BIOTECH OUTREACH ACTIVITY REPORT

UNCLAS SECTION 01 OF 04 PRETORIA 000004

SIPDIS

SIPDIS

SENSITIVE BUT UNCLASSIFIED

DEPT FOR EB/TPP/ABT, OES/PCI, AND AF/S
DEPT PASS EB/TPP/ABT - JMENARD, TLERSTEN, AND MKOCH
USDA FAS FOR OSTA/NTPMB/MICHAEL HENNEY AND ANTHONY GILBERT
USDA APHIS FOR THOMAS C. NESBITT

E.O. 12958: N/A
TAGS: EAGR ECON ETRD SENV SF
SUBJECT: BIOTECH OUTREACH ACTIVITY REPORT

REF: A) STATE 202514 B) PRET 000357


1. (U) Summary: From September 15-28, 2007, FAS/Pretoria hosted
Thomas C. Nesbitt, Outreach and Communications
Specialist/Biotechnology Regulatory Service(BRS)/ Animal Plant
Health Inspection Service(APHIS)/USDA to undertake biotechnology
outreach activities funded by the Department of State's Bureau for
Economic, Energy, and Business (EEB). Dr. Nesbitt participated in
several meetings related to agricultural biotechnology regulatory
policy with government officials, researchers, and industry
representatives in Pretoria, South Africa. He gave presentations
and discussed U.S. regulatory policy with staff at the Council for
Scientific and Industrial Research, the Department of Environment
and Tourism, the GMO Act Executive Council, the Department of Trade
and Industry, and the Department of Agriculture. He also gave a
lecture hosted by the Public Understanding of Biotechnology Project
(PUB) and presentations at two events organized by AfricaBio. End
Summary.


2. (U) Funding for this activity was provided by EEB's biotech
outreach funds to improve the understanding of the U.S. regulatory
system and risk assessment methodologies. Representatives from the
Department of Environment and Tourism had requested to discuss risk
assessment methodologies with APHIS regulators - a significant
invitation from South African officials who have been reticent to
engage with U.S. officials, and whose role in the South African
regulatory system has been recently elevated.

Background
--------------


3. (U) Commercial production of genetically engineered (GE) crop
varieties has been authorized in South Africa since 1997. In 2006,
acreages of GE varieties accounted for approximately 44% of corn,
79% of soybean, and 92% of cotton. The approval process for both
field releases and commercial commodity imports, first defined in
the 1997 Genetically Modified Organism (GMO) Act is as follows: An
application is first submitted to the GMO Registrar in the National
Department of Agriculture. The Registrar reviews the application
for compliance with the Act, and then submits the package to an
independent scientific advisory committee for scientific review and
risk assessment. This committee makes recommendations to the
Registrar to either approve or to seek additional information. Once
the committee makes a recommendation, the Registrar forwards the
recommendation to an Executive Council that administers the GMO Act
and makes the final decision regarding the approval. The Executive
Council is composed of representatives from eight national-level
government ministries: Department of Agriculture (DoA),Department
of Science and Technology (DST),Department of Environment and
Tourism (DEAT),Department of Trade and Industry (DTI),Department
of Health (DoH),Department of Labor (DoL),Department of Water
Affairs and Forestry (DWAF),and Department of Arts and Culture
(DAC)


4. (SBU) Several factors are reported to have contributed to a
slowdown in field release and commercialization approvals in recent
years, including: significant personnel change in some agencies with
accompanying loss of institutional memory; amendment of the National
Environmental Management and Biodiversity Act in 2004, giving new
responsibilities to DEAT; addition of DWAF and DAC to the Executive
Qresponsibilities to DEAT; addition of DWAF and DAC to the Executive
Council following revisions of the GMO Act in 2007; and an economic
impact analysis on commodity clearance being conducted by DTI.


Council for Scientific and Industrial Research (Sept. 17)
--------------


5. (U) In a two-hour meeting, Dr. Nesbitt gave presentations on the
U.S. Coordinated Framework, an overview of other Federal acts
affecting biotech (e.g., NEPA, TES),and an in-depth review of
notification, permit, and petition procedures. CSIR is an R&D
organization funded through the Department of Science and
Technology. Meeting participants included research scientists and
breeders developing transgenic sorghum varieties (for which release
permits had recently been denied by the Executive Council),
researchers developing vaccine-producing crops, and ecologists
conducting biotechnology-related risk research. Several staff from
DEAT were also present.


6. (SBU) Much of the discussion following the presentations
centered on criticism of South Africa's ability to effectively use
the expert input of its biotech scientific advisory committee.
Several meeting participants had the perception that the Executive

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Council disregarded the advice of the advisory committee, and would
second-guess assessments by requesting additional "safety"
information from applicants with perhaps dubious scientific
justification.

Department of Environment and Tourism (Sept. 17)
--------------


7. (U) The afternoon included an informal, two-hour discussion with
DEAT's Director of Biosafety/GMOs and the Director of Biodiversity
Management. Discussion centered on the two different authorities
used by DEAT to regulate biotech crops: the 1998 National
Environmental Management Act (NEMA) and the more recently-amended
2004 National Environmental Management Biodiversity Act (NEMBA).
The latter explicitly gives DEAT the authority to conduct an
"environmental impact assessment" if the DEAT Minister has reason to
believe a biotech crop could impact biodiversity and to conduct
"monitoring"; the former is a broader environmental protection
authority. DEAT is attempting to develop internal procedures to
reconcile how and when it will conduct its risk assessments under
the two different authorities, and how this may or may not be
reconciled with the risk evaluations conducted under the GMO Act by
the Executive Council, of which DEAT is a member. Participants also
discussed the similar challenges faced by APHIS regulators in
conducting risk assessments under the authorities of both NEPA and
the Plant Protection Act. Ironically, APHIS is now moving towards
separating the two assessments; DEAT was considering combining
theirs. It should be noted that none of the various assessments to
be conducted by DEAT would be publicly available (Note: Dr. Nesbitt
enquired about this directly). Rather, they seemed to be intended
as internal advisories for the GMO Act Executive Council.

GMO Act Executive Council (Sept. 18)
--------------

8. (U) Dr. Nesbitt presented on overview of U.S. regulatory policy
and APHIS' process to this meeting of the Executive Council.
Participants asked many questions about specific policy issues,
including stacked genes, LLP/AP, regulation of pharma trials,
inspection and monitoring, recent rice issues and lawsuits, etc. He
also spent a great deal of time discussing the Coordinated
Framework; in particular, how the three agencies are able to make
decisions independently and the consequences of working with three
different agencies (differences in timing, different implications
for commercialization, different legal weights of reviews (i.e.
FDA),etc).

Department of Trade and Industry (Sept. 19)
--------------

9. (SBU) Discussion that followed a presentation on the U.S.
regulatory policy ranged very widely, including: liability and
redress, identity preservation and labeling, commodity clearance,
food safety, etc. Some participants seemed to be very positive
about biotechnology, but, for example, felt that "labeling is a very
good thing." Others seemed very concerned about "unresolved" food
safety issues, and asked many questions about recent
quasi-scientific publications (Pusztai, etc.). In general, DTI
staff expressed a desire to study the economic impacts of biotech
commodity imports, but appeared to be grappling with what to analyze
and how.

Department of Agriculture (Sept. 20)
--------------
Q --------------


10. (U) Dr. Nesbitt gave a short talk on U.S. and APHIS regulation
of biotechnology to a small group of NDA officials who were
primarily plant protection specialists from the Agricultural
Products Inspection Service and the Pest Risk Assessment group
within the Plant Health program. There was some discussion of
biotechnology import permits and inspections (especially BRS'
collaboration with Plant Protection and Quarantine (PPQ)),but
participants did not play an active role in regulating biotechnology
in South Africa.


Public Understanding of Biotechnology (Sept. 20)
--------------



11. (U) In this meeting, Dr. Nesbitt gave a public talk on risk
perception, risk communication, and public perception of
biotechnology. The talk was hosted by the Public Understanding of
Biotechnology (PUB) Project, an outreach program funded by the South
African Agency for Science and Technology Advancement (SAASTA, a

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business unit within the Department of Science and Technology). PUB
has a nationwide outreach program with educational materials and
brochures, grade school education programs, public meetings and
lectures, etc., and its managers appeared to have well-established
relationships with biotechnology risk communication experts in the
United States and internationally. Talk attendees included PUB
staff, several interns and staff from DEAT and DST, and a few
others.

AfricaBio Business Breakfast (Sept. 21)
--------------


12. (U) Dr. Nesbitt presented a talk to AfricaBio's business council
on U.S. regulation of biotechnology, with some added emphasis on
upcoming changes to 7CFR340. As the participants were largely from
the local research and business community, conversation following
the talk was similar to discussions with representatives of these
groups earlier in the week.

AfricaBio Workshop (Sept. 26)
--------------


13. (U) AfricaBio organized a week-long workshop entitled "Biosafety
Course of the Non-Biotechnologist" (Sept. 25-29). Participants
included primarily policy makers, regulators, and risk assessors
from several counties in south and east Africa. Dr. Nesbitt gave a
very short overview of the U.S. regulatory system, but time for
discussion was limited.

Analysis and Recommendations
--------------


14. (U) Explaining the inner workings of the U.S. regulatory system
to South African regulators and policy makers seemed to have a large
impact on the South African's perception of U.S. policy.
Misunderstanding of the U.S. regulatory system (or even of its
existence at all) was widespread. Throughout the week, many
government regulators who initially seemed skeptical of
presentations expressed pleasant surprise to learn that the U.S.
"actually thought about risk" and "didn't just say 'yes' to
everything multinational companies asked for." Audiences were often
surprised that U.S. regulators included risk assessors and
scientists from a wide range of disciplines, and that the United
States is assessing many of the same kinds of risks and regulatory
challenges they were. These meetings have the potential to be the
early foundations for relationships between U.S. and South African
regulators as regulators, benefiting from exchange of technical
expertise and discussion of the similar challenges each faces.


15. (SBU) A significant difference between the U.S. and South
African regulatory systems lies in the role of the GMO Act Executive
Council (EC) as the final decision-making body in South Africa.
Unlike in the United States, where each of the three coordinated
framework agencies makes its decision independently based upon
distinct expertise and authorities, in South Africa the EC makes a
single consensus decision. A scientific advisory council and each
individual agency submit separate assessments to the EC, but these
documents are not made public and are all apparently open for
reconsideration at the EC level. When applications are made to the
GMO Registrar, the Registrar formally solicits public comment, but
individual EC members also independently receive public comment
through back channels which they take into consideration. The EC
also meets infrequently, often requesting new data of applicants
Qalso meets infrequently, often requesting new data of applicants
through the Registrar, but not considering the new data until much
later meeting cycles. Perhaps most significantly, the consensus
nature of the EC decision-making means that individual members have
the ability to request additional data from applicants outside their
particular areas of expertise or regulatory jurisdiction (as a
hypothetical example, an economist from the Department of Trade and
Industry may wish to have additional food safety data). The ad hoc
rethinking at the EC level does not appear to be couched within any
formal risk assessment framework. Because only the final decision
document is made public and all of the deliberations occur behind
closed doors, applicants expressed frustration that the
decision-making process is not very transparent and it is difficult
to reconstruct on what basis individual decisions are made.


16. (SBU) The decision-making ability of the Executive Council might
be improved by building the risk-assessment competence and
confidence of each of the individual member agencies. In many
instances, the persons who are responsible for their agency's
separate risk assessments are also the same individuals who sit on
the EC. Improving this confidence might make separate agency risk

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assessments "pass through" the EC intact, and perhaps be better
communicated in the final decision documents. Continuing to foster
working relationships and technical exchanges between U.S. and South
African regulators at the risk assessment level is likely to benefit
both countries.


17. (U) Comment: Post looks forward to developing this
relationship further in 2008 and will submit its proposal to EEB in
January. End comment.
Bost