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US Chemical Regulations: TSCA and State Regulations

With a team of regulatory scientists based in North America, we are well situated to support your regulatory journey through TSCA and State regulations in the USA and the Canadian Environmental Protection Act (CEPA)) in Canada including Ontario. Through our integrated regulatory consultancy service we can guide you through all the scientific, technical and administrative requirements of dossier creation and submission, and help guide you to success.

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In-house US team 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 and state-led initiatives

In the USA, chemicals are governed at both the country and the state level. The Toxic Substances Control Act (TSCA) is the primary US 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 US 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, record keeping, testing requirements and restrictions for chemicals. Although the TSCA is the primary US legislation, most states have their own specific chemical regulations and policies, for example, the well-publicized Proposition 65 in California. These chemical-management policies are evolving all the time, so finding efficiencies in how to approach both country- and state-level needs requires joined-up thinking and on-the-ground know how.

We have a proven history of guiding customers through the TSCA chemical regulations, keeping you on track to achieve regulatory success for your chemical across the entire country.

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. This sets your regulatory path and whether you need to prepare pre-manufacture 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.

What You Get

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. 

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