TSCA Fees for EPA-Initiated Risk Evaluations
EPA requires payment of fees from manufacturers (including importers) of a high-priority chemical substance undergoing a TSCA risk evaluation. Because the manufacturers and importers of the chemical may not be known, EPA will initiate a process to identify those entities subject to the TSCA fees. This page describes the requirements and processes related to TSCA fees for this activity.
For EPA-initiated risk evaluations under TSCA section 6, manufacturers (including importers) of the high-priority chemical substance undergoing risk evaluation are subject to the TSCA fee and associated requirements. Note that EPA has announced its intention to consider proposing exemptions from the TSCA Fees Rule for three categories of manufacturers subject to EPA-initiated Risk Evaluation fees and associated requirements: 1) importers of articles containing a high-priority substance; 2) producers of a high-priority substance as a byproduct; and 3) producers or importers of a high-priority substance as an impurity. For more information on this action and what it means for manufacturers of one of the 20 chemicals currently undergoing EPA-initiated risk evaluation, see:
- Frequent Questions about TSCA Fees for EPA-Initiated Risk Evaluations
- Information on Plan to Reduce TSCA Fees Burden and No Action Assurance
For EPA-initiated risk evaluation, EPA will initiate a process to identify manufacturers (including importers) subject to fees, including:
- publication of a preliminary list that identifies manufacturers and importers based on information available to EPA;
- a public comment period (to facilitate self-identification as required by the final rule, certification as a “small business concern,” certification of cessation or no manufacture; and correction of errors); and
- publication of a final list of fee payers.
The Preliminary List
To develop a preliminary list of manufacturers, EPA uses sources like information collected under the Chemical Data Reporting (CDR) and TSCA Inventory Notification (Active/Inactive) rules; data collected by the Toxics Release Inventory Program; other TSCA reporting notices; and publicly-available information or information submitted to other agencies to which EPA has access.
Public Comment Period
Publication of a preliminary list coincides with the opening of a public comment period of no less than 30 days. As required in the final rule at 40 CFR 700.45(b), all manufacturers (including importers) of the subject chemical undergoing risk evaluation, regardless of whether or not they appear on the preliminary list developed by EPA, must take the following actions during this period:
- Self-identify as a manufacturer/importer subject to the fee obligation, irrespective of whether or not they are listed on the preliminary list;
- Provide certain basic company information to EPA, such as name, address and telephone number for a technical contact; and
- Certify as to whether they qualify as a “small business concern.”
Where appropriate, manufacturers (including importers) of the subject chemical may also take the following actions:
- Certify as to not manufacturing/importing the high-priority chemical in the last five years (and therefore not responsible for the fee); or
- Certify as to having ceased manufacture/import activity for the chemical prior to the cutoff date listed in the final rule at 40 CFR 700.45(b)(6), and certify they won’t re-enter the market for a period of 5 years (and therefore not responsible for the fee)
EPA’s Central Data Exchange (CDX) system is set up to facilitate the required and optional certifications, consistent with the requirements in the fees rule. EPA will use the information collected in CDX to facilitate future communications with and, where appropriate, invoicing for a portion of the TSCA fees. For more information and instructions on how to complete this reporting activity, see:
- Instructions for self-identification and other certifications in CDX
- Accessing TSCA submissions and invoices through the Central Data Exchange (CDX)
- How to register for CDX
- CDX risk evaluation rule user guide
The public may also submit comments during this time at www.regulations.gov.
The Final List
After considering responses from the manufacturers/importers and other public input, EPA will develop the final lists of responsible fee payers. Each final list will be published no later than concurrent with publication of the final risk evaluation scope document. Manufacturers and importers identified on a final list are subject to a portion of the TSCA fee for the risk evaluation activity.
For EPA-initiated risk evaluations under TSCA section 6, the total fee amount is $1,605,000. The total fee amount is shared among the manufacturers/importers identified on the final lists. The amount each entity is responsible for will vary depending on the total number of fee payers identified, and the number of entities identified as “small business concerns.” See the final rule at 40 CFR 700.45(f). Entities that meet the criteria for a “small business concern” receive an 80% discount off their respective share of the fee.
Fee payments are due within 120 days of publishing the final scope of an EPA-initiated risk evaluation.
Fees for EPA-initiated risk evaluations under TSCA section 6 will be invoiced electronically by EPA. Invoice notices will be populated into the specific user's “Copy of Record” screen in CDX and will contain a button that will initiate the payment process. When an invoice is generated, notification e-mails will be sent to the user's CDX inbox and the e-mail address associated with the relevant CDX account. Payment information will be collected in CDX and then submitted to Pay.gov for processing. Users should not attempt to make payments directly to Pay.gov.
Entities can either pay individually or to join together and form consortia to pay the TSCA fees for these activities. In order to form a consortium, a principal sponsor must notify EPA via CDX that the consortium has formed. The notification must generally occur within 60 days of the publication of the final scope of a chemical risk evaluation for an EPA-initiated risk evaluation under TSCA section 6. The consortium is responsible for determining how to divide the fee among its constituents and submitting payment to EPA. See the final rule at 40 CFR 700.45(f). Learn how to access and submit payment for an initial response in CDX.
Refunds are NOT available for fee payments made for EPA-initiated risk evaluations under TSCA Section 6. See the final rule at 40 CFR 700.45(h) for more information on refunds.