Cablegate: 6th U.S.-China Technical Working Group Meeting in Beijing

VZCZCXRO1416
OO RUEHCN RUEHGH RUEHVC
DE RUEHBJ #3394/01 3520855
ZNR UUUUU ZZH
O 180855Z DEC 09 ZDK
FM AMEMBASSY BEIJING
TO RUEHC/SECSTATE WASHDC IMMEDIATE 7288
RUEHRC/DEPT OF AGRICULTURE WASHDC
INFO RHEHNSC/NSC WASHDC IMMEDIATE
RUEATRS/DEPT OF TREASURY WASHINGTON DC IMMEDIATE
RUEHOO/CHINA POSTS COLLECTIVE
RUCPDOC/DEPT OF COMMERCE WASHDC

UNCLAS SECTION 01 OF 03 BEIJING 003394

SENSITIVE
SIPDIS

STATE FOR EEB/TPP/MTAA/ABT ARYAN
STATE FOR C MPLOWDEN
STATE FOR J BOBO
STATE PASS USDA/ERS
STATE PASS USDA/FAS/OSTA BERMAN/PORTER/JONES
STATE PASS USDA/FAS/OCRA CHINA DESK
STATE PASS USDA/OGA
STATE PASS USDA/APHIS/SIMMONS/HERON
STATE PASS USTR FOR STRATFORD
STATE PASS USTR CLARKSON
STATE PASS FDA/DEITZ
STATE PASS EPA/WOZNIAK

E.O. 12958: N/A
TAGS: SNAR SENV EAGR ETRD ECON CH

SUBJECT: 6th U.S.-China Technical Working Group Meeting in Beijing

(U) This cable is Sensitive But Unclassified. Please protect
accordingly.

1. (SBU) On September 15, officials and technical experts from the
United States and China convened the Sixth Meeting of the U.S.-China
Biotechnology Technical Working Group on Food and Environmental
Safety (TWG). Discussion focused on scientific and regulatory
issues relevant to genetically engineered plants and the foods
derived from them. Included in this discussion was an explanation
of both the U.S. and Chinese approaches to the low level occurrence
in commerce of unauthorized genetically engineered (GE) plants and
material derived from such plants. The discussions were very
informative and open, with the Chinese delegation presenting
detailed information about their development of Bt rice. The formal
TWG meeting was preceded by a field trip to Shanghai to discuss the
development of transgenic goats, environmental safety assessment of
biotech products, and database and detection methods for biotech
products. END SUMMARY.

BIOTECH RELATIONSHIP MOVES FORWARD
----------------------------------

2. (SBU) Prior to the TWG, the MOA hosted a field trip to Shanghai
to continue the recent TWG tradition of "hands-on" visits with
experts to discuss technical issues related to agricultural
biotechnology. Accompanied by Mr. Fu Zhongwen, Project Officer with
the Shanghai Center for Science and Technology Development,
APHIS-Biotechnology Regulatory Services met with key province
officials from the Science and Technology Department and Division of
Foreign Affairs of the Shanghai Municipal Agricultural Commission.
Meetings with private sector researchers, including the Chairman of
the Board and President, Cheng Guoxiang, of Shanghai Genon
Bio-Engineering Company provided significant new information about
Chinese researchers' achievements related to transgenic animals.
This relatively new company, founded in 1999, has developed
transgenic goats, which express human lactoferrin and lysozyme
intended for use in nutritionally-enhanced foods. Additionally,
Genon is undertaking research focused on improving animal health,
particularly gene expression related to scrapies. Discussions at
Fudan University with Professor Lu Bao-Rong, a key National
Biosafety Committee (NBC) member and other academics focused on rice
gene flow research used to support China's environmental safety
assessment of GE rice. Professor Lu provided numerous peer-reviewed
research studies which have been shared with MOA regulators. USDA
also met with Professor Zhang Dabing, another NBC member, at
Shanghai Jiao Tong University to discuss database and detection
methods for biotech products and reference material preparation.
Much of Professor Zhang's research efforts are aimed at providing
resources to assist in the enforcement of China's labeling policy
and to harmonize and standardize testing methodologies. Professor
Zhang is actively engaged in various on-going international
cooperation activities on detection methodologies. Shanghai Jiao
Tong University will also be the future home of a special center for
consumer education on biotechnology.

3. (SBU) The United States and China convened the 6th Meeting of the
U.S.-China Biotechnology Technical Working Group (TWG) in Beijing,
September 15, 2009, hosted by the Chinese Ministry of Agriculture.
Beverly Simmons, Associate Deputy Administrator, Biotechnology
Regulatory Services, Animal and Plant Health Inspection Service led
the U.S. delegation, which included representatives from USDA's
Foreign Agricultural Service (FAS), the USDA's Animal Health and
Plant Inspection Service (APHIS), the USDA's Agricultural Research
Service (ARS), the Food and Drug Administration (FDA)'s Center for
Food Safety and Applied Nutrition (CFSAN) and Office of
International and Special Programs/Office of the Commissioner (OC),
and the Environmental Protection Agency (EPA) Office of Pesticides,
Biopesticides and Pollution Prevention Division (OPP/BPPD). Duan
Wude, Director General, Center for Science and Technology
Development, Ministry of Agriculture (MOA), led the Chinese
delegation, which included representatives from the Ministry of
Agriculture, the Chinese Academy of Agricultural Sciences (CAAS),
the China Agricultural University, the Chinese Academy of Inspection
and Quarantine Sciences, and the Ministry of Health's (MOH) Center

BEIJING 00003394 002.2 OF 003

for Disease Control (CDC).,

4. (SBU) In the lead up to the TWG, both U.S. and Chinese regulators
outlined three meeting objectives which included: 1) enhance the
scientific basis of safety regulation and mitigate risks, 2) improve
the understanding of the policies and practices of the relevant
regulatory agencies in the United States and China, and 3) identify
ways to communicate relevant information that can help regulators to
better address low level presence (LLP). Following the agreed
schedule, the meeting focused on: 1) technical support to safety
regulation in the wake of the rapid development of modern
biotechnology and the biotech industry, and 2) approaches used in
the United States and China where there is LLP of GE plants that
have not yet completed all of the relevant regulatory reviews.

5. (SBU) FDA, EPA, and APHIS representatives provided an update on
recently completed U.S. evaluations and products under review.
China responded with questions about how the regulatory agencies
evaluate and regulate products, the length of the review process,
and USG interaction with developers and the public. After further
U.S. explanation, China complimented the U.S. on its early
interaction with researchers and the transparency of its regulatory
system, including the information provided on its web site. China
noted its interest in receiving more specific information on VIP
proteins as used in insect resistant cotton and maize, particularly
EPA's Science Advisory Panel reports. EPA offered to supply this
additional information.

6. (SBU) Professor Wu Kongming, Chairman of the National Biosafety
Committee, from the Chinese Academy of Agricultural Sciences
provided a detailed presentation on the environmental monitoring of
Bt cotton after commercialization in China. China noted that Bt
cotton continues to control Cotton and Pink Bollworm, although
predators, and specifically mirids, have increased significantly as
chemical applications in Bt cotton fields have decreased. These
findings have implications for China's evaluation of other BT crops,
especially corn, since cross resistance concerns will need to be
addressed.

7. (SBU) EPA provided a summary of the requirements for
environmental monitoring for plant-incorporated protectants and food
safety evaluation for those products entering the food and feed
supply, including how the requirements have changed over time. The
use of refuges to address insect resistance was also raised.

8. (SBU) The United States invited China to ask questions about the
U.S. risk assessment process. China expressed interest in receiving
more detailed information on how risks are assessed for new products
with insect resistance traits, altered nutritional quality, and
drought tolerance. The United States suggested these could be
topics for future technical discussions. China also asked if there
were any new considerations on labeling in the United States. In
reply, FDA described the U.S. approach to the labeling of foods
produced through biotechnology. China responded by noting its own
labeling situation as complex, and opined whether traits that
improve crop quality, such as high oleic acid soybeans raise
questions about the principle of substantial equivalence.

9. (SBU) Considerable time was devoted to discussing low level
presence (LLP) policies in China and the United States, including
their application, interagency coordination, and communication to
the public. FDA provided an overview of the U.S. policy and its
application. U.S. regulatory officials discussed why, when, and how
regulatory violations would be determined under U.S. LLP policies as
well as when mitigation would be needed. FDA and EPA emphasized
the serious regulatory consequences if food has pesticidal
substances or residues that exceed allowable levels (tolerances) or
if an exemption from tolerance has not been established. Both sides
discussed some ideas about ways to avoid such occurrences, and there
was general agreement that this could be a useful area for further
discussion before the next TWG. Regulatory officials also presented
case studies on LL601 rice and Bt10 maize to illustrate how U.S.
regulatory agencies have responded to LLP incidents and lessons
learned. Questions were raised regarding the presence of LL601 rice

BEIJING 00003394 003 OF 003

on the U.S. market and why it was never commercialized, as well as
planting and export plans for LL62 rice.

10. (SBU) Professor Jia Shirong (Biotechnology Research Institute,
CAAS) presented a detailed case study on the development,
characteristics, and effectiveness of Chinese Bt63 rice. China
noted that low levels of Bt63 rice were found in Hubei Province in
2005. In response, the government of Hubei Province conducted
inspections of the rice producing counties in order to control the
original seed source and to prevent illegal seed production.
Illegal Bt63 rice seedlings were destroyed. Follow up action also
included sampling rice seed on the market, conducting Bt gene
testing before planting for ensuing years, and surveying,
inspecting, and testing breeding materials. When asked when China
would engage other regulatory authorities around the world on Bt63
rice, Chinese officials hesitated before stating that they already
had approached the EU and that both countries considered Bt63 rice
to be a safe product. During further discussion, they could not say
when Bt63 rice might be approved for commercialization in China and
when or if they would seek import approval from third country
regulators. This was the most detailed discussion that the Chinese
representatives have had with US officials on Bt-rice, and the U.S.
delegates were encouraged that this exchange might lead to
additional exchange of technical information that would be relevant
to regulatory reviews in each country.

11. (SBU) MOA presented China's developing policy on LLP. MOA
stated that China is: observing international discussions on LLP, as
well as conducting its own scientific research; continuing to work
with its trading partners on LLP, including the United States and
the EU; and trying to find a solution that fits its situation. MOA
reminded the U.S. delegation that China maintains a zero tolerance
for unapproved events because there is no legal provision in Chinese
law for LLP. That said, Chinese officials recognize that the United
States attaches great importance to this issue, as does industry,
and acknowledged that it would be very difficult to completely ban
products based on a zero tolerance. They said that China's goal is
to develop a science-based LLP policy that is feasible to implement
in a way that will control risks. The relationship between LLP and
China's compulsory labeling requirement indicated that changes to
China's labeling policy may be necessary. Noting China's lack of a
legal framework for LLP, Chinese officials repeatedly suggested that
they hope the USG can strengthen its management of research
institutions and trading companies so as to reduce the occurrence of
LLP.

NEXT STEPS
-----------------

12. (SBU) Director General Duan Wude expressed satisfaction with the
meeting and commented that the discussion was more diverse,
detailed, and comprehensive than in the past. He believes both
sides now have a better understanding of each other's position on
the issues. He expects the discussions at future TWG meetings will
become broader and deeper. For future TWG meetings, he would like
to discuss the product review process - such as the petition
process-at a more in-depth level.

13. (SBU) ADA Simmons expressed continued USG support for the TWG.
Simmons suggested that we find ways to more easily share information
of interest because we have so many common interests. She noted
that as global leaders on biotechnology, both countries should
strive to advance our common interests in international fora.

14. (SBU) Priority areas of follow-up could include the development
of guidance for Chinese developers on how to navigate the U.S.
regulatory system. Similarly, additional attention should be given
to reengaging the Chinese in the area of risk communication, and
building on previous work in this area.

GOLDBERG

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