Evaluation of the Lab Escape risk by the Chinese authorities
Note: this is a short adaptation of a section of ‘Outlines of a probabilistic evaluation of possible SARS-CoV-2 origins’ by G. Demaneuf and R. De Maistre, http://dx.doi.org/10.5281/zenodo.4067919.
A review of Chinese scientific papers and government-aligned publications shows that the relevant Chinese supervising authorities and the Chinese government itself have consistently evaluated the Lab Escape risk as all too real. Their declarations and writings are therefore consistent with the scale of the Lab Escape risk highlighted in this paper. Here is a quick review of such evaluations:
Yang Zhanqiu’s evaluation of the risk in Chinese BSL labs (16th Feb 2020):
Yang Zhanqiu, a deputy director of the pathogen biology department at Wuhan University, was recently quoted by the Global Times, a Chinese newspaper considered as strongly aligned with the government [52]. The article shows a clear understanding of the risks:
‘The Ministry of Science and Technology issued new rules [ — ] that experts said could fix chronic inadequate management issues [ — ]. The release of the guideline deals with chronic loopholes at laboratories [ — ]
“Laboratories in China have paid insufficient attention to biological disposal”, Yang said.
Lab trash can contain man-made viruses, bacteria or microbes with a potentially deadly impact on human beings, animals or plants.
“Some researchers discharge laboratory materials into the sewer after experiments without a specific biological disposal mechanism”, Yang explained.
Medical staff and experts have long been asking for better regulation and supervision of biological research institutes in China, but with mixed results.‘
‘Notice on Strengthening the Biosafety Management of Pathogenic Microorganism Laboratories’ (9th Feb 2020)
On the 9th Feb 2020, 6 government offices (of the Ministry of Agriculture and Rural Affairs, Ministry of Education, Ministry of Science and Technology, the National Health Commission, the Customs Administration, the National Forestry and Grassland Administration) and the Chinese Academy of Sciences together issued a notice detailing new rules to strengthen the security of Chinese bio-labs [58].
That notice starts by mentioning that in recent years the safety of bio-labs has ‘significantly improved’ but that some ‘problems and risks’ still remain. It then calls for
- cooperation in the review of new, developed or expanded BSL-3 and BSL-4 labs
- increased sharing of information relative to BSL-3 and BSL-4 labs across departments
- improved regulation of the attributions of authorisations for experimental activities
- suspension of any lab activity if the lab cannot meet the approval or review criteria
It further calls for a strict supervision and enforcement of the laws and regulations, especially with regards to labs activities which have not received the relevant authorisations and stipulates that any scientific results from such irregular activities shall not be recognized (which may tentatively be interpreted as meaning that the need to publish is a common factor behind such activities).
It also reminds that only specialized institutions and laboratories designated by the Ministry of Agriculture and Rural Affairs are allowed to keep stocks of bacteria and viruses, either isolated strains or samples. It further asks for the supervising administrations to either destroy offendings stocks and samples according to the relevant regulations or to send them to a specialized institution.
If then calls for the bio-laboratories to properly implement relevant safety guidelines, covering transport, reception and use of the pathogens, putting particular emphasis on the transport and shipment of these.
The collection of pathogens is also addressed, stressing that this must be done according to relevant regulations and that the exact sources, collection samples and methods should be properly documented.
It then asks laboratories to improve the process for disposal of wastes from experimental activities (in particular as to proper sterilization), to reinforce their organization and management, to implement information and record management and develop better training and biosafety awareness.
Last, it explicitly asks all [A]BSL-3 and BSL-4 labs to proactively engage with relevant public offices and to fully accept their supervision and guidance — which may seem to suggest that a few BSL-3s may not always have been exactly cooperative in this regard.
Yuan Zhiming’s evaluation of the risk in Chinese BSL-2 and BSL-3 labs (Oct 2019):
A good introduction to the very real risk of a lab related accident is provided by Yuan Zhiming — the director of the WIV (the Wuhan P4 lab) and a top CCP representative there. In October 2019, the Journal of Biosecurity and Biosafety published an article by Y. Zhiming [59] that highlighted major structural issues with Chinese labs, including lack of funding, lack of training, lack of standard operating procedures:
‘[…] due to different investment sources, affiliations, and management systems, the implementation of these laboratories faces difficulties converging objectives and cooperation workflows. This scenario puts laboratory biosafety at risk since the implementation efficiency and timely operations are relatively compromised.
[…] several high-level BSLs have insufficient operational funds for routine yet vital processes. Due to the limited resources, some BSL-3 laboratories run on extremely minimal operational costs or in some cases none at all.
Currently, most laboratories lack specialized biosafety managers and engineers. In such facilities, some of the skilled staff is composed by part-time researchers. This makes it difficult to identify and mitigate potential safety hazards in facility and equipment operation early enough.’
Yuan Zhiming & al evaluation of the risk in Chinese BSL labs (2016):
This 2019 assessment above essentially repeats the one offered in a 2016 paper [60] co-authored by Yuan Zhiming (with an additional insight on issues at the BSL-4), thus showing perduring chronic issues:
[translation from the original document]
‘China has certain problems in the construction and management of high-level biosafety laboratory systems.
At present, only one BSL-4 laboratory has been built in the country, and the management and maintenance of its key equipment and the personnel’s mastery of the standardized operating procedures (SOP) of Level 4 laboratories are not mature enough.
Among the BSL-3 laboratories that have been built, the distribution of laboratories across the country is uneven, and many laboratories have low utilization rates due to insufficient construction, operation and maintenance funds.
On the whole, the problems of China’s high-level biosafety laboratory system are mainly manifested in:
(1) In terms of overall layout, the industry and economic development and the needs of special fields are not fully considered. [..]
(2) In terms of funding and operating mechanism, long-term stable maintenance funding, incomplete sharing and cooperation mechanism, lack of stable operating funding, and the disconnection between construction and operation, resulting in some laboratories not completing construction or being difficult to operate normally after completion.
(3) In terms of management and support system development, the laws, regulations and standard system of high-level biosafety laboratories need to be further improved, and the construction of supporting research conditions such as information resources and experimental data is somewhat lagging behind. The confluence of technology, management and strategy research needs to be strengthened.’
Mainstream article in the China Daily mentioning the risk of working with dangerous pathogens in labs (2015):
Discussing the challenges faced by China in its biosafety laboratories was not just limited to a circle of experts. The China Daily, an English language newspaper owned by the CCP and often used as a guide to Chinese government policy, published an article in February 2015 titled ‘Be ready to fight potential risks from P4 lab’ [61].
The article welcomes the opening of the first Chinese P4 lab but ends this with a clear reminder about the existing issues with management, maintenance and supervision of high biosafety level labs, with a rather dramatic illustration that would be unthinkable in the current charged context.
‘But the government will also have to tighten supervision and monitoring of research on dangerous and exotic pathogens, and strengthen the management of the facilities where such research is carried out. Besides, the tools equipped to counter risks must be battle ready and under good control to ensure that they work properly in time, and not backfire and cause harm to the people.
This is very important because as a country we cannot afford another accidental leakage of pathogens like the one in 2004.’ [note: meaning the 2004 SARS lab accidents in Beijing, see 53]
Illustration from China Daily article, Feb 2015: ‘Be ready to fight potential risks from P4 lab’ [61]
Chinese CDC (Beijing) review of general issues with the construction and operation of BSL-3 labs in China (2014):
Part 3 of a 2014 review by the Chinese CDC of general issues with construction and operation of BSL-3s [63] offers a very pointed discussions of some structural issues:
‘1. Failure to pass the environmental assessment. Some laboratories were unable to pass [the environmental assessment] because they were located too close to public places and residential areas
2. Insufficient construction funds and operation and maintenance funds. […] 43.5% of the surveyed [BSL-3] units considered insufficient construction or operation and maintenance costs as one of the main difficulties. Insufficient government investment and insufficient pre-construction research are the main reasons for this problem. There are also situations in which funds are insufficient during the construction process or the operation and maintenance funds cannot be in place after completion. […]. All localities must adhere to the principle of adapting measures to local conditions and reasonable configuration, and not blindly build BSL-3 laboratories.
3. Weak operation and maintenance capabilities. The BSL-3 laboratory facilities and equipment are highly professional and their operation is highly risky. […]. Among the laboratories that have been in operation, three units are operated and maintained by their own personnel, and there are only 1 to 2 maintenance personnel.
4. Deviation in the principle of laboratory staffing. […] it should be emphasized that a high professional title and a high degree of education are not prerequisites for entering the BSL-3 laboratory. A high sense of responsibility, emphasis on biosafety, familiarity with experimental projects and personal protection operations, and regular participation in targeted training are also necessary conditions.’
Incidentally it may be worth noting that despite these repeated acknowledgements of structural issues affecting directly laboratories safety, our count from publicly available data shows that the yearly increase in the number of new accredited lab-complexes with BSL-3s has been very stable over the last 15 years. China has effectively been building up both its labs numbers (still very low compared to the US) and its biosafety capabilities at the same time, while recognizing that it was short on both accounts.
References:
[52] Liu Caiyu and Leng Shumai (quoting Yang Zhanqiu), “Biosafety guidelines issued to fix chronic management loopholes at virus labs,” Global Times, Feb 16, 2020. Accessed at https://www.globaltimes.cn/content/1179747.shtml
[53] Jane Parry. ‘Breaches of safety regulations are probable cause of recent SARS outbreak, WHO says’. British Medical Journal. May 2004. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC416634/
[58] ‘Notice on Strengthening the Biosafety Management of Animal Pathogenic Microorganism Laboratories’. Issued by 6 government offices and the Chinese Academy of Sciences. Feb 2020. Available at: http://www.moa.gov.cn/gk/zcfg/qnhnzc/202002/t20200228_6337907.htm
[59] Yuan Zhiming, “Current status and future challenges of high-level biosafety laboratories in China”, Journal of Biosafety and Biosecurity, Volume 1, Issue 2, Sep 2019, pp. 123–127. Accessed at: https://doi.org/10.1016/j.jobb.2019.09.005.
A count of BSL-3 labs in China
Note: this is a short adaptation of a section of ‘Outlines of a probabilistic evaluation of possible SARS-CoV-2 origins’ by G. Demaneuf and R. De Maistre, https://zenodo.org/record/4067919.
In this article we show that there are at least 112 individual BSL-3 labs in China across 62 lab complexes, and we further show how this number has evolved over the last 15 years.
Ways of counting labs
Counting BSL-3 labs in China is rather difficult as there is no official count and the few numbers published can be rather contradictory. Note also that there may be two ways of counting the labs:
- One can count individual labs. For instance the P3 of the Wuhan National Biosafety Laboratory at the Zhengdian site (NBL-3) has 5 BSL-3 individual labs [11].
- One can count lab-complexes in the same building. In this case the 5 individual BSL-3 labs at the NBL-3 should be counted as one.
One reason for doing a lab-complexes count may be that all the BSL labs of the same level in the same premises likely share some of the same physical infrastructure, especially as to waste disposals. However this way of counting may result in an understatement of the risk, as the risk of Laboratory Acquired Infection should roughly be proportional to the number of researchers in these labs, hence roughly to the number of individual BSL-3 labs.
Some institutions do not indicate the number of individual-labs in their lab-complexes. In this case we counted only one individual lab for such a lab-complex. The true count of individual labs (for the lab complexes that we identified) is therefore likely higher than the one we give,
We also wish that available LAI risk estimates in the literature were a bit more precise on this point. In this paper we use the lab-complexes count which is a conservative way of interpreting the available LAI risk estimates.
Number of [A]BSL-3 labs across time
Based on available counts and our own count, we can show how the number of Chinese [A]BSL-3 labs has evolved across time.
It is important to put these numbers into their proper context. The US has about 1,500 [A]BSL3 labs, so a much higher number (see for instance [73], page 25, for a similar graph for the US as of 2008). What matters here is not necessarily the number of [A]BSL-3 labs itself but the adequacy between the number, the available number of experienced workers, the proper implementation of biosafety processes (including working at the right BSL level) and the proper maintenance of these labs — all of which are potential risk factors if deficient.
Available BSL-3 counts:
Here are the few Chinese pubic sources we can find giving some BSL-3 lab counts, going from the most recent to the oldest:
- An article in the Southern Metropolis Daily (南方都市报) [81] gives the most detailed recent counts that we could find in Chinese sources:
‘According to Ankang, a representative of the National People’s Congress and chairman of Hualan Bio, there are currently 89 domestic biosafety level 3 (BSL-3) laboratories (hereinafter referred to as P3), of which 55 are cell laboratories.’
According to incomplete statistics from the “Caijing” magazine, there are currently 68 P3 laboratories in mainland China, of which 55 are cell research laboratories (BSL-3) and 13 are infectious animal laboratories (ABSL-3).’
‘Bai Chunli, Secretary of the Party Leadership Group and Dean of the Chinese Academy of Sciences, published a signed article “Providing Strong Scientific and Technological Support for Comprehensively Improving the National Biosafety Governance Capability” in the “Flag” magazine in April 2020. China revealed that there are currently 81 P3 laboratories in China that have passed the review of the Ministry of Science and Technology, and 2 P4 laboratories are officially in operation.’
- The ‘National Biosafety Systems’ review [82] by the University of Pittsburgh Medical Center (UPMC) for Health Security (2016) mentions 63 accredited BSL-3/ABSL-3 labs in China.
- Yuan Zhiming [59] gives a detailed count as of end 2013:
‘As of December 31st 2013, 53 BSLs, including 42 BSL-3s, had been fully accredited in China and more laboratories have completed the accreditation in recent years.
In addition, more than 1000 BSL-2 labs are currently being operated in universities, research institutions, hospitals and R&D entrepreneurship centers.
In addition, four mobile BSL-3 laboratories were imported from Labover (Montpellier, France) and distributed to institutes in Beijing, Shanghai, and Guangdong for the nation-wide surveillance of pathogens and the emergency response of post-disaster and global public health events. In addition, a self-designed and self-constructed mobile BSL-3 was composed of two 9125 mm containers and met the biosafety requirements for pathogen diagnosis.’
Note: the text is not entirely clear: In ’53 BSLs including 42 BSL-3s’, the 53 BSLs must mean 53 [A]BSL-3+, so most likely the author means 42 BSL-3 and 11 ABSL-3.
- At least 30 [A]BSL-3 laboratories built and more 10 planned, based on respondents to a Nov 2013 survey [63].
- ‘In addition, as of August 31, 2013, there were 42 BSL-3 laboratories in China’, as per 2016 paper co-authored by Yuan Zhiming [60].
For reference, the mainstream Chinese press seems to be seriously underreporting the number of BSL-3 labs. See for instance a reference to ‘more than 20 BSL-3’ as of May 2020 in the Global Times [84].
Our own count of BSL-3s:
We were able to determine that at least 112 individual [A]BSL-3 were operating in China as of August 2020, across 62 lab-complexes (excluding mobile laboratories).
For the exact list of BSL-3 labs, see: https://zenodo.org/record/4067919/files/BSL3_Labs_In_China.xlsx?download=1
What about BSL-4s?
While this article does not include BSL-4s in the probabilities, we shall still give a count for reference. We counted two active BSL-4s from available public data: the Wuhan National BSL-4 and the Harbin BSL-4 [85, 86]. Additionally the National Development and Reform Commission of People’s Republic of China set the goal of building 5 to 7 BSL-4s by 2025, as part of the ‘High-level biosafety laboratory system construction plan for 2016–2025’ [87, 62].
References:
[11] Chinese Academy of Sciences, Wuhan National Biosafety Laboratory Equipment. Accessed at: http://lssf.cas.cn/en/facilities-view.jsp?id=ff8080814ff56599014ff59e677e003d
[59] Yuan Zhiming, “Current status and future challenges of high-level biosafety laboratories in China”, Journal of Biosafety and Biosecurity, Volume 1, Issue 2, Sep 2019, pp. 123–127. Accessed at: https://doi.org/10.1016/j.jobb.2019.09.005.
[60] Yang Xu, Liang Huigang, Xuping, Shen Yi, Yuan Zhiming. “Consideration about improving the planning of high-level biosafety laboratory systems in China”. Oct 2016. Available from: http://www.bulletin.cas.cn/zgkxyyk/ch/reader/create_pdf.aspx?file_no=20161016&flag=1&year_id=2016&quarter_id=10
[61] China Daily, San Juan. “Be ready to fight potential risks from P4 lab”. Feb 2015. Accessed at: https://www.chinadaily.com.cn/opinion/2015-02/06/content_19505683.htm
[62] The National Development and Reform Commission of People’s Republic of China. “High-level biosafety laboratory system construction 2016–2025 plan”. 2016. Available from: http://www.most.gov.cn/fggw/zfwj/zfwj2016/201701/W020170111563956252675.pdf
[63] Liu Xiao-yu, Li Si-si, Rong Rong, Zhao Chi-hong, Wang Zi-jun. “Construction and management of biosafety level-3 laboratories in China”. Nov 2013. This paper is a good discussion of the haphazard construction of BSL-3 without proper preparation and budget. Available from: http://web.archive.org/web/20200525165731/http://www.jbjc.org/JBJC/html/article_8085.htm
[73] United States Government Accountability Office (GAO), Report to Congressional Requesters, ‘High Containment Laboratories — National Strategy for Oversight Is Needed’. Sep 2009. Available at: https://www.gao.gov/new.items/d09574.pdf
[81] Jian Wen, Southern Metropolis Daily. ‘7 provinces are planning to build a new provincial CDC, and nearly 20 P3 laboratories nationwide are under construction simultaneously’. Aug 2020. Accessible at: https://www.sohu.com/a/412594506_161795
[82] UPMC Center for Health Security. “National Biosafety Systems”. Jul 2016. Available from: https://www.centerforhealthsecurity.org/our-work/pubs_archive/pubs-pdfs/2016/National%20Biosafety%20Systems.pdf
[83] Global Times. “Guangdong Province to build 25–30 P3 labs, one P4 lab within five years”. May 2020. Accessed at: https://www.globaltimes.cn/content/1189394.shtml
[84] Global Times. “All provinces in China are asked to set up P3 lab: ministries”. May 2020. Accessed at: https://www.globaltimes.cn/content/1188916.shtml.
[85] Global Times. ‘Opening of Harbin ABSL-4’. Aug 2018. Accessed at http://www.globaltimes.cn/content/1114487.shtml
[86] WHO Consultative Meeting on High/Maximum Containment (Biosafety Level 4) Laboratories Networking. Meeting Report. Dec 2017. Available from: https://www.who.int/ihr/publications/WHO-WHE-CPI-2018.40/en/
[87] Han Xia,Yi Huang, Haixia Ma, Bobo Liu, Weiwei Xie, Donglin Song, Yuan Zhiming. “Biosafety Level 4 Laboratory User Training Program, China”. Mar 2019. Available from: https://www.researchgate.net/publication/332071471_Biosafety_Level_4_Laboratory_User_Training_Program_China