Chemical compliance (TSCA) - USA
The Toxic Substances Control Act of 1976 (TSCA) grants EPA authority to collect data on chemicals used to evaluate, assess, mitigate and control risks that might be posed by their manufacture, processing and use. TSCA provides a variety of control methods to prevent chemicals from posing unreasonable risks, including reporting, recordkeeping and testing requirements and restrictions related to chemical substances and mixtures.
Understanding the TSCA requirementsThe Toxic Substances Control Act (TSCA) gives the Environmental Protection Agency (EPA) the authority to regulate new and existing chemicals. Although initially passed in 1976, the Act was amended in 2016 to include updated provisions that require the EPA to evaluate existing chemicals in a timely fashion, outline new risk-based safety standards, increase public transparency on chemical substances and differentiate chemical risk evaluations based on whether they present a high or low risk. As a result, there are deadlines for manufacturers and importers of chemical substances to meet in 2019 and beyond. Different sections of TSCA provide EPA with various authorities, a few of which are listed below:
- Section 5: Require pre-manufacture notification for "new chemical substances" before manufacture/import
- Section 4: Testing of chemicals by manufacturers, importers, and processors where risks or exposures of concern are found
- Section 5: Issue Significant New Use Rules (SNURs) when it identifies a significant new use that could result in exposures to, or releases of, a substance of concern
- Section 8(b): Maintain the TSCA Inventory
- Sections 13 and 12(b) respectively: Require importers and exporters of chemicals, to comply with certification reporting and/or other requirements
- Section 8(a): Require manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce in large quantities
- Section 8(e): Require that any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment to immediately inform EPA, except where EPA has been adequately informed of such information
TSG can helpWe can help with all aspects of chemical compliance under TSCA including:
- Prepare TSCA compliance manuals
- Prepare Premanufacture Notices (PMN)
- Assist with consent order negotiations
- Prepare Significant New Use Notices (SNUN)
- Make polymer exemption determinations
- Prepare Low Volume Exemption applications (LVE)
- Provide chemical import/export advice
- Assist with chemical data reporting (CDR)
- Perform TSCA compliance audits and training
- Prepare TSCA inventory NOA Form B
- Prepare Microbial Commercial Activity Notices (MCAN)
- Prepare TSCA Environmental Release Application (TERA)
- Assist with Confidential Business Information (CBI) substantiation
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG has a team of scientists, regulatory and environmental compliance consultants who manage all aspects of TSCA compliance. Our TSCA team is led by Saadia Eltayeb who has more than 20 years of experience preparing and submitting premanufacture notices (PMNs), Low Volume Exemptions (LVEs), polymer exemption determinations and consent order negotiations under Section 5 of TSCA and NSNs under CEPA. She also routinely audits chemical facilities to ensure compliance and provides import and export guidance.
I am writing to express my gratitude for the work Dr Eltayeb performed on a PMN for our company and a foreign vendor partner. This PMN was accepted with no 5e consent order or SNUR in an EPA review that took less than 4 months. I appreciate the technical rigor, hard work, and good communication skills Dr Eltayeb brought to our multicontinental and multicultural team.