Cablegate: Readout of South African Biotechnology Outreach Events

DE RUEHSA #2513/01 3191445
R 141445Z NOV 08




E.O. 12958: N/A

REF: A) STATE 160639 B) PRET 000004

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

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

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


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.


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


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

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.

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