The information below was correct when it was published in 2018. To view the many updates since this publication, such as the 2023 update that included 86,000 substances, please view the Regulatory Updates on the news page of UL.com.
By Stacie Abraham, UL Senior Regulatory Specialist
The deadline for manufacturers and importers to notify chemical substances as active under the Toxic Substances Control Act (TSCA) Inventory Notification (Active-Inactive) Reporting Requirements Rule has now expired. The reporting period ended on February 7, 2018, while the reporting period for processors ends on October 5, 2018.
If you need assistance with understanding and executing your compliance obligations under this reporting rule, and the potential impacts of not fulfilling them, our UL Regulatory Advisors can assist. As an independent, confidential third-party provider, UL is well-positioned to be your partner to deliver compliance assurance for uninterrupted business continuity. Contact us for further assistance.
Background
In November of last year, the Environmental Protection Agency (EPA) published a preliminary list of 10,730 chemical substances reported under the TSCA Inventory Notification (Active-Inactive) Rule.
The Rule requires chemical manufacturers and importers to notify substances to the EPA that are on the TSCA Inventory, and for which manufacture or import for non-exempt commercial purposes occurred at a U.S. site between June 21, 2006 and June 21, 2016. The purpose of this reporting is to designate these substances as active on the TSCA Inventory.
The EPA has indicated that they plan on publishing a draft Inventory identifying active-inactive substances within approximately 60 days of the February 7 deadline. Processors of substances that have not yet been identified as active have until October 5, 2018 to notify substances as active to the EPA.
In addition to this, if you have manufactured, imported or processed a chemical substance on the confidential portion of the Inventory prior to June 22, 2016, you must submit a request to the EPA if you wish to maintain an existing confidentiality claim for the specific chemical identity of the substance.
Compliance Issues
It appears that industry has found it difficult to comply with the February 7, 2018 deadline due to a number of issues with the mandatory electronic Central Data Exchange (CDX) reporting system, challenges in obtaining necessary information from upstream suppliers (especially when confidential business information (CBI) is involved), and when coordinating submissions with non-U.S. suppliers who are not familiar with the TSCA requirement, or the CDX system. An additional layer of complexity is introduced for mixtures where CBI is involved and cooperation is required from two or more entities.
The primary purpose of this reporting is to identify substances still active in commerce in order to better focus on the existing chemicals review program under TSCA Section 6. While this reporting deadline is a statutory requirement and cannot be extended, EPA is urging manufacturers and importers who missed the deadline to file as soon as possible, to facilitate the Agency’s ability to accurately designate substances as active or inactive on the TSCA Inventory.
Considerations for manufacturers and importers
If you are a manufacturer or importer, there are a number of key points to consider:
- Are you certain that you have identified all reportable substances, and have met the February 7, 2018 reporting deadline?
- Do you have substances for which you missed the reporting deadline?
- Have you had difficulty obtaining required information from upstream suppliers, especially those outside the U.S.?
- Have you had difficulty using CDX?
- Are you ready and able to file as soon as possible?
- Are you aware of the additional self-reporting actions potentially required if filing a late submission?
Considerations for processors
If you are processor, there are also a number of key issues to be taken into consideration:
- Do you have the means to monitor and review the draft active-inactive inventory once it is published?
- Are you able to identify your substances that have not yet been notified as active?
- Are you registered in CDX, and are you familiar with the filing requirements and process?
- Do you have the means to obtain necessary information from upstream suppliers, especially where CBI is concerned?
- Will you be able to meet the October 5, 2018 reporting deadline?
Next Steps
UL’s global Regulatory Assurance Team includes a number of leading industry experts on TSCA, who can help you understand and execute your compliance obligations under this reporting rule. Contact us to find out more.
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