TSCA Consent Order (CO) and Significant New Use Rule (SNUR)

US TSCA Chemical Regulatory Services – Consent Orders (CO) and Significant New Use Rules (SNUR)

The Lautenberg Chemical Safety for the 21st Century Act amendment of the TSCA requires the EPA to make a risk determination on each pre-manufacture notification (PMN). The EPA must determine if the chemical:

• is not likely to present an unreasonable risk;
• may present an unreasonable risk; or
• presents an unreasonable risk. 

If the EPA determines that the new chemical may or does present an unreasonable risk, they may issue a risk management measure, namely a Consent Order or Significant New Use Rule.

Consent Orders (CO) are issued specifically to the submitter of a PMN and are often given if the chemical may present an unreasonable risk; if there is insufficient information to allow a determination of risk; or if the chemical’s projected manufacture/import volume is substantial.

Should your substance become subject to a consent order, Intertek can:

• Support any required testing for toxicity or environmental hazard;
• Develop any required hazard communication language, including use of PPE and engineering controls
• Interpret any distribution or use restrictions
• Develop a plan for any required recordkeeping.

Significant New Use Rule (SNUR)

Consent orders are only binding for the original PMN submitter for that substance. In contrast, a SNUR applies to any parties intending to manufacture, import or use the chemistry of interest. SNURs are also a more flexible form of risk management as they can be applied to new or existing chemistry and alongside or in place of other risk management measures, like the Consent Order.

SNURs require that manufacturers, importers and processors of certain substances notify the EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use." The details of each “significant new use” are specific to their particular chemistry but generally consider factors such as volume, type of human exposure and potential for release to the environment.

If you suspect that your chemistry is subject to a SNUR, Intertek’s scientific and regulatory affairs experts can assist by:

• Reviewing the language of the SNUR to confirm if your use of the substance is covered
• Reviewing the data requirements associated with the SNUR and strategize as to the best way to generate the required information
• Supporting or coordinating any required testing
• Compiling and completing the Significant New Use Notice (SNUN)