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By Lynn L. Bergeson, Carla N. Hutton, and Holly M. Williams

On June 30, 2020, the Trump Administration released the Spring 2020 Unified Agenda of Regulatory and Deregulatory Actions for the U.S. Environmental Protection Agency (EPA.)  According to the Unified Agenda, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on several rulemakings under the Toxic Substances Control Act (TSCA).  Rulemakings at the proposed stage are listed below:

  • Review of Dust-Lead Post-Abatement Clearance Levels.  On June 24, 2020, EPA published a proposed rule that would lower the amount of lead that can remain in dust on floors and windowsills after lead removal activities (dust-lead clearance levels (DLCL)) from 40 micrograms (µg) of lead in dust per square foot (ft2) to 10 µg/ft2 for floor dust and from 250 µg/ft2 to 100 µg/ft2 for window sill dust.  85 Fed. Reg. 37810.  Comments on the proposed rule are due August 24, 2020.  EPA intends to publish a final rule in September 2020.
     
  • Reporting and Recordkeeping for Certain Chemicals under TSCA Section 8(a).  EPA is developing a rulemaking under TSCA Section 8(a) to add certain chemicals that are on the TSCA Work Plan to the Chemical-Specific Reporting and Recordkeeping rules in 40 C.F.R. Part 704, Subpart B.  EPA is developing this rule to obtain information about potential hazards and exposure pathways related to certain chemicals on the TSCA Work Plan, particularly occupational, environmental, and consumer exposure information.  EPA states that this information is needed to inform prioritization and risk evaluation of the chemical substances, as mandated under TSCA Section 6.  EPA intends to issue a notice of proposed rulemaking (NPRM) in November 2020 and a final rule in June 2021.
     
  • Revisions to the Fees Rule under TSCA.  EPA is reviewing its 2018 final rule that established the requirements and procedures for setting and collecting fees from chemical manufacturers (including importers) and, in some cases, processors, submitters of new chemical substances, and others.  TSCA Section 26(b)(4)(F) requires EPA to review and adjust the fees every three years and to consult with parties potentially subject to fees when the fees are reviewed and updated to reflect changes in program costs.  EPA states that in addition to possible revisions resulting from this review, consistent with its announcement in March 2020, it will also consider proposing exemptions to the current rule’s self-identification requirements associated with EPA-initiated risk evaluations for manufacturers that:  (1) import the chemical substance in an article; (2) produce the chemical substance as a byproduct; and (3) produce or import the chemical substance as an impurity.  EPA intends to issue an NPRM in December 2020 and a final rule in October 2021.  More information on EPA’s March 2020 announcement is available in our April 17, 2020, blog item.
     
  • Updates to New Chemicals Procedural Regulations to Reflect the 2016 TSCA Amendments:  EPA states that the 2016 amendments impacted how it reviews and makes determinations on new chemical notices under TSCA Section 5.  EPA acknowledges that as a result of these increased responsibilities, “it has become more challenging for EPA to complete reviews within 90 days.”  This rulemaking seeks to revise the procedural regulations in 40 C.F.R. Part 720 to improve the efficiency of EPA’s review process and to align its processes and procedures with the new statutory requirements.  EPA intends to increase the quality of information initially submitted in new chemicals notices and improve its processes to reduce unnecessary rework in the risk assessment and, ultimately, the length of time that new chemicals are under review.  EPA intends to publish an NPRM in September 2020 and a final rule in July 2021.

Rulemakings at the final stage include:

  • Significant New Uses of Chemical Substances; Updates to the Hazard Communication Program and Regulatory Framework; Minor Amendments to Reporting Requirements for Premanufacture Notices.  On July 28, 2016, EPA proposed amending components of the Significant New Uses of Chemical Substances regulations at 40 C.F.R. Section 721, specifically the “Protection in the Workplace” (40 C.F.R. Section 721.63) and “Hazard Communication Program” (40 C.F.R. Section 721.72).  The proposed changes are intended to align, where possible, EPA’s regulations with the revised Occupational Safety and Health Administration (OSHA) regulations at 29 C.F.R. Section 1910.1200.  EPA intends to issue a final rule in August 2020.  More information on the proposed rule is available in our July 29, 2016, memorandum, “:  TSCA:  Proposed Revisions to Significant New Use Rules Reflect Current Occupational Safety and Health Standards.”
     
  • Long-Chain Perfluoroalkyl Carboxylate (LCPFAC) and Perfluoroalkyl Sulfonate Chemical Substances (PFAS); Significant New Use Rule (SNUR).  In a January 21, 2015, proposed SNUR for LCPFAC and PFAS chemical substances, EPA proposed to require notification of significant new uses from persons who import a subset of LCPFAC chemical substances as part of any article.  80 Fed. Reg. 2885.  EPA proposed to make the exemption from notification requirements for persons who import the chemical substance as part of an article inapplicable for the import of a subset of LCPFAC chemical substances in all articles.  As reported in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles,” EPA issued a supplemental proposal that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles.  EPA intended to issue a final rule in June 2020.
     
  • Decabromodiphenyl Ether (DecaBDE); Regulation of Persistent, Bioaccumulative, and Toxic (PBT) Chemicals under TSCA Section 6(h).  TSCA Section 6(h) directs EPA to issue regulations under Section 6(a) for certain PBT chemical substances identified in the 2014 update of the TSCA Work Plan.  EPA states that it is selecting among the available prohibitions and other restrictions in TSCA Section 6(a) to address risks of injury to health or the environment that the Administrator determines are presented by the chemical substances and reduce exposure to the chemical substances to the extent practicable.  Since the statute states that a risk evaluation is not required for these chemical substances under TSCA Section 6(h), EPA developed an exposure and use assessment.  According to the Unified Agenda item, EPA intends to take final action on all of the chemicals that were addressed in the July 29, 2019, proposed rule (i.e., the following PBT chemicals identified in TSCA Section 6(h):  DecaBDE; phenol, isopropylated phosphate  (PIP) (3:1); 2,4,6-tris(tert-butyl)phenol (TTBP); pentachlorothiophenol (PCTP); and hexachlorobutadiene (HCBD).  Although addressed in a single proposed rule, EPA intends to issue separate final rules.  EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of DecaBDE, and articles and products to which DecaBDE has been added with several exceptions, and proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements.  EPA intends to issue a final rule in December 2020.  More information is available in our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA.”
     
  • PIP (3:1); Regulation of PBT Chemicals under TSCA Section 6(h).  EPA proposed to prohibit the processing and distribution in commerce of PIP (3:1), and products containing the chemical substance with several exceptions; prohibit releases to water from the non-prohibited processing, distribution in commerce, and commercial use activities.  Persons manufacturing, processing, and distributing PIP (3:1), and products containing PIP (3:1), in commerce would be required to notify their customers of these restrictions, and EPA proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements.  EPA intends to issue a final rule in December 2020.
     
  • TTBP; Regulation of PBT Chemicals under TSCA Section 6(h.).  EPA proposed to prohibit the distribution in commerce of 2,4,6-TTBP and products containing 2,4,6-TTBP in any container with a volume of less than 55 gallons for any use to prevent the use of 2,4,6-TTBP as a fuel additive or fuel injector cleaner by consumers and small commercial operations (e.g., automotive repair shops, marinas).  The proposed restriction also would prohibit processing and distribution in commerce of 2,4,6-TTBP, and products containing 2,4,6-TTBP, for use as an oil or lubricant additive, regardless of container size.  EPA also proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements.  EPA intends to issue a final rule in December 2020.
     
  • PCTP; Regulation of PBT Chemicals under TSCA Section 6(h).  EPA proposed to prohibit the manufacture (including import), processing, and distribution in commerce of PCTP, and products containing PCTP, unless in concentrations at or below one percent by weight; and proposed to require affected persons to maintain, for three years from the date the record is generated, ordinary business records that demonstrate compliance with the restrictions, prohibitions, and other requirements.  EPA intends to issue a final rule in December 2020.
     
  • HCBD; Regulation of PBT Chemicals under TSCA Section 6(h).  For HCBD, EPA proposed no regulatory action.  EPA intends to issue a final rule in December 2020.

 

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
 

On May 28, 2020, the U.S. Environmental Protection Agency (EPA) Office of Inspector General (OIG) issued a report entitled EPA Toxic Substances Control Act Consent Orders Need Better Coordination.  OIG conducted the evaluation to determine what actions EPA took to verify compliance with the requirements of the 2009 Toxic Substances Control Act (TSCA) Premanufacture Notice Consent Order with DuPont (responsibilities transferred to The Chemours Company in 2015) to prevent the release of GenX chemicals in the Cape Fear River in North Carolina.  OIG notes that GenX chemicals are a type of per- and polyfluoroalkyl substances (PFAS) found in surface water, groundwater, drinking water, rain water, and air emissions.  OIG found insufficient communication and coordination between the two EPA offices responsible for developing and enforcing the consent order requirements designed to reduce risks in the manufacture of GenX chemicals.  Under the 2009 Consent Order, EPA required DuPont to determine how to recover and capture 99 percent of GenX’s manufacturing discharges and air emissions.  The Consent Order was not reviewed or approved by the Office of Enforcement and Compliance Assurance (OECA), which is responsible for conducting inspections to verify compliance, however.  Until June 2017, EPA’s actions to verify compliance with the 2009 Consent Order and new chemicals testing requirements consisted of tracking and reviewing information provided by the manufacturer.  According to OIG, following the local media coverage of the presence of GenX chemicals in the Cape Fear River in 2017, Region 4 and EPA contractors conducted EPA’s first on-site compliance monitoring inspection at the Fayetteville Works facility, which manufactures GenX.  OIG found that the Region 4 inspectors were unaware of the 2009 Consent Order and its requirements until the inspection was requested by EPA headquarters.
 
OIG recommends that EPA establish and implement processes:

  1. For OECA to review and approve the terms and conditions of TSCA Section 5(e) Consent Orders that it is responsible for verifying during compliance monitoring and enforcement activities; and
     
  2. To provide final TSCA Section 5(e) Consent Orders to regions and verify that the regions have the final consent orders.

OIG states that EPA “did not provide an acceptable corrective action for Recommendation 1, and we consider this recommendation unresolved.”  For Recommendation 2, EPA provided an alternative course of action that OIG finds acceptable.  OIG considers Recommendation 2 resolved with corrective action pending.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On May 20, 2020, the U.S. Environmental Protection Agency (EPA) issued a press release announcing a final agreement with Swix Sport USA (Swix) resolving Toxic Substances Control Act (TSCA) violations associated with the importation of noncompliant ski wax products containing per- and polyfluoroalkyl substances (PFAS).  According to the press release, Swix agrees to pay a fine and develop a $1 million educational program to raise awareness in ski communities about PFAS chemicals in ski waxes.  EPA states that Swix violated the TSCA Premanufacturing Notice requirements and Import Certification requirements when it imported ski wax products containing six different PFAS chemicals on at least 83 occasions that were not included on the TSCA Inventory or otherwise exempt for commercial purposes.  Once the chemicals were identified, Swix immediately ceased importation of the products containing the PFAS substances and quarantined products in its control in the United States.
 
Under the terms of the settlement, Swix has agreed to spend approximately $1 million to develop and implement an outreach and training program referred to as a Responsible Waxing Project (RWP) and pay a $375,625 civil penalty.  The RWP is aimed at:  (1) educating the ski racing community about PFAS chemicals in racing waxes and their impact on the environment; and (2) promoting the use of wax alternatives with lower environmental impact, including but not limited to racing waxes that are PFAS-free.  Another objective of the RWP is to educate and motivate the ski racing community to phase out (and ultimately eliminate) the use of PFAS-containing waxes in ski racing beginning with the 2020 ski season.
 
EPA notes that the RWP has several elements, including an education and training component for ski wax technicians on the proper disposal of racing wax shavings and the use of appropriate personal protective equipment (PPE) during the waxing process.  Other RWP elements include:

  • PFAS ski wax education program, including two on-site presentations at a major ski event that attracts more than 10,000 participants;
     
  • Training for wax technicians on the proper use of PPE, proper ventilation, and proper disposal of wax shavings;
     
  • Program for ski wax coaches available online and used at on-site presentations at a minimum of ten events designed for coach certifications;
     
  • Additional outreach to college racing teams and clubs that educates high school and college level skiers about the RWP content;
     
  • A dedicated Swix project manager who oversees the project to completion;
     
  • Website development for all videos created as part of the settlement for technicians, coaches, and teams; and
     
  • Distribution of PFAS alternative wax information materials at a minimum of 50 ski sites.

EPA’s Environmental Appeals Board approved the consent agreement and final order on May 13, 2020.


 

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 Susan M. Kirsch

On May 22-23, 2018, the U.S. Environmental Protection Agency (EPA) hosted a Polyfluoroalkyl Substances (PFAS) National Leadership Summit (Summit) in Washington, D.C.  The Summit convened federal and state regulators, including representatives from EPA’s Office of Water (OW), EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), the U.S. Food and Drug Administration (FDA), the U.S. Department of Defense (DOD), a small group of invited industry participants, and representative from the environmental non-governmental organization (NGO) community.  The goals of the Summit were:

  • To share information on efforts to characterize risks from PFAS and to develop monitoring and remediation technologies/techniques;
  • To identify near-term actions to address current state and local challenges; and
  • To develop risk communication strategies to address public concerns and questions surrounding PFAS.

EPA broadcast the opening remarks and perspectives delivered by EPA Administrator Pruitt; Peter Grevatt, Director of the Office of Ground Water and Drinking Water; Jeff Morris, Director of the Office of Pollution Prevention and Toxics (OPPT); Craig Butler, Direct of the Ohio Environmental Protection Agency and Chair of the Environmental Council of the States (ECOS) Water Committee; and Jessica Bowman, Senior Director of Global Fluoro-Chemistry, at the American Chemistry Council.  During his remarks, Pruitt announced that EPA will soon classify two fluorochemicals, perfluorooctanoic acid (PFOA) and perfluoroctane sulfonate (PFOS), as hazardous substances, and that EPA will begin to development maximum contaminant levels (MCL) for PFOA and PFOS under the Safe Drinking Water Act.  PFOA and PFOS are largely legacy chemicals that were the subject of voluntary phase out by chemical manufacturers.  The presence of PFOA and PFOS at former manufacturing sites and detections in groundwater and drinking water have raised public health concerns and made headlines over the last several months, particularly in Northeast states.

Butler’s remarks highlighted the key questions that ECOS and state participants hoped to have addressed by EPA over the course of the Summit, including any plans for MCL development, guidance on contaminated site remediation and PFAS analytical methods, and EPA’s plan to address data and knowledge gaps about PFOA and PFOS, as well as the alternative short-chain PFAS chemistry that makes up the majority of current and new uses of PFAS.  States are eager for direction and assistance from EPA on standard-setting and, in the absence of federal standards, some states have begun to set their own standards.  A copy of the ECOS statement is available here.

Grevatt shared plans for further co-regulator discussions and community engagement as part of an EPA “roadshow” beginning in late June in Portsmouth, New Hampshire.  Morris provided an overview of the rigors of the pre-market review process under the Toxic Substances Control Act (TSCA) and OPPT’s ongoing work to better understand the diverse range of PFAS in the marketplace. 

EPA intended for the Summit to serve as a formal launch of an ongoing dialogue with states, the public, and industry on PFAS, and more details will likely be shared in the coming weeks and months.  A recording of the May 22, 2018, broadcast is available on EPA’s YouTube channel.  Copies of the slide presentations from the Summit are available on EPA’s PFAS Summit website.

Tags: PFAS, PFOS, PFOA, EPA, Summit