Standardized Set of Significant New Uses

If the ERA concludes that the submitter of the bona fide letter does have a bona fide intent to manufacture, import, or process the substance, the ERA will tell the submitter if its proposed use is subject to a SNUR. If the proposed use is not subject to a SNUR, the ERA will tell the submitter what uses are significant new uses. Notwithstanding ERA s statement in the cross-referenced SNUR that it will inform the submitter of a bona fide letter of the significant new uses, the ERA has said otherwise in at least one SNUR preamble. 

In that preamble, the ERA said that it will only reveal whether the intended manufacturing volume that the submitter of a bona fide letter says it intends to make is more or less than the confidential volume that qualifies the manufacture as a significant new use. If the submitter s volume is less, the ERA will not reveal the trigger volume. In that case the submitter must submit another bona fide letter if it later intends to increase its manufacturing volume. The practical implication is that a submitter should give the ERA the maximum potential volume it may make in the initial bona fide letter, or it will risk having to make a series of bona fide requests. 

There is a thirty-day time limit in the cross-referenced SNUR for EPA s response, but it is likely that a response will take longer and submitters should plan accordingly and consider fifing a SNUN to determine if the use is a significant new use. 

Part B of the SNUR regulations is a listing of standardized significant new uses. These significant new uses apply to a particular chemical only if they are cross-referenced in the SNUR for that chemical. The standardized 

The standardized set of significant new uses appears on its surface to set out requirements for handling a SNUR substance. In effect, they are requirements because most manufacturers, importers, and processors of SNUR substances would rather follow the requirements of the SNUR than file a SNUN if at all possible. However, looking at the standardized set of significant new uses from a different, more literal, perspective, they are only a Hst of handhng procedures, and if anyone handles SNUR substances any other way, they will be engaging in a significant new use. 

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