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) 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 February 22, 2022, the release of the updated Mercury Electronic Reporting (MER) application and compliance guide for calendar year 2021 data reporting. According to EPA, the updates make it easier to report information about the supply, use, and trade of mercury. The mercury rule applies to any person who manufactures (including imports) mercury or mercury-added products (including pre-assembled products that contain mercury-added components) or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides). This information is required to be submitted every three years using the online MER application, accessed through EPA’s Central Data Exchange (CDX).
 
EPA states that it updated the mercury inventory reporting rule compliance guide to reflect the new requirement to report pre-assembled products that contain mercury-added components, such as a watch with a mercury-added battery. According to EPA, the guide explains the requirements for manufacturers and importers to report information about the supply, use, and trade of mercury to EPA; provides an overview of the legal requirements; and describes how EPA intends to use the information it collects. Diagrams and examples are provided to help companies determine whether they must report information about mercury to EPA.
 
EPA updated the MER application to include a drop-down year list to allow users to report for previous reporting years and to make the system easier for EPA to maintain. According to EPA, the updated resources will help it carry out the statutory requirements to identify any manufacturing processes or products that intentionally add mercury and recommend actions to achieve further reductions in mercury use in the United States. This will further assist the United States in its implementation of the Minamata Convention on Mercury, a global treaty to protect human health and the environment from the adverse effects of mercury. The deadline to report 2021 data is July 1, 2022. More information on the mercury inventory reporting rule is available in our June 25, 2018, memorandum.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 2, 2022, that it is inviting small businesses, governments, and not-for-profit organizations to participate as Small Entity Representatives (SER) for a Small Business Advocacy Review (SBAR) Panel. The Panel will focus on EPA’s development of a rule that would require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) from certain persons who have manufactured (including imported) a PFAS in any year since January 1, 2011.
 
As reported in our June 11, 2021, memorandum, the fiscal year 2020 (FY2020) National Defense Authorization Act (NDAA) amended the Toxic Substances Control Act (TSCA) to add Section 8(a)(7), mandating that EPA promulgate a rule “requiring each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report certain information. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. EPA states that the proposed rule will help it better understand the sources and quantities of PFAS manufactured in the United States and support its research, monitoring, and regulatory efforts under the PFAS Strategic Roadmap. Comments on the proposed rule were due September 27, 2021.
 
EPA states that in response to public comments and additional information received during the comment period, it “is interested in convening an SBAR Panel.” The Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. According to EPA, the Panel members will ask a selected group of SERs to provide advice and recommendations on behalf of their companies, communities, or organizations to inform the Panel about the potential impacts of the proposed rule on small entities.
 
EPA seeks self-nominations directly from the small entities that may be subject to the rule requirements. Other representatives, such as trade associations that exclusively or at least primarily represent potentially regulated small entities, may also serve as SERs. Self-nominations must be received by February 16, 2022.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on January 24, 2022, the automatic addition of four per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) list. The Fiscal Year 2020 National Defense Authorization Act (NDAA) provides the framework for adding additional PFAS to the TRI each year. For TRI Reporting Year 2022 (reporting forms due by July 1, 2023), reporting is required for four additional PFAS. NDAA Section 7321(c) identifies certain regulatory activities that automatically add PFAS or classes of PFAS to the TRI beginning January 1 the following year, and EPA states that its development of a final toxicity value is one of the triggering actions. In April 2021, EPA issued a final toxicity value for perfluorobutane sulfonic acid (PFBS) and potassium perfluorobutane sulfonate; therefore, these substances have been added to TRI. According to EPA, PFBS-based compounds are replacement chemicals for perfluorooctane sulfonic acid (PFOS), a chemical that was voluntarily phased out by the primary U.S. manufacturer by 2002. PFBS has been identified in the environment and consumer products, including surface water, wastewater, drinking water, dust, carpeting and carpet cleaners, and floor wax.
 
EPA notes that it previously updated the Code of Federal Regulations with PFAS that were added to the TRI on January 1, 2021, pursuant to NDAA Section 7321(c) and their being regulated by an existing significant new use rule (SNUR) under the Toxic Substances Control Act (see 40 C.F.R. § 721.10536). EPA states that it has since determined that one additional PFAS, Chemical Abstracts Service Registry Number (CAS RN) 65104-45-2, is designated as “active” on the TSCA Inventory and is covered by the SNUR. Therefore, this substance has also been added to the TRI pursuant to the NDAA.
 
Additionally, under NDAA Section 7321(e), EPA must review confidential business information (CBI) claims before adding any PFAS to the TRI list whose identity is subject to a claim of protection from disclosure under 5 U.S.C. Section 552(a). EPA previously identified one PFAS, CAS RN 203743-03-7, for addition to the TRI list based on the NDAA’s provision to include certain PFAS upon the NDAA’s enactment (Section 7321(b)(1)); due to a CBI claim related to its identity, this PFAS was not included on the TRI list until EPA completed its review of the CBI claim. EPA included this PFAS in updates to the confidential status of chemicals on the TSCA Inventory published in October 2021, and thus added it to the TRI list due to the CBI declassification.
 
EPA states that as of January 1, 2022, facilities that are subject to reporting requirements for these chemicals should start tracking their activities involving these PFAS as required by Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA). Reporting forms for these PFAS will be due to EPA by July 1, 2023, for calendar year 2022 data.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On November 8, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule revising the regulations associated with persons who must report data to the mercury inventory established under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 61708. The revisions implement an order issued by the U.S. Court of Appeals for the Second Circuit on June 5, 2020, that vacated the exemption at 40 C.F.R. Section 713.7(b)(2) for persons who import pre-assembled products that contain a mercury-added component. As a result, such persons are now required to report pursuant to 40 C.F.R. Section 713.7(b). EPA states that the rule is effectuating the vacatur ordered by the Second Circuit by making necessary amendments to the corresponding text in 40 C.F.R. Section 713.7(b). The final rule will be effective on December 8, 2021. EPA states in its November 2, 2021, press release that the final rule “offers impacted communities adequate notice of the amended reporting requirements, as the deadline for reporting 2021 data is July 1, 2022.” EPA will update the mercury inventory reporting rule compliance guide and other supporting materials to reflect these new reporting requirements.
 
As reported in our June 25, 2018, memorandum, “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory,” the mercury rule and its reporting requirements apply to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process (including processes traditionally not subject to TSCA, such as for the manufacture of pharmaceuticals and pesticides).


 

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
 
The U.S. Environmental Protection Agency (EPA) announced on September 24, 2021, that it is extending the submission deadline for manufacturers (including importers) of 50 chemicals to report data from certain unpublished health and safety studies. The deadline for the reporting rule was originally September 27, 2021, and EPA has extended the deadline until December 1, 2021, for 20 of the 50 chemicals and to January 25, 2022, for 30 of the 50 chemicals. The 50 chemicals include:

  • Twenty chemicals designated by EPA as high-priority substances and currently undergoing risk evaluation under the Toxic Substances Control Act (TSCA). The deadline for manufacturers to submit studies on these chemicals will be December 1, 2021. EPA states that this deadline “ensures that health and safety studies will be received in time for use in risk evaluations on these chemical substances.”
     
  • Thirty organohalogen flame retardants being evaluated for health risks by the Consumer Product Safety Commission (CPSC) under the Federal Hazardous Substances Act (FHSA). The deadline for manufacturers to submit studies on these chemicals will be January 25, 2022.

EPA will publish a notice in the Federal Register extending the deadline. A pre-publication version of the notice is available on EPA’s website. EPA has also posted a “historic” question and answer document about reporting under TSCA Section 8(d). Detailed information about the reporting rule is available in our June 29, 2021, memorandum, “Manufacturers and Importers of 20 High-Priority Chemicals and 30 Organohalogen Flame Retardants Must Submit Data to EPA.”


 

Bergeson & Campbell, P.C. (B&C®) is pleased to offer the recording, slides, and written Question and Answer (Q&A) document from our “PFAS Reporting Rules -- What Every Company Needs to Know” webinar, focusing on the U.S. Environmental Protection Agency’s (EPA) proposed reporting rules for per- and polyfluoroalkyl substances (PFAS), presented by B&C Managing Partner Lynn L. Bergeson and Director of Chemistry Richard E. Engler, Ph.D.
 
Do you wonder if the PFAS reporting rules extend to domestically-produced articles? Or if businesses that incorporate PFAS into their products are required to notify the end users? Do you know whether you need to report your Low Volume Exemption (LVE) substance? We encourage you to view the webinar and read the additional materials to learn answers to these and other questions related to EPA’s recent PFAS actions.
 
We also encourage you to consider the following issues discussed in the webinar and to submit comments to EPA regarding how these will affect your operations:

  • Identifying chemicals subject to reporting (i.e., specific PFAS and whether to include imported articles);
  • Considerations for economic analysis;
  • Submission period;
  • Potential duplicative reporting concerns;
  • Scope of “existing environmental and health information” collected;
  • Additional data elements or information collected;
  • EPA’s use and publication of non-confidential business information (CBI);
  • Availability of joint submissions; and
  • Small manufacturer considerations (i.e., regulatory and non-regulatory assistance and outreach).

Comments on EPA’s proposed PFAS rules are due on September 27, 2021.
 
The recording and slides are available online. E-mail .(JavaScript must be enabled to view this email address) to request written answers to selected questions from the Q&A session of the webinar.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 24, 2021, for stakeholders to learn how to access and use the pollution prevention (P2) information collected by the Toxics Release Inventory (TRI) Program about projects implemented by companies to eliminate or reduce the creation of chemical waste. According to EPA, community members, local government representatives, facility personnel, and others can access this information through multiple online resources and use it to further the identification and advancement of P2 opportunities. The webinar will include a live demonstration of how to find P2 data for specific facilities, chemicals, and industry sectors, as well as:

  • Details on what data facilities are required to report;
  • Examples of P2 projects implemented at manufacturing facilities; and
  • Resources for and benefits of implementing P2 projects at facilities.

The webinar is also part of a series of webinars to mark the 35th anniversary of the TRI Program. Registration is now open.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On September 17, 2021, the U.S. Environmental Protection Agency (EPA) published a final rule amending the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 51823. Specifically, EPA is extending the compliance date applicable to the processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used to make those articles, from March 8, 2021, to March 8, 2022. For such articles, EPA states that it is also extending the compliance date for the recordkeeping requirements applicable to manufacturers, processors, and distributors from March 8, 2021, to March 8, 2022. According to EPA, the articles covered by the amendment “include a wide range of key consumer and commercial goods such as cellular telephones, laptop computers, and other electronic and electrical devices and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.” The final rule is effective September 17, 2021. More information on the final PIP (3:1) rule and on EPA’s plan for a new rulemaking on persistent, bioaccumulative, and toxic (PBT) chemicals is available in our September 3, 2021, memorandum, “EPA Plans New Rulemaking for PBTs, Extends Compliance Dates for PIP (3:1) Rule.”


 
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