• EPA’s new chemicals review process for active cases under review includes eight key stages.
• If the substance is determined “not likely to present an unreasonable risk,” the submitter of the PMN or MCAN must provide an NOC to EPA within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes.
• The chemical substance is considered to be on the TSCA Inventory as soon as a complete NOC is received by EPA.

After submission of a premanufacture notice (PMN) or Microbial Commercial Activity Notice (MCAN), the notice goes through several stages of review.

1. Pre-submission,
2. Incoming cases,
3. Risk assessment,
4. Risk characterization,
5. Awaiting submitter information/action,
6. Regulatory decision and action development,
7. Awaiting submitter signature on consent order, and
8. Final determination.

If the Environmental Protection Agency (EPA) fails to make a determination, fees may be refunded; however, nothing relieves EPA of its obligation to make a determination.

Notice of commencement

Under Toxic Substances Control Act (TSCA) section 5(g), when EPA makes a determination that a chemical substance or microorganism is “not likely to present an unreasonable risk,” the submitter of the PMN or MCAN may commence manufacture of the substance, notwithstanding any remaining portion of the applicable review period. If manufacture is commenced, then:

• The submitter of the PMN or MCAN must provide a Notice of Commencement of Manufacture or Import Form (NOC) to EPA within 30 calendar days of the date the substance is first manufactured or imported for nonexempt commercial purposes.
• NOCs must be submitted electronically to EPA.
• If the submitter claims any information on the form as confidential, the claim must be asserted and substantiated in accordance with 40 CFR 703 (along with 40 CFR 720.102, 725.80, and/or 725.190, if applicable) and must be submitted via EPA Form 7710-56.
• The chemical substance is considered to be on the TSCA Inventory as soon as a complete NOC is received by EPA. Actual EPA processing of the NOC to complete the transaction takes about four weeks.
• Excess research and development substances may be used or sold after expiration of the PMN review period and does not require submission of an NOC. The substance will not be placed on the Inventory until an NOC is received; however, an NOC may not be submitted for the substance before commercial manufacture (non-research and development) begins.

New chemicals and microorganisms are added to the TSCA Inventory after the PMN or MCAN review period has completed and the PMN or MCAN submitter has commenced nonexempt commercial manufacture.