Nearly every company involved in the chemical industry doing business in the U.S. is impacted by Toxic Substances Control Act (TSCA) regulations to some degree (with some exceptions among food, drug, cosmetic, nuclear and pesticides companies). Raw materials, intermediates, finished goods and some articles are all regulated by TSCA. Full lifecycle, or cradle to grave, compliance is an essential component of TSCA, as most manufacturing, importing, processing and disposal activities are TSCA regulated.
Penalties for non-compliance can include civil litigation and monetary settlements, criminal prosecution, fines, damage to a company's brand or reputation, and negative impact on a company's ability to do business. Willful violators can face imprisonment.
Increased TSCA requirements resulting from EPA's chemical management reform as mandated by the TSCA Reform bill signed into law June 2016 and increased enforcement will accelerate the burden on organizational EH&S compliance activities. To ensure compliance with TSCA, 3E recommends developing and maintaining a comprehensive and detailed plan, which should include the following:
- Checking the TSCA 8b inventory for substances imported or manufactured, including the ingredients in finished products
- Reviewing individual state regulations for banned or restricted substances
- Establishing TSCA compliance status for all raw materials, intermediates and finished goods
- Reviewing TSCA R&D and other exemption requirements and setting up procedures to govern related activities
- Providing import certification once the status of the substance or product to be imported has been checked against the TSCA inventory
- Establishing processes for tracking TSCA 12(b) exports and assisting with export notification
- Establishing processes for compliance with adverse effects reporting TSCA 8c and 8e and recordkeeping
- Monitoring and tracking regulatory changes that are likely to impact business
- Maintaining required records and auditing against various recordkeeping requirements such as Chemical Data Reporting (CDR)
- Establishing a TSCA compliance program documented in a manual that includes management of change procedures
If your company requires additional data, resources and expertise, 3E stands ready to provide comprehensive TSCA support.
Checking the TSCA 8b Inventory
To determine if your products are impacted by TSCA, a subscription to Ariel® WebInsight provides instant access to the TSCA Inventory for searching by a variety of criteria including CAS RN and chemical name. Subscribers can also access the full text of the regulation as well as helpful guidance documents and overviews. Individual state regulations for banned or restricted substances is also part of the subscription, providing a single centralized repository for all your regulatory research needs.
Support You Need, When You Need It
3E Company provides outsourced support for the complex and time-consuming tasks associated with TSCA compliance requirements. Leveraging 3E's team of experienced regulatory professionals who are actively involved and engaged in these activities on a daily basis can be a highly efficient and effective way to address the challenges associated with ensuring compliance with chemical control laws.
Learn more about our TSCA Compliance Services and the many functions we can support.