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 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.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) published a proposed rule on September 28, 2021, that would codify the definition of “parent company” for purposes of reporting to the Toxics Release Inventory (TRI). 86 Fed. Reg. 53577. Although the existing regulation requires a facility reporting to TRI to identify its parent company in annual reporting forms, no codified definition of this data element exists. EPA states that a codified definition of parent company would allow it to address various corporate ownership scenarios explicitly and reduce the reporting burden caused by regulatory uncertainty. The proposed rule would clarify existing regulations to reporting facilities and add a foreign parent company data element, if applicable, while improving data quality. The proposed rule addresses the following ownership scenarios:

  • A facility is owned by a single company that is not owned by another company;
  • A facility is owned by a single company that is owned by another company;
  • A facility is owned by multiple companies, including companies that are themselves owned by other entities;
  • A facility is owned by a joint venture or cooperative;
  • A facility is owned, at least in part, by a foreign company; and
  • A facility is owned by the federal government, or a state, tribal, or municipal government.

EPA also proposes to require facilities reporting to TRI to use standardized naming conventions for parent company reporting, as provided in the annual TRI Reporting Forms and Instructions (RFI), available as a downloadable Excel file (“Standardized Parent Company Names”) at http://www.epa.gov/tri/rfi. EPA states that these naming conventions address common formatting discrepancies, such as punctuation, capitalization, and abbreviations (for example, “Corp” for “Corporation”). Comments are due November 29, 2021. According to the notice, under the Paperwork Reduction Act, comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of comments by October 28, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On August 23, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on guidance on two petition processes applicable to the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) regulations. 86 Fed. Reg. 47102. The guidance covers petitions for full exemption of byproduct substances that are recycled or otherwise used within site-limited, physically enclosed systems and petitions for partial exemption of chemicals for which the CDR processing and use information has been determined to be of “low current interest” by EPA. EPA states that the guidance “is designed to elucidate the process and requirements of CDR-specific petitions and is consistent with both existing regulations and guidance.” The CDR regulations require manufacturers (including importers) of certain chemical substances included on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on the manufacturing, processing, and use of the chemical substances. According to EPA, the guidance identifies and clarifies examples of the types of information submitters can provide to EPA in support of petitions for full or partial exemption from CDR rule requirements. EPA expects the guidance to make the requirements and process of submitting a CDR-specific petition “more comprehensible,” enabling petitioners to determine if a petition is appropriate and to provide better a petition containing the information needed for EPA to reach a determination. Comments on the guidance are due December 21, 2021.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) is scheduled to publish a final rule on May 18, 2021, that will rescind the October 18, 2020, rulemaking that established procedures for issuing, modifying, withdrawing, and using guidance documents. According to the final rule, after consideration and review, “EPA has concluded that the internal rule on guidance deprives the EPA of necessary flexibility in determining when and how best to issue public guidance based on particular facts and circumstances, and unduly restricts the EPA's ability to provide timely guidance on which the public can confidently rely.” EPA states that it will continue to make Agency guidance available to the public at https://www.epa.gov. In addition, EPA will comply with all statutory obligations pertaining to posting documents for public accessibility. EPA will also continue its practice, as appropriate, of soliciting stakeholder input on guidance of significant stakeholder and public interest. EPA notes that consistent with the Administrative Procedure Act (APA), stakeholders may still petition EPA at any time regarding its regulatory programs, including requests to issue, amend, or repeal EPA guidance. The final rule will be effective when published in the Federal Register.


 

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 September 14, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication version of a final rule establishing the procedures and requirements for how EPA will manage the issuance of guidance documents consistent with Executive Order (EO) 13891, “Promoting the Rule of Law Through Improved Agency Guidance Documents.”  The final regulation provides a definition of guidance document for the purposes of this rule, establishes general requirements and procedures for certain guidance documents issued by EPA, and incorporates additional requirements for guidance documents determined to be significant guidance.  EPA notes that the regulation, consistent with the EO, also provides procedures for the public to petition for the modification or withdrawal of active guidance documents as defined by the rule or to petition for the reinstatement of a rescinded guidance document.  EPA states that the regulation is intended to increase the transparency of its guidance practices and improve the process used to manage its guidance documents.  The final rule will be effective 30 days after publication 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 February 28, 2020, the U.S. Environmental Protection Agency (EPA) announced that, in support of President Trump’s (R) Executive Order to promote transparency, EPA launched a new guidance portal that provides public access to its guidance documents.  According to EPA, the new searchable database will make it easier for the regulated community to find and follow agency guidance.  On October 9, 2019, President Trump issued Executive Order 13891, Promoting the Rule of Law Through Improved Agency Guidance Documents, to promote transparency by ensuring that all active guidance documents are made available to the public.  The portal provides an indexed database that allows the public to search for documents based on a range of criteria that include date of issuance, general subject matter, and summary of contents.  EPA states that prior to the launch of the portal, it conducted an exhaustive review of its current guidance documents and withdrew those documents that it determined to be no longer relevant.  The guidance portal provides a mechanism for the public to request modification or withdrawal of any documents.  EPA notes that it uses guidance documents “to clarify existing obligations for interested parties, but not as a vehicle for implementing new, binding requirements on the public.”  According to EPA, it will release by August 28, 2020, a regulation that establishes the processes and procedures for issuance of new guidance documents.

 

Try our new TSCA Tutor™ online e-training platform, offering expert, efficient, essential TSCA training.


 

By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Molly R. Blessing

Bergeson & Campbell, P.C. (B&C®) will present a webinar regarding confidential business information (CBI) as related to chemical regulation on September 18, 2018.  Register for “TSCA Confidential Business Information and Generic Naming: Analyzing the New Rules” online.  This webinar is part of the 2018 Chemical Policy Summit Series presented by B&C and Bloomberg Next.

On June 21, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended to “assist companies in creating structurally descriptive chemical names for chemical substances whose specific chemical identities are claimed confidential, for purposes of protecting the specific chemical identities from disclosure while describing the chemical substances as specifically as practicable, and for listing substances on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory.”  EPA states that the guidance, Guidance for Creating Generic Names for Confidential Chemical Substance Identity Reporting under the Toxic Substances Control Act, was developed in response to the requirement under new TSCA Section 14(c)(4) that EPA “develop guidance regarding – (A) the determination of structurally descriptive generic names, in the case of claims for protection from disclosure of specific chemical identity…” and the requirement under new TSCA Section 14(c)(1)(C) that submitters who assert a confidentiality claim for a specific chemical identity must include a structurally descriptive generic name developed consistent with EPA guidance.  The guidance updates and replaces the 1985 guidance published in the TSCA Inventory, 1985 Edition (Appendix B: “Generic names for Confidential Chemical Substance Identities”).  EPA states that, also consistent with Sections 14(c)(4) and 14(c)(1)(C), EPA will be reviewing generic names upon receipt in TSCA filings where chemical identity is claimed as confidential for consistency with the guidance.  EPA encourages companies to consult the Agency’s Office of Pollution, Prevention, and Toxics (OPPT) if they feel that it will be necessary to mask more than one structural element of a specific chemical name to mask a confidential chemical identity.  More information on this guidance is available in our full memorandum


 

By Lynn L. Bergeson and Carla N. Hutton

On June 22, 2018, the U.S. Environmental Protection Agency (EPA) announced that it has met its statutory responsibilities under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) to release guidance and policy on confidential business information (CBI), a strategy to reduce animal testing, and a final mercury reporting rule.  As noted in our June 29, 2016, memorandum, “TSCA Reform:  EPA Publishes First Year Implementation Plan,” the Lautenberg Act included mandatory actions for EPA to complete by June 22, 2018, two years after former President Barack Obama signed the Act, which significantly amended the Toxic Substances Control Act (TSCA).  EPA lists the following milestones that it has completed at the two-year anniversary:

In addition, registration is still available for Bergeson & Campbell, P.C.‘s (B&C®) June 25, 2018, complimentary webinar, “TSCA at 2: An Update on Implementation and Hot Topics.”  Speakers will include:

  • Nancy B. Beck, Ph.D., DABT®, Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention, EPA;
  • Misty L. Bogle, Global Product Stewardship Manager, Vertellus;
  • Michael Gould, EH&S Committee Chairman, RadTech North America; and
  • Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C.

More information on these developments will be available in our forthcoming memorandum and posted to our Recent Regulatory Developments web page, as well as in our subsequent TSCA blog items.


 

By Lynn L. BergesonCharles M. Auer, and Carla N. Hutton

On June 20, 2018, the U.S. Environmental Protection Agency (EPA) issued guidance intended “to improve transparency with the public and with companies seeking Agency review of their new chemical substances under the Toxic Substances Control Act (TSCA).”  EPA states that the guidance, entitled Points to Consider When Preparing TSCA New Chemical Notifications, “promotes early engagement and communication, and enhances overall understanding of EPA’s technical review and analysis to better move chemicals through the evaluation process.”  EPA incorporated comments from a December 2017 public meeting and feedback received on a November 2017 draft of the document into its guidance.  EPA also issued a “Response to Comments Received on Points to Consider Posted for Comment November 2017.”  EPA states that it expects that use of the guidance will result in “more robust submissions.”  EPA encourages companies to contact its new chemicals program to set up a pre-submission (or “pre-notice”) meeting before submitting their premanufacture notices (PMN).  According to EPA, the pre-submission meeting is an opportunity to discuss the planned new chemical submission and to understand EPA’s approach to reviewing new chemicals for potential risks early in the process.

More information will be available in our detailed analysis to be issued in a memorandum later today and posted to our Recent Regulatory Developments web page.


 
 1 2 >