By Lynn L. Bergeson and Carla N. Hutton
 
In February 2023, the Office of Information and Regulatory Affairs (OIRA), within the Office of Management and Budget (OMB), published a summary of learnings and potential recommendations on broadening public engagement in the federal regulatory process. The learnings and recommendations were developed from written submissions and a public engagement session in November 2022 with hundreds of participants. OIRA invites feedback on the recommendations as it continues to consider them, with these questions as a starting point:

• Which of the recommendations would most effectively broaden public engagement in the federal regulatory process, especially from members of underserved communities and those who do not typically participate in the regulatory process? Are there recommendations that are not helpful?
   
• Are there obstacles or barriers to greater public participation, especially for underserved communities, that are not addressed by these recommendations? If so, are there other recommendations that we should consider?
   
• Are there existing materials, such as guides or tools, that would be especially effective in revising and potentially implementing these recommendations? What new tools or guidance are needed?
   
• How can intermediaries -- such as trade associations or coalitions -- be helpful in reaching individuals and small organizations or businesses, where have they been successful in doing so, and where might they be insufficient?

Interested members of the public can submit their feedback to .(JavaScript must be enabled to view this email address) as written feedback or recorded audio and video submissions. OIRA will be actively reviewing any submissions received through 5:00 p.m. (EST) March 10, 2023. OIRA states that it is also planning an additional virtual listening session during which members of the public can provide their views on these recommendations, to be held 3:00 p.m. - 4:30 p.m. (EST) on Tuesday, March 7, 2023.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On February 15, 2022, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget a final rule regarding a further compliance date extension for phenol, isopropylated phosphate (3:1) (PIP (3:1)). EPA proposed in October 2021 to extend 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 until October 31, 2024, along with the associated recordkeeping requirements for manufacturers, processors, and distributors of PIP (3:1)-containing articles. EPA noted that the articles covered by the proposed rule 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, construction, agriculture, forestry, mining, life sciences, and semiconductor production. The proposed rule followed a final rule that extended 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, along with the associated recordkeeping requirements. More information on the proposed rule is available in our October 25, 2021, memorandum. It is not clear when OMB will complete its review or if the final rule will be published prior to the current March 8 compliance deadline.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On February 8, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on an Information Collection Request (ICR) that EPA is planning to submit to the Office of Management and Budget (OMB): “Notification of Substantial Risk of Injury to Health and the Environment under the Toxic Substances Control Act (TSCA),” identified by EPA ICR No. 0794.17 and OMB Control No. 2070-0046. 87 Fed. Reg. 7173. The ICR represents the renewal of an existing ICR that is currently approved through October 31, 2022. Before submitting the ICR to OMB for review and approval under the Paperwork Reduction Act (PRA), EPA is soliciting comments on specific aspects of the information collection activities and burden estimates. Comments are due April 11, 2022.
 
Under TSCA Section 8(e), any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information that reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment is required to inform EPA immediately of such information unless they have actual knowledge that EPA has been adequately informed of such information. There is also an option for those who wish to submit voluntarily “For Your Information” (FYI) notices. More information on TSCA Section 8(e) requirements is available in our TSCA frequently asked questions (FAQ).
 
EPA estimates that the total estimated number of potential respondents is 51 and that the total estimated average number of responses for each respondent is 343. There is a decrease of 3,847 hours from the last approval (from 21,412 to 17,565 hours). According to EPA, this reflects an overall decrease in the number of Section 8(e) and FYI submissions, which decreased from 408 to 343 Section 8(e) submissions and 13 to six FYI submissions, respectively. EPA has also increased the total annual costs due to an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead).
 
EPA notes that in addition, OMB has requested that it move toward using the 18-question format for ICR Supporting Statements used by other federal agencies and departments that is based on the submission instructions established by OMB in 1995, replacing the alternate format developed by EPA and OMB prior to 1995. EPA states that it does not expect this change in format to result in substantive changes to the information collection activities or related estimated burden and costs.

• Email This
• Print

By Lynn L. Bergeson and Carla N. Hutton
 
On January 20, 2022, the U.S. Environmental Protection Agency (EPA) submitted a proposed rule to the Office of Management and Budget (OMB) concerning the procedures for submitting information subject to business confidentiality claims under the Toxic Substances Control Act (TSCA). According to an item in the fall 2021 Unified Agenda, EPA is considering proposing new and amended rules concerning the assertion and maintenance of claims of business confidentiality (i.e., confidential business information (CBI)) under TSCA. The 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments included several new provisions concerning the assertion and EPA review and treatment of confidentiality claims. The Unified Agenda item states that EPA is considering procedures for submitting and supporting such claims in TSCA submissions, including substantiation requirements, exemptions, electronic reporting enhancements, and maintenance or withdrawal of confidentiality claims. EPA is also considering whether the proposed rule should also elaborate on its procedures for reviewing and communicating with TSCA submitters about confidentiality claims. EPA expects the proposed rule to include new provisions, as well as revisions to existing rules on asserting confidentiality claims to conform to the 2016 TSCA amendments.

• Email This
• Print

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.

• Email This
• Print

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.

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

• Email This
• Print

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.

• Email This
• Print

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).

• Email This
• Print

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.”

• Email This
• Print

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.”

• Email This
• Print