Successfully bridging significant data gaps in chemical and regulatory technology
Despite advancements in data collection and storage, roadblocks still exist
Data is critical and tells us crucial things about our programs and businesses. Acquiring that data is often a complicated process. As someone who has worked as a B.S. Chemist for over 35 years in the highly regulated chemical industry and more importantly, and as a Product Safety and Regulatory Affairs (PS&RA) Specialist for the past ten years, I’ve witnessed remarkable progress in data collection and storage technology during that time. Despite these advances, the average PS&RA Specialist still struggles daily to collect and manage rapidly increasing amounts of compliance data. I joined PeerAspect late last year to be a part of an incredibly easy and innovative solution to that problem. PeerAspect is a unique data acquisition and analysis company that accelerates your ability to gain insights from your data and take effective action. I am optimistic because their empathetic approach to the user guides the design and flexibility of the system, making all things data much less painful for everyone.
Information Technology and the Safety Data Sheet (SDS)
In the realm of PS&RA and in the Chemical Industry overall, we are grateful for and eager to employ any tools developed to acquire, process and store our data. After all, many of the rules and regulations that legally require us to manage the data are still relatively new (in chemical industry terms, anyway!). The Occupational Safety and Health Administration (OSHA) is a great example – it was only established in 1970. More recently (in 1983), Material Safety Data Sheets (MSDS) requirements for all shipments were enacted. The MSDS(s) were technical documents providing detailed information about the physical properties of chemicals, along with possible effects on health and environment and safe handling and transport of materials. At the time, these were typed documents and relatively free form.
Progress since the 1980s has brought us a much more systematic approach thanks to information system technologies and the development of programs to author Safety Data Sheets (SDS). (The SDS term was adopted along with the Global Harmonized System (GHS) in 2015.) The best of these tools are, in my opinion, SDS authoring systems. SAP or The Wercs are two technological authoring systems that come to mind but there are many options available. These can typically be connected to other systems for procurement (SAP, Oracle, etc.), regulatory websites such as Ariel or Decernis, and quality control systems (SAP, Aramis and others). The authoring system collects the product compositions, toxicology, physical and chemical data, and the SDS required regulatory data and systematically creates an accurate, consistent and compliant document. Yet, even with all the advancement in tools available to the regulatory specialist, gaps in data collection remain and challenge our ability to author the most accurate and effective SDS needed to keep our own employees, customers, and the general public as safe as humanly possible.
Anyone working in product safety as I have understands that the task of SDS authoring alone can be overwhelming and, yet, that is only one requirement of a PS&RA professional. I spent much of my time “putting out fires” -- responding to the urgent requests of the plants, as well as inquiries from R&D and business folks needing my support immediately to continually develop new products. With that in mind, many companies have decided to outsource the SDS authoring to one of the many successful and excellent options available. This allows a company to downsize regulatory personnel or enables the existing staff to focus on other pertinent tasks. However, many companies still prefer to keep their regulatory staff and do their own authoring, largely because outsourcing requires a sharing of compositional information -- something many manufacturers are uncomfortable with, even if a legal confidentiality agreement is signed. In addition, many like having control of composition and process, as well as the flexibility to respond to changes, inquiries, and maintaining assets, including employees.
At my former employer, we authored our own SDS using an SAP system with an Ariel interface. To help put this in context, the pie chart in Figure 1 represents a rough breakdown of tasks required of a typical PS&RA professional - with the understanding that priorities change on a dime and the “squeaky wheel gets the grease”. This breakdown certainly may vary for you:
As the chart shows, PS&RA personnel have varied responsibilities. Despite this there are a few themes that seem to challenge all of us, no matter where we work. What follows is an overview of the gaps in data collection for compliance, but I know there are many more of various magnitudes.
Technology Challenge #1: Outbound data collection from raw material suppliers. Your SDS is only as thorough and effective as the product composition is accurate. Your product can be analyzed and product specifications created, but how do you know what to test for if you do not have the complete composition from your suppliers? For example, there may be impurities at less than 1%, not listed in section 3 of the supplier SDS. PS&RA needs to assess every substance added to their product and determine if each is: (a) consumed in the process as part of the final product; (b) removed in the process; or (c) remains in the final product. We typically fill this gap with an inquiry sent to a supplier with many questions. It is often an email without a tracking process and therefore, the sender isn’t even sure if the correct person was contacted to complete the form. Can we get these completed more effectively and efficiently?
Technology challenge #2: Inbound data from our customers. Turnabout is fair play, correct?! Our customers expect us to complete inquiries similar to what we send to them. How many different tools must you access to complete their forms? For me, it was at least five, and one form could take several hours to complete. These had very low priority on my daily “to do list” even though I knew how important they were! Can we lessen the time required to complete this task and quicken our response to our highly valued customers?
Technology challenge #3: Responding to regulatory changes. A simple but currently applicable example is the mandatory labeling adopted for California Proposition 65 (CA Prop 65) in late 2016. If section 15 of a supplier SDS does not currently provide the CA Prop 65 label warning, you must petition your suppliers to add it and then assess your products and label accordingly. At the very least, you must have chain of custody type assurance stating that no label is required. The bigger task at hand is the TSCA reform of 2016. How will we ensure all of our raw material and final product CAS numbers remain on the TSCA inventory and/or stay ahead of the changes and additions to the priority chemicals and toxicology mandates? Could we have a tool to accomplish this?
Technology challenge #4: Chemical Data Reporting (CDR). The EPA requires every manufacturer submit data using Form U. Submission is required every four years but, in reality, is continuous because it involves tracking each chemical, from the time of purchase to disposal or recycling. The EPA provides us with Form U, but in reality, this only gives us the format the EPA requires for your data. The actual task of collecting it requires exceptional sharing, coordination, corporate cooperation, and then aggregation of all data collected. As Form U doesn’t allow for this, could we develop a flexible, secure tool that made all of this information sharable, trackable, and storable?
Our current options for data collection are limited
We all understand the challenges companies have to face in dealing with chemicals. The question is: How are we going to address them? While there are many possible solutions, there are a few things that a truly effective tool must accomplish to get this work done the right way (quickly, comprehensively, and affordably).
First, we need a tool to extract data from procurement, quality and authoring systems. This will help fully qualify raw material suppliers, monitor supplier changes, assist in new material set ups (new product, change in composition or package size) and establish final product specifications.
Next, we need a tool to help our suppliers send inquiries, track response progress, store responses, and upload them to other systems (procurement, authoring, etc.).
Currently, the preferred tools for responding to data collection challenges are:
Outsourcing tasks such as authoring as previously discussed
Office-based documents (Word, Excel, PDF)
- Cumbersome data collection portals used to collect survey data.
We all know from experience that the above options do not solve the challenges I’ve outlined. This is not the fault of any of the solutions per se. They simply weren’t created to be interactive! In fact, the only reason they’re still so frequently used is due to the considerable power of inertia: this is just the way it’s always been done, even if it’s broken.
A better solution
With the significant increase in data demands currently being experienced in the chemicals sector, it’s beyond time for a solution. It’s time for a solution that allows you to easily create an electronic version of surveys that “stay alive” over time, allowing you to continuously store, update, and report collected data.
It’s time for a solution that allows you to communicate with your responders and track all of the conversations.
It’s time for a solution that allows you to share your collected data with whichever other systems you use – Enterprise Resource Planning (ERP), procurement, supply chain, etc. – rather than having it stuck in a proprietary black box that makes internal cooperation and collaboration nearly impossible.
It’s time for a solution that is flexible and easy to use and, therefore, doesn’t require a team of consultants to make even small changes to the system.
It’s time to bridge the gaps.
It will probably not surprise you that our company – PeerAspect – exists specifically to bridge these gaps. It is the solution I wish I could have had throughout my career in PS&RA, and you’ll be hearing a lot more about it – both on this blog and elsewhere.
I appreciate this opportunity to introduce myself. In subsequent blogs, I will be going into more detail about these (and other) problems and the way we address them. I look forward to connecting more with you. In the meantime, if you have any questions about how PeerAspect can assist your company in managing increasing amounts of data requests, acquisition, analysis, and secure storage, please send an email to firstname.lastname@example.org.
Lorrie Ritter is a Chemist and Product Safety Specialist with over 35 years of experience, having retired from Arkema in 2016 but continuing with them as a contract worker through and beyond the Global Harmonized System (GHS) transition. Lorrie was very excited to meet Sujeesh Krishnan at Society for Chemical Hazard communication (SCHC) meeting this past September and joined PeerAspect as Program Manager in early November. Lorrie understands the chemical industry and as one who loves to problem solve, her role here is to help find better solutions to your regulatory challenges using Sheets, PeerAspects system.
Lorrie graduated Magna Cum Laude from Fairleigh Dickinson University in Madison, NJ. She has extensive experience in Medical Laboratory Technology, Chemical Indexing, Environmental Science, Quality Control Analysis, High Pressure Liquid Chromatography (HPLC) column manufacturing, testing and sales. At Arkema, she worked in Analytical Chemistry, New Product Development, and Product Safety and Regulatory Affairs.
PeerAspect is a cloud-based exchange for compliance and sustainable innovation data. Companies can securely store this business critical information in an online vault and use Sheets – digital living documents – to collect and share the data with partners in their supply chains and within their own organizations. PeerAspect is the ideal replacement for inefficient solutions such as emails and spreadsheets and is being used to exchange data within the supply chains of a number of diverse multinational corporations, including Halliburton, Solvay, Fossil, SNF, Specialized Bicycle Components.