Below is a select list of treaties, conventions, laws, policies, regulations, and directives. As biosecurity is a relatively new and rapidly developing field, many countries have yet to devise or implement biosecurity laws. Since biosecurity has much in common with national security, biosafety, bioterrorism, biological weapons, import / export of dual-use materials, and biodiversity, some countries may develop biosecurity laws by adapting existing laws within these other areas. Therefore, biosecurity legislation as well as laws, treaties, and conventions applicable in other areas that could potentially be used as background for biosecurity legislation are included here.

Biological Legislation Information

International Agreements

Regional Agreements

European Council Directives

National Legislation

 

Biological Legislation Information Top

This site links only to official texts and/or verified unofficial translations. Several existing sites have a wide variety of information on legislation relating to security, biosafety, bioterrorism, biological weapons, import / export of dual-use materials, and biodiversity.

• The Biological and Toxins Weapons Convention Website's National Legislation Section

  • This site provides a comprehensive list of worldwide legislation involving the regulation of biological materials and in particular the national implementation of the Biological and Toxin Weapons Convention (BWC).
     
• International Committee of the Red Cross: International Humanitarian Law Database
  • This database provides documentation and commentaries concerning the implementation of international humanitarian law at the national level.
     
• VERTIC's Collection of national BWC implementation legislation

  • VERTIC is an independent, non-governmental organization. According to their website, VERTIC, "promotes effective and efficient verification as a means of ensuring confidence in the implementation of international agreements and intra-national agreements with international involvement." In support of this mission, VERTIC maintains an extensive online database of BWC implementation legislation.
     
• BioWeapons Monitor Database

  • The BioWeapons Monitor is a searchable online database that track compliance of governments and other entities with the 1972 Biological and Toxin Weapons Convention (BTWC) and other international treaties that codify the norm against biological weapons.
    
    
     

International Agreements Top

• United Nations Security Council Resolution (UNSCR) 1540
• Date: Adopted on 28 April, 2004
• Comment: This UNSCR requires all UN member states to pass and implement national legislation to prevent the proliferation of weapons of mass destruction (WMD) to non-state actors. The resolution specifies that states “shall take and enforce effective measures to establish domestic controls to prevent the proliferation of nuclear, chemical, or biological weapons and their means of delivery, including by establishing appropriate controls over related materials…”

 

Regional Agreements Top

Africa

• Model Law on Biosafety

  • Date: 2001
  • Comment: This Model Law criminalizes the use of genetic engineering for criminal or hostile purposes. It states that any person, organization or corporation that uses genetically modified organisms to damage "human health, biological, diversity, the environment or property" are subject to fines and incarceration.

 

South America

• The Mendoza Accord

  • Date: 5 September, 2001
  • Comment: Argentine, Brazil and Chile signed the Mendoza Commitment in which they agreed not to develop, acquire, stockpile or retain, transfer directly or indirectly or use biological weapons.

 

European Council Directives Top

• European Council (EC) Regulation 3381/94/EED

  • Date: Adopted 19 December, 1994
  • Comment: This regulation sets up a community regime for controlling the export of dual use goods.

• European Council (EC) Regulation 1334/2000

  • Date: Adopted in 2000
  • Comment: EC Regulation 1334/2000 established a system within the whole European Community for controlling the export of dual-use items by requiring authorization for their export to a non-EC state. The list of items considered dual use, which has been amended since its inception, contains microorganisms that might be genetically engineered as well as various bacteria, viruses, ricksettiae, toxins, and protective equipment. This legislation is binding in all EC states.

 

National Legislation Top

Australia

• Weapons of Mass Destruction Act

  • Date: 1995
  • Comment: This act prohibits the sale of relevant materials or services to states or organisations that are suspected of pursuing weapons of mass destruction.

• The Biological Control Act 1984

  • Date: 22 November, 1984
  • Comment: This legislation criminalizes the release of controlled agents, specifically those on the Australia group list. This act has been revised numerous times as the list of items covered expands.

 

Austria

• Austrian Criminal Code 60/1974

  • Date: 23 January, 1974
  • Comment: This legislation implements the BWC and contains provisions on ‘production and proliferation of weapons of mass destruction.’

 

Belgium

• The Biological Weapons Convention Implementation Law 1978

  • Date: 1 July, 1978
  • Comment: This law implements Article IV of the BWC and criminalizes biological weapons related activities in Belgium or by Belgian citizens.
    
   

Brazil

• Biosecurity Law

  • Date: 2005
  • Comment: This law regulate and monitors research and activities involving genetically modified organisms (GMOs).

 

Canada

• Biological and Toxin Weapons Convention Implementation Act [Not in force]
  • Date: 2004
  • Comment: This act implements nationally the Biological and Toxin Weapons Convention. It has not yet entered into force.
  
  
• Export and Import Permits Act

  • Date: 1992
  • Comment: This act implements nationally the Australia Group regulations and grants the government the power to create Export & Import Control Lists that control certain goods. This act has been revised numerous times since inception.

• Human Pathogens Importation Regulations Act

  • Date: 1992
  • Comment: Through this act, The Office of Laboratory Security within Health Canada is responsible for regulating biosecurity and biological weapon non-proliferation (as well as biosafety). It also controls and tracks the use of imported dangerous pathogens.
     
• Criminal Code
• Date: 1985
• Comment: The Criminal code section dealing with "Terrorism" and "Firearms and Other Weapons" describe penalties for the use of biological weapons. This act has been revised numerous times since inception.

 

China

• Regulations for Transporting Infectious and Highly Pathogenic Human Microorganisms, Bacteria, Viruses, or Specimens

  • Date: February 2006
  • Comment: These regulations indicate that when transporting highly pathogenic
    microorganisms, bacteria, viruses, or specimens, permission should be obtained from the Administrative Office in the Department of Health above the provincial level. Offenders will be punished according to the applicable Articles of Regulations for Pathogenic Microorganism and Laboratory Organism Safety Management by the State Council.

• Regulations on Biosafety Management of Pathogenic Microorganism Laboratories

  • Date: November 2004
  • Comment: The regulations cover research, teaching, detection, and diagnosis activities related to pathogenic microorganisms.

• Decree No. 365 (2002) of the State Council of the People’s Republic of China – Regulations on Export Control of Dual Use Biological Agents and Related Equipment and Technologies (Click here for an abridged English translation)

  • Date: October 2002
  • Comment: The regulations adopt international practices such as licensing systems, end-user and end-use certificates and catch-all principles, and has strict control over the export of dual-use biological agents and related equipment and technologies. The export defined by the regulations includes not only export for trade, but also exchange for gifts, exhibitions, assistance, provisions for service, and other forms of technological transfer to foreign countries including scientific information.

• Amendment III to the Criminal Law of the People’s Republic of China

  • Date: December 2001
  • Comment: This law bans the illegal manufacturing, transporting, storing, or using infectious pathogens and other criminalizes other conduct jeopardizing public security.

Source: Working Paper submitted by the Chinese Delegation to the 2005 BWC Meeting of Experts on Adopting and Implementing Codes of Conduct for Scientists

 

Cuba

• Law Against Acts of Terrorism

  • Date: 20 December, 2001
  • Comment: This Law provides penalties both for terrorist offences committed in Cuba and for offences involving preparations carried out in another country which have an effect within Cuba. All preparatory acts, attempts, and consummated acts of terrorism are punishable under this Law.
     
• Biosecurity Law

  • Date: 1999
  • Comment: This law regulates the use and transfer of biological agents in Cuba.

 

Czech Republic

• Act No. 594/2004 on the EU (regulatory) System for Exports of Goods and Dual-use Technologies

  • Date: 2004
  • Comment: This act, which was adopted after the Czech ascension to the EU, replaced Act No. 21/1997 Coll., on the Export and Import of Goods. This act adopts the EU regulations governing the import and export of dual-use technologies and those designated as sensitive by the Australia Group.
     
• Act No. 281/2002 on Some Measures Related to Prohibition of Bacteriological (Biological) and Toxin Weapons and on Amendments to Trades Licensing Act

  • Date: 30 May, 2002
  • Comment: This act implements the BWC into the Czech national legal system and designates the State Office for Nuclear Safety (SÚJB) as the responsible authority. This act was amended by Act No. 186/2004 Coll.
     

 

Finland

• Act on the control of export of dual-use goods (unofficial translation)

  • Date: 1996
  • Comment: This act governs the export of goods deemed to have both civilian and military purposes.
     
• The Biological Weapons Act

  • Date: 1975
  • Comment: This act implements the Biological Weapons Convention into the Finnish legal system.
     
• The Penal Code (unofficial translation)

  • Date: 1889
  • Comment: Prior to this amendment, criminal acts involving biological weapons would have been punishable as warfare offences, health endangerment or aggravated health endangerment. Previous legislation however did not cover certain acts involving biological weapons outside the context of warfare. A specific provision ‘Breach of the Prohibition of Biological Weapons’ was inserted into the Penal Code in 2003 (chapter 11, section 7b). It constitutes a dedicated criminalization of all acts that are contrary to the BWC. This act has been revised numerous times since inception.

 

France

• Law No. 1338 / 2004

  • Date: 8 December, 2004
  • Comment: This Law relates to inventions in biotechnology

• Law No. 206 / 2003

  • Date: 12 March, 2003
  • Comment: This law authorizes the approbation of the Carthagena protocol on biotechnological risks that followed from the biological diversity conference. The law attempts to ensure biodiversity by means of the regulation of the use etc. of genetically modified organisms.

• Ministerial Order published in the Official Journal of the French Republic JO/ 223

  • Date: September 2001
  • Comment: This order bans the fraudulent use or acquisition of dangerous pathogens by requiring government authorization for any acquisition, distribution and transport of certain agents which generate infectious diseases, pathogenic micro-organisms and toxins. A second Ministerial Order (also published JO/223) classifies those agents to be covered. Yearly reports of pathogen stocks are required by the French Agency for Sanity Safety and Health Products.

• Law N° 72 / 467

  • Date: 1992
  • Comment: This law implements the BWC into the French national legal system.
 

Germany

• Foreign Trade and Payments Ordinance

  • Date: 28 December, 1986
  • Comment: Sets requirements for the export of dual-use equipment and in its annex entitled, "The Export List," it details the biological materials and system components requiring export licenses. This act has been revised numerous times since its inception.
     
• The Act to the Convention of 10 April 1972 on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction

  • Date: 21 February, 1983
  • Comment: This act implements the BWC into German national legislation, using both attributed and non-attributed language of Article I of the BWC as prohibitive legislation. This supercedes German regulations that date from 1964 (pre-dating the BWC) relating to biological weapons.

• Infectious Disease Act

  • Date: 1979
  • Comment: This act establishes a permitting system for certain microorganisms in risk group 2 or higher.
     
• Foreign Trade and Payments Act

  • Date: 28 April, 1961
  • Comment: Sets requirements for the export of dual-use equipment. This act has been revised numerous times since its inception.
     
• War Weapons Control Act
  • Date: 1961
  • Comment: This act made the German Federal Government responsible for control of the manufacturing, transporting or marketing weapons designed or warfare.
    

India

• The Weapons of Mass Destruction and Their Delivery Systems (Prohibition of Unlawful Activities) Bill

  • Date: May, 2005
  • Comment: This bill prohibits all activities unlawful activities real ted to WMD in India, including their means of delivery and dual-use materials, equipment, and technology.
     
• Rules for the Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/ Genetically Engineered Organisms or Cells

  • Date: 5 December, 1989
  • Comment: These rules layout a framework for the use, import, and export of various microorganisms. It also identifies the authorities competent to ensure implementation of the rules and provides guidelines on the ethical and social responsibilities of the scientists, industries, institutes and funding bodies which are involved with the biological sciences.
     
• Environmental Protection Act
  • Date: 23 May, 1986
  • Comment: This Act fives the Indian Government the authority to protect the environment by establishing procedures and safeguards for handling and distributing hazardous materials.

 

Israel

• Export and Import Control Order

  • Date: 30 March, 2004
  • Comment: This order was designed to consolidate and further regulate control over chemical, biological and nuclear exports. It prohibits the export of materials and items designated for WMD programs and establishes a licensing requirement for sensitive items based on lists of the Australia Group.

 

Italy

• The Ratification Act No.618

  • Date: 1974
  • Comment: This act implements Article I of the BWC in Italy.

Japan

• Japanese National Defence and Citizen Protection from Attack by Force

  • Date: June, 2004
  • Comment: In the event that Japan is attacked, this law stipulates the responsibility of central and local government (e.g. – responsibilities of the Minister of Health and Labour in the event of an infectious disease attack) and mandates cooperation of citizens, evacuation of dwellers in order to protect citizens from the attack, and minimize the effect of the attack on Japanese society and its economy. It also stipulates that, in the event of an armed attack, the government may order facilities containing biological materials to move, restrict access to, or destroy those materials.

• Governmental Basic Directions for Addressing Bio-Chemical Terrorism

  • Date: November, 2001
  • Comment: These directions were set after the 2001 Anthrax attacks in the US in order to prevent the imitation of such crimes and other types of bio-chemical terrorism in Japan . This directions call for strengthening: the sanitary and medical systems (e.g. – through vaccine research), the ability of medical and other related organizations to address bio-terror attacks, the management of bio-chemical products, the bio-terror response abilities of police, self-defence force, and other disaster-prevention related organizations, and public knowledge of appropriate biological information.

• Ministerial Notice on Laboratory Safeguards

  • Date: October, 2001
  • Comment: The Japanese Minster of Health, Labour & Welfare issued a notice advising research institutes and laboratories to establish safeguard systems for dangerous pathogens, to ensure adequate security measures, to keep a register of dangerous pathogens and to maintain records of the possession of select agents as well as their stated purpose.

• Law Concerning Prevention of Infectious Diseases and Patients with Infectious Diseases
• Date: 1 April, 1999
• Comment: This law stipulates the responsibility of various public sector entities in regards to infectious diseases. It also categorizes diseases according to their perceived threat level. The law was amended on November 5, 2003.

• Foreign Exchange and Foreign Trade Control Law (Export Control)
• Date: 1997
• Comment: This law designates technologies (dual-use) that require a permit prior to exportation.
   
• The Law on the Prevention of Personal Injury by Sarin

  • Date: April 21, 1995
• Comment: This law stipulates the responsibility of various public sector entities in regards to an attack involving Sarin or any other chemical compound.
   
• Law Implementing Biological Weapons Convention
• Date: June, 1982
• Comment: This law prohibits the possession or use of biological weapons, in accordance with Article IV of the BWC. It was amended in 2001.
   
• Foreign Exchange Control Order
• Date: 1980
• Comment: This law requires that all transactions having an impact on national interests, including WMD related materials, require a license from the Minister of International Trade and Industry. It has been amended numerous times since its inception.
  
• Foreign Exchange and Foreign Trade Law
• Date: 1949
• Comment: This law requires that all transactions having an impact on national interests, including WMD related materials, require a license from the Minister of International Trade and Industry. It has been amended numerous times since its inception.

• Exchange Trade Control Order
• Date: 1949
• Comment: This law lays out the items which are regulated by the Foreign Exchange and Foreign Trade Law. It has been amended numerous times since its inception.

 

Kazakhstan

• Criminal Code

  • Date: 1 January, 1998
  • Comment: The Kazakh criminal code has numerous articles referring to biological weapons. Articles 158 and 159 of the code makes production, acquisition, sale, and use of WMD is illegal. Article 243 states that the illegal export of technology, scientific and technical information, or services that could be used for the production of WMD, conventional arms, or military equipment subject to special export control, is punishable fines and/or incarceration. Article 250 prohibits the smuggling of nuclear, biological, and chemical weapons, or materials and equipment that could be used in the production of these weapons, across borders.
    

• Law on Export Control of Weapons, Military Technology, and Dual Use Goods

  • Date: 18 June, 1996
  • Comment: This law sets up an export control regime for WMD materials and agents listed by the Australia Group.

 

New Zealand

• Hazardous Substances and New Organisms Act 1996 (Linked to the "Statutes of New Zealand" page and the Act is found under "H" at left of page)
  • Date: 10 June, 1996
  • Comment: This Act restates and reforms the law relating to the management of hazardous substances and new organisms. This act has been revised numerous times since its inception.
    
    
• Biosecurity Act 1993 (Linked to the "Statutes of New Zealand" page and the Act is found under "B" at left of page)

  • Date: 26 August, 1993
  • Comment: An Act that restates and reforms the law relating to the exclusion, eradication, and effective management of pests and unwanted organisms. In this context, biosecurity refers to invasive species that affect agriculture and Biodiversity. This act has been revised numerous times since its inception.

 

Russia

• Regulation No. 634 - Control Over Foreign Activity in respect to Pathogens...Equipment and Technologies

  • Date: 2001
  • Comment: COMING SOON
     
• Presidential Decree No. 1004 - Approval of the List ... Subject to Export Control

  • Date: August 8, 2001
  • Comment: This decree approved the list of biological agents, materials, equipment, and technologies subject to export control.

  
  
• Federal Law No. 183 - Export Control

  • Date: 1999
  • Comment: This law specifies the rules governing the export of materials, equipment, and information that could be used in the production of WMD.

  
  
• Presidential Decree No. 651 & Governmental Resolution No. 906

  • Date: 1999
  • Comment: Creates the Russian Munitions Agency which is responsible for for monitoring compliance of Russia's international obligations in terms of biological weapons.
     
• Criminal Code
  • Date: 1996
  • Comment: The Russian criminal code has numerous articles referring to biological weapons. Article 188 and 189 prohibit the movement through customs borders or the transfer to foreign nationals of equipment, materials, or knowledge that can be used to produce WMD. Article 226 explicitly criminalizes the stealing of WMD and likewise of materials or equipment which can be used in their development. Article 248 proposes the penalties for the violation of safety rules that deal with microbiological or other biological agents or toxins. Articles 355 and 356 make the use or sale of any type WMD, including biological weapons, illegal.
     
• Presidential Decree No. 390 - Ensuring Fulfillment of International Obligations in the Field of Biological Weapons

  • Date: 11 April, 1995
  • Comment: This decree states that no activities in conflict with the Biological Weapons Convention are permitted inside Russian territory.

 

Singapore

• Biological Agents & Toxins Bill

  • Date: 18 October, 2005
  • Comment: The bill sets up a framework regulating biological activities in Singapore which addresses import/export controls, biosafety, and biological terrorism. It imposes up to a one million dollar fine and life imprisonment for anyone found flouting its rules.

 

South Africa

• The National Health Act No. 61, 2003

  • Date: 2003
  • Comment: This act lays out the functions of Ethics Committees.

• The Non-Proliferation and Weapons of Mass Destruction Act
  • Date: 1993
  • Comment: Implements the BWC through national legislation: provides for the control, register and inspection of certain controlled goods. This act was amended in 1995 and 1996.

 

South Korea

• Counter Terrorism Act 2001

  • Date: 2001
  • Comment: This act establishes a National Counter-Terrorism Council and gives more authority to the government's fight against terrorism.

 

Switzerland

• Ordinance on the Export, Import, and Transfer of Dual-Use Goods (In French)

  • Date: 25 June, 1997
  • Comment: This ordinance enforces the Australia Group regulations in Switzerland and grants trade permits for dual-use items. It has been revised since inception.

• The Federal Law on War Materials (In French)
  • Date: 13 December, 1996
  • Comment: Implements the BWC into Swiss national legislation. It has been revised since inception.
     
• The Ordinance on the Contained Use of Organisms (In French)
  • Date: 25 August, 1995
  • Comment: This ordinance regulates the use and transport of GMOs, pathogens, and certain types of confidential information. It has been revised since inception.

 

United Kingdom

• Export Control Act 2002

  • Date: 2002
  • Comment: The secondary legislation to the Export Control Act 2002, introduced in 2004, added provisions which regulate the transfer of intangible technologies.

 

United States

• Syria Accountability and Lebanese Sovereignty Restoration Act of 2003

  • Date: 12 December, 2003
  • Comment: The act states that “the government of Syria should … cease the development and production of biological and chemical weapons.” The act makes U.S. policy that “Syria’s acquisition of weapons of mass destruction and ballistic missile programs threaten the security of the Middle East and the national interests of the United States .”