Guidance for you and your chemical through TSCA safety evaluation
We have a dedicated team of regulatory scientists in the USA. By working collaboratively with our wider team of over 40 regulatory scientists and our in-house study teams, we can provide an integrated approach. This means leveraging data from other jurisdictions and targeting testing strategically to ensure cost effectiveness and improved time to approval. Let us guide you decisively through the EPA’s prioritization, risk-assessment and risk-management steps. We can provide support through all stages: assessment, scoping, hazard assessment, exposure assessment and risk characterization. Be it preparing PNMs, developing hazard or exposure assessment or responding to test evaluation requests, we can help. Whether it is to support registration of a new chemical or compliance for existing chemicals, we can guide you through the process.
Support answering TSCA technical, scientific and administrative questions for new or existing chemicals
Our US team can help you with all technical, scientific and administrative aspects of the TSCA.
For new chemicals, this includes preparation and submission of:
- pre-manufacture notices (PMN)
- significant new-use notices (SNUN)
- exemption applications, e.g., low volume exemption (LVE); research and development exemption; low releases and low exposures exemption (LoREX); polymer exemption
- chemical data reports (CDR)
- TSCA inventory NOA Form B
- TSCA Environmental Release Application (TERA)
For existing chemicals, this includes supporting you in preparing technical comments at all points in the EPA process for prioritization, risk assessment and risk evaluations. We can also provide specific support for responses to EPA-drafted risk-specific or technical-issue guidance. As part of these technical comments, we can:
- provide independent exposure or hazard analysis (e.g., exposure modeling, dose-response modeling and weight of evidence analysis)
- support submission of confidential exposure or hazard data
- support placement of test orders issued by EPA
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. This typically includes submissions through public comments, position papers or via independent risk analysis.