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By Lynn L. Bergeson and Carla N. Hutton

On January 11, 2021, the U.S. Environmental Protection Agency (EPA) published a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule.  86 Fed. Reg. 1890.  Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation and to ensure that public health and the environment continue to be protected.  TSCA requires EPA to review its fees every three years and, after consulting with parties potentially subject to the fees, to adjust the fees if necessary.  The proposed rule describes the proposed modifications to the TSCA fees and fee categories for fiscal years 2022, 2023, and 2024 and explains the methodology by which these TSCA fees were determined.  The proposed updates include:

  • Regarding EPA-initiated risk evaluations, narrowing the scope of the TSCA fees rule by exempting from the requirement to pay fees importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that manufacture or import a chemical in de minimis amounts, companies that manufacture or import chemicals solely for research and development (R&D) purposes, and companies that produce a chemical as a non-isolated intermediate;
  • Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
  • Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
  • Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
  • Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
  • Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations (MRRE); and
  • Adding three new fee categories, two associated with new chemicals activities and one with test orders.

Comments are due February 25, 2021.  More information is available in our December 30, 2020, memorandum, “EPA Intends Proposed Rule to Increase Flexibility and Reduce Burdens under TSCA Fees Program.”


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 8, 2021, that it released an updated and improved version of OncoLogic™, a system used to evaluate a chemical’s potential to cause cancer.  EPA states that, in partnership with the Organization for Economic Cooperation and Development (OECD), it developed “a more user-friendly version of the most widely used piece of this system, greatly expanding its usability across the agency and the scientific community.”  According to EPA, the updated module (version 9) is used to analyze organic chemicals, the largest group of chemicals contained in this tool.  It features:

  • A streamlined interface that does not require expert knowledge to navigate;
  • A standardized reporting format that allows users to view and export results quickly; and
  • Increased transparency in the science behind the predictions provided by the model.

EPA notes that OncoLogic™ is one of many publicly available assessment methods, databases, and predictive tools it developed to estimate hazard to humans and the environment, particularly in the absence of test data.  According to EPA, these tools and models support it in implementing programs and regulations, such as the Toxic Substances Control Act (TSCA), and help external users assess and manage chemical risks.  EPA states that version 8.0, which continues to include modules for fibers, metals, and polymers, will remain available to the public.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) to provide advice and recommendations to two Small Business Advocacy Review (SBAR) Panels.

One Panel will focus on EPA’s development of a proposed rule to address unreasonable risks identified in EPA’s recently completed Toxic Substances Control Act (TSCA) risk evaluation for perchloroethylene.  As reported in our December 17, 2020, memorandum, of the 61 conditions of use that EPA reviewed for perchloroethylene, EPA found that 59 present unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders.  The conditions of use that EPA determined do not present an unreasonable risk are distribution in commerce and industrial and commercial use in lubricants and greases for penetrating lubricants and cutting tool coolants.  EPA found no unreasonable risks to the environment.

The second Panel will focus on a risk management rulemaking for n-methylpyrrolidone (NMP).  As reported in our December 29, 2020, memorandum, of the 37 conditions of use that EPA reviewed for NMP, EPA found that 26 present unreasonable risks to workers and consumers.  These uses include an unreasonable risk to workers when domestically manufacturing or importing NMP, processing NMP for a variety of uses, and when used in a variety of industrial and commercial conditions of use.  These uses also include an unreasonable risk to consumers from one consumer use.  EPA found that NMP does not pose an unreasonable risk when distributed in commerce or in a variety of industrial and commercial and consumer applications.  EPA also determined that NMP does not present an unreasonable risk to the environment and the general population.

EPA is now moving to the risk management step in the TSCA process by working to draft regulations to protect public health from the unreasonable risks identified in the final risk evaluations.  According to EPA, the Regulatory Flexibility Act requires agencies to establish an SBAR Panel for rules that may have a significant economic impact on a substantial number of small entities.  The SBAR Panels will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.  The SBAR Panels will select SERs to provide comments on behalf of their companies, communities, or organizations and advise the Panels on the potential impacts of the proposed rule on small entities.  EPA states that it is seeking self-nominations directly from the small entities that may be subject to the rules’ requirements.  EPA notes that other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs.  Self-nominations may be submitted online and must be received by January 19, 2021.

EPA states that in addition to engaging with small businesses, it “is executing a robust outreach effort on risk management that includes formal consultations with state and local governments, tribes, and environmental justice communities.”  EPA notes that there will also be an open public comment period on any draft risk management regulations.


 

By Lynn L. Bergeson and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) will hold webinars on February 2, 2021, and February 18, 2021, to consult with environmental justice communities on risk management for the cyclic aliphatic bromide cluster (HBCD) and carbon tetrachloride.  The webinars will focus on the environmental justice impacts of EPA’s development of proposed rules to address the unreasonable risks identified in the final TSCA risk evaluations for these chemicals.  EPA states that both sessions will address HBCD and carbon tetrachloride.  EPA is offering repeated sessions to increase opportunities for participation.  According to EPA, both sessions will provide an overview of the TSCA risk management requirements, the findings from the final risk evaluations, the tools available to manage the unreasonable risks from HBCD and carbon tetrachloride, and discussion of environmental justice concerns.  EPA notes that in addition to being open to the public, it is inviting national, local, and non-governmental organizations, communities, and other interested stakeholders to participate.
 
EPA states that in addition to environmental justice consultations, it is executing a “robust outreach effort” on risk management that includes formal consultations with small businesses, state and local governments, and tribes.  There will also be an open public comment period on the proposed risk management regulations.  More information on EPA’s final risk evaluations is available in our September 28, 2020, memorandum, “EPA Publishes Final Risk Evaluation for HBCD,” and in our November 4, 2020, memorandum, “Final Risk Evaluation for Carbon Tetrachloride Finds Unreasonable Risks to Workers and Occupational Non-Users.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) for five persistent, bioaccumulative and toxic (PBT) chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (86 Fed. Reg. 866); decabromodiphenyl ether (decaBDE) (86 Fed. Reg. 880); hexachlorobutadiene (HCBD) (86 Fed. Reg. 922); pentachlorothiophenol (PCTP) (86 Fed. Reg. 911); and phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894).  TSCA required EPA to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable.  EPA identified these five PBT chemicals for expedited action, following criteria outlined in TSCA.  The final rules limit or prohibit the manufacture (including import), processing, and/or distribution in commerce for the following:

  • DecaBDEA flame retardant in plastic enclosures for televisions, computers, audio and video equipment, textiles and upholstered articles, wire and cables for communication and electronic equipment, and other applications;
     
  • PIP (3:1)A plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive in hydraulic fluid, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants, and plastic articles;
     
  • 2,4,6-TTBPAn intermediate/reactant in processing, and it is incorporated into formulations destined for fuel and fuel-related additives;
     
  • HCBDA chemical used as a halogenated aliphatic hydrocarbon that is produced as a byproduct during the manufacture of chlorinated hydrocarbons; and
     
  • PCTP:  A chemical used to make rubber more pliable in industrial uses.

The final rules will be effective February 5, 2021.  More information on the final rules is available in our December 23, 2020, memorandum, “EPA Releases Final TSCA Section 6(h) Rules for Five PBT Chemicals.”


 

By Lynn L. Bergeson and Carla N. Hutton
 

The U.S. Environmental Protection Agency (EPA) announced on January 5, 2021, that it is reopening the reporting period under the Toxic Substances Control Act (TSCA) Inventory notification active-inactive rule where companies identified chemicals that were manufactured, imported, or processed in the United States during the ten-year time period ending on June 21, 2016.  As reported in our June 26, 2017, memorandum, “EPA Issues Final TSCA Framework Rules,” the final TSCA Inventory notification (active-inactive) rule established a retrospective electronic notification of chemical substances on the TSCA Inventory that were manufactured (including imported) for nonexempt commercial purposes during the ten-year time period ending on June 21, 2016, with provision to also allow notification by processors.  From August 11, 2017, through October 5, 2018, chemical manufacturers and processors provided information on which chemicals were manufactured, imported, or processed in the United States over the past ten years.  The reporting period included an opportunity for submitters to assert claims to retain specific chemical identities as confidential business information (CBI).  In May 2020, EPA posted an interim list of chemicals expected to lose their CBI status and move to the public portion of the TSCA Inventory.  In its January 5, 2021, announcement, EPA states that it since become aware of “submitter confusion and issues regarding CBI claims” during the initial reporting period.  EPA is allowing companies to submit, amend, or withdraw filings under the TSCA Inventory notification (active-inactive) rule to maintain existing CBI claims for specific chemical identity.  The reporting period will reopen 30 days after publication in the Federal Register and run for 60 days after that date.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On December 21, 2020, the U.S. Environmental Protection Agency (EPA) announced that a report compiling the letter peer reviewers’ comments on the revised draft Toxic Substances Control Act (TSCA) risk evaluation of C.I. Pigment Violet 29 (PV29) is now available in Docket EPA-HQ-OPPT-2018-0604.  EPA states that it is in the process of reviewing the letter peer reviewers’ comments and will use the feedback received from the peer review and public comments to inform the final risk evaluation.
 
According to EPA, after it issued the draft risk evaluation in November 2018, it received additional data in response to test orders, as well as additional information voluntarily submitted by the sole U.S. manufacturer.  EPA states that these new data led it to revise its analytical approach for evaluating the potential exposure and health effects of PV29.  As a result of this updated analysis, the revised draft risk evaluation now shows unreasonable risk to workers for 11 out of 14 conditions of use.  Because these new data had a significant impact on EPA’s risk evaluation and ultimately the risk determinations, EPA provided an opportunity for the public to give input before issuing the final risk evaluation.
 
EPA notes that it also conducted a letter peer review of the revised draft risk evaluation using independent scientists, including one who has served as a member and several who have served as ad hoc peer reviewers for the TSCA Science Advisory Committee on Chemicals (SACC).  The peer review focused on charge questions supplied by EPA.  The report made available December 21, 2020, is the result of this letter peer review.


 

By Lynn L. Bergeson, Carla N. Hutton, and Richard E. Engler, Ph.D.
 
The U.S. Environmental Protection Agency (EPA) has posted a Compliance Advisory entitled “Applicability of the Toxic Substances Control Act to Chemicals made from Petroleum and Renewable Sources Used as Fuels and Fuel Additives and Distillates.”  The Compliance Advisory states that EPA is reaffirming that chemical substances used as fuels, fuel additives, and distillates made from either petroleum or renewable sources are subject to the Toxic Substances Control Act (TSCA).  Anyone who plans to manufacture (including import) a chemical made from petroleum or renewable sources must comply with the statutory and regulatory new chemical requirements under TSCA Section 5.  According to the Compliance Advisory, EPA has received stakeholder inquiries “as to whether fuel and fuel additives made from renewable sources (such as renewable naphtha) are subject to the TSCA new chemicals requirements under section 5.”  EPA states that it is issuing the Compliance Advisory “to affirm that fuel and fuel additives either made from petroleum or renewable sources are subject to TSCA and have been subject to its requirements since 1976.”
 
According to the Compliance Advisory, there are about 142 “naphthas” and 178 “distillates” (that compositionally can qualify as naphthas) currently on the TSCA Inventory, and they are considered Unknown, Variable composition, Complex, or Biological (UVCB) substances.  Any substance that is not on the TSCA Inventory is a new chemical under TSCA Section 5(a)(1)(A).  Prior to manufacture (including import) of a new chemical for commercial use, a premanufacture notice (PMN) must be filed with EPA under TSCA Section 5.  The Compliance Advisory includes several questions and answers (Q&A), including:
 
Can you manufacture or import a chemical substance made from a renewable source if it is not listed on the TSCA Inventory?
 
No.  Anyone who intends to manufacture (including import) a new chemical substance that is subject to TSCA for a non-exempt commercial purpose is required to submit a PMN at least 90 days prior to the manufacture of the chemical.  Manufacturers (importers) are in violation of TSCA if they fail to comply or are late in complying with TSCA notice requirements.  If you are required to submit a PMN, failure to do so is a violation of TSCA Section 15 and you may be subject to penalties.  PMN submissions must include all available data, pursuant to 40 CFR 720.45 and 720.50.  TSCA requires EPA to review the notice and make a determination; and, if appropriate, regulate the proposed activity.
 
EPA’s “compliance advisory” is disappointing.  It signals this EPA is disinclined to promote renewable petroleum cuts and essentially (and emphatically) reaffirms what we believe to be EPA’s inflexible and unimaginative stance on “source” being determinative in petroleum cut UVCBs.  This position, as we have noted in a variety of regulatory contexts, is a substantial disincentive to commercializing renewable petroleum cuts.  EPA’s view is especially problematic when a refinery might wish to use a combination of petroleum and renewable feedstocks to make a single naphtha (or other distillate) cut.
 
For example, to avail itself of the equivalence determination, a company would have to submit a PMN for the renewable equivalent of a petroleum cut, sign the almost certain resultant consent order (EPA will undoubtedly identify aquatic toxicity concerns and may also identify health concerns), commence manufacture, file a Notice of Commencement of Manufacture or Import (NOC), and then request an equivalency determination.  If EPA denies the equivalency determination, any downstream processor or user will have to either segregate the renewable products from the petroleum products so that the downstream entity can maintain records of compliance with the consent order or treat both the renewable and petroleum products as being subject to the order.  Neither option is commercially feasible or sustainable.
 
This sequence of events illustrates why commercial entities are disinclined to avail themselves of renewable sources in the distillate space.  EPA’s “compliance advisory” is an unexpected and, to many, unwanted parting gift from the Trump Administration.  The Biden Administration may wish to revisit the wisdom and prudence of this inflexible, antiquated, and inequitable view.


 

By Lynn L. Bergeson and Carla N. Hutton
 

On December 22, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of new interim guidance on destroying and disposing of certain perfluoroalkyl and polyfluoroalkyl substances (PFAS) and PFAS-containing materials for public comment.  85 Fed. Reg. 83554.  The interim guidance outlines the current state of the science on techniques and treatments that may be used to destroy or dispose of PFAS and PFAS-containing materials from non-consumer products, including aqueous film-forming foam for firefighting.  According to EPA’s December 18, 2020, press release, the interim guidance assembles and consolidates information in a single document that generally describes thermal treatment, landfill, and underground injection technologies that may be effective in the destruction or disposal of PFAS and PFAS-containing materials.  To help ensure informed decision-making, the technology-specific information describes uncertainties and how those uncertainties should be weighed given situation-specific factors, such as the waste’s physical phase (liquid, solid, gas).
 
As required by the National Defense Authorization Act for Fiscal Year 2020 (FY20 NDAA), the interim guidance addresses PFAS and PFAS-containing materials including:

  • Aqueous film-forming foam (for firefighting);
  • Soil and biosolids;
  • Textiles, other than consumer goods, treated with PFAS;
  • Spent filters, membranes, resins, granular carbon, and other waste from water treatment;
  • Landfill leachate containing PFAS; and
  • Solid, liquid, or gas waste streams containing PFAS from facilities manufacturing or using PFAS.

EPA notes that the interim guidance is not intended to address destruction and disposal of PFAS-containing consumer products, such as non-stick cookware and water-resistant clothing.  EPA is also providing guidance on testing and monitoring air, effluent, and soil for releases near potential destruction or disposal sites.  The interim guidance captures the significant information gaps associated with PFAS testing and monitoring and identifies specific research needs to address the FY20 NDAA requirements.  Comments are due February 22, 2021.

Tags: PFAS, Guidance

 

By Lynn L. Bergeson and Carla N. Hutton
 
On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule.  According to EPA, the proposed rule “reflects real-world situations, narrows the broad scope of current requirements, significantly reduces the burden on American businesses, and increases the flexibility for surrounding TSCA fees requirements.”  Under TSCA, EPA collects fees from chemical manufacturers and processors to help fund implementation to ensure that public health and the environment continue to be protected.  TSCA requires EPA to review its fees every three years and, after consulting with parties potentially subject to the fees, to adjust the fees if necessary.  The proposed updates include:

  • Narrowing the scope of the TSCA fees rule by exempting importers of articles containing a chemical substance, companies that produce a chemical as a byproduct or manufacture or import as an impurity, companies that produce a chemical in de minimis amounts, companies that use chemicals solely for research and development (R&D) purposes, and companies that manufacture a chemical that is produced as a non-isolated intermediate from fees;
     
  • Using cost data gathered over the past two years, instead of estimates, to update the fee calculations;
     
  • Ensuring fees are fairly and appropriately shared across companies by proposing a production-volume based fee allocation and including export-only manufacturers for EPA-initiated risk evaluations;
     
  • Allowing for corrections to be made to the list of manufacturers subject to fees for EPA-initiated risk evaluations after the final list is published, ensuring the accuracy of the list;
     
  • Increasing flexibility for companies by extending the amount of time to form consortia to share in fee payments;
     
  • Ensuring that EPA can fully collect fees and enabling companies to prepare better for paying fees by allowing payments in installments for EPA-initiated and manufacturer-requested risk evaluations; and
     
  • Adding new fee categories associated with new chemicals activities.

Comments will be due 45 days after EPA publishes the proposed rule in the Federal Register.  More information will be available in a forthcoming memorandum that will be posted on our website.


 
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