VZCZCXYZ0028
OO RUEHWEB

DE RUEHRL #0227/01 0551643
ZNR UUUUU ZZH
O 241643Z FEB 09
FM AMEMBASSY BERLIN
TO RUEHC/SECSTATE WASHDC IMMEDIATE 3390
INFO RUEHLO/AMEMBASSY LONDON PRIORITY 9607
RUEHFR/AMEMBASSY PARIS PRIORITY 0179
RUEHTC/AMEMBASSY THE HAGUE PRIORITY 1181
RUEHGV/USMISSION GENEVA PRIORITY 1440
RUCNDT/USMISSION USUN NEW YORK PRIORITY 0684

UNCLAS BERLIN 000227 
 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: PARM PREL GM BWC
SUBJECT: UNITED STATES AND GERMANY IN GENERAL AGREEMENT ON 
OVERSIGHT OF THE DNA SYNTHESIS INDUSTRY 
 
REF: A. 08STATE 127980 
     ¶B. STATE 4627 
 
¶1. Summary: The German government is approaching oversight of 
the DNA synthesis industry by relying on the Industry 
Association for Synthetic Biology (IASB) to develop and 
promote voluntary self-regulation.  The proposed IASB 
oversight mechanisms are very much in line with the USG 
policy framework on this issue.  While Germany has not 
specifically regulated the DNA synthesis industry, existing 
German genetic engineering regulations effectively require 
many of the screening and record keeping components of the 
proposed USG framework and IASB recommendations.  Germany 
also has regulations that provide additional oversight 
mechanisms not present in the United States, especially in 
the area of personnel reliability.  The U.S., Germany, and 
IASB also have similar views on the scientific and software 
challenges that need to be resolved for effective technical 
screening.  Law enforcement in Germany, however, is largely 
implemented by the Laender (states), providing challenges for 
international law enforcement cooperation. 
 
¶2. The United States and Germany agreed to meet again in 
person in three or four months, and possibly earlier via 
teleconference.  Future meetings will be to share future USG 
developments on technical and customer screening, record 
keeping, and communication between law enforcement and DNA 
synthesis providers.  The United States and Germany agreed to 
work together to promote a screening framework in the 
international community, utilizing various multilateral fora, 
as a screening will only be effective if harmonized 
internationally. End Summary. 
 
¶3. Based on recommendations from the National Science 
Advisory Board for Biosecurity (NSABB), the USG is currently 
developing a framework for screening of commercial orders for 
gene synthesis.  The United States and Germany are the two 
most active countries in this new and fast growing field of 
DNA synthesis, but many other countries are involved.  As the 
USG begins to work out the parameters of these guidelines, it 
seeks to coordinate efforts with other important players to 
ensure consistent international practices. 
 
¶4. The USG requested a meeting with the German government 
(Ref. A) to bring together representatives of the relevant 
federal agencies in both countries to share current policy 
views and practices in this area.  The proposed agenda is 
contained in Ref. B. 
 
¶5. The first round of discussion took place on Feb. 23, 2009, 
in Berlin.  Six USG representatives from the Departments of 
State (ISN/CB), Commerce (BIS), Homeland Security (S&T), 
Health and Human Services (ASPR), and Justice (FBI) attended. 
 German attendees included representatives from counterpart 
agencies in the German government as well as the Ministry of 
Education and Research, and representatives of the Industry 
Association for Synthetic Biology (IASB; soon to be renamed 
the International Association for Synthetic Biology), the 
major industry consortium of DNA synthesis providers. 
 
¶6. The USG representatives provided presentations on an 
overview of USG activities with respect to dual-use life 
science research, a summary of the USG policy framework for 
addressing government oversight of DNA synthesis orders, and 
a review of the dialogue between the FBI and major DNA 
synthesis providers.  German representatives presented 
existing German and EU laws and regulations that provide 
mechanisms that effectively provide oversight of dual-use 
biological research.  IASB representatives presented an 
industry perspective on DNA screening of synthesis providers. 
Discussion focused on understanding the legal and regulatory 
frameworks in each country and identifying commonalities in 
approaches and issues for future collaboration. 
 
¶7. Risk and Technological Change: The Germans do not see a 
high-level or near-term risk, but agree that DNA synthesis 
requires oversight.  In response to the suggestion by one 
industry representative that consideration be given to 
registering high throughput DNA synthesizers, there was some 
inconclusive discussion about whether or not monitoring 
synthesizers was useful.  Both sides agreed that regulatory 
frameworks need to be adaptive in light of the rapid rate of 
increase in DNA synthesis capability by both gene foundries 
and desktop synthesizers. 
 
¶8. Extant German Legal Frameworks: Germany has several 
regulatory mechanisms that implicitly provide oversight of 
the DNA synthesis industry.  The relevant regulations include 
genetic engineering regulations, codes of conduct affecting 
grant proposal preparation and review, personnel reliability 
practices for working in BSL-3/4 laboratories, and licensing 
of life scientists working with specific pathogens.  Current 
German research funding practices, however, do not allow 
funding to be tied to a requirement to buy only from 
companies that screen orders. 
 
¶9. Law Enforcement: Germany is very interested in U.S. 
efforts to provide guidance to industry on reporting 
suspicious orders and would like followup information as 
policies evolve.  Personnel reliability is enforced through 
multiple mechanisms: life scientists are licensed for working 
with specific pathogens and BSL-3/4 workers require security 
clearances.  Items checked include criminal history, 
financial history, mental health status, and personal 
interviews.  Germany has challenges in providing a single 
point of contact for suspicious orders because of the 
dominant role of the Laender in law enforcement.  Germany 
does not appear to have considered how to handle company 
concerns regarding suspicious orders.  Also, there currently 
does not appear to be a mechanism to allow the United States 
to alert Germany about suspicious orders. 
 
¶10. Technical Challenges to Be Resolved: The German 
government, German industry representatives, and the USG have 
common views on the technical challenges for implementing a 
screening framework, particularly on an international basis. 
These issues include database content and annotation of 
sequences for both pathogenicity and housekeeping, access 
control for both modifying and using content, and whether or 
not a database should be centralized or distributed. 
Responsible parties for maintenance and curation need  to be 
designated. 
 
¶11. Strategy for International Engagement: The United States 
and Germany agree that broad international adoption requires 
early engagement of key developing countries in addition to 
key developed countries.  Promoting global adoption of 
screening will also require engaging multiple multilateral 
fora including OECD, WHO, BWC, Australia Group, and other 
nonproliferation venues.  The IASB can also play a pivotal 
role in reaching out to gene foundries in developing 
countries.  It is critical that the developing countries not 
perceive this effort as being pushed on them by the developed 
countries, but buy into it as industry "best-practice." 
 
¶12. Future Discussions: German government and industry 
representatives readily agreed to the US suggestion to hold 
another face-to-face meeting once US studies of technical 
aspects of order screenings were better-developed.  US also 
suggested that a video conference in April might be useful. 
US and German representatives agreed to jointly brief other 
close allies at a planned meeting in Paris on March 4, 2009. 
 
¶13. Comment: IASB representatives were much more engaged in 
the discussions than those from the German government (apart 
from Foreign Ministry technical expert Volker Beck). 
Clearly, the German government is generally content to let 
industry take the lead.  While Germany will be supportive, 
they are not inclined to be particularly energetic in seeking 
adoption by other governments.  The industry association, on 
the other hand, may be a very active partner.  In future 
bilateral discussions, participation of German industry 
should be continued.  End Comment. 
 
¶14. Members of the U.S. delegation have cleared on this cable. 
Koenig