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) filed a complaint with the Environmental Appeals Board on March 15, 2022, pursuant to Section 16(a) of the Toxic Substances Control Act (TSCA). According to the complaint, as the result of an EPA inspection of the Vorbeck Materials facility on June 20, 2019, and its follow-up actions, EPA alleges that Vorbeck has violated TSCA Section 12(b) and the Notice of Export rule requirements at 40 C.F.R. Part 707, Subpart D, thereby violating TSCA Section 15(3)(B). EPA notes that TSCA Section 12(b), and the regulations set forth at 40 C.F.R. Section 707.60, require any person who exports or intends to export a chemical substance or mixture for which a rule has been proposed or promulgated under TSCA Sections 5 or 6 to notify EPA of such exportation to a particular country. According to EPA, Vorbeck exported a carbon nanomaterial substance that is subject to a TSCA Section 5(e) consent order on one occasion to one country without prior notification to EPA as required by TSCA Section 12(b) and 40 C.F.R. Section 707.60, and as specified in 40 C.F.R. Sections 707.65 and 707.67. The complaint states that Vorbeck has claimed the identity of the carbon nanomaterial as TSCA confidential business information (CBI). Vorbeck has subsequently submitted a TSCA Section 12(b) export notification for the carbon nanomaterial.
 
Based upon the facts alleged in the complaint, and upon the nature, circumstances, extent, and gravity of the violations alleged, as well as Vorbeck’s ability to pay, effect on ability to continue to do business, any history of prior such violations of TSCA, the degree of culpability, and such other matters as justice may require, EPA proposed a penalty of $8,277 for the alleged violations. According to the April 19, 2022, final order of the Environmental Appeals Board, EPA received full payment of the penalty ($8,277), and the case is resolved.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit in the U.S. Court of Appeals for the District of Columbia against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA). As reported in our March 25, 2022, blog item, EPA announced on March 24, 2022, that it issued a second round of test orders under TSCA Section 4 to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. The VI seeks judicial review of the test order under federal law, including but not limited to the Administrative Procedure Act (APA), TSCA, and EPA’s regulations promulgated thereunder. The VI seeks a determination that, inter alia, the test order violates these authorities; is arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with the law; is in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; is without observance of procedure required by law; is unsupported by substantial evidence; and is otherwise contrary to law. The VI asks that the court hold unlawful, vacate, enjoin, set aside, and remand the test order.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 24, 2022, that it is extending the public comment period for the April 12, 2022, proposed rule that would prohibit ongoing uses of chrysotile asbestos to give stakeholders more time to review the proposed regulation and prepare comments. EPA is extending the comment period an additional 30 days, from June 13, 2022, to July 13, 2022.
 
As reported in our April 7, 2022, memorandum, the proposed rule would ban chrysotile asbestos, the only known form of asbestos that is currently imported into the United States and is found in products like asbestos diaphragms used by the chlor-alkali industry, sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets also imported into the United States. EPA also proposed targeted disposal and recordkeeping requirements in line with industry standards, Occupational Safety and Health Administration (OSHA) requirements, and the Asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP). The proposed disposal and recordkeeping requirements would take effect 180 days after the effective date of the final rule.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. In April 2022, EPA issued corrections to the following test orders:

  • 1,1,2-Trichloroethane: EPA amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to 1,1,2-trichloroethane. Appendix D only explains the process for identifying order recipients. EPA states that this correction does not change the obligations that apply to manufacturers and processors of 1,1,2-trichloroethane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,1,2-trichloroethane.
     
  • 1,2-Dichloroethane: EPA amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to 1,2-dichloroethane. Appendix D only explains the process for identifying order recipients. EPA states that the correction does not change the obligations that apply to manufacturers and processors of 1,2-dichloroethane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,2-dichloroethane.
     
  • 1,2-Dichloropropane: EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to 1,2-dichloropropane. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of 1,2-dichloropropane, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of 1,2-dichloropropane.
     
  • 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA): EPA states that it amended the list of recipients to replace INEOS USA LLC with INEOS Enterprises US Holdco LLC. The effective date for INEOS Enterprises US Holdco LLC is five days after April 20, 2022, the date the memorandum was signed. The effective date for the companies listed in the original order issued on March 24, 2022, will remain March 29, 2022. EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to TBBPA. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of TBBPA, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of TBBPA.
     
  • o-Dichlorobenzene: EPA amended Appendix D -- Order Recipient Selection. EPA states that Appendix D referred to p-dichlorobenzene, although it should have referred to o-dichlorobenzene. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of o-dichlorobenzene, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of o-dichlorobenzene.
     
  • Phosphoric acid, triphenyl ester (TPP): EPA amended the list of recipients to replace Axalta Coating Systems LLC with ChemSpec Ltd. The effective date for ChemSpec Ltd is five days after April 20, 2022, the date the memorandum was signed. The effective date for the companies listed in the original order issued on March 24, 2022, will remain as March 29, 2022. EPA also amended Appendix D -- Order Recipient Selection. According to EPA, Appendix D referred to p-dichlorobenzene, although it should have referred to TPP. Appendix D only explains the process for identifying order recipients. The correction does not change the obligations that apply to manufacturers and processors of TPP, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of TPP.
     
  • Trans-1,2-dichloroethylene: EPA amended the list of recipients to add the companies listed below. The effective date for the order for these companies will be five days after April 20, 2022, when the modification was signed. The effective date of the order for the companies listed in the March 24, 2022, order will also have the effective date of five days from April 20, 2022, when the modification was signed (i.e., both the companies listed below and the companies in the order signed on March 24, 2022, for trans-1,2-dichloroethylene will have an effective date five days after April 20, 2022, the date the memorandum was signed):
    • Chemical Compounding Co;
    • Dow Inc;
    • MicroCare LLC;
    • Occidental Chemical Holding Corp;
    • Olin Corp; and
    • Versum Materials Inc.

EPA amended Appendix D -- Order Recipient Selection. Appendix D referred to p-dichlorobenzene, although it should have referred to trans-1,2-dichloroethylene. Appendix D only explains the process for identifying order recipients. EPA states that the correction does not change the obligations that apply to manufacturers and processors of trans-1,2- dichloroethylene, pursuant to TSCA Section 4(a)(2). EPA identified the recipients of the order through those sources related to manufacturers and processors of trans-1,2-dichloroethylene.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 18, 2022, that it will hold a webinar on May 11, 2022, entitled “Data-Driven Solutions to Reducing Animal Use in Ecotoxicity.” Speakers will include:

  • Carlie LaLone, Ph.D., EPA Office of Research and Development (ORD), on “The Sequence Alignment to Predict Across Species Susceptibility (SeqAPASS) Tool: Extrapolating Knowledge Computationally.” EPA states that regulatory decision-making for chemical safety relies upon toxicity data generated from laboratory test species for the protection of wildlife in the environment. Typically, ecological risk assessments integrate safety factors to account for interspecies variability. According to EPA, the SeqAPASS tool is a more informed way to extrapolate knowledge from model species to other species that does not require the use of animals in toxicity testing and instead uses existing protein sequence knowledge. LaLone will describe EPA’s SeqAPASS tool and its applications for cross-species extrapolation relative to understanding conservation of biology and predicting chemical susceptibility.
     
  • Michael Lowit, Ph.D., EPA Office of Pesticide Programs (OPP), on “Exploring Potential Reductions in Fish Testing in a Regulatory Context.” According to EPA, as part of its commitment to reducing animal testing, OPP is conducting retrospective analyses of existing data to evaluate critically which EPA guideline studies form the basis of regulatory decisions. EPA states that the results from these analyses can inform if reductions can be made to the number of animals used without reducing the quality of ecological risk assessments. EPA is currently conducting a retrospective analysis for fish acute toxicity tests, which are used by OPP to assess potential risk to fish species from pesticides. For each pesticide, EPA typically requires in vivo testing of three different fish species. Lowit will focus on the relative sensitivity among species subjected to in vivo fish acute toxicity studies. The results of this analysis will inform whether there is a basis for reducing the number of species while providing sufficient information to support pesticide registration decisions.

The webinar is co-organized by the People for the Ethical Treatment of Animals (PETA) Science Consortium International, EPA, and the Physicians Committee for Responsible Medicine (PCRM). EPA notes that it does not necessarily endorse the views of the speakers. Registration is now open.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) proposed on April 12, 2022, to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. 87 Fed. Reg. 21706. EPA proposes under Section 6(a) of the Toxic Substances Control Act (TSCA) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA proposes that these prohibitions take effect two years after the effective date of the final rule. EPA also proposes to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products (not including the National Aeronautics and Space Administration (NASA) Super Guppy Turbine aircraft use), and other chrysotile asbestos-containing gaskets. EPA proposes that these prohibitions take effect 180 days after the effective date of the final rule. EPA further proposes to prohibit manufacture (including import), processing, and distribution in commerce of: aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. EPA proposes that these prohibitions take effect 180 days after the effective date of the final rule. EPA also proposes disposal and recordkeeping requirements under which regulated parties would document compliance with certain proposed prohibitions. Comments on the proposed rule are due June 13, 2022. A detailed analysis of the proposed rule is available in our April 7, 2022, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 24, 2022, that it has issued a second round of test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on eight of the next 20 chemicals undergoing risk evaluation. EPA states that after reviewing reasonably available data on these chemicals, it determined additional data are needed and is using its TSCA test order authority to require companies to develop and submit information on avian and aquatic environmental hazard and consumer exposure. The chemicals are:

  • Chlorinated Solvents:
    • 1,1,2-Trichloroethane;
    • 1,2-Dichloroethane;
    • 1,2-Dichloropropane;
    • Trans-1,2-Dichloroethylene;
    • o-Dichlorobenzene; and
    • p-Dichlorobenzene;
  • Flame Retardants:
    • 4,4ʹ-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA); and
    • Phosphoric acid, triphenyl ester (TPP).

According to EPA, this is the third time it has used its new authority to issue test orders under Section 4 of amended TSCA. As reported in our January 15, 2021, blog item, in January 2021, EPA issued test orders for nine chemicals -- the eight chemicals above plus 1,1-dichloroethane -- requiring testing on aquatic environmental hazard and inhalation and dermal exposures for workers. EPA states that the information obtained through the orders will help ensure that its risk evaluations are “robust, credible, and use the best available data.”
 
EPA has posted a document describing the process of developing, drafting, and issuing Section 4 test orders. Companies subject to test orders may provide EPA with existing data, if available, or may conduct new tests. EPA states that companies are “encouraged to form consortia to consolidate costs and burden and avoid unnecessary duplication of testing.”


 
By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 8, 2022, that it is planning to consolidate several Information Collection Requests (ICR) covering reporting and recordkeeping activities under Section 8 of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12954. Before submitting the consolidated ICR to the Office of Management and Budget (OMB) for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection. The consolidated ICR is entitled “Reporting and Recordkeeping Under Section 8 of the Toxic Substances Control Act (TSCA)” and is identified under EPA ICR No. 2703.01 and OMB Control No. 2070-[NEW]. According to EPA, it intends to streamline the presentation of the paperwork burden estimates for these various activities and eliminate any duplication, which in turn is expected to reduce the administrative burden for both the public reviewers and EPA. EPA’s Supporting Statement summarizes the currently approved ICRs that would be consolidated in the new ICR:
  • TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR): Under TSCA Section 8(a), persons who manufacture or import chemical substances listed at 40 C.F.R. Section 712.30 are subject to the Section 8(a) PAIR requirements. These manufacturers and importers must submit information about production, use, and/or exposure-related data. Certain specific chemical testing and reporting requirements under 40 C.F.R. Part 766 Subpart B that are very similar to the PAIR requirements are also covered within this information collection activity.
     
  • Chemical-Specific Rules, TSCA Section 8(a): Under TSCA Section 8(a), persons who manufacture, import, or process certain chemical substances or mixtures, or propose to manufacture, import, or process certain chemical substances or mixtures, are subject to chemical-specific rules promulgated under TSCA Section 8(a). A chemical-specific Section 8(a) rule requires more detailed and more types of information than is required by a PAIR rule. Any chemical covered by TSCA for which the Office of Pollution Prevention and Toxics (OPPT), other EPA offices, or another federal agency has a reasonable need for information, and that cannot be satisfied via readily available sources or by use of other rulemakings, is a proper potential subject for a chemical-specific TSCA Section 8(a) rulemaking.
     
  • Recordkeeping and Reporting Requirements for Allegations of Significant Adverse Reactions to Human Health or the Environment: Under TSCA Section 8(c), persons who manufacture, import, process, or distribute in commerce any chemical substance or mixture must keep records of significant adverse reactions to health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. TSCA Section 8(c) requires that allegations of adverse reactions to the health of employees be kept for 30 years, and all other allegations be kept for five years. The rule also prescribes the conditions under which a firm must submit or make the records available to a duly designated representative of the Administrator.
     
  • Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies: Under TSCA Section 8(d), certain persons, who manufacture, import, process, or distribute in commerce (or propose to manufacture, import, process, or distribute in commerce) chemical substances and mixtures, are required to submit to EPA lists and copies of health and safety studies in their possession that relate health and/or environmental effects of the chemical substances and mixtures.
Comments are due May 9, 2022.

 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 4, 2022, the availability of the latest Toxic Substances Control Act (TSCA) Inventory. EPA states that the biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA plans the next regular update of the Inventory for summer 2022. According to EPA, the Inventory contains 86,631 chemicals, of which 42,039 are active in U.S commerce. Other updates include new chemical substance additions, commercial activity data and regulatory flags, such as polymer exemptions, TSCA Section 4 test orders, and TSCA Section 5 significant new use rules (SNUR). EPA notes that on October 15, 2021, it announced a list of 377 specific chemical identities that were expected to lose their confidential status and move to the public portion of the Inventory. According to EPA, these 377 are listed in this public Inventory posting by their specific chemical identities.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On February 25, 2022, the U.S. Environmental Protection Agency (EPA) announced that it is revoking the 1980 guidelines and associated procedures for correcting the specific chemical identities of incorrectly described chemical substances submitted to EPA in 1978 using the original reporting form for inclusion on the Toxic Substances Control Act (TSCA) Inventory. 87 Fed. Reg. 10781. EPA states that it is providing a final opportunity to use the 1980 guidelines and form to request corrections of Inventory listings to address errors with the chemical identities submitted in the original reporting forms. The regulated community will have until April 26, 2022, to submit any final Inventory corrections. EPA also announced the discontinuation of the related form and associated approval of the collection activities under the Paperwork Reduction Act (PRA). The revocation will be effective May 31, 2022. All final Inventory corrections must be received on or before April 26, 2022.
 
After April 26, 2022, EPA does not intend to accept requests to correct original Inventory reporting forms. If, after April 26, 2022, a person discovers for any reason an error in the specific chemical identity of a chemical substance submitted on an original Inventory reporting form, a premanufacture notice (PMN) or exemption notice may need to be filed if the chemical substance is not already listed on the TSCA Inventory.
 
EPA notes that this action does not impact its authority for initiating, at its discretion, corrections to the Inventory should EPA determine on its own that, for example, a chemical substance listed on the Inventory has been unintentionally misidentified. EPA states that only in this situation will it, at its discretion, request and accept documentation from a company to support an Inventory correction in lieu of requiring a PMN or exemption notice. This action also does not impact EPA’s regular maintenance of the Inventory that can include nomenclature updates and correcting minor errors to listings.
 
EPA’s unilateral decision seems ill-considered and unwise. At the least, EPA should seek comment from the TSCA stakeholder community to inform its judgment.


 
 1 2 3 >  Last ›