Material Technical Advisory Committee
(MTAC)
Committee Title: MTAC meeting
Date: August 9, 2012
Time: 10:00 AM
Location: Herbert C. Hoover Building
Attendance:
Material TAC Members:
Tom May, Chairman - Boeing
Kimberly Orr, Designated Federal Officer – DoC/BIS
Gillian Woollett* – Avalere Health
Peter Witting – Harper International
Clara Zahradnik – DuPont
Judith Johnson* – Toho Tenax
Anthony Lubiniecki* - Centocour
David Manger – Toray Composites America
US Government:
Kevin Wolf - Assistant Secretary for Export Administration
Jody Lang – DoD/DTSA
Sean Harbottle – DTSA
Tracy O’Donnell - BIS
Elizabeth Sangine – BIS
Chris Park – DOS
Mike Rithmire - DOC
Public/Visitor:
Bill Root – Legal Consultant
Janelle Gamble – Boeing
Bruce Ruscio – Novartis
Aaron Guffery - NCITD
Annalyn Monson – Tyco International
Corey Norton – Keller and Heckman
Matt Beck – AT&T
Amy Chen – Argosy International
Dan Sherwin – Eastman
Mark Sagrans - DuPont
The meeting was opened at 10:00 AM
Commerce Address – Assistant Secretary for Export Administration - Kevin Wolf
The Assistant Secretary reported that many good comments have been received addressing the proposed rules for the definition of “specially designed” and the “Transition Rule”. Commerce is still digesting the comments and continues to strive for the proper balance between control text complexity and potential over-coverage. BIS is finding there was a broad range of interpretations of “specially designed” under the existing text – some interpretations were liberal enough that adopting criteria based on part or component “uniqueness” would still result in a control rollback.
Looking forward, BIS is working to identify key areas of concern to industry which have not yet been positively impacted by recent initiatives. Encryption controls is the area of greatest industry concern. There is a need to significantly clarify the encryption controls as they are currently the source for considerable confusion. Another area of interest is in deemed exports. Reforms in the deemed export area could be quite challenging as some factions are taking strongly opposing positions. It is believed resolution of the deemed export regulations would consume considerable time and human effort.
Category XI of the USML has been completed and is in the USG approval cycle. AS Wolf was not sure when the PR for XI would be posted.
Other key priorities for Commerce include:
- Simplification
- Intra Company Transfer
- Rationalized conditions for licensing
- Requirement for markings on NLR items
- Restructure of the country list
- Definition of “Art”
- Updating the LVS thresholds
- AVS cleanup
- Expansion of LVS to CIV items
BWC Activities – Mr. Christopher Park, DOS Office of Biological Policy
Mr. Park opened with a brief history of the Biological Weapons Convention as follows:
- The BWC entered into force in 1975
- The convention prohibits the development of biological weapons
- The original focus of the convention was on state-sponsored development of WMDs
- The focus is now moving to address smaller scale production
- Discussions addressing verification protocol stalled in 1990’s
Mr. Park reported on the most recent Review Conference. The US objective for the conference was to address development of weapons by “non-state actors”. The conference focus was in the following areas:
- Strengthening of national implementation
- Approaches to increase transparency
- Confidence Building Measures
- Voluntary actions
- Scientific Advancements
- Synthetic toxins
- Gene synthesis / order screening
- Governance / conduct / awareness
- Preparedness / Response
- Prevention and detection
- Surge capacity for vaccine production
- Legal issues associated with outbreak response (FDA approval)
Budget constraints are limiting discussion time and are impacting progress of the group. There has been some talk of moving discussion off-line to enable continued progress on the issues. Mr. Park reported the State Department and the Implementation Support Unit of the BWC will continue to reach out to industry to obtain their perspectives on the issues faced by the Convention. Invitations have been made to industry associations and entities outside of those represented on the MTAC have been engaged. It was further reported, with respect to ISU activities within the US, that the US Department of State is not always involved by the ISU when entities within the US are engaged.
It was reported the Schedule 1 listing of the CWC includes some bio-toxins and may overlap other control regimes. The overlap was considered to be preferred to possible gaps. However, jurisdictional confusion is the result and folks are questioning if a single listing should be established to simplify compliance.
The US volunteered to host a visit to Ft. Detrick and the visitors consisted mostly of ambassadors from States Parties. The visitors received a briefing on US biodefense programs and a facility tour. The objective was to “demystify” US activities, particularly at Ft. Detrick, and the visit was perceived to be a success.
There is a conference on health and security coming up in the fall. The conference will address public health system capability and capacity to react to military threats. The panel should include Commerce - Beth Scott-Sangine will follow-up.
Several members of the MTAC expressed concern regarding the content of a recent ISU presentation. The MTAC members believed the pitch cast a negative light on biological research. Further, the MTAC members believed the ISU may be overstepping its bounds by directly engaging US industry. MTAC members were concerned US industry should be engaged through the DOS as opposed to interacting directly with the ISU.
Mr. Park indicated he agreed the State Department should be aware of the ISU/ US industry interactions and agreed to convey that to the ISU. However, he did not see major issues associated with direct ISU engagement of US industry to augment inputs received from the MTAC. It was pointed out the MTAC has no formal charter with respect to the BWC but that the MTAC is the only existing formal advisory body. Dr. Park agreed to meet with members of the TAC off-line to further discuss the ramifications.
A further question was posed by the audience regarding the definition of a biological weapon. Mr. Park reported there were ongoing efforts to establish the definition and pathogenicity, transmissibility, and environmental stability are candidate parameters to be used in the definition. Category XIV of the USML is currently under rewrite and the audience was encouraged to review and comment on the proposed rule.
Sub Team Reports:
BWC Working Group: – Dr. Gillian Woollett
Dr. Woollett reiterated the BWC Working Group position that the Department of Commerce and the MTAC should be the interface between the DOS and industry for BWC issues.
Chem. Processing Equipment Working Group – Mr. Eric McClafferty
Nothing new for open session
Activities of the Composite Working Group – Mr. Tom May
Several technical initiatives continue to be active:
- A proposal to amend 1C210 (2.C.7-NSG) to align it with the logic and limits of 1C010. The 1C210 proposal no longer contains language to change the carbon fiber limits and is now only addressing relief for glass fiber and the possible addition of a Tg threshold.
- A proposed summary of classifications to address export of scrap or recycled materials and parts. A table of classifications has been developed for materials and scrap parts throughout the material life cycle. A brief discussion was held regarding how the information might be used and we concluded an Advisory Opinion may be a viable approach.
- A review of controls on composite parts exerted by 9E003
- Sub team reviews of:
- Composite equipment controlled by 1B001 / 101
Status Of Control Regime Activities:
Wassenaar Arrangement: Mr. Mike Rithmire
Several clarifications are moving ahead in the WA deliberations. Inclusion of powered air devices in 1A004 has now been posted. Further clarification is being made to help differentiate between soft and hard body armor.
In the intersessional meeting this summer, there was talk of modernizing the 1C001 listing addressing radar absorbing materials. Materials potentially picked up by the current listing are increasingly used in consumer electronics and other applications. Tom offered the assistance of the CWG as some of these materials are of interest to CWG members.
Mr. Rithmire indicated he was working on a proposal to establish better definitions of composite “tow” and “tape” material forms and is looking at the ramifications to coverage of equipment items described under 1B001 and 1B101.
Representatives from DuPont also expressed issues contained in the USML fragmentation note contained in the proposed rule for CAT XIII. Mark Sagrans from DuPont will contact Mr. Rithmire for further discussion off-line.
Biological Weapons Convention:
Nothing in addition to Mr. Park’s discussion.
MTCR:
No report for open session
Australia Group: Dr. Kimberly Orr
Dr Orr reported on changes from the 2011 plenary which included the 1) dropping of Bartonella
Quintana and Rickettsia Riicketsii, 2) revisions to clarify the technical notes 1 and 4 of ECCN 1C353, 3) a new technical note to 2B350 clarifying items performing sealing functions do not impact the control status of the end item unless the seals are interchangeable, and 4) addition of converted values for lower limits to the control parameters of 2B350.i, and 5) add condenser control parameters of liters / 24hours for steam sterilizable dryers addressed in 2B352.e.
The 2012 AG plenary was in June and the following changes were agreed:
- Only race 3 biovar 2 of Ralstonia Solanacearum is controlled
- The following plant fungi were added:
- Tilletia indica
- Thecophora Solani (potato smut)
- The following human and animal pathogens were added:
- Clostridium argentinese (formerly known as CI bot Type G)
- Clostridium baratii, bont producing strains
- Clostridium butyricum – bont producing strains
- Clostridium perringens – epsilon toxin producing types
- The E.Coli control was delineated to include Shinga toxin producing E.Coli(STEC) of serogroups 026, 045, 0103, 0104, 0111, 0121, 0145, 0157, and other shinga toxin producing serogroups
- There was a decrease in the staphylcoccus aureus toxins controlled – limited to only enterotoxins, hemolysin alpha toxin, and toxic shock syndrome toxin (formerly staph enterotoxin F)
- Spray dryers meeting the following thresholds were added:
- Water evaporation capacity greater than .4kg/hour and less that 400 kg/hr
- Ability to generate mean product particle size of less than 10 micrometers or easily adapted to do so
- Capable of being sterilized or disinfected in-situ
Public Comments:
Mr. Bill Root suggested tools and dies listed under the proposed XIII (k) should be looked at as a potential candidate for movement to the CCL under the 600 series.
Next Meeting:
Future MTAC meetings are currently scheduled as follows:
2012:
November 14
2013:
February 7
May 9
August 8
November 14
