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DE RUEHBJ #3394/01 3520855
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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