What Is TSCA Compliance? PMN, PFAS Reporting, and Penalties

TSCA compliance means following the Toxic Substances Control Act and the EPA rules built on it: notifying the agency before you make or import a new chemical, reporting on the ones you already handle, keeping the records the law requires, and respecting any restrictions EPA has placed on specific substances. Get it wrong and civil penalties start at $25,000 per day of violation, with each day counted separately.¹ What follows walks through who has to comply, what the main obligations look like, and where the biggest enforcement risks sit right now.

Who Has to Comply

TSCA reaches anyone who manufactures, imports, processes, distributes, commercially uses, or disposes of chemical substances and mixtures.² That is a wider net than most people expect.

The catch that surprises companies most often is the definition of “manufacturer.” Under TSCA, importers count as manufacturers. If you bring finished electronics, textiles, cookware, or other consumer goods into the country and those goods contain regulated substances such as PFAS or formaldehyde-emitting composite wood, you can carry the same reporting obligations as a company that produces the chemical itself.

Downstream processors, meaning companies that use or transform chemicals they bought from someone else, also have obligations. They may qualify for exemptions from certain reporting rules as small businesses, but they still have to keep records and follow any use restrictions EPA has placed on a specific substance.

What Falls Outside TSCA

Several categories of substances are excluded from TSCA because other federal laws regulate them:³

Pesticides regulated under FIFRA when manufactured or distributed for use as a pesticide.
Food, food additives, drugs, cosmetics, and medical devices regulated under the Federal Food, Drug, and Cosmetic Act.
Tobacco and tobacco products.
Source material, special nuclear material, and byproduct material under the Atomic Energy Act.
Firearms, ammunition, and their components subject to the firearms and ammunition excise tax.

The phrase “when manufactured or distributed for use as” does real work here. A chemical that is a pesticide ingredient when sold for pest control can still fall under TSCA if the same substance is sold for an unrelated industrial use. The exclusion follows the use, not the molecule.

New Chemicals: The Pre-Manufacture Notice

Any chemical not already on the TSCA Inventory is “new.” You cannot manufacture or import it for commercial purposes without first notifying EPA, and the primary vehicle is the Pre-Manufacture Notice (PMN).⁴

File the PMN at least 90 days before commercial production or import begins. EPA uses that 90-day window to evaluate potential risks and can extend the review if it needs more data. The standard PMN fee is $37,000, dropping to a maximum of $6,480 for companies that qualify as small businesses.⁵

Even after a substance clears PMN review, EPA can issue a Significant New Use Rule (SNUR) that forces a new notification if someone wants to use the chemical in a way that changes exposure. Before starting any use covered by a SNUR, you file a Significant New Use Notice and wait for EPA to complete its review.⁶

Exemptions From the Full PMN

Not every new chemical requires the full 90-day process. Three exemptions carry most of the traffic:

The research and development exemption applies when you manufacture the substance solely for R&D. No PMN is required, but you must notify everyone who handles it of any health risks you have reason to suspect, whether through container labels, posted notices, or written communications. If you send the substance outside your company, written notice must state that it is for R&D use only and include the risk information.⁷

The Low Volume Exemption covers new chemicals produced in quantities of 10,000 kilograms or less per year. Notice to EPA is still required at least 30 days before manufacture, but the review is shorter.⁸

The polymer exemption lets certain polymers skip the PMN if they meet detailed criteria on molecular weight, small-molecule content, and monomer sourcing. Water-soluble cationic polymers, polymers designed to degrade, and certain fluorinated polymers are excluded. The criteria are technical enough that most companies confirm eligibility with a regulatory specialist before relying on this route.⁹

Existing Chemicals and Risk Evaluation

For chemicals already on the Inventory, EPA runs a three-step process: prioritization, risk evaluation, and, where warranted, risk management. High-priority designation triggers a formal risk evaluation examining hazards, exposure routes, and real-world conditions of use. Cost is not part of either the priority decision or the evaluation.¹⁰ If EPA concludes a chemical presents an unreasonable risk, it must impose restrictions on manufacturing, processing, distribution, use, or disposal sufficient to eliminate that risk.

Five persistent, bioaccumulative, and toxic chemicals received expedited treatment from Congress and skipped the full evaluation process: decaBDE, PIP (3:1), 2,4,6-TTBP, HCBD, and PCTP. Restrictions on these are already in force and range from outright prohibitions to limits on specific uses.¹¹

Substance-Specific Rules You May Hit

Several TSCA programs impose their own compliance requirements on top of the general framework.

PCBs

Polychlorinated biphenyls are among the most heavily restricted substances under TSCA. Manufacturing, processing, distributing, and using PCBs are prohibited except in totally enclosed systems, with narrow exceptions. PCB-containing equipment must be disposed of following EPA rules that specify approved methods and facilities.¹²

Asbestos in Schools

Local education agencies must inspect for asbestos-containing materials, develop management plans, and carry out response actions that protect occupants. Acceptable responses include removal, encapsulation, enclosure, and repair. Transportation and disposal of asbestos waste must follow EPA guidance.¹³

Lead-Based Paint

Two obligations apply to pre-1978 housing. Sellers and landlords must disclose known lead-based paint hazards before a sale or lease, provide any available records, and give the buyer or tenant EPA’s lead safety pamphlet.¹⁴ Any renovation, repair, or painting project in pre-1978 housing or a child care facility that disturbs lead-based paint must be performed by an EPA-certified lead-safe contractor.¹⁵

Formaldehyde in Composite Wood

TSCA Title VI sets emission limits for hardwood plywood, particleboard, and medium-density fiberboard sold or imported in the U.S., with specific ppm caps for each product type. Panels and bundles must be labeled with the producer’s name, lot number, certifying third-party body number, and a statement that the products are TSCA Title VI certified. Finished goods carry a label with the fabricator’s name, production date, and a compliance statement. A limited exception applies to finished goods where the total regulated wood content is 144 square inches or less, measured by the surface area of the largest face.¹⁶

PFAS Reporting: The Deadline You Cannot Miss

The single most active compliance obligation right now is the one-time PFAS report required under TSCA Section 8(a)(7). Anyone who manufactured or imported a per- or polyfluoroalkyl substance for commercial purposes in any year from 2011 through 2022 must submit detailed data to EPA.¹⁷

The reporting window runs from April 13, 2026 to October 13, 2026 for most manufacturers. Small businesses reporting solely because they imported articles containing PFAS have until April 13, 2027.¹⁸

This rule sweeps in far more companies than most TSCA obligations. There is no minimum concentration threshold and no volume floor. Any amount of PFAS imported for commercial purposes during the lookback period triggers reporting. Companies that imported finished goods containing PFAS, such as nonstick cookware, water-resistant textiles, or electronics with fluorinated coatings, are considered manufacturers and must report. Where multiple importers were involved in the same transaction, each one is on the hook if no report is filed.¹⁹ Article importers can use a streamlined form, but even that form requires describing PFAS identity with as much structural detail as possible.

Recurring Reporting and Recordkeeping

TSCA compliance is not a one-time exercise. Several obligations repeat.

The Chemical Data Reporting rule requires manufacturers and importers to submit production data every four years, covering production volumes, chemical identities, and uses. The threshold is 25,000 pounds or more of a chemical at any single site during a reporting year, dropping to 2,500 pounds for substances subject to certain EPA rules or orders.²⁰ The next CDR submission window runs from June 1 to September 30, 2028, covering calendar years 2024 through 2027.²¹

Under Section 8(c), manufacturers and importers must maintain records of significant adverse reactions to health or the environment that are alleged to have been caused by their chemicals. These are not routine production records; they capture claims of harm that come to the company’s attention, and EPA can request access at any time.²²

Retention periods depend on the specific rule. Most Section 8(a) records must be kept for three years from creation or submission. Asbestos-related records must be kept for five years.²³

Every chemical shipment entering the U.S. also requires a TSCA certification statement filed with Customs and Border Protection. The importer certifies either that the shipment complies with all applicable TSCA rules and orders, or that the chemicals are not subject to TSCA. CBP will not release the shipment without it.²⁴ These certifications are filed electronically through the Automated Commercial Environment system.²⁵

Small Manufacturer Relief

TSCA cuts obligations for companies that qualify as small manufacturers. Two paths qualify you. The first is total annual sales below $120 million (including any parent company), provided you do not produce more than 100,000 pounds of any single reportable substance at a given site. The second is total annual sales below $12 million regardless of production volume.²⁶

Small-manufacturer status brings reduced PMN filing fees, the extended PFAS reporting deadline, and exemptions from certain Section 8(a) reporting rules. Qualification is substance-specific in some cases, so a company can be small for one chemical and not for another based on volume.

Penalties

Civil penalties for violating TSCA start at $25,000 per day of violation under the base statutory amount, with each day treated as a separate violation.¹ EPA adjusts that figure upward each year for inflation, so the actual annual maximum is higher. When setting an amount, EPA weighs the nature and severity of the violation, the violator’s history, ability to pay, and degree of fault.

Knowing or willful violations carry criminal exposure: fines up to $50,000 per day and up to one year in prison. If a knowing violation places someone in imminent danger of death or serious bodily injury, individuals face fines up to $250,000 and up to 15 years in prison, and organizations face fines up to $1,000,000 per violation.¹

Self-Disclosure Can Cut the Penalty

A company that finds its own TSCA violation has a real incentive to come forward. EPA’s Audit Policy offers up to a 100 percent reduction in gravity-based penalties for entities that discover a violation through a systematic compliance audit, disclose it in writing within 21 days, and correct it within 60 days. Even without a formal audit program, self-disclosure can earn a 75 percent penalty reduction if the other conditions are met.²⁷

The relief has limits. Violations that caused serious actual harm, presented an imminent and substantial danger, or breached an existing consent agreement are not eligible. Repeat violations within three years at the same facility, or a pattern across multiple facilities within five years, are also excluded. EPA keeps the right to collect any economic benefit the company gained from the period of non-compliance, even when it grants full mitigation of the gravity-based portion.²⁷

1
Office of the Law Revision Counsel. 15 USC Ch. 53: Toxic Substances Control
2
eCFR. 40 CFR Part 710 – Compilation of the TSCA Chemical Substance Inventory
3
Office of the Law Revision Counsel. 15 US Code 2602 – Definitions
4
eCFR. 40 CFR Part 720 – Premanufacture Notification
5
US EPA. TSCA Fees Table
6
US EPA. Actions under TSCA Section 5
7
eCFR. 40 CFR 720.36 – Exemption for Research and Development
8
eCFR. Chemical Substances Manufactured in Quantities of 10,000 Kilograms or Less Per Year
9
eCFR. 40 CFR 723.250 – Polymers
10
eCFR. 40 CFR Part 702 Subpart A – Procedures for Prioritization of Chemical Substances for Risk Evaluation
11
U.S. EPA. Persistent, Bioaccumulative, and Toxic (PBT) Chemicals under TSCA Section 6(h)
12
eCFR. 40 CFR Part 761 – Polychlorinated Biphenyls (PCBs) Manufacturing, Processing, Distribution in Commerce, and Use Prohibitions
13
eCFR. 40 CFR Part 763 Subpart E – Asbestos-Containing Materials in Schools
14
US EPA. Lead-Based Paint Disclosure Rule (Section 1018 of Title X)
15
U.S. Environmental Protection Agency (EPA). Lead Renovation, Repair and Painting Program
16
eCFR. 40 CFR Part 770 – Formaldehyde Standards for Composite Wood Products
17
US EPA. TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances
18
US EPA. EPA Extends Reporting Period for PFAS Manufacturers
19
U.S. Environmental Protection Agency (EPA). TSCA Section 8(a)(7) Rule Frequently Asked Questions
20
eCFR. 40 CFR Part 711 – TSCA Chemical Data Reporting Requirements
21
US EPA. Chemical Data Reporting under the Toxic Substances Control Act
22
US EPA. Reporting and Recordkeeping Under TSCA Section 8(c)
23
eCFR. 40 CFR Part 704 – Reporting and Recordkeeping Requirements
24
U.S. Customs and Border Protection. Importing Toxic or Hazardous Substances (i.e., Chemicals, Petroleum)
25
Federal Register. Toxic Substance Control Act Chemical Substance Import Certification Process Revisions
26
Federal Register. Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under TSCA Section 8(a)
27
US EPA. EPA’s Audit Policy