VZCZCXYZ0001
PP RUEHWEB

DE RUEHC #2895 0911752
ZNR UUUUU ZZH
P 311746Z MAR 08
FM SECSTATE WASHDC
TO AUSTRALIA GROUP COLLECTIVE PRIORITY
RUEHKV/AMEMBASSY KYIV PRIORITY 0000
RUEHVB/AMEMBASSY ZAGREB PRIORITY 0000
INFO RUEAIIA/CIA WASHINGTON DC PRIORITY 0000
RUEKJCS/SECDEF WASHINGTON DC
RHMFISS/JOINT STAFF WASHINGTON DC
RUCPDOC/USDOC WASHINGTON DC 0000
RHMCSUU/DEPT OF ENERGY WASHINGTON DC

UNCLAS STATE 032895 
 
SIPDIS 
 
SENSITIVE 
SIPDIS 
 
E.O. 12958: N/A 
TAGS: PARM ETTC CBW SIPDIS
SUBJECT: AUSTRALIA GROUP: U.S.-UK PROPOSAL FOR REVISION 
TO THE DUAL-USE BIOLOGICAL EQUIPMENT CONTROL LIST 
 
¶1.  (U) This is an action request.  Please see paragraph 
¶3. 
 
¶2.  (SBU) Background: The Australia Group (AG) will hold 
its 2008 plenary session in Paris on April 14-18, 2008. 
The USG plans to make several presentations and policy 
proposals at the plenary, including a revision to the 
current control for cross (tangential) flow filtration 
(CFF) equipment.  The current control only governs CFF 
equipment that can be sterilized or disinfected in 
place.  This limitation is becoming problematic because 
a number of industries, including the biotechnology and 
pharmaceutical industries, increasingly prefer CFF 
systems with disposable components over sterilization- 
capable systems because they offer better performance at 
a lower cost.  This proposal, developed in cooperation 
with the UK, is intended to address the issue of 
disposable CFF equipment by shifting the control's key 
characteristics from sterilization capability to the 
requirement for external propagation of aerosols. 
 
¶3.  (U) Action Request:  Drawing on the background 
above, request all AG country posts provide the non- 
paper in paragraph 5 to the appropriate host government 
officials and report a response. In delivering this non- 
paper, posts should indicate that the U.S. is sharing 
this paper as part of our preparation for the April 14- 
18 AG plenary.  Also request Embassy Canberra provide 
the non-paper to the AG chair for circulation as an 
official AG document.  Please begin all responses with 
Australia Group and slug for ISN. 
 
¶4.  (SBU) Begin text of non-paper: 
 
 
AG-In-Confidence 
 
AUSTRALIA GROUP 
 
Australia Group Doc 
AG/Apr08/CL/USA/UK/xx 
 
Control List of Dual-Use Biological Equipment and 
Related Technology: Updating and Clarifying the Control 
of Cross (Tangential) Flow Filtration Equipment 
 
Issue 
 
The current test involving the control of cross 
(tangential) flow filtration (CFF) equipment leaves room 
for broad interpretation resulting in unclear export 
control of CFF equipment and components.  We propose a 
review of the control because of this uncertainty in 
interpretation, new development in the application of 
CFF equipment, and the growing use of disposable systems 
and components. 
 
Background 
 
CFF equipment and components are controlled by the 
Australia Group (AG) because of its potential use in 
biological weapons programs.  The AG currently controls 
CFF equipment capable of in-situ sterilization and 
disinfection.  It also controls components that: 1) have 
a filtration area equal to or greater than 0.2 square 
meters for each component and 2) are designed for use 
with CFF equipment. 
 
Unfortunately, the terms 'sterilization,' 
'disinfection,' and 'sanitization' have created more 
confusion than originally anticipated.  Some 
manufacturers classify their items as controlled while 
other manufacturers with comparable products do not 
classify their items as controlled.  This difference in 
interpretation results in inconsistent export control 
licensing of items within this entry among AG members. 
 
CFF is useful in a wide variety of applications, 
including the filtration of drinking water and beer, 
fruit juice processing, diesel oil separation and 
production of biological products.  Such biological 
products would include highly beneficial products such 
as medicines, as well as dangerous pathogens and toxins. 
 
The biotechnology, pharmaceutical and other industries 
are increasingly using single-use, disposable units in 
place of traditional equipment and components that 
require cleaning, disinfection or sterilization before 
re-use.  Disposables offer many advantages, including 
increased speed, reduced cleaning requirements, greater 
batch-to-batch consistency, higher yields, decreased 
risk of cross-contamination, and enhanced sterility and 
quality assurance.  During the Implementation Meeting of 
the 2007 Australia Group Plenary, the UK raised the 
increased availability and use of disposable 
bioreactors, and delegations re-affirmed that those 
having a capacity of 20 liters of greater and operation 
without the propagation of aerosols were controlled 
items. 
 
It is not clear that disposable or single-use CFF 
components are controlled under the existing wording, 
which stipulates the necessity for controlled equipment 
and components to be 'capable of being sterilized or 
disinfected in-situ.' 
 
Discussion 
 
The Technical Note appearing in the Control List of 
Dual-Use Biological Equipment and Related Technology 
defines 'sterilized' as the elimination of ALL viable 
microbes from the equipment through the use of either 
physical (e.g. steam) or chemical agents.  'Disinfected' 
means the destruction of potential microbial infectivity 
in the equipment through the use of chemical agents with 
germicidal effect.  The above terminology gives rise to 
variable interpretations among different companies. 
Some companies claim their products cannot withstand the 
hard treatment of chemicals or autoclaving without 
affecting the integrity of their products.  Other 
companies refrain from claiming that ALL viable microbes 
(including Gram positive microbes or spores) are 
eliminated with chemical agents. 
 
There has also been some confusion regarding the term 
'without propagation of aerosols.'  Based on discussions 
with other countries, some companies claim there is 
propagation of aerosols within the filtration system 
(i.e., internally).  They claim the internal propagation 
means the system does not meet the ?without propagation 
of aerosols? threshold, thereby rending the system 
uncontrolled.  Amending the control to read ?without the 
external propagation of aerosols? will more clearly 
describe the intent of the control, which has always 
been to capture those systems that can harvest 
pathogenic materials, including those with internal 
propagation. 
 
Recent innovations for CFF cassettes and modules as 
disposable, single-use entities would make these items 
not eligible for control as they are not designed to be 
'sterilized' or 'disinfected.' They would not meet the 
current criteria of the current CFF equipment control. 
 
The most advanced water filtration systems use CFF 
technology to purify water and remove illness causing 
organisms.  The N.B. to the control specifies that 
reverse osmosis (RO) equipment is not controlled. 
Recognizing the difference between RO equipment 
(including components) and CFF (including nano-, ultra-, 
and micro-filtration CFF and components), we propose 
that the exemption for RO equipment be retained and 
expanded to include components.  Thus an additional 
clarification to the N.B. is proposed to ensure these 
systems, as well as other beverage and fuel filtration 
systems are not inadvertently captured. 
 
The CFF equipment control is intended to control CFF 
systems designed for biological harvesting and 
pharmaceutical processing.  These systems are capable of 
separation of pathogenic micro-organisms without the 
propagation of aerosols as the key discriminating 
criteria.  This is also noted that filtration components 
listed in the control must be designed for use in such a 
system in order to be controlled. 
 
We suggest modifying the CFF equipment control as 
follows: 
 
¶1.  Remove 'capable of being sterilized or disinfected 
in-situ.'  This removal will eliminate the varied 
interpretations and will capture disposable systems and 
components. 
 
¶2.  Amend the phrase ?without propagation of aerosols? 
to 'without the external propagation of aerosols' In the 
first paragraph of the control. 
 
¶3.  Modify the N.B. to read as follows: 'N.B.: This 
control excludes reverse osmosis equipment and 
components as specified by the manufacturer, and water, 
oil or beverage purification systems that are unsuitable 
due to their design for the separation of pathogens and 
toxins.' 
 
¶4.  Remove the Technical Note at the end of the control 
that addresses 'sterilization' and 'disinfection.' 
 
Proposal 
 
Cross (tangential) Flow Filtration Equipment 
 
Cross (tangential) flow filtration equipment capable of 
separation of pathogenic micro-organisms, viruses, 
toxins, or cell cultures, without external propagation 
of aerosols, having a total filtration area equipment to 
or greater than 1 square meter (1 m2). 
 
N.B.:  This control excludes reverse osmosis equipment 
and components as specified by the manufacturer and 
water, oil, or beverage purification systems that are 
unsuitable due to their design for the separation of 
pathogens and toxins. 
 
Cross (tangential) flow filtration components (e.g., 
modules, elements, cassettes, cartridges, unites or 
plates) with filtration area equal to or greater than 
0.2 square meters (0.2 m2) for each component and 
designed for use in cross (tangential) flow filtration 
equipment as specified above. 
 
N.B.:  This control includes both multiple-use and 
disposable, or single-use, filtration components, and 
their holders. 
 
End text of the non-paper 
 
¶5.  (U) Please contact ISN/CB Andrew Souza at 202-647- 
4838 or via unclassified e-mail at souzaam@state.gov for 
additional information or clarifications. 
 
¶6.  (U) Post?s assistance is appreciated. 
RICE