New Chemical Consent Orders and Significant New Use Rules (SNURs)
On this page you will find:
I. What is a Consent Order?
One outcome of EPA's review of a premanufacture notice (PMN) for a new chemical substance is the issuance of an order under section 5(e) of the Toxic Substances Control Act (TSCA). Most TSCA section 5(e) orders issued by EPA are Consent Orders that are negotiated with the submitter of the PMN. When reviewing a PMN for a new chemical substance, the Agency can determine that use under certain specific conditions and with appropriate precautions would not pose an unreasonable risk, but that use under other conditions may pose an unreasonable risk. In addition, EPA may determine that the chemical substance may be produced in substantial quantities and will either enter the environment in substantial quantities or may result in significant or substantial human exposure. In such cases, EPA may develop a Consent Order based on a finding of potential unreasonable risk ("risk-based" order) or significant/substantial exposure ("exposure-based" order). A TSCA section 5(e) Consent Order typically contains some or all of the following requirements as conditions:
- testing for toxicity or environmental fate once a certain production volume or time period is reached
- use of worker personal protective equipment
- New Chemical Exposure Limits (NCELs) for worker protection
- hazard communication language
- distribution and use restrictions
- restrictions on releases to water air and land, and
Consent Orders generally follow relatively standard formats, and there are "boilerplate" versions of these formats.
A Company subject to a TSCA section 5(e) Order that requires testing to be conducted must notify, in writing, the EPA Monitoring Assistance and Media Programs Division (2227A), Office of Enforcement and Compliance Assurance (OECA), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington D.C. 20460, of certain study-related information within 10 days of scheduling any study required to be performed pursuant to the Order. In older TSCA section 5(e) Orders, the OECA group for this notification had been the Laboratory Data Integrity Branch. All such notifications should now be submitted to the Monitoring Assistance and Media Programs Division.
II. New Chemical SNURs
There are two types of SNURs for new chemicals, TSCA section 5(e) and non-section 5(e). These are discussed below. Because there is detailed communication between EPA and PMN submitters during the review period leading to the Agency's final regulatory decision, these SNURs are generally issued as a "direct final" rule (see 54 FR 31299 (PDF) (21 pp, 3.6MB, about PDF).
TSCA section 5(e) SNURS. TSCA section 5(e) Consent Orders are only binding on the original PMN submitter that manufactures or imports the substance. Consequently, after issuing 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. The notification required by SNURs, known as a Significant New Use Notification (SNUN), allows EPA the opportunity to review and if necessary prevent or limit potentially adverse exposure to, or effects from, the new use of the substance.
TSCA non-section 5(e) SNURS. Even though EPA does not find that the manufacture, processing, use and disposal of a PMN substance, as described in the PMN, may present an unreasonable risk to human health and the environment, the Agency may promulgate a SNUR in the absence of a Consent Order. EPA takes this regulatory action when it determines that potential new uses different from those identified in the PMN 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-section 5(e) SNURs." For example, if EPA identifies an environmental toxicity concern concentration (e.g., 5 parts per billion, or ppb) in surface waters that is not expected to be exceeded under the circumstances described in the PMN but which might be exceeded under other potential use scenarios, the Agency could choose to take no regulatory action on the PMN submitter (e.g., via a consent order), but instead promulgate a non-section 5(e) SNUR requiring notification for any other uses that have releases that could result in exceedance of that surface water concentration.
III. How Can I Tell if My Chemical is Subject to a SNUR?
To facilitate determining whether a substance is subject to a SNUR, substances on the TSCA Inventory that are subject to SNUR requirements are designated as such by an "S" flag in the Inventory listing. 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 90 days prior to the manufacture of that substance.
Several steps should be followed 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. Because the chemical identities of the chemical substances can be claimed to be Confidential Business Information (CBI) by the submitters of PMNs, EPA maintains a CBI version of the TSCA 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 that has a listing on the Confidential Inventory, the Agency will notify the submitter of the existence of the SNUR.
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.