R 111352Z MAR 09
FM AMEMBASSY NAIROBI
TO SECSTATE WASHDC 8800
INFO DEPT OF COMMERCE WASHDC
DEPT OF TREASURY WASHDC
USDA FAS WASHDC 1771
ENVIRONMENT SCIENCE AND TECHNOLOGY COLLECTIVE

UNCLAS NAIROBI 000496 
 
 
USDOC FOR BECKY ERKUL AND CASSIE PETERS 
 
STATE PLEASE PASS USTR PATRICK DEAN COLEMAN, WILLIAM JACKSON, GINA 
VETERE, AND JENNIFER CHOE GROVES 
 
STATE PASS USAID/EA AND GEORGIA SAMBUNARIS 
 
STATE ALSO FOR EEB/TPP/ABT JACK BOBO AND GARY CLEMENTS, AF/E, 
AF/RSA, AF/EPS, AND EB/TPP/IPE CARRIE LACROSSE AND JOSH HALLOCK 
 
TREASURY FOR REBECCA KLEIN 
 
AGRICULTURE FOR ANDREW RUDE AND FARAH NAIM 
 
ADDIS ABABA FOR REO KIRSTEN BAUMAN 
 
E.O. 12958: N/A 
TAGS: TBIO EAGR KIPR ETRD SENV EINV ECON PGOV KE
SUBJECT: CAUTIOUS KENYA FINALLY ENACTS LONG AWAITED BIOSAFETY ACT OF 
2009 
 
REFS: (A) 08 NAIROBI 2309 (B) USDA FAS GAIN REPORT KE8022 
 
 
¶1.  Summary: On February 12, 2009, Kenyan President Mwai Kibaki 
signed the long awaited and hotly disputed Biosafety Act of 2009 
into law.  Kenya thus becomes the fourth African country (following 
South Africa, Egypt, and Burkina Faso) to enact legislation 
establishing the legal framework to govern trade in and use of 
genetically modified organisms as required by the Cartagena Protocol 
on Biosafety.  The adoption of biotechnology is viewed by proponents 
as a long overdue, long term strategy to address Kenya's persistent 
food insecurity.  The Act's regulatory and enforcement provisions 
seek to allay the worries of skeptics, but some, including the 
president of the African Biological Safety Association, are already 
calling for amendments to the act to mitigate bio-security concerns. 
 End summary. 
 
¶2.  Although Kenya made history in 2000 by being the first country 
to sign the Cartagena Protocol on Biosafety (ratifying the protocol 
in 2003), it hesitated to adopt biotechnology.  Following the demise 
of Kenya's cotton industry and renewed fears of widespread hunger 
and famine, biotechnology proponents, pointing to the success of GMO 
agriculture in South Africa, made the case before Parliament last 
fall that the technology could help revive Kenyan cotton and address 
the country's chronic food insecurity.  An inaugural "All Africa 
Congress on Biotechnology" on the merits of biotechnology, organized 
by the Nairobi-based African Biotechnology Stakeholders Forum 
(ABSF), further galvanized local proponents (ref A). 
 
¶3.  Agriculture Minister William Ruto subsequently led the charge in 
Parliament for passage of a biosafety bill, which President Mwai 
Kibaki signed on February 12. (Note: the USAID-funded Program for 
Biosafety Systems created linkages among key national institutions, 
thus building support for the bill among policymakers and biosafety 
regulatory agencies.  The program also provided technical regulatory 
support to facilitate confined field trials of genetically modified 
cotton and corn.) 
 
¶4.  The Biosafety Act of 2009 is to facilitate responsible research 
into genetically modified organisms (GMOs); ensure an adequate level 
of oversight and protection for the safe transfer, handling, and use 
of GMOs with respect to public health and the environment; and 
establish a transparent, science-based and predictable process for 
reviewing and making decisions on the transfer, handling, and use of 
GMOs and related activities. 
 
¶5.  In terms of scope, the Act covers the import and export of GMOs 
and products containing GMOs, and it stipulates how they are to be 
marketed, sought and sold, stored, released into the environment, 
and used.  It specifies the legal requirements and procedures 
required for obtaining approval before introducing GMOs for research 
or commercial purposes.  The Act defines what information is 
required from applicants, establishes a "risk assessment process," 
and specifies the roles of different regulatory agencies in ensuring 
compliance. 
 
-------------------------------- 
New National Biosafety Authority 
-------------------------------- 
 
¶6.  The Act establishes a "National Biosafety Authority," operating 
under the Ministry of Science and Technology, with a 17-member board 
comprised of eminent scientists, experts, permanent secretaries from 
key ministries, the secretary of the National Council on Science and 
Technology, directors of existing biosafety regulatory agencies 
(such as the Kenya Plant Health Inspectorate Service-KEPHIS), and 
civil society representatives.  Key functions of the Authority 
embrace overall supervision and control of the development, 
transfer, handling and use of genetically modified organisms for 
research or commercial purposes.  The Authority, in carrying out its 
role of coordination, may consult with the following key regulatory 
agencies: Department of Public Health; Department of Veterinary 
Services; Kenya Bureau of Standards; Kenya Plant Health Inspectorate 
Services; Kenya Industrial Property Institute; Kenya Wildlife 
Service; Pest Control Products Board; and National Environmental 
Management Authority.  (Note: all these agencies already operate 
under existing legislation which refers to GMOS.)  The new law also 
establishes an Appeals Board to review the decisions of the National 
Biosafety Authority whenever significant new scientific information 
on the biosafety of GMOs or contained use activities emerges. 
 
¶7.  The Authority is to promote public awareness and education to 
enhance understanding of biosafety.  The Act outlines mechanisms for 
obtaining and incorporating public input.  Notices will be published 
in the Kenya Gazette to invite comments from the public on pending 
decisions to approve introduction of GMOs for research or commercial 
purposes. 
 
---------------------- 
GMO Safeguard Measures 
---------------------- 
 
¶8.  To ensure safe and responsible use of GMOs, the Act requires 
that an assessment and management of risks be first undertaken.  It 
sets severe penalties against persons who deal in GMOs without 
written approval of the Authority or who fail to furnish correct 
information to the agency.  Under Part IX, Section 52(g), those 
found guilty of manufacturing, exporting, importing, transporting, 
trading, marketing, and/or using GMOs without the approval of the 
Authority are subject to a fine not exceeding KSh2 million ($25,000) 
and/or a prison term not exceeding ten years. 
 
¶9.  Cessation orders stipulate immediate directives for terminating 
activities that pose an imminent danger to the conservation and 
sustainable use of biological diversity, taking into account risks 
to human health.  "Environmental restoration orders" set forth legal 
sanctions to be enforced to remedy or rehabilitate damage to the 
environment as a result of negligence or deviation from risk 
management measures.  Violators of the Act are "to restore the 
environment as near as it may be to the state in which it was before 
the release of a genetically modified organism." 
 
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Biosafety Inspectors' Prerogatives 
---------------------------------- 
 
¶10.  Part VII of the Act provides for biosafety inspectors.  It 
authorizes them to enter any premises, facility, vessel, or property 
"at all reasonable times and without a warrant" to determine whether 
someone is violating the Act.  The inspector may conduct a search 
and seizure if s/he has reason to believe that a violation is taking 
place.  The inspector has the authority to take "appropriate 
samples" of any organism, article, or substance which appears to 
contain genetically modified organisms that might pose a biosafety 
risk.  The inspector may then require that the substance be tested 
but s/he has not have unrestricted discretion and authority to 
damage or destroy the suspect material(s). 
 
¶11. Prior to the signing of the Biosafety Act, Kenya's national 
biosafety system was governed by the Science and Technology Act of 
1980 that created the National Council for Science and Technology 
(NCST).  In 1995, the NCST initiated a process of developing the 
national Biosafety guidelines and regulations that made a provision 
for the creation of a National Biosafety Committee (NBC), to serve 
as the technical arm of the council in overseeing coordination and 
implementation of Biosafety issues. 
 
¶12. Genetically modified products that have been approved for 
contained and confined field trials include insect-resistant maize 
and cotton, tissue culture bananas, GM sweet potato, virus-resistant 
cassava, and rinderpest vaccine.  Confined field trials of 
genetically-modified insect-resistant cotton and maize are already 
underway in Kenya.  The Kenya Agricultural Research Institute 
intends to begin open field trials of transgenic cotton Bt in 
October 2009.  While these products are approaching the 
commercialization phase, the Science and Technology Act of 1980 
lacked substantive provisions to move on-going research products 
from research stage to commercialization. The adoption of the 
Biosafety Act of 2009 addresses these regulatory gaps, thus ensuring 
that commercial release of potentially beneficial products is done 
in a safe and responsible manner 
 
¶13.  Biotechnology is now seen by policymakers as a way to maximize 
productivity and sustainability of agriculture; protect the 
environment and human health; and stimulate trade and industry. 
Previously some were unduly concerned about the potential risks 
posed by the technology.  Their anxieties blocked potential corn 
imports by requiring that imported corn not exceed a two percent 
adventitious presence for biotechnology-produced corn.  This 
provision led to unnecessary corn supply constraints resulting in 
food deficits and artificially high corn prices. 
 
¶14.  There remain skeptics.  Dr. Willy Tonui, a researcher at the 
Kenya Medical Research Institute (KEMRI) and the founding president 
of the African Biological Safety Association (AfBSA), told a March 9 
gathering of medical and laboratory professionals that the Act must 
be amended to "capture bio-security concerns."  But for the vast 
majority of professionals in the field, biotechnology holds the 
promise of improved food security in Kenya. 
 
Ranneberger