Premanufacture notices and TSCA filing explained for importers
A premanufacture notice tells EPA about a new chemical before US manufacture or import. Learn the filing rules, exemptions and how to check PMN status.
A premanufacture notice (PMN) is a submission to the US EPA before nonexempt commercial manufacture or import of a new chemical. Under TSCA, a new chemical substance is one absent from the Inventory, and manufacture includes import into US customs territory. These definitions come from 40 CFR 720.3.
Ordinarily, EPA must receive a complete PMN at least 90 calendar days before manufacture begins. Section 720.40 sets the filing deadline. But passing day 90 does not give permission to start. EPA must issue its determination and take the associated required action, as section 720.75 requires.
When is a premanufacture notice required?
Start with the substance's Inventory status. A chemical can be new to your company without being a new chemical under TSCA. The legal test is whether it is on the Inventory, not whether your business has made or sold it before. See the definition of a new chemical substance.
A public search may leave that question unresolved. EPA says a Bona Fide Intent to Manufacture or Import Notice may be necessary when Inventory status is uncertain. Don't treat an unsuccessful public search as proof that the substance is absent. Follow EPA's filing guidance before choosing the filing route.
Next, check whether an exemption applies. Low volume and polymer exemptions have conditions, so a small production plan or a polymer identity alone does not settle eligibility. The relevant rules are section 723.50 and section 723.250.
These are US requirements. For a UK business planning US imports, the import element matters. The US exemptions described here do not establish eligibility under UK domestic law.
The premanufacture notification form and 90-day review
The PMN form is EPA Form 7710-25. Prepare it using e-PMN software and submit it electronically through EPA's Central Data Exchange, or CDX. Supporting documents also go through electronic submission under section 720.40.
Prepare information on chemical identity, intended uses, production volume and the manufacturing process. EPA also lists byproducts, environmental releases, disposal, human exposure and existing health or environmental test data. Its PMN filing page describes these information categories.
The notice must contain required information known or reasonably ascertainable to the submitter. It must also include relevant test data in the submitter's possession or control. That requirement should not be read as a universal fixed testing package for every chemical. Use the information requirements in section 720.40.
Completeness affects the clock. The applicable review period runs from receipt of a complete notice, or the date EPA determines it complete under the rule. An initial upload is not necessarily the starting date. Section 720.75 sets the timing and commencement conditions.
Wait for the determination. Review completion does not necessarily mean unrestricted manufacture. A "not likely to present an unreasonable risk" determination can permit manufacture before the review period ends. Check the determination and any applicable order against section 720.75, rather than relying on elapsed days.
Low volume and polymer exemptions
A low volume exemption, or LVE, covers manufacture of 10,000 kg or less per year, subject to its conditions. Submit the exemption notice at least 30 days before manufacture. Do not start until EPA notifies you that the substance meets the terms. The notified sites, uses and exposure or release controls matter under section 723.50.
Quantity alone is insufficient. The current rule excludes PFAS under its own structural definition. It also excludes a PBT chemical substance with anticipated environmental releases and potentially unreasonable exposures to humans or environmental organisms. Apply the exact definitions and conditions in section 723.50, rather than importing another program's definitions.
The polymer exemption follows a different framework. A substance must meet the polymer definition, avoid exclusions and satisfy the exemption criteria. Reporting and recordkeeping also apply. Polymer identity alone does not establish eligibility under section 723.250.
The rule includes molecular-weight and oligomer criteria or a specified polyester route. Certain polymer types and monomer or reactant Inventory issues can prevent eligibility. It also requires a report by January 31 of the year following initial manufacture or import. Do not confuse that reporting requirement with the LVE's advance notice and EPA notification process. Check the full polymer exemption rule.
New microorganisms subject to Part 725 use a Microbial Commercial Activity Notice, or MCAN, with exclusions. Domestic manufacture and import are covered under section 725.105. The MCAN generally must be submitted at least 90 calendar days before manufacture or import under section 725.150.
How to check an EPA PMN number
Use the case number to check review status. Keep this separate from checking whether the substance is on the Inventory.
- Obtain the EPA case number. EPA's status landing page gives examples such as P-16-0420 and allows partial-number searches. It also describes searches by case type, status, final determination or date.
- Open the PMN and SNUN table. Use its Search control to locate the matching case. Export to CSV is available if you need to work with the table outside the page.
- Read the interim status and final disposition separately. The table also shows received, meeting, effective and SNUR effective dates. Those columns describe different stages, not one universal clearance date.
- Check the determination and any applicable order before deciding whether manufacture can begin. A public status row does not replace those documents. The commencement rule still applies.
Read each date with its column heading. The Received Date records receipt, while the Scoping or Focus Meeting Date concerns EPA's review. The PMN and SNUN table lists Final Disposition separately from Effective Date and SNUR Effective Date. Do not record a received date as the date manufacture became permissible.
For an internal review record, keep the case number alongside the status field you relied on. Identify whether you read an interim recommendation or a final disposition. This keeps the public lookup distinct from the determination and any order needed for a commencement decision.
Interim status reflects staff-level recommendations after the initial risk assessment at the Focus meeting. The final risk determination can differ. EPA explains this distinction on the PMN and SNUN table page.
The displayed columns do not include chemical name or CAS number. This makes the table a case-status tool, not a substitute for substance identification or an Inventory search. For other case types, use EPA's separate MCAN table or exemptions table.
A missing row leaves a question open. EPA says cases appear after the Focus meeting on its status landing page. Check new-chemical notices received for another record of a submission. Neither a missing row nor a received-notice entry establishes permission to manufacture.
After manufacture or import begins
A submitter commencing nonexempt commercial manufacture after its section 5 notice must file a Notice of Commencement, or NOC. Submit EPA Form 7710-56 electronically through CDX no later than 30 calendar days after the first day of manufacture. For an importer, commencement is the date of US customs clearance under section 720.102.
RegAffairs AI's answer on premanufacture notices and review-status checks links the official filing and status sources.
Completed PMN review alone does not add the substance to the Inventory. EPA says the substance is considered on the Inventory when it receives a complete NOC. The public Inventory is updated every six months, so a recent NOC may not yet be visible in a public search. See EPA's filing guidance.