[Federal Register Volume 85, Number 173 (Friday, September 4, 2020)]
[Notices]
[Pages 55283-55286]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19668]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2019-0677; FRL-10014-28]


Final Lists Identifying Manufacturers Subject to Fee Obligations 
for EPA-Initiated Risk Evaluations Under Section 6 of the Toxic 
Substances Control Act (TSCA); Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: As required by the final rule on fees for the administration 
of the Toxic Substances Control Act (TSCA) (the Fees Rule), in which 
the Environmental Protection Agency (EPA) established fees to defray 
some of the costs of administering certain provisions of TSCA, EPA this 
document announces the availability of the final lists identifying the 
manufacturers (including importers) of the 20 chemical substances that 
have been designated as a High-Priority Substance for risk evaluation 
and for which fees will be charged. In January 2020, EPA announced the 
availability of and solicited public comment on the preliminary lists 
identifying manufacturers subject to fee obligations for EPA-initiated 
risk evaluations under TSCA. During the comment period, which closed on 
June 15, 2020, manufacturers (including importers) were also required 
to self-identify as a manufacturer of one of the 20 High-Priority 
Substances irrespective of whether they are included on the preliminary 
lists. Where appropriate, entities had the opportunity to avoid or 
reduce fee obligations by making certain certifications consistent with 
the Fees Rule. The public had the opportunity to correct errors or 
provide comments on

[[Page 55284]]

the preliminary lists. Manufacturers (including importers) identified 
on the final list will be subject to applicable fees.

DATES: Effective on August 27, 2020.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Benjamin Dyson, Environmental Assistance Division (7408M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(202) 774-8976; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action applies to entities that manufacture (including import) 
one or more of the High-Priority Substances currently undergoing a risk 
evaluation under TSCA section 6(b). The action may also be of interest 
to chemical processors, distributors in commerce, and users; non-
governmental organizations in the environmental and public health 
sectors; state and local government agencies; and members of the 
public. The Agency has not attempted to describe all the specific 
entities and corresponding NAICS codes for entities that may be 
interested in or affected by this action.

B. What action is the Agency taking?

    EPA is announcing the availability of the final lists identifying 
manufacturers (including importers) that are subject to fee obligations 
under 40 CFR 700.45. These entities manufacture or import one or more 
of the 20 High-Priority Substances subject to EPA-initiated risk 
evaluations under TSCA section 6.

C. Why is the Agency taking this action?

    As amended by the Frank R. Lautenberg Chemical Safety for the 21st 
Century Act of 2016 (Pub. L. 114-182, see also https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act), TSCA authorizes EPA to establish, by 
rule, a fee structure to defray some of the costs of administering 
certain provisions of TSCA. Pursuant to the Fees Rule, the Agency will 
collect payment from identified manufacturers (including importers) who 
manufacture (including import) a chemical substance that is the subject 
of a risk evaluation under TSCA section 6(b) (Ref. 1). As intended by 
Congress, these fees are a sustainable source of funds for EPA to 
fulfill its legal obligation to conduct risk evaluations to determine 
whether a chemical substance presents an unreasonable risk of injury to 
health or the environment, as required under TSCA section 6. Pursuant 
to TSCA section 6(b) and its implementing regulations, EPA has 
designated 20 chemical substances as High-Priority Substances for risk 
evaluation (Ref. 2) (84 FR 71924, December 30, 2019) (FRL-10003-15); 
those substances are listed in Unit III. EPA is now identifying the 
manufacturers (including importers) that are subject to fee obligations 
associated with the risk evaluations of these High-Priority Substances.

D. What is the Agency's authority for this action?

    TSCA provides EPA with authority to establish fees to defray a 
portion of the costs associated with administering EPA-initiated TSCA 
section 6 risk evaluations. On September 27, 2018, EPA finalized a rule 
imposing a fee for persons who manufacture (including import) a 
chemical substance that is the subject of an EPA-initiated risk 
evaluation under TSCA section 6 (Ref. 1). The requirements for those 
fee payments are codified in 40 CFR 700.45.

II. Background

A. How was the final list developed?

    TSCA section 6(b)(1) requires EPA to prioritize chemical substances 
as High-Priority Substances for risk evaluation. In accordance with 
TSCA section 6(b) and 40 CFR 702.7, on March 21, 2019, EPA initiated 
the prioritization process for 20 chemical substances identified as 
candidates for High-Priority Substance designation (Ref. 3). On August 
23, 2019, EPA proposed to designate the same 20 chemical substances as 
High-Priority Substances for risk evaluation (Ref. 4). EPA finalized 
the High-Priority Substance designations of the same 20 chemical 
substance proposed for High-Priority Substance designations (Ref. 2) 
and announced on January 27, 2020 the availability of the preliminary 
lists for the 20 High-Priority Substances designated (Ref. 5) (see 
docket EPA-HQ-OPPT-2019-0677). EPA provided a 60-day comment period, 
with two additional extensions closing the second comment period on 
June 15, 2020 (Ref. 6 and Ref. 7) (March 13 (https://www.regulations.gov/document?D=EPA-HQ-OPPT-2019-0677-0058) and May 28 
(https://www.regulations.gov/document?D=EPA-HQ-OPPT-2019-0677-0087).
    EPA developed each preliminary list using the most up-to-date 
information available, from information submitted to the Agency (i.e., 
information submitted under TSCA section 8(a) (including the Chemical 
Data Reporting (CDR) Rule) and TSCA section 8(b), and the Toxics 
Release Inventory (TRI)). To include the two most recent CDR reporting 
cycle data (collected every four years) and to account for annual or 
other typical fluctuations in manufacturing (including import), EPA 
used six years of data submitted or available to the Agency under CDR 
and TRI to create the preliminary lists (2012-2018). EPA considered 
using other sources of information available to the Agency, such as 
publicly available information (e.g., Panjiva, Datamyne) or information 
submitted to other agencies to which EPA has access (e.g., U.S. Customs 
and Border Protection data) but concluded that data quality limitations 
would create more false positives than appropriate additions to the 
lists. Following publication of the preliminary lists, manufacturers of 
the 20 High-Priority Substances who had manufactured or imported the 
chemical substance in the previous five years were required to self-
identify to EPA, irrespective of whether they were included in the 
preliminary lists. See 40 CFR 700.45(b)(5).
    EPA is now announcing the final list of manufacturers (including 
importers) for the 20 High-Priority Substances who are responsible for 
fee payments (Ref. 8). EPA is also providing the list of companies that 
certified to ceasing manufacture for each of the 20 High-Priority 
Substances (Ref. 9).
    EPA believes the requirement to self-identify, established by 40 
CFR 700.45(b)(5), was sufficient to identify additional manufacturers 
(including importers). Manufacturers (including importers) on the 
preliminary lists had an opportunity to certify through CDX that: (1) 
They had already ceased manufacturing prior to the defined cutoff dates 
and will not manufacture (including import) for five years; or (2) they 
have not manufactured the chemical substance in the five-year period 
preceding publication of the preliminary lists. For this group of 20 
chemicals, the cutoff date for ceasing manufacture or import of a 
chemical substance was March 20, 2019, which is the day prior to 
initiation of the prioritization process for the applicable designated 
High-Priority Substance. If EPA received such a certification statement 
from a manufacturer, then the manufacturer was not identified on the

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final list and will not be obligated to pay the fee. Additionally, EPA 
found that the broad scope of the current Fees Rule unintentionally 
imposes potentially significant burdens on importers of chemical 
substances in articles, and manufacturers of byproducts and impurities, 
and that certain stakeholders would be obligated to undertake 
significant and burdensome efforts to attempt to determine the presence 
of the 20 High-Priority Substances in their products and processes. EPA 
announced the Agency's intention to immediately begin the rulemaking 
process to amend the Fees Rule to propose exemptions to the self-
identification requirements in the Fees Rule associated with EPA-
initiated risk evaluations for three categories of manufacturers of 
chemical substances subject to such risk evaluations: (1) Importers of 
articles containing the chemical substances; (2) producers of the 
chemical substances as a byproduct; and (3) producers or importers of 
the chemical substances as an impurity. As a bridge to the final 
revised rule EPA provided a ``No Action Assurance'' on March 24, 2020 
(Ref. 10).
    Additionally, the Agency was asked whether a manufacturer that has 
ceased manufacture of one of the 20 High-Priority Substances prior to 
the cutoff date for ceasing manufacture or import of a chemical 
substance (March 2019) other than manufacture in the three categories 
impacted by the planned regulatory change, and that also commits to not 
manufacturing the chemical in the future five years, other than in 
those same three categories should be subject to fee obligations. The 
Agency responded that in light of the rulemaking announcement, EPA does 
not expect to identify entities who otherwise meet the criteria for 
``cessation'' except for manufacture or potential manufacture in one of 
the three categories--and who certify as such in the ``Additional 
Information'' field in CDX--on the final lists of responsible fee 
payers. Finally, entities had the opportunity to certify as to whether 
they meet the definition of a ``small business concern'' as defined in 
the Fees Rule and qualify for an 80% reduced fee amount.

B. What are the final lists and fee obligations of manufacturers 
(including importers)?

    This Notice announces the availability of EPA's final list of 
manufacturers (including importers) of the 20 High-Priority Substances 
subject to risk evaluation who are responsible for payment of fees, as 
required by 40 CFR 700.45 (Ref. 2). The final lists are available at 
docket number EPA-HQ-OPPT-2019-0677 at http://www.regulations.govand on 
EPA's website at http://www.epa.gov/TSCA-fees. Also included in the 
docket are the list of companies that certified to having ceased 
manufacturing by March 20, 2019 and have no plans to restart 
manufacturing in the next five years (Ref. 9) as well as those that 
certified to not manufacturing the chemical substance in the five-year 
period preceding publication of the preliminary lists (Ref. 11). The 
``Certification of Cessation'' list also includes those manufacturers 
who ceased manufacturing by March 20, 2019 except for manufacture of a 
byproduct, or impurity or in an article. The final list of 
manufacturers differs from the preliminary lists (see docket number 
EPA-HQ-OPPT-2019-0677) for several reasons. For example, many CDR/TRI 
manufacturers that were identified on the preliminary list had either 
ceased manufacturing prior to the cutoff dates were not manufacturers 
(or importers) of the chemical substances. Such entities were not 
included on the final lists. Other entities from the preliminary lists, 
in accordance with the planned regulatory change, that only 
manufactured (or imported) chemicals as a byproduct, impurity, or in an 
article and certified as such, were not included in the final list. The 
only company that self-identified for TCEP imported a very small 
quantity in 2019 for R&D use only. The Agency used the discretion 
offered by the TSCA Fees Rule to not collect a fee from this one 
company. As a result, there are no fees associated with the risk 
evaluation for tris (2-chloroethyl) phosphate (115-96-8). The TSCA Fees 
Rule provides EPA flexibility to refine the final list of manufacturers 
in a manner that is reasonable and prudent, in light of statutory and 
regulatory obligations related to TSCA risk evaluations and associated 
fee payment obligations. As such, the Agency decided to not charge a 
fee to those importers who were only importing small quantities of the 
20 HPS for research and development purposes only.
    This document announces the availability of EPA's final list of 
manufacturers (including importers) of the 20 High-Priority Substances 
subject to risk evaluation who are responsible for payment of fees, as 
required by 40 CFR 700.45 (Ref. 2). The final lists are available at 
docket number EPA-HQ-OPPT-2019-0677 at http://www.regulations.gov and 
on EPA's website at http://www.epa.gov/TSCA-fees. Also included in the 
docket are the list of companies that certified to having ceased 
manufacturing by March 20, 2019 and have no plans to restart 
manufacturing in the next five years (Ref. 9) as well as those that 
certified to not manufacturing the chemical substance in the five-year 
period preceding publication of the preliminary lists (Ref. 11). The 
``Certification of Cessation'' list also includes those manufacturers 
who ceased manufacturing by March 20, 2019 except for manufacture of a 
byproduct, or impurity or in an article. The final list of 
manufacturers differs from the preliminary lists (see docket number 
EPA-HQ-OPPT-2019-0677) for several reasons. For example, many CDR/TRI 
manufacturers that were identified on the preliminary list had either 
ceased manufacturing prior to the cutoff dates were not manufacturers 
(or importers) of the chemical substances. Such entities were not 
included on the final lists. Other entities from the preliminary lists, 
in accordance with the planned regulatory change, that only 
manufactured (or imported) chemicals as a byproduct, impurity, or in an 
article and certified as such, were not included in the final list. 
Other entities that were not included on a preliminary list, such as 
importers of chemical substances for laboratory or R&D use that 
imported volumes below the CDR 25,000 lb threshold, self-identified as 
a manufacturer (including importer) during the reporting period and 
were therefore included on a final list. There are no fees associated 
with the risk evaluation for tris (2-chloroethyl) phosphate (115-96-8).
    Fee obligations are set forth in 40 CFR 700.45 and include a total 
fee of $1,350,000 for EPA-initiated risk evaluations, with a reduced 
fee amount for small business concerns (Ref. 1). The total fee is 
shared amongst all identified manufacturers (including importers). The 
Fees Rule provides more detailed information on how EPA established the 
fee for EPA-initiated risk evaluations (Ref. 1).
    In recognition of the unprecedented and unforeseen challenges to 
the economy as a result of public health emergency, the Agency is 
exploring options for payment flexibilities, including payment plans 
and extended due dates for fees. Manufacturers may also form a 
consortium to pay fees in accordance with 40 CFR 700.45(f)(3). The 
consortium must notify EPA that a consortium has formed within 60 days 
of the publication of the final scope of a risk evaluation. Once 
established, the consortium would determine how the fee would be split 
among the members, and ultimately paid to EPA. For additional 
information on the possible

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division of costs amongst consortia and individual manufacturers, 
please see the Fees Rule Unit III.J, Multiple Parties Subject to Fee 
Obligation (Ref. 1).

C. How can I access the final list?

    The final list of manufacturers that will be subject to the Fees 
Rule for EPA-initiated risk evaluations under section 6 of TSCA can be 
found at docket number EPA-HQ-OPPT-2019-0677 at http://www.regulations.gov and on EPA's website at http://www.epa.gov/TSCA-fees.

III. Public Comments on Preliminary Lists and EPA Responses

    EPA received public comments from 78 entities on the preliminary 
lists. As a general matter, many of the comments raised questions 
asking further clarification of what constitutes a byproduct or 
article; requesting a de minimis exemption; etc. The Agency responded 
to the questions by communicating directly with individual 
stakeholders, hosting conference calls with stakeholders, participating 
in webinars for stakeholders, improving web content, and adding 
Frequently Asked Questions to the EPA web page at https://www.epa.gov/tsca-fees/frequent-questions-about-tsca-fees-epa-initiated-risk-evaluations.

IV. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

    1. EPA. Fees for the Administration of the Toxic Substances 
Control Act. Federal Register. (83 FR 52694, October 17, 2018) (FRL-
9984-41).
    2. EPA. High-Priority Substance Designations Under the Toxic 
Substances Control Act (TSCA); Notice of Availability. Federal 
Register. (84 FR 71924, December 30, 2019) (FRL-10003-15).
    3. EPA. Initiation of Prioritization Under the Toxic Substances 
Control Act (TSCA); Notice. Federal Register. (84 FR 10491, March 
21, 2019) (FRL-9991-06).
    4. EPA. Proposed High-Priority Substance Designations Under the 
Toxic Substances Control Act (TSCA); Notice of Availability and 
Request for Comment. Federal Register. (84 FR 44300, August 23, 
2019) (FRL-9998-29).
    5. EPA. Preliminary Lists Identifying Manufacturers Subject to 
Fee Obligations for EPA-Initiated Risk Evaluations Under Section 6 
of the Toxic Substances Control Act (TSCA): Notice of Availability 
and Request for Comment. Federal Register. (85 FR 4661, January 27, 
2020) (FRL-10003-14).
    6. EPA. Preliminary Lists Identifying Manufacturers Subject to 
Fee Obligations for EPA-Initiated Risk Evaluations Under Section 6 
of the Toxic Substances Control Act (TSCA): Notice of Availability 
and Request for Comment; Extension of Comment Period. Federal 
Register. (85 FR 14677, March 13, 2020) (FRL-10006-03).
    7. EPA. Preliminary Lists Identifying Manufacturers Subject to 
Fee Obligations for EPA-Initiated Risk Evaluations Under Section 6 
of the Toxic Substances Control Act (TSCA): Notice of Availability 
and Request for Comment; Extension of Comment Period. Federal 
Register. (85 FR 32036, May 28, 2020) (FRL-10010-37).
    8. EPA. List of Final Manufacturers for all 20 High Priority 
Substances. August 2020
    9. EPA. List of Manufacturers Who Certified as Ceasing 
Manufacture. August 2020.
    10. EPA. ``No Action Assurance Letter'' of March 24, 2020.
    11. EPA. List of Manufactures Who Self-Identified as ``No 
Manufacture''. August 2020.

    Authority: 15 U.S.C. 2625.

Andrew Wheeler,
Administrator.
[FR Doc. 2020-19668 Filed 9-3-20; 8:45 am]
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