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 Margaret R. Graham

On October 17, 2018, the U.S. Environmental Protection Agency (EPA) issued its final fees rule under the Toxic Substances Control Act (TSCA) in the Federal Register.  83 Fed. Reg. 52694.  The final rule largely tracks the proposed rule.  EPA is establishing fees applicable to any person required to submit information to EPA; or a notice, including an exemption or other information, to be reviewed by EPA; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation.  This final rulemaking describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021, and explains the methodology by which the final TSCA fees were determined.  It identifies some factors and considerations for determining fees for subsequent fiscal years; and includes amendments to existing fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices. As required in TSCA, EPA is also establishing standards for determining which persons qualify as “small business concerns” and thus would be subject to lower fee payments.  Small businesses will be eligible to receive a substantial discount of approximately 80 percent on their fees.  EPA will host a series of webinars focusing on making TSCA submissions and paying fees under the final rule.  The first webinar was held on October 10, 2018.  The other two webinars will be held on October 24, 2018, from 1:00 p.m. to 2:30 p.m. (EDT) and on November 7, 2018, from 1:00 p.m. to 2:30 p.m. (EDT).  Our memorandum provides an overview of the final rule with specific information about final fee amounts and timing and a commentary.  The final rule is effective on October 18, 2018.


 

By Lynn L. Bergeson and Margaret R. Graham

On September 27, 2018, the U.S. Environmental Protection Agency (EPA) issued the user fees final rule for the administration of the Toxic Substances Control Act (TSCA), the fourth and remaining framework rule to be issued in final under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).

This final rule, that amends 40 C.F.R. Parts 700, 720, 723, 725, 790, and 791, “describes the final TSCA fees and fee categories for fiscal years 2019, 2020, and 2021”; “explains the methodology by which the final TSCA fees were determined”; “identifies some factors and considerations for determining fees for subsequent fiscal years”; and “includes amendments to existing fee regulations governing the review of premanufacture notices, exemption applications and notices, and significant new use notices.”   The final rule has not been published yet in the Federal Register so an effective date is not yet available; a pre-publication version is available here.

Specifically, EPA is establishing fees applicable to any person required to submit information to EPA under TSCA Section 4; or a notice, including an exemption or other information, to be reviewed by EPA under TSCA Section 5; or who manufactures (including imports) a chemical substance that is the subject of a risk evaluation under TSCA Section 6(b).  EPA is also establishing standards for determining which persons qualify as "small business concerns" and thus would be subject to lower fee payments.  

In the press release announcing the rule, EPA Acting Administrator Andrew Wheeler states that this rule will “provide resources needed to support the valuable work EPA does to review chemicals for safety, manage risk as required, and make chemical information available as appropriate.”  During fiscal years 2019-2021, EPA states it will “work to track costs and will use that information to adjust future fees, if appropriate.”

EPA also announced that it will be hosting a series of webinars focusing on making TSCA submissions and paying fees under the final rule.  The webinars are scheduled for October 10, 2018, from 1:00 p.m. - 2:30 p.m. (EST); October 24, 2018, from 1:00 p.m. - 2:30 p.m. (EST); and November 7, 2018, from 1:00 p.m. - 2:30 p.m. (EST).

More information on TSCA implementation is available on our website under key phrase Lautenberg Implementation.  A detailed Bergeson & Campbell, P.C. (B&C®) memorandum on the TSCA user fees final rule is forthcoming.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 27, 2018, the U.S. Environmental Protection Agency (EPA) issued two direct final rules promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA).  The first direct final rule promulgates SNURs for ten chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 43527.  The second direct final rule promulgates SNURs for 19 chemical substances that were the subject of PMNs.  83 Fed. Reg. 43538.  In each rule, EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rules require persons who intend to manufacture (defined by statute to include import) or process any of these 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 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.  Both direct final rules will be effective on October 26, 2018.  Written adverse comments on one or more of the SNURs must be received by September 26, 2018.  If EPA receives written adverse comments, on one or more of these SNURs before September 26, 2018, EPA will withdraw the relevant sections of the direct final rules before their effective date.  In addition to the direct final rules, EPA published proposed rules for both the direct final rules.  83 Fed. Reg. 43606, 83 Fed. Reg. 43607.  Comments on the proposed rules are due September 26, 2018.


 

By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton

On August 1, 2018, the U.S. Environmental Protection Agency (EPA) issued a direct final rule promulgating significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that were the subject of premanufacture notices (PMN).  83 Fed. Reg. 37702.  EPA notes that the chemical substances are subject to consent orders issued by EPA pursuant to TSCA Section 5(e).  The direct final rule requires persons who intend to manufacture (defined by statute to include import) or process any of these 145 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 initiates EPA’s evaluation of the intended use within the applicable review period.  Persons may not commence 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 taken such actions as are required with that determination.  The rule will be effective on October 1, 2018.  Written adverse comment must be received by August 31, 2018.  If EPA receives timely written adverse comment on one or more of the SNURs, it will withdraw the relevant section(s) of the direct final rule.

Please see the full memorandum for more information on this rulemaking and a commentary that details a few of the differences specific to these SNURs.


 

By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton

On June 22, 2018, the U.S. Environmental Protection Agency published a prepublication version of the final rule regarding reporting requirements for applicable persons to provide information to assist in the preparation of an “inventory of mercury supply, use, and trade in the United States,” where “mercury” is defined as “elemental mercury” and “a mercury compound” (mercury).  The final rule applies 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 the Toxic Substances Control Act (TSCA), such as for the manufacture of pharmaceuticals and pesticides).  EPA will use data from the 2018 reporting year for the 2020 mercury inventory.  The 2018 reporting year is from January 1, 2018, to December 31, 2018, and the submission deadline for the 2018 reporting year is July 1, 2019.  The final rule will be effective 60 days after publication in the Federal Register, which is scheduled for June 27, 2018

The reporting requirements include activities that are established TSCA terms, including manufacture, import, distribution in commerce, storage, and export.  EPA notes that the reporting requirements also apply to the otherwise intentional use of mercury in a manufacturing process.  Persons who manufacture (including import) mercury or mercury-added products, or otherwise intentionally use mercury in a manufacturing process, are required to report amounts of mercury in pounds (lbs.) used in such activities during a designated reporting year.  Reporters must also identify specific mercury compounds, mercury-added products, manufacturing processes, and how mercury is used in manufacturing processes, as applicable, from preselected lists.  For certain activities, reporters must provide additional, contextual data.

The final reporting requirements do not apply to:  (1) persons who do not first manufacture, import, or otherwise intentionally use mercury; (2) persons who only generate, handle, or manage mercury-containing waste; (3) persons who only manufacture mercury as an impurity; and (4) persons engaged in activities involving mercury not with the purpose of obtaining an immediate or eventual commercial advantage.  Within the category of persons who must report, there are certain persons who are not required to provide specific data elements.  To avoid reporting that is unnecessary or duplicative, the final rule includes certain exemptions for persons who already report for mercury and mercury-added products to the TSCA Section 8(a) Chemical Data Reporting (CDR) rule and the Interstate Mercury Education and Reduction Clearinghouse (IMERC) Mercury-Added Products Database, respectively.

More detail is provided in our June 25, 2018, memorandum regarding the provisions of the final rule, including EPA’s rationale for fulfilling specific statutory provisions and terms.  While the final rule includes summaries of public comments received and EPA’s responses and determinations, EPA notes that some of these issues are discussed in greater detail in its Response to Comments.  EPA states that its Response to Comments will be available in Docket EPA-HQ-OPPT-2017-0421, although it is not there at this time.


 

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. Bergeson and Margaret R. Graham

On May 7, 2018, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) received the U.S. Environmental Protection Agency’s (EPA) final rule entitled Mercury; Reporting Requirements for the TSCA Mercury Inventory

The OIRA 2018 Spring Regulatory Agenda for this rulemaking, item RIN 2070-AK22, states that EPA’s rulemaking to implement new Toxic Substances Control Act (TSCA) Section 8(b)(10)(D) will promulgate reporting requirements “for applicable persons to provide information to assist in the preparation of an ‘inventory of mercury supply, use, and trade in the United States,’ where ‘mercury’ is defined as ‘elemental mercury’ and ‘a mercury compound.’  The requirements would be applicable to any person who manufactures (including imports) mercury or mercury-added products, or otherwise intentionally uses mercury in a manufacturing process.”

More information on the proposed rule issued in October 2017 is available in our blog item “EPA Issues Proposed Rule on Reporting Requirements for Mercury Inventory Under New TSCA.”


 

By Lynn L. Bergeson and Margaret R. Graham

On February 7, 2018, the U.S. Environmental Protection Agency (EPA) is scheduled to issue in the Federal Register a final rule on Voluntary Consensus Standards Update; Formaldehyde Emission Standards for Composite Wood Products that will revise the formaldehyde standards for composite wood products regulations.  The revision updates the incorporation by reference of multiple voluntary consensus standards originally published in the Toxic Substances Control Act (TSCA) Title VI formaldehyde emission standards for composite wood products final rule on December 12, 2016, that have been updated, superseded, or withdrawn, and provides a technical correction to allow panel producers to correlate their approved quality control test method to the ASTM E1333-14 test chamber, or, upon showing equivalence, the ASTM D6007-14 test chamber.  EPA withdrew its direct final rule to update voluntary consensus standards for composite wood products in December 2017 due to its receipt of adverse comment on the rule.  The final rule will be effective upon publication.

More information on composite wood products under TSCA is available on our blog.


 

By Lynn L. Bergeson and Margaret R. Graham

On December 8, 2017, the U.S. Environmental Protection Agency (EPA) is scheduled to publish in the Federal Register a notice that it is withdrawing its direct final rule issued on October 25, 2017, to update the voluntary consensus standards that were originally published in the Toxics Substances Control Act (TSCA) Title VI formaldehyde emission standards for composite wood products final rule on December 12, 2016.  EPA issued both a direct final rule and a proposed rule on October 25, 2017.  EPA states that, due to its receipt of adverse comment on the rule, it must withdraw the direct final rule and proceed with issuing a final rule only after it has considered all of the comments received during the comment period which ended on November 9, 2017. 

The proposed updates apply to emissions testing methods and regulated composite wood product construction characteristics.  EPA states that several of those voluntary consensus standards (i.e., technical specifications for products or processes developed by standard-setting bodies) were updated, withdrawn, and/or superseded through the normal course of business by these bodies to take into account new information, technology, and methodologies.

As a reminder, EPA has extended the compliance dates for the formaldehyde emission standards for composite wood products final rule that was issued on December 12, 2016.  The extensions for compliance are:

  • Emission standards, recordkeeping, and labeling provisions -- from December 12, 2017, to December 12, 2018;
  • Import certification provisions -- from December 12, 2018, to March 22, 2019;
  • Laminated product producer provisions -- from December 12, 2023, to March 22, 2024; and
  • The conclusion of the transition period for California Air Resources Board (CARB) Third-Party Certifiers (TPC) -- from December 12, 2018, to March 22, 2019.

Visit our TSCA Reform News & Information page for more TSCA implementation news and analysis.  You can also sign up for TSCABlog updates to be delivered to your inbox.


 

By Lynn L. Bergeson and Margaret R. Graham

On August 11, 2017, the U.S. Environmental Protection Agency (EPA) published the third Toxic Substances Control Act (TSCA) framework final rule in the Federal Register, the TSCA Inventory Notification (Active-Inactive) Requirements.  This final rule is effective as of August 11, 2017 (the date of publication).

As further detailed in the final rulemaking, chemical manufacturers and importers are required to submit notifications for chemicals that were manufactured or imported over the ten year look-back period of June 21, 2006, to June 21, 2016.  Pursuant to the rulemaking, the retrospective reporting period for manufacturers begins on August 11, 2017, and ends on February 7, 2018.  The submission period for processors also begins on August 11, 2017, but processors have until October 5, 2018, to submit retrospective activity notifications.

More information on the final rule is available in our memorandum EPA Issues Final TSCA Framework Rules.


 
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