Unraveling Regulatory Reporting: Importance & Challenges of Chemical Inventory Reporting
Whether you work at a sprawling biotech complex or a bustling academic lab, we can all agree – accurate chemical inventory reporting is crucial for transparency, accountability, and regulatory compliance.
Unfortunately, such reporting can be one of the most tedious aspects of the job.
In part 1 of this series, we looked at why complying with fire codes and maximum allowable quantities (MAQs) is so challenging. (If you missed that article, you can find it here.)
Now we're going to dive into the role of regulatory reporting, including Tier II/Right-to-Know (RTK), and take a closer look at the challenges faced by commercial and university labs in reconciling their chemical inventory reporting.
What is regulatory reporting?
Regulatory reporting is the process of compiling, verifying, and submitting data to regulatory bodies. In the US, life sciences, pharmaceutical, academic, and biotech labs are often required to report on their chemical inventories to various regulatory bodies. These include state and local authorities, as well the United States Environmental Protection Agency (EPA).
What is the role of regulatory reporting, and why is it important to labs?
Regulatory reporting plays an important role in maintaining safety standards within laboratories handling hazardous materials.
Imagine a pharmaceutical lab that regularly handles volatile chemicals as part of its research and development activities. The lab maintains detailed records of the types, quantities, and locations of these hazardous materials for regulatory reporting.
This information is crucial to make sure that the quantities of chemicals stored stay within safe limits, reducing the risk of accidents or exposure to harmful substances.
Accurate reporting also enables the lab to track potential hazards, such as flammable or reactive materials, and enforce compliance with fire safety regulations. And, in the event of an emergency, the information in these reports provides lab personnel, emergency responders, and community stakeholders with essential information about hazardous chemicals present in the facility.
Maintaining detailed records, quantities, and locations for hazardous materialsis crucial for regulatory reporting.
What is TierII/Right-to-Know (RTK)?
Among the various types of regulatory reports, Tier II/Right-to-Know (RTK) reports hold particular significance for labs.
Under the Emergency Planning and Community Right-to-Know Act (EPCRA), facilities in the US are required to submit annual reports on the storage and use of hazardous chemicals above certain threshold quantities. The information in these reports enables emergency responders, local authorities, and the public to prepare for and respond to chemical emergencies.
Tier II reports typically include details such as the name and quantity of each hazardous chemical stored onsite, its location within the facility, and any associated hazards. RTK, or Right-to-Know, refers to the provision that allows any citizen to request access to this information.
What are the challenges of regulatory reporting for labs?
Despite the critical importance of regulatory reporting for researchers, first responders, and communities, labs encounter unique challenges in managing and reconciling their chemical inventory data for reporting.
1. Keep your chemical inventory up-to-date
One of the most basic challenges for labs is the sheer volume and complexity of chemical inventory data that they must track, manage, and report. A single facility may house hundreds of chemicals, each with its own storage and reporting requirements. With chemicals constantly being received, used, and disposed of, managing all the moving pieces can sometimes feel like herding cats.
With space at a premium, researchers sometimes resort to “creative” storage solutions like stashing samples in hallways, breakrooms, and broom closets. In a recent SciSure webinar, Sarah Eck, PE, CCPSC, Sr Process Safety Engineer, DEKRA North America, said she's seen everything from flammable solvents shoved in regular cabinets to boxes labeled “refrigeration required” tucked away under a table because someone didn’t know where to put it. Add to that items that get left in the receiving room or forgotten because they were sent to the wrong building — along with non-lab spaces like janitor closets — and simply knowing what you have on hand is a full-time job.
2. Tracking the location of chemicals within your facility
In addition to knowing what chemicals you have on hand; you'll also need to know where chemicals are located within your facility. This is necessary to produce reliable regulatory reports for Tier II/RTK and fire code compliance.
If you're calculating totals toward MAQs, for example, you need to be able to report on all the chemicals within a control area or zone.
This is especially challenging when you have multiple lab groups operating in shared spaces. “Rarely does a single researcher have that zone all to themselves,” explained Jeffrey Foisel, R&D Lab Process Safety Technology Leader at the Dow Chemical Company, in a recent SciSure webinar.
Having a centralized chemical inventory system that can locate all the chemicals on hand that fall under a specific regulation — regardless of which lab group they belong to — and generate reliable reports at the aggregate unit becomes crucial to streamline your reporting processes.
3. Staying on top of changing regulations
As we discussed in our fire code compliance article, reporting requirements can be complex and vary based on factors such as the type of chemicals used, the volume of chemicals stored, and the regulations in your jurisdiction. For example, NFPA and IBC/IFC have different MAQ limits and different methods for calculating these limits.
To make matters more complicated, different states and regulatory agencies may have different reporting formats and submission requirements, adding to the complexity for labs. In California, for example, facilities subject to Tier II/RTK reporting are required to submit their chemical inventory data electronically through the CERS platform.
Without a real-time chemical inventory reporting solution, labs may struggle to ensure accuracy and consistency across all their evolving reporting obligations.
4. Compiling and formatting data for reporting
Traditional methods of regulatory reporting often involve manual data collection, entry, and calculations, which can be time-consuming and error-prone.
Let's say you need to compile a Tier II/RTK report. Unless you have regulatory reporting software like SciSure in place, you might begin by reviewing your purchase and disposal records to identify all reportable chemicals present in the facility.
Then, you would need to gather information about each chemical, including its name, quantity, storage location, and associated hazards. You’d most likely have to perform some pretty complicated calculations before organizing this information into the required format, which typically includes filling out a standardized reporting form or submitting data electronically through a designated portal.
Finally, you’ll need to double-check that all required fields are accurately completed — and cross your fingers that you haven’t made any mistakes — before hitting “Submit”.
5. Allocating time and personnel for reporting
EHS and Lab Ops teams juggle so many different tasks and responsibilities, leaving little time and resources for regulatory reporting. This can lead to delays or oversights in reporting tasks.
For instance, picture a research lab at a small university. The lab may have a dedicated researcher who is also responsible for regulatory compliance tasks, such as chemical inventory reporting. However, because the researcher's primary focus is on conducting experiments, they may struggle to find time to fulfill reporting requirements.
As a result, reporting tasks might be delayed or overlooked, leading to non-compliance with regulatory deadlines and requirements.
While you likely can't afford an extra FTE to handle these tasks, a chemical inventory reporting solution like SciSure can reduce the time spent on tasks like managing inventory and reporting by as much as 80% — freeing scientists up to focus on their research.
Reduce the time spent on tasks by more than 80%automating inventory management and regulatory reporting
What are the risk of inaccurate chemical inventory reporting?
The consequences of failed audits and non-compliance with regulatory reporting requirements can be severe, ranging from fines and penalties to reputational damage and legal liabilities. What's more, inaccurate or incomplete reporting can hinder emergency response efforts, putting both facility personnel and first responders at risk in the event of a fire or chemical emergency.
But don’t take our word for it. Here are some statistics that underscore the importance of accurate chemical inventory reporting:
- In 2022, local fire departments in the US responded to approximately 5 million fires, with about 9% occurring in nonresidential structures. Nonresidential fires resulted in 150 civilian deaths, 1,400 injuries, and $4 billion in property damage.
- Hazardous materials accounted for 433,500 fire department calls in 2022. (Source: NFPA)
- Consequences of fire code violations vary by state. Here in Massachusetts, for example, repeat offenders may face fines of at least $1,000 and/or jail time of at least one year. (Source: Massachusetts Legislature)
- The EPA imposed nearly $250,000 in fines for violations related to Tier II reporting in 2018. (Source: EHS Daily Advisor)
- The majority of Tier II violations involve a handful of chemicals commonly found in labs, such as sulfuric acid and ammonia. (Source: JD Supra)
- The EPA is in the process of hiring more than 300 new inspectors, attorneys, and technical staff to conduct more inspections and enforcement in the coming year. (Source: US EPA)
Your takeaway
Given the risks and challenges of regulatory compliance and reporting, accurate and timely chemical inventory reporting is an urgent priority. By embracing innovative tools and best practices, labs can mitigate risks, enhance safety, and focus on their core mission of scientific discovery.
In the third part of this series, we'll show you how real-time reporting solutions can enhance compliance and streamline your reporting processes.
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