EPA Updates Safer Chemicals Ingredients List

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On September 23, 2023, EPA announced that it is adding 10 chemicals to the Safer Chemicals Ingredients List (SCIL), a list of chemicals which have been reviewed by EPA’s Safer Choice Program and meet its Safer Choice Criteria.  The chemicals on the list are considered to be among the safest chemicals for their functional use class (such as surfactants, solvents, or chelating agents), allowing manufacturers to choose the safest available chemicals for each type of ingredient in a product.

Manufacturers can apply to have chemicals added to the SCIL.  During the application process, a third-party profiles the substance and the Safer Choice Program assesses whether it meets Safer Choice criteria, which includes toxicity and fate standards.  Products containing chemicals that meet Safer Choice criteria may be eligible to enter into partnership with the program, which grants use of a Safer Choice product label.

According to EPA, the updated SCIL includes 1,071 substances.  The 10 chemicals added to the list in September 2023 are shown below.

List Name CAS Registry Number Functional Use Class
Fats and Glyceridic oils, vegetable, hydrogenated 68334-28-1 Emollients
Tocopherols 1406-66-2 Preservatives and Antioxidants
Sulfuric acid, dimethyl ester, compd. with .alpha.,.alpha.’,.alpha.”,.alpha.”’-[1,6-hexanediylbis(nitrilodi-2,1-ethanediyl)]tetrakis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] 247074-09-5 Polymers
Glycolipids, sophorose-contg., Candida bombicola-fermented, from D-glucose and mahua Madhuca longifolia fats and glyceridic oils 1573124-58-9 Surfactants
1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,2-ethanediol, .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) and 1,2-propanediol, ester with .alpha.-methyl-.omega.-hydroxypoly(oxy-1,2-ethanediyl) 152442-40-5 Polymers
Dodecanoic acid, ester with 1,2-propanediol 37321-62-3 Solvents
Diisopropyl succinate 924-88-9 Solvents
Diisopropyl sebacate 7491-02-3 Solvents
Methyl propanediol 2163-42-0 Solvents
Methyl ethyl ketone 78-93-3 Solvents

EPA Releases Draft Supplement for 1,4-Dioxane

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In July 2023, EPA announced the release of a draft supplement to the Risk Evaluation for 1,4-dioxane for public comment and peer review.  1,4-dioxane is solvent used to manufacture other chemicals such as adhesives and sealants.  It is also used as a processing aid and laboratory chemical. In addition, some manufacturing processes, such as the process used for making commercial and consumer dish soaps, result in the chemical being present as a byproduct.

The draft supplement focuses on air and water exposure pathways that were not included in the 2020 Risk Evaluation.  The 2020 Risk Evaluation focused on health risks to workers, consumers, and the general public, but not from drinking water, the air, or exposure where 1,4-dioxane is present as a byproduct.  The omission was identified by the Scientific Advisory Committee on Chemicals (SACC) as an oversight.  The SACC informed EPA that failure to assess the risks posed to the general population from exposure to the chemical may present a risk to human health – with an emphasis on drinking water as an exposure pathway.

The draft supplement identified cancer risk estimates higher than 1 in 10,000 for 1,4-dioxane present as a byproduct and higher than 1 in 1 million for general population exposure scenarios associated with 1,4-dioxane in drinking water sourced downstream of release sites and in air within 1 km of releasing facilities.

The draft supplement did note that the risk estimates include inherent uncertainties and the overall confidence in specific risk estimates fluctuates.  However, the document also stated that the information is beneficial in helping the Agency make a determination on whether the chemical poses an unreasonable risk to people with occupational exposure, through sources of drinking water, and breathing air near release sites.

EPA Sued Over Delayed Risk Evaluations

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Environmental groups have filed a lawsuit against EPA for failing to complete risk evaluations for 22 substances that may cause harm to humans and the environment.

Under section 6 of the Toxic Substances Control Act, EPA is required to conduct risk evaluations on “high priority” existing substances to determine whether they pose an unreasonable risk to human health or the environment.  Section 6(b)(4)(G) requires EPA to complete risk evaluations “as soon as practicable, but not later than 3 years after” they are initiated, with a one-time six-month extension possible.

According to the complaint, EPA missed this statutory 3.5-year deadline for 22 ongoing risk evaluations which were initiated in 2019 and early 2020.  Plaintiffs allege that this delay harms their members, staff, and children by prolonging their exposure to substances with serious health risks and by depriving them of information about their exposures.

The complaint seeks declaratory and injunctive relief, requesting that the U.S. District Court for the District of Columbia set deadlines for EPA to complete the risk evaluations.

The case is Community In-Power and Development Association v. EPA, No. 1:23‑cv‑02715-DLF.

EPA Proposes SNURs for Flame Retardants

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EPA has proposed significant new use rules (SNURs) for three flame retardants under the Toxic Substances Control Act (TSCA). The three flame retardants are tris(2-chloroethyl) phosphate (TCEP), tetrabromobisphenol A (TBBPA), and triphenyl phosphate (TPP).  All three substances are currently undergoing TSCA risk evaluations.  The proposed significant new uses are manufacture (including import) or processing for any use, except for those uses being considered in the risk evaluations.  In the Federal Register notice, EPA explained that significant new uses would encompass the following categories:

  • Manufacture and processing for uses that have ceased;
  • Manufacture and processing for uses that have not yet ceased but for which all manufacture and processing has ceased; and
  • Manufacture and processing for uses for which EPA has no information demonstrating that the use has previously commenced in the United States.

The Agency sought public comment on its description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses not identified by the Agency in the risk evaluation scope documents.

EPA noted that “The issuance of a SNUR is not a risk determination itself, only a notification requirement for ‘‘significant new uses,’’ so that the Agency has the opportunity to review the [Significant New Use Notification] for the significant new use and make a TSCA section 5(a)(3) risk determination.”  In other words, “Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence.”

In its discussion of the significant new use determination, EPA explained that the Agency considered information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA section 5(a)(2):

  • The projected volume of manufacturing and processing of a chemical substance,
  • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance,
  • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance and
  • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

According to the Federal Register Notice, current uses of TCEP are as follows:  TCEP is imported into the United States and processed for commercial use in paints and coatings, for industrial or commercial use in polymers for use in aerospace equipment and products, and for commercial use as a laboratory chemical.

EPA found that TBBPA is currently manufactured (including imported) in the United States. It is processed as a reactant or intermediate to create other flame retardants; incorporated into formulation, mixture, or reaction products; and incorporated into articles. The Agency noted that the predominant uses for TBBPA are as a reactive flame retardant in electrical and electronic products and as an additive flame retardant in electrical and electronic products. In addition, epoxy resin containing TBBPA can be used in adhesives, laminate for aviation and automobile interiors and building/ construction materials.

The Agency reported that TPP is manufactured (including imported) in the United States.  It is processed as a reactant; incorporated into formulation, mixture, or reaction products; and incorporated into articles.  Commercial uses include in plastic and rubber products and in paints and coatings. The chemical is also used in lubricants and greases.  In addition, consumer uses were reported in foam seating and bedding products.

Comments can be viewed in docket EPA–HQ–OPPT–2023–0012 at regulations.gov.

EPA Launches New Interface for the Chemicals and Products Database

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EPA has released a beta version of ChemExpo, a free, publicly available web application that allows users to explore and visualize data on how chemicals are used in commerce.

ChemExpo will serve as a user-friendly interface for EPA’s Chemicals and Products Database (CPDat).  According to EPA, CPDat maps “more than 49,000 chemicals to a set of terms categorizing their usage or function in 16,000 consumer product types (e.g., shampoo, soap) based on what chemicals they contain.”  EPA characterizes this data, which is curated from public documents, as addressing important gaps in the exposure information needed to evaluate chemicals’ safety under the Toxic Substances Control Act.

The ChemExpo team welcomes comments and feedback on the beta, particularly regarding functionality and usability.

EPA Requests Information on Addressing PFAS in the Environment for the Superfund Program

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EPA has published a notice of proposed rulemaking, Addressing PFAS in the Environment, asking for public input, which the Agency will use to develop future per- and polyfluoroalkyl substance (PFAS) regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The Agency asked for information on the potential future hazardous substance designation of a number of PFAS, categories of PFAS, and several PFAS precursors.

Request for Public Input Regarding Potential Future Hazardous Substance Designation of Seven PFAS

EPA had previously proposed designating PFOA and PFOS and their salts and structural isomers as hazardous substances under CERLA. The present notice requested feedback as to whether the agency should initiate action designating an additional seven PFAS and their salts and structural isomers or a subset thereof as CERCLA hazardous substances as well. The seven PFAS being considered for designation are:

  • Perfluorobutanesulfonic acid (PFBS), CASRN 375–73–5
  • Perfluorohexanesulfonic acid (PFHxS), CASRN 355–46–4
  • Perfluorononanoic acid (PFNA), CASRN 375–95–1
  • Hexafluoropropylene oxide dimer acid (HFPO–DA), CASRN 13252–13–6
  • Perfluorobutanoic acid (PFBA) CASRN 375–22–4
  • Perfluorohexanoic acid (PFHxA) CASRN 307–24–4
  • Perfluorodecanoic acid (PFDA) CASRN 335–76–2

EPA asked interested parties to submit information on whether any of these compounds may present substantial danger to public health or welfare or the environment. Such information could include data on mobility, persistence, and prevalence.

Request for Public Input Regarding Potential Future Hazardous Substance Designation of Precursors to PFOA, PFOS, and PFAS

The Agency is also considering initiating action that would designate certain PFAS precursors as hazardous substances under CERCLA. To make this determination, EPA requested information to help the Agency identify compounds that degrade to these PFAS through environmental processes such as biodegradation and hydrolysis.

Request for Public Input Regarding Potential Designation, or Designations, of Categories of PFAS as Hazardous Substances

Additionally, EPA is considering initiating action that would designate groups or categories of PFAS as CERCLA hazardous substances. These groups or categories would be based on characteristics that determine risk to human health and the environment, such as chemical structure, physical and chemical properties, mode of toxicological action, and precursors or degradants. To inform its decision-making, the Agency solicited the following information:

  • Published scientific literature that can inform whether categories of PFAS could or could not be designated as hazardous substances. This could include findings on the similarities or differences of a specific characteristic among PFAS. Also useful would be data on the relationship between different characteristics, such as the relationship between chemical structure and specific chemical, physical, or toxicological properties.
  • Other information that could inform EPA’s determination of whether to designate one or more categories of PFAS as hazardous substances.
  • Information that would contribute to economic analysis of the potential costs and benefits, including impacts on small entities, associated with a potential rulemaking designating categories of PFAS as hazardous substances. (Although CERCLA section 102(a) precludes EPA from taking cost into account in the designation of a hazardous substance, the Agency is requesting this information to help the Agency understand the potential costs and benefits associated with any potential future regulatory action.)

The deadline for submitting comments was extended from June 12 to August 11, 2023, during which period over 600 comments were submitted. The comments can be reviewed here.

EPA Releases Draft IRIS Assessment of PFHxS and Related Salts

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On July 24, 2023, EPA released a draft IRIS Toxicological Review of Perfluorohexanesulfonic Acid (PFHxS) and Related Salts.  Comments on the draft assessment will be accepted through September 22, 2023.

The IRIS assessment found that, given sufficient exposure conditions, PFHxS is likely to cause thyroid and developmental immune effects in humans.  Other evidence suggests but is insufficient to infer that PFHxS exposure might cause teratological, hepatic, neurodevelopmental, and cardiometabolic effects in humans.  EPA concluded that there is inadequate information to assess whether PFHxS exposure can result in hematopoietic, reproductive, renal, and carcinogenic effects.

PFHxS is one of three PFAS currently undergoing IRIS assessments, along with PFNA and PFDA.  EPA previously published final IRIS assessments for two other PFAS: PFBA in December 2022 and PFHxA in April 2023.

EPA Faces Lawsuit for Classifying Water Filtration System as a Pesticide Product

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The U.S. District Court for the Northern District of Texas will be tasked with determining whether EPA’s Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) enforcement actions against Berkey, a water filters brand, were arbitrary and capricious in the case Shepherd v. Regan.  The case concerns seven Stop Sale, Use and Removal Orders (SSUROs) issued by EPA against third-party distributors and manufacturers of Berkey water filtration products due to their alleged use of silver as an unregistered antimicrobial pesticide.

The complaint does not deny the presence of silver in Berkey products.  However, the plaintiffs say that they are unaware of any instances where a Berkey-authorized entity claimed that the silver in their products was “used for any purpose other than to protect the filter itself.”  This is significant because articles treated with a FIFRA-registered pesticide for the purpose of protecting the article are exempt from FIFRA under the treated articles exemption at 40 CFR 152.25.

The plaintiffs argue that the orders were the result of an unlawful reinterpretation of a 2007 notice, which clarified EPA’s position that equipment that uses electrodes to emit ions for pesticidal purposes is a “pesticide,” rather than a “device,” under FIFRA.  The complaint alleges that EPA reinterpreted this notice without opportunity for public comment to “now apply to the presence of inert silver in water filters.”

In its response, EPA argues that the plaintiffs—which do not represent Berkey itself—lack standing.  The Agency also characterizes the 2007 notice referenced in the complaint as a “straw man” with no bearing on the case.  EPA does not believe there is any ambiguity regarding the distinction between “pesticides” and “devices,” arguing that EPA has excluded water filters containing pesticidal substances from its interpretation of “devices” since 1975.

EPA focuses on claims made by the SSURO recipients, which allegedly advertised that Berkey filters removed viruses and pathogenic bacteria.  The Agency has long held that such public health claims make a product ineligible for the treated article exemption, EPA says.  Combined with knowledge of the presence of silver in the products, and no pesticide registration, EPA argues that it had “reason to believe” (the requirement for issuance of an SSURO) that the substances were sold in violation of FIFRA.

DuPont De Nemours Inc. Sues EPA Regarding GenX Test Order

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Earlier this year, the US Court of Appeal for the Third Circuit ordered EPA to provide documentation regarding the Agency’s decision to order DuPont De Nemours Inc. to provide information on GenX chemicals through two section 4 test orders under the Toxic Substances Control Act (TSCA). DuPont brought this case to challenge the testing requirements imposed on the company, asserting that EPA had incorrectly identified the company as a manufacturer of the chemicals identified in the test orders:  hexafluoropropylene oxide (also known as trifluoro(trifluoromethyl)oxirane) and 6:2 Fluorotelomer sulfonamide betaine, two GenX chemicals. The test orders required testing on the inhalation effects toxicity of the chemicals in order to enable EPA to further understand protentional risks posed to human health and the environment. In addition to the cost of the toxicity studies, the manufacturers subject to the orders were assessed a fee of $11,650 to be split evenly amongst them.

After receiving the order to provide documentation, EPA requested several time extensions, but eventually stipulated to an agreement dismissing the case. The motion filed in May 2023 released DuPont from the test orders on 6:2 fluorotelomer sulfonamide betaine and hexafluoropropylene oxide. The Court then dismissed the case.

Audit Finds EPA’s New Chemicals Program Lacks Sufficient Guidance

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On August 2, 2023, EPA’s Office of Inspector General (“OIG”) released a report on its audit of EPA’s New Chemicals Program. The audit identified recordkeeping and quality assurance issues with the program as administered by EPA’s New Chemicals Division (“NCD”). The audit, which began in October 2021, was conducted in response to several internal complaints submitted to OIG.

The New Chemicals Program reviews whether new chemicals or significant new uses of existing chemicals pose an “unreasonable risk” to human health or the environment under the Toxic Substances Control Act (“TSCA”). According to the report, NCD did not have finalized, up-to-date guidance for recordkeeping or for many of the steps in the new chemicals review process, contrary to EPA protocol.  OIG stated that these issues resulted from insufficient staff resources, which prevented NCD from both conducting the chemical reviews within statutory time frames and finalizing guidance for the activities composing the review process. The report also found frequent technical issues with NCD’s TSCA Confidential Business Information systems.

Some of the complaints to OIG alleged that staff were pressured to focus on deadlines rather than chemicals’ potential risks during the new chemical review process. However, OIG found no evidence of this; for example, the report notes that NCD employees were not evaluated on the speed at which they reviewed chemicals.

OIG made the following four recommendations to EPA’s Office of Pollution Prevention and Toxics (“OCSPP”) based on its findings:

  1. Develop a plan to regularly review NCD’s guidance documents,
  2. Develop a plan to periodically assess the effectiveness of NCD’s recordkeeping system,
  3. Develop a plan to identify the root causes of the technical issues, and
  4. Conduct periodic reviews of NCD’s workload.

OCSPP’s response, which was included in the report, agreed with each of OIG’s recommendations and proposed corrective actions in line with the recommendations.

This audit was not the first to find issues with EPA’s implementation of TSCA provisions. A 2019 GAO report identified similar issues, such as insufficient guidance and resources, with the new chemicals review process. In 2020, OIG found that EPA had missed deadlines on existing chemical risk evaluations and that EPA’s ability to meet future deadlines was at risk. EPA has since proposed a fee adjustment designed to increase TSCA fee collections. Most recently, in February 2023, GAO determined that EPA had missed most TSCA deadlines for reviewing new and existing chemicals.  In general, EPA agreed in part or in full when recommendations were made in these reports and corrective actions have been completed or are pending.