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
 
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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On December 16, 2020, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft compliance guide that outlines which imported articles are covered by EPA’s July 2020 final significant new use rule (SNUR) that prohibits companies from manufacturing, importing, processing, or using certain long-chain per- and polyfluoroalkyl substances (PFAS) without prior EPA review and approval.  85 FR 81466.  The draft guide will be “the official compliance guide for imported articles that may contain long-chain perfluoroalkyl carboxylate chemical substances as part of a surface coating.”  Specifically, the guide provides additional clarity on what is meant by a “surface coating,” identifies which entities are regulated, describes the activities that are required or prohibited, and summarizes the notification requirements of the final SNUR.  More information on the draft compliance guide is available in our December 14, 2020, memorandum, “EPA Publishes Draft Compliance Guide Addressing Surface Coatings under PFAS SNUR.”  Comments on the draft guide are due January 15, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On December 14, 2020, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for perchloroethylene.  The final risk evaluation determined that there are unreasonable risks to workers, occupational non-users (ONU), consumers, and bystanders from 59 out of 61 conditions of uses:

  • Consumers and Bystanders:  EPA found unreasonable risks to consumers and bystanders from all consumer uses of perchloroethylene.  Common consumer uses include as a dry cleaning solvent; in cleaning and furniture care products; automotive care products like brake cleaners, lubricants, and greases; and adhesives in arts and crafts.  The risk to consumers from perchloroethylene’s use in dry cleaning is from short-term skin exposure to items cleaned with perchloroethylene; and
     
  • Workers and ONUs:  EPA found unreasonable risks to workers from all but two occupational uses of perchloroethylene.  Additionally, EPA found unreasonable risks from most commercial uses of perchloroethylene to workers nearby but not in direct contact with perchloroethylene (known as ONUs).  This includes an unreasonable risk to workers and ONUs when domestic manufacturing or importing perchloroethylene; processing as a reactant and intermediate; incorporation into cleaning and degreasing products; uses in a variety of industrial and commercial applications such as degreasing, dry cleaning, in adhesives and sealants, and in paints and coatings; and disposal.  The primary health risk identified in the final risk evaluation is neurological effects from short- and long-term exposure to perchloroethylene.  The conditions of use in the final risk evaluation 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 next step in the process required by the Toxic Substances Control Act (TSCA) is developing a plan to address the unreasonable risks identified in the final risk evaluation.  EPA states that it “is moving immediately to risk management for this chemical and will work as quickly as possible to propose and finalize actions to protect against the unreasonable risks.”  Potential actions EPA could take to address these risks include regulating how perchloroethylene is used or limiting or prohibiting the manufacture, processing, distribution in the marketplace, use, or disposal of perchloroethylene, as applicable.  EPA notes that as with any chemical product, it “strongly recommends that users of products containing perchloroethylene continue to carefully follow all instructions on the product’s label and safety data sheet.”  More information 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 November 30, 2020, that it is inviting small businesses, governments, and not-for-profits 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 carbon tetrachloride.  As reported in our November 4, 2020, memorandum, EPA reviewed 15 conditions of use, “all of which are associated with industrial and commercial work and primarily involve the manufacturing of other chemicals.”  EPA found unreasonable risks to workers and occupational non-users (ONU) for 13 of the 15 conditions of use.  EPA found no unreasonable risks to the environment.  According to EPA, there are no consumer uses of this chemical.  The second Panel will focus on a risk management rulemaking for trichloroethylene (TCE).  As reported in our November 24, 2020, memorandum, of the 54 conditions of use that EPA reviewed, EPA found that 52 present an unreasonable risk to workers, ONUs, consumers, and bystanders.  EPA determined that distribution in commerce and consumer use of TCE in pepper spray do not present an unreasonable risk.  EPA also found no unreasonable risks to the environment.  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 company, community, or organization 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 December 14, 2020.

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) announced on December 8, 2020, that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM).  According to EPA, OTNE is used as a fragrance ingredient, and the four chemicals were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.
 
EPA states that it “worked diligently with the manufacturers to ensure this request was high-quality, complete, and met all the necessary legal requirements.”  Two chemicals in the category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, and EPA describes this request for a manufacturer-requested risk evaluation as “part of EPA’s overall efforts to address PBTs.”
 
Within 15 business days of receiving a facially complete request, EPA must notify the public of receipt of the request under 40 C.F.R. Section 702.37(e)(2).  Within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment.  The docket will contain the manufacturer request, EPA’s proposed additions of conditions of use, and the basis for those proposed additions.  During the public comment period, the public may comment on the request, as well as the additional conditions of use EPA proposes for inclusion.  After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection (EPA) will hold a webinar on December 10, 2020, to educate stakeholders on the risk management process under the Toxic Substances Control Act (TSCA) and the findings in the final risk evaluation for carbon tetrachloride.  The webinar will also provide an opportunity for the public to provide input on considerations EPA should take into account for managing these unreasonable risks.  Registration is open.  Stakeholders who would like to provide oral comments must register by December 8, 2020, at 1:00 p.m. (EST).  As reported in our November 4, 2020, memorandum, “Final Risk Evaluation for Carbon Tetrachloride Finds Unreasonable Risks to Workers and Occupational Non-Users,” EPA reviewed 15 conditions of use, “all of which are associated with industrial and commercial work and primarily involve the manufacturing of other chemicals.”  EPA found unreasonable risks to workers and occupational non-users (ONU) for 13 of the 15 conditions of use.  EPA found no unreasonable risks to the environment.  According to EPA, there are no consumer uses of this chemical.
 
On December 15, 2020, EPA will hold a webinar on the findings in the final risk evaluation for trichloroethylene (TCE)Registration is open, and stakeholders who would like to provide oral comments must register by December 11, 2020, at 5:00 p.m. (EST).  As reported in our November 24, 2020, memorandum, “EPA Evaluates 54 Conditions of Use for TCE, Finding That 52 Present an Unreasonable Risk,” of the 54 conditions of use that EPA reviewed, EPA found that 52 present an unreasonable risk to workers, ONUs, consumers, and bystanders.  EPA determined that distribution in commerce and consumer use of TCE in pepper spray do not present an unreasonable risk. EPA also found no unreasonable risks to the environment.


 

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.”


 
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