BIORISK MANAGEMENT STANDARDS
One of the most versatile and useful Biorisk management guidelines that has been published during recent years is the
BIORISK MANAGEMENT STANDARD: CWA 15793 and the IMPLEMENTATION GUIDE FOR THE CWA 15793: CWA 16393 together with the BIORISK MANAGEMENT COMPETENCE STANDARD: CWA 16335. All three standards are worth implementing in any institution, facility, or laboratory working with biological agents. In many cases same documents can be adapted to the large scale pharmaceutical industry as well where there rarely are biological agents present, as the pharmaceutical industry is based on chemical starting materials and large scale synthesis of medical compounds. The pharmaceutical industry is as heavily GMP regulated as the vaccine industry, and many guidelines from both can inspire on the opposite field. The CWA 15793 has become a very popular document as it can be downloaded for free from the internet as several western based biosafety organizations “bought it out” back in 2008.
In November 2019 the new ISO 35001 standard: “Biorisk management for laboratories and other related organizations” was published. This standard is intended to replace the CWA 15793. Like any ISO standard it needs to be purchased by the individual institution. The ISO 35001 does not conflict in any way with the content of the CWA’s, they requirements are written in a different way, and the sections are organized a little different.
WHO – PUBLICATIONS
WHO has published the GAPIII guideline, the PIM guideline and the TRS 629. These documents focus on Polio and the current readication effort; however, the GAPIII guideline is the first that tries “to serve two masters”. It is the first time that GMP and biorisk management requirements for high risk pathogens have been written together into one document. Recognizing that many facilities do not work with polio, we still find that there are many good aspects in these documents from WHO. We can see the foundational principles listed in these two documents be applied to a broader scope for all soon to be eradicated or emerging diseases. These documents are published together with a couple of other inspirational documents at the WHO website.
The fourth edition of the WHO LABORATORY BIOSAFETY MANUAL, (published in 2020), acts as the main international source of information for biosafety laboratory requirements, but does not necessarily cater to the large scale production industry.
HIGH RISK PATHOGENS
MINIMUM BIORISK MANAGEMENT STANDARDS FOR LABORATORIES WORKING WITH FOOT-AND-MOUTH DISEASE VIRUS: This is another helpful guideline for the animal community is the European Commission for Control of Foot and Mouth Disease (FMD).
Integrated European Checklist for Laboratory Biorisk Management in Handling of High Consequence Risk Group 3 and 4 Agents : We find this useful, but would like to point to our general skeptical stance on checklists as a single tool to create a safe environment in the facilities.
This page will point to a couple of special guidelines we have found helpful. It is by far a comprehensive list, but for the curious novice who wants a little more insight into what is applicable on a national level, we wanted to pave the way. If you have your favorite guideline, do not hesitate to share it with us. We will look through our list and figure out why we did not list it in first round, and most likely fix the error.
Plant pathogens
Plants live their own life without RG levels, but depending on how dangerous they are for the environment they require certificates. That could give some indication of the severeness. So RG levels are only if this is dangerous for animals and people, not if it is just dangerous for the food supply. Only a few fungi are dangerous for people.
If the plant pest is on the UK, Australia and Select Agent and Toxins list it is of concern from a bioterror perspective, but most often it will not have direct impact on the human reseracher, however, it might harm the environment. This means that one approach could be to “think along GMO containment” when working with these pathogens in the labs. The USDA Animal and Plant Health Inspection Service has a helpful homepage, and so does webpages focused on phytosanitary certificates.
Canada
Canada Biosafety Standard (CBS) 2nd ed (2015) This guideline is quire interesting as it is aiming at listing evidence-based requirements. http://canadianbiosafetystandards.collaboration.gc.ca/cbs-ncb/assets/pdf/cbsgnldcb-eng.pdf
Canada Biosafety Handbook, 2nd ed (2016) This guideline is quire interesting as it is aiming at listing evidence-based requirements.
United States
US National Institutes of Health (NIH) Facility Design (USA):”NIH DRM ” http://orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesD esignPoliciesandGuidelines/DRMHTMLver/Chapter2/Pages/Section2- 5ContainmentLaboratoriesatBSL-3Level.aspx
American Biological Safety Association (USA) lab design: http://www.absa.org/trainingtools.html University of California Design Guides (USA): http://www.ucop.edu/risk–services/_files/labdesign_guide.pdf
The US BMBL http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf is another influential guidance document
EU
The EU Directive 2000/54: from 1998, provides a short-list of containment measures for each class of laboratory. http://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=CELEX:32000L0054
UK
The United Kingdom has in 2020 published the Code of Practice: Biological Agents, Code of Practice for the Safety,
Health and Welfare at Work. (Biological Agents). Regulations 2013 and 2020. (S.I. No. 572 of 2013 as amended by
S.I. No. 539 of 2020).
Denmark
Denmark has as one of the only counties in the world issued a BIOSECURITY LAW aiming at controlling biological agents and dual-use equipment in alignment with UNCRS 1540. Biosikring følger af lov nr. 474 af 17. juni 2008 og bekendtgørelse nr. 981 af 15. oktober 2009 med senere ændringer samt bekendtgørelse af lov om sikring af dyrepatogener (LBK nr. 53 af 11/01/2017) og den tilhørende bekendtgørelse nr. 803 af 22/06/2017. https://www.biosecurity.dk/biosecurity/.
Denmark has also published a practical handbook on how to develop a biosecurity system where nothing is currently existing.
Holland
Holland is another country in Europe who has addressed the aspects of UNSCR 1540. They chose a BIOSECURITY CODE OF CONDUCT as their national 1540 implementation strategy.