Changes to Fee Obligations for EPA-Initiated Risk Evaluations
On 27 January 2020, US EPA published a notice containing the preliminary lists of manufacturers and importers of the 20 chemical substances that have been designated as a High-Priority Substance for risk evaluation (also see here). The lists identified companies where the Agency already had information to suggest that they may be subject to fee obligations for the evaluations. US EPA required companies that are subject to the fee rule but not included on the preliminary lists to self-identify, as well as those that may be eligible for certain exemptions.
At that time, companies subject to the fee rule included:
- All domestic manufacturers and importers of the chemical
- Manufacturers and importers of articles containing the chemical
- Manufacturers and importers of byproducts that include the chemical as a component
- Manufacturers and importers of substances that include the chemical as an impurity
- Companies that ceased manufacture or import of the substance prior to 21 March 2019 and will not resume manufacture or import until after 21 March 2024
- Companies that have not manufactured or imported the chemical substance after 27 January 2015
The deadline for self-identification was originally set for 27 March 2020. On 8 March 2020, the Agency extended the deadline to 27 May 2020. On 25 March 2020, US EPA released a “no action assurance” memo exempting self-identification requirements for companies that:
- Import the chemical substance in an article
- Produce the chemical substance as a byproduct
- Produce or import the chemical substance as an impurity
“No action assurance” means that the Agency will not pursue enforcement action against entities in these three categories for failure to self-identify while the Agency works to propose amendments to the existing final rule later this year, with a goal to finalise the revisions in 2021.
In other words:
- For companies that fall into one of these three categories but (1) were not identified on a preliminary list and (2) have not yet self-identified, US EPA does not expect any further action
- Companies that have been identified on a preliminary list but fall into one of these three categories should certify that one of those categories applies to them in the Central Data Exchange (CDX) portal
- Companies that fall into one of the three categories but have already self-identified as a manufacturer have the option to change their response in CDX before the deadline on 27 May 2020
For the purpose of this action, the definitions of article, impurity and byproduct remain essentially the same as those listed in 40 CFR §720.3, although for byproducts the exemption as articulated in this action is slightly less proscriptive.
This “no action assurance” will remain in place until 30 September 2021 or the effective date of a final rule amending the fee regulations, whichever occurs first. As part of the same rulemaking effort, US EPA may also consider adjustment to the fees and other changes to the TSCA Fees Rule scope and structure.
TSCA Risk Evaluation Response Options in CDX
Self-Identification - I represent a company that is a manufacturer or importer of the chemical substance subject to this Risk Evaluation Activity. I understand the fee obligation for this activity.
- The company was included on the Preliminary List.
- The company was not included on the Preliminary List.
Certification of No Manufacture - I represent a company that was or was not included on the Preliminary List. I certify that the company EITHER has not manufactured or imported the chemical substance subject to the Risk Evaluation Activity at any point in the five-year period preceding publication of the Preliminary List, OR falls into one or more of the following categories: (1) imports the chemical in an article, (2) produces the chemical as a byproduct, or (3) produces or imports the chemical as an impurity.
Based on this certification, the company should not be included on the final list of responsible fee payers subject to fee obligations for this activity.
Certification of Cessation - I represent a company that was a manufacturer or importer of the chemical substance subject to this Risk Evaluation Activity, and either was or was not included on the Preliminary List. I certify that the company has ceased manufacturing/importing the chemical substance prior to initiation of the prioritization process for the chemical substance (21 March 2019) and further certify that the company will not manufacture or import the chemical substance again for at least five years from the date of this certification. The company is not subject to fee obligations for this activity.