Q.01

What is a premanufacture notice?

A premanufacture notice (PMN) is a filing to the US EPA under Section 5 of the Toxic Substances Control Act (TSCA). It must be submitted by "anyone who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose," and it tells EPA about the substance before commercial production starts (EPA, Filing a Pre-Manufacture Notice).

What EPA's page says about it:

  • Importers are covered. Under TSCA, "manufacture" includes import, so importers must file too.
  • Timing. The PMN must be filed "at least 90 days prior to the manufacture of the chemical." The 90-day review period starts when EPA receives the notice and sends an acknowledgment letter.
  • What goes in it. "All available data" on:
    • chemical identity
    • process description and production volume
    • byproducts
    • intended use
    • environmental release and disposal practices
    • human exposure
    • "existing available test data on the effect to human health or the environment"
  • EPA's review. EPA decides whether the substance "presents an unreasonable risk of injury to health or the environment" or whether it needs more information. EPA states it "will make affirmative findings for all PMNs."
  • Fees. PMNs are subject to the TSCA fees rule (the 2018 final rule as amended).
  • After approval. Once commercial manufacture or import begins, the submitter "must provide a Notice of Commencement of Manufacture or Import Form (NOC) to EPA within 30 calendar days."

The detailed procedural rules are in 40 CFR Part 720. I couldn't open that part on eCFR this time, so I haven't quoted its section wording here. I also couldn't query EPA's PMN case-status register or the TSCA significant new use rules on this run.

Approach: I tried EPA's "Status of Pre-Manufacture Notices" case register and the TSCA significant new use rules, then used EPA's official page on filing a PMN.

Sources:

Q.02

How do I check a new chemical's review status?

If you have the case number, look it up in EPA's "Status of Pre-Manufacture Notices" tables. You can search them "by case type, by case number, status, final determination, or date," and enter all or part of a case number or status term, for example "P-16-0420, L-16-0479, Invalid or just the number 0001" (EPA status page).

Which table to use (all on the same EPA page):

What a status entry shows: the PMN, SNUN, MCAN, TERA or exemption number, plus:

  • the Focus Meeting date
  • the interim status after the Focus meeting
  • the final determination
  • the effective date

Timing: cases only appear "after the Focus meeting." A case that EPA has received but that hasn't gone to Focus yet won't be in these tables.

Before the Focus meeting: EPA publishes a separate list of section 5 submissions it has received. It covers PMNs, SNUNs, MCANs, TMEAs, Notices of Commencement and section 5 test information, and EPA says it is "updated on a regular basis." That page also links to a statistics page for tracking active new-chemicals cases (EPA, New Chemical Notices Received).

Contact: the status page sends inquiries to Edelstein.Rebecca@epa.gov.

I couldn't look up an individual case in EPA's case-status register this time, so I can't show you a live entry. If you give me a case number, I can try again.

Approach: I tried EPA's TSCA section 5 new-chemicals case-status register, then used EPA's official status and notices-received pages.

Sources:

Q.03