Possible Outcomes of a PMN Review
TSCA section 5(e) Orders: Almost 90 percent of PMNs submitted to EPA complete the review process without being restricted or regulated in any way. However, EPA may issue a TSCA section 5(e) Order to prohibit or limit activities associated with the substance, if EPA determines that:
- there is insufficient information to evaluate the human health and environmental effects of the substance, and
- that the substance may present an unreasonable risk of injury to human health or the environment (the "risk-based" finding), or
- that the substance will be produced in substantial quantities and may be anticipated to enter the environment in substantial quantities or there may be significant or substantial human exposure (the "exposure-based" finding).
In practice, these section 5(e) Orders are almost always issued as "Consent Orders" that are signed by both EPA and the chemical manufacturer. Given the "insufficient information" finding, most Section 5(e) Orders require the PMN submitter to develop and submit to EPA certain toxicity or fate tests before exceeding a specified production volume ("test trigger") designed to allow sales of the chemical to generate enough revenue to pay for the testing. Exposure-based section 5(e) Orders consist primarily of a requirement to conduct triggered testing (plus recordkeeping and "risk notification" in case the test data indicates a risk.) Risk-based TSCA section 5(e) Orders, depending on the type of concerns identified by EPA for a given PMN substance, typically also require exposure controls such as gloves, goggles, respirators, specified disposal technologies or restrictions on releases to water, and hazard communication such as material safety data sheets (MSDS), labels, and training.
TSCA section 5(a)(2) Significant New Use Rules (SNURs): Once a substance subject to a section 5(e) Order is listed on the TSCA section 8(b) Inventory, any other company may manufacture the substance without being required to notify EPA or comply with any other restrictions under TSCA section 5, unless EPA promulgates a significant new use rule (SNUR) pursuant to section 5(a)(2) of TSCA. Therefore, when the Agency regulates a substance under a risk-based section 5(e) Order, EPA develops a SNUR concurrently with the Order. The SNUR defines a significant new use so as to require reporting to EPA before any manufacturer or processor of the same chemical undertakes activities inconsistent with requirements of the section 5(e) Order. Thus, EPA has an opportunity to review those activities before they occur because, under section 5(a)(1)(B) of TSCA, any company wishing to undertake the activities designated in the SNUR must submit a SNUN to EPA at least 90 days before doing so. These SNURs appear in 40 CFR Part 721.
TSCA section 5(f) Actions: If EPA determines that a new chemical will present unreasonable risk before a TSCA section 6 rule can be promulgated, EPA may (1) limit the amount or impose other restrictions on the substance via an immediately effective proposed rule, or (2) completely prohibit the substance by issuing a proposed order or applying to a US District Court for an injunction.