As a startup, leveling up can be exhilarating and terrifying at the same time. You’ll run into new challenges you’ve never encountered before, requirements you may not be aware of, and problems you didn’t anticipate.
The consequences of making a mistake at this stage in the game can range from frustrating to fatal for your business. Data from the Bureau of Labor Statistics shows that about one in five businesses fails in their first year. Life science startups have it even harder due to the cost and complexity of taking a scientific discovery and turning it into a viable business.
That said, regulatory hurdles and safety issues shouldn’t be the reason you can’t succeed. We spoke with Corey Martin, founder and CEO of Spotlight Safety Inc., to learn more about the most common lab safety challenges and tripping points that startups face.
No matter what stage your company is in — whether you have a product or not — it’s never too early to start thinking about the ways a well-established safety program can help you operate smoothly and avoid stumbling blocks.
Here are our takeaways and seven common challenges to watch out for:
1. Wastewater Regulations and Permitting
Whether you’re looking for a facility to house a new startup or are moving a growing company into a bigger space, wastewater permitting considerations can have dramatic downstream implications.
Before you sign a lease, make sure the property is equipped to handle the volume and makeup of wastewater you’ll be producing and ask whether the landlords or the tenants hold the permit. Selecting laboratory space with a landlord-held wastewater permit may come with a slightly higher cost, but doing so can save significant time, effort, and potential capital expense depending on the situation.
Corey recommends taking the time to estimate what types and volumes of wastewater you expect to produce during the length of your occupancy at the facility (not simply the initial projections). Not all wastewater systems are created equal and new or remodeled systems carry large (and often unexpected) capital expenses when required.
Additionally, which permits you’ll need depends on your activities, projected volumes, and physical location. Each state, county, or even city may have its own permitting requirements and application process. The time it takes to obtain the necessary permits can also vary by location (up to 3-12 months required lead time depending on the system complexity and regulatory body), so it’s best to look into this as early as possible.
Even if state or local permitting requirements aren’t applicable, it’s advisable to reach out to the municipal wastewater facility to establish a relationship and communicate the anticipated wastewater profile.
2. OSHA Bloodborne Pathogen Standard
Bloodborne pathogens are a major concern for research startups that handle human source materials. A needlestick or other unintentional exposure to blood, human cell lines or tissues, or other bodily fluids can put scientists at risk of a serious or life-threatening illness and jeopardize your entire operation.
Combined with proper controls and personal protective equipment (PPE), training can greatly reduce chances of an employee coming into contact with infectious materials.
One of the first things you must do is identify employees who have a potential for occupational exposure. OSHA requires you to provide bloodborne pathogen (BBP) training for all employees with potential for occupational exposure. This is true even if your employees have had prior training or education at a previous employer or institution. Employees must receive this training prior to performing tasks where exposure to bloodborne pathogens could occur, such as handling blood or human cell lines. After that, refresher training is required at least once a year.
In addition, employers must offer a Hepatitis B vaccine to employees within 10 days of starting a job that carries a potential for bloodborne pathogen exposure. If accepted, the vaccination must be provided free of charge to the employee. If the employee has received the vaccine previously, employers must still offer at-risk employees the option to receive a titer and booster, as needed. This offer must be formalized using an HBV vaccination form, sometimes referred to as a declination form, as the employee has the right to refuse vaccination. Employees who decline the vaccination initially can change their minds at any point during employment and may receive the vaccination free of charge as long as the potential for occupational exposure remains.
3. Hazardous Waste Management
Waste disposal is a more complex issue than most startups realize. Biological, chemical, and other hazardous waste materials generated by research activities such as medical waste, chemical waste, sharps, radioactive waste, and broken glassware can be very dangerous to employees and downstream workers if improperly disposed of. Not only that, but it can cost your company thousands of dollars to clean up and dispose of waste that has leaked, spilled, or been improperly mixed, labeled, or otherwise disposed of incorrectly.
The good news is that most waste disposal problems can be greatly diminished or eliminated through proper education and vigilance on the part of everyone in your organization. By training employees on how to properly handle, store, and dispose of chemical and other hazardous waste, you’ll be in a much better position to avoid a costly cleanup, disposal, or worse, an injury!
Taking the time to help your personnel understand why proper waste disposal is so important is a good use of time. Having more personal buy-in for the additional effort required will absolutely help ensure team-wide compliance.
As your company scales, making sure everyone on your team has received training will become a greater challenge. You might consider implementing a system that allows you to track your requirements and document compliance so that managing training is less of a burden.
While it may seem time- or resource-intensive to build a culture of good waste management, doing a little forecasting on the costs of repeated mistakes will quickly show that the upfront investment in education and buy-in will easily pay for itself.
Furthermore, regulatory requirements for hazardous waste management and oversight increase as waste generation volumes increase. Monitoring how much hazardous waste is being generated in a calendar month is a critical component of proper designation of the company’s hazardous waste generator status, and thus disposal and oversight requirements (see Section 7 for more on this).
4. Chemical Purchasing and Inventory Management
When purchasing chemicals for your company, it’s important to understand and plan for the entire lifecycle of those products, because things can get expensive. Fast.
A chemical that costs $50 might not seem like much up front (especially for those enticing bulk purchases), but once that chemical is off the truck, it’s your responsibility to store and dispose of properly. No backsies.
Always take the time to consider the expected rate of use, expiration date, storage requirements, hazard classification, flammable control area limits, and experimental longevity. Avoid bulk purchases of short-lived, high-hazard chemicals or those required for a new set of experimental processes that are provisional in nature.
Storage requirements and chemical classification are critical considerations, and it’s always important to consult the chemical Safety Data Sheet (SDS) before ordering a new chemical.
If special storage is required, such as an explosion proof fridge (for cold storage of volatile solvents), that can carry a major expense and/or delivery and installation time considerations that need to be worked out before placing the order. Additionally, some highly hazardous, reactive, or otherwise unstable chemicals can carry high disposal costs due to the safety and security requirements. Furthermore, it’s important to consider whether the new chemical will require a new, distinct waste stream or whether it can be collected with existing streams.
One way to prevent this uncertainty and possible expense is by keeping a close eye on purchases and proactively seeking as much information as possible when considering new chemical orders or experimental processes. Implementing a robust inventory management system with callouts for hazardous chemical purchases and duplicate orders has the direct benefit of stopping over-purchasing, reducing storage and disposal costs, and improving safety oversight.
5. Peroxide Former Management
Many early-stage R&D laboratory facilities will have peroxide forming chemicals onsite at some point during their research operations. The most common in the biotech and life science research environment tend to include Ethyl Ether, Tetrahydrofuran (THF), and 1,4-Dioxane, though many others exist.
As peroxides form in these chemicals, the material may become shock-sensitive over time if not properly managed, tested, or disposed of. Unexpected explosions really get in the way of conducting research and discovery.
Proper storage and inventory oversight is critical for safe peroxide former management, as exposure to light and oxygen can accelerate the peroxide formation process. Material prone to peroxide formation should be frequently tested or disposed of after a certain period of time (often 12 months from receipt or 6 months from opening). Thus, the danger occurs when these chemicals are purchased and then forgotten in the back of a cabinet, especially if they’re improperly stored.
Even small containers pose a risk if kept well beyond their expiration dates, especially considering their likelihood of being stored with other flammable materials. This particular scenario can amplify the effects of a peroxide detonation, resulting in a far more severe and dangerous explosion.
One way to effectively manage this problem is to avoid ordering more of a chemical than you need and actively labeling and tracking all peroxide formers from receipt through disposal. Proper inventory management and purchasing control will also help you reduce duplicate orders and unnecessary disposal costs.
Chemical inventory management software can help you determine the rate at which you go through peroxide forming chemicals. This can keep you from over-purchasing and having to throw away unused chemicals, or under-purchasing and having to wait for an order to come in.
As a growing startup, it may be difficult to predict how much of a particular chemical you will use. That’s why it’s so important to have an airtight system for monitoring your chemical inventory. When you know how long it is from a chemical being received to being disposed of (which any good chemical inventory system should be able to do for you), you can tell how quickly you’re going through your stock.
Any company that uses peroxide formers must have a way to keep track of when chemicals were purchased, opened, and when they expire. These programs would also greatly benefit from an active gatekeeping system for all incoming chemicals upon receipt.
When peroxide formers reach their expiration date, make sure they are disposed of immediately through the proper waste collection process. And, should you find a peroxide former that is past its expiration date, address it immediately and with caution. Most waste transporters have experienced technicians who can be called upon for evaluation, mitigation, and disposal support, as needed.
Ignoring the problem will only make it worse and more expensive. We’ll say it again, because it is such a common and costly occurrence: ignoring the problem will only make it worse and more expensive.
6. Flammable Storage and Control Area Limits
An unexpected fire or explosion in your lab is one of the worst scenarios imaginable and can lead to costly equipment and facility damage, operational downtime, and employee exposure or injury. These risks are manageable, but only if you keep a close watch on flammable material use and storage — including both stock chemicals and flammable waste.
Flammable solvent use and waste generation is a very common element of laboratory research and can become a major safety concern if not properly managed. For example, mass spectrometers and HPLCs both use large volumes of reagent materials and can quickly generate significant amounts of flammable waste during regular use.
When you’re trying to anticipate how much flammable inventory “budget” each of these instruments will require, Corey recommends using an initial ballpark estimate of about 10-15 gallons of waste per calendar month, depending on the frequency of use.
As with most things, preparation is key. It’s wise to have a plan in place for dealing with flammable waste before you start generating it. What activities might result in flammable waste? How will you store the waste? Will special containers be needed? What local, state, or federal regulations apply? Does your facility control area design, flammable permit limit, and hazardous waste generator status allow for the anticipated increase in reagent chemicals and hazardous waste volume as you add new processes or equipment.
Perhaps most importantly, do you know all of the questions you need to be asking about your current and future flammable storage needs as you grow?
7. Hazardous Waste Generator Status - The Switch from VSQG to SQG
The switch between VSQG and SQG status trips up a lot of growing startups. To understand why, we need to rewind a bit.
The Environmental Protection Agency (EPA) classifies hazardous waste generators into three distinct categories based on the amount of waste they produce or manage: Very Small Quantity Generator (VSQG), Small Quantity Generator (SQG), and Large Quantity Generator (LQG).
The amount of waste you generate in a single calendar month determines your generator status, and thus what level of hazardous waste requirements you must follow.
In the early stages of your startup, you'll likely be classified as a VSQG. However, as the pace of research increases, you may find that you're generating more hazardous waste per month. At a certain point, you will likely need to start closely monitoring your monthly hazardous waste generation volumes and consider updating your waste generator status as you approach the status thresholds.
VSQGs are allowed to generate up to 220 pounds (roughly 27 liquid gallons) of hazardous waste per calendar month, with the important exception of not being able to generate any “acutely hazardous waste”. Any acutely hazardous waste generation, requires either SQG or LQG status with the threshold being 2.2 pounds.
One of the advantages to being designated as a VSQG for a startup laboratory is that you have more flexibility in scheduling waste pickups, as there are no time limits associated with waste accumulation. Conversely, SQGs and LQGs are required to dispose of waste accumulated in their Main Accumulation Area (MAA) within 180 or 90 days, respectively.
The general management requirements for proper accumulation, labeling, storage, and disposal of hazardous waste is consistent across all generator levels, but the formal requirements for documentation, training, and oversight increase as the status increases. As your company grows and waste volumes increase, you will need to assess your waste storage area design and volume limits, waste area checklist documentation, training requirements, and emergency planning.
Notably, how you collect and dispose of hazardous waste has a large impact on waste disposal costs. While some waste streams have very specific volume or container type limitations, others (such as common flammable solvent waste) may have more flexible collection and disposal options that could drastically decrease the cost per unit volume. As a result, having proactive conversations with a consultant or waste transporter, as well as focusing on waste minimization efforts, can go a long way toward reducing the overall cost of research operations.
Does your startup face any of these challenges?
No matter what stage your company is in — whether you have a product or not — it’s never too early to start thinking about the ways safety can help you operate smoothly, or cause stumbling block after stumbling block.
It’ll be a lot easier to grow your business when you have the right systems in place from the start rather than putting out fires as they pop up. This will allow you and your personnel to focus on the science and not get distracted by regulatory or permitting problems.