What’s Significant About TSCA’s Significant New Use Rule

Premanufacture notices

SNURs are directly connected and sometimes identical to TSCA premanufacture notices (PMN) consent orders the EPA develops for new chemicals.  Through PMN consent orders, the EPA imposes conditions and restrictions on the manufacture, processing, and distribution in commerce of new chemicals. 

After development of a PMN consent order, the EPA will issue an SNUR, which will generally specify the conditions under which any new use of the chemical covered by the PMN may occur.   A significant new use notice (SNUN) must be submitted to the EPA by any company that intends to manufacture, process, or distribute the same chemical in a manner that would be significantly new under the SNUR.  The intent of the SNUN is to provide the EPA with information that will help the Agency evaluate the intended uses of the chemical and prohibit or limit activities that may present an unreasonable risk to human health or the environment.

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The first three bulleted items are primarily concerned with public exposure to the chemical.  As implied in the fourth item, a significant new use can also apply to exposures to workers in the manufacturing environment.  Therefore, SNURs may require PPE such as gloves or respirators for workers.

When there is a large production run involving many workers, companies may find such requirements costly and difficult to implement.  One way to avoid having to comply with such requirements is to demonstrate to the EPA that the concerns that gave rise to the restrictions in the PMN consent order have been otherwise resolved and, therefore, the significant new use (i.e., absence of PPE) can occur. 

Test data

The demonstration can be made through the submission of test data.  Under TSCA, an SNUN or PMN must contain test data required by the EPA only when the chemical is subject to a Section 4 test rule.  Otherwise, only those data in the company’s possession must be submitted in the SNUN.  In addition, the company must describe any other data known or reasonably ascertainable.

However, on review of PMNs and SNUNs, the EPA has the authority to require other appropriate testing to substantiate any claim that the significant new use does not present unreasonable risks to human health or the environment.  For example, the EPA may require that a dermal absorption study be conducted before authorizing a significant new use wherein gloves are not worn by workers. 

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SNUN submitters should be aware that the EPA will generally be better able to evaluate SNUNs that provide detailed information on the following:

  • Human exposure and environmental release that may result from the significant new use of the chemical substances,
  • Potential benefits of the chemical substances, and
  • Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

The EPA also recommends that potential SNUN submitters contact the Agency early enough so that they will be able to conduct the appropriate tests.

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