Biosecurity

Biosecurity A set of preventive measures designed to reduce the risk of intentional removal (theft) of a valuable biological material. These preventative measures are a combination of systems and practices usually put into place at a legitimate bioscience laboratory that could be sources of pathogens and toxins for malicious use. Although security is usually thought of in terms of "Guards, Gates, and Guns", biosecurity encompasses much more than that and requires the cooperation of scientists, technicians, policy makers, security engineers, and law enforcement officials.

Components of a laboratory biosecurity program include:

* Physical security
* Personnel security
* Material control & accountability
* Transport security
* Information security
* Program management


Challenges in Biosecurity

The destruction of the World Trade Center in Manhattan on September 11, 2001 by terrorists, and subsequent wave of anthrax attacks on U.S. media and government outlets (both real and hoax), led to increased attention on the risk of bioterror attacks in the United States. Proposals for serious structural reforms, national and/or regional border controls, and a single co-ordinated system of biohazard response abounded.

The proliferation of high biosafety level laboratories around the world has many experts worried about availability of targets for those that might interested in stealing dangerous pathogens. Emerging and Re-emerging disease is also a serious biosecurity concern. The recent growth in containment laboratories is often in response to emerging diseases, many new containment lab's main focus is to find ways to control these diseases. By strengthening national disease surveillance, prevention, control and response systems, these labs are raising international public health to new heights.

UNU/IAS Research into Biosecurity & Biosafety emphasizes "long-term consequences of the development and use of biotechnology" and need for "an honest broker to create avenues and forums to unlock the impasses."

Biosecurity Incidents

* 1984 Rajneeshee religious cult attacks Dalles, Oregon

* Objective: Gain control of the Wasco County Court by affecting the election
* Organism: Salmonella typhimurium, purchased from commercial supplier
* Dissemination: Restaurant salad bars
* 751 illnesses, Early investigation by CDC suggested the event was a naturally occurring outbreak. Cult member arrested on unrelated charge confessed involvement with the event

* 1990s Aum Shinrikyo attempts in Tokyo, Japan

* Objective: Fulfill apocalyptic prophecy
* Organisms: Bacillus anthracis (Vaccine strain), Clostridium botulinum (Environmental isolate, Avirulent strain) Aum Shinrikyo ordered Clostridium botulinum from a pharmaceutical company, and Ebola virus (Attempted to acquire from Zaire outbreak under guise of an “Humanitarian mission”)
* Dissemination: Aerosolization in Tokyo (B. anthracis and Botulinum toxin)
* Leader Asahara was convicted of criminal activity

* 2001 Anthrax attacks in the US
* 1995—Larry Wayne Harris, a whitesupremacist, ordered 3 vials of Yersinia pestis from the ATCC
* 1995—Laboratory technician Diane Thompson removed Shigella dysenteriae Type 2 from hospital’s collection and infected co-workers
* Professor Thomas Butler, United States, 2003

* 30 vials of Yesinia pestis missing from lab (never recovered); Butler served 19 months in jail

* Dr. Mario Jascalevich, New Jersey doctor, accused of poisoning 5 patients with this plant-derived toxin - Tubocurarine: 1966
* Arnfinn Nesset, nursing home operator in Norway, killed 27 residents at a nursing home with curacit: May 1977 – November 1980
* Dr. David Acer, Florida dentist, infects 6 patients with HIV, unclear if this was a deliberate act: 1987 – 1990
* Dr. Ray W. Mettetal, Jr., a neurologist in Virginia, was found in possession of ricin after arrest on another issue: 1995
* Debora Green, a physician, convicted of trying to murder her estranged husband with ricin
* Richard Schmidt, a gastroenterologist in Louisiana, convicted of attempted second degree murder for infecting nurse Janice Allen with HIV by injecting her with blood from an AIDS patient: 1998
* Brian T. Stewart, a phlebotomist, sentenced to life in prison for deliberately infecting his 11-month-old baby with HIV-infected blood to avoid child support payments: 1999
* Physician reports theft of a vial of Mycobacterium tuberculosis: June 1999
* Japan 1964-1966, Dr. Mitsuru Suzuki was a physician with training in bacteriology

* Objective: Revenge due to deep antagonism to what he perceived as a prevailing seniority system
* Organisms: Shigella dysenteriae and Salmonella typhi
* Dissemination: Sponge cake, other food sources
* He was later implicated in 200 – 400 illnesses and 4 deaths
* Official investigation started after anonymous tip to Ministry of Health and Welfare. He was charged, but was not convicted of any deaths

* Hospital in Dallas, TX, 1996, Diane Thompson was a clinical laboratory technician

* Objective: Unclear, possibly revenge against former boyfriend and cover-up by infecting co-workers
* Organism: Shigella dysenteriae Type 2, acquired from clinical laboratory
* Dissemination: Contaminated pastries in the office breakroom
* Infected 12 of her coworkers, She was arrested, convicted, 20 year sentence

Helpful References


* Laboratory Biosafety and Biosecurity Guidance

* WHO Laboratory Biosafety Manual, 3rd edition, 2004

* Chapter 9 on Laboratory Biosecurity

* WHO/FAO/OIE joint guidance – Biorisk Management: Laboratory Biosecurity Guidance, 2006
* CDC/NIH Biosafety in Microbiological and Biomedical Laboratories, 5th edition, 2007

* Extensive recommendations on biosecurity

* Laboratory Biosecurity Handbook, CRC Press, 2007

* Training and Other Key Online Resources

* APBA: www.a-pba.org
* NIH/WHO TTT: beta.sandglass.com/asiapacific/index.html
* Biosecurity Engagement Program: www.BEPstate.net
* Sandia: www.biosecurity.sandia.gov

* USDA and pork producers

* US scientific societies

Conferences and related events

* Biosecuritycodes.org - A detailed list of past and future Biosecurity events dating from 1928. Brought to you by the International Futures Program of the OECD. The site is available in English and French with a limited Japanese version.

* MOP3 (Third Meeting of the Parties to the Cartagena Protocol on Biosafety) 13 - 17 March / Curitiba - Brazil

* BIOSAFETY and BIOSECURITY Training Course

* Fort Collins, CO

* Controlling Biorisks Course

* At Sandia National Labs, NM

Biosecurity Regulations

* US Select Agent Regulations

* Facility registration if it possesses one of 81 Select Agents
* Facility must designate a Responsible Official
* Background checks for individuals with access to Select Agents
* Access controls for areas and containers that contain Select Agents
* Detailed inventory requirements for Select Agents
* Security, safety, and emergency response plans
* Safety and security training
* Regulation of transfers of Select Agents
* Extensive documentation and recordkeeping
* Safety and security inspections

* Biological Weapons Convention addresses three relevant issues:

* National Implementing Legislation
* National Pathogen Security (biosecurity)
* International Cooperation
* States Parties agree to pursue national implementation of laboratory and transportation biosecurity (2003)

* UN 1540

* urges States to take preventative measures to mitigate the threat of WMD proliferation by non-state actors
* “Take and enforce effective measures to establish domestic controls to prevent the proliferation of . . . biological weapons . . .; including by establishing appropriate controls over related materials”

* European Commission Green Paper on Bio-Preparedness (November 2007)

* recommends developing European standards on laboratory biosecurity including Physical protection, access controls, accountability of pathogens, and registration of researchers

* Organization for Economic Cooperation and Development

* published “Best Practice Guidelines for Biological Resource Centers” including a section on biosecurity in February 2007

* Kampala Compact (October 2005) and the Nairobi Announcement (July 2007)

* stress importance of implementing laboratory biosafety and biosecurity in Africa

Agents of Concern

The following agents are deemed a biosecurity concern by the US Government through the US Select Agent List. The list is divided between agents that can infect only humans, zoonotic agents (which can infect both humans and animals), agents that can only infect animals, and agents that can infect only plants.