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By Lynn L. Bergeson and Carla N. Hutton
 
On June 3, 2020, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a final significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances.  On March 3, 2020, EPA published a proposed supplemental SNUR for LCPFAC chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  85 Fed. Reg. 12479.  Under the proposed supplemental SNUR, issued under Section 5(a)(2) of the Toxic Substances Control Act (TSCA), this subset of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates.  The supplemental proposal would require importers to notify EPA at least 90 days before commencing the import of these chemical substances in certain articles for the significant new use described in the proposed SNUR.  The required significant new use notification would initiate EPA’s evaluation of the conditions of use associated with the intended significant new use.  Manufacturing (including import) or processing for the significant new use would be prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.  As noted in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles,” one of the goals of the proposed supplemental SNUR is to establish the ground rules for EPA’s consideration of the article exemption in future SNUR actions.  The final SNUR that is under OMB review is not publicly available, so it remains to be seen whether EPA has successfully established policies and procedures that both align with statutory requirements and also are workable, effective, predictable, transparent, and justified scientifically.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our October 1, 2019, blog item, on September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  According to OMB’s website, OMB completed its review on February 14, 2020.  EPA has not yet publicly released the proposed rule.
 
According to the item on the rulemaking in EPA’s fall 2019 Unified Agenda, EPA is developing a supplemental proposal to its 2015 proposed LCPFAC SNUR amendments.  EPA states that the supplemental proposal would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles.  According to EPA, this supplemental proposal is necessary to be responsive to the article consideration provision in Section 5(a)(5) of the Toxic Substances Control Act (TSCA) that was added with the 2016 amendments to TSCA.  Under the provision, articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification.  Insofar as this new provision has not been used previously for chemical substances with a history of prior import in articles, EPA’s approach to and its arguments in making this required affirmative finding will be important for all stakeholders to consider carefully.

 

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Tags: OMB, SNUR, PFAS, LCPFAC

 

By Lynn L. Bergeson, Charles M. Auer, and Carla N. Hutton
 
On September 25, 2019, the U.S. Environmental Protection Agency (EPA) submitted a proposed significant new use rule (SNUR) on long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate (PFAS) chemical substances to the Office of Management and Budget (OMB) for review.  The item on the rulemaking in EPA’s Spring 2019 Regulatory Agenda states that in 2015, EPA proposed amending the SNURs under Section 5(a)(2) of the Toxic Substances Control Act (TSCA) for LCPFAC chemical substances and for perfluorooctanoic acid (PFOA) or its salts.  80 Fed. Reg. 2885 (Jan. 21, 2015).  Specifically, EPA proposed to amend the SNUR for LCPFAC chemical substances by designating as a significant new use manufacturing (including importing) or processing of an identified subset of LCPFAC chemical substances for any use that will not be ongoing after December 31, 2015, and all other LCPFAC chemical substances for which there are currently no ongoing uses.  EPA also proposed to make inapplicable the exemption for persons who import LCPFAC chemical substances as part of articles.  In addition, EPA proposed to amend the SNUR for PFAS chemical substances that would make inapplicable the exemption for persons who import PFAS chemical substances as part of carpets.  Persons subject to these SNURs would be required to notify EPA at least 90 days before commencing such manufacture or processing.  The required notifications would initiate EPA’s evaluation of the intended use within the applicable review period.  Manufacture and processing for the significant new use would be unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.
 
EPA states that it is developing a supplemental proposal for the LCPFAC SNUR amendments to make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of certain articles.  According to EPA, this supplemental proposal is necessary to be responsive to the article consideration provision in TSCA Section 5(a)(5) that was added with the 2016 amendments to TSCA.  Under the provision, articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification.  Insofar as this new provision has not been used previously for chemical substances with a history of prior import in articles, EPA’s approach to and its arguments in making this required affirmative finding will be important for all stakeholders to consider carefully.


 

By Lynn L. Bergeson and Carla N. Hutton

On August 31, 2018, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) for review a final rule regarding user fees for the administration of the Toxic Substances Control Act (TSCA).  As reported in our February 9, 2018, memorandum, “Administrator Pruitt Signs TSCA User Fee Proposal,” as amended by the Frank Lautenberg Chemical Safety for the 21st Century Act, TSCA provides EPA the authority to levy fees on certain chemical manufacturers, including importers and processors, to “provide a sustainable source of funding to defray resources that are available for implementation of new responsibilities under the amended law.”  Under the amendments to TSCA, EPA has authority to require payment from manufacturers and processors who:

  • Are required to submit information by test rule, test order, or enforceable consent agreement (ECA) (TSCA Section 4);
  • Submit notification of or information related to intent to manufacture a new chemical or significant new use of a chemical (TSCA Section 5); or
  • Manufacture or process a chemical substance that is subject to a risk evaluation, including a risk evaluation conducted at the request of a manufacturer (TSCA Section 6(b)).

EPA’s February 26, 2018, proposed rule described the proposed TSCA fees and fee categories for fiscal years (FY) 2019, 2020, and 2021, and explained the methodology by which the proposed TSCA user fees were determined and would be determined for subsequent FYs.  In proposing the new TSCA user fees, EPA also proposed amending long-standing user fee regulations governing the review of Section 5 premanufacture notices (PMN), exemption applications and notices, and significant new use notices (SNUN).  Under the proposed rule, after implementation of final TSCA user fees regulations, certain manufacturers and processors would be required to pay a prescribed fee for each Section 5 notice or exemption application, Section 4 testing action, or Section 6 risk evaluation for EPA to recover certain costs associated with carrying out certain work under TSCA.  EPA did not propose specific fees for submission of confidential business information (CBI).


 

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 December 22, 2017, the U.S. Environmental Protection Agency (EPA) sent to the Office of Management and Budget (OMB) a proposed rule establishing fees on certain submissions under amended Toxic Substances Control Act (TSCA) Sections 4, 5, and 6.  EPA has indicated that it expects to propose the rule in the early part of the New Year:  EPA’s regulatory agenda lists February 2018 for the proposed rule and September 2018 for the final rule.

More information on the TSCA fees rulemaking and requirements is available in our blog item “EPA Hosts August 11, 2016, Public Meeting on Proposed Rule for Revised TSCA Fees,” in our memorandum “TSCA Reform:  An Analysis of Key Provisions and Fundamental Shifts in the Amended TSCA,” and in our September 20, 2016, webinar “‘The New TSCA’ Webinar 4: Administration of the Act, Preemption, Fees, and Green Chemistry.”

Tags: TSCA fees, OMB

 

By Lynn L. Bergeson and Carla N. Hutton

On August 17, 2017, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule regarding reporting requirements for a mercury inventory to the Office of Management and Budget (OMB).  The proposed rule would establish reporting deadline(s) and information requirements for the purpose of assisting EPA’s periodic update and publication of the inventory of mercury supply, use, and trade in the U.S.  As required under the Frank R. Lautenberg Chemical Safety for the 21st Century Act, EPA must “carry out and publish in the Federal Register an inventory of mercury supply, use, and trade” in the U.S.  The Lautenberg Act defines mercury as “elemental mercury” or “a mercury compound.”  The inventory was to be published no later than April 1, 2017, and every three years thereafter, as supported by a rule authorized in the Lautenberg Act.  As reported in our March 29, 2017, blog item, EPA published an initial inventory report on March 29, 2017.  For subsequent inventories, EPA is authorized to promulgate a rule to “assist in the preparation of the inventory” so that “any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator, at such time and including such information as the Administrator shall determine.”  EPA expects future triennial inventories of mercury supply, use, and trade to include data collected directly from such persons.  In future inventories, EPA also will “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.”  EPA must promulgate a final rule by June 22, 2018.


 

By Lynn L. Bergeson and Margaret R. Graham

On June 13, 2017, the White House Office of Management and Budget (OMB) received a notice from the U.S. Environmental Protection Agency (EPA) submitting its draft Guidance to Assist Interested Persons in Developing and Submitting Draft Risk Evaluations Under the Toxic Substances Control Act (TSCA) (RIN 2070-ZA18) for review and approval.  Under Section 26(l)(5), EPA is required, “[n]ot later than 1 year after the date of enactment … [to] develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator.”  While the “framework rules” have been the subject of considerable focus since last June, this guidance is as important, subject to the one year deadline, and likely to provide significant insights into EPA’s thinking on risk evaluations.  EPA must publish the final rule in the Federal Register by June 22, 2017.

More information on the final rule on Procedures for Evaluating Existing Chemical Risks under TSCA is available in our memorandum EPA Releases Proposed Chemical Risk Evaluation Process under New TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On May 23, 2017, the U.S. Environmental Protection Agency (EPA) submitted its final rulemaking on the Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act (TSCA) to the Office of Management and Budget (OMB) for review and approval.  In the proposed rule, EPA 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 preparing final priority designations.  EPA also incorporates all of the elements required by new TSCA, but also supplements those requirements with additional criteria it expects to consider, some clarifications intended to provide greater transparency, and additional procedural steps to ensure effective implementation.  Comments were due March 20, 2017; 70 comments were filed.  Pursuant to new TSCA, EPA must publish the final rule in the Federal Register by June 22, 2017

More information on the rule as proposed is available in our memorandum EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA.


 

By Lynn L. Bergeson and Margaret R. Graham

On March 6, 2017, the White House’s Office of Management and Budget (OMB), via the Office of Information and Regulatory Affairs (OIRA), issued Memorandum:  Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions, a memorandum for regulatory policy officers at executive departments and agencies and managing and executive directors of certain agencies and commissions, with the subject:  Spring 2017 Data Call for the Unified Agenda of Federal Regulatory and Deregulatory Actions.  Per EO 12866 (Oct. 4, 1993), federal agencies are directed to prepare a “Regulatory Plan (Plan) of the most important significant regulatory actions that the agency reasonably expects to issue in proposed or final form in that fiscal year or thereafter,” which they usually do semi-annually, in the spring and the fall.  This memo reiterates the directives of past executive orders on the regulatory agendas, but also includes new directives and focus, referring largely to the directives in the January 30, 2017, Executive Order (EO), Reducing Regulation and Controlling Regulatory Costs

The memorandum states that the Unified Agendas should “describe all regulations under development or review during the 12 months following publication.  Agencies should include, at a minimum, any plans to publish or otherwise implement an Advance Notice of Proposed Rulemaking (“ANPRM”), a Notice of Proposed Rulemaking (“NPRM”), or a Final Rule,” but also requests them to reflect attention to the following:

  • The total incremental costs of any new significant regulatory actions issued between noon on January 20, 2017, and September 30, 2017, shall, to the extent permitted by law, be fully offset as of September 30, 2017; and
  • Agencies should, for each new significant regulatory action that imposes costs and that an agency plans to issue on or before September 30, 2017, identify two existing regulatory actions the agency plans to eliminate or propose for elimination on or before September 30, 2017.

In an effort to “facilitate the fiscal year 2018 regulatory budget planning process,” the memorandum requests that spring 2017 submissions also include “a preliminary estimate of the total costs or savings associated with each of your planned fiscal year 2018 significant regulatory actions and offsetting deregulatory actions.”  The memorandum also lists suggested steps that it states will improve an agency’s Unified Agenda, including:

  • Considering whether the listing of “long-term” entries benefits readers, especially for those for which no substantial activity was expected within the coming year;
  • Removing entries that agencies do not realistically intend to take action on over the next 12 months, especially ones that the agency does not have the resources to take action on; and
  • Other more administrative suggestions, such as categorization; consistency of agency data; accuracy of timetable information; and abstract information for the entries that informs readers of the reason the rulemaking is under development and what the agency intends to accomplish.

Agencies must submit all of their Unified Agenda materials by March 31, 2017


 
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