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Consent Orders and Significant New Use Rules (SNURS)
I. Consent Orders
One outcome of the PMN review is the negotiation of a Toxic Substances Control Act (TSCA) section 5(e) Consent Order. When reviewing a PMN for a new chemical substance the Agency can determine that use under certain specific conditions and with agreed precautions would not pose an unreasonable risk, but that use under other conditions may pose an unreasonable risk. In such cases, EPA may develop a Consent Order based on a finding of potential unreasonable risk or substantial exposure, and these findings may be based either on information about the chemical substance or its close analogs showing that it can pose problems or on inadequacy of information available to the Agency.
A Section 5(e) Consent Order can allow the PMN submitter to manufacture or import the new substance under specified conditions. Risk-based 5(e) Consent Order typically contain requirements regarding toxicity or environmental fate testing by a certain production volume, worker personal protective equipment, New Chemical Exposure Limits (NCELs), hazard communication, distribution, release to water, other disposal options, and recordkeeping. Exposure-based 5(e) Consent Orders typically require testing, risk notification, and recordkeeping. Consent Orders generally follow relatively standard formats, and there are "boilerplate" versions of these formats.
II. SNURs
Section 5(e) Consent Orders are only binding on the original PMN submitter that manufactures or imports the substance. Consequently, after signing a Section 5(e) Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order. The SNUR requires that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use." These new use designations are typically those activities prohibited by the Section 5(e) Consent Order and are generally promulgated as a "direct final" rule (see 54 FR 31299 (PDF) (21 pp, 3.6MB, about PDF). The notification required by SNURs allows EPA to prevent or limit potentially adverse exposure to, or effects from, the new use of the substance. Such a SNUR would require the submission of a Significant New Use Notification (SNUN) 90 days prior to commercial manufacture not conforming to the conditions of the SNUR.
The Agency may also promulgate a SNUR in the absence of a Consent Order when it identifies potential new uses different from those identified in the PMN that could result in increased exposures to or releases of the substance, and may result in an unreasonable risk to health or the environment. These SNURs are referred to as "non-5(e) SNURs."
The 1995 TSCA PMN rule amendments expanded the types of significant new use designations that EPA may promulgate as direct final rules (see 60 FR 16311). This change is intended to improve the efficiency of the SNUR procedure for both EPA and the chemical industry.
To facilitate determining whether a substance is subject to a SNUR, substances on the Inventory that are subject to SNUR requirements are designated as such in the Inventory listing; such substances are indicated by an "S" flag (note: in electronic medium versions of the Inventory the flags may be on another line, rather than following the substance name). If your chemical substance is subject to a SNUR and your intended manufacture, processing, or use of the substance is a significant new use, you would be required to submit a SNUN prior to the manufacture of that substance.
Several options are available to ascertain the TSCA Inventory/SNUR status of a chemical substance. Information on non-confidential chemical substances can be found in the TSCA Chemical Substance Inventory. If an intended manufacturer submits a PMN or a Notice of Bona Fide Intent to Manufacture (pursuant to the procedures at 40 CFR Section 720.25) on a substance which has a listing on the Confidential Inventory, the Agency will notify the submitter of the existence of the SNUR in informing the submitter that PMN need not be made.
It is always the obligation of the manufacturer or processor selling a chemical substance to notify the user of the SNUR status of that substance. Buyers of a chemical substance whose identity is confidential, and thus not disclosed to them, should seek certification from the sellers that their intended use is not a significant new use.