US Toxic Substances Control Act (TSCA)
Toxic Substances Control Act (TSCA) is the primary U.S. chemicals management law. TSCA gives the EPA authority to police the production, importation, use and disposal of chemical substances and/or mixtures in the USA. It mandates the evaluation of chemicals in the U.S. market, defines risk-based safety standards, ensures public transparency of chemical information and enshrines funding for the EPA in law. As the regulator, the EPA determines reporting, recordkeeping, testing requirements and restrictions for chemicals.
Covance has a proven history of guiding customers through the TSCA regulatory process. With constantly evolving regulation, we can keep you on track to achieve regulatory success for your chemical
- U.S. network of expert regulatory scientists with vast experience in submitting chemical registrations to TSCA
- Expertise in leveraging existing data from other jurisdictions to meet TSCA registration requirements
- Supporting you through the scientific, technical and administrative burden of TSCA submissions
Determining your chemical’s inventory status
Navigating the TSCA Chemical Substance Inventory is the first step you need to take to determine if your chemical is listed as an existing chemical or is classed as a new chemical substance. That sets your regulatory path and whether you need to prepare premanufacture notices (PMNs).
Requirements for TSCA safety evaluation
Unlike other global regulations, data requirements under TSCA are not pre-set. This means that information requirements are targeted and variable. This can cause challenges when you try to strategically leverage existing dossiers from other jurisdictions. The EPA Chemical Categories approach allows for new substances, which fall into an existing category, to be assessed for potential health or environmental concerns identified by the EPA for the category and subsequent assessment of likely test requirements to address these concerns.
Implications of substance use
You need to know how your chemical substance is used as this informs risk assessments and subsequent risk management plans. Keeping abreast of new uses for chemicals is also important in order to comply with substance use requirements
Guiding you and your chemical through TSCA safety evaluation
Our dedicated team of over 40 regulatory scientists work together with our in-house study teams. This joined up approach enhances the efficiency of regulatory submissions to TSCA and where possible, we can leverage data from other jurisdictions to ensure cost-effectiveness and improve time to approval. Let us guide you decisively through the EPA’s prioritization, risk assessment and risk management steps. From preparing premanufacture notices (PNMs), to developing hazard and exposure assessment to responding to test evaluation requests, Covance can help.
Helping you answer TSCA technical, scientific and administrative questions
With a dedicated team in the USA, we can help you with all technical, scientific and administrative aspects of TSCA. This includes preparation and submission of:
- Premanufacture Notices (PMN)
- Significant New Use Notices (SNUN)
- Exemption applications eg Low Volume Exemption (LVE), Research and Development Exemption, Low Releases and Low Exposures Exemption (LoREX), Polymer Exemption
- Exemption applications eg Low Volume Exemption (LVE)
- Chemical data reports (CDR)
- TSCA inventory NOA Form B
- TSCA Environmental Release Application (TERA)
As your partner, our expert team can act as advocates at EPA hearings to defend submissions. Our firm grounding in the science behind the regulation allows us to make comprehensive and convincing regulatory arguments on your behalf.