Relevant quotes

Primary motivation

“In the 19th century. there were 10 of these conferences.”
In the mid-nineteenth century a series of “International Sanitary Conferences” were held in Paris, Vienna, Constantinople, Washington, Rome and Dresden with the goal of interrupting recurring epidemics of three diseases recently arrived or reappearing in Europe and North America: cholera, plague and yellow fever
Over the course of 14 meetings starting in 1851 and ending in 1938, participants from the medical and diplomatic communities debated the origins of these diseases and the preventive actions that could be taken to “protect [people] and control” biological agents. This was the naissance of biosecurity in its most straightforward sense, and in retrospect is surprising given that the germ theory of disease was, at that moment in history, barely being formulated and understood.

https://en.wikipedia.org/wiki/International_Health_Regulations#Early_history
https://www.sciencedirect.com/science/article/pii/B9780128018859000019?ref=pdf_download&fr=RR-2&rr=7db3d3682c437306

https://watermark.silverchair.com/jmi029.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAAs0wggLJBgkqhkiG9w0BBwagggK6MIICtgIBADCCAq8GCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMgzFWErzIfXnajOC_AgEQgIICgJ94v0DiauV_UcC6oFjtB76nw97Ks1GS9xUf8X3FuJ9oMxhZk_xYjnomaxwoM3ZzU0IUIStxLU7eeCaBR6hulyFY0EJN5-x11r-gCPDN5bye-EIkAWdyYpxUvY_t-IQmzOxNCkaq8viPhLwxaWplRNn4dXKSwc8oL67p0TviOA185TbJht-VCZS3EJMIoyNiA-RPeeZOdPt_D0ELPkm6fbtHSSUPOh50vjdu4F8YdWn1z8AdsVYvY0WAcG4x5Od8hKY_ZHcj5pab8qPAOW0_WUM_fpWQfzS5vPt7a5RDaRaOkeLhdNhqiJTrGITxkxOtMZ95LqsapULooxwDiz37wXYbZ569TmLV3LsCpL3S0KTtSwMliPz-293nsJjTRxCA_zap4Yc4LTMcSNSPKsyCteWcZVnYonyn7ozaWlWT9sTeJSf6WmymXONW6NA1nnYKZvH6xZtZwJ-pgFB91EeYb9GTnLfRExXSlM_kXO5auvg090g8yzKWBhx1-6WR8cBVwbjpGtkeXhqSEZLaPBUjF7AWN_myE3sDFj5ziR3cyrPgnGjb0pLICXm1asyqdUX1z1yHHHgP8-NApjuQZYpKdlgMtI1B7V4FsEyg2413BkLl0vwhvplkC-Er6Cr7FMdH2H9-U2kaO_lZrTpnq5JEOndSM5KbtOdm9q8OS6g99Lc0Z8G8KHThllk3ZVzi-z5duCC0NVIildJhO28kgmSFAmh52L3V6BQNSP-pUtJqvW0YElaRLbAnUgnggU-vwwnxbCQFL6dbs5sQNFosB1AoJcZL5s802Wy4_5jT5cCN9UpGuRDecUrEYiRxFYwXBmWmQ4IOzIkUo35GP_thM8YyqMg

As the Sanitary Conferences continued to meet, in December 1907 representatives decided to formalize the forum into the “Office International d’Hygiène Publique” (OIHP), ultimately subsumed into the League of Nations at the end of World War I. It became known as the League’s “Health Organization”

The Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or other Gases, and of Bacteriological Methods of Warfare
However, only the use—and not the development or possession—of chemical and biological weapons was banned. Many signatories reserved the right to retaliate in-kind against states that violated the Protocol, making it de facto more of a “nofirst-use” agreement.

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

The OIHP continued to operate until 1946 when the nascent World Health Organization (WHO), today’s premier international health security institution, subsumed its functions

https://www.sciencedirect.com/science/article/pii/B9780128018859000019?ref=pdf_download&fr=RR-2&rr=7db3d3682c437306

https://en.wikipedia.org/wiki/International_Health_Regulations#Early_history

“the International Plant Protection Convention (IPPC) in 1951, a multilateral treaty deposited with the Food and Agriculture Organization of the United Nations (FAO). The IPPC is the standard setting organization for the “Agreement on the Application of Sanitary and Phytosanitary Measures” (the SPS Agreement) of the World Trade Organization (WTO). Specific “International Standards for Phytosanitary Measures” (ISPMs) cover topics such as lists of quarantine organisms, pest risk analysis, or the design of plant quarantine stations, all of which are relevant when applying plant pests under containment in a laboratory or plant growing facility (FAO/IPPC, 2019a).”

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

Became IHR - the ISR were revised and renamed the 'International Health Regulations'.”

https://en.wikipedia.org/wiki/International_Health_Regulations#Early_history

https://www.ippc.int/en/history-of-the-ippc/#:~:text=The%20IPPC%20came%20into%20force,previous%20international%20plant%20protection%20agreements

The Work Organization and Supervision Law (195484) outlines governmental inspection authority for laboratories under MITL oversight, establishes the Institute of Safety and Hygiene, and institutes requirements for institutional safety committees, trustees, and officers.

https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

“ABSA now represents biosafety professionals in 20 countries,”

https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf

https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf

https://www.researchgate.net/publication/276294176_Laboratory_Biorisk_Management_Biosafety_and_Biosecurity

Traditionally addressing animal health and zoonoses only, these codes have been expanded to also cover animal welfare, animal production, and food safety in recent updates (OIE, 2019).

These organizations and conventions provide governance on biosafety and biosecurity through a set of internationally accepted reference documents setting out objectives, principles, and requirements. Depending on the document, some of them have a legal basis while others are considered as best practices documents.
Some of these reference documents have also served as the foundation for the development of national biosafety and biosecurity legislation, regulations and policies, either by including and refining the concepts mentioned in these documents or including the compliance with these documents as a requirement in the legislation.

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://en.wikipedia.org/wiki/International_Health_Regulations

The Work Safety Ordinance (New Version), published in 197084,87, establishes oversight and regulatory authority for biological, chemical, and medical laboratories.

https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

The relevant regulations and guidelines are found in four places
Releavnt part: the General Duty Clause. Also includes mention of protective equipment

https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf

In 1971, Paul Berg was able to construct the first recombinant viral vector system by splicing genes into the simian virus, SV40. Members of the scientific community began a peer exchange of views that resulted in the first Asilomar conference, held in January 1973.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3900000/

It took until 1972, with the “Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction” (commonly known as the “Biological Weapons Convention” or BWC), before also the development, production, storage, or otherwise acquiring or retaining biological agents and toxins, or related biological weapons or equipment, was prohibited.

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

At the 1973 Gordon Research Conference on Nucleic Acids, Herbert Boyer10 described methods that radically improved the ease of recombinant DNA production and made it possible to combine DNA from any two organisms.

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://intelligence.org/files/TheAsilomarConference.pdf

The so-called Asilomar Conference was really the second Asilomar Conference. The first was a year and a half earlier and dealt with risks from working with tumor viruses

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://intelligence.org/files/TheAsilomarConference.pdf

https://www.hse.gov.uk/legislation/hswa.htm

The relevant regulations and guidelines are found in four places

https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.132
https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf
"https://www.osha.gov/personal-protective-equipment/standards
https://www.osha.gov/sites/default/files/publications/osha3151.pdf"

Classification of Etiological Agents on the Basis of Hazard published

n 1974, the CDC had published the Classification of Etiological Agents on the Basis of Hazard (US Centers for Disease Control and Prevention 1974), which introduced the concept of establishing ascending levels of containment that correspond to risks associated with handling groups of infectious microorganisms that present similar characteristics—or so-called agent risk groups.

https://www.researchgate.net/publication/276294176_Laboratory_Biorisk_Management_Biosafety_and_Biosecurity

https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf

They also updated their Biological Weapons Act (1974), which defined such acts as criminal and subject to life imprisonment. The range of forbidden acts was widened to include “aempt, preparation, conspiracy, assistance, promotion, persuasion, and other acts.” The law was also given extraterritorial force and applied to British subjects abroad

https://www.academy.ac.il/SystemFiles/21677.pdf

July: The chair of the seven-member NAS committee presents the committee’s recommendations, including for the
deferral of certain risky types of rDNA research; the establishment by NIH of an advisory committee to assess the
risks of the research, develop procedures to limit such risks,
and develop guidelines for research; and the convening of a
conference to further discuss ways to deal with hazards of
rDNA research (Berg et al., 1974).

Gordon Conference attendees discussed hazards informally, then voted to write to the President of the National Academy of Sciences (NAS) asking that a group be set up to examine the risks. Singer and conference co-chair Dieter Söll, wrote this letter13 and made it public. The NAS responded by forming a committee, chaired by Paul Berg, to examine the risks and benefits of recombinant DNA technology. In July 1974 the Berg committee called for a voluntary moratorium on a class of recombinant DNA experiments.14 While there was some disagreement about this action, the moratorium was universally adhered to. The moratorium was, in part, intended to give time for a conference that would assess the risks. This was the Asilomar Conference on Recombinant DNA Molecules.

the NIH RAC had been in existence since 1975 and functioning as a review body since 1976

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3900000/

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

In response to WHO 1976 publication
The “NIH guidelines”, revised in 1979, were used as a starting point for many regulations on contained use
The relevant regulations and guidelines are found in four places
Following the conclusion of the conference, a letter was published in Science that confirmed the paucity of knowledge about the consequence of this type of experimentation (Berg et al., 1974). Shortly thereafter, the National Academy of Sciences established a committee to study recombinant DNA technology; this move brought the matter to the attention of both the press and the public. The second Asilomar conference was convened in February 1975, and this resulted in an extensive debate about the putative dangers of recombinant DNA experimentation. Inevitably, there were definitive differences of opinion, but the participating scientists agreed to a voluntary moratorium on certain kinds of experiments. On the first day following the conference, Dr. Donald Fredrickson, then director of the National Institutes of Health (NIH), set in motion the machinery that resulted in the formation of the NIH Recombinant DNA Advisory Committee (RAC). Members of the RAC began the formidable task of creating the NIH Guidelines for Research Involving Recombinant DNA Molecules. On June 23, 1976, the NIH Guidelines were first published in the Federal Register.

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3900000/

Sgaramella V., Letter Addressed to Maxine Singer of the National Institutes of Health.

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

Prior to this event, the World Health Organization (WHO) had informed Henry Bedson, the head of the medical microbiology department, that his facilities did not conform to the WHO guidelines. Bedson failed to make any of the WHO’s recommended changes in lab procedures

https://www.researchgate.net/publication/276294176_Laboratory_Biorisk_Management_Biosafety_and_Biosecurity

https://academic.oup.com/jlb/article/8/1/lsab020/6311556

Biosafety, biosecurity

https://en.wikipedia.org/wiki/Epidemiology_of_HIV/AIDS

The Advisory Committee on Dangerous Pathogens (ACDP) is an advisory
committee of the Health and Safety Commission and also advises Health and
Agriculture Ministers.
The ACDP was set up in 1981 following a second outbreak (resulting in a third
death) of laboratory-acquired smallpox and was the successor to the
Dangerous Pathogens Advisory Group. The Committee has an independent
chairman and a joint secretariat provided by the Department of Health and the
Health and Safety Executive.
There are eight expert members chosen from names put forward by
professional bodies, four representatives of employees and four of employers
(see overleaf). In addition, the committee is attended by observers from HSE,
the Department of Health, the Ministry of Agriculture, Fisheries and Food, the
Ministry of Defence and government departments in Scotland, Wales and
Northern Ireland.

https://www.hseni.gov.uk/sites/hseni.gov.uk/files/publications/%5Bcurrent-domain%3Amachine-name%5D/categorisation-of-biological-agents.pdf

2001: In Article 125, the contents of the expression ‘illegally sell, buy, or transport nuclear material’ are expanded to include ‘illegally produce, sell, buy, transport, or store toxic, radioactive, or contagiously pathogenic substances’. In Article 127, the ‘theft of toxic, radioactive and contagiously pathogenic substances’ is added to the sentencing criterion for the offences of ‘theft of firearm, ammunition, and explosives’. In Article 291, the item ‘deploying fake explosive, toxic, radioactive, or contagiously pathogenic substances, starting a rumour about an explosion, bio-menace, radioactive hazard, and other frightening information, or knowingly spreading fabricated frightening rumours’ is added

Biosafety, biosecurity

These organizations and conventions provide governance on biosafety and biosecurity through a set of internationally accepted reference documents setting out objectives, principles, and requirements. Depending on the document, some of them have a legal basis while others are considered as best practices documents.
Some of these reference documents have also served as the foundation for the development of national biosafety and biosecurity legislation, regulations and policies, either by including and refining the concepts mentioned in these documents or including the compliance with these documents as a requirement in the legislation.
These documents established the paradigm of biosafety containment levels that should be implemented for work with certain agents

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://www.researchgate.net/publication/276294176_Laboratory_Biorisk_Management_Biosafety_and_Biosecurity
https://www.who.int/publications/i/item/9241546506

These documents established the paradigm of biosafety containment levels that should be implemented for work with certain agents
"These organizations and conventions provide governance on biosafety and biosecurity through a set of internationally accepted reference documents setting out objectives, principles, and requirements. Depending on the document, some of them have a legal basis while others are considered as best practices documents.
Some of these reference documents have also served as the foundation for the development of national biosafety and biosecurity legislation, regulations and policies, either by including and refining the concepts mentioned in these documents or including the compliance with these documents as a requirement in the legislation.
released by the NIH and CDC.2
The relevant regulations and guidelines are found in four places"

https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf
https://www.researchgate.net/publication/276294176_Laboratory_Biorisk_Management_Biosafety_and_Biosecurity
https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

https://www.phe.gov/s3/BioriskManagement/biosecurity/Pages/History.aspx

https://www.researchgate.net/publication/276294176_Laboratory_Biorisk_Management_Biosafety_and_Biosecurity

Categorisation of biological agents according to hazard and categories of containment

The first edition of the now familiar categorisation of pathogens from the ACDP
appeared early in 1984 and following thorough review, a revision was published
in 1990. Those publications set and helped maintain new practical standards
for the safe conduct of laboratory work with infectious agents. Both editions
had the status of guidance supporting the Health and Safety at Work Act and
more lately the Control of Substances Hazardous to Health Regulations 1988
(COSHH).
Included Approved list of biological agents from 1995, published separately from 2000

https://www.hseni.gov.uk/sites/hseni.gov.uk/files/publications/%5Bcurrent-domain%3Amachine-name%5D/categorisation-of-biological-agents.pdf

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

GMO contained use and deliberate release

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

GMO contained use and deliberate release

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

Worker protection

“A group of 43 State Parties to the BWC has joined forces in the so-called “Australia Group”, an informal forum for countries to assist in the implementation of consistent export controls on goods that might contribute to the proliferation of biological or chemical weapons, thereby fulfilling their obligations to both the BWC and the Chemical Weapons Convention (AG, 2020).”

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://en.wikipedia.org/wiki/Australia_Group
https://www.dfat.gov.au/publications/minisite/theaustraliagroupnet/site/en/controllists.html

Canada Occupational Health and Safety Regulations (SOR/86-304)

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://laws-lois.justice.gc.ca/eng/regulations/sor-86-304/page-1.html

Worker protection

Customs Law (NPC Standing Committee, 1987; most recent amendment, 2017)*

https://academic.oup.com/jlb/article/8/1/lsab020/6311556

A brief history of the development of infectious disease prevention, control, and biosafety programs in China

These organizations and conventions provide governance on biosafety and biosecurity through a set of internationally accepted reference documents setting out objectives, principles, and requirements. Depending on the document, some of them have a legal basis while others are considered as best practices documents.
Some of these reference documents have also served as the foundation for the development of national biosafety and biosecurity legislation, regulations and policies, either by including and refining the concepts mentioned in these documents or including the compliance with these documents as a requirement in the legislation.

the United States toughened the sanctions in its Biological Weapons Anti-Terrorism Act of 1989, which forbids “any person from knowingly engaging in the following actions: manufacture, possession, use, stockpiling, storage, transfer, and associated actions regarding dangerous biological agents as defined in the act, for any purpose not permied by law.”

https://www.academy.ac.il/SystemFiles/21677.pdf

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

GMO contained use and deliberate release

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

GMO contained use and deliberate release

Work Supervision Organization Regulations (Environmental Monitoring and Biological Monitoring of Persons Handling Dangerous Agents)

The Work Supervision Organization Regulations (Environmental Monitoring and Biological Monitoring of Persons Handling Dangerous Agents), published in 1990, “impose environmental monitoring at an enterprise or workplace engaged in work with certain harmful agents,” specifically “harmful chemical and physical agents located in the workplace to which the workers are exposed in the course of work.”

https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

Animal protection

The relevant regulations and guidelines are found in four places

https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030
https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf
"https://www.osha.gov/bloodborne-pathogens/quick-reference
https://www.ncbi.nlm.nih.gov/books/NBK570561/"

History of and suggestions for China’s biosafety legislation

Australia Group agrees to control the export of biological agents

"Evidence of the diversion of dual-use materials to biological weapons programs in the early 1990s led to participants’ adoption of export controls on specific biological agents. The control lists developed by the Group have also expanded to include technologies and equipment which can be used in the manufacturing or disposal of chemical and biological weapons."

https://www.dfat.gov.au/publications/minisite/theaustraliagroupnet/site/en/origins.html
https://www.britannica.com/topic/Australia-Group

The Canadian Council of Ministers of the Environment (CCME) published the document “Guidelines for the Management of Biomedical Waste in Canada” (1992) as a basis for development of local regulations

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

the Convention on Biological Diversity
(CBD) and its associated Cartagena and Nagoya Protocols,
The Convention has three main goals: the conservation of biological diversity (or biodiversity); the sustainable use of its components; and the fair and equitable sharing of benefits arising from genetic resources. Its objective is to develop national strategies for the conservation and sustainable use of biological diversity, and it is often seen as the key document regarding sustainable development.

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://en.wikipedia.org/wiki/Convention_on_Biological_Diversity

In general, a systematic legal system for human gene technology is lacking in China.

History of and suggestions for China’s biosafety legislation

Germany
Amended in 2008 https://www.ecolex.org/details/legislation/act-amending-the-genetic-technology-act-the-genetic-engineering-implementation-act-and-the-new-foodstuffs-and-new-ingredients-ordinance-lex-faoc081030/

Comparison of International Guidance for Biosafety Regarding Work Conducted at Biosafety Level 3 (BSL-3) and Gain-ofFunction (GOF) Experiments
https://www.nihs.go.jp/dnfi/pdf/German%20Genetic%20Engineering%20Act%20(GenTG).pdf

The national Sanitary Regulations (SR) in 1993 were Russia’s first published policy on biosafety practices. This document has been updated since its original publication and includes facility biosafety categorizations, accountability to biosafety policy, and a standard for biosafety training.157

https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

From 1994 to 2009, federal oversight of human pathogens and toxins was limited to facilities importing
human pathogens and toxins into Canada under the Human Pathogens Importation Regulations (HPIR).

https://www.phac-aspc.gc.ca/publicat/ccdr-rmtc/15vol41/dr-rm41s-6/assets/pdf/15vol41s-6_regulations-reglementation-eng.pdf

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

These organizations and conventions provide governance on biosafety and biosecurity through a set of internationally accepted reference documents setting out objectives, principles, and requirements. Depending on the document, some of them have a legal basis while others are considered as best practices documents.
Some of these reference documents have also served as the foundation for the development of national biosafety and biosecurity legislation, regulations and policies, either by including and refining the concepts mentioned in these documents or including the compliance with these documents as a requirement in the legislation.

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://www.woah.org/en/what-we-do/standards/

Traditionally addressing animal health and zoonoses only, these codes have been expanded to also cover animal welfare, animal production, and food safety in recent updates (OIE, 2019).

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full
https://www.woah.org/en/what-we-do/standards/

On April 19, 1995 the Alfred P. Murrah Federal Building in Oklahoma City was destroyed by a truck bomb planted by Timothy McVeigh, a former solider and militia movement sympathizer. This event, which resulted in 169 deaths and hundreds of injuries and property damage in excess of a half-billion dollars, stood as the deadliest terrorist attack on US soil until the downing of the World Trade Center 6 years later.
Prompted the antiterrorism act

https://www.sciencedirect.com/science/article/pii/B9780128018859000019?ref=pdf_download&fr=RR-2&rr=7db3d3682c437306

Select agent regulations

https://www.selectagents.gov/overview/history.htm

Select agent regulations

The Reporting of Injuries, Disease and Dangerous Occurrences Regulations 1995 (RIDDOR) (Updated in 2008, 2013) HSE guidelines for reporting incidents

https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

A former Aryan Nations member illegally obtained a bacterium that causes plague (Yersinia pestis) by mail order. As a result, Congress passed Section 511 of the Antiterrorism and Effective Death Penalty Act of 1996 requiring HHS to publish regulations for the transfers of select agents that have the potential to pose a severe threat to public health and safety (Additional Requirements for Facilities Transferring or Receiving Select Agents, 42 CFR Part 72.6; effective April 15, 1997).

● “Establish and maintain a list of each biological agent that has the potential to pose a severe threat to public health and safety,” based on specific criteria including effect on human health, degree of contagiousness, availability and effectiveness of immunization and treatments for illness caused by the agent, and “any other criteria that the Secretary considers appropriate in consultation with scientific experts.”
● Regulate transfers of listed biological agents including establishing and enforcing safety procedures, safeguards to prevent access to listed agents for use in terrorism or other criminal purposes while maintaining “appropriate availability of biological agents for research, education, and other legitimate purposes”

https://www.selectagents.gov/overview/history.htm
https://www.sciencedirect.com/science/article/pii/B9780128018859000019?ref=pdf_download&fr=RR-2&rr=7db3d3682c437306

Select agent regulations

The final rule took into account over 200 written comments and was published in the FR on October 24, 1996

https://www.researchgate.net/publication/276294176_Laboratory_Biorisk_Management_Biosafety_and_Biosecurity
https://www.sciencedirect.com/science/article/pii/B9780128018859000019?ref=pdf_download&fr=RR-2&rr=7db3d3682c437306

Select agent regulations

https://www.cdc.gov/washington/testimony/2007/t20071004a.htm

Select agent regulations

https://nap.nationalacademies.org/catalog/18577/oversight-and-review-of-clinical-gene-transfer-protocols-assessing-the

With the regulations that went into effect in April 1997 (42 CFR 72.6), the Secretary of HHS established a list of biological agents that have the potential to pose a severe threat to public health and safety.
The relevant regulations and guidelines are found in four places
Code of Federal Regulations: Select Agent and Toxins Rule, HHS and USDA

Select agent regulations

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

Under the Control of Substances Hazardous to Health Regulations 2002, Biological agents are defined as any micro‐organism, cell culture, prion or human endoparasite which could be hazardous to human health. This includes genetically modified as well as non GM agents. Biological agents are classified into one of four hazard groups (HG1‐4) and concordant containment levels (CL1‐4) that indicate what kind of containment and control measures should be in place in the laboratory. Regulation is based on the categorization of pathogens into 4 groups, CL1‐4

Comparison of International Guidance for Biosafety Regarding Work Conducted at Biosafety Level 3 (BSL-3) and Gain-ofFunction (GOF) Experiments
https://www.hse.gov.uk/biosafety/management-containment-labs.pdf
https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

The Canadian Environmental Protection Act 1999 (S.C. 1999, c. 33), Part 6 – Animate Products of Biotechnology

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

GMO contained use and deliberate release

“LMOs [Living Modified Organisms] that are subject
to intentional transboundary movement within the scope of
the Protocol are [to be] handled, packaged, and transported
under conditions of safety, taking into consideration relevant
international rules and standards”

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

The Needlestick Safety and Prevention Act (the Act) (Pub. L. 106-430) was signed into law on November 6, 2000. Because occupational exposure to bloodborne pathogens from accidental sharps injuries in healthcare and other occupational settings continues to be a serious problem, Congress required modification of OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) to set forth in greater detail (and make more specific) OSHA's requirement for employers to identify, evaluate and implement safer medical devices such as needleless systems and sharps with engineered sharps protections. The Act also mandated additional requirements for maintaining a sharps injury log and for the involvement of non-managerial healthcare workers in identifying, evaluating and choosing effective engineering and work practice controls.

https://www.osha.gov/bloodborne-pathogens/quick-reference

Comparison of International Guidance for Biosafety Regarding Work Conducted at Biosafety Level 3 (BSL-3) and Gain-ofFunction (GOF) Experiments
https://osha.europa.eu/en/legislation/directives/exposure-to-biological-agents/77#:~:text=This%20Directive%20lays%20down%20minimum,to%20biological%20agents%20at%20work.&text=Definitions%20of%20the%20terms%20biological,micro%2Dorganisms%20and%20cell%20culture.

Comparison of International Guidance for Biosafety Regarding Work Conducted at Biosafety Level 3 (BSL-3) and Gain-ofFunction (GOF) Experiments
https://ablis.business.gov.au/service/ag/australian-new-zealand-standard-as-nzs-2243-3-2010-safety-in-laboratories-microbiological-safety-and-containment/31039#:~:text=Description,conditions%2C%20without%20requiring%20a%20licence.

https://www.academy.ac.il/SystemFiles/21677.pdf

Work Safety Regulations (Occupational Safety and Hygiene in the Handling of Dangerous Agents in Medical, Chemical and Biological Laboratories)

The Work Safety Regulations (Occupational Safety and Hygiene in the Handling of Dangerous Agents in Medical, Chemical and Biological Laboratories), published in 2001, define pathogen risk groups and differentiates types of laboratories (e.g., biological, chemical; medical, research, teaching, quality control). They also delineate responsibilities of the laboratory holder and workers and specify occupational safety measures for laboratories, worker training requirements, and notification of intent to work with “dangerous agents.” (NOTE: these regulations precede the official Dangerous Agents list and presumably refer to “dangerous agents” in the general sense). Additionally, these regulations cover the general experience level for workers and supervisors, physical containment requirements, and personal protective equipment (PPE) for each risk group of biological agents.

https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

Following the anthrax attacks of 2001 that resulted in five deaths, Congress significantly strengthened oversight of select agents by passing the USA PATRIOT Act in 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requiring HHS & USDA to publish regulations for possession, use, and transfer of select agents (Select Agent Regulations, 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73; effective February 7, 2003).
While not directly impacting laboratory biosecurity, the Act defines possessing a biological weapon as a crime and also defined a “restricted person” as one who may not ship or transport any biological agent or toxin that is listed as a select agent

https://www.selectagents.gov/overview/history.htm
https://docs.google.com/document/d/165__Rv23pa05j14e4RelAqRdOAsU3denChe4Uu8d8aI/edit
"https://www.cdc.gov/washington/testimony/2007/t20071004a.htm
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4285169/ "

Select agent regulations

https://www.osha.gov/bloodborne-pathogens/quick-reference

Select agent regulations

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00650/full

Select agent regulations

https://www.academy.ac.il/SystemFiles/21677.pdf

Safety Oversight Order for Medical, Biological and Chemical Laboratories

All Israeli academic research institutions have safety units, a full-time safety director, and safety committees. Each safety system complies with the relevant laws and the directives of the Ministry of Industry, Trade and Labor (MITL) Workplace Inspection Division. Relevant laws include the Workplace Safety Order (1970), the Workplace Inspection Organization Law (1945), and the Safety Oversight Order for Medical, Biological and Chemical Laboratories (2001).

https://link.springer.com/article/10.1007/s11948-008-9075-4

Management, design, and operation of microbiological containment laboratories

UK
The Management, design, and operation of microbiological containment laboratories (2001) ACDP guidelines for general management of BSL 2‐3 facilities

https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

The Anti‐terrorism Crime and Security Act 2001 (ATCSA) allows the policy to impose security measures on laboratories which handle pathogens of particular concern. Implemented by the National Counter‐Terrorism Security Office (NaCTSO)

https://web.archive.org/web/20161109085425/http://www.upmchealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/Combined%20Biosafety%20Case%20Studies%20final%20draft%20062116.pdf

Regulations on the Export Control of Dual-Use Biological Products and Related Equipment and Technologies (State Council, 2002)**

https://academic.oup.com/jlb/article/8/1/lsab020/6311556

Public Health Security and Bioterrorism Preparedness and Response Act

Following the anthrax attacks of 2001 that resulted in five deaths, Congress significantly strengthened oversight of select agents by passing the USA PATRIOT Act in 2001 and the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requiring HHS & USDA to publish regulations for possession, use, and transfer of select agents (Select Agent Regulations, 7 CFR Part 331, 9 CFR Part 121, and 42 CFR Part 73; effective February 7, 2003).
required institutions to notify HHS and/or the USDA of possession of select agents or high-consequence pathogens and instituted increased oversight mechanisms for use of and access to the agents.
The Secretaries of both HHS and USDA must undertake a biennial review of select agents and are instructed to consider agents that should be added or removed from the SATL. The purpose of including the Department of Agriculture was so that biological materials dangerous to animals or plants could be included in the SATL. This would thus enlist the expertise of specialists in the USDA not necessarily available at CDC. ● Required all persons in possession of a Select Agent notify the Secretary of HHS by September 2002. ● Required security risk assessments to be conducted by the FBI of the Department of Justice, in effect security clearances for all individuals who might work with select agents in any laboratory possessing them. ● Required all facilities in possession of select agents to designate an RO who “will need to inventory its facility and consult with others (e.g. principal investigators) as necessary to obtain the information required for this application”

https://www.selectagents.gov/overview/history.htm
https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf
https://www.sciencedirect.com/science/article/pii/B9780128018859000019?ref=pdf_download&fr=RR-2&rr=7db3d3682c437306
"https://www.cdc.gov/washington/testimony/2007/t20071004a.htm
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4285169/ "

Select agent regulations

Laboratory Security and Emergency Response Guidance for Laboratories working with Select Agents

https://pubs.fas.org/pir/2011fall/2011fall-bioagents.pdf

Select agent regulations

https://en.wikipedia.org/wiki/International_Health_Regulations#Early_history

General Guidelines for Biosafety in Microbiological and Biomedical Laboratories (WS 233 – 2002)

In December 2002, the Ministry of Health approved and promulgated the industry standards: General Guidelines for Biosafety in Microbiological and Biomedical Laboratories (WS 233 – 2002), a pioneering achievement in the field of biosafety in China.

A brief history of the development of infectious disease prevention, control, and biosafety programs in China

Interim Measures for the Management of Infectious SARS Virus Research Laboratories (Ministry of Science and Technology, Ministry of Health, State Food and Drug Administration, and State Environmental Protection Administration, 2003)***

Among the two earliest in the paper

https://academic.oup.com/jlb/article/8/1/lsab020/6311556

a report from the National Research Council of the National Academies entitled, Biotechnology Research in an Age of Terrorism , often referred to as the “Fink Report” was released. This report called for more oversight from and self-policing by scientists in life sciences and recommended that the Department of Health and Human Services (HHS) set up a national board to offer guidance to funding agencies
The National Research Council in 2003 released “Biotechnology Research in an Age of Terrorism” [20]. This document focused mainly on Dual Use Research of Concern, but also recommended the creation of a National Science Advisory Board for Biodefense (NSABB) that, inter alia would periodically review existing federal government legislation to “provide protection of biological materials and supervision of personnel working with these materials

https://www.phe.gov/s3/BioriskManagement/biosecurity/Pages/History.aspx
https://www.sciencedirect.com/science/article/pii/B9780128018859000019?ref=pdf_download&fr=RR-2&rr=7db3d3682c437306