Where Industry and Security Intersect
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The MTAC meeting was held on 4 August 2005 in the Department of Commerce (DoC) building, room 3884. The meeting was called to order at 10:30 AM by Mr. Jeffrey Tripp, 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 two main topics: a presentation on the status of the Biological Weapons Convention (BWC) and codes of conduct and the addition of select agents to the Commerce Control List (CCL).
Attendance:
Materials TAC Members:
Dr. James Estep, Chairman
Ms. Marybeth Kelliher
Dr. Samuel McDonald
Mr. Jeffrey Tripp, Designated Federal Officer – DoC
Mr. Matt Borman, Deputy Assistant Secretary for Export Control
Dr. Doug Brown - DoC
Mr. Steven Goldman – DoC
Mr. Jim Seevarntwam - DoC
Visitors:
Ambassador Don Mahley – Department of State
Gordon L. Boezer, Deputy Director, TIAC, IDA
Tim Dunn – DTSA
Kenneth W. Hutton – Hyperion Catalysis Int’l, Inc
Mark Lincoln – Talk Radio News Service
Barton Reppert – Independent S&T Writer
William A. Root – Export Control Consultant
John W. Thomas – Association of Veterinary Biologics Co.
The meeting was opened with introductions of the MTAC members, visitors from the business community, DoC staff, and Ambassador Don Mahley.
After introductions, Mr. Tripp introduced Mr. Borman who expressed his appreciation to the MTAC members on their work to provide information on the movement of the US to unilaterally add the select agents to the CCL.
Following his opening remarks, Mr. Borman asked if there were questions from the visitors. Mr Root asked specifically for feedback on a comment he had sent on nuclear grade graphite material. Mr. Borman said he was not aware of the comment, but promised he would ask about the status of the DoC response.
At this time then Mr. Borman introduced Ambassador Don Mahley, who has been the Department of State leader on Biological and Toxin Weapons Convention (BWC) for well over ten years.
Ambassador Mahley introduced the topic of codes of conduct for the BWC, and gave a short history on the protocol to the convention. He first expressed his appreciation to industry members that had provided valuable input to the discussions and development of the U.S. position on the protocol over the last six plus years. He said that the protocol was obviously going to have significant impact on the U.S. industry and this input along with many factors allowed for the determination that the protocol was never going to advance and the U.S. bounced the protocol. The protocol would have allowed for a great deal of access to industry facilities and developing technology information, while not providing a lot of input for working an issue of alleged biological agent use. Access to the state-of-art facilities so governments could conduct an assessment of an alleged use was not worth the risk to information needed to be protected. There would have been a great deal of access and little security value to the U.S. He also said the position of the U.S. was not the fault of industry and they should not be blamed for the demise of the protocol.
Ambassador Mahley expressed his opinion that he believes there are still countries seeking a biological weapons (BW) capability, but that he felt there is not a rogue state holding an inventory of agents to use. The current acceptance of the BWC is that signatories are in agreement that they would not emphasize BW use as part of their state policy and were obligated to insure that no one else develop BW capabilities in areas under their jurisdiction. Additionally, he expressed his concern that the BWC does not apply to terrorist organizations, as none of them are signatories to the document. He used al Qaeda as an example of terrorist organizations that are not signatories, operate outside the law, and could be interested in developing BW capabilities; he was not providing information on al Qaeda per se, just as an example. He also expressed that the U.S. position is that signatories must develop national legislation that precludes the development of BW capabilities by organization in areas under their control and have the legal means to remove any organization that tries to develop the capability. In 2006 there will be a review conference during which signatories must document that they have implemented legislation that meets this requirement. He expects that the convention will identify those countries that have legislation, those that are working on it, and those that are not working on it.
Ambassador Mahley also discussed the difference between biosafety and biosecurity. He stated that biosecurity is also a requirement in each signatory country, but that for some countries the words are the same. Russia is a country were biosafety and biosecurity are the same word. Biosafety is to keep people safe from exposure to dangerous pathogens. This is accomplished by isolation of agents in glove boxes and the use of sterility techniques in the laboratory. In contrast, biosecurity is to keep pathogens safe from people. This is accomplished through registration of agents and quantities, accountability for agents in your possession and external security (physical security) that precludes unauthorized access. He stated that the agreement on biosecurity will be tightened up so pathogens will not wander around within and between countries. There will be an impact on industry. Industry will be accountable so nothing inadvertently escapes laboratories. Companies must have a program in place so they can say escape is not possible from their facilities.
On the issue of natural outbreak of disease and bioterrorist use, the Department of Homeland Security is concerned with developing consequence management of a biological event. The management of a biological event would not be substantially different from what CDC (Centers for Control and Prevention) does now during natural disease outbreaks. The main concerns are control spread, intensely manage disease occurrence and develop casualty list to assess impact. The CDC response to Asian flu would be about the same as a biological terrorist event and they should be able to deal with these outbreaks.
On the issue of novel agents, either natural or laboratory modified, the Ambassador was not as concerned with these as he is about the standard or known agents. He stated that terrorists are most likely to deal with classic agents. He mentioned a few disease agents that have been intentionally introduced at some time in history; cholera, anthrax, smallpox, and plague. These are all good agents and disease from them is not common in much of the world, yet the agents are present and terrorist would be able to get them.
The main topic of the discussion was the Ambassador’s discussion on a code of conduct. He expressed that the U.S. is attempting to increase control over biological agent research without becoming a draconian state. If we are too aggressive in controlling behavior then we could become a police state, not much better than a terrorist group. The concept of a code would be a self-imposed standard that members of organizations would volunteer to adhere to because of the inherent value of the code to increase national security.
The code would contain some basic elements, such as an evaluation process for scientist and their research looking at unintentional potential of the research to be used for dangerous application by others. Scientists seem to inherently dispute the potential for an evil nature or application of their work, since they see it for the good work they intend. Other elements or effects of a code would be to raise conscience and education of those working in the field to the potential of the work to be used for the wrong application. A code would become self-enforcing. The Ambassador used the example of mouse pox research in Australia that would have been evaluated as having high potential for abuse and been stopped. A code would not be a federal or state program to look over scientists’ shoulders or question what they are doing, but an evaluation of the research for the potential of bad application; scientists evaluating scientists. The Ambassador stated that the U.S. Government position was not to get to something like the McCarty era of the 1950’s, but more of a whistle blowing exercise to bring attention to research so it can be properly evaluated.
The U.S. Government adopted the opinion that a code of conduct would not be a uniform code nor one code applies to all. There is an understanding that “one-size-fits-all” would not be possible. Biomedical research is so diverse that one code of conduct would not be applicable to all work. The intent is for each organization or group to come up with its own code that is tailored to the group’s focus and members activities. Also, the code would be forced up from the bottom to the top leadership; grass roots effort. For industry the code would be about placing priority on research that leads to a product and strengthening security, which is already important to industry for controlling information. The problem comes when selling your product, not in the controlling of the processes, Good Manufacturing Practice and Good Laboratory Practice, for consistency in the laboratory work. Codes of conduct are perceived to be more of a problem for academia than industry due to the inherent controlling and focused nature of research in industry.
The U.S. Government is trying to get other countries to come up with codes of conduct for security awareness. There was a good meeting in Geneva this summer where many non-government organizations were there and this allowed for a good start on this process.
Summary of Ambassador Mahley’s code of conduct message is that the U.S. position is to try to get responsible professional societies to instill in their membership a concept that they should work under the general principles of a code. The code should make members aware of the security risk. The U.S. Government is also inserting at next year’s review conference that countries should bring examples of codes of their organizations to share with others.
Ambassador Mahley asked for questions after his presentation. Dr. Marybeth Killiher asked if there were any parallel efforts on the CWC with regard to non-state actors and protecting CPI during inspections. The Ambassador said the CWC annex is not applicable to the BWC. The Ambassador went on to say there appears to be information suggesting that under the CWC there is good confidentially. Inspectors are doing their job without pressing the secret/CPI information aspects. The CWC does have confidentially statements, but no code of conduct requirement.
The nature of CW threat is that it is probably broader and more acute than the BW threat. In regional context it is not clear that states are not building a CW capability, but the threat to the U.S. by another state party is low. Most countries know the U.S. will beat you if you go there. For terrorist group, such as Aum Shinrikyo, there is ability to develop low-grade chemical agents. Also with micro-reactors there is better control of exothermic reactions and easier to turn out quantities that groups can use for a terrorist action. Overall, the chemical threat does still remain from countries and terrorist groups.
Mr. Bill Root asked about challenge inspections for biological toxins of ricin and saxitoxin which are on both the CWC and BWC. Ambassador Mahley replied that challenge inspections require an accumulation of a stockpile of material, which is not true for BWC; having a pathogen does not mean making a weapon. You can make 4 grams of chemical agent and this not a problem. In regards to biological agents making 50 grams of anthrax is legal, if it is for defense work, yet it is enough for a terrorist event. Additionally, Ambassador Mahley said he believes that the nature of what is being done in chemical facility setup and production of schedule 2 chemicals has a low level of security of the amount of material being made. Scale is important for challenge inspections and biological agents are harder then chemical in this regard. Overall, there is potential for inspections under the CWC for these toxins and this could lead to a problem under some circumstances.
Mr. Steve Goldman stated that the presentation by Ambassador Mahley was a good overview of the development of the BWC process. He then asked if there is any discussion on new techniques for biological agent changes and where is the U.S. Government going to address this technical development. Ambassador Mahley stated the USG is not going into this area. He said that it is becoming increasingly more difficult if not impossible to get the world to comprehend any commonality in this business. He went on to say the U.S., as a target of BW, is the toughest target because of our security position, but also due to our consequence management. The U.S. has a good capability to manage disease outbreak by CDC. The U.S. is better than the rest of the world due to the number of beds, amount of stockpiled materials, communication, and ability to move material around the country. Other things the U.S. is better at is preschool immunization program and purifying water. We naturally take out from water more things then most biological weapons contain everyday.
The Ambassador went on to say that other countries have a real biosecurity problem compared to the U.S. Other countries say the U.S. has such a strong biosecurity position jus to avoid sharing our biotechnology information with other countries (referencing article 10 of the BWC).
In summary, Ambassador Mahley returned to the topic of codes of conduct and restated that the position of the U.S. Government is not to have a national code of conduct, but relying on organizations to develop their own. The position is to stay away from driving this through a regulation.
Mr. Tripp thanked Ambassador Mahley for his time and extensive comments.
The next topic on the agenda was a presentation on the status of the addition of biological agents to the CCL. Dr. Doug Brown gave the update. He said the DoC has contacted the CDC and the USDA to inform them of their intent to update the CCL list. The DoC has drafted language to initiate this change. The language has gone to the DoC lawyers for review and comment. Once the lawyers have commented on the language it will move through the agency quickly to get it implemented. The language will not itemize the list of agents, but just reference the CFRs (42 CFR 73, 7 CRF 331, 9 CFR 121) for the list. The reason for this, as an example, is that the USDA can quickly change 9 CFR to add or remove an agent. If the CCL listed the agents then it too would have to change. By referencing the CFR, when that changes the DoC language would still be current. This approach should not be a problem for industry since most people/companies are familiar with what is on the biological agent list.
Dr. Brown said this approach may encounter some opposition within the DoC as this is not the usual approach. Mr. Bill Root commented that this is the approach taken by the munitions list where the CDC list is referenced.
Another points made by Dr. Brown is that anthrax is not a weapon. It is an agent, but if added to munitions then it is a weapon. Also, E coli is not an agent, but if modified with additional DNA, it could be an agent to be used as a weapon.
It was also pointed out that the current CCL or current Australian Group list remains the same CCN. It will just reference the biological agent not elsewhere specified. The control process will remain the same and a license will be required for all shipping destinations.
The last topic on the agenda was to select the next meeting date. The date selected was December 8, 2005. The next meeting will start at 10:30 AM at the Department of Commerce.
The meeting was adjourned at approximately 12:30 PM.