US EPA finalized a Toxic Substance Control Act (TSCA) rulemaking
that will require manufacturers and importers of 50 chemical substances to report health and safety data.
Under TSCA Section 8(d), EPA requires persons who manufacture (including import) certain chemical substances to report health and safety data to EPA before they commence the activity. The new rule adds fifty substances to the TSCA Section 8(d) Health and Safety Data Reporting rule.
These reporting requirements will now apply to manufacturers (including importers) of chemicals of 50 more chemicals total:
- 20 chemicals that EPA has designated as High-Priority for the purpose of TSCA chemical risk evaluations; and
- 30 organohalogen flame retardants being evaluated for risks by the Consumer Product Safety Commission (CPSC).
The reporting is required by September 27, 2021.
The Final Rule describes in detail the types of health and safety reports and data that chemical manufacturers must submit to EPA. In essence, EPA will require submission of "lists and copies of certain unpublished health and safety studies."
EPA named the next twenty high-priority chemicals
for TSCA risk evaluations in January 2020. The list includes formaldehyde, 1,3-butadiene, BBP, DBP, DIPB, o-dichlorobenzene, p-dichlorobenzene, HHCB, DEHP, and others.
The list of thirty organohalogen flame retardants covered by the new rule is available in the Final Rule text.
The data submitted will inform EPA’s effort to prioritize and evaluate the risks of the chemicals under TSCA. It will also help CPSC begin a rulemaking process for this class of chemicals under the Federal Hazardous Substances Act (FHSA).
These TSCA reporting requirements
apply to person who:
- Have manufactured or imported a listed chemical substance in the ten years preceding the date the chemical is listed;
- Are currently manufacturing or importing, a chemical substance on the date it is listed; or
- Propose to manufacture or import a listed chemical substance in the future.
Electronic Reporting Required
Under 40 CFR 716.30, EPA requires chemical manufacturers to report electronically using EPA’s Chemical Information Submissions System (CISS). This reporting tool is available through EPA’s Central Data Exchange or CDX.
Learn more about CDX or submit reports at EPA’s website.
Online Training to Master TSCA Compliance
Be confident you’re meeting your TSCA chemical management and reporting responsibilities! Sign up now for the interactive TSCA Regulations Online Course
or call 888-546-6511 to speak with a Lion regulatory expert.
The Toxic Substances Control Act (TSCA) is complex and enforcement is stringent, making a comprehensive understanding of the rules critical for compliance. The law has broad applicability, subjecting all companies that “manufacture, use, process, distribute, import, or export chemical products” to complex reporting and management requirements.