VZCZCXRO1227
RR RUEHDU RUEHJO
DE RUEHSA #2513/01 3191445
ZNR UUUUU ZZH
R 141445Z NOV 08
FM AMEMBASSY PRETORIA
TO RUEHC/SECSTATE WASHDC 6439
RUEHRC/USDA FAS WASHDC 1992
INFO RUEHTN/AMCONSUL CAPE TOWN 6276
RUEHJO/AMCONSUL JOHANNESBURG 8629
RUEHDU/AMCONSUL DURBAN 0416

UNCLAS SECTION 01 OF 04 PRETORIA 002513 
 
SIPDIS 
 
DEPT FOR EB/TPP/ABT, OES/PCI, AND AF/S 
DEPT PASS EB/TPP/ABT - JBOBO, JFINN, GCLEMENTS, AND MKOCH 
USDA FAS FOR OSTA/NTPMB/MHENNEY AND FNAIM 
USDA FAS FOR OCRA AFERRUS 
USDA FAS FOR OCBD KSKUPNIK AND JMAURER 
 
E.O. 12958: N/A 
TAGS: EAGR ECON ETRD KPAO PREL SENV SF TBIO
SUBJECT:  READOUT OF SOUTH AFRICAN BIOTECHNOLOGY OUTREACH EVENTS 
 
REF: A) STATE 160639 B) PRET 000004 
 
Summary 
------- 
¶1. SUMMARY From September 15 - 19, Dr. Chris Wozniak, Biotechnology 
Special Assistant, U.S. Environmental Protection Agency (EPA), was 
in South Africa under the auspices of the State/EB agricultural 
biotechnology outreach program to make presentations on the U.S. 
coordinated framework and risk analyses and assessments to South 
Africa's GMO Biotechnology Advisory Committee and Subcommittee 
members, government partners, and stakeholders .  The visit of Dr. 
Wozniak was funded by State/EB funds.  USDA/FAS supplemented these 
funds with $12,000 and provided a second speaker for this trip, Dr. 
Robyn Rose, USDA/Animal Plant Health Inspection Service (APHIS). 
 
¶2. Drs. Wozniak and Rose's trip included two one-day presentations 
to new members of the South African GMO Advisory committees and 
subcommittees as well as presentations at the Bio2Biz biotechnology 
forum sponsored by the South African Department of Science and 
Technology and presentations at the International Centre for Genetic 
Engineering and Biotechnology's (ICGEB) Biosafety course. END 
SUMMARY. 
 
Advisory Committee and Subcommittee 
----------------------------------- 
¶2.  The GMO Advisory Committees (AC) are panels of independent 
experts that review and evaluate all applications for GMOs.   Their 
evaluation is written up as a decision memo to the Executive Council 
(EC), who makes the final approval decision on the application. 
During the review by the AC, there may be subcommittees established 
to look at particular aspects of the application.  During a recent 
review of Advisory Committee and Subcommittee expertise, several 
areas of deficiencies were identified.  The deficiencies were 
addressed by increasing the number of Advisory Committee and 
Subcommittee members and widening the disciplines represented. 
 
¶3.  Drs. Wozniak and Rose were invited by the South African 
Directorate of Biosafety of the National Department of Agriculture 
to be international expert speakers at a workshop aimed at new 
entrants to the Advisory Committees and Sub-Committees.  The new 
entrants come from research institutes, universities, and government 
institutions.  This two-day workshop was held in Pretoria and in 
Cape Town.  Drs. Wozniak and Rose led the first day of the workshop, 
focused on risk analyses and assessments, in both locales. 
 
¶4.  The format in Pretoria and Cape Town were similar, but there 
were noticeable differences in audience participation, interest, and 
interaction.  In both workshops, Drs. Wozniak and Rose presented on 
the U.S. Coordinated Framework, to bring into context the reasons 
why the USG focuses on certain areas of risk assessments.  Each 
speaker focused on his or her specialty areas; Dr. Wozniak spoke of 
the EPA's role in regulation of genetically engineered organisms 
(GEO) and Dr. Rose focused on APHIS' role.  After an initial 
introduction to the U.S regulatory system, Dr. Wozniak spoke on the 
basics of risk assessment, specifics of risk assessment of plant 
incorporated pesticides, and risk communication.  Dr. Rose spoke on 
the role of APHIS in the regulatory process, insect resistance 
management, and ecological risk assessments. 
 
¶5.  In most instances members of the AC and Sub AC are also employed 
in other capacities, usually as professors or university 
Qin other capacities, usually as professors or university 
researchers, unlike in the United States where full time staff 
handles most, if not all, of the regulatory matters needed to 
approve a crop for field release and/ or commercialization. 
Therefore, the actual time AC and Sub AC members have available to 
conduct a thorough review of documentation to provide a 
recommendation to the Executive Council, could be limited depending 
on workload from their primary employment. 
 
¶6.  The audience in Pretoria was made up of representatives from the 
research community, universities, private industry, and government. 
All participants were PhDs with expertise including veterinary 
science, ecology, molecular biology, pharmacology, biochemistry, 
genetics, and biotechnology.  The Cape Town audience was made up 
mostly of academia, all PhDs, with several from the medical 
community.   The audience in Cape Town was more engaged and entered 
into livelier discussions with the speakers.  The format was 
identical to Pretoria, but there were many more questions and 
discussions with the speakers. 
 
 
¶7.  The participants interacted with the speakers and asked 
questions that demonstrated differences in viewpoints involving 
environmental issues and methodologies for assessing the state of 
 
PRETORIA 00002513  002 OF 004 
 
 
any particular area (e.g. fields, grasslands, etc).  Specifically, 
there was a concern that the United States should survey the 
environment for various ill described parameters to look for subtle 
effects of GEOs.  The same participant expressed concern for food 
safety aspects of genetically engineered (GE) crops, overall. 
Additional concerns from AC members focused more on logistical or 
practical issues involving completing a review or experiment and 
determining what types of data needed to be gathered for risk 
assessment.  Overall, the speakers saw a definite confidence in the 
different audiences relative to the use of GE technology in 
agriculture. 
 
¶8.  Many participants in attendance took something away from the 
training, even if it was just an affirmation of the South African 
process through contrast with the United States. 
 
¶9.  Since the workshop in Pretoria, several participants have 
contacted Drs. Rose and Wozniak with further questions and requests 
for guidance.   Both speakers have expressed their interest in 
continuing the dialogue with their South African counterparts, and 
genuinely are interested in providing the information they have 
access to further the work of the AC. 
 
¶10.  Comment.  South African agriculture, cultural practices, and 
regulatory processes are distinctly different from the United 
States, and the approval process of the United States should not and 
will not be a perfect fit for the South Africa.  However, there are 
parts of our process that do make sense to be incorporated in the 
South African process i.e., allergenicity studies, and other issues 
that are the same between the two countries.  But there are also 
vast differences in production practices that dictate the use of 
certain methodologies in the United States that would not be 
appropriate in South Africa.  For example, the United States' 
Midwest can be characterized as a corn monoculture; therefore insect 
resistance management is an issue that needs to be addressed in 
order to ensure the GE events that are introduced in the area 
continue to perform efficiently and do not result in the creation of 
insect resistance.  In South Africa, however, there are no 
monocultures to the extent of the Midwest in the United States. 
Therefore, the expense of incorporating and managing insect 
resistance management practices in South Africa would far outweigh 
any benefit gained.  End Comment 
 
Bio2Biz 
------- 
 
¶11.  Dr. Wozniak was present at the 2008 Bio2Biz technology forum in 
Johannesburg on Tuesday, Sept 16, 2008.  He sat on a panel for 
Health Biotech in Developing Countries where he spoke on plant 
incorporated protectants and risk assessments in EPA.  The 
conference was a bit disorganized and audience participation was at 
a minimum. 
 
ICGEB 
----- 
 
 
¶12.  Both speakers also participated as speakers at the biosafety 
course entitled "Benefits, Opportunities, and Risks from the Release 
of GMOs in Africa" offered by the Cape Town component of the 
International Centre for Genetic Engineering and Biotechnology 
(ICGEB).  This course was sponsored by the ICGEB, Biosafety South 
Africa, CSIR, Italian Ministry of the Environment, and Institute of 
Plant Biotechnology for Developing Countries of the University of 
Gent, Belgium.  It was held during the week of September 15 -19. 
QGent, Belgium.  It was held during the week of September 15 -19. 
Over 40 people from all over the world, including Egypt, Zimbabwe, 
Nigeria, Kenya, Colombia, Peru, Namibia, Uganda, South Africa, 
Cameroon, and Italy participated in the course.  Drs. Wozniak and 
Rose participated on September 18th and 19th.   USDA/FAS also 
sponsored the participation of Dr. Hector Quemada, Calvin College, 
Michigan.  Dr. Rose presented on the coordinated framework of the 
United States, the role of APHIS in the process, and insect 
resistance management.  Dr. Wozniak spoke on post gene flow risk 
assessments, viral coat proteins, and RNAi- based mechanisms.  Dr. 
Quemada participated throughout the week and made special 
presentations on the risk analysis with hands-on exercises on the 
evaluation of transgenic squash. 
 
¶13.  The presence of these three speakers from the United States was 
particularly important as many of the other   instructors were from 
Europe.  Although the European speakers were not overtly against 
biotech, there were noticeable differences between their perspective 
of risk analysis and risk communication and those of the American 
speakers.  The contributions of the American delegation provided a 
 
PRETORIA 00002513  003 OF 004 
 
 
balance to the workshop's agenda that the audience would not have 
received without the USG participation. 
 
Future Activities 
----------------- 
 
¶14.  Both trainings were comprehensive in explaining the main 
aspects of the United States regulatory system.  Many issues were 
not discussed that are of equal importance, including data 
submission, formatting, record keeping, confidentiality, review and 
maintenance fees, dockets, and other paper work that can be critical 
to a sustainable system and adherence to statutes.  South Africa has 
shown definite movement in the past month towards a mandatory GE 
labeling requirement which will rely significantly on monitoring and 
enforcement, two additional issues South Africa will need to focus 
on to ensure compliance.  South Africa would also benefit from 
further training in USDA/GIPSA sampling and monitoring for 
unapproved events in grain and soy imports or exports as well as the 
role the FDA consultation process and its impact in the approval 
process. 
 
Background 
---------- 
 
¶15.  South African biotechnology policy is formulated under the 
Genetically Modified Organisms (GMO) Act of 1997.  This act was 
modified by Cabinet in 2005 to bring it in line with the Cartagena 
Biosafety Protocol (CBP) and again in 2006 in order to address some 
economic and environmental concerns.    These amendments were 
published and gazetted on April 17, 2007.  Implementing guidelines 
have not yet been published.  These amendments are said to be 
administrative in nature, but there a few substantive changes that 
may impact the current biosafety regulatory system. 
 
Increase in EC Representatives 
------------------------------ 
 
¶16.  Executive Council (EC) membership, which is responsible for 
making regulatory decisions, was increased from six to eight members 
by adding representatives from the Department of Arts and Culture 
and the Department of Water Affairs and Forestry.  Currently, the EC 
is made up of the following representatives: Department of 
Agriculture, Department of Science and Technology, Department of 
Environment and Tourism, Department of Trade and Industry, 
Department of Health; and, Department of Labor. 
 
¶17.  Comment.  The addition of two new representatives to the EC may 
be only administrative, but it could potentially impact the work of 
the EC.  The new representatives may not have significant knowledge 
of biotechnology and biosafety, nor have any interest in the 
subject.  It may also be more difficult to get a quorum to have an 
EC meeting and to reach consensus decisions because the EC functions 
by consensus and each member has the right to veto a decision he or 
she does not endorse.  This could delay decisions on permit 
applications.  End comment. 
 
Other Potentially Significant Changes to the Current Law 
------------------------------- 
 
¶18.  One other amendment to the GMO Act authorizes the EC to 
determine if an environmental impact assessment (EIA) is required 
under the National Environmental Management Act, giving the EC 
significant power to decide if a costly and potentially 
time-consuming Environmental Impact Assessment is required.  If one 
representative of the EC wants an EIA done, it will be required 
since the EC works on consensus. 
 
 
¶19.  The amendments also add specific legislation to allow 
Q19.  The amendments also add specific legislation to allow 
socio-economic considerations to factor into decision-making and 
makes those considerations significantly important in the decision 
making process.  A final change that could impact the GMO approval 
process is a statement in the GMO Amendments Act that declares that 
a summary of the scientifically-based risk assessment on 
environmental and human/animal health impact cannot be kept 
confidential.  Releasing this information to the public may provide 
more transparency and public participation, but could also add cost 
and time to the regulatory process for the applicants and the 
Registrar. 
 
National Environmental Management Biodiversity Act 
--------------------------------------------- ----- 
 
¶20.  The 2004 National Environmental Management Biodiversity Act 
 
PRETORIA 00002513  004 OF 004 
 
 
(NMBA) protects South Africa's biodiversity from specific threats, 
and includes GMOs as one as those threats.  NMBA also ensures there 
is a sharing of benefits from South Africa's biological resources. 
NMBA Section 78 gives the DEAT Minister power to deny a permit for 
general or trial release applied for under the GMO Act, if that GMO 
may pose a threat to any indigenous species or the environment, 
unless an environmental assessment has been conducted. 
 
¶21.  Few GMO environmental assessments have been conducted as a 
result of the NMBA requirements.    However, if the Minister deems 
it necessary, and the criteria for that decision are not clear, an 
expensive and time-consuming process would have to be completed 
before the EC could move forward with the GMO permit application. 
 
¶28.  Comment.  NMBA has changed DEAT's role in the EC.  This new 
responsibility to ensure that GMOs are correctly assessed and do not 
pose a risk to the environment has forced them to ask more pointed 
questions and request more data before deciding on the status of new 
GMO permits. End Comment.