Bergeson & Campbell, P.C. (B&C®) is a Washington, D.C. law firm providing chemical and chemical product stakeholders unparalleled experience, judgment, and excellence in matters relating to TSCA, and other global chemical management programs.

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 28, 2021, announcing a 30-day comment period on the Toxic Substances Control Act (TSCA) Interagency Testing Committee’s (ITC) revisions to the Priority Testing List.  86 Fed. Reg. 22414.  In the 74th ITC Report, ITC revised the TSCA Section 4(e) Priority Testing List by adding the following 15 high-priority substances designated pursuant to TSCA Section 6(b) and 24 organohalogen flame retardants:

Chemical Substance Chemical Abstracts Service Registry Number
High-Priority Substances
1,3-Butadiene 106-99-0
Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester 85-68-7
Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester) 84-74-2
o-Dichlorobenzene 95-50-1
p-Dichlorobenzene 106-46-7
trans-1,2- Dichloroethylene 156-60-5
1,2-Dichloropropane 78-87-5
Dicyclohexyl phthalate 84-61-7
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-(2methylpropyl) ester) 84-69-5
Formaldehyde 50-00-0
1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB) 1222-05-5
Phthalic anhydride 85-44-9
4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA) 79-94-7
1,1,2-Trichloroethane 79-00-5
Organohalogen Flame Retardants
Bis(hexachlorocyclopentadieno)cyclooctane 13560-89-9
1,2-Bis(2,4,6-tribromophenoxy)ethane 37853-59-1
1,1'-Ethane-1,2-diylbis(pentabromobenzene) 84852-53-9
2-(2-Hydroxyethoxy)ethyl 2-hydroxypropyl 3,4,5,6-tetrabromophthalate 20566-35-2
2,2'-[(1-Methylethylidene)bis[(2,6-dibromo-4,1-
phenylene)oxymethylene]]bis[oxirane]
3072-84-2
Mixture of chlorinated linear alkanes C14-17 with 45-52 % chlorine 85535-85-9
N,N-Ethylene-bis(tetrabromophthalimide) 32588-76-4
Pentabromochlorocyclohexane 87-84-3
(Pentabromophenyl)methyl acrylate 59447-55-1
Pentabromotoluene 87-83-2
Perbromo-1,4-diphenoxybenzene 58965-66-5
Phosphonic acid, (2-chloroethyl)-, bis(2-chloroethyl) ester 6294-34-4
Propanoic acid, 2-bromo-, methyl ester 5445-17-0
Tetrabromobisphenol A-bis(2,3-dibromopropyl ether) 21850-44-2
Tetrabromobisphenol A bis(2-hydroxyethyl) ether 4162-45-2
Tetrabromobisphenol A diallyl ether 25327-89-3
Tetrabromobisphenol A dimethyl ether 37853-61-5
2,4,6-Tribromoaniline 147-82-0
1,3,5-Tribromo-2-(prop-2-en-1-yloxy)benzene 3278-89-5
Tris(2-chloroethyl) phosphite 140-08-9
Tris(2,3-dibromopropyl) phosphate 126-72-7
1,3,5-Tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione 52434-90-9
Tris(tribromoneopentyl)phosphate 19186-97-1
2,4,6-Tris-(2,4,6-tribromophenoxy)-1,3,5-triazine 25713-60-4

ITC requests that EPA add these chemical substances and the other five high-priority substances and six organohalogen flame retardants currently on the Priority Testing List to 40 C.F.R. Section 716.120(a), the list of substances subject to the TSCA Section 8(d) Health and Safety Data Reporting rule (40 C.F.R. Part 716).  The rule requires manufacturers (including importers) of chemical substances and mixtures added to the Health and Safety Data Reporting rule to submit lists and copies of unpublished health and safety studies to EPA.  Comments are due May 28, 2021.
 
EPA notes that in addition to the chemical substances being added to the Priority Testing List in the 74th ITC Report, the Priority Testing List includes two alkylphenols, 45 High Production Volume (HPV) Challenge Program orphan chemicals, cadmium, a category of cadmium compounds, six non-phthalate plasticizers, 25 phosphate ester flame retardants, two other flame retardants, nine chemicals to which children living near hazardous waste sites may be exposed, and 19 diisocyanates and related compounds.


 

By Christopher R. Blunck
 
On November 25, 2020, the U.S. Environmental Protection Agency (EPA) released updates to the interim final list of manufacturers and importers subject to fees for the next 20 chemicals undergoing risk evaluation under Section 6(b) of the Toxic Substances Control Act.  According to EPA, “[t]he updated list includes additional manufacturers not identified on the final list of companies and removes manufacturers that self-identified in error or imported the chemical solely for the purpose of research and development.”  EPA stated it is committed to ensuring this list is accurate and that it planned to use this updated list to begin invoicing for fees in early November.  EPA also stated that due to the public health emergency, EPA is exploring options for payment flexibilities.
 
On September 4, 2020, EPA published a Federal Register notice announcing the final lists identifying the manufacturers (including importers) of the 20 chemical substances that have been designated as high-priority substances for risk evaluation and for which fees will be charged.  85 Fed. Reg. 55283.
 
More information is available in our September 4, 2020, memorandum, “EPA Publishes Final Scope Documents and List of Manufacturers Subject to Fees for Risk Evaluations of High-Priority Chemicals.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a Federal Register notice on April 23, 2020, announcing the availability of the draft scope documents for the risk evaluations to be conducted for the remaining seven of the 20 high-priority substances designated in December 2019.  85 Fed. Reg. 22733.  The draft scope document for each chemical substance includes the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk evaluation for that chemical substance.  EPA is also opening a 45-day comment period on these draft scope documents to allow for the public to provide additional data or information that could be useful to EPA in preparing the final scope documents.  Comments are due June 8, 2020.  More information on the draft scope documents is available in our April 21, 2020, memorandum, “EPA Releases Second Set of Draft Scope Documents for Remaining High-Priority Substances.”


 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) announced on April 6, 2020, that the first set of draft scope documents for the next group of chemicals undergoing risk evaluation under the Toxic Substances Control Act (TSCA) is available for comment.  As reported in our December 20, 2019, memorandum, EPA designated these chemicals as a high priority for risk evaluation in December 2019.  According to EPA, seeking public input on the conditions of use to be included in the risk evaluations for these chemicals is the next step in the process outlined in TSCA.  EPA states that “it is important to note that being designated as a high-priority chemical does not mean that a chemical is high risk.”
 
EPA is releasing draft scope documents for 13 of the next 20 chemicals undergoing risk evaluation:

EPA will publish a Federal Register notice announcing the availability of the draft scope documents for public comment.  Publication of the notice will begin a 45-day comment period.  EPA states that it will use feedback received from the public comment process to inform the final scope documents.  More information on the first batch of draft scope documents will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on March 25, 2020, that it will consider a proposed rule that would look at potential exemptions to the Toxic Substances Control Act (TSCA) fees rule in response to stakeholder concerns about implementation challenges.  EPA states that by considering a proposal to narrow the broad scope of the current requirements, it “could significantly reduce burden on potentially thousands of businesses across the country while maintaining the ability to successfully implement the Lautenberg Act amendments” to TSCA to protect human health and the environment.  According to EPA, it plans to initiate a new rulemaking process to consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:

  • Import the chemical substance in an article;
  • Produce the chemical substance as a byproduct; or
  • Produce or import the chemical substance as an impurity.

EPA states that it may also consider proposing other changes to the rule during this process consistent with TSCA’s requirement to reevaluate the fees rule every three years.  EPA notes that it believes that considering exempting certain entities from self-identification requirements will not impede the ability to collect fully the necessary fees and will still allow it to achieve the ultimate objective of the TSCA fees rule and the statute -- “to defray a portion of EPA’s TSCA implementation costs.”  EPA intends to issue proposed amendments to the current fees rule later in 2020, with the goal of promulgating the amendments in 2021.

EPA states that additionally, “in light of the extremely unusual circumstances of this situation and the undue hardship imposed on certain businesses who would be required to collect and report information” under the TSCA fees rule, EPA issued a “no action assurance” for the three categories of manufacturers at this time.  More specifically, EPA “will exercise its enforcement discretion regarding the self-identification requirement for the three categories of manufacturers” for which EPA intends to propose an exemption.

EPA suggests that businesses that are erroneously on the preliminary lists of fee payers or fall into one of the three categories discussed above should see its frequently asked questions (FAQ) for more information about how to certify as such to EPA and to avoid fee obligations.  EPA posted more information on its announcement, as well as a copy of the no-action assurance, on its website.  More information is available in our March 9, 2020, blog item, “EPA Extends Deadline to Self-Identify as a Manufacturer or Importer of a High-Priority Chemical to May 27.”


 

By Lynn L. Bergeson and Carla N. Hutton

On March 9, 2020, the U.S. Environmental Protection Agency (EPA) announced that it has extended the deadline to self-identify as a manufacturer or importer of a high-priority chemical to May 27, 2020.  EPA states that it is working to address issues identified with implementation of the Toxic Substances Control Act (TSCA) Fees Rule and EPA-initiated risk evaluations.  EPA “is actively seeking ways to address the many implementation impracticalities that have been brought to our attention and to reduce concerns by affected entities.”  During the extended comment period extension, EPA “will continue to receive input from the regulated community and analyze options to address some of the implementation challenges with the final rule and reduce stakeholder concerns.”  EPA will publish a Federal Register notice announcing the extension of the comment deadline.  A pre-publication version of the notice is available.

Background

As reported in our February 26, 2020, memorandum, on February 24, 2020, EPA hosted a conference call to review certain provisions of the final rule on fees for the administration of TSCA, particularly those related to EPA-initiated risk evaluations.  EPA published a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 high-priority chemical substances for risk evaluation for which fees will be charged.  85 Fed. Reg. 4661.  During the comment period, 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.

Resources

Our March 4, 2020, memorandum, “EPA Plans to Provide Additional Clarification on Self-Identifying as a Manufacturer or Importer of a High-Priority Chemical,” suggests that industry stakeholders that believe they may be impacted by the January 27 notice may wish to consider suspending ongoing internal deliberations on self-reporting obligations until EPA provides additional guidance.

Information on forming a consortium is available in our March 2, 2020, memorandum, “The Essential Value of Forming TSCA Consortia.”

More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”

More information on the final TSCA fees rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a Federal Register notice on January 27, 2020, identifying the preliminary lists of manufacturers (including importers) of the 20 chemical substances that EPA designated as high-priority substances for risk evaluation and for which fees will be charged.  Publication of the Federal Register notice will begin a 60-day comment period during which manufacturers (including importers) will be required to self-identify as a manufacturer of a high-priority substance irrespective of whether they are included on the preliminary lists identified by EPA.  EPA states that where appropriate, entities may also avoid or reduce fee obligations by making certain certifications consistent with the final rule on fees for the administration of the Toxic Substances Control Act (TSCA).  During the 60-day comment period, the public will have the opportunity to correct errors or provide comments on the preliminary lists.  According to the notice, EPA expects to publish final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope document for risk evaluations of the 20 high-priority substances.  Manufacturers (including importers) identified on the final lists will be subject to applicable fees.

Once the Federal Register notice is published, the preliminary lists will be available in docket number EPA-HQ-OPPT-2019-0677 at http://www.regulations.gov and on EPA’s website at http://www.epa.gov/TSCA-fees.  EPA states that it developed each preliminary list “using the most up-to-date information available, including information submitted to the Agency (e.g., information submitted under TSCA section 8(a) (including the Chemical Data Reporting (CDR) Rule) and section 8(b), and to the Toxics Release Inventory (TRI)).”  According to the notice, EPA considered using other sources of information, such as publicly available information or information submitted to other agencies to which EPA has access, but EPA “concluded that data quality limitations would create more false positives than appropriate additions to the lists.”  Additionally, EPA notes that it believes the Self-Identification process, established by 40 C.F.R. Section 700.45(b)(5), will be sufficient to identify additional manufacturers (including importers), as appropriate.  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 states that it used six years of data submitted or available to it under CDR and TRI to create the preliminary lists (2012-2018).

More information on the 20 substances designated as high-priority substances is available in our December 20, 2019, memorandum, “Final List of High-Priority Chemicals Will Be Next to Undergo Risk Evaluation under TSCA.”  More information on the final TSCA fees rule is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”

See Also: "Are You Potentially Responsible for TSCA Fees? EPA Issues Preliminary Lists of Companies Responsible for TSCA Risk Evaluation Fees" episode of All Things Chemical™ podcast


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) published on December 20, 2019, the final list of high-priority chemicals.  These chemicals will be the next 20 chemicals to undergo risk evaluation under the amended Toxic Substances Control Act (TSCA).  According to EPA, issuing the final list of high-priority chemicals for risk evaluation “represents the final step in the prioritization process outlined in TSCA and marks another major TSCA milestone for EPA in its efforts to ensure the safety of existing chemicals in the marketplace.”  The 20 chemicals consist of seven chlorinated solvents, six phthalates, four flame retardants, formaldehyde, a fragrance additive, and a polymer precursor:

  1. p-Dichlorobenzene;
  2. 1,2-Dichloroethane;
  3. trans-1,2- Dichloroethylene;
  4. o-Dichlorobenzene;
  5. 1,1,2-Trichloroethane;
  6. 1,2-Dichloropropane;
  7. 1,1-Dichloroethane;
  8. Dibutyl phthalate (DBP) (1,2-Benzene- dicarboxylic acid, 1,2- dibutyl ester);
  9. Butyl benzyl phthalate (BBP) - 1,2-Benzene- dicarboxylic acid, 1- butyl 2(phenylmethyl) ester;
  10. Di-ethylhexyl phthalate (DEHP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis(2-ethylhexyl) ester);
  11. Di-isobutyl phthalate (DIBP) - (1,2-Benzene- dicarboxylic acid, 1,2- bis-(2methylpropyl) ester);
  12. Dicyclohexyl phthalate;
  13. 4,4'-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA);
  14. Tris(2-chloroethyl) phosphate (TCEP);
  15. Phosphoric acid, triphenyl ester (TPP);
  16. Ethylene dibromide;
  17. 1,3-Butadiene;
  18. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB);
  19. Formaldehyde; and
  20. Phthalic anhydride.

More information will be available in a forthcoming memorandum that will be posted on our website.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 23, 2019, the U.S. Environmental Protection Agency (EPA) published a Federal Register notice proposing to designate 20 chemical substances as high-priority substances for risk evaluation under the Toxic Substances Control Act (TSCA).  84 Fed. Reg. 44300.  The notice includes a summary of the approach used by EPA to support the proposed designations, the proposed designation for each of the chemical substances, and instructions on how to access the chemical-specific information, analysis, and basis used by EPA to make the proposed designation for each chemical substance.  Comments are due November 21, 2019.  More information is available in our August 26, 2019, memorandum, "EPA Proposes to Designate 20 Chemical Substances as High-Priority Substances for Risk Evaluation under TSCA."


 

By Lynn L. Bergeson

The U.S. Environmental Protection Agency (EPA) released on March 20, 2019, a list of 20 chemicals that EPA has suggested as candidates for high priority designation under the Toxic Substances Control Act (TSCA), as reported in our March 22, 2019, memorandum "EPA Releases List of 40 Chemicals Undergoing Prioritization for Risk Evaluation."  Should those chemicals go forward as high priority, they will be subject to risk evaluation under TSCA Section 6.  Industry stakeholder responses to this candidate list proposal and follow up actions with EPA related to risk evaluation work optimally will be conducted under existing or potentially newly formed chemical consortia.  But what if your chemical is not on the list of 20?  If you want to protect or even increase your business market advantage, consider inviting your commercial rivals to join an industry advocacy group anyway.  This is particularly important if you have a chemical of commercial interest on the TSCA Work Plan Chemicals list.  For more information on this issue, please see our full memorandum.


 
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