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Frequent Questions about TSCA Fees for EPA-Initiated Risk Evaluations

The following frequent questions are intended to clarify the requirements associated with the TSCA Fees Rule. They should be used for informational purposes only and are not a substitute for the TSCA Fees Rule. You should carefully review the regulations located at 40 CFR Part 700.45 for specific information on how to comply with TSCA Fees Rule requirements. If you need assistance after reviewing these questions, please contact us. Last updated March, 2020.

March 2020 Rulemaking Announcement and No Action Assurance

  1. Why is EPA announcing its intention to propose exemptions to the TSCA Fees rule?
  2. What is the expected timing for this rulemaking?
  3. Is EPA considering any other changes to the TSCA Fees Rule as part of this rulemaking?
  4. What does the “No Action Assurance” mean?
  5. Do entities in the three categories in the planned regulatory change still have to self-identify during the comment period closing on May 27, 2020?
  6. Are entities in the three categories impacted by the planned regulatory change still responsible for paying a portion of the risk evaluation fee?
  7. What should I do if I’ve already self-identified as a manufacturer, but fall into one of the three categories in the planned regulatory change?
  8. What should I do if I’ve been identified on a Preliminary List, but fall into one of the three categories in the planned regulatory change?
  9. What should I do if I fall into one of the three categories in the planned regulatory change, but have NOT yet self-identified and was NOT identified on a Preliminary List?
  10. What constitutes an “article” for purposes of the planned regulatory change?
  11. What constitutes a “byproduct” for purposes of the planned regulatory change?
  12. What constitutes an “impurity” for purposes of the planned regulatory change?

Reporting for TSCA Fees

  1. What do I have to do if my entity was erroneously on a Preliminary List?


March 2020 Rulemaking Announcement and No Action Assurance

1. Why is EPA announcing its intention to propose exemptions to the TSCA Fees rule?

Based on stakeholder concerns regarding the practicalities of self-identifying under the TSCA Fees Rule given broad definition of “manufacture” and the lack of exemptions, EPA announced its intention to propose 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 one of the twenty high-priority substances; 2) producers of one of the twenty high-priority substances as a byproduct; and 3) producers or importers of one of the twenty high-priority substances as an impurity. Learn more about EPA's plan to reduce TSCA fees burden and the no action assurance.

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2. What is the expected timing for this rulemaking?

EPA intends issue proposed amendments to the current fees rule later this year, with the goal of finalizing the amendments  in 2021. 

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3. Is EPA considering any other changes to the TSCA Fees Rule as part of this rulemaking?

As part of the same rulemaking effort, EPA may also consider any necessary adjustment to fee amounts and potential additional improvements to the overall TSCA Fees Rule scope and structure.  EPA will consider feedback received on TSCA Fees Rule to date and expects to further engage with stakeholders as required in TSCA section 26. 

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4. What does the “No Action Assurance” mean?

Consistent with the planned regulatory change (i.e., to propose exemptions from the TSCA Fees Rule for EPA-initiated risk evaluation for three categories of manufacturers), EPA is exercising its enforcement discretion, as a bridge to the final revised rule, regarding the self-identification requirement.  The three categories of manufacturers are: 1) importers of articles containing one of the twenty high-priority substances; 2) producers of one of the twenty high-priority substances as a byproduct; and 3) producers or importers of one of the twenty high-priority substances as an impurity.  Thus, the gency will not pursue enforcement action against entities in the three categories for failure to self-identify under the TSCA Fee Rule.  Learn more about EPA's plan to reduce TSCA fees burden and the no action assurance.

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5. Do entities in the three categories in the planned regulatory change still have to self-identify during the comment period closing on May 27, 2020?

EPA is no longer expecting the three categories of “manufacturers” of one of the twenty high-priority substances to self-identify under the TSCA fees rule.  EPA is exercising its enforcement discretion consistent with the planned regulatory change and will not pursue enforcement action against entities in those three categories for failure to self-identify.  However, if an entity in one of the three categories has been identified in a Preliminary List, they should certify in CDX before the close of the comment period on May 27, 2020, that they fall into one of those categories to avoid identification on EPA’s final list. See question #8.


 

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6. Are entities in the three categories impacted by the planned regulatory change still responsible for paying a portion of the risk evaluation fee?

It depends.  Entities identified on a final list of responsible fee payers are subject to a portion of the TSCA fee for the risk evaluation activity.  See 40 C.F.R. § 700.45(b)(7)-(8).  EPA will develop the Final Lists of responsible fee payers based on information received during the current comment period.  Each Final List will be published no later than concurrent with publication of the final risk evaluation scope document.  If an entity self-identifies to EPA as a manufacturer of one of the twenty high-priority substances, EPA will include the entity on the Final List, and that entity will be responsible for a portion of the risk evaluation fee.  Entities included on a Preliminary List in error must certify as such to EPA to avoid being identified in the Final List.  Likewise, an entity in one of the three categories that was listed on a Preliminary List must certify to EPA in CDX that they fall into one of those three categories and therefore should not be listed on the Final List or responsible for the risk evaluation fee.  EPA has modified CDX to facilitate a new appropriate response in line with the planned regulatory change. Find instructions for reporting in CDX.       

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7. What should I do if I’ve already self-identified as a manufacturer, but fall into one of the three categories in the planned regulatory change?

Entities who 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 close of the comment period on May 27, 2020.  EPA has modified CDX to facilitate a new appropriate response in line with the planned regulatory change. Find instructions for reporting in CDX.       

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8. What should I do if I’ve been identified on a Preliminary List, but fall into one of the three categories in the planned regulatory change?

Entities who have been identified on a Preliminary List, but fall into one of the three categories in the planned regulatory change should certify in CDX before the close of the comment period on May 27, 2020, that they fall into one of those categories, and therefore should not be listed on the Final List and not subject to the risk evaluation fee.  EPA has modified CDX to facilitate a new response consistent with the planned regulatory change. Find instructions for reporting in CDX. 

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9. What should I do if I fall into one of the three categories in the planned regulatory change, but have NOT yet self-identified and was NOT identified on a Preliminary List?

For those who fall into one of the three categories but both (1) were not identified on a preliminary list and (2) have not yet self-identified, EPA does not expect those entities to take any further action.  EPA is exercising it enforcement discretion consistent with the planned regulatory changes and will not pursue enforcement action against these entities for failure to self-identify.  Additionally, EPA expects to use self-identification information to develop the final list of responsible fee payers and only those entities on the final list will be subject to the risk evaluation fee.  

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10. What constitutes an “article” for purposes of the planned regulatory change?

Article means a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.

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11. What constitutes a “byproduct” for purposes of the planned regulatory change?

Byproduct means a chemical substance produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance or mixture.

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12. What constitutes an “impurity” for purposes of the planned regulatory change?

Impurity means a chemical substance which is unintentionally present with another chemical substance.

Reporting for TSCA Fees

1. What do I have to do if my entity was erroneously on a Preliminary List?

If your entity was included on a Preliminary List by mistake (i.e., not a manufacturer under TSCA), the entity is required to certify to EPA in CDX that they have not manufactured/imported the high-priority chemical in the five years preceding publication of the Preliminary List (and therefore are not responsible for the fee).  In this scenario, the appropriate response option is “certification of no manufacture." Find instructions for reporting in CDX. 

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