The threat of biological materials in any lab, research, or R&D space varies. Some biological materials will cause widespread disease if improperly managed, while others will cause minor issues to certain members of the population. These issues are mitigated with biosafety considerations, broken up into specific biosafety levels.
Across industries, biosafety is one of the most important safety programs. Consideration for biosafety design, augmented with proper training and education programs, effectively protects both operational staff and the community as a whole.
Biological Materials: Necessary But Highly Dangerous
So many high-tech organizations would come to an R&D or production standstill without biological materials. These necessary substances power the development of innovative therapies, medicines, and more. That’s not to say that they are a miracle, however—their use comes with extreme risk if improperly handled.
The public is especially sensitive to public health threats—yet many labs must work with the same hazardous materials that cause these health threats for any valuable R&D, discovery, or production. These materials include anything that is in total (or part of) an organism, living or dead, including:
- Single cell organisms
- Microorganisms
- Fungi
- Insects and plants
- Viruses
- Blood and other human materials
Any lab worker that interacts with these or other biological materials runs the risk of contracting and spreading illness through:
- Physical contact, such as when unprotected hands or other body parts come into contact with samples. This would also include mucous membrane contact like via the eyes, nose, or mouth.
- Ingestion, via hand-to-mouth actions or through contaminated food, drink, gum, etc.
- Inhalation, which can occur over the course of normal operations when substances take aerosol form; an example of which could be if there are spills, leaks, or uncapped samples that create fumes
Every lab that handles or stores biological materials will have an assigned biosafety level from which safety decisions and best practices need to be based.
Biological Materials Are A Threat to The Community and The Ecosystem
If a biological material happens to “escape” from a lab, this can pose a major danger risk to the surrounding community. Egress routes include:
- Lab drains and plumbing systems, which may ultimately empty out into public waterways. If contaminated water flows into these public waterways, that means that drinking water, ponds, streams, and the like may end up contaminated as a result.
- Substandard waste management systems. If mishandled, waste containers can become biologically contaminated; Coming into contact with such a compromised container can cause direct injury or may cause a researcher to become a vector for the substance when they leave the lab space.
- Aerosolized particles that accumulate on a floor or other surface, or that could be exhausted through the buildings HVAC systems. When disturbed, these particles fill the air and workers with insufficient personal protective equipment (PPE) inhale them.
- Common pests, such as flies or mosquitos. Such creatures may come into contact with biological material then fly out of the lab. As they continue to touch down on surfaces or other humans, they carry the contaminant—and thus, the risk—with them.
As such, lab interaction with biological materials is heavily scrutinized, requiring adherence to biosafety best practices.
Biosafety Mitigates Risks
Biosafety as a concept governs the safe interaction with biological materials, primarily aligned with human health concerns. This can apply to such things as a lab’s:
- Layout
- Standard operating procedures (SOPs)
- PPE requirements
Labs working with biological materials will get a designated biosafety level based on the threat level of those biological materials. These biosafety levels range from Level 1 to Level 4; At biosafety level 1 (BSL1), substances tend to be less risky and as such there are only a few required engineering controls needed to be compliant. At higher biosafety levels, like biosafety level 3 (BSL3) or biosafety level 4 (BSL4), higher levels of controls are needed to prevent material from escaping.
Biosafety lab design involves a variety of layout components, related protocols, and solutions, including:
- Clean rooms
- Floor bermings
- Decontamination ability and standard operating procedures (SOPs)
- Lab layout considerations
- Methods to ensure that aerosolized particles are static until they can be cleaned
- Ventilation systems
- Equipment maintenance programs
- Pest control routines
Overall biosafety lab design (in alignment with relevant biosafety level) relies on the basic idea of likelihood. What type of operations must the lab space support with what types of biological materials? What are the risks of these operations and biological materials combining in a way that introduces risk? For instance, how likely is it that a fly or other bug can enter the lab in the first place? What are the odds of researchers flushing contaminated wastewater down a sink rather than properly disposing of it?
As such, it’s crucial to have a workspace that is set up for the biosafety level that your operations require. For biosafety levels 2 through 4 (BSL2-BSL4), you’ll likely need local municipal inspectors to review your site and issue permits for the work.
Biosafety Levels Ensure a Standardized Approach
Biosafety levels are used to help ensure a standardized approach to managing biological materials and easily communicate the amount of caution necessary when handling certain biological materials. Threats are measured and designated to a certain biosafety level that correlates to a material’s:
- Type (fungus, virus, cell line, etc.)
- Potential severity (how it affects human and ecological well-being)
- Ability to spread (via air, water, etc.)
- Scope of work it supports (all sorts of R&D or production work)
A lab’s biosafety level will dictate almost everything about that lab, including:
- Lab design
- Researcher personal protective equipment (PPE) requirements
- Operational considerations and best practices
- Training requirements
With this in mind, we’ll explore the various different biosafety levels.
Biosafety Level 1 (BSL1):
This is the lowest biosafety level and includes anything that is not hazardous to healthy humans. Note that, depending on the circumstances, this may not include immuno-compromised humans.
Biosafety level 1 (BSL1) examples include:
- Plants
- Fungus
- Laboratory strains of coli
- Some animal derived materials
Biosafety Level 2 (BSL2):
Includes anything that is potentially hazardous, or that could cause potential illness in humans. It doesn’t comprise, however, anything life-threatening or debilitating. These are human and some animal-generated materials (including serum, blood, and tissues) that cause illnesses that have readily available treatment and countermeasures at hospitals or treatment centers.
Biosafety level 2 (BSL2) examples include:
- Staphylococcus auerus
- Hepatitis B
- Human-sourced materials
Biosafety Level 3 (BSL3):
Materials at this level carry the risk of actual potential fatalities or general debilitating health risk to those exposed. These biological materials cause illnesses for which treatment is still readily available—but still pose serious harm. BSL3 is where serious contamination guidelines begin to really be needed to protect workers in the lab and prevent any diseases from escaping.
Biosafety level 3 (BSL3) examples include:
- Tuberculosis
- Anthrax
- West Nile virus
Biosafety Level 4 (BSL4):
BSL4 includes biological materials that spread pathogens that we have no means of treating. New and emerging illnesses, that are poorly understood by researchers and lack treatment methods, initiate at BSL4; It’s important to ensure as much protection as possible while determining the risk associated with certain materials.
Over time, with the creation of vaccines and treatment methods, some substances that initiate at this biosafety level will end up moving down biosafety levels as more is known about them.
Biosafety level 4 (BSL4) examples include:
- Ebola
- Marburg Virus
- Lassa Virus
Biosafety Compliance
Ultimately, no matter how long they’ve been known to researchers and the public, some materials and pathogens are going to require high biosafety and biosecurity measures to mitigate the risks to personnel and the community. As such, it’s crucial to understand:
- What you are working with
- How it relates to a biosafety level
- Which methods will maintain safety
There are set federal rules that organizations must generally follow to support lab biosafety. There is no one biosafety plan that will apply to every organization, or even every lab, however—regulations and enforcement will vary from region to region (down to the municipality level), and specific recommendations and best practices will be altered based on the specific operations, workflows, and requirements of any given lab space. Any two adjacent cities or towns may have drastically different rules, as may two adjacent labs within the same facility. There is no one exact example of a perfectly designed lab—what is compliant in one place may not be in another.
The rules also tend to be especially stringent where there are dense clusters of life science organizations. In such loci—like Cambridge, Research Triangle Park, San Francisco, and the like—local authorities tend to develop their own strict protocols. On top of this, a large organization spread out over multiple regional sites will need to accommodate all local rules.
These rules will affect how a lab can proceed and be operated. As such, one of the most challenging aspects of biosafety is optimizing and configuring the lab space according to all the variables. The complex and hyperlocal rules underscore the importance of a biosafety program with strict oversight.
Biosafety Enforcement and Other Worries
Once your lab is in operation, expect routine visits from municipal inspectors checking for compliance. If your organization is deemed noncompliant, an auditor can issue a stop work order (STO) or even levy a big fine—it all depends on the community or inspector. To avoid infractions in the first place, it’s best to be proactive in compliance—and that means keeping training front and center as well as establishing an Institutional Biosafety Committee (IBC) to:
- Review all pertinent municipality biosafety requirements
- Demonstrate proper lab design
- Ensure training is current and relevant
Depending on the size of a facility, the IBC should meet at least annually. However, given that a local government or inspectors may apply special requirements to a facility depending on its ongoing operations, more frequent IBC meetings are a wise move.
Training: Key to Successful Biosafety
Once biosafety considerations are accounted for in your lab space, training should be the next step. No federal laws specifically require training, but the National Institutes of Health (NIH) have established a set of practices and guidelines that most cities have adopted to create the rules and regulations for their specific municipality.
An effective biosafety training program will cover:
- How to maintain basic cleanliness
- Decontamination steps
- Access/exit controls, which involves education to support:
- A proper waste program
- The prevention of material escaping via the drain pipe
- Pest control, to prevent insects or other small animals from getting into the lab, wherein they could come into contact with biological material and exit as a carriers of a virus or other disease
- Basic handling of biological materials, including:
- Necessary PPE
- Best practices for handling materials
- How to store biological materials
- The difference between biosafety levels, including why there are such strict controls for lab designs and operations adjustments, as well as how to perform all tasks according to the lab’s biosafety rating
It’s crucial to ensure training is relevant to specific biosafety level of the laboratories researchers will be working within. Annual refresher courses is a good best practice for anyone and everyone handling biological materials, regardless of any varied training cadence requirement. This includes people with only the potential for exposure to these materials, like janitorial staff.
Partnering for Full Biosafety Compliance
Regardless of biosafety level, the complexity and extreme riskiness of working with biological materials—and of staying safe and compliant within each biosafety level—means you need a skilled, seasoned biosafety partner to:
- Review localized compliance requirements
- Assist with facility design, especially during lab moves or upgrades
- Design and/or host trainings
To assess your lab operations and make a biosafety plan, you need this qualified partner; one with teams that have seen it all and know just how to keep your operations compliant and your teams safe.
The team at Triumvirate Environmental can handle all of this—and more. For more information about any of these services, contact Triumvirate Environmental today.
