
CHEMICALS: SCIENTIFIC AND REGULATORY SUPPORT
- TSCA Chemical Support
- PFAS
- CDR Reporting under TSCA
- California Safer Consumer Products (CSCP) Regulations
- California Proposition 65
TSCA Chemical Support
The Toxic Substances Control Act (TSCA) is the “other side of the house” of the United States Environmental Protection Agency (US EPA), and is the law that gives the US EPA the authority to regulate and screen all chemicals that are produced or imported into the United States to prevent unreasonable risk to health and the environment. toXcel can help you determine whether the chemical you intend to manufacture or import is indeed a new chemical substance and what, if any, exclusions or exemptions may apply to a chemical substance or its use, and navigate you through your requirements under US EPA/TSCA.
toXcel’s dedicated technical support staff can help prepare Premanufacture Notifications (PMNs), Low Volume Exemptions (LVEs), and Significant New Use Notifications (SNUNs). We have expertise in exposure modeling, structure activity relationships (SAR), and bridging/waiver justifications in addition to study placement/ monitoring. toXcel routinely prepares and submits documents to US EPA on behalf of clients via the CDX portal and acts as liaison in dealing with the Agency throughout the review process.
toXcel can help prepare your:
- Premanufacture Notifications (PMN)
- Low Volume Exemptions (LVE)
- Significant New Use Notifications (SNUN)
- Bona fide intent requests to search the TSCA Inventory
- PFAS reporting requirements under TSCA 8(a)(7)
PFAS
PFAS is a very hot topic in the chemical regulatory world! So what is it exactly? PFAS (per- and polyfluoroalkyl substances) chemicals, also called “forever chemicals” in the media due to their prolonged presence, consist of a large group of persistent fluorinated chemicals that have been manufactured and used as raw materials in several industries.
toXcel has staff focused on PFAS and follows the numerous federal and state regulatory updates in this developing area under US EPA/TSCA and other regulatory bodies.
toXcel has provided technical and scientific support for client submissions of PFAS-impurities under TSCA Section 5. toXcel can review available information from companies to help determine their potential liabilities related to PFAS, develop strategies related to testing, determine reporting requirements, develop risk and exposure assessments, and help companies navigate forward in this developing area.
toXcel is also familiar with the new TSCA one-time reporting rule (rule promulgated in late 2023) under TSCA, having presented on this subject to the Household and Commercial Products Association (HCPA) regarding due diligence efforts related to PFAS (contact us if you are interested in seeing this presentation), and is available to assist clients in understanding their reporting requirements and how to gather the required documentation for these persistent substances. US EPA recently extended the initial reporting period again for this one-time rule due to the Agency’s budget constraints in getting set up to receive the data. But don’t wait – the deadlines in 2026 are still coming up fast and there is more to do than you think! toXcel follows the major PFAS developments to keep you up to date.
CDR Reporting under TSCA
The Chemical Data Reporting (CDR) rule requires manufacturers (including importers) to report data to the U.S. Environmental Protection Agency (US EPA) every four years. The CDR rule requires all companies to report data electronically through EPA’s Central Data Exchange (CDX) system. The most recent reporting year was in 2024 – this reporting period covered chemicals manufactured or imported between 2020 and 2023. The next reporting year will be 2028.
toXcel can assist companies to review possible exemptions their business may qualify for (including low volume and polymer exemptions) and determine reporting requirements. Under the rule, manufacturers and importers are required to report to EPA exposure-related information, including information on the types, quantities, and uses of chemical substances produced domestically and imported into the United States. toXcel assists in preparing this information in the required CDX form and aiding companies in the submission process.
California Safer Consumer Products (CSCP) Regulations
The California Safer Consumer Products Regulations, promulgated under AB-1879 and SB-509, require the development of green chemistry alternatives for chemicals present in consumer products that are sold in California. This law was implemented on October 1, 2013. CSCP is managed by the California Department of Toxic Substances Control (DTSC).
toXcel can assist affected manufacturers and distributors in navigating the DTSC system, developing key required documents for submission to be compliant with DTSC deadlines, and developing comments on key DTSC-generated documents, as needed.
toXcel staff routinely follow developments in the CSCP program to alert clients to DTSC news and rule-makings which may affect key aspects of their business.
California Proposition 65
toXcel’s goal is to protect your business by minimizing regulatory risks and exposure liabilities under California’s Proposition 65 (Safe Drinking Water and Toxic Enforcement Act). This law safeguards California residents from toxic chemical exposures via products, drinking water, and the environment, and is administered by the Office of Environmental Health Hazard Assessment (OEHHA).
With extensive experience across antimicrobials, pesticides, cosmetics, personal care, cleaning products, and medical devices, toXcel develops product-specific exposure assessments to proactively manage risks and defend against enforcement actions. We have successfully suspended OEHHA actions and achieved chemical de-listings from Prop 65 — rare accomplishments that set us apart. When warnings are unavoidable, we craft compliant, least-impactful Proposition 65 warning statements tailored to your products.
White Papers and Other Downloadable Resources


New List of Chemicals Regulated Under California Proposition 65
toXcel is experienced in helping companies that may potentially be affected by the requirements under Proposition 65. Read more Here
Toxic Substance Control Act (TSCA)
TSCA requires the notification of USEPA’s Office of Chemical Safety and Pollution Prevention of any “new” chemical substances manufactured in the United States or imported for the first time…
California Safer Consumer Products Regulation
The California Safer Consumer Products Regulations, promulgated under AB-1879 and SB-509, require the development of green chemistry alternatives for chemicals present in consumer products that are sold in California…
California Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, was developed to protect consumers in California from exposures to reproductive/developmental toxicants and potential cancer-causing substances…