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
 
On June 10, 2021, the Retail Industry Leaders Association’s (RILA) Retail Compliance Center (RCC) and Lynn L. Bergeson, Managing Partner, Bergeson & Campbell, P.C. (B&C®), presented “TSCA - It Is Not What You May Think.” While the Toxic Substances Control Act (TSCA) has long been regarded as a law applying to chemical producers, reforms made in 2016 have drawn many retailers, product manufacturers, and other “article” manufacturers into TSCA’s reach. Nothing illustrates this more clearly than a recent final rule under Section 6(h) limiting or prohibiting the manufacture (including import), processing, and/or distribution in commerce of five persistent, bioaccumulative, and toxic (PBT) chemicals, including phenol, isopropylated phosphate (3:1) (PIP (3:1)). This complimentary webinar, intended for large and small retailers, product stewards, and professionals throughout the product supply chain, covered:

  • What TSCA is and why it matters to retailers;
  • What retailers need to know about their products;
  • What the PIP (3:1) case study signals about the potential reach of TSCA; and
  • What steps to take to prepare for new regulations.

A full recording of this webinar is available now, along with slides and detailed responses to the Q&A portion of the event.


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our January 6, 2021, blog item, the U.S. Environmental Protection Agency (EPA) issued final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) for five persistent, bioaccumulative, and toxic (PBT) chemicals, including phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894). The final rules limit or prohibit the manufacture (including import), processing, and/or distribution in commerce of the five PBTs, with certain exceptions. In accordance with Biden-Harris Administration Executive Orders and directives, as well as “[‌n]ewly-raised compliance issues” associated with the PIP (3:1) rule, EPA announced on March 8, 2021, that it would ask for additional public comment. EPA also issued a temporary 180-day “No Action Assurance” (NAA) indicating that the Agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.
 
Under the final rule, each person who manufactures PIP (3:1) for any use after March 8, 2021, must, prior to or concurrent with the shipment, notify persons to whom PIP (3:1) is shipped, in writing, of the prohibitions on processing, distribution, and releases to water. 40 C.F.R. § 751.407(e)(1). Each person who processes or distributes in commerce PIP (3:1) or PIP (3:1)-containing products for any use after July 6, 2021, must, prior to or concurrent with the shipment, notify persons to whom PIP (3:1) is shipped, in writing, of the prohibitions on processing, distribution, and releases to water. 40 C.F.R. § 751.407(e)(2). The final rule clarifies that the downstream notification requirement applies only to those scenarios where a product has an accompanying safety data sheet (SDS). EPA also included an alternative method of compliance for downstream notification. If a manufacturer, processor, or distributor chooses, they may include specified text on their label, instead of on their SDS.
 
EPA’s NAA applies only to the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added. It does not apply to the downstream notification requirements or to the downstream notification requirements for manufacturers that began March 9, 2021. Processors and distributors should review the regulations now to ensure that they are prepared to begin providing downstream notifications on July 7, 2021. Information regarding Bergeson & Campbell, P.C.’s TSCA services is available on our website.


 

By Christopher R. Blunck, Carla N. Hutton, and Lynn L. Bergeson
 
On June 11, 2021, the Office and Management and Budget released its “Spring 2021 Unified Agenda of Regulatory and Deregulatory Actions” (Regulatory Agenda). It includes an entry for an interim final rule planned by the U.S. Environmental Protection Agency (EPA) entitled “Regulation of Persistent, Bioaccumulative, and Toxic Chemicals Under TSCA Section 6(h); Reconsideration and Extension of Certain Compliance Dates.” This action, planned for publication in September 2021, would be in follow-up to EPA’s March 16, 2021, proposed rule that sought additional public comment on final rules published on January 6, 2021, covering five persistent, bioaccumulative, and toxic (PBT) chemicals, i.e., decabromodiphenyl ether; 2,4,6-tris(tert-butyl)phenol; hexachlorobutadiene, pentachlorothiophenol; and phenol, isopropylated phosphate (3:1) (PIP (3:1)).
 
In the March 16, 2021, proposed rule, EPA stated that it sought additional public comment in “accordance with the January 21, 2021, Executive Order entitled “Protecting Public Health and the Environment and Restoring Science to Tackle the Climate Crisis” and other Biden-Harris Administration Executive orders and other direction.” EPA stated also in the proposed rule that it is “aware of and plans to consider revisions in response to implementation issues that have been raised by a range of stakeholders” and that “[‌i]n particular, EPA is seeking comment on newly-raised issues associated with the March 8, 2021, compliance date in the PIP (3:1) rule for certain regulated articles.”
 
Concurrent with EPA’s announcement on March 8, 2021, of the March 16, 2021, proposed rule that opened the PBT rules for comment, EPA issued a temporary 180-day “No Action Assurance” (NAA) indicating that EPA would exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added. EPA stated that it “is taking this [NAA] action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.” EPA stated that the NAA “is to remain in effect until either (1) 11:59 PM ET, September 4, 2021, or (2) the effective date of a final action addressing the compliance date for the prohibition on processing and distributing in commerce of PIP (3:1); including in PIP (3:1)-containing articles, whichever occurs earlier.”
 
The Regulatory Agenda entry for the interim final rule states that EPA intends to address compliance date issues in the action, and that if it “determines to further amend the recent final [PBT] rules, EPA will address those amendments in one or more future Regulatory Agenda entries.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on April 1, 2021, that it is extending the public comment period for a manufacturer-requested risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  As reported in our February 18, 2021, blog item, EPA notes that two chemicals in the OTNE category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under the Toxic Substances Control Act (TSCA), “meaning they are toxic, can remain in the environment for long periods of time, and can build up or accumulate in the body.”  EPA “welcomes all public comments,” particularly on the following:

  • Any information not included in the manufacturer request that commenters believe EPA would need to conduct a risk evaluation;
  • Additional conditions of use EPA is proposing to include in the risk evaluation; and
  • Information on conditions of use not included in the manufacturer request or in the additional conditions of use EPA proposes to include in the risk evaluation, specifically the inclusion of any additional conditions of use and potentially exposed or susceptible subpopulations.  EPA states that it “is in the process of broadly re-examining how it intends to implement these and other provisions of the amended [TSCA] including determining how new executive orders will be addressed.  This process would benefit greatly from stakeholder feedback.”

Comments were due April 5, 2021, but EPA is extending the comment period an additional 30 days.  After the comment period closes, EPA will review the comments and either grant or deny the request to conduct a risk evaluation within 60 days.  If EPA grants the request, the manufacturers would be responsible for half the cost of the risk evaluation.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM).


 

By Lynn L. Bergeson and Carla N. Hutton
 
As reported in our March 9, 2021, blog item, the U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  On March 16, 2021, EPA announced that comments on the final rules are due May 17, 202186 Fed. Reg. 14398.  EPA seeks comment on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on March 8, 2021, that “in accordance with Biden-Harris Administration executive orders and directives,” it is asking for additional public input on five final rules for persistent, bioaccumulative, and toxic (PBT) chemicals issued on January 6, 2021, under the Toxic Substances Control Act (TSCA).  EPA states that as a first step in its efforts to review these rules immediately, EPA is opening a 60-day comment period for the public to provide new input on:

  • Whether the rules sufficiently reduce exposure to these chemicals, including exposures to potentially exposed or susceptible subpopulations and the environment;
  • Newly raised compliance issues associated with the final rule on phenol, isopropylated phosphate (3:1) (PIP (3:1)), including the compliance dates for certain regulated articles; and
  • Whether to consider additional or alternative measures or approaches.

EPA states that it will use the feedback received during the comment period to determine the best path forward, which could include amending the final rules to include additional or alternative exposure reduction measures or extending compliance dates for certain regulated products and articles.  Upon publication of the Federal Register notice, EPA will accept public comments for 60 days.
 
Stakeholders recently informed EPA that the prohibition on processing and distribution of PIP (3:1) could impact articles used in a wide variety of electronics, from cell phones, to robotics used to manufacture semiconductors, to equipment used to move COVID-19 vaccines and keep them at the appropriate temperature.  EPA states that stakeholders “note that the complexity of international supply chains makes locating the presence of, and finding alternatives to, PIP (3:1) in components challenging.”  According to EPA, stakeholders assert that an extension to the compliance deadline is necessary to avoid significant disruption to the supply chain for a wide variety of articles.  EPA states that it was not its intent during the development of the final rule to have such a broad disruptive impact.  Thus, EPA “is also announcing its expectation that this specific issue will be addressed as part of the broader re-examination of these rules.”  EPA “intends to extend compliance dates as necessary for the prohibitions on processing and distribution of PIP (3:1) for use in some articles, and some of the articles to which PIP (3:1) has been added.”
 
EPA states that for these same reasons, it is issuing a temporary 180-day “No Action Assurance” indicating that the agency will exercise its enforcement discretion regarding the prohibitions on processing and distribution of PIP (3:1) for use in articles, and the articles to which PIP (3:1) has been added.  EPA “is taking this action to ensure that the supply chain of these important articles is not interrupted while EPA continues to collect the information needed to best inform subsequent regulatory efforts and allow for the issuance of a final agency action to extend the March 8, 2021, compliance date as necessary.”


 

By Lynn L. Bergeson and Carla N. Hutton

On February 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that it is reviewing actions issued under the previous Administration and will take any needed steps to ensure that they protect human health and the environment.  The announcement included an update on the following chemical safety actions that have immediate or near-term effective dates or other steps associated with them.  According to the announcement, these actions, along with other chemical safety actions identified by the Biden-Harris Administration, “will undergo review (and, as necessary, revisions) to ensure they are protective of human health and the environment.”

PBT Final Rules

Under the Toxic Substances Control Act (TSCA), EPA was required to take expedited action on certain persistent, bioaccumulative, and toxic (PBT) chemicals and promulgate final risk management actions no later than the statutory deadline of December 2020.  As reported in our December 23, 2020, memorandum, EPA released on December 22, 2020, final rules under TSCA Section 6(h) for five PBT chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (86 Fed. Reg. 866); decabromodiphenyl ether (decaBDE) (86 Fed. Reg. 880); hexachlorobutadiene (HCBD) (86 Fed. Reg. 922); pentachlorothiophenol (PCTP) (86 Fed. Reg. 911); and phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894).  The final rules took effect February 5, 2021.  EPA states that it “is aware of concerns about these rules, including implementation issues, that have been raised by a range of stakeholders and may consider additional measures, approaches, or revisions that build upon the steps taken thus far.”

Dust Lead Post-Abatement Clearance Level (DLCL) Final Rule

In January 2021, EPA issued a final rule establishing lower clearance levels for the amount of lead that can remain in dust on floors and window sills after lead removal activities (abatement), strengthening lead regulations to protect children’s health.  86 Fed. Reg. 983.  The DLCL final rule goes into effect on March 8, 2021.  EPA states that it will continue to consider the DLCL final rule and the related final rule for Dust-Lead Hazard Standards, which was revised in 2019, as a part of its broader review of actions, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration.

TSCA Risk Evaluations and Risk Management for First Ten Chemicals

EPA issued final TSCA risk evaluations for the first ten chemicals starting in June 2020 and immediately began the risk management process for each of these chemicals.  According to EPA, while outreach and stakeholder engagement on risk management activities for these chemicals will continue to move forward, EPA “is actively reviewing the final risk evaluations in light of statutory obligations and policy objectives related to use of the best available science and protection of human health and the environment, in accordance with the Executive Orders and other direction provided by the Biden-Harris Administration.”  More information on the final risk evaluations is available in our memoranda available at https://www.lawbc.com/regulatory-developments/tsca.


 

By Lynn L. Bergeson and Carla N. Hutton
 
On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued final rules under Section 6(h) of the Toxic Substances Control Act (TSCA) for five persistent, bioaccumulative and toxic (PBT) chemicals -- 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP) (86 Fed. Reg. 866); decabromodiphenyl ether (decaBDE) (86 Fed. Reg. 880); hexachlorobutadiene (HCBD) (86 Fed. Reg. 922); pentachlorothiophenol (PCTP) (86 Fed. Reg. 911); and phenol, isopropylated phosphate (3:1) (PIP (3:1)) (86 Fed. Reg. 894).  TSCA required EPA to take expedited action on specific PBT chemicals to address risk and reduce exposures to the extent practicable.  EPA identified these five PBT chemicals for expedited action, following criteria outlined in TSCA.  The final rules limit or prohibit the manufacture (including import), processing, and/or distribution in commerce for the following:

  • DecaBDEA flame retardant in plastic enclosures for televisions, computers, audio and video equipment, textiles and upholstered articles, wire and cables for communication and electronic equipment, and other applications;
     
  • PIP (3:1)A plasticizer, a flame retardant, an anti-wear additive, or an anti-compressibility additive in hydraulic fluid, lubricating oils, lubricants and greases, various industrial coatings, adhesives, sealants, and plastic articles;
     
  • 2,4,6-TTBPAn intermediate/reactant in processing, and it is incorporated into formulations destined for fuel and fuel-related additives;
     
  • HCBDA chemical used as a halogenated aliphatic hydrocarbon that is produced as a byproduct during the manufacture of chlorinated hydrocarbons; and
     
  • PCTP:  A chemical used to make rubber more pliable in industrial uses.

The final rules will be effective February 5, 2021.  More information on the final rules is available in our December 23, 2020, memorandum, “EPA Releases Final TSCA Section 6(h) Rules for Five PBT Chemicals.”


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on December 8, 2020, that it received a complete manufacturer request to conduct a risk evaluation of octahydro-tetramethyl-naphthalenyl-ethanone (OTNE), a category of chemical substances consisting of four inseparable individual isomers.  International Flavors and Fragrances, Inc., Privi Organics USA Corporation, and DRT America, Inc. formally requested the risk evaluation through the OTNE Consortium managed by B&C® Consortia Management, L.L.C. (BCCM).  According to EPA, OTNE is used as a fragrance ingredient, and the four chemicals were identified in the 2014 Update to the Toxic Substances Control Act (TSCA) Work Plan.
 
EPA states that it “worked diligently with the manufacturers to ensure this request was high-quality, complete, and met all the necessary legal requirements.”  Two chemicals in the category are considered persistent, bioaccumulative, and toxic (PBT) chemicals under TSCA, and EPA describes this request for a manufacturer-requested risk evaluation as “part of EPA’s overall efforts to address PBTs.”
 
Within 15 business days of receiving a facially complete request, EPA must notify the public of receipt of the request under 40 C.F.R. Section 702.37(e)(2).  Within 60 business days of receipt of a facially complete request, EPA will submit for publication the receipt of the request in the Federal Register, open a public docket for the request, and provide no less than 45 calendar days for public comment.  The docket will contain the manufacturer request, EPA’s proposed additions of conditions of use, and the basis for those proposed additions.  During the public comment period, the public may comment on the request, as well as the additional conditions of use EPA proposes for inclusion.  After the comment period closes, EPA has up to 60 days to either grant or deny the request to conduct a risk evaluation under 40 C.F.R. Section 702.37(e)(6).


 

By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on September 20, 2019, that it will extend the public comment period for its proposed rule intended to reduce exposures to certain chemicals that are persistent, bioaccumulative, and toxic (PBT).  84 Fed. Reg. 36728.  EPA identified five chemicals pursuant to Section 6(h) of the Toxic Substances Control Act (TSCA):  decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)), also known as tris(4-isopropylphenyl) phosphate; 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The proposed rule would restrict or prohibit manufacture (including import), processing, and distribution in commerce for many uses of all of the chemicals except HCBD, for which EPA is proposing no regulatory action.  For the other four chemicals, the proposed rule includes recordkeeping requirements, as well as additional downstream notification requirements for PIP (3:1).  Comments are now due October 28, 2019.  EPA is required to issue a final rule by December 2020.  Our June 24, 2019, memorandum, “EPA Publishes Proposed PBT Chemicals Rule under TSCA,” provides a detailed review and analysis.

Tags: PBT, Section 6,

 
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