Material Technical Advisory Committee
(MTAC)
Committee Title: MTAC meeting
Date: November 14, 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
David Manger – Toray Composites America
Bruce Ruscio – Novartis
Scott Hubinger – BIS
Ken Foot – Dow Corning
US Government:
Kevin Wolf - Assistant Secretary for Export Administration
Jody Lang – DoD/DTSA
Tracy O’Donnell - BIS
Mike Rithmire – DOC
Rizwan Ramakdawala – DoD
Kennedy Willson – DoS
Matt Borman – BIS
Joe Giunta – BIS
Betty Lee – BIS
Wesley Johnson - BIS
Public/Visitor:
Bill Root – Legal Consultant
Greg Hermetet – ATMI
Matt Beck – ATMI
Nina Hon – Harper International
Janelle Gamble – Boeing
Cecil Hunt – Wiltshire and Grannis
Charles McCourt – Dow Chemical
Mark Brown – Northrop Grumman
Corey Norton – Keller and Heckman
The meeting was opened at 10:00 AM
Commerce Address – Assistant Secretary for Export Administration - Kevin Wolf
The Assistant Secretary reported there are 22 regulations currently within OMB. The next proposed rules to be published will cover electronics (category XI in the USML and corresponding CCL changes). BIS is currently drafting “The Beast” which combines a number of previous PRs including “specially designed” into a single rule. BIS has received many comments from industry addressing the definition for “specially designed” and has generated 114 different versions of the definition in efforts to optimize the language.
The STA exception is now being used more and there have been 300 instances of usage already. The real benefit of the STA exception will accrue when used for the upcoming 600 series items.
AS Wolf brought a team to present questions regarding a developing Wassenaar Arrangement proposal. This change is intended to provide guidance for discriminating between tow placement/fiber placement machines and automated tape laying machines.
It was proposed to use a material width parameter to differentiate between the two machine types. The draft threshold was written such that any machine that could process materials 1” in width or less was defined as a tow / fiber placement machine. Machines capable of laying materials between 1 and 12 inches in width were to be considered to be tape laying machines. In the ensuing discussion, it was suggested that filament winding machines are also machines capable of processing materials thinner than 1 inch and applying the proposed criteria as the sole criteria for identifying a tow placement machine would inadvertently pick up filament winders as a subset of tow placement machines. In order to isolate the fiber placement capability, it was suggested that an additional criteria addressing “cut/restart” be added to the description of tow placement machines. Filament winding machines do not have cut/restart capability. Also discussed was the possibility of eliminating the upper limit of the definition of tape laying machines in order to pick up possible future applications.
ATMI Presentation : Greg Hermetet, Matt Beck
ATMI made a presentation of their life sciences activities including description of their manufacturing facilities for single-use bioreactors. The bulk of mfg. operations are in Belgium.
ATMI provided information on the advantages of single use bioreactors including the fact they are easier to set up and operate. Bioreactors, especially large ones, are complex and expensive. Single use bioreactors are much easier to use as there are no requirements for complex and highly reliable sterilization systems. ATMI provided a description of different types of single-use bioreactors which included their PadReactor, iCELLis, and Xpansion products.
The process controller is the most critical component of the bioreactor system and it can control the mixing, ph, oxygen, temperature, pumps, and data capture. Off-the-shelf controllers are available. It is possible to sterilize single use reactors but chemical sterilization methods cannot be used – Gamma radiation sterilization is the only feasible approach for the single use vessels.
ATMI believes our existing licensing approaches are working and are not currently seeing a market loss due to licensing although EU regulations are different than those in the US.
Non-Proliferation Regimes: Doug Brown
Chemical Weapons Convention:
The meeting of National Authorities will take place over Thanksgiving holiday and Tracy O’Donnell will represent BIS.
A 3rd CWC inspection is approaching this year bringing to total to near 200 since inception. The third inspection site will be within the US.
The US annual declaration is being prepared and there will be 1-schedule 1, 19-schedule 2, and 45-schedule 3 facilities reporting. With respect to the notice of inquiry regarding access to schedule 1 chemicals(including intermediate production), there were some cases reported within the US including some mustards.
A topic being addressed this year is how to handle inspections for plants that have mixed production of both schedule 2 and schedule 3 chemicals. Such a situation may make the site subject to multiple inspections and may be posing an unnecessary burden on the sites that have production from two different schedules.
Also under discussion within the CWC is question of concentration thresholds. The US has threshold concentration levels set considerably higher than the CWC and Industry would like the thresholds set higher still.
Biological Weapons Conference:
There will be a meeting of States Parties for the BWC in mid-December. The Confidence Building Measures are on the agenda and are under review. Currently about 20 percent of the parties participate in the CBMs. For the US submittal, FDA data on vaccine production sites will be used and companies will be contacted before any information is submitted. The Department of Commerce will be collecting comments from companies regarding the contents of the report but may not have complete control over what is submitted.
Transparency measures continue to be proposed for US facilities but BIS leadership has been opposing this.
Additional Protocols NSG
BIS will host site access visits at some US sites.
Public Comments:
None
Next Meeting:
Future MTAC meetings are currently scheduled as follows:
2013:
February 7
May 9
August 8
November 14
