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Materials Technical Advisory Committee

March 2, 2006

The MTAC meeting was held on 2 March 2006 in the Department of Commerce (DoC) building, room 3884. The meeting was called to order at 10:30 AM by Dr. Steve Goldman in place of Mr. Jeffery Tripp. Due to illness Mr. Tripp has stepped down as the DoC Designated Federal Officer for the TAC. The meeting consisted of an open session only with non-MTAC/public visitors in attendance. The meeting agenda consisted of three topics: Introduction of the newly appointed Designated Federal Officer, Review of the actions and accomplishments of the MTAC over the last 5 years, and Discussion of the legal requirements for the operation of a MTAC working group.

Attendance:

Material TAC Members:

Dr. James Estep, Chairman

Mr. Anthony Lubiniecki

Mr. Tom May

Mr. Tim Dunn - DSTA

Dr. Kimberly Orr, Designated Federal Officer – DoC

Dr. Doug Brown – Director, CBC, DoC

Mr. Steven Goldman – DoC

Ms. Yvette Springer, Govt. Liaison - DoC

Visitors:

C. Randall Pratt, Senior Counsel, CoC/BIS

Mike Rithmire, BIS/NPTC, DoC

Alex Lopes – Dir, DEED, Doc/BIS/NSTTC

Gordie Boezer, Deputy Director ITAC, IDA

Kenneth W. Hutton – Hyperion Catalysis Int’l, Inc

William A. Root – Export Control Consultant

Delores Ruilova - United Technologies Corporation

The meeting was opened at 10:30 AM with an introduction by Mr. Steve Goldman. Due to illness Mr. Jeff Tripp has been replace by Kimberly Orr, D.V.M., Ph.D. as the Designed Federal Officer (DFO) for the MTAC. Dr. Orr introduced herself and gave her history with the Department of Commerce (DoC). She is a senior advisor for biological issues in the DoC who bring a wealth of experience to the program. Following this introduction, it was announced that Dr. Douglas Brown is the new Director of the Chemical and Biological Control Division of IBS/DoC.

Following this introduction of the new DFO and relevant changes in the IBS/DoC, Dr. Estep asked for introduction from the MTAC membership and visiting public. This meeting consisted of only an open meeting and all present remained for the duration of the meeting.

The first action was a review of the accomplishments since 11 September 2001 of the Chemical and Biological Controls Division’s Australia Group given by Dr. Brown. Many of the actions had technical input from the MTAC when developing the U.S. position . There have been major accomplishments in the control of chemical and biological materials over the past five years. Dr. Brown provided a summary of his presentation which is appended to the end of this report.

One question was raised by Mr. Bill Root on the intangible technology issues. This was discussed by Mr. Goldman and Dr. Brown. One point of the discussion is that technology control is not limited to hardcopy, equipment, or software sharing. This brought the discussion to “deemed” export within a country’s border. It was stated that in general deemed export is not interpreted the same in other countries compared to the U.S. Examples of intangible technology transfer would be visual inspection of verbal discussion of equipment or technology. The technology could be deemed exported if not in the public domain.

Another question was raised by Mr. Tom May on any effort to reduce license requirements, such as taking certain countries as exclusions. This discussion was general in nature but overall the burden on industry and on IBS is incorporated where possible. Data was presented on expected change in the number of licensing requirements due to regulation changes and it appears not excessively burdensome in chemical and biological area.

The next topic was a legal review on the question of the ability of the MTAC to create a formal subcommittee, such as the initiative to establish a Composite Working Group. The legal opinion was provided by Ms. C. Randall (Randy) Pratt, Senior Counsel, BIS/DoC. Her comments:

1) MTAC is a Federal Advisory Committee under that ACT

2) Having non-members represent the TAC is inconsistent with the ACT

3) Alternatives would be to have 1) the TAC solicit input from industry members who are subject matter experts (SMEs) and channel through TAC members, 2) hold open meeting with the public present and drawing SMEs that may attend and to provide for information that can be used by the TAC, and 3) design a subcommittee to support the TAC in its function but does not act outside the TAC oversight.

Another approach that was discussed was to have composite subcommittees drawn from members of different TAC, as there is expertise within the DoC and other TACs that could be used to increase the discussion on technical issues. This “joint committee” approach was recommended to be explored by Mike Rithmere (BIS/NPTC), Tom May (MTAC) and Gordie Boezer (TIAC/IDA). This will be explored before the next meeting.

Following the discussion on subcommittees, the Chairman asked for a motion to table the current pending action on the “Composite Working Group Initiative” that had been brought forward by Tom May during the December 2005 MTAC meeting. This motion was made and seconded. Following discussion the motion was approved. This initiative will be revisited when the option of a joint TAC working group has matured.

The final action was to identify the date for the next meeting. It was decided to hold the next meeting after the Australia Group meeting in mid-June. The Chair recommeded 29 June and the membership voted in favor of this date.

The meeting was adjourned.

Chemical and Biological Controls Division’s Australia Group Accomplishments

Since September 11, 2001, the Chemical and Biological Controls (CBC) Division has worked with our interagency colleagues to draft, negotiate, and obtain international consensus for the following Australia Group changes. These changes were implemented in the EAR in the cited Federal Register notices.

Major Regime and/or U.S. Regulatory Changes with Significant Impact

At the June 2002 Australia Group (AG) Plenary, the AG agreed to adopt formal guidelines for the licensing of sensitive chemical and biological commodities. The guidelines are public, consistent with the AG’s strong commitment to transparency, and all countries are encouraged, via outreach, to adhere to them in the interest of international peace and security. See Federal Register notice dated June 10, 2003 for additional details regarding changes to the Export Administration Regulations as a result of this agreement.
In addition, at the June 2002 meeting, AG participants also agreed to formally adopt ‘Catch-All’ provisions for the licensing of non-listed items. This was the first time that an export control regime agreed to include a ‘Catch-All’ licensing requirement in its public documents, reflecting the resolve of participating national governments to use all available means at their disposal to fight the spread of chemical and biological weapons. See Federal Register notice dated March 30, 2005 for additional details regarding changes to the Export Administration Regulations as a result of this agreement.
Also, at the June 2002 meeting, AG participating countries agreed to expand the license requirement for the export of AG-listed biological agents to apply to all destinations worldwide, with an exception for intra-European Union (EU) trade. See Federal Register notice dated June 10, 2003. Note: Since the EAR already included a worldwide licensing requirement for these biological agents, the rule made no changes in the existing EAR licensing provisions for these agents. See also Federal Register notice dated May 31, 2002 for the expansion of U.S. licensing requirements on the export of human pathogens and toxins, animal and plant pathogens, and genetically modified organisms to Canada.
Finally, on April 14 th, 2005, the Department of Commerce published a Federal Register notice expanding the licensing requirement for Chemical and Biological (CB) Equipment to include all non-Australia Group (AG) countries. The new controls are intended to bring the United States into compliance with the adopted AG licensing guidelines. As of September 7 th, 2005, Commerce has approved 189 licenses for the export of CB equipment to countries for which a license was not required prior to the publication of this rule. CBC estimates that this rule will result in approximately 500 additional license applications per year.

Specific Entry Changes
The following Australia Group agreements adopting control list changes provide a substantial increase in security against countries of concern and terrorists seeking to acquire chemical and biological weapons of mass destruction.
At the October 2001 AG Plenary and in subsequent intersessional discussions, AG participating governments agreed to:

Tighten controls on chemical equipment (valves) useful for the production of chemical agents. See Federal Register notices dated May 31 st, 2002 and August 2, 2002.

Expand controls on critical components which can be used to convert non-controlled chemical equipment into controlled equipment. See Federal Register notice dated May 31 st, 2002.
Broaden licensing requirements for biological protective equipment (suits) by expanding controls to hoods, as well as full and half suits, that are dependent on a tethered external air supply and operated under positive pressure. See Federal Register notice dated May 31, 2002.
Tighten licensing requirements for biological equipment (freeze dryers) by changing the control threshold from 50 kilograms of ice per 24 hours to 10 kilograms of ice per 24 hours. See Federal Register notice May 31, 2002.
At the June 2002 Plenary and in subsequent intersessional discussions, AG participating governments agreed to:

Tighten controls on small biological fermenters useful for the production of biological agents by terrorists by lowering the control threshold from 100 liters to 20 liters. See Federal Register notice dated June 10, 2003.

Add new controls on technology of the development or production of biological agents and dual-use biological equipment and on the transfer of controlled technology by intangible means. Note: Since U.S. controls in these two areas were already present in the EAR, no changes were made to the EAR as a result of these two agreements. See Federal Register notice dated June 10, 2003 for additional details.
Add new controls on eight (8) additional biological toxins. See Federal Register notice June 10, 2003.
Tighten controls on biological filtration equipment (tangential cross flow) by lowering the control threshold for such equipment for total filtration area from 5 m 2 to 1 m 2 and by adding a new control filtration equipment components with filtration area equal to or greater than 0.2 m 2. See Federal Register notice dated June 10, 2003.

At the June 2003 Plenary and in subsequent intersessional discussions, AG participating governments agreed to:

Add new controls on additional biological agents as follow: twelve new viruses and two new bacteria added to the list of controlled human and zoonotic pathogens; two viruses added to the list of controlled animal pathogens. See Federal Register notice dated March 18, 2004.

At the June 2004 Plenary and in subsequent intersessional discussions, AG participating governments agreed to:

Add new controls on additional plant pathogens as follows: three new bacteria and two new viruses added to the list of controlled plant pathogens. See Federal Register notice dated December 29, 2004.

Add new controls on the chemical weapons precursor sodium hexafluorosilicate and eight other new chemical weapons precursors. See Federal Register notice December 29, 2004.
Add a new factor to the agreed “Guidelines for Transfers of Sensitive Chemical or Biological Items” requiring AG participating countries to take into consideration the extent and effectiveness of the export control system in the importing country and in any intermediary countries through which the items being exported or reexported will transit or be transhipped en route to the importing country. See Federal Register notice dated December 29, 2004.
At the April 2005 Plenary and in subsequent intersessional discussions, AG participating governments agreed to:

Add controls on certain aerosol generators considered to be commercial off-the-shelf biological weapons delivery systems. See Federal Register notice dated August 5, 2005.