EPA Proposes Addition of 12 Chemicals to Toxic Chemical List

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

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.

EPA PFAS Strategic Roadmap

EPA has compiled a roadmap outlining Key Actions to address the risks posed by PFAS.  The roadmap identifies key actions under TSCA and other statutes including the Clean Water Act, the Safe Drinking Water Act, and Superfund.

TSCA

The roadmap calls for EPA to “close the door” on abandoned PFAS; i.e., PFAS chemicals that are no longer produced.  Many of these substances have no restrictions under TSCA.  This leaves the door open for manufacturers to start producing the chemicals again.  The roadmap intends for EPA to designate all uses of these substances that are not current uses as Significant New Uses.  This will allow EPA to review and make determinations on the potential risks, and require safety measures, before allowing the manufacturing of those chemicals again.   The roadmap states that EPA plans to implement this action item during the summer of 2022.

There is an ongoing goal of completing toxicity assessments for two PFAS known as GenX chemicals.  EPA also has a goal to publish health advisories for GenX chemicals and PFBS in Spring 2022.

Other actions under TSCA include

  • Publish national PFAS testing strategy,
  • Review previous decisions on PFAS, and
  • Finalize new PFAS reporting under TSCA Section 8.

TRI

Another key action in the roadmap is for EPA to categorize PFAS on the Toxic Release Inventory (TRI) as “Chemicals of Special Concern” and to remove the de minimis eligibility from supplier notification requirements for all Chemicals of Special Concern.  Adding PFAS to TRI has a projected completion goal of 2022.

CWA

The roadmap calls for restricting PFAS discharges from industrial sources through a multi-faceted Effluent Limitations Guidelines (ELG) program.  EPA plans to undertake rulemaking to restrict PFAS discharges from organic chemicals, plastics and synthetic fibers, metal finishing, and electroplating operations.  A proposed rule for plastics and synthetic fibers is expected in Summer 2023, and a rule for metal finishing and electroplating is expected in Summer 2024.  Other industries EPA is considering issuing PFAS ELGs for include electrical and electronic components, textile mills, and landfills.

SDWA

EPA has goal to establish a national primary drinking water regulation for PFOA and PFOS.  EPA regulates drinking water for over 90 contaminants but that does not include any for PFAS.  EPA expects to issue a proposed regulation in Fall 2022.  The agency has a statutory deadline of March 2023 to complete this action.

Superfund

EPA is developing a Notice of Proposed Rulemaking to designate PFOA and PFOS as CERCLA hazardous substances.  This would require facilities to report on PFOA and PFOS releases that meet or exceed set reportable quantities.  The proposed rulemaking will be available for public comment in Spring 2022.   EPA is also asking for public comment on designating additional PFAS as hazardous substances under CERCLA.

CAA

The Clean Air Act requires EPA to regulate emissions of hazardous air pollutants, which do not currently include PFAS.  EPA plans to identify sources of PFAS air emissions, concentration levels, and cost-effective mitigation technologies.

PCRRTK Friday Forum with Tala Henry and Jeff Dawson on PFAS

Join the ABA/SEER’s Pesticide, Chemical Regulation, Right-to-Know Committee for a remote Friday Forum with EPA’s Tala Henry, Deputy Director, Office of Pollution Prevention & Toxics, and Jeff Dawson, Deputy Director, Health Effects Division, Office of Pesticide Programs for an overview of EPA’s PFAS Roadmap with emphasis on OCSPP key activities. The program will be held on Friday, December 17th 11-12 pm ET. There is no charge for participation. RSVP to ihantman@verdantlaw.com if you would like to attend.

EPA Extends Submission Deadline for Health and Safety Studies on 50 Chemicals

EPA is allowing manufacturers and importers additional time to submit unpublished health and safety studies’ data for 50 chemicals.  The new deadline for 20 of the 50 chemicals is December 1, 2021, updated from September 27, 2021.  The new deadline for the remaining 30 chemicals is January 25, 2022.  The 20 chemicals in the first group fall into the category of high priority for risk evaluation – note that EPA explains that being classified as high priority does not necessarily mean that a chemical is high risk.  These chemicals are currently undergoing Risk Evaluation under TSCA.  The Health and Safety studies will help EPA prepare scoping documents that identify the hazards, exposures, conditions of use of the chemicals, and potential exposures to them.

The 30 chemicals in the second group are organohalogen flame retardants.  These chemicals are being evaluated by the Consumer Product Safety Commission, which is a member of TSCA’s Interagency Testing Committee.

Additional information on the reporting requirements for the 50 chemicals can be found here and additional information on initial addition of the chemicals to the list here.

EPA Releases Final Scope Documents Under New Policy

On August 31, 2021, EPA released Toxic Substance Control Act (TSCA) final scope documents for diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP).  The final scope documents are the first to implement the Agency’s new policy for considering exposure to the chemicals from media that are regulated outside of TSCA including air and water, including drinking water.  In a press release on the path forward for risk evaluations, the Agency noted that the previous administration’s “…approach to exclude certain exposure pathways also resulted in a failure to consistently and comprehensively address potential exposures to potentially exposed or susceptible subpopulations, including fence-line communities (i.e., communities near industrial facilities).”  Both risk evaluations were requested by the manufacturer, ExxonMobil, through the American Chemistry Council’s High Phthalates Panel (ACC HPP).

The scope documents for these risk evaluations includes the following information: the conditions of use, potentially exposed or susceptible subpopulations (PESS), hazards, and exposures that EPA plans to consider, along with a description of the reasonably available information and science approaches EPA plans to use in the risk evaluations, a conceptual model, an analysis plan, and the plan for peer review of the draft risk evaluation for this category of chemical substances.

Some of these conditions of use were identified in the manufacturer request as circumstances on which EPA was requested to conduct a risk evaluation. EPA identified other conditions of use from information reported to EPA through Chemical Data Reporting (CDR), published literature, and consultation with stakeholders for both uses currently in production and uses whose production may have ceased

EPA plans to evaluate releases to the environment as well as human and environmental exposures resulting from the conditions of use of these substances that EPA plans to consider in the risk evaluation.  In addition to including occupational exposure, consumer and bystander exposure, and PESS, the scope of the risk evaluations will include general population exposures.  Specifically, EPA plans to evaluate general population exposure to the substances via the oral route from drinking water, surface water, groundwater, ambient air, soil, fish ingestion, and human breast milk; via the inhalation route from air and drinking water; and via the dermal route from contact with drinking water, surface water, groundwater and soil.

In addition to considering the data and information sources provided by the ACC HPP submissions, EPA conducted a comprehensive search to identify and screen multiple evidence streams (i.e., chemistry, fate, release and engineering, exposure, hazard) to inform the development of these scoping documents.

EPA Requires Reporting on Fifty Chemicals

On June 29, 2021 EPA finalized a rule that requires manufacturers of 50 chemicals to report health and safety studies data to the EPA.  This rule was issued under the Toxic Substances Control Act (TSCA), section 8(d) and pertains to 20 chemicals EPA designated as high-priority for risk evaluation and 30 chemicals that are organohalogen flame retardants.  EPA is also requiring manufacturers to report unpublished studies for the chemicals relating to environmental effects, occupational, general population, and consumer exposure.

The TSCA Interagency Testing Committee added these 50 chemicals to their Priority Testing Lists in its 69th through 74th reports, which led to the issuing of this rule.  EPA’s goal with this rule is to determine if there is an unreasonable risk to health or environment under the chemical’s conditions of use.  Additionally, this information will be considered in situations, as applicable, in read across and category development for assessing new chemicals.  The final rule is effective July 29, 2021.

False Claims Suit Against Danimer Scientific

Danimer Scientific is facing a federal securities class action after an investor, Darryl Keith Rosencrants, filed a suit against the manufacturer in May, 2021.  The suit is a result of severe stock price drops after the publication of articles alleging the manufacturer made false claims on their products.  Danimer maintains that their claims are accurate.

Danimer sells polyhydroxyalkanoates (PHAs) under their brand name Nodax.  These PHAs are used in the creation of various plastic items, such as water bottles, straws, and food containers.  Danimer claims on their website that their Nodax products are 100 percent renewable and biodegradable in marine, freshwater, and soil environments.  They further state that the biodegradability due to certain microorganisms means the Nodax products have the possibility to biodegrade in landfills.

The plaintiff alleges Danimer overstated and exaggerated claims on the biodegradability of Nodax in oceans and landfills.  The plaintiff further claims that these statements led to an inflated value of the company and resulted in the severe drop in stock price once publication reported on the issue.  An article published in the Wall Street Journal on March 20, 2021 states Danimer made misleading claims and cites at least one expert calling Nodax’s biodegradability “not accurate” and “greenwashing”.  When stock trading opened again, Danimer’s value dropped 12.87 percent.

Spruce Point Capital Management, an investment firm, published a report critical of Danimer on several issues, including degradability, on April 22, 2021.  Throughout the trading day, the stock dropped 8.04 percent.  From March 20, 2021 to April 22, 2021, the total drop in value was 54 percent.  The Plaintiff and other Class members are claiming losses and damages due to the precipitous decline of Danimer’s market value securities.

Confidential Status Change of TSCA Chemicals

The confidential business information status of chemicals on the TSCA Inventory is scheduled for change, removing the confidential chemical identity status for 390 chemicals.  This will move the chemicals to the public portion of the TSCA Inventory.  During the 2012, 2016, and 2020 reporting periods, one or more manufacturers reported these chemicals as non-confidential, which is a result of at least one of these manufacturers not reporting a previous confidential chemical as confidential.

EPA recognizes that some manufacturers may have simply been in error for not reporting their chemicals as confidential.  However, EPA states that for each of the 390 chemicals, there is independent reporting based and EPA validated reasons to include the chemicals on the list.  EPA intends to move these chemicals from the confidential chemical identity status of the TSCA Inventory to the public portion sometime during the summer of 2021.

EPA also recognizes stakeholder interest in the status change for these chemicals and has given June 30, 2021 as a deadline for interest, questions, or concerns regarding the change.

Policy Changes for PFAS Entering the Market

On April 27, 2021 EPA announced policy changes regarding new PFAS prior to the chemicals entering the market.  Previously, low volume exemptions were allowed for some new PFAS.  EPA will implement new rules for reviewing and managing the low volume exemption requests.  After receiving the request, EPA has 30 days to conduct the review and determine if the chemical in the request could cause serious human health effects or significant environmental effects.  If either of the effects are determined, or if the process would take more than 30 days, the request is denied.

EPA stated it is unlikely to grant any low volume exemptions for PFAS due to the chemicals’ history of damaging health effects and the complexity of the process resulting in longer than 30 days to complete a review.  Denying these lengthy process reviews of PFAS allows the EPA to devote more time on pre-manufacture notice review processes and mitigate potential risks of the chemicals.  EPA is also looking for way to work with companies which have been granted low volume exemptions for PFAS and have them voluntarily withdraw their low volume exemptions.