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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By Lynn L. Bergeson, Kathleen M. Roberts, and Carla N. Hutton

On April 25, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would amend the Toxic Substances Control Act (TSCA) Section 8(a) Chemical Data Reporting (CDR) requirements and the TSCA Section 8(a) size standards for small manufacturers.  84 Fed. Reg. 17692.  The current CDR rule requires manufacturers (including importers) of certain chemical substances listed on the TSCA Chemical Substance Inventory (TSCA Inventory) to report data on chemical manufacturing, processing, and use every four years.  EPA is proposing several changes to the CDR rule to make regulatory updates to align with new statutory requirements of TSCA, improve the CDR data collected as necessary to support the implementation of TSCA, and potentially reduce the burden for certain CDR reporters.  Proposed updates to the definition for small manufacturers, including a new definition for small governments, are being made in accordance with TSCA Section 8(a)(3)(C) and impact certain reporting and recordkeeping requirements for TSCA Section 8(a) rules, including CDR.  EPA states that the definitions may reduce the burden on chemical manufacturers by increasing the number of manufacturers considered small.  Overall, according to EPA, the regulatory modifications may better address EPA and public information needs by providing additional information that is currently not collected; improve the usability and reliability of the reported data; and ensure that data are available in a timely manner.  Comments are due by June 24, 2019.  More information on the proposed rule is available in our full memorandum.

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By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

On April 23, 2019, the U.S. Environmental Protection Agency (EPA) issued a proposed rule regarding its plan to review certain confidential business information (CBI) claims to protect the specific chemical identities of substances on the confidential portion of the Toxic Substances Control Act (TSCA) Inventory.  84 Fed. Reg. 16826.  The CBI claims that would be reviewed under this plan are those that were asserted on Notice of Activity (NOA) Form A’s filed in accordance with the requirements in the Active-Inactive rule.  Comments are due June 24, 2019.  See the full memorandum for more information on the proposed rule. 

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By Lynn L. Bergeson, Charles M. Auer, Richard E. Engler, Ph.D., and Carla N. Hutton

The U.S. Environmental Protection Agency (EPA) issued on October 16, 2018, a proposed rule that would establish significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN).  83 Fed. Reg. 52179.  The proposed rule is significant.  Unlike other recent SNURs (i.e., those enacted since entry into force of amended TSCA), the 13 chemical substances are not also subject to consent orders.  For this reason, the preamble contains novel language to address the new circumstances and legal issues encountered in the proposed rule.  The proposed SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of the 13 chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.  The required notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence the manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.  Comments on the proposed SNURs are due November 15, 2018.

Please see the full memorandum for more information on the proposed rule and an illuminating commentary.

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By Lynn L. Bergeson and Margaret R. Graham

On December 19, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice extending the comment period for the proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory for 16 days, from December 26, 2017, to January 11, 2018.  The notice states that “EPA received requests to extend the comment period and believes it is appropriate to do so … to give stakeholders additional time to assess the impacts of the proposal, review technical documents in the docket, and prepare comments.  The 2016 amendments TSCA require EPA to establish periodic mercury reporting requirements for any person that manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process to assist in the development of an inventory of mercury and other recommended actions.  EPA’s proposed rule, issued on October 26, 2017 (82 Fed. Reg. 49564), specifically requires reporting on the manufacture, import, distribution in commerce, storage, and export of mercury.  

More information on this proposed rule is available in our memorandum December 26, 2017, Deadline Approaching for Comments on EPA’s Proposed Reporting Requirements for TSCA Mercury Inventory.

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By Lynn L. Bergeson and Margaret R. Graham

On October 26, 2017, the U.S. Environmental Protection Agency (EPA) published in the Federal Register a proposed rule on reporting requirements for the Toxic Substances Control Act (TSCA) mercury inventory.  82 Fed. Reg. 49564.  Under TSCA Section 8(b)(10)(B), the mercury inventory, which includes mercury “supply, use, and trade” in the United States, is required to be published every three years.  Information on the 2017 mercury inventory report is available in our blog item "EPA Releases Inventory Report of Mercury Supply, Use, and Trade in the U.S."

Through this proposed rule, EPA is on its way to delivering timely on its mandate under TSCA Section 8(b)(10)(D) to promulgate a rule within two years of the enactment of new TSCA (by June 22, 2018) that will require “any person who manufactures [including import] mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process” to make periodic reports to EPA to assist in the preparation of the mercury inventory. 

TSCA Section 8(b)(10)(C) further directs to “identify any manufacturing processes or products that intentionally add mercury; and … recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use.”  The proposed rule, however, states that “[a]t this time, EPA is not making such identifications or recommendations.” 

The proposed rule requests comments on several changes, including:

• On the proposed limited data collection requirements, such as the identification of countries that manufacture, import, or export mercury-added products (i.e., countries of origin and destination), as well as the identification of purchasing or receiving industry sectors via North American Industrial Classification System (NAICS) codes, to inform activities under the Minamata Convention on Mercury;
• On whether to require one-time reporting for exports of the mercury compounds prohibited from export under TSCA Section 12(c)(7);
• On its proposal to apply the proposed reporting requirements to any person who manufactures (including imports) mercury, mercury-added products or otherwise intentionally uses mercury in a manufacturing process regardless of the amount of mercury at issue;
• On its proposal that because of the similarities in the intentional addition of mercury to manufacture a product and otherwise intentional use of mercury in a manufacturing process, all quantities of mercury used in both activities should be reported without a reporting threshold;
• On what kinds of information would be particularly important to address for small entities if EPA were to develop compliance guides tailored to small entities that will be required to comply with the reporting requirements;
• On whether the proposed reporting requirements should apply to persons who do not manufacture or import mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, but engage in the supply, use, and trade of mercury in the United States; and
• On its proposal to require mandatory electronic reporting.

EPA also requests comments on the proposed timelines and reporting deadlines; and on the proposed interpretations of activities to be considered as part of supply, use, and trade of mercury in the United States -- as described below.

For those who will need to report, EPA proposes the following reporting periods and deadlines:

• The 2020 reporting year will be from January 1 to December 31, 2018; subsequent recurring reporting years will be from January 1 to December 31 at three-year intervals beginning in 2021;
• All information reported for an applicable reporting year must be submitted on or before the first day of July following the reporting year.  The 2020 submission deadline is July 1, 2019; subsequent recurring submission deadlines are from July 1, in three-year intervals, beginning in 2022.

EPA’s proposed interpretations of activities to be considered as part of the supply, use, and trade of mercury in the United States are as follows:

• Import of mercury or a mercury added product with the purpose of obtaining an immediate or eventual commercial advantage for the importer, except where such mercury is generated as a byproduct not used for commercial purposes or an impurity.
• Manufacture (other than import) of mercury or a mercury-added product with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer, except where such mercury is generated as a byproduct not used for commercial purposes or an impurity. In this context, EPA considers manufacture to be the intentional production of mercury, a mercury compound, or a mercury-added product.
• Otherwise intentional use of mercury in a manufacturing process, other than the manufacture of a mercury compound or a mercury-added product, with the purpose of obtaining an immediate or eventual commercial advantage for the user, except where such mercury is generated as a byproduct not used for commercial purposes.
• Distribution in commerce, including domestic sale or transfer, of mercury or a mercury-added product.
• Storage of mercury after manufacture (including import).
• Export of mercury or a mercury-added product, including the determining and controlling the sending of mercury (unless specifically prohibited) or a mercury-added product to a destination out of the customs territory of the United States.

Comments on the proposed rule are due by December 26, 2017.

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By Lynn L. Bergeson and Margaret R. Graham

On May 1, 2017, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register stating it was reopening and extending the comment period for two proposed rules:  (1) to prohibit the use of trichloroethylene (TCE) in vapor degreasing; to require manufacturers (including importers), processors, and distributors, except for retailers, of TCE for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require limited recordkeeping (issued January 19, 2017); and (2) to prohibit the manufacture (including import), processing, and distribution in commerce of methylene chloride and N-methylpyrrolidone (NMP) for consumer and most types of commercial paint and coating removal; to prohibit the use of methylene chloride and NMP in these commercial uses; to require manufacturers (including importers), processors, and distributors, except for retailers, of methylene chloride and NMP for any use to provide downstream notification of these prohibitions throughout the supply chain; and to require recordkeeping (issued January 19, 2017).  82 Fed. Reg. 20310.

This is the second extension of the comment period for the proposed rule to ban TCE use in vapor degreasing and the first extension of the comment period for the proposed rule to ban the uses of NMP and methylene chloride for consumer and most types of commercial paint and coating removal.  Comments on both proposed rules are now due on May 19, 2017.  

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By Lynn L. Bergeson and Margaret R. Graham

On February 9, 2017, the U.S. Environmental Protection Agency (EPA) announced it was extending the comment period for the two recently proposed rules issued under Section 6 of the Toxic Substances Control Act (TSCA) to ban certain uses of trichloroethylene (TCE):  proposed rule to ban certain uses of TCE in aerosol degreasing and as a spot cleaner in dry cleaning facilities (issued December 16, 2017); and proposed rule to regulate the use of TCE in vapor degreasing (issued January 19, 2017).  EPA is extending the comment period for the proposed ban on TCE as an aerosol degreaser and for spot cleaning in dry cleaning facilities from the initial deadline of February 14, 2017, to March 16, 2017, and for the proposed ban on TCE as a commercial vapor degreaser from the initial deadline of March 20, 2017, to April 19, 2017.  EPA did not state any information on why it was extending the deadline, but requests for extensions were filed in both dockets.

More information on the proposed rules is available in our memorandum EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a) and in our blog item EPA Proposes Prohibiting Use of TCE.

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By Lynn L. Bergeson and Margaret R. Graham

The U.S. Environmental Protection Agency (EPA) recently published three Toxic Substances Control Act (TSCA) proposed framework rules:  TSCA Inventory Notification (Active-Inactive) Requirements (Jan. 13, 2017); Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (Jan. 17, 2017); and Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (Jan. 19, 2017).  Summaries, insights, and commentary from B&C’s TSCA experts on these rules are available in memoranda on the B&C website.  Below please find links to the memoranda:

• EPA Proposes Requirements for TSCA Inventory Notification (Active-Inactive);
• EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA; and
• EPA Releases Proposed Chemical Risk Evaluation Process Under New TSCA.

B&C’s experts have also recently written up summaries and analysis related to the following other TSCA-related rulemakings:

• EPA Proposes Regulation of TCE Use in Vapor Degreasing under TSCA Section 6(a); and
• EPA Promulgates Final TSCA Reporting and Recordkeeping Rule for Nanoscale Materials.

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By Lynn L. Bergeson, Carla N. Hutton, Charles M. Auer, and Oscar Hernandez, Ph.D.

The U.S. Environmental Protection Agency (EPA) is scheduled to publish a proposed rule in the January 17, 2017, Federal Register that would establish a risk-based screening process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time.  The pre-publication version of the proposed rule describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and finalizing designations of priority.  EPA notes that prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent amendments to the Toxic Substances Control Act (TSCA).  Publication of the notice will begin a 60-day comment period.  More information on the final rule will be available in our forthcoming memorandum, which will be available on our website under the key phrase TSCA.

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