AUSTRALIA GROUP: U.S.-UK PROPOSAL FOR REVISION

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