TSCA’s 20 High-Priority Substances Requirement for Manufacturers/Importers to Self-Identify
Latest update:
On March 25, 2020, the EPA released a plan to consider a proposed rule that would look at potential exemptions to EPA’s fee’s rule.
These three categories of exemptions are: (1) importers of articles containing one of the 20 high-priority substances; (2) domestic producers of one of the 20 high-priority substances as a byproduct; and (3) domestic producers or importers of one of the 20 high-priority substances as an impurity.
These manufacturers will not need to self-identify and will not be subject to the risk evaluation fees.
In addition, since the rule isn’t final, and won’t be likely until 2021, the EPA also issued a “no action assurance” memo promising that the EPA will exercise its enforcement discretion for those three categories. This essentially means that even though the law hasn’t been formally changed, the EPA will not pursue any companies that didn’t self-identify because they fall into one of those three categories.
To summarize, if any of the 20 high-priority substances is present in products imported into the US either as part of an article or as an impurity, then no action is required for self-identification, and importing companies WILL NOT be subject to the fees rule. Domestic manufacturers (in the US) may also be absolved from self-identification if they manufacture one of the 20 high-priority substances as a by-product.
On January 27, 2020, the EPA published a Federal Register notice identifying the preliminary list of manufacturers (including importers) of the 20 high-priority substances for which the fees will be charged. During the comment period, currently scheduled to end March 27, 2020, ALL manufacturers (and importers) of any of the 20 high-priority substances are required to self-identify, whether or not they were included on EPA’s initial list. This is also an opportunity for manufacturers (and importers) to certify they were improperly included on the list. The EPA announced publicly that they are likely going to extend the comment period through May 27, 2020, although this has not yet become finalized.
What are the 20 high-priority substances?
The substances can be found on the EPA website at:
Does this impact my company?
Currently, ONLY manufacturers and importers of any of the 20 high-priority chemicals are subject to self-identifying. If your company is a domestic US company AND does not import any raw materials/products, then there is no obligation for self-identifying. Processors and users of feedstocks containing any of the 20 high-priority chemicals are not subject to self-identification.
If your company exports products into the US that contain any of the 20 high-priority chemicals, it is recommended to provide relevant information to your US importers to support their requirement for self-identification.
My company imports a product whereby one of the high-priority chemicals is an impurity. Do I still need to self-identify?
Unfortunately – the answer is YES. Currently, there is no lower limit for any of the chemicals identified as high-priority under TSCA. As of now, the fees rule did not carve out any exemptions for de minimis limits, impurities, or even articles that could contain any of the 20 chemicals. The EPA has recently spoke about assessing potential carve-out options, but for now, there are no exemptions/ de minimis thresholds.
What is the estimated cost to my company?
The current fee for the review of a high priority chemical (assigned by the EPA) is $1.35 Million per substance. It will be shared amongst all identified parties who manufacture/import the substance. What is not known is to what extent parties will pay, as this was not captured in the fees bill. It will likely be either distributed evenly across all parties or it will be somehow adjusted based on volume. None of that has been defined.
What do I need to do to self-identify?
If your company has confirmed it manufactures (or imports) any of the 20 high-priority chemicals, the next step is to self-identify. This process is done through EPA’s CDX software. If you are a current user of CDX, this is done through the CSPP portal. If your company is not currently using EPA’s CDX software, you must first register with CDX. This process could take several weeks in some instances. Once you are a registered user, then you can connect your account to the CSPP portal and complete the self-identification.
