Addressing some key issues in the chemical regulatory world
PeerAspect works with companies from around the world, and through our industry associations and outreach activities, we are in constant contact with many more. In our conversations, we have found several reoccurring concerns that are common to many organizations. I will briefly touch upon these “hot topics” here, and elaborate on them more in future blog entries. I am eager to learn if these are your hot topics as well or if you have an existing or emerging data challenge to add to our list. Reach out and let me know! As I outline each issue, I will also touch upon the current technology approaches to the hotspot, and suggest better approaches (including our own, of course!) where applicable.
TSCA Reform 2016 and Beyond
In June of 2015, Congress passed and former President Barrack Obama signed a bipartisan bill to reform the Toxic Substances Control Act (TSCA), the first major update to the environmental statute in 20 years. The bill was passed suddenly, and without much detail or instruction. Those details are finally surfacing, but in phases. So what will happen as the reformed TSCA rules take effect?
First, some existing chemicals listed on the inventory will be re-evaluated. The Environmental Protection Agency (EPA) is now required to systematically prioritize and evaluate risk (and risk management) of chemicals on a specific and enforceable schedule. Within a few years, EPA’s chemicals program will have to assess at least 20 chemicals at a time, and begin another chemical review as soon as one is completed. Second, the EPA will evaluate chemicals purely on the basis of the Risk Assessments considering conditions of use and the health and environmental risks they pose. This is a very practical approach – it takes into consideration not only the toxicity and potential risk of exposure to human health and the environment, but the ways the chemical is being handled in the process or product as well.
Next, they will take steps to eliminate any unreasonable risks found. The new law provides a consistent source of funding for EPA to carry out its new responsibilities by significantly increasing the fees. The EPA will now be able to collect up to $25 million a year in user fees from chemical manufacturers and processers, supplemented by Congressional budgeting, to pay for these improvements. All of this has a significant impact on the development of new chemical products as well as existing products.
So how will all of this affect you? Well, you are certainly going to need to know what chemicals (intended, impurities, or by-products) are in your raw materials and final products. This will require some means of surveying your suppliers and obtaining the composition needed to ensure compliance with TSCA reform. (We can help with this!)
CA Prop 65 Changes of 2016
Last fall, the state of California updated the CA Prop 65 regulations. (There now exists an even more extensive list of chemical components to evaluate.) Proposition 65 is a warning requirement for cancer and reproductive risk that must be provided if any of the listed chemicals are known to be in your product. All products being sold into the state of California must be assessed against the list. If the product contains a listed component, the product must be clearly labeled with one or both of these mandatory warnings:
· WARNING: This product contains a chemical known to the State of California to cause cancer.
· WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm.
Typically product labels are also in Section 15 of the SDS. If there is no warning required for CA Prop 65 (the product does not contain any of the listed chemicals), the SDS should indicate:
· This product does not contain any chemical known to the State of California to cause cancer, birth defects or another reproductive harm.
The key here, as we discussed previously, is getting accurate composition information for your raw materials from the suppliers, including CAS numbers of components present at less than 1%. If the supplier indicates no chemical requiring CA Prop 65 warnings, you may want further certification as a “chain of custody” assurance. If the SDS indicates there are one or more chemicals of concern, you must request they provide the CAS number and amount present so you can determine if this chemical remains in your final product at a reportable amount.
Once again, the first step for your company is to have complete raw material compositions. (And once again, we can help!)
General Chemical Compliance
Do you send regulatory certification forms to customers? (Here, I’m referring to the extensive list of regulations usually not covered by an SDS). If so, you need to ensure compliance. Some common cases include conflict minerals, RoHS, global inventory, FDA status, etc. Most likely, you receive these from your customers as well. Most companies we meet are still doing this with Excel questionnaires, Word documents, PDFs, etc. There are better solutions out there, and PeerAspect’s Sheets platform is one of them.
Raw Material Assessment Process and Supply Chain Changes
The goal of most companies in this area is to qualify materials for use, keeping costs down and reliability and deliverability high. All raw materials should be qualified at the plant level to meet production specifications and address any safety concerns, and Product Safety should evaluate for any regulatory non-compliance. Any change in suppliers may affect the composition and/or SDS and therefore requires review. Customers are telling us they need a robust system to flag the change in the production system (SAP, Oracle, etc.) and initiate the process to ensure the new or replacement chemical conforms. This is another area where advancements over Excel, Word, and PDFs are extremely helpful.
Supply Chain: New Product Set Up
The routine process of setting up a newly developed finished product or adding a SKU to an existing product should be simple, but typically it is not. In fact, it requires several people to either review or complete a spreadsheet to ensure the material has all of the required information to complete the Bill of Lading. product label, SDS, NAFTA certification, HTS # (harmonized tariff Schedule), packaging review, etc.)
This is an area that cries out for better software solutions, and requires a platform that makes sharing of data collection and management much easier than it has been in the past. For example, it is extremely helpful to be able to take a subset of the overall assessment and send it to the person responsible for that activity within your organization. Any discussion, questions and/or comments should be captured directly in the assessment, greatly reducing the need for emails and other communications outside of the platform. These assessments should also be updatable, as regulatory needs change and evolve over time.
Conflict Minerals and RoHS
Although these are separate laws, we find they go hand-in-hand for many companies:
1. Conflict Minerals regulations impose a supply chain challenge for purchasing minerals including titanium, tin, gold or tungsten. Because this only affects a few manufactures and is very complicated, I’m including a reference to the specifics here. For those affected, this is very important.
2. From the website: “RoHS, also known as Lead-Free, stands for Restriction of Hazardous Substances. RoHS, also known as Directive 2002/95/EC, originated in the European Union and restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market after July 1, 2006 must pass RoHS compliance. RoHS impacts the entire electronics industry and many electrical products as well[L1] .”
CDR: Chemical Data Reporting
I know, you must still be recovering from submitting this last fall! But In my experience, a four year cycle goes very fast and this will be back on your plate in no time. So it’s much better to treat it as a continuing process of collecting this data over the course of the cycle, making the final report less painful. For those unfamiliar with this continuous approach, lucky you! (But seriously, here is a link.)
We did address this in my previous post. To recap: “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?”
The sort of flexible tool I allude to here is becoming more and more of a necessity as the regulatory environment gets increasingly complicated. There are some options out there (we have one too, of course) but whatever solution you end up using, I hope that this look at the hot topics of chemicals regulations helps you put your needs in perspective, and sets you on the road to better management of your regulatory data. Feel free to reach out with any questions or comments.
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 software exchange for compliance and sustainable innovation data. Companies can securely store this business critical information in their own 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, and Specialized Bicycle Components.