How do I request TSCA and PMN support from SciQra?

You can request TSCA regulatory and PMN support by contacting SciQra at info@sciqra.com or +1-609-917-6181, or through the contact form at sciqra.com/contact-us. Scope, timeline, and cost depend on the chemical substance, available data, and target markets.

TSCA Regulatory & PMN Support

Q: How can I determine whether my chemical is listed on the TSCA Inventory?

TSCA Inventory status depends on the specific chemical identity and the information contained in the Inventory. SciQra offers TSCA Inventory screening support to help determine a substance's status and applicable regulatory obligations.

Q: Does a chemical not found on the public TSCA Inventory automatically require a PMN?

Not necessarily. Further evaluation may be needed to determine whether exemptions apply or whether the substance's status is subject to confidential business information (CBI) considerations before a Premanufacture Notice is required.

Q: What is a Bona Fide Intent Notice?

A Bona Fide Intent Notice is used when a substance is not identified on the public TSCA Inventory and its confidential Inventory status needs to be determined before proceeding with manufacture or import.

TSCA Regulatory & PMN Support

With scientific leadership from a former U.S. EPA Science Advisory Committee on Chemicals (SACC) peer reviewer and a Board-Certified Toxicologists (DABT), we support organizations in addressing the scientific and regulatory considerations associated with chemical substances under Toxic Substances Control Act (TSCA).

Scientific Leadership:

Udayan Apte, PhD, DABT, FAASLD

Board-Certified Toxicologist (DABT), American Board of Toxicology
Fellow, American Association for the Study of Liver Diseases (FAASLD)
Peer Reviewer, EPA Science Advisory Committee on Chemicals (SACC) - evaluated EPA draft risk assessments under TSCA Section 6

Our Support Includes:

TSCA Inventory Screening and Regulatory Applicability

Determination of the Inventory status, including Active/Inactive status assessments
Bona Fide Intent Notice preparation and submission support for substances not identified on the public TSCA Inventory
Evaluation of TSCA applicability, potentially relevant exemptions, exclusions, and regulatory pathways
Significant New Use Rule (SNUR) Identification and Significant New Use Notice (SNUN)

Premanufacture Notice (PMN) - TSCA Section 5

Preparation, review, and organization of Premanufacture Notices (PMNs) and associated supporting documentation for submission to the U.S. EPA
Identification of key scientific and regulatory data gaps, and assessment of readiness for PMN preparation
Development and evaluation of relevant exposure scenarios and supporting information
CDX submission and consent order support
Scientific and regulatory support during EPA review processes, including responses to EPA inquiries and requests for information

Chemical Hazard Assessment and Risk Characterization

Hazard identification dose-response assessment, uncertainty analysis, mode-of-action evaluation, and critical endpoint characterization
Application of read-across strategies, New Approach Methodologies (NAMs), Benchmark Dose (BMD) modeling, Weight-of-Evidence (WoE) approaches, and other quantitative toxicological methodologies
Scientifically justified technical opinions for regulatory and legal contexts

TSCA Reporting & Ongoing Compliance

Notice of Commencement (NOC) preparation and submission following commencement of manufacture or import
Notice of Activity (NOA) Form B support for applicable confidential Inventory status considerations
Chemical Data Reporting (CDR) applicability assessments, production volume documentation, and CBI substantiation support
Ongoing scientific and regulatory support for TSCA compliance obligations

Risk Evaluation Support - TSCA Section 6

Scientific review and analysis of EPA draft risk evaluations
Development of public comments and supporting technical documentation
Support associated with SACC review proceedings and related scientific evaluations

Integrated Global Chemical Compliance

Development of coordinated TSCA and REACH compliance strategies for global chemical portfolios

Frequently Asked Questions

What is TSCA and why is it important for chemical manufacturers and importers?

The Toxic Substances Control Act (TSCA) is the primary U.S. federal law governing the manufacture, import, processing, distribution, use, and disposal of certain chemical substances. Companies manufacturing or importing chemical substances in the United States need to evaluate applicable TSCA requirements before placing substances into commerce.

How can I determine whether my chemical is listed on the TSCA Inventory?

TSCA Inventory status is determined based on the identity of the chemical substance and relevant Inventory information. SciQra supports TSCA Inventory screening to help determine whether a substance is listed and whether further regulatory evaluation may be required.

Does a chemical that is not found on the public TSCA Inventory automatically require a PMN?

Not necessarily. A substance not identified on the public Inventory may require further evaluation to determine whether it is subject to TSCA Section 5 notification requirements or whether an applicable exemption, exclusion, or confidential Inventory consideration applies.

What is a Premanufacture Notice (PMN)?

A Premanufacture Notice (PMN) is a notification submitted to the U.S. EPA under TSCA for certain new chemical substances before manufacture or import for a non-exempt commercial purpose. SciQra provides PMN feasibility, preparation, and submission support based on the applicable regulatory requirements.

What is a Bona Fide Intent Notice?

A Bona Fide Intent Notice is used by a company with a genuine intent to manufacture or import a chemical substance when the substance is not identified on the public TSCA Inventory and its confidential Inventory status needs to be determined by EPA.