Background
The Frank R. Lautenberg Chemical Safety for the 21st Century Act became law on June 20, 2016. The Lautenberg Act is an amendment to TSCA and drastically changes the way the Environmental Protection Agency (EPA) approves and regulates chemicals and microbials. The most significant change is a new four-step process that EPA must follow to evaluate all chemicals, whether new or existing. EPA first needs to determine which chemicals are in commerce in the United States. Then it must prioritize those chemicals, making a determination which ones require a risk evaluation. EPA must then perform a risk evaluation on high-priority chemicals and, if required, regulate the chemical to ensure safe use.
Right now, industry needs to comply with the first step in the process, known as the “inventory reset.” EPA maintains a list, known as the TSCA Inventory, of all chemicals that were either in existence when TSCA was enacted or approved since that time. If a chemical is not on that list, it cannot legally be used in the United States. EPA is in the midst of determining which chemicals on the inventory are still in active commerce, referred to as the inventory reset.
Chemical manufacturers or importers need to report to EPA any chemical manufactured or imported during the 10-year period prior to June 21, 2016. This reporting must be completed by Feb. 7, 2018. EPA will then compile a preliminary list and give chemical processors — defined as any other entity that uses chemicals — an opportunity to report chemicals not previously identified. That reporting period closes Oct. 5, 2018.
This seemingly small reporting obligation has significant impact: If a chemical is not identified and reported or subject to a reporting exemption, it will not be placed on the “active” inventory, and that chemical will not be legal for use in the United States. This includes all chemicals used in manufacturing consumer electronics, juvenile products, pharmaceuticals, clothing, paints, coatings, adhesives, lubricants, cleaners etc.; even if the end product is regulated under a different statute, the constituent chemicals are still regulated under TSCA and must be included in the inventory.
Common Questions
All companies that manufacture, use, process, import, export or sell products containing chemicals must ask themselves the following questions:
- Do we know what chemicals we make and/or use in products or are contained in our products?
If a chemical is not identified, it won’t be legal for use. If a company does not know what it uses, it cannot guarantee the legal status of the chemicals in its products. - What do we know about the chemicals that we make or use or that are in our products?
If you do not know the supplier, formulator or distributor, it may be difficult to ensure that the responsible party is indeed reporting. This is a particular concern for entities that import chemicals solely for further distribution. Under TSCA, an importer has the same legal obligation as a manufacturer, and therefore importers need to report. Companies may need to obtain new compliance certifications from suppliers to cover this new obligation. - Does anyone else make or use the same chemical?
Although the law requires each manufacturer/importer to report, if you are a user and know that there are multiple manufacturers, it increases the likelihood that the chemical is being reported. - Is any information we have confidential business information?
EPA recognizes that many manufacturers will not divulge the exact identity of chemicals supplied to customers due to concerns about confidential business information. EPA allows for joint submissions, but these submissions need to be coordinated.
As mentioned, the initial reporting period closes in less than a month and the reporting period for chemical processors ends on Oct. 8, 2018. Accordingly, businesses should now consider whether they need to take additional steps to meet these obligations.
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