TANZANIA COMMISSION

FOR SCIENCE
AND TECHNOLOGY
(COSTECH)
PROGRAM FOR
BIOSAFETY SYSTEMS
(PBS)
WORKPLAN - CAPACITY BUILDING TOWARDS A
FUNCTIONAL BIOSAFETY SYSTEM IN TANZANIA:
OCT 2013-SEPT 201
SUBMITTED TO: USAID TANZANIA
OCTOBER 2013
P!"#!$% &"! B'"($&)*+ S+(*)%( (PBS): B'"($&)*+ P",'-+
I%.,)%)/*$*'"/ '/ T$/0$/'$
1
P!"."()1 W"!2 P, $/3 O-*"4)! 13 2013 5 S).*)%4)! 303 201
EXECUTIVE SUMMARY
The Government of Tanzania under the support of UNEP-GEF has accomplished
developing the National Biosafety Frameor! "NBF# that consists of a legal and
institutional regulatory frameor!$ %oever& one of the challenges ith this frameor!
is the stringent lia'ility and redress provision in the 'iosafety regulations "())*#$ +ther
challenges include limited capacity in terms of s!illed human resource 'ase&
infrastructure& funding& and s!etchy understanding of the 'enefits and safety of G,
technology 'y the general pu'lic& regulators& decision ma!ers& layers and scientists
among others$
This or! plan addresses the a'ove mentioned challenges through implementation of
activities addressing - strategic o'.ectives/ "i# 0trengthening the 'iosafety regulatory
frameor! through the revie of strict lia'ility clause in the 'iosafety regulations ())*
so as to ensure it supports the development and responsi'le use of G,+s in Tanzania1
"ii# enhancing capacity of the regulatory authorities 'y developing2finalizing specific
guidelines i$e$ for 3onfined Field Trials "3FT# and for commercialization& and "iii#
implementing colla'orative outreach and aareness activities that promote pu'lic
understanding of modern 'iotechnology and 'iosafety$
PB02Tanzania ill implement these activities in the or! plan in colla'oration ith
3+0TE3%& the 4ice President5s +ffice-6ivision of Environment "4P+#& the Tropical
Pesticides 7esearch 8nstitute "TP78# and the 9gricultural 8nnovation 7esearch
Foundation "987F# among others$
The main focus of the proposed F: ()1; or! plan includes 'uilding an ena'ling
environment for a functional 'iosafety frameor! in Tanzania and ultimately promoting
acceptance and adoption of the G, technology in Tanzania$
1. Background
Tanzania5s national policy on 'iotechnology "()1)# emphasizes the technology5s
potential to enhance the country5s food security and trade position$ The 'road o'.ective
of the policy is to ensure that Tanzania has the capacity and capa'ility to capture the
proven 'enefits arising from health& agriculture& industry and environmental applications
of 'iotechnology hile protecting and sustaining the safety of the community and
environment$ %oever& it has 'ecome apparent that !ey sta!eholders 'elieve
Tanzania5s current 'iosafety regulations are too stringent and that the national
o'.ectives for 'iotechnology development might not 'e achieved$
(
Furthermore& Tanzania<s Biosafety 7egulations of ())* employ the =Precautionary
Principle= hich means that a lac! of scientific evidence is not a 'asis for refusing or
restricting G,+s or 'iotech products$ The regulations also employ the =0trict >ia'ility=
principle& hich 'roadly states that any ?person ho imports& arranges transit& ma!es
use of& releases or places on the mar!et a G,+ or product of a G,+ shall 'e strictly
lia'le for any harm caused 'y such a G,+ or product of a G,+@& hich should 'e =fully
compensated=$ The lia'ility for any perceived =harm& in.ury or loss=& even to vaguely
defined =social or cultural principles& livelihoods& indigenous !noledge systems or
technologies= eAtends to all players associated ith the G,+2'iotech product such that
even a secretary or!ing for an agro-processing firm donating a gene for research
could 'e sued if someone perceived harm from the 'iotech product$ This =guilty until
proven innocent= approach is contrary to most of the rest of the orld& including
neigh'ors Benya and Uganda& hich 'ase their legislation on a =Fault Based >ia'ility=
principle& here harm and negligence must 'e proved$ +n the other hand& human
medical trials and nuclear poer plants do not typically employ strict lia'ility principles$
This or! plan focuses mainly on creating understanding to policy and decision ma!ers
on the conseCuences of having strict lia'ility in the Tanzania 'iosafety regulations and
influencing them to revie the regulations$ 0pecific communication and outreach
activities using various tactics ill 'e deployed accordingly$ The revie of strict lia'ility
ill allo 7D6 in genetic engineering& technology transfer and availa'ility of full range of
tools to improve the livelihoods of smallholder farmers in the Tanzania$
PB0& financially supported 'y U0986& engages ith the Government of Tanzania5s
institutions and other sta!eholders as they em'ar! toards communication D outreach
and capacity enhancement in managing modern agricultural 'iotechnology$ This or!
plan has 'een developed 'ased on recommendations from !ey ministries and a tas!
force meeting held in 0eptem'er ()1- involving !ey national partners$
2. Rati onal e
3urrently a ide range of pu'lic 7D6 institutions are involved in agricultural
'iotechnology in Tanzania& ith pro.ects on virus-resistant cassava and drought-tolerant
maize as nota'le eAamples of G, applications$ There is also an increasing interest in
the application of G,& insect-resistant cotton folloing positive eAperiences in other
9frican countries such as Bur!ina Faso$
-
9 regulatory frameor! for modern 'iotechnology in Tanzania as developed under the
Environmental ,anagement 9ct of ());& hich as revised to incorporate provisions
for regulating the development& handling and use of G,+s$ 0ection E* of the la
addresses 'iosafety issues$ 8mplementing regulations ere issued in ())*$ The !ey
areas covered 'y the regulations are general guiding principles& institutional
arrangements& procedures for notification and approval& eAport& deli'erate release&
confined use& contained use& transit and placing on the mar!et of G,+s and their
products& ris! assessment and management& lia'ility and redress& offences and
penalties and schedules$
3+0TE3%& as the focal point for promoting 'iotech in the country& initiated a
consultative process in ()1) through the ,inistry of 3ommunication& 0cience D
Technology ",30T# to advise the government regarding the unnecessary restrictive
provisions in the 'iosafety regulations$ This process is ongoing ith active colla'oration
of the ,inistry of 3ommunication 0cience and Technology ",30T# and the ,inistry of
9griculture Food 0ecurity and 3ooperatives ",9F3#$
3. PBS/ Tanzani a: Goal and O! e"ti #e$
PB0 supports partner countries in 9frica and 9sia in the responsi'le development and
use of agricultural 'iotechnology1 hence& PB02Tanzania is proposing - !ey strategic
o'.ectives "'elo# for implementation ith partners in Tanzania$ PB0 has partnered ith
3+0TE3% and the 4ice President5s +ffice "4P+# 6epartment of Environment as the
local implementing organizations and it has a country coordinator ho interfaces ith
the Government of Tanzania& U0986 and all relevant sta!eholders$ The 3oordinator is
also connected to a larger PB0-9frica netor! and therefore acts as a conduit for
sharing information and 'est practices from other 9frican countries$
3. 1 Overal l Goal and Strategi c Obj ecti ves
O6)!$,, #"$,: To strengthen the 'iosafety regulatory frameor! in Tanzania
3. 2 Strategi c obj ecti ves
a# 0trengthening the 'iosafety regulatory frameor! through the revie of strict
lia'ility clause in the 'iosafety regulations ())* so as to ensure it supports the
development and responsi'le use of G,+s in Tanzania1
'# Enhancing capacity of the regulatory authorities 'y developing2finalizing specific
guidelines "i$e$& for 3FTs& commercialization#& improving system efficiencies and
training of regulators1
c# 6eveloping and implementing a strategy for colla'orative outreach and
aareness that improves the understanding and communication s!ills of
;
decision-ma!ers and enhances pu'lic understanding of modern 'iotechnology
and 'iosafety$
%. P&o'o$ed A"t i #i t i e$ ( St&ate)i " O! e"ti #e$
4.1 Strengthening the biosafety regulatory framework through the review of strict
liability clause in the biosafety regulations 2009 so as to ensure it supports the
development and responsible use of GMOs in Tanania (strategic objective 1)
Given the importance in achieving a functional 'iosafety regulatory frameor!& PB0 ill
place priority on providing the necessary legal and technical assistance in this area$ The
folloing activities are anticipated/
$) T7) .!"4,)% S*$*)%)/*
Policy ma!ers and enforcers in the ,inistry of Environment& 4ice President5s +ffice
"4P+#& 6ivision of Environment "6+E# and other !ey ,inistries do not consider strict
lia'ility in the Biosafety 7egulations ())* as a 'arrier to technology transfer in Tanzania
hile developers and end users see it as a 'arrier to G, crop development$
Furthermore there has 'een personalization of strict lia'ility issue and resistance to
change for a num'er of government employees$
W7$* /))1( *" 4) 1"/)
Face-to- face dialogue ith the ,inister for Environment to inform her on the
implications of strict lia'ility to the agricultural sector and national development in
general$ The face-to-face dialogue ill 'e conducted through a meeting ith the
,inister$
S.)-'&'- $-*'6'*')( *" 4) -"/18-*)1
i$ 8dentify champions1
ii$ Prepare tal!ing notes1
iii$ +rganize a meeting of 1) influential people "6G 3+0TE3%& 6irector 7esearch
and 6evelopment "676# ,9F3& 6irector& ,inistry of 3ommunication 0cience
and Technology "60T#& Prof$ Fumanne ,aghem'e ",inister for ater and
irrigation# and E other influential persons and eAperts "t'd# to meet ith the
,inister for Environment and discuss conseCuences of strict lia'ility clause in the
regulations$
4) P!"4,)% (*$*)%)/*
T7) A**"!/)+ G)/)!$,9( O&&'-) are draftsmen of las and regulations 'ut they have
limited understanding on the 'enefits of G, technology and the conseCuences of
having strict lia'ility in the Tanzania 'iosafety regulations$
S.)-'&'- A-*'6'*')(
G
To create understanding to the 9G 3ham'ers staff and other relevant ministerial
layers on ho prohi'itive regulatory frameor! hinders 'iotechnology development in
Tanzania through a or!shop using case studies on the impact of restrictive2prohi'itive
'iosafety regulatory frameor! on 'iotech in agricultural sector development$ PB0 ill
conduct this activity in colla'oration ith 3+0TE3% and ,9F3$
-) P!"4,)% S*$*)%)/*
,any decision ma!ers are unaare that the ongoing genetic engineering cassava
research in the la'oratory at 978-,i!ocheni ill not progress further until and unless
strict lia'ility clause is revieed$ Furthermore they also are unaare that the state of art
confined field trial "3FT# facility at ,a!utopora& 6odoma has 'ecome a hite elephant
despite of huge investment$
S.)-'&'- A-*'6'*')(
To arrange for visits of the ,inisters from ,inistry of 3ommunication 0cience and
Technology ",30T#& ,9F3& ,inistry of >ivestoc! and Fisheries 6evelopment ",>F6#&
,inistry of Trade and 8ndustry ",T8#& Tamisemi& ,inistry of Environment& ,inistry of
Natural 7esources& ,inistry of 3onstitution and >as& ,inistry of %ealth and ,inistry of
:outh and 0ocial 0ervices to 978 ,i!ocheni and ,a!utopora$
1) P!"4,)% S*$*)%)/*
The Permanent 0ecretaries in various ministries have limited understanding and limited
a'ility to grasp and use science 'ased information to ma!e informed decisions$
S.)-'&'- A-*'6'*')(
7aising aareness and understanding on 'iotechnology and 'iosafety issues of
Permanent 0ecretaries through the folloing activities/
To conduct a or!shop for Permanent 0ecretaries so as to raise aareness and
understanding on 'iotechnology D 'iosafety and ho strict lia'ility affects 'iotech
development in the country$ PB0 ill conduct the or!shop in colla'oration ith
3+0TE3%& ,30T and ,9F3$
SO 1: Deliverables and er!or"ance indicators
!olicies"regulations"administrative procedures analyed as a result of #SG assistance
,inister endorsed the revie of the 'iosafety regulations "())*#$
Government leaders recognizing the need to revie prohi'itive regulations that
hinder the progress of research in emerging technological fields& including
'iosafety regulations$
E
8ncreased a'ility to use science 'ased information to ma!e effective decisions
related to technology and G, crops 7D6$
!olicies"regulations"administrative procedures drafted and presented for
public"stakeholder consultation as a result of #SG assistance
Ena'ling and practical 'iosafety regulations and guidelines in place
$umber of individuals who have received #S government %#SG& supported short'term
agricultural sector productivity or food security training
9t least -) policy and decision ma!ers eAposed on legal aspects of 'iosafety
regulation
4. 2 Enhanci ng capaci t y of t he regul at ory aut hori t i es by devel opi ng /
fi nal i zi ng speci f i c gui del i nes on CFTs and for commerci al i zat i on (st rat egi c
obj ect i ve 2
PB02Tanzania has esta'lished close colla'oration ith 4P+2Environment focusing on
technical& legal and regulatory factors associated ith contained and confined field-
testing& and relevant ris! assessment and ris! management procedures$
This or! started& in F: ()1-& ith a technical revie of current guidelines for field trial
developed over the past years ith UNEP-GEF support and development of ne
guidelines for commercialization$ 8t ill 'e folloed 'y discussions of the to documents
'y various sta!eholders$ PB0 ill or! ith the ,inistry of 9griculture5s 9gricultural
Biotechnology 0cientific 9dvisory 3ommittee and the 4P+ to address any remaining
gaps and necessary ad.ustments$ 8n addition& consultations ill 'e held ith technology
developers such as the HE,92maize pro.ect in order to identify their plans for 3FTs
and technical training needs$ 0pecific activities ill include/
a# To support a sta!eholders< or!shop on their inputs of the revised 3FT guideline
and the nely developed commercialization guidelines during F: ()1-1
'# To support development of ( additional& !ey guidelines and 0+Ps to support
research and commercialization of G, products$
SO 2: Deliverables and er!or"ance indicators
I
!olicies"regulations"administrative procedures drafted and presented for
public"stakeholder consultation as a result of #SG assistance
0et of ( ena'ling guidelines for revieing and implementing confined field trials and
commercialization of G, products$
$umber of individuals who have received #S government %#SG& supported short'term
agricultural sector productivity or food security training
9t least E) sta!eholders gave inputs on the revised and ne developed 3FT and
commercialization guidelines$
4. ! "mpl ement i ng col l aborat i ve out reach and a#areness act i vi t i es t hat
enhance publ i c underst andi ng of modern bi ot echnol ogy and bi osafet y
(st rat egi c obj ect i ve !
9 PB02Tanzania aareness and outreach component for decision ma!ers ill 'e
implemented ith national and international partners such as 80999& 9BNE and 99TF
in order to enhance familiarity ith current developments around G, crops and
'iosafety decision-ma!ing$ This ill include information sharing and activities geared to
a 'roader audience including farmers& policy ma!ers& politicians& and media$ 8n
preparation for 3FTs& there ill 'e a need to develop user-friendly materials to target
!ey sta!eholders in government& farming and media communities$ PB0 ill concentrate
on policy ma!ers and decision ma!ers5 needs to 'e conversant ith the technology to
ma!e informed decisions$
Field visit programs to various countries& hich are ahead of Tanzania in the utilization
of 'iotech products& ill 'e targeted to the !ey influential sta!eholders$
There is a need to develop a strategic approach to 'iotechnology2'iosafety
communication and outreach& 'uilding on the diverse 'ut disparate initiatives currently
active in Tanzania$ 9 positive recent development is the launching of the +pen Forum
on 9gricultural Biotechnology "+F9B#& spearheaded 'y 3+0TE3% and 99TF$ PB0 has
already developed close colla'oration ith +F9B$
PB02Tanzania ill develop practical& hands-on training events 'ased on successful
approaches applied in other partner countries such as Benya& Uganda and Bur!ina
Faso$ The main target group for such training ill 'e regulators and revieers "e$g$&
4P+& 9B093& and the National Biosafety 3ommittee#& and 3FT inspectors$ Training
events may 'e conducted in a neigh'oring country "Uganda or Benya# here cassava&
cotton and maize 3FTs are ongoing$
J
i$ 8n colla'oration ith other service providers such as 9BNE and 99TF to organize
a field trip of () influential decision ma!ers and regulators to Uganda to o'serve
ongoing G, research and eAchange ideas ith their counterparts$
ii$ To develop 'iosafety communication strategy using netmapping data in
colla'oration ith +F9B 2 99TF$
SO 3: Deliverables and er!or"ance indicators
$umber of individuals who have received #S government %#SG& supported short'term
agricultural sector productivity or food security training
8ncreased aareness ith at least E) influential decision ma!ers regarding
'iotechnology& 'iosafety and strict lia'ility provisions1
9t least -) regulators and inspectors acCuired training on commercialization
guidelines$
*