time to create an effect. Monsanto is convinced that they are doing something right; therefore, it is
difficult to bring opposing vi
ews. He did, however, stress that he is not saying that they are deliberately
poisoning people but with no evidence and information it is difficult to make judgements.


He also pointed out that there is no immediate link between academic research and gover
nment
regulation. He is concerned that research and government links are not as strong as they should be. One
issue is that the work of researchers is difficult to come by and the question is ‘how does a person
ensure that research connects to government r
egulations?”. The important point is that regulation
should look at the possible consequences and not identified consequences. Dr. Putsztai stated “At the
moment there is no extreme side to support, so the ball could go to either side”.


Introduction to as
sessing the environmental impact of GMOs
-

Mrs Muffy Koch,
Golden Genomics, South Africa.


M
rs. Koch

gave
an
overview on the environmental safety of GMOs. Concerns about GM
could

fall
under four categories
; environmental, food and feed safety, economic and

social. Bio
-
safety
concentrates on the first two issues, however, panels could be formed to evaluate socio
-
economic risks
as well.
She l
isted some concerns and possible negative impact
s

on the environment. Bio
-
safety risk
assessment usually consists

of

molecular characterisation, human health, and the impact on living and
non
-
living
components

of the release environment. There is not a general formula for safety checks
and they differ on
a
case
-
by
-
case basis, but most of the time molecular characterisa
tion and its effects
on the environment
are

investigated on various aspects. There are many international guidelines on
GMO
s
, and
she
listed
some
examples by

the

International Organisation for Biological Control. There
is no one method for RA and reviewer
s must develop systems that work for them,
with

more
experience build
ing

more confidence

(Annex 6)
.
For further information refer to:
www.gmo
-
guidelines.info


Discussion


When asked what are acceptable risks
, Mrs. Koch replied that there are no set formulas to evaluate
acceptable risks. It is like using cell phones, it has its risks but people are prepared to accept those risks
-

the same applies in this case. The bottom line is if there is a small consequenc
e then its acceptable. If
not acceptable
-

more information is needed.


Another question asked was on how to apply the “precautionary principle” while there are unlimited
questions with limited answers. The response was that the whole process is a precauti
onary process.

9

Bio
-
safety requires that each activity be assessed whether it is acceptable or not, and if not acceptable
then additional information is required


Socio
-
economic and ethical aspects of GMOs
-

Haruko Okusu, University of
Sheffield, UK


Ms. Oku
su highlighted documents that made provision for socio
-
economic and ethical
issues. She referred to international agreements such as Cartagena Protocol, SPS and
TBT agreements. She also touched upon the importance of considering socio
-
economic and ethical
issues. She further looked at national regulations, and referred to
the OAU model and used examples from Denmark to strengthen her point of socio
-
economic issue considerations. Lastly she had a look at the Namibian Bio
-
safety Bill
and highlighted the provi
sions for socio
-
economic issues. However she recommended
the following questions be kept in mind when dealing with such issues:



Which Socio
-
economic and ethical aspects?



Who investigates?



What expertise is needed?



How about the public?



When is this done?



How is this taken into account within the authorisation of application?


Refer to detailed presentation in Annex 7.


Discussion


The definition of ‘ethical’ was discussed. It was mentioned that it depends which principles are valid
for whom, thus in this r
egard ethics differ depending on what the interests are. Each new GM food
raises new ethical issues, therefore it is encouraged to have an extended scope and leave it open
-
ended.
Application of medicine/pharmaceutical is different thus ethics will be diff
erent. The challenge for the
government is to look at the potential to bring such issues under a regulation regime. The fact is that
not all can be satisfied so it’s a question of majority rules, and thus the society depends on how
government rules.


Simil
arly the issue of what expertise is needed depends on the aspects in consideration. For example, in
dealing with economic issues the opinion of different experts/stakeholders is needed, and it often
depends on what these people think is important. However,

it is important to lay down a framework
before tackling expertise.


Human experimentation issues were also discussed. However it was mentioned that such issues would
not be dealt with by the bio
-
safety Act, but rather in the larger Biodiversity Act. Ther
e are limits to
biotechnology and GM technology, and human experimentation is excluded, but experimenting on
tumours growing for instance is allowed, but that is covered under the Health Act.


The cost of undertaking risk analysis should be considered, esp
ecially countries like Namibia that has
‘thin on the ground’ experiences and needs to be assisted with costs. Southern African countries are
experiencing problems such as field tests that are done, but the results are never implemented due to
financial con
straints, with the end result being products ending up on laboratory shelves. It is
important to evaluate how this can be made effective and cost efficient. In Canada there is a regulation
stating that it is irrelevant where information is from, so they c
an get information from other countries
that did RAs before and use what is applicable, because it is recognised that no government can afford
to do everything. Namibia could adopt similar type of approach. The bottom line is information from
anywhere can
be used but decision
-
making should be on a national level.





10

Acquisition of scientific based information
-

Dr Andre de Kathen, Ministry of
Higher Education, Training and Employment Creation


Dr. de Kathen gave an
overview of risk assessment and the importa
nce of science
-
based RA, sources of
information and how they might be accessible.
He i
ntroduced some web
-
based information and
database sources.
He also u
nderlined that much information is available, but
it
may be difficult to
locate the information need
ed, and to evaluate the accuracy of information.


Discussion


Discussion
was mostly
on how to access full
-
text articles from journals

and

on
accessing information
versus references for application purposes.
Dr. de Kathen mentioned that there is an in
ser
tion on case
-
by
-
case analysis

involved
and

that there are

costs involved in accessing
this

information
.

In
general
there is a
lack of knowledge on certain technologies.


End of Information Session



Introduction of case studies/applications


Mrs
M
uffy
Koch

introduced the
simulation work that participants would look at. They were provided
with two
case studies

(applications)
, one on trial release and the other on general release.
Participants

would be split into four groups by their own preference: environm
ental safety on trial release and
general release, food and feed safety on general release, and socio
-
economic impacts on general release

(Annex 8)
.

The tasks of the working groups were to give recommendations on approval of the
application based on the fo
llowing issues:


1.

Risk assessment (Risks, likelihood, consequences)

2.

Risk management

3.

Monitoring

4.

Inspection

5.

Benefit

6.

Scientific capacity identification




DAY 2


Mr. Shikongo welcomed everyone to the second day of the workshop. He also recapped on the
discussi
ons of the previous day, referring to the Namibian Biosafety Bill objectives, also highlighting
the discussions on health and environmental safety which were of great interest the previous day.
Furthermore he mentioned some changes in the programme, which
will start with two presentations
that did not take place on the first day due to logistical issues. He also announced that a
press
conference

would take place during the day. The day kicked off with a presentation on Field trail case
study introduction (H
R maize) and Commercial release case study introduction (Bt maize).



Field trail case study introduction (HR maize) and Commercial release case
study introduction (Bt maize)
-

Mr Vincent Volckaert , SYNGENTA
-

South
Africa


Mr Volckaert started his presenta
tion by giving an overview about Syngenta and its activities. He
mentioned that Syngenta is one of the worlds leading agribusiness companies. The company ranks first
in crop protection, and third in the high
-
value commercial seeds market and

is committed

to sustainable
agriculture through innovative Research and Technology. Syngenta is
committed to the responsible
use of modern technology in order to obtain more and better foods, while respecting the environment.
It also promotes the concept of sustainab
le agriculture, which aims to optimise the use of resources,
while protecting the long
-
term economic viability of farming. He underlined that all food products

11

originating from GM crops have to pass safety tests before they can be put onto the market for
c
onsumption. He assured the participants that

Syngenta will never put products onto the market until
they have been evaluated and approved for consumption in accordance with the corresponding
legislation on the protection of health, safety and the environm
ent. The most important point to
remember is that

Syngenta operates only in countries that have credible bio
-
safety and consumer safety
regulations in place. Syngenta provides patented technology, royalty
-
free to benefit subsistence
farmers in developing

nations, on a case
-
by
-
case basis, through agreements with research institutions.
He also referred to some of the projects that they are involved in such as
Bt (insect resistant) potato
project in South Africa, Insect Resistant Maize for Africa project (I
RMA), the Golden Rice project and
other projects. Lastly he explained the case studies (applications) that the working groups were tasked
to look at in detail, since it was an example of an application of Syngenta (Annex 9).


Discussion


The issue o
f how Syngenta tests their products before consumption and how many companies sell their
products and how often, was raised. Syngenta sells products themselves or contracts to different
companies. In the US there is no difference between GM or non
-
GM maize

therefore consumers could
at any given time buy whichever product they wish. If the product is safe for food or feed use then
there is no difference between the foodstuffs on the market shelf. That raised the question of labeling.
The participants were re
assured that Syngenta labels their seeds, which again depends on the market
demand for these products.


During his (Vincent’s) presentation there was mention that Bt has no effect on non target organisms.
The concern among the participants was that if th
is is the case then there is need to qualify where the
research is done and that introduction of the product is not the potential place for research. The
response to this enquiry was that lots of studies were done on different organisms, such rats, feeds,
poultry, cattle and others. This is done before products are released into the market. Other institutions
such as universities and private laboratories do research and tests on Bt 11 products. This has been
done for at least six years, so there is a fair a
mount of knowledge and information available. In terms of
non target organisms being affected, the test was not done on all crops, there is a need to look at what
type of insects are in the crop fields and in some cases there are similar patterns of insect
s in maize
fields so then it is possible to do a homology for most fields. This would enable you to see the type of
insects found in field.


A question with regard to Syngenta’s policy on biodiversity was raised, but it was indicated that they
do not have
a clear policy on it, but are aware of this and are cautious about it and thus look at potential
outcrosses and gene flow consequences. Syngenta is sensitive to this issue and how to approach risks of
any type of new technology. However, in some cases they

look at the benefits outweighing potential
risks, but this issue is up for discussion. The important point is that they are extremely sensitive to
maintaining biodiversity and especially with regard to centres of origins.


Are there guidelines to delay bu
ilding up of resistance and after how many years does this occur were
two questions raised. The answer given was that there are basically two options for farmers
-

the 5 %
and 20% refuse technique. If they opt for the 5% refuse option they can plant 5% of n
on GM maize,
and are not allowed to spray any Bt insecticides on those. If they want to use Bt insecticide they should
plant 20% of non GM maize. But so far no build up of resistance was noticed. The South African
government obliges farmers to look at ref
use areas. In this case farmers are privileged not to re
-
plant
and this reduces risk of refuse build
-
up.


Environmental Assessment issues of concern
-

Dr Desmond Mahon, Office of Bio
-
safety Environment, Canada


There are five strategic areas that need to b
e taken into consideration. The weight on each of these
issues depends on each country. There are requirements from each country on each of these issues and
it is the duty of that country to have knowledge on their own environment and its conditions. The i
ssues
are:

1.

Invasiveness

2.

Weediness

3.

Gene flow

4.

Toxicity


12

5.

Impact on Biodiversity


Invasiveness

has 1 consequence, namely displacements of local populations (dealing with species in
managed and non managed systems) if it moved from managed to non managed systems
. It is
important to know the biology (comparative and generic) of the organism before attempting to change
it.


Weediness

has two elements, which are related to crop production. The question to be asked is what is
the potential for the weed to grow outsid
e a managed system and how is this determined. Thus there are
agronomic and non
-
agronomic forms of weediness. The issue with weediness is how do you define it
and what are the attributes involved. The issues to consider are:

-

Increased fecundity


consider
if there is a higher potential to produce more of the seed, there
has to be a balance.

-

Loss of controls
-

is the organism modified so severely that it is difficult to control it or is it more
resistant

-

Increased survival
-

is it likely to survive longer


Ge
ne flow

is basically an issue of choice and it is an issue that needs to be addressed in terms of
whether there is gene flow and what are the consequences. Questions that should be asked in this
regard are: “What is the potential for genes to flow within s
pecies or inter species?” If there is such
likelihood what is the consequence thereof. What is the danger of having the trait in environment? If
that happens, there is need to look at impacts on non
-
target species in order to determine consequences.
The ge
neral problem with uncertainty is that there could be negative or adverse effect.


Toxicity
-

the following questions need to be asked in this regard:

-

Is the plant toxic to either non
-
target or target organisms?

-

What are the consequences, and if non
-
targe
t organisms are involved
-

is there any further
information needed and what does that entail? In such cases it is necessary to determine the
potential of toxicity to non
-
target organisms, soil organisms, micro fauna and flora organisms as
well as feed on cr
ops such as grazers. In the case of grazers this could be beneficial, but if not
toxic does it have effect on other organisms?

-

Another issue to consider is: is the nutritional quality of the plant changed and what is the
consequence.


Impact on Biodivers
ity

is very difficult to determine. Biodiversity varies from country to country,
therefore each country needs to identify conditions for these based on the information available and its
country conditions. The country must have the knowledge on what its bi
odiversity is, and it should also
be able to develop criteria for its protected and endangered species for example. This will enable them
to determine the impact. In some cases it might be necessary to do ecosystem assessments as part of the
criteria devel
opment process. In this case it is important to go to the population level and individual
displacement and look at the impact. In most cases it is impossible to do a broad scale assessment, but
it is important to make national criteria that you will use to

make assessments.


An EA is done to identify what consequences are involved and how these can be dealt with.


Discussion


A concern with regard to the Namibian government signing international agreements without fully
determining whether the country is r
eady or not was raised, especially with regard to determination of
biodiversity impacts. Realizing the concern of lack of expertise and capacity in this field, there is
nevertheless an effort made towards running a biodiversity programme, which has establi
shed different
working groups working on different issues. It is good to know your limitations but better to have
legislation intact in order to control biodiversity impacts.


Elaboration on weediness problems was required from the presenter. He addressed

this issue by
mentioning that it depends on the evaluation of field trials, and also the economic system, which in turn
depends in the reduction of yields and its efficiency. So it is important to look at environmental
impacts. It again depends on the cou
ntry you are dealing with and its agronomic system in place. There
are also a number of socio
-
economic impacts that needs to be considered.



13

Gene flow is not regarded as an issue of concern and if that is the case the presenter was asked to
provide positi
ve examples. There is always a concern because it has consequences. To address the
adverse effects there must be incentives to address the consequences.


Working groups


After the information session, the participations were divided into 4 working groups,

namely:

1.

General releases


Environment

2.

Feed and Food

3.

Environmental assessments

4.

Socio
-
economic


The working groups were instructed to make recommendations on the following focus areas:

-

Risk Assessment (concentrating on hazards, likelihood and consequences)

-

Risk management

-

Monitoring needs

-

Inspection needs

-

Benefits

-

Identification of scientific capacity (expertise)


Working group report back


Group 1: General release: Environment


See Annex 10 for detailed presentation of group work. Some of the issues that
the group looked at
were:



Effects on soil organisms
-
insects etc,



Awareness of Bt strains in Namibia
-

due to different agricultural systems
-

different soil
system



Water
-
as transport source
-

if there are floods
-

what happens
-

no information about magnitudes

therefore no idea about consequences.



What limits spreading of maize?


The group also looked at Risk management. A clause about limited commercial
release with room for questions that can be answered in 5 years should be included.
They also looked at Gene

flow and consequences deciding that not enough
information is provided thus consequences are unknown.


Recommendations from the group:

1)

no commercial release unless questions have been answered with particular reference to
‘Caprivi’ issues (can be done in

the lab or restrictive field trial)

2)

commercial release restricted to irrigated areas


strict limitation and monitoring applies

Discussion


The issue that commercial release be restricted to irrigated area is not possible as suggested by
Syngenta, because

monitoring of this is difficult. This has been done by US only for feed and food use.
This is a theoretical option in principle and the condition would apply only if the company refuses the
application.


Conclusion on general release is that it is importa
nt to determine if there is a concern about impact on
soil or non
-
target organisms. Therefore look at question depending on its purpose. To burn and bury
remains of plants is not considered in any general release.



14

Group 2: Food and Feed safety


The group
was guided by the Namibian regulations. However they needed specific information to
process the application such as:

-

PAT maize leaves, silk tassel below detection in kernel pollen, root or stalk

-

BTK (Ng/ml plant protein)


roots, stalks, leaves, kernels,
pollen


The group looked at the following issues in depth:

Regulations Namibia

1.)

Intended use for food and feed


we need the information mentioned on 9 14


separate assessment

2.)

Description of the production of food and feed p4

3.)

Packaging (p5), storage, handl
ing transport (p3)

4.)

Method for detecting transformation including limitations

-

Actual data missing p 11


Detailed dossier is missing

-

Toxicity

-

Allergenicity

-

Intolerance

-

Nutritional value

Draft regulations


How far is the company responsible for labeling. Wha
t happens with unintentional
use?


Risk Management

-

absence of proper risk assessment


difficult to propose management


Monitoring

-

Absence of risk assessment


Inspection

-

Inspect clear labelling


Benefit

-

Health benefits are not stated.

-

Need more information

-

Nutritional benefits

-

Production cost benefits


Scientific capacity

-

assess when risk assessment is completed


Recommendation

-

Application rejected

-

Not enough information available to do risk assessment

-

We need more time to study relevant information and do
a proper risk assessment before we shall
come up with a recommendation


Discussion


The issue of information availability was discussed in detail and an issue that came up was how much
of the information is credible. The response was that information shou
ld be dealt with on a case
-
by
-
case assessment basis. However the applicant is held responsible for provision of information. For
example the clinical trials are not done in Namibia, so there should be a list of priorities of studies that
should be done, b
ecause not all studies can be done. In any case the cost of trials will be too high
versus benefits.



15

In reality the dossier with information contains a lot of information and will take from 1 to 6 months,
therefore the regulations of the Bill should have
guidelines in cases where regulation is not clear. The
participants were assured that the Bill will have explanatory notes.


Group 3: Environmental Assessments


Gaps identified:



No references to scientific articles



Protocol of experiments (general design)



Origin of gene unknown



Not enough information on soil
-
micro
-
flora (possible reaction
-
gene flow)



No information of length
-

period of deformation of gene



No information of purpose of trial (Why trial will be done here)


According to the Draft Bill
-

applicant

provide information on similar experiment
-

under same
conditions (environmental and trial release).


Risk Assessment



Invasiveness is low



Information satisfied
-

gene flow satisfied



Recommend: requirement end of trial
-

no maize will be grown for following
growing season.



Toxicity needs entomologist
-

impact on Biodiversity information missing, microbiologist
needed



Transported under lock
-
and key



Harvested seed
-

no conditions were identified
-

recommend lock and key as for sowing.



Monitoring
-

missing protocol,

What is purpose of doing trials



Inspection
-

Unannounced government inspection



Experts
-

entomologist, ecologist, botanist, microbiologist, soil scientist


Purpose for trial
-

Result: Application disapproved on basis of not enough information provided.


Disc
ussion


Lack of information was identified as the major problem, thus it was important that mechanisms are in
place to get information. The workshop agreed that the matter could be referred to the applicant for
more information. A follow
-
up concern that wa
s raised was if there are these gaps of knowledge, how
could low risks be determined. The response was that it depends on where the trial will be. The basis of
a field trail is isolation, and it should be totally contained.


Group 4: Socio
-
economic impac
t


The group first looked at economical and social aspects separately.


Economical
-

When considering such applications, in a Namibian context, have to
consider communal and commercial conditions.

Communal Farming:



What losses of traditional farming practic
es are possible (availability of seeds)

What are the economical and social consequences of reduced pesticide use
-

finally communal farmers
don’t use pesticides



What is the potential possibility of release leading to increase in economic disparity



What in
creasing yields are possible (communal, commercial, irrigation, dry land)



How much of the increase in seed cost is fixed priced



Seed saving must be allowed



What positive impacts on labour use have been found


ageing farmers, urbanisation,
HIV/Aids



How dro
ught tolerant seed variety


rain
-
fed or irrigated



What are the costs of policing/ regulation after release and who pays



16

Commercial farming



How great is the potential market loss for the export industry



Value of market > / < than increase in value



How ca
n you ensure protection from anti
-
competitive practices? Proof of worth



What is impact on employment in commercial farming


General



How quickly are marginal returns diminished



Has the variety been tested under similar conditions (environmental & socio econ
omic) in
Namibia


Ethics (Social) aspects:



What is the cost of publicity needed to overcome negative reactions


divide into generic vs.
specific publicity



Is the variety for human (white maize) or animal consumption (yellow)?



What are the costs and benefi
ts of nutritional changes



What must be the ethical consequences of limited release (i.e. commercial only)



White commercial farmers grow maize but do not consume. How will potential negative
consumer be eliminated



Will instructions / Extension reach all Nam
ibians

Risk management

-

Yellow maize less risky than white

-

Release into commercial areas less risky than communal areas


more control

-

Release below VCF less risky than above

-

Cost of monitoring & regulation much less if commercial release only

-

Test under al
l / Namibian conditions


maize triangle vs. Caprivi


Monitoring

-

Monitor that economic benefits are real in all Namibian conditions

-

On
-
going assessment of marginal returns

-

Perception monitoring of non release area & non adopters


Skills

-

Agricultural econom
ists

-

Perception monitors


sociologists

-

Environmental economists

-

Development workers who can communicate with communities


Economic & social selection criteria

1.)

Proven benefits > Proven costs


Legal aspects

-

Art 16


missing “sound science”


e.g. plasmid co
nstruction references

-

Art 1d


missing trial design (protocol) & duration (dates)

-

Art 2b


not enough information about biology of unmodified organism

-

Art 2c


no information about origin and transfer method used for “PAT” gene

-

Art 2d


equivalent to 1d

-

Ar
t 2e


missing information about possible interaction of GMO with soil micro organisms (maize
disease) & degradation of Bt protein in the soil

-

Art 2f


missing information about the purpose of the trial protocol



Assumption


efficacy against local populati
on of borers

-

Art 2g


where are the conditions similar?


1.)

Risk assessment

-

Invasiveness


very low

-

Weediness


satisfied with conditions

-

Gene flow


satisfied with conditions

-

By the end of the trial do not grow maize for 1 year


400m, year monitoring volunt
eers


17

-

Toxicity


entomologist needed


How are non pest lepidopteras/ endangered/ endemic species
affected

-

Impact on biodiversity


soil micro
-
flora affected
-
> Bt protein degradation in soil


2.)

Risk management

Requirements

-

No maize grown on trial plot for n
ext season

-

Save store of harvested seed (lock & key)

-

Training and awareness required for all research station staff


3.)

Monitoring

-

Missing trial protocol (strategy & plans)


4.)

Inspection

-

Regular and advanced visits of government inspectors must be allowed


Expe
rts needed:


Entomologist

Microbiologist

Plant pathology

Ecologist

Agronomist

Botanist

Food & feed safety


Result
: Application rejected
-

not enough information


Discussion


The discussion was based on drought tolerance effect on food security in Namibia
.
Therefore it is important to look at the two socio
-
economic farming sectors. Also
there should be consideration of storage/packaging of seeds or products in traditional
ways.


The distinction between white and yellow maize should not be made because the
colour of the maize should not make a difference. Maize should be safe in general, but
if either one is not safe, the application will be withdrawn.


There is also not enough information on the crop loss estimates in Namibia. Working
group had no idea on p
ost
-
harvest loss/harvest losses thus without baseline
information, it was difficult to conclude. An agronomic assessment should be done
long before risk assessment, because if there is no benefit from the application, then
there will not be any products.


There should be a grower’s agreement requirement by bio
-
safety board to make sure
refuge area of farmer is managed properly. The farmers are allowed to keep seeds and
re
-
plant but are not allowed to sell products from such activities, because if he sells h
e
becomes part of trade which is not allowed because then he is in competition with the
company.


A general concern was whether Dr Putsztai’s work is duplicated
-

if not why not? The response was that
he cannot make companies replicate. He only did GM potat
oes
-

never touched on GM foods. To
review what is known about research in this field will contribute to great evidence do not follow
scientific publication (unclear). Why studies not repeated
-

interesting all parties in UK (royal society,
science and techn
ology committee) said questions were valid but work was criticised, Therefore there

18

needs to be general advance made on attempts to reproduce
-

with criticism or not. If work like this is
not published in peer review, it is a loss because it will not be in
scientific circulation. In general, Dr
Putsztai mentioned that it would be useful if industries comply with scientific methods.


Special insert: Press Conference


Dr Martha Kandawa Schulz gave an overview of the workshop, highlighting the objectives of the

workshop and the need to build national capacity to deal with the technology. She also mentioned that
participants of workshop were give practical exercises to look at applications and follow the RA
processes. She gave the floor to the different resource
persons that were invited to the workshop to
mention highlights of discussions during the workshops.


Dr Andre de Kathen mentioned that environmental effects are considered when dealing with Bt
insecticides, which could affect pest or other non
-
target orga
nisms. There are no set guidelines for
socio
-
economic and ethical issues and it depends on the application, crop type, trade partners and
economic situation of country.


Dr Putztai mentioned that when looking at draft Bill, the relevant the questions wer
e asked, and during
the training exercise, some questions could not be answered due to time limitations. In practice it is
important to clear up general principles of the Bill before considering applications. The questions and
concerns are answered in deta
il by the draft Bill and that Namibians can be proud of what they have
achieved.


Mrs Muffy Koch talked about products for consumers and that the Bio
-
safety bill meets requirements
for public participation. However lack of information is the biggest proble
m for consumers. For
example maize is insect tolerant
-

but is it safe to eat, does it taste the same, does it have the same
nutrition, how can information get through and can it be labelled. The most important thing is that
consumers want enough informatio
n to accept product.


Mr Volckaert was representing Sangenta and he mentioned that their company provided the training
documents that participants used during this workshop. He also mentioned that biotechnology should
be seen as tools for food security. He

stressed that their company does not want to work in countries
where there are no regulations in place and that the sooner Namibia has an Act in place the better. He
concluded by commenting that the Bill is a credible document.


Discussion


Press:

How wil
l the information be disseminated to consumers?

Response:

The Bill should provide provisions for that, but also it’s the responsibility of authorities to
provide information to consumers.


Press
: What is the Namibian public opinion?

Response:

A Survey has

been conducted on the issue, and it has shown that knowledge on
Biotechnology is low but it has increased since then. An awareness campaign will also be conducted to
obtain the public’s opinion.


Press
: Is it safe to eat GM food?

Response
: There are a lot

of uncertainties with regard to food and feed safety, however the Bio
-
safety
Bill puts in place regulations to assess these foods.


Press:

What does Golden
-

Genomics do?

Response:

It is a consulting company dealing with issues such as biotechnology, agr
iculture,
sustainable farming
-

how GM seeds relate to sustainable farming.


Press
: Are there GM foods in Namibia and are there any pending applications.

Response
: It is not known, maybe processed foods, since its not labelled properly it is difficult to
control and monitor. There is currently no law in place that could allow such foods, so based on that
there are no GM foods in Namibia. There are some applications pending, but they will be on hold until
the law is in place.



19

Press were thanked for their
attendance and their interest in Biotechnology and their interest in the
country’s future in general.




DAY 3


Report back of Decision making committee


The general response was that the application was rejected, mostly due to the fact that
more informati
on was required.


Discussion


The issue of confidentiality of information was discussed. Article 34 of the Bill makes
provision for an applicant to keep information confidential. In case of public
information, a certain amount of information is not allowed

to be released to third
parties. Confidential means it does not form part of public domain information.


The Board will take comments of each working group (previous day’s work) into consideration. Board
members should also do homework and sort it out (r
elevant and irrelevant information).


Gaps from working groups


The facilitator (Sem Shikongo) posed the question: “what are the areas that are not reflected in the Bill
and regulations?” to participants. In order to answer this question, participants had
to focus on the
following:



Legal gaps and loopholes



Administrative procedures



Risk assessment



Decision making

The participants were given three cards for each issue. These cards were then clustered according to
similar ideas (Annex 11).


The major outcome
s of these clusters were:

Legal Gaps and
loopholes

Administrative
procedures

Risk Assessment

Decision making

-

Interim measures

-

Training
inspectors

-

Linkages with
other regulators

-

Technical
guidelines

-

Legal payment
measures

-

Dumping
measures

-

Other concerns

-

Information/


clarification needed

-

Structure

-

Training/capacity
building

-

Financial issues

-

Registrar

-

Timeline


-

More information
needed

-

Survey and
evaluation

-

Capacity building

-

Pharmaceuticals

-

RA effects

-

Standards


-

Database

-

Transparency

-

Process of
decision m
aking

-

Training and
capacity building

-

Public
participation

-

Liability

-

Expert
identification




20


Gaps in evaluation and audit of RA


The participants were given 2 cards each, to answer the question: What are the important points
omitted by the working groups
in relation to evaluation and audit of the RA (Annex 12).


The outcomes of this exercise were:

-

Capacity building and infrastructure needed

-

Training needed

-

Brief lists of annexes needed

-

More time to study applications needed

-

Experts identification


Identif
ication of future training needs


Participants were given two cards, each to identify the future training needs.

The training needs identified were:


-

Administrative (training) structure

-

Training requirements should be clarified

-

Laboratory analysis

-

Training

for inspectors

-

Training/public awareness

-

Training material should be developed

-

Training on legal aspects.


Way Forward


The comments on the draft Bill from this meeting will be handed to the Minister by December 2003.

The bio
-
safety clearing house (BCH) w
ill become operational once Namibia ratifies the protocol. This
body will be responsible for legal requirements on applications and considerations.


Questions and comments on any of these issues should be directed to the NABA address:
naba@unam.na
.















Workshop Evaluation


To evaluate whether the workshop has achieved its objectives, the facilitator asked participants to
complete evaluation forms and the following sentences:


“ I came here with the expectat
ion of….. and I am leaving with …….”


The overall response from participants was that they came with the expectation of learning more about
GMOs and Risk Assessments as well as to learn and understand the contents of the Bill and its status.
For most part
icipants the workshop was a success and the objectives as well as their expectations were
Terms Clarified during workshop:



Accession
-

if not ratified, then country has no rights and
has to accept terms of agreement



Signing
-

Country signs an agreement with which it
accepts the major principles



Ratification
-
Makes the country legally bound to the
agreement principles and it has to implement them.
Gives a country
-
voting powers.




21

met. The participants also commented on the excellent choice of experts (resource persons) that were
selected to attend the workshop.


Recommendations for future ref
erence were that more experts from Namibia should be invited,
especially from the health sector.


Workshop adjourned at 13:15




Special insert: Teleconference
-
19 November 2003: Introduction of labelling regimes with main
emphasis on the SA proposed guidel
ines.
-

Dr Wilna Jansen Van Rilssen
-

Directorate of Food
control
-

SA.


Dr Van Rilssen talked about the introduction of Risk assessment and application of knowledge used
into area (unclear). There has been a change from safe foods to RA of foods.

The FAO a
nd WHO bodies looked at Codex with the purpose looking at food standards. Based on this
governments are discussing food standards, which should be based on sound principles for food trade.
She gave a very detailed overview of the Codex approach of Risk ana
lysis, mentioning that it consists
of risk assessments, risk management and risk communication. Risk assessment deals with advisory
level and number of experts
-

multidisciplinary team
-

to provide sound principles, which do not include
pure science and soc
io
-
economics. Risk management is where decisions are taken and risk
communication is dealing with consumers. She also described risk assessment with GM food versus
risk assessments with chemicals. She also discussed risk hazards and exposure assessment. T
his deals
with what is consumed by populations, which, in turn, gives an idea of how much is consumed. From
this it can be established how much exposure is encountered. Risk assessment teams should comprise:



Plant microtechnologist



Animal technologist



Gen
eticist



Statistician



Chemist



Microbiologist



Toxicologist



Nutritionist



Entomologist


She futher gave a detailed description of Labelling of food according to the Codex principles. Labelling
should have no false claims, and not be misleading or erroneous, w
ith justifiable, substantiated, and
verifiable information. A few concerns that she raised in terms of labelling were: how many people
read labels, what are the economic and ethical aspects that people need to make choices. Labelling
should be able to inf
orm the public on nutritional value, components, storage, cooking, and preparation
methods of product. She also touched on the cost of labelling which is very expensive, especially for
the laboratory analysis. She concluded by saying that there are no simp
le answers, when it comes to
RA.


Discussion


The participants were interested to hear about labelling, especially how SA deals with it. The response
was that labelling food for GM or non GM contents differs from country to country based on its laws in
pla
ce. The SA labelling laws are based on Codex principles. They look at safety health and nutrition
issues. This has been a hot debate in SA and still there is no consensus on GM labelling.



A question on appropriate timing for field trials were raised by
participants. The response was that
there are 9 differential areas, which include all aspects of the crop in question.


Another question that was raised was whether SA has a Novel food regulation. Dr Van Rilssen
admitted that this was a new field of study
within this research and it will be a focus for the future.



22

Dr Kandawa
-
Schulz thanked Dr Van Rilssen and her colleague for taking time off to share with the
participants their experiences and information on Risk Assessment. She said that it will contribut
e to
understanding of concepts and will have added value when dealing with the Namibian Bio
-
safety Bill.

















Annexes


Annex 1 : Main points of the Biosafety Bill, national needs and international obligations
-

Mr Sem
Shikongo, Ministry of Envi
ronment and Tourism


Annex 2: Overview of Namibian Biosafety Bill, Mr Johann Malan



Annex 3: Regulations of Proposed Bill
-

Martha Kandawa
-
Schulz, University of Namibia/ Namibian
Biotechnology Alliance (NABA)


Annex 4: Environmental Assessment issues of co
ncern
-

Dr Desmond Mahon, Office of Bio
-
safety
Environment, Canada


Annex 5: GM Food Safety issues of concern
-
Dr Arpad Putsztai, Aberdeen, UK


Annex 6: Introduction to assessing the environmental impact of GMOs
-

Mrs Muffy Koch, Golden
Genomics, South Africa
.



Annex 7: Socio
-
economic and ethical aspects of GMOs
-

Haruko Okusu, University of Sheffield, UK


Annex 8: List of working groups


Working Groups

Trial environment

Gen


food & feed

Gen


Env

Gen


socio
-
econ

T. Ahveendo

Elsabe

R. Roels

Percy

S. Niee
temba

Kanta GVB

Immo

Jorsie

Shigwedha

Gina

Eugene

Peter

Joyce

Tjihaiko

Patrick

Ben



Johann









Annex 9: Field trail case study introduction (HR maize) and Commercial release case study
introduction (Bt maize)
-

Mr Vincent Volckaert , SYNGENTA
-

Sou
th Africa




“Risk assessment is about knowledge, experience
s and
common sense!” Dr Van Rilsssen



23

Annex 10: Report back of working group 1: General Release
-

Environment



The group highlighted the current situation in Namibian with cultivation areas of total about 50.000
to/a. with two distinct systems of cultivation:



Dryland: Caprivi, Kav
ango, Otavi Triangle



Irrigated: Orange, Hardap, Kombat, Omusati

Different issues the group looked include:

Agricultural Production and Management

(Syngenta ?):

Farmer’s agreement


are they renewed every season or only at first purchase ?

(Agreement befor
e seeds are handed out). Questions asked within the group were:

How can applicant ensure that seed is not sold, directly or indirectly (secondary users), to farmers w/o
cultivation agreements? Information needed were Contractual agreements, Inspectors, inf
ormation on
non
-
registered donors. Practicability with respect to small scale vs large scale farmers (traceability,
refuge area, management and documentation, monitoring


precaution: no experience with small plots)

REQUEST: seed sales strictly controlled/
renewed/contract


avoid use by third parties

Hazard: damage to non
-
target
-
effects:

Probability
-

What is the need for insect (f.e. stemborer) control that might be facilitated by Bt
-
maize?

a)

dryland


low incidence

b)

irrigated


high incidence

c)

market forces de
termine what farmers will produce

Proteins in soil from Bt
-
maize


persistence and effect, plant remains and herbivorous insects?

Bt
-
strains in the Namibian soils?

Physical, chemical and biological degradability under different (dryland/wetland) conditions

(pH,
moisture, MO
-
diversity), effect on aquatic invertebrates (only Daphnia)?

Toxicity on collembola and earthworms (in Namibia?), ants, termites (plant remains, nest), coleoptera,
lepidoptera (insect fauna


food web, cattle dung


dung beetle, fly larva
e?)

Effect on soil insect diversity/compaction, pest control




24

Persistence of Bt in water/flooding, accidental distribution by flooding (calculate worst case scenario:
all Bt, water)

Area

Probability 1
-
5

Magnitude 1
-
5

Consequence

Caprivi wetland

3

?

?

No
rthern dryland

3

?

?

Northern
irrigation

1

?

?

Southern
irrigation

1

?

?

Probability higher in Caprivi and ND because plant remains and area is left


irrigated monocultures:
tillage, 2 seasons

Hazard: invasiveness

Area

Probability 1
-
5

Magnitude 1
-
5

Co
nsequence

Caprivi wetland

1

2?

?

Northern dryland

0

0

Irrelevant

Northern
irrigation

0

0

Irrelevant

Southern
irrigation

0

0

irrelevant


Limited number of volunteers outside the field, Caprivi!

What limits the volunteers (rain
-

insects?)?

Failure
-
fri
endliness is limited: no complete recall possible, will volunteers

Can volunteer populations survive without constant supply

Management: monitor, control or inhibit seed sales, sunset clause (temporal or spatial conditional
release and ‘do something’, i.e.

monitoring)

Hazard: gene
-
flow consequences:

Within species


25

Area

Probability 1
-
5

Magnitude 1
-
5

Consequence

Caprivi wetland

5

2

relevant

Northern
dryland

5

2

Relevant

Northern
irrigation

5

0

Irrelevant

Southern
irrigation

5

0

irrelevant

Contaminatio
n of dry land varieties

Problem with farmers saving seeds (contamination, mixture)

Failure
-
friendliness


no complete recall since certain level of contamination can’t be excluded

Management: keeps a distance (especially in irrigated areas, cut
-
off GM
-
seed

supplies, subsidise non
-
GM)

Between species

Area

Probability 1
-
5

Magnitude 1
-
5

Consequence

Caprivi wetland

1

?

?

Northern dry
land

1

?

?

Northern
irrigation

1

?

?

Southern
irrigation

1

?

?


Bt
-
strains in Namibia?

RECOMMENDATION

3)

no commercial release
unless questions have been answered with particular reference to
‘Caprivi’ issues (can be done in the lab or restrictive field trial)

4)

commercial release restricted to irrigated areas


strict limitation and monitoring applies




26


Annex 11: Clusters of Cards

on areas that are not reflected in the Bill and regulations




27




28



29



30

Annex 12: Evaluation and audit of the RA




31

ANNEX 13: FUTURE TRA
INING NEEDS