February 07, 2026

Bringing a new chemical substance into the United States market requires strict compliance with the Toxic Substances Control Act (TSCA), administered by the U.S. Environmental Protection Agency (EPA). Companies planning to manufacture, import, or introduce a new chemical must navigate the TSCA Premanufacture Notification (PMN) process, a science-driven regulatory pathway designed to evaluate human health and environmental risk before commercialization.

This 2026 regulatory guide from Maven Regulatory Solutions explains the four critical steps of U.S. EPA chemical registration, key exemptions, documentation requirements, TSCA fees, risk evaluation timelines, and compliance strategies using the most current regulatory expectations.

Overview: TSCA Chemical Control Framework

Under TSCA, new chemical substances and certain Significant New Uses (SNURs) for existing substances require EPA review before manufacture or import. EPA evaluates:

  • Hazard potential
  • Environmental fate
  • Worker and consumer exposure
  • Release pathways
  • Risk management needs

This pre-market review ensures chemicals do not present unreasonable risk under their intended conditions of use.

STEP 1 TSCA Inventory Status Determination

The first and most critical step is determining whether the substance is already listed on the TSCA Inventory.

When PMN Is Required

A PMN is needed when:

  • The substance is not listed on the public or confidential TSCA Inventory
  • An existing substance has a Significant New Use Rule (SNUR)
  • A new manufacturing process changes exposure potential

Substances Outside TSCA Jurisdiction

Some materials are regulated under other laws and excluded from TSCA:

Excluded Category

Regulatory Authority

Foods & food additives

FDA

Drugs & pharmaceuticals

FDA

Cosmetics

FDA

Pesticides

FIFRA (EPA)

Tobacco

FDA

Nuclear materials

DOE/NRC

Ammunition

ATF

Materials Not Subject to PMN

  • Naturally occurring materials
  • Impurities
  • By-products
  • Mixtures (but not individual components)
  • Articles
  • Substances manufactured solely for export

STEP 2 Determine Eligibility for TSCA Exemptions

EPA offers several risk-based exemptions that reduce or eliminate PMN requirements.

Exemption Type

Applicability

Low Volume Exemption (LVE)

<10,000 kg/year

LoREX

Low exposure & release

Polymer Exemption

Qualifying low-risk polymers

R&D Exemption

Research quantities

Test Marketing Exemption (TME)

Limited market trials

Strategic exemption use can reduce timelines by 60–80% compared with full PMN.

STEP 3 Pre-Submission Meeting & PMN Dossier Preparation

EPA strongly encourages pre-notice consultations before submission. These meetings:

  • Clarify data expectations
  • Reduce PMN incompleteness risk
  • Discuss hazard modeling approaches
  • Improve regulatory predictability

Core Data Required in PMN Submission

Data Category

Key Requirements

Chemical Identity

CAS (if assigned), structure, formula

Manufacturing

Process description, flow diagrams

Production Volume

Estimated annual volume

Use Profile

Industrial, consumer, commercial

Exposure

Worker, environmental, general population

Environmental Fate

Degradation, persistence, bioaccumulation

Health Effects

Toxicology data or modeling

By-products

Impurity characterization

Disposal

Waste treatment & recovery

SDS

If available

Trending 2026 addition: EPA increasingly expects New Approach Methodologies (NAMs), QSAR modeling, and read-across data in PMNs.

STEP 4 PMN Submission, Fees & EPA Review

Submission Platform

All PMNs are submitted electronically through EPA Central Data Exchange (CDX).

TSCA PMN Fees (Post-2024 Rule)

Business Type

Fee

Standard

~$37,000

Small Business

~$6,480

EPA Risk Evaluation Timeline

EPA review typically takes 90 days, but extensions are common.

Review Phase

Activities

Initial 30 Days

Screening, data sufficiency check

Next 60 Days

Risk assessment & exposure modeling

Final Decision

Approval, restrictions, or prohibition

Possible outcomes:

  • Not likely to present unreasonable risk
  • Order with restrictions
  • Significant New Use Rule (SNUR)
  • Prohibition pending more data

Post-Decision Obligations

After approval:

  • Maintain records
  • Follow any EPA consent orders
  • Submit Notice of Commencement (NOC)
  • Comply with downstream reporting requirements

Common Reasons PMNs Are Delayed

  • Missing exposure data
  • Insufficient impurity profiles
  • Incomplete hazard assessment
  • Lack of worker protection details
  • Poorly defined use scenarios

2026 Regulatory Trends in TSCA Compliance

  • Greater reliance on computational toxicology
  • Increased scrutiny on PFAS and persistent chemicals
  • Expansion of SNUR enforcement
  • Focus on environmental justice exposure pathways
  • Integration of green chemistry risk mitigation

FAQs – U.S. EPA Chemical Registration

Q1: How do I check TSCA Inventory status?
Via EPA inventory search or confidential inquiry procedures.

Q2: Can I manufacture before approval?
No. Manufacture/import before PMN review completion is prohibited.

Q3: Do polymers always require PMN?
No   many qualify for polymer exemption.

Q4: What happens after approval?
You must submit a Notice of Commencement within 30 days of manufacture.

Q5: Can PMN be withdrawn?
Yes companies often withdraw to avoid adverse decisions.