Regulatory Developments

B&C Frequently Asked Questions (FAQ) on TSCA Fees for EPA-Initiated Risk Evaluations, Preliminary Lists for 20 High-Priority Chemicals, and Self-Identification Requirements

April 27, 2020

Under the amended Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency (EPA) has authority to collect fees from chemical manufacturers and importers to defray a portion of the EPA costs associated with implementation efforts. The EPA fees rule, which became effective on October 18, 2018, required payment of fees for eight categories of fee-triggering events under TSCA, including EPA-initiated risk evaluations under TSCA Section 6.

As part of the final fees rule, EPA is required to prepare a preliminary list of manufacturers subject to fee obligations for EPA-initiated Section 6 risk assessments. On January 27, 2020, EPA published a Federal Register notice identifying the preliminary lists of manufacturers (including importers) of the 20 high-priority chemical substances for risk evaluation for which fees will be charged. The notice included information on the circumstances and processes for which manufacturers (including importers) are required to self-identify as manufacturers of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.

This FAQ addresses issues that have caused confusion and anxiety for industry stakeholders regarding the self-identification criteria, time lines, and procedures.

Who is required to respond to the January 27, 2020, notice?

A company that has manufactured or imported any of the 20 high-priority chemicals since January 27, 2015, must respond, whether they are listed on the preliminary manufacturers list or not.

A company that is on the preliminary list but has not manufactured or imported the subject chemical since January 27, 2015, must also respond; otherwise, it will be assessed a share of the fees.

A company that processes or uses a subject chemical, or incorporates it into a product, but does not manufacture or import the subject chemical is not required to respond.

Will all responding companies be subject to paying a portion of the fees?

If a company has manufactured or imported since January 27, 2015, but can certify that it has not manufactured or imported the subject chemical since March 20, 2019 (the day before the publication of the proposed high-priority chemical list on March 21, 2019), and the company will certify that it will not manufacture or import the subject chemical in any amount for five years, or until January 27, 2025, the company is not subject to the fee obligation.

Will all companies on the preliminary list of manufacturers be subject to paying a portion of the fees?

If a company is included on a subject chemical preliminary list but has not manufactured or imported the subject chemical in any amount since January 27, 2015, it can certify this to EPA and be relieved from the fee obligation.

When and how must responses be submitted?

Responses to the EPA preliminary list, including required self-identification and/or certifications on time lines for manufacture or imports, are due by May 27, 2020. Responses must be submitted to EPA via the Central Data Exchange (CDX). General comments on the EPA notice can be submitted to the docket and are also due by May 27, 2020.

Are there exemptions for responding to the January 27, 2020, notice?

While the EPA 2018 final fees rule offers no exemptions for chemicals manufactured or imported as an impurity, byproduct, in an article, or in trace amounts, EPA issued a notice on March 25, 2020, that it intends to consider a proposed rule that would provide exemptions to the October 2018 TSCA fees rule. Specifically, EPA indicates that it plans to initiate a rulemaking to exempt manufacturers that (1) import the chemical substance in an article, (2) produce the chemical substance as a byproduct, and (3) produce or import the chemical substance as an impurity.

Because it will not be possible for EPA to promulgate such a rulemaking prior to when reporting is needed for the 20 high-priority chemicals, EPA also states in the notice that it issued a “no action assurance” for the three categories. This means that EPA will exercise its enforcement discretion if a company fits within these three categories that will be exempted but does not self-identify.

An EPA FAQ on the March 2020 rulemaking announcement and no action assurance is available.

Is there a de minimis volume exemption?

No. If the subject chemical was manufactured or imported at any volume and does not meet the proposed exemptions noted above ((1) import the chemical substance in an article, (2) produce the chemical substance as a byproduct, or (3) produce or import the chemical substance as an impurity), it would still trigger the need to self-identify as a manufacturer.

Is there a research and development (R&D) exemption?

No. There is no exemption for subject chemicals manufactured or imported as R&D within the time lines specified.

Are there any other exemptions or exclusions?

Substances not considered “chemical substances” under TSCA (e.g., chemicals manufactured or imported for use solely as a food, food additive, drug, cosmetic, tobacco product, pesticide, and special nuclear materials) are not subject to this reporting requirement.

Likewise, chemicals manufactured solely for the purpose of export from the United States consistent with TSCA Section 12(a) are not subject to the fees rule, unless EPA has found that the chemical presents an unreasonable risk.

What do I include in comments to the docket to get my company off the preliminary list?

While there is an opportunity for stakeholders to submit comments on the January 27, 2020, EPA notice, companies that are required to respond -- either to self-identify or to provide input on inclusion of a manufacturer list -- must do so via CDX.

If an entity wishes to make a public comment to post on the docket, it can certainly do so; but if it is required to respond to the notice, it will need to go into CDX and submit its response.

What is the process for submitting responses to CDX?

Responses must be made within the Chemical Safety and Pesticides Program (CSPP) section of CDX by choosing the “TSCA risk evaluation rule” option from the Chemical Information Submission System menu. The respondent can complete the five-step process by creating an “Initial Response” submission. An Initial Response must be submitted for each substance of interest.

Step 1 -- Provide contact information for the respondent;

Step 2 -- Provide required company information, including whether the reporting entity meets the criteria of a small business concern as defined by 40 C.F.R. Section 700.43, and whether the entity will join a consortium (e.g., yes, no, not sure);

Step 3 -- Select the substance of interest and one of the following response options:

  • Self-Identification -- 40 CFR 700.45(b)(5): 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 -- 40 CFR 700.45(b)(5)(iii): 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 -- 40 CFR Section 700.45(b)(5)(ii): 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 (March 21, 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.
     

Step 4 -- Confirm the contact information, and that the submitter is a legally responsible party for the submitting company.

Step 5 -- Certify that the submission is complete and accurate.

A sixth step, that may apply for some responses, is to provide substantiation if information in the submission is claimed as confidential business information (CBI).

Is there a step-by-step process to determining response?

Bergeson & Campbell, P.C. (B&C®) has prepared a decision tree that outlines the steps provided below.

Step 1: Determine if your company is included in any of the 20 chemicals on the preliminary manufacturer lists. If so, verify whether your company manufactured or imported any amount of the subject chemical in the past five years prior to publication of the list (since January 27, 2015) -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities. (NOTE: EPA opted to use Toxic Release Inventory reporting as a potential surrogate for manufacture, so it is feasible that a company could be misidentified.)

If your company has not manufactured or imported the subject chemical in any amount in the five years prior to the EPA notice (i.e., since January 27, 2015) -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities -- submit an Initial Response that includes a certification to EPA attesting to no manufacture or import. That certification must be submitted by May 27, 2020, via CDX.

If your company has manufactured or imported the subject chemical since January 27, 2015 -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities -- determine whether manufacture or import in any amount has occurred since March 20, 2019, the day before the chemicals were initially identified as high priority.

If your company can certify that it has not manufactured or imported the subject chemical in any amount since March 20, 2019 -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities -- and will not manufacture or import in any amount for the next five years (until January 27, 2025), it will not be obligated to pay the TSCA fees. The certification must be submitted in an Initial Response by May 27, 2020, via CDX.

If your company did manufacture after March 20, 2019, or cannot certify that it will not manufacture or import in the next five years -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities -- it will be subject to TSCA fees. Even though included on the preliminary list, the company still needs to submit an Initial Response via CDX by May 27, 2020, to provide EPA with contact information and small business certification, if applicable.

Step 2: Evaluate the chemicals included on the list of 20 high-priority chemicals in light of the EPA notice that it intends to exempt chemicals imported in articles, produced as byproducts, or produced or imported as impurities, to determine if your company is a manufacturer or importer.

If your company has not manufactured or imported the subject chemical in any amount in the five years prior to the EPA notice (i.e., since January 27, 2015) -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities -- they are not obligated to pay TSCA fees. No action is needed.

If your company has manufactured or imported any amount of the subject chemical since January 27, 2015, taking into account the anticipated exemptions for imported articles, byproducts, and impurities, determine whether manufacture or import in any amount has occurred since March 20, 2019, the day before the chemicals were initially identified as high priority -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities.

If your company can certify that it has not manufactured or imported the subject chemical in any amount since March 20, 2019, and will not manufacture or import in any amount for the next five years (until January 27, 2025) -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities -- it is not obligated to pay the TSCA fees. The certification must be submitted in an Initial Response by May 27, 2020, via CDX.

If your company did manufacture or import after March 20, 2019, or cannot certify that it will not manufacture or import in the next five years -- taking into account the anticipated exemptions for imported articles, byproducts, and impurities -- it will be subject to TSCA fees and must self-identify in an Initial Response by May 27, 2020, via CDX.

Are import brokers required to respond?

Typically, the company that is the importer of record is the party that is obligated to comply with TSCA regulations. EPA is currently working on additional guidance on this issue specific to the fee rule, but based on feedback during the April 16, 2020, EPA webinar, we expect EPA to follow its Chemical Data Reporting (CDR) rule guidance related to importer responsibilities. That CDR guidance indicates that as long as one of the parties to the import transaction satisfies the TSCA obligation, EPA is satisfied. If none of the parties of the import transaction satisfies the obligation, EPA will consider all parties in violation.

In this case, as long as one of the parties involved in the import transaction properly self-identifies and pays its share of the fee, EPA will be satisfied. If none of the import transaction parties self-identifies or pays the share of the fees, all parties will be considered in violation.

Do I have to report volumes manufactured or imported?

The self-identification process does not require reporting any volumes.

Do I need to request information from my foreign supplier on the presence of priority chemicals?

It is our view that a decision to self-identify related to a subject chemical’s presence should be based on documented information. If there is no specific indication or clear knowledge that the subject chemical is actually present as part of an imported product, a company could take the position that it is not subject to the fee rule and no reporting is required.

If a foreign supplier does not provide documentation as to whether any of the 20 high-priority chemicals are included in the imported material, there is no basis for a company to self-identify. Of course, if the chemical(s) are clearly identified as present on the importation records, safety data sheet, or other records, your company would be expected to self-identify.

What happens if the need to report is discovered after fees are assessed?

EPA has stated that once it issues the final list of companies subject to the fees rule, it would not be revisiting that list. EPA has indicated that there could be enforcement actions and potential penalty fees if a company was aware of a chemical’s presence but did not self-identify.

We understand, however, that once the initial fee payment is made, there is no requirement for others to contribute -- even if they were out of compliance. EPA can and likely will collect penalty fees if EPA becomes aware of instances of non-compliance, but this would be separate and apart from the TSCA manufacturer fees.

Am I required to join a consortium?

There is no requirement to join a consortium; however, companies are urged to consider doing so.

Forming a consortium has the benefit of the consortium determining how the fees to EPA should be divided among its members. Perhaps as important, a consortium provides members a means of engaging effectively in advocacy in the risk evaluation process for substances of interest. This engagement includes developing and submitting comments during the scoping phase, ensuring that EPA is using the best available data and science to conduct the risk evaluation, and providing to EPA data on conditions of use that reflect realistic exposure scenarios and workplace controls.

EPA has stated its preference for working with consortia as they create efficiencies for EPA and the member companies.

EPA should be notified of consortium formation, including the names of its members, within 60 days of EPA’s publication of the final scope of the risk evaluation for the subject chemical.

What are the 20-high priority chemicals?

As reference, we have provided the list of the 20 high-priority chemicals below:

Chemical Name CAS
p-Dichlorobenzene 106-46-7
1,2-Dichloroethane 107-06-2
trans-1,2-Dichloroethylene 156-60-5
o-Dichlorobenzene 95-50-1
1,1,2-Trichloroethane 79-00-5
1,2-Dichloropropane 78-87-5
1,1-Dichloroethane 75-34-3
Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester) 84-74-2
Butyl benzyl phthalate (BBP) (1,2-Benzene-dicarboxylic acid, 1-butyl 2-(phenylmethyl) ester) 85-68-7
Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester) 117-81-7
Di-isobutyl phthalate (DIBP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-methylpropyl) ester) 84-69-5
Dicyclohexyl phthalate 84-61-7
4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA) 79-94-7
Tris(2-chloroethyl) phosphate (TCEP) 115-96-8
Phosphoric acid, triphenyl ester (TPP) 115-86-6
Ethylene dibromide 106-93-4
1,3-Butadiene 106-99-0
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyran (HHCB) 1222-05-5
Formaldehyde 50-00-0
Phthalic anhydride 85-44-9

 
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