Science, Safety, Security Quarterly

May 2012 Issue 2

News for the Federal Biorisk Management Policy Community Editor: Laura Kwinn, Ph.D. , [email protected] Contents Page 2 Policy Announcement: United States Government Policy Interagency Biorisk Management Working for Dual Use Research of Concern Group is Established The Federal Government has to public health and safety, agri- Under this Policy, review will fo- released a new policy for over- cultural crops and other plants, cus on research involving one or Page 3 sight of life sciences dual use animals, the environment, ma- more agents or toxins that are Outcome of the Biological research of concern (DURC) teriel, or national security. The considered to pose the greatest Weapons Convention 7th that is funded or conducted by Policy will establish regular re- risk of deliberate misuse with Review Conference the USG. For the purpose of view of this research in order the most significant potential for this Policy, DURC is defined as mass casualties or devastating to mitigate risks and collect in- Page 4-5 life sciences research that, based effects to the economy, critical formation to inform policy up- Deemed Exports and on current understanding, can infrastructure, or public confi- dates, and aims to preserve the Licenses in Biological be reasonably anticipated to dence. The Policy includes a list benefits of life sciences research Research provide knowledge, information, of these specified agents and products, or technologies that while minimizing the risk of mis- toxins (on pg. 8), as well as a list Page 5 could be directly misapplied to use of the knowledge, informa- of categories of experiments be- FBI Connects Science and pose a significant threat with tion, products, or technologies ing conducted with these agents Security Communities broad potential consequences provided by such research. and toxins for review. cont. from pg. 1 cont. on pg. 8

Page 6-7 Treaties and Weapons of FBI Connects Science and Security Communities Mass Destruction Crossword The Biological Countermeasures Unit (BCU) Puzzle within the FBI Weapons of Mass Destruction Di- Page 7 rectorate stays busy with a full schedule of events Call for Submissions aiming to reach and connect the scientific and security communities. The BCU educates members Page 8 of both communities on the importance of biose- Policy Announcement: United curity and available tools to mitigate the potential States Government Policy security risks involved with working with biological materials and technologies. Scientists in industry, for Dual Use Research of researchers in academic facilities, students, bio- Concern cont. from pg. 1 safety and compliance professionals, information Crossword Puzzle Key technologists, first responders, environmental and public health officials, local law enforcement, and emergency management professionals are among Workshops1 take place at colleges and universi- those included in the FBI’s target audience for ties across the country and aim to improve the education and outreach, both in the United States cooperation among law enforcement agencies and and with their international partners. research institutions to mitigate potential biosecurity issues that may affect public health and safety. A long list of conferences and workshops speak The BCU offers workshops, free of charge, to in- to the value placed on this type of outreach by terested institutions. Over 20 have been carried the BCU. Regional FBI Academic Biosecurity 1Link to FBI Regional Academic Biosecurity Workshops cont. on pg. 5 Page 2

Interagency Biorisk Management Working Group is Established

The term “biorisk In January 2012, the White issues. The IBMWG will facilitate House Office of Science and awareness among Federal and management” Technology Policy (OSTP) con- non-Federal stakeholders about vened the first meeting of the ongoing outreach activities rel- describes the Interagency Biorisk Manage- evant to understanding and ad- development ment Working Group (IBMWG). dressing biological threats, and Established by action of the Na- will develop and promote the and application tional Science and Technology use of common terminology Council Committee on Home- and consistent messages about of practices and land and National Security biorisk management by Federal Subcommittee on Biodefense departments and agencies. Fi- procedures to Research and Development, nally, the IBMWG will enhance reduce biosafety, the IBMWG is tasked with ex- international partnerships to amining the current framework strengthen global biorisk man- biocontainment, for local and Federal research agement and establish mecha- laboratory biorisk management nisms to continually review and and biosecurity oversight. The term “biorisk improve Federal biorisk manage- management” describes the ment policies, practices, and pro- risks posed by development and application of cedures, and assess the efficacy practices and procedures to re- of IBMWG outreach efforts. working with duce biosafety, biocontainment, The IBMWG will review recom- and biosecurity risks posed by hazardous mendations developed by, inter working with hazardous bio- ries operated within the United alia, the Trans-Federal Task Force logical agents in research labo- States or supported by the Unit- biological agents on Optimizing Biosafety and ratories. The IBMWG provides ed States Government. The IBM- Biocontainment Oversight, Na- in research participating Federal agencies WG will identify gaps in Federal tional Science Advisory Board with a focused forum to coordi- biorisk management policies and for Biosecurity, Federal Experts laboratories. nate and collaborate on mecha- procedures for these research Security Advisory Panel, Europe- nisms to strengthen research activities, develop a strategy and an Committee for Standardiza- laboratory biorisk management implementation plan to address tion (Comité Européen de Nor- and to promote outreach and gaps and priority recommenda- malisation [CEN]), and World education programs that inform tions, and ensure that Federal ef- Health Organization to identify scientists, biosafety profession- forts in biorisk management are those that may inform options als, institutional officials and the harmonized. Where appropriate, for improvements or alterna- public on biorisk management. the IBMWG will evaluate the ap- tives in Federal biorisk manage- IBMWG membership includes plicability of its findings to biorisk ment oversight. representation from sixteen management oversight for non Federal departments and agen- high- or maximum-containment IBMWG Co-chairs: laboratories. cies, and three organizations Joe Kozlovac: Joseph.Kozlovac@ within the Executive Office of In addition to strengthening re- ars.usda.gov the President. search laboratory biorisk man- Theresa Lawrence: Theresa. agement oversight, the IBMWG The IBMWG will examine the [email protected] current oversight framework and will coordinate Federal outreach evolving oversight practices for and educational programs de- Erik Prentice: [email protected] signed to inform scientists, bio- local and Federal biorisk man- IBMWG Executive Secretary, safety professionals, institutional agement of research and related Marci Wright: Marcienne. officials and the public on bior- activities at high- and maximum- [email protected] containment (Biosafety Levels isk management and relevant 3 and 4, respectively) laborato- federal regulations and related Page 3

Outcome of the Biological Weapons Convention 7th Review Conference

The Review Conference is held every five years with the goal of addressing specific The 7th Review Conference of five years until the 8th RevCon of State Tom Countryman, dur- issues designed to the Biological Weapons Conven- in 2016. ing his remarks at the American tion (BWC) took place last De- It is evident that the States Par- Society for Microbiology Biode- keep the treaty cember in Geneva, Switzerland. ties were united in focusing on fense and Emerging Diseases Re- The Review Conference is held these critical issues, among oth- search Meeting in February, af- in a position to every five years with the goal firmed that the “Administration er items. In its summary of the address the ever- of addressing specific issues de- meeting, the Biological Weapons is pleased with the outcome of signed to keep the treaty in a po- Convention Implementation the 2011 Review Conference.” changing nature of sition to address the ever-chang- Support Unit (ISU) posted the In the Final Document the States ing nature of biological threats. following on the United Nations Parties decided to include in biological threats. The United States delegation Office at Geneva website: “In the their 2012 – 2015 intersessional entered the discussions with a decisions and recommendations, program a standing agenda item focus on three critical issues, the Review Conference retains on developments in the field of including bolstering confidence the previous structures of an- science and technology related building measures, addressing de- nual Meetings of States Parties to the Convention. The three velopments in science and tech- preceded by annual Meetings of standing agenda items, as well nology, and building capacity for Experts; makes cooperation and as a two-year focus on improv- nations to detect and respond assistance, a review of developing the relevance of the CBMs, to disease outbreaks (more in- ments in the field of science and and another two years on pre- formation can be found here). In technology, and strengthening na- paredness and response will be addition to the formal BWC Re- tional implementation all Stand- guided by a new arrangement view Conference sessions, U.S. ing Agenda Items to be discussed of the BWC Chairman and two Conference on Disarmament during the intersessional period; Vice Chairmen. Algeria has the Ambassador and BWC Repre- establishes a database system to rotating position for Chairman sentative Laura Kennedy hosted facilitate requests for and offers for 2012 from the non-aligned three events that provided an of exchange of assistance and movement, Switzerland and Po- overview of the U.S. approach cooperation among States Par- land will take the Vice Chair po- to several critical BWC areas, ties; establishes a sponsorship sitions for the Western European including U.S. biodefense pro- programme to increase the par- and Others Group and Eastern grams, U.S. assistance provided ticipation of developing States European Group, respectively. under Article X of the BWC, and Parties in the meetings of the in- The Conference agreed to hold international preparedness and tersessional programme; adopts the Experts Meeting July 16-20 response. More information on revised reporting forms for all and Annual Meeting from De- these events can be found here. Confidence Building Measure cember 10-14. U.S. BWC Rep- The three- week session con- submissions; requests States Par- resentative and Conference on cluded with the States Parties’ ties to promote universalization Disarmament Ambassador Laura adoption of a Final Document of the Convention through bilat- Kennedy will continue to lead related to countries’ views on eral contacts and regional and the U.S. delegation as she did for how the Articles of the Conven- multilateral activities; and renews the Review Conference. tion are being implemented and the mandate of the Implementa- a series of decisions and recom- tion Support Unit from 2012 Biological Policy Staff: mendations covering the next to 2016.” Assistant Secretary [email protected] Page 4

Deemed Exports and Licenses in Biological Research

Relevant to recent tional who (1) trolled pathogen using tech- is granted per- niques that are not in the public events regarding manent resi- domain or are not fundamental dence, as dem- research. There are also exclu- communication of onstrated by sions from licensure based on dual use research the issuance of publications (please review 734.8 a permanent through 734.12 and the appendix of concern, resident visa to 734 of the Export Administra- (i.e., “Green tion Regulations (EAR)). Release technology controls Card”); or (2) of controlled 1E001 technology is granted U.S. would necessitate a deemed ex- may also apply citizenship; or port license if the scientist was to technical data Export control regulations are (3) is granted learning “development” or pro- federal laws that restrict the status as a “protected person” duction” of a controlled organ- transmitted in oral passage of certain materials, de- under 8 U.S.C. 1324b(a)(3). ism. When you look at the EAR vices and technical information Much more information is avail- definition of these terms, it would or written form. outside of the United States or able on the Bureau of Industry mean the researcher would be to foreign nationals within the and Security website. licensed for how to grow, maintain, quality check, etc a pathogen. United States. These regulations Many people have questions on Most of this technology is in the apply to research activities that what triggers a requirement for public domain. If the researcher are not considered “fundamen- a deemed export license for was working on a sensitive proj- tal” research, or that which “is biological research. There are ect where they were working on defined to mean basic and- ap several factors and Export Con- biodefense or some other type plied research in science and trol Classification Numbers (EC- of research that would not be engineering where the resulting CNs) to consider. The ECCNs allowed to be published and in- information is ordinarily pub- that cover pathogens of con- volved a controlled listed patho- lished and shared broadly within cern are 1C351, 1C352, 1C353, gen being grown in non-standard the scientific community.” Bio- 1C354, and 1C360. These agents conditions (not in the scientific logical research, including the are Australia Group listed or literature), then 1E001 might ap- agents studied, the equipment are Select Agents. However, it ply. There is also 1E351 disposal used, and the technology applied is not the pathogen itself that technology but it doesn’t really may be regulated by export con- is the subject of control for a apply because biological agents trols. Relevant to recent events deemed export license, but the are destroyed through autoclave, regarding communication of dual technology association with that chemicals, etc, in standard uni- use research of concern, tech- pathogen. If the pathogen were versal techniques. nology controls may also apply to be shipped from the US to the to technical data transmitted in foreign national, that would be a Another area of concern is 2E001 oral or written form. Discussion regular export license. A deemed and 2E002 technology controls of export-controlled technology export license is for a foreign for development and production at conferences or even in labo- worker in the US. If technology - these would only apply if the re- ratory settings should be evalu- is to be exported to a foreign searcher was developing 2B352 ated for possible requirements country, that is considered a controlled biological equipment for export control. technology export – the differ- (fermenters, cross flow filtra- Export controls also apply to the ence is where the technology is tion equipment, class 3 glove release of controlled technol- imparted. boxes, for example). The third area to look at is 2B301 which ogy to a foreign national inside ECCN 1E001 is technology for is “use’ of biological equipment. the United States. The term for the development or production (see below). All six parts of the such a release of technology is (definitions below) of controlled components of use as defined in “deemed export”. Any foreign na- biological agents. The key ques- the EAR must be met. Of course tional is subject to the “deemed tion is if the foreign national is the technology might be public export” rule except a foreign na- learning how to “grow” a con- Cont. on pg. 5 Page 5

FBI Connects Science and Security Communities cont. from pg. 1 out since Jan 2011. The 2011 FBI there is at least one in each of mental remediation to potential Synthetic Biology III Workshop the 56 FBI Field Offices. WMD new medical therapeutics. Spon- Safe and Secure Science: Partners Coordinators are Special Agents sorship of iGEM has allowed the of Today and Tomorrow and the that are trained and experienced FBI to raise awareness and in- February 2012 meeting Bridging in dealing with chemical, bio- culcate the culture of security in Science and Security for Biological logical, radiological, and nuclear the next generation of research- Research: A Dialogue Between Uni- threats and incidents. They have ers and entrepreneurs. This has versities and the FBI, jointly spon- established partnerships with been accomplished through sored by AAAS, APLU, AAU, and Federal regional counterparts, workshops promoting respon- FBI1, are examples of the effort state, county, and local response sible research and working with to engage the science and secu- agencies and entities in their ju- iGEM to incorporate security rity communities and foster a risdiction, as well as having the in the judging process. At the dialogue leading to mutual ben- reach-back capabilities to FBI same time, the FBI developed efit and understanding. and other Federal Department the Synthetic Biology Tripwire and Agency headquarters. By es- Initiative, in partnership with the The FBI is also actively involved tablishing relationships with the U.S. synthetic biology industry, in policy discussions and ac- WMD Coordinators SAP enti- to facilitate and encourage the tivities dealing with biosecurity, ties have access to an array of reporting of suspicious requests particularly regarding biological resources and expertise to miti- for genetic sequences mitigat- select agents and toxins. Dur- gate potential biosecurity risks. ing risks for abuse and ensuring The FBI is ing the Select Agent Program advances in science and technol- Workshop Series, sponsored by The BCU pursues other innova- ogy remain open and accessible. also actively the CDC and USDA-APHIS and tive avenues of outreach to the held in Knoxville, TN in Novem- scientific community by spon- The FBI Biological Countermea- involved in policy ber 2011, leadership and person- soring the annual International sures Unit will continue its pre- nel at entities registered with Genetically Engineered Machine vention activities in a way that discussions and the Select Agent Program were (iGEM) Competition. Starting at strikes a balance between secu- activities dealing encouraged to participate in the undergraduate level, iGEM rity and supporting advances in the Regional Biosecurity Work- exemplifies the tremendous ben- scientific research and protect- with biosecurity, shops and connect with their lo- efits and rapid advances in the ing public safety. cal WMD Coordinator, of which field of synthetic biology with particularly Ed You: [email protected] projects ranging from environ- 1Meeting report regarding biological

Deemed Exports and Licenses in Biological Research cont. from pg. 4 select agents domain depending on what type of item they were Development: (General Technology Note)— and toxins. learning to use. If someone from a CB2 country on “Development” is related to all stages prior to se- the CCL country list (supplement 1 to part 738) rial production, such as: design, design research, de- country comes to the United States to learn how sign analyses, design concepts, assembly and testing to operate, install, maintain, repair, overhaul, and of prototypes, pilot production schemes, design refurbish 2B352 equipment then they should get data, process of transforming design data into a a deemed export license. This is not the normal product, configuration design, integration design, activity of researchers. In conclusion, a deemed ex- layouts. port license is only required for a foreign national Use: (All categories and General Technology in the United States learning technology controlled Note)—Operation, installation (including on-site by the Export Administration Regulations. installation), maintenance (checking), repair, over- Definitions haul and refurbishing. Production: (General Technology Note) (All More information is available here. Categories)—Means all production stages, such as: product engineering, manufacture, integration, Kimberly Orr, DVM, PhD: Kimberly. assembly (mounting), inspection, testing, quality [email protected] assurance. Page 6

Treaties and Weapons of Mass Destruction by Dr. Dana Perkins, [email protected]

ACROSS DOWN 1 Not processed or refined 1 This type of conference occurs every 5 years 4 Confidence Building Measure A Part I re- 2 Anti-aircraft warfare fers to this biosafety level 3 Weapons that are capable of a high or- 8 Third person singular present indicative of be der of destruction and lethality 10 Exposure Assessment and Management Program; 4 G-man process of assessing and controlling worker’s 5 An eloquent public speaker risk of exposure to hazardous substances 6 Basque word for “water” 12 Dissuading a potential adversary from initiating an attack 7 Unit of radiation dose equivalence 16 Yes, in Romanian 8 Collective abbreviation for the CIA, 17 United Nations Office of Disarmament Affairs- DIA, FBI, ODNI, NSA and others promotes nonproliferation and disarmament 9 The number of Confidence-Building 18 The 12th letter of the Greek alphabet Measure forms under the BWC 19 Abbreviation for ibidem 11 Epidemics that cover a wide geographical 21 Network behavior anomaly detection; continuous area or affect a large number of people monitoring to detect unusual events or trends 12 Referring the good and bad uses of life sciences 23 The symbol for the element tantalum 13 Disease that is naturally present in an area 25 City in Papua New Guinea that is home 14 Tonga, abbreviated of to the University of Technology 15 Something that has no force or meaning 27 Emotional Intelligence; ability to identify, assess 20 The intentional use or threat of use of biologi- and control the emotions of oneself or others cal agents against humans, animals, or plants 28 Anaphylaxis reaction carried out in vitro with ex- 22 Proscribe cised tissue, also known as Schultz-____Reaction 24 Adenine and thymine Page 7

ACROSS DOWN 29 Biological toxin which affects the nervous sys- 26 Dot on the Rhine tem, made by Clostridium botulinum 29 Relating to or caused by bacteria 30 Forty of them have been awarded the No- 31 It docked with “Atlantis” bel Prize between 1901 and 2009 34 The state of being in accordance with estab- 32 Net-speak for “more” generally found on lolcats lished agreements or treaty requirements 33 Toxic Industrial Materials; toxic or radioactive substances that 35 Brunei, abbreviated may be used for industrial, medical, or commercial purposes 36 Body invasion by pathogenic microorganisms 34 Confidence-Building Measure 37 Venezuela, abbreviated 37 A process to demonstrate compliance with 38 Mathematical analysis of data an agreement or treaty requirements based on frequencies 41 Cyanide 39 Acronym for the organization established 42 Area of a hospital for the acute care of patients at the BWC 6th Review Conference 43 Simian fibroblasts immortalized with SV40 virus 40 An infectious disease caused 44 Chemical symbol for neon by Bacillus anthracis 45 ____ Lawquane “We want no trouble here” (“Star 47 Second base in mathematics Wars: War of the Clones” character) 48 Airborne, abbreviated 46 Snare, ambush, stratagem 49 Biological Weapon 48 Man on a five 50 Common abbreviation for the Treaty on the 50 Nitric oxide Non-Proliferation of Nuclear Weapons 51 A prodromal symptom of an infectious disease 51 Chemical symbol for cerium 52 Biological Weapons Convention (a.k.a. Convention on the 54 Based in The Hague, The Neth- Prohibition of the Development, Production, and Stockpiling of erlands, this organization moni- Bacteriological and Toxin Weapons and on their Destruction). tors compliance with the CWC 53 The spread of weapons of mass destruc- 55 Join a hunger strike tion and related technologies and materials 56 Chemical symbol for osmium 57 Apex in anatomy 60 Ubiquitous article 58 Babylonian water-deity 63 Working group, abbreviated 59 “____ jacta est”- The dice has been cast (Latin, plural) 60 Chemical symbol for titanium 61 Cicatrices 62 Chemical symbol for a radioactive gas CROSSWORD formed by the decay of radium PUZZLE KEY 63 Acronym for the United Nations organization co- on pg. 8 ordinating international public health response 64 Scientific abbreviation for molecular weight 65 It triggers antibody production

Call for Submissions We want to hear from you! Please contact Laura Kwinn with news ideas for future editions of S3 Quarterly. Feel free to submit general information for inclusion or drafted articles. If you have an idea, we are happy to work with you in drafting a piece. Articles should be in MS Word format, fewer than 1000 words, with author/contact name and email address. Pictures and diagrams in jpg format are encouraged and welcome. Thank you! [email protected] Page 8

Policy Announcement: United States Government Policy for Dual Use Research of Concern cont. from pg. 1

The Policy outlines the responsibilities of Federal departments and agencies (D/A) that conduct or DURC Policy fund life sciences research. Following a review of List of Agents and Toxins all research projects, the D/A should identify any that meet the definition of DURC and assess the risks and benefits of such projects. Based on this • Avian influenza virus risk assessment, and in collaboration with the in- (highly pathogenic) stitution or researcher, the D/A should develop • Bacillus anthracis a risk mitigation plan to apply any necessary and appropriate risk mitigation measures. Within 60 • Botulinum neurotoxin days of issuance of the Policy Federal D/A are • Burkholderia mallei requested to report those projects that include work with one or more of the listed agents or • Burkholderia pseudomallei Based on this risk toxins and produce, aim to produce, or are rea- assessment, and in sonably anticipated to produce one or more of • Ebola virus the effects in the listed categories to John Bren- • Foot-and-mouth disease virus collaboration with nan, the Assistant to the President for Homeland Security and Counterterrorism. Within 90 days, • Francisella tularensis the institution or D/A are requested to identify those projects that are identified as DURC, as well as a summary of • Marburg virus researcher, the D/A risks and mitigation measures already in place or • Reconstructed 1918 Influenza should develop proposed. D/A are additionally requested to sub- virus mit biannual reports on these items. • Rinderpest virus a risk mitigation As necessary and appropriate, the USG will continue to consult with the NSABB or convene the • Toxin-producing strains of plan to apply Countering Biological Threats Interagency Policy Clostridium botulinum any necessary Committee for guidance on matters relating to DURC. The Policy will be updated, as needed, • Variola major virus and appropriate following discussions with domestic and interna- • Variola minor virus tional partners, including members of the scien- risk mitigation tific and security communities. • Yersinia pestis measures. The full Policy can be found here.

CROSSWORD PUZZLE KEY from pgs. 6-7