Before a manufacturer or importer can make or import a new chemical substance, the business must submit information to the US EPA for review. Once EPA has reviewed the chemical and added it to the Toxic Substances Control Act (TSCA) master inventory list, manufacture or import can begin and the chemical can be distributed in commerce. While this requirement mostly applies to initial manufacturers or importers of new chemicals, TSCA establishes notification requirements and restrictions for manufacturing existing chemicals as well.
Pre-Manufacture Notice (PMN)
The initial manufacturer of a chemical not already listed on TSCA’s master inventory must go through the Pre-Manufacture Notification (PMN) process. This involves submitting a PMN and waiting through a 90-day review period during which EPA looks for certain red flags that raise concern about the chemical’s environmental or health effects. The review results in one of three outcomes:
No Action — the substance can be manufactured or imported without any restrictions
Prohibition — the substance cannot be manufactured in or imported into the United States
Consent Order — a formal agreement between the manufacturer/importer and EPA that prohibits or limits some activities involving the substance.
If subject to a Consent Order, limited or prohibited activities can include manufacture, import, processing, distribution, use, or disposal of the chemical, and the manufacturer will be required to inform customers of these limitations. However, the consent order is only binding on the initial manufacturer/importer. So what about other companies that might decide to manufacture or import the same chemical?
The Significant New Use Rule (SNUR)
The Significant New Use Rule (SNUR) is EPA’s mechanism for applying the limitations or prohibitions of the consent order to subsequent manufacturers, importers, or processors. For each substance on the master inventory, EPA establishes criteria for what constitutes a “significant new use.” Criteria can include, but are not limited to:
Uses that require specified personal protection
Uses where a specified hazard communication program has not been developed
Specific types of industrial, commercial, or consumer uses
Uses resulting in incineration or land disposal
Uses resulting in release to the water
The specific uses considered “significant” are identified for each chemical in 40 CFR 721, Subpart E.
Significant New Use Notification (SNUN)
Each subsequent manufacturer, importer, or processor of a chemical subject to a SNUR must submit a Significant New Use Notification (SNUN) to EPA on Form 7710-25 at least 90 days prior to beginning manufacture, import, or processing. This is the same form and the same 90-day review period used for the PMN. As with most TSCA paperwork, EPA will only accept electronic submissions of SNUNs through the Central Data Exchange.
As new chemicals subject to consent orders are added to the master inventory, EPA also adds SNURs for those chemicals to 40 CFR 721, Subpart E. These new SNURs are announced in the Federal Register, most recently on July 8th and July 9th of 2014.
TSCA reporting violations are a common reason chemical manufacturers face EPA fines. Be confident you know the latest TSCA rules that apply to the chemicals you manufacture, import, or use. Get live, instructor-led training at the TSCA: Chemical Reporting & Recordkeeping Webinar on October 23, from 1-3 p.m. ET. Prefer to train at your own pace? Enroll in the TSCA Regulations Online Course, available 24/7.
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