PIP (3:1) Compliance Date Extended to October 31, 2024

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On January 6, 2021, EPA issued a rule limiting manufacturing, importing, processing, and distribution of products containing phenol, isopropylated phosphate (3:1) (PIP (3:1)).  That rule was scheduled to take effect on February 5, 2021, with a March 8, 2021, compliance date.  After this date, companies would be prohibited from processing and distributing PIP (3:1) and PIP (3:1)-containing products unless there was an applicable exclusion.  Furthermore, after the compliance date, the rule prohibited the release of PIP (3:1) into water during manufacturing, processing, and distribution.  This final rule also required commercial users to follow existing regulations and best practices to prevent the release of PIP (3:1) and products containing PIP (3:1) into water.  On March 8, 2022, the effective compliance date of the rule was extended to October 3, 2024.

The March 2022 extension applies to the following consumer and commercial goods: cellular telephones, laptop computers, electronic devices, and industrial and commercial equipment used in various sectors including transportation, life sciences, and semiconductor production.  Notably, this is not an exhaustive list of the goods affected by the rule.  This extension follows the publication of the initial rule in January 2021, no action assurance issued in March 2021, and the September 2021 extension which expired on March 8, 2022.  These milestones are discussed in greater detail below.

In January 2021, EPA released risk management rules under the Toxic Substances Control Act (TSCA) intended to mitigate exposure to five chemicals that are persistent, bioaccumulative and toxic (PBT).  The five chemicals listed under this rule are decabromodiphenyl ether (DecaBDE); phenol, isopropylated phosphate (3:1) (PIP (3:1)); 2,4,6-tris (tert-butyl) phenol (2, 4, 6-TTBP); hexachlorobutadiene (HCBD); and pentachlorothiophenol (PCTP).  The rules were designed to either limit or prohibit manufacturing, importing, processing, and distributing the aforementioned chemicals.  Following the publication of these rules, EPA received numerous comments from manufacturers and processors of PIP (3:1) asserting that the March 8, 2021, compliance date did not provide stakeholders with enough time to find viable chemical substitutes.  Consequently, on March 8, 2021, EPA provided a no action assurance letter on enforcement of the rule.  The no action assurance expired on September 4, 2021.  Subsequently, on September 17, 2021, EPA issued a short-term extension of specific compliance deadlines for the processing and distribution of PIP (3:1) and articles containing PIP (3:1) to March 8, 2022. On March 8, 2022, a further extension was granted, which moved the compliance deadline to October 31, 2024.

EPA Implements Collaborative Research Program to Support PMN Reviews

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On February 24, EPA announced a new effort “to modernize the process and bring innovative science to the review of new chemicals.”  In addition, the effort is expected to “increase the transparency of the human health and ecological risk assessment process.”  The Office of Chemical Safety and Pollution Prevention (OCSPP) is collaborating on this effort with the Agency’s Office of Research and Development (ORD) and other federal entities including the National Toxicology Program at the National Institute of Environmental Health Sciences.

The draft Strengthening the Science and Process to Evaluate New Chemicals Under TSCA; TSCA New Chemicals Collaborative Research Program: Problem Statement, Vision and Action Plan was released for public comment on March 9.  Written comments will be accepted through April 26, 2022.  In addition, stakeholders may comment at a virtual public meeting on April 20 and 21, 2022.  Instructions for registering for the meeting are available here.

EPA explains that the Collaborative Research Program (CRP) “will refine existing approaches and develop and implement new approach methodologies (NAMs) to ensure the best available science is used in TSCA new chemical evaluations.”  Components of this effort include:

  • Updating the methodology for using data from analogous chemicals to determine potential risks from new chemicals where health effects data on the new substance are not available.
  • Updating and augmenting the models used for predicting a chemical’s physical-chemical properties and environmental fate/transport, hazard, exposure, and toxicokinetics.
  • Developing a decision support tool to integrate the information streams used in new chemical risk assessments into a final risk assessment.

The docket for this effort is EPA-HQ-OPPT-2022-0218.

 

Litigation Over the De Minimis Concentration and Alternate Threshold Exemptions in the PFAS TRI Reporting Rules

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On January 20, 2022, the National PFAS Contamination Coalition, Sierra Club, and Union of Concerned Scientists (collectively the “Coalition”) filed a complaint in the District Court for the District of Columbia challenging two final rules promulgated by EPA related to TRI PFAS Reporting.  Specifically, the Coalition asserts that two rules violate the National Defense Authorization Act for Fiscal Year 2020 (NDAA) by allowing two exemptions to the Act’s PFAS reporting mandate — the de minimis concentration and alternate threshold exemptions.  These rules are “Implementing Statutory Addition of Certain Per- and Polyfluoroalkyl Substances; Toxic Chemical Release Reporting” (85 Fed. Reg. 37,354) and the “Implementing Statutory Addition of Certain Per- and Polyfluoroalkyl Substances (PFAS) to the Toxics Release Inventory Beginning With Reporting Year 2021” (86 Fed. Reg. 29,698) (collectively the “TRI PFAS Rules”).

According to the Coalition, allowing the de minimis exemption means that PFAS otherwise subject to the rule “will not be reported to the TRI because they are used in mixtures in low concentrations —even where the total amount of the PFAS manufactured, processed, or otherwise used is well over the 100-pound threshold set by Congress.”  The compliant further explains that the alternate threshold exemption permits covered facilities that release and disposal of less than 500 pounds per year of a TRI-listed PFAS to submit “a bare-bones certification rather than the detailed toxic chemical release form, reducing the information disclosed to the public.”

Adopting these rules without allowing for notice and opportunity for comment, promulgation violated the notice and comment provisions of the Administrative Procedure Act, according to the Coalition.  The Coalition further asserts that the NDAA did not authorize EPA to allow an exemption for de minimis concentrations.  Nor, according to the Coalition, does the NDAA allow for alternate threshold exemptions.  The Coalition argues that “the TRI PFAS Rules are also arbitrary and capricious because they are premised on the idea that communities do not need to know about releases of small amounts of toxic chemicals, or even releases of large amounts where the chemical of concern is present in low concentrations, flouting evidence that exposure to even extremely low levels of PFAS is dangerous.”

The complaint argues that Plaintiffs’ members are deprived of critical information by the de minimis concentration and alternate threshold exemptions.   According to the Coalition, the exemptions deprive Plaintiffs of knowledge about the toxic air and water pollution that they and their families are exposed to, which impairs their ability to advocate for stronger protections from that pollution.  The absence of these data also impairs Plaintiff’s ability to “conduct the research and analysis needed to inform communities and guide policy development.”

As previously posted, EPA complied a roadmap outlining key actions and commitments on PFAS for 2024.  This roadmap states that EPA intends to propose a rulemaking in 2022 to remove the “de minimis eligibility” from supplier notification requirements for Chemicals of Special Concern for TRI reporting, and categorize PFAS as such.

Four PFAS Added to TRI

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On January 28, EPA announced the addition of four per- and polyfluoroalkyl substances (PFAS) to the Toxics Release Inventory (TRI) list.  These additions were prompted by the fiscal year 2020 National Defense Authorization Act (NDAA).  Section 7321 of the NDAA provides a framework for adding PFAS to the TRI.  Specific PFAS were added to the TRI by the act including perfluorooctanoic acid (PFOA) and its salts and perfluorooctane sulfonic acid (PFOS) and its salts. These were added to the TRI list on January 1.

The NDAA mandates the addition of other PFAS substances to the TRI list when they are the subject of certain regulatory actions.  Such actions include finalizing a toxicity value, issuing a significant new use rule (SNUR), and the addition of a PFAS substance to an existing significant new use rule.  The reporting requirement goes into effect January 1 the year following the regulatory action.

In April 2021, EPA finalized a toxicity value for perfluorobutane sulfonic acid (PFBS) (CASRN 375-73-5) and potassium perfluorobutane sulfonate (CASRN 29420-49-3). These two PFAS substances are being added to the TRI list because EPA finalized a toxicity value. PFBS-based compounds are replacement chemicals for PFOS, a chemical that the primary U.S. manufacturer voluntarily phased out by 2002.

A third PFAS, a substance being regulated by an existing SNUR, was designated as “active” on the TSCA Inventory.  Therefore, this substance has also been added to the TRI.

The fourth PFAS is a substance for which EPA had to review CBI claims before adding it to the TRI list: CASRN 203743-03-7.  The NDAA provides for Agency review of any CBI claims before adding any PFAS to the TRI list whose identity is listed on the confidential Inventory.  For this substance, CBI claims were “declassified.”

Reporting requirements for these PFAS substances are in effect for 2022.  Facilities that manufacture, process or otherwise use more than 100 pounds of any listed PFAS substance during 2022 are required to submit an EPCRA Section 313 report.  Reporting for calendar year 2022 is required by July 1, 2023.  Reports are submitted through EPA’s CDX TRIMEweb.

EPA Announces Order for PFAS Testing – Response to Petition from Public Health and Environmental Justice NGOs

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On December 28, 2021, EPA announced that the Agency was granting a petition from several North Carolina public health and environmental justice organizations to require companies to conduct health and toxicity testing of certain PFAS.  In its announcement, EPA explained that the petitioners’ request “plays a key role in advancing the Agency’s plans for a National PFAS Testing Strategy.”

The National PFAS Testing Strategy requires PFAS manufacturers to provide EPA with toxicity data and other information on categories of PFAS.  This approach breaks the thousands of PFAS into categories based on characteristics and assesses what data are presently available for each category.  The test data will eventually be used to inform regulatory efforts to protect human health and the environment.

The petition asking the Agency to require testing on the health and environmental impacts of 54 PFAS was first submitted in October 2020.  The petition was submitted by the Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance.   The petition identified the 54 substances at issue as PFAS manufactured by the Chemours Company.   In January 2021, the previous Administration denied the petition.  In March 2021, the petitioners asked EPA to reconsider its denial.  In September 2021, EPA agreed to do so “in light of the change in administration and in policy priorities concerning PFAS.”

In granting the petition, EPA is requiring testing under the National PFAS Testing Strategy.  EPA’s first test orders under the Testing Strategy, for 24 categories of PFAS, will provide human health hazard data that covers 30 of the 54 petition chemicals.  Nine of the PFAS identified in the petition belong to a single category included in the Testing Strategy.  EPA is assessing if the existing data is sufficient and will likely order testing in the future.  EPA explained that the 15 remaining petition chemicals do not fit the definition of PFAS used in developing the Testing Strategy.  However, the Agency will analyze available data on these substances to inform later phases of testing.

In response to the petition, EPA also announced that the Agency is taking part in and analyzing many ongoing human studies on PFAS.  This includes evaluations of potentially exposed workers and communities in North Carolina.

The petition requested the development or submission of analytical standards with the test orders.  In response, EPA is requesting comment on whether to require the submission of existing analytical methods for PFAS.  This would occur through a future PFAS rulemaking.

The Agency’s press release on the petition quotes Administrator Michael S. Regan: “By taking action on this petition, EPA will have a better understanding of the risks from PFAS pollution so we can do more to protect people.”

OIG to Audit EPA New Chemicals Review

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EPA’s Office of Inspector General (OIG) has informed the Office of Chemical Safety and Pollution Prevention (OCSPP) that it will audit EPA’s process for conducting reviews of new TSCA chemicals (i.e., substances submitted to the Premanufacture Notification (PMN) and PMN exemption processes).  This is a self-initiated audit to accomplish OIG’s oversight plan for fiscal year 2022, to address ensuring safe use of chemicals, and to address complaints from the OIG Hotline.  OIG seeks to determine the extent EPA is following records-management requirements, quality-assurance requirements, and employee performance standards.  OIG will also be looking at how EPA manages human health and environmental risks for approving new chemicals under TSCA.

OIG has asked OCSPP to assist in expediting the audit by providing all materials, handbooks, and anything related to the review of new chemicals; the resource allocations for chemical review from fiscal years 2018 through 2021; scopes of work for any contracts related to chemical review; any guidance they have received on chemical review; and new chemicals review program organization charts before and after the October 2020 reorganization.

OIG notes authority under the Inspector General Act of 1078, as amended, to have timely access to their requests and personnel.  In addition to the Inspector General Act, in its request, OIG references EPA Manual 6500 and statements from Administrator Michael S. Regan.

EPA Announces Improvements to the TSCA Risk Evaluation Process  

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On December 20, 2021, EPA released a draft TSCA Systematic Review Protocol. In its announcement on the new Protocol, the Agency explained that the Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform TSCA Risk Evaluations and ensure that EPA has the best tools under TSCA to protect human health and the environment.  The draft protocol comprises nearly 700 pages.

The draft Protocol notes that EPA’s Office of Pollution Prevention and Toxics (OPPT) applies systematic review principles in the development of its Risk Evaluations of existing chemicals.  It provides specific systematic review approaches which they use for identifying and evaluating evidence for the hazard and exposure assessments that support Risk Evaluations. OPPT added that the draft Protocol responds to key recommendations received from the National Academies of Sciences, Engineering, and Medicine (NASEM).

The Protocol was developed in response to NASEM’s critique that EPA had not previously documented how TSCA prioritization and problem formulation relate to the TSCA Systematic Review.  The Protocol aligns the TSCA prioritization and scoping processes with the steps of the Protocol.  In addition, the Protocol defines how EPA’s systematic review efforts will identify data gaps and data needs in the Risk Evaluations process.  OPPT explains that identifying these data gaps and data needs will provide the Agency with the information it needs “to strategically exercise TSCA authorities to require testing or information collection for use in TSCA prioritization and Risk Evaluation.”

The Protocol reports that for the 20 high-priority substances currently undergoing Risk Evaluation and substances undergoing manufacturer-requested Risk Evaluation, EPA has implemented a new, unified literature search process.  This process, as described in the Protocol, uses chemical identifiers to maximize the capture of relevant literature, which in turn provides consistency and efficiency to the literature search.  In addition, OPPT announced that the Protocol includes new methods to reduce bias and improve evaluation through the use of calibration exercises and data evaluation training for reviewers.  This is a response to NASEM recommendations, SACC comments, and public comments.

In addition, the Protocol includes a description of the evidence integration process.  A step that was not part of the 2018 TSCA systemic review document. This addition was also made in response to recommendations by the NASEM and the SACC. OPPT explains that the Protocol’s evidence integration approach relies on methods related to those in EPA’s IRIS Handbook.

The draft protocol will undergo peer review by at a meeting of the SACC on April 19-21, 2022.  OPPT noted that the agency will use this feedback to further improve the document. The date, time for the public peer review virtual meeting will be announced on the SACC website.

Ending Inventory Correction for Substances Listed to the Initial TSCA Inventory

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On February 24, 2022, EPA announced that is revoking the process for correcting the substance identities of substances that were incorrectly described when they were listed on the initial TSCA Inventory in 1978.  Guidelines for Inventory correction were published in 1980 when the Agency recognized that a number of the substances reported to the initial Inventory had been unintentionally, incorrectly described.  Starting on April 26, 2022, companies will be required to submit a premanufacture notice (PMN) in order to request a change to the chemical identity of a substance listed on the Inventory.  Until that time, EPA will continue to accept correction requests that meet the 1980 guidelines.

In its announcement, EPA noted that the 1980 guidelines did not identify a time period during which corrections to the Inventory could be submitted.  However, EPA stated they never intended for the correction period to be indefinite, noting that companies have had more than 40 years since the 1980 publication of the revised TSCA Inventory to make corrections.

EPA stated they will continue to initiate Inventory corrections for substances that it determines were unintentionally misidentified.  For those cases, EPA may request information from a company to support an Inventory correction in lieu of requiring a PMN.  The announcement noted that the revocation will not affect regular maintenance of the Inventory which does include updates to substance identity nomenclature.

EPA Proposes Addition of 12 Chemicals to Toxic Chemical List

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EPA is proposing to add 12 chemicals to the list of toxic chemicals which are subject to the reporting requirements under the Emergency Planning and Community Right-to-Know Act (EPCRA), section 313.  Under EPCRA section 313(e)(1), any person may petition EPA to add chemicals to or delete chemicals from the list. EPA issued a statement of policy in the Federal Register of February 4, 1987 (52 FR 3479) (FRL-3101-6) providing guidance regarding the recommended content of and format for petitions.  Additionally, EPA believes one chemical should be classified as a persistent, bioaccumulative, and toxic (PBT) chemical.  The Toxics Use Reduction Institute filed a petition for EPA to consider 25 chemicals for inclusion the toxic chemicals list. EPA reduced the list to 12 because the other chemicals did not meet the statutory criteria listed below.

The chemicals substance identities and CASRNs are:

  • 1-Bromopropane; 106-94-5
  • Dibutyltin dichloride; 683-18-1
  • 1,3-Dichloro-2-propanol; 96-23-1
  • Formamide; 75-12-7
  • 1,2,5,6,9,10-Hexabromocyclododecane; 3194-55-6
  • 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta[g]-2-benzopyran (HHCB); 1222-05-5 (PBT chemical identified by EPA)
  • N-Hydroxyethylethylenediamine; 111-41-1
  • Methylhexahydrophthalic anhydride; 25550-51-0
  • Nitrilotriacetic acid trisodium salt; 5064-31-3
  • Nonylphenol; 25154-52-3
  • p-(1,1,3,3-Tetramethylbutyl)phenol; 140-66-9
  • 1,2,3-Trichlorobenzene; 87-61-6
  • Triglycidyl isocyanurate; 2451-62-9
  • Tris(2-chloroethyl) phosphate; 115-96-8
  • Tris(1,3-dichloro-2-propyl) phosphate; 13674-87-8
  • Tris(dimethylphenol) phosphate; 25155-23-1

EPCRA section 313 allows for the addition of chemicals if they meet one of three different requirements: acute human health effects criterion, chronic human health effects criterion, and environmental effects criterion.   Substances can be added to the section 313 list if:

  • The chemical can reasonably be anticipated to cause significant health issues in humans, existing beyond the facility site, as a result of continued releases.
  • The chemical can reasonable be anticipated to cause cancer, reproductive issues, neurological disorders, heritable genetic mutations, or other chronic health effects in humans.
  • The chemical can reasonably be anticipated to cause a significant adverse effect on the environment to due to its toxicity that it warrants reporting under this section in the judgment of the Administrator.

EPA believes these 12 chemicals in moderately low to low doses/concentrations each meet at least one of the criteria. EPA is proposing a 100-pound reporting threshold for HHCB because it has been shown to be bioaccumulative in aquatic species with bioconcentration factor values greater than 1,000.  The threshold for reporting non-PBT, toxic chemicals is 10,000 pounds of the chemical used at a facility per year.

White House Plan to Combat PFAS

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The White House announced a multi-agency plan to address the risks posed by PFAS.  The plan involves eight federal agencies including the Departments of Agriculture, Defense, Agriculture, Homeland Security, and Health and Human Services (HHS).   The White House explained that “To safeguard public health and protect the environment, the efforts being announced will help prevent PFAS from being released into the air, drinking systems, and food supply, and the actions will expand cleanup efforts to remediate the impacts of these harmful pollutants.”

A key element in this plan is EPA’s PFAS Roadmap, which addresses PFAS through a number of environmental statutes from TSCA to the Safe Drinking Water Act.

The White House Council on Environmental Quality (CEQ) Chair Brenda Mallory will lead the newly-formed Interagency Policy Committee on PFAS. The committee on PFAS will work to coordinate and help develop new policy strategies to support research, remediation, and removal of PFAS in communities across the country.

The White House Fact Sheet also identified efforts underway at the DOD, FDA, and other HHS agencies.

DOD is conducting PFAS cleanup assessments at the nearly 700 DOD installations and National Guard locations where PFAS were used or may have been released.  The Department expects to complete its initial assessments by the end of 2023.  In addition, DOD manages a large research and development program on PFAS detection, treatment, and destruction—with $70 million devoted to a PFAS-free replacement firefighting foam.

The FDA will expand its testing of the food supply to advance efforts to estimate dietary exposure to PFAS from food.  In addition, FDA will report on the process of phasing out sales of certain PFAS from food contact uses, following the 3-year phase out agreements reached with certain manufacturers in 2020.  Outreach efforts are also underway to ensure that companies are reminded of packaging requirements that are intended to reduce human exposure to PFAS.  The FDA will also monitor the presence of and potential exposure to PFAS in cosmetics.

HHS will review the research on human health and PFAS.  This includes a study by two HHS agencies, Centers for Disease Prevention and Control (CDC) and Agency for Toxic Substances and Disease Registry (ATSDR), in eight states that will provide information about the health effects of PFAS exposure.