Strengthening its core knowledge, the Department of Science of Technology – Biosafety Committee (DOST-BC) invited Dr. Delphine Beeckman of Bayer and BASF to present the “Regulatory Overview of Biosafety and Biosecurity in Containment” during its 146th DOST-BC Meeting last September 25, 2021, via Zoom platform.

Dr. Beeckman has over 15 years of experience in the field of biosafety. She has been working for Bayer and BASF as Site Biosafety Manager (Belgian Innovation Center Sites) (2010-2014); Regional Biosafety Manager, EMEA (2014-2018) and Global Biosafety Manager (2018-up to present). She was also the Founder and co-chair of the Bayer Biosafety Panel from 2017-2018, and after Bayer Seeds was divested to BASF, Dr. Beeckman founded and is now co-chairing the Global Agricultural Solutions Biosafety Steering Committee.

Before diving into the topic, Dr. Beeckman emphasized that when biosafety for contained use is addressed in international fora and discussions, often the topic is limited to working with genetically modified organisms (GMOs) in facilities such as laboratories, animal facilities, and greenhouses. However, the scope of biosafety in containment encompasses many other types of biological materials, such as human, animal and plant pathogens, nucleic acids, proteins, human samples, animals or plants, or by-products thereof, and overlaps often with the topic of biosecurity. This is also reflected in the regulations that apply for activities with biological materials in contained facilities. The common denominator of these regulations is the focus on protection of people and environment, that of environmental biosafety which is the deliberate release of GMOs into the environment and anything that deals with the Cartagena Protocol on Biosafety.

Dr. Beeckman explained that biosafety has multiple accepted definitions depending on the disciplines involved, but biosafety in containment focuses on principles, technologies, and practices that are implemented to prevent the unintentional exposure to biological material or their accidental released. Also, the term is sometimes used interchangeably with “biosecurity, which is defined as the protection, control, and accountability for biological agents and toxins within facilities in order to prevent their loss, theft, misuse, diversion, unauthorized access, or international unauthorized release. On the other hand, containment is defined as a set of measures including biological containment, practices, safety equipment, and facility safeguards that protect workers, the community and the environment from exposure to and/or unintentional escape of biological material. She also clearly differentiates the purpose of Biosafety and Biosecurity wherein Biosafety is to prevent untoward accidents or loss of containment while Biosecurity is the prevention of bioterrorism, sabotage, espionage, and bribing.

In the Hierarchy of laws and regulations, Dr. Beeckmans discussed the following

  • International – considered as the highest level where Agreements, Charters, Conventions, Treaties, and Protocols on a global level are crafted and implemented to be cascaded to the regional level.

  • European Union – exemplified by Treaties, Regulations, Directives, Decisions, Recommendation, and Advice

  • National – country will craft these (Conventions, Treaties, Protocols, etc.) into a national law and implementing decisions detailing the requirements that needs to be followed

  • Sub-Regions – laws and implementing decisions

  • Local – (City or Community) these are the police-directives, fire department, informal instruments, and often very case-specific.

Biosafety and Biosecurity Legislation

Dr. Beeckman also enumerated and discussed the drivers and the objectives of Biosafety:

  • Protecting Workers and the Public against Hazardous Biological Agents
    • References to biosafety practices in microbiology laboratories date from the time of Pasteur and Koch (period of the 1860's–1890's), when, following the first reports of disease in laboratory personnel, the need was identified to implement safety measures in response to potential risks associated with exposure to micro-organisms cultured in the lab. Dr. Koch decided to handle them in a glazed tabletop box with two openings fitted with oilcloth sleeves,  thus, the idea of “bio-containment” was born. This paved the way to the concept of protecting the workers and public against hazardous biological agents and then lead to the implementation of physical containment measures, work practices, and Personal Protective Equipment (PPEs).

  • Protecting Animal and Plant Health
    • To prevent and control the introduction and spread of plant and animal pests from targeted activities with the pathogen, the World Organization for Animal Health (OIE) was established in 1924 and the International Plant Protection Convention (IPPC) in 1951

  • Dealing with Uncertainty/Protecting the Environment
    • Following the experiments with rDNA and cloning, the First Asilomar Conference was held in 1973 where an appeal was made for a voluntary moratorium on experiments involving recombinant DNA until an international conference to assess the potential risks of such experiments was held. Then the Second Asilomar Conference was held in 1975 where basic principles were adopted such as for containment to be part of experimental design, risk based, adherence to Good Microbiological Practice (GMP) and classification of experiments and corresponding containment levels.

She also discussed the two (2) main Biosecurity Objectives:

(1) Protection Against Loss, Theft, Misuse, Diversion or International Release. These are Valuable Biological Materials (VBM) that can cause potential harm or misuse (dual use research). She further explained that these materials must observe strict administrative oversight, control, accountability, and protective measures and monitoring compliance.

(2) Preventing Development of Biological Weapons and Addressing Bioterrorism, in 1925 through the Geneva Protocol, it was the first international agreement that included biological weapons as a separate arms category. However, signatories reserved the right to retaliate in-kind against states that violated the Protocol, making it de facto, a “no-first-use agreement.  

Dr. Beeckman further explained that clearly, biosafety and biosecurity are complementary disciplines that need to be aligned in containment. These are often addressed together through a biorisk management program to ensure compliance with the requirements and good practices in both international guidance documents as well as in different local legislative frameworks.

Some international framework and guidance documents that she mentioned were:

  1. WHO Laboratory Biosafety Manual 3rd Ed. (2004)
  2. ISO 35001:2019 Biorisk management for laboratories and other related organization
  3. Biosafety in Microbiological and Biomedical Laboratories 5th (2009) & 6th Ed. (2020)
  4. NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (2019)
  5. CDC Guidelines for Safe work practices in Human and Animal medical diagnostic Laboratories (2012)
  6. Canadian Biosafety Standard 2nd Ed. (2015); Canadian Biosafety Handbook 2nd Ed. (2015)

Aside from these, Dr. Beeckman also explained and gave examples of other regulatory frameworks that have provisions on handling biological materials such as:

  1. Cartagena Protocol on Biosafety – requirements for transboundary movement of living modified organisms (LMOs)
  2. Nagoya Protocol – biological and physical traceability requirements
  3. Plant and Animal Health – requirements for import/export and traceability
  4. Occupational Hygiene – chemical, physical and biological agents at the workplace
  5. Transport/Movement – Dangerous Goods Regulations

In the end, these scientific breakthroughs and advancements are highly regulated, strictly monitored and embedded in various international, regional and national regulations and guidance dealing with handling, storage, containment measures, transport, packaging, and labeling of biological organisms under contained use to ensure the protection of human/workers, animal and plant health as well as the environment. #