EPA Releases Proposed Rule on Regulatory Requirements for New HAP Additions

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Last month, EPA published a proposed rule that would amend the National Emission Standards for Hazardous Air Pollutants (NESHAP) to facilitate the addition of pollutants to the list of Hazardous Air Pollutants (HAP) under the Clean Air Act (CAA).  The proposed rule seeks to address applicability and compliance issues that EPA identified following the Agency’s 2022 decision to add 1-bromopropane (“1-BP”) to the list of HAP, which was the first addition to the HAP list since its inception in 1990.  Comments on the proposed rule are due on November 13, 2023.

The proposed rule makes the following clarifications:

  • EPA proposes language clarifying that a new HAP would not be regulated under NESHAP promulgated before the effective date of the listing.
  • EPA states that beginning on the effective date of the listing, a new HAP must be included in calculating a facility’s actual emissions, potential emissions, and whether a facility is considered an area source or a major source under CAA. Any facility that becomes a major source under CAA section 112 solely due to the addition of a new HAP, known as a major source due to listing (“MSDL”) facility, will need to evaluate whether any major source NESHAP applies to its operations.  EPA proposes that each MSDL facility be considered an “existing source” under CAA section 112, a designation that typically results in less stringent NESHAP emissions standards.  EPA also proposes that MSDL facilities would not be subject to the original NESHAP compliance schedules, which in many cases would require instantaneous compliance, and instead proposes that these facilities be subject to new deadlines based on the nature of the NESHAP emissions limitations or requirements.
  • When a facility triggers one or more major source NESHAP, it is required to submit an initial notification under each newly applicable NESHAP. EPA proposes that MSDL facilities include a statement that the facility is a major source due to HAP listing in their notification.

The proposed rule does not include any changes to the CAA Title V program.  MSDL facilities that do not elect to reduce their emissions to non-major levels would be required to apply for a Title V operating permit.  Though the proposed rule focuses on the immediate compliance obligations following the addition of a new HAP, EPA states that “future actions within NESHAP will address rule-specific issues,” such as identifying emissions sources and promulgating standards for new HAP.

1-BP was added to the Toxics Release Inventory list of reportable chemicals in 2015.  According to EPA’s website, the Agency “is now in the process of writing a proposed rule to take action to regulate 1-BP” following EPA’s 2022 determination that the chemical poses an unreasonable risk to human health.

EPA Proposes Revisions to the Air Emissions Reporting Requirements

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On August 9, 2023, EPA released a lengthy proposed rule revising the Air Emissions Reporting Requirements (AERR), which requires state, local, and some tribal agencies (“States”) to collect and report data on air pollutant emissions to EPA.

Perhaps most importantly, the proposed rule would require the reporting of point source emissions of Hazardous Air Pollutants (HAP), as enumerated in Clean Air Act section 112(b) and amended in 40 CFR 63 Subpart C.  EPA is proposing to expand the definition of “point source” accordingly to include certain emitters of HAP pollutants.  Owners/operators of point sources would be required to report HAP data directly to EPA unless a State chooses to report these emissions on behalf of owners/operators of point sources within the State.

In addition to the reporting of HAP, EPA proposes that:

  • Owners/operators of point sources report performance test results and performance evaluations that meet certain criteria;
  • States report data on “small generating units” that operate at point sources and meet specific criteria, and
  • Point source reporting should be done for the same sources every year, eliminating the current triennial approach that requires more facilities to be reported every third year by making the triennial year thresholds permanent, among a myriad of other changes.

The comment period for the proposed rule was extended until November 17, 2023.  Though the proposed changes have varying implementation dates, most importantly, most facilities would be required to begin submitting HAP data for the 2026 inventory year.

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

DOJ Files Lawsuit Against eBay for Environmental Violations

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On behalf of EPA, the Department of Justice (DOJ) has filed a lawsuit against the online retailer eBay for selling and distributing “hundreds of thousands of products” that allegedly violate the Clean Air Act (CAA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the Toxic Substances Control Act (TSCA).

DOJ first alleges that eBay violated the CAA by selling or causing the sale of over 343,000 automotive aftermarket defeat devices.  These devices, which are often advertised as vehicle power enhancers, “can cause motor vehicles to emit hundreds to thousands of times more pollution than a motor vehicle with properly functioning emission controls,” the complaint says.  DOJ alleges that each aftermarket defeat device sold, offered for sale, or caused to sell by eBay constitutes a violation of CAA section 203(a)(3)(B), which forbids selling or offering to sell a motor vehicle part that bypasses an emission-related element of design.

Second, the complaint alleges that eBay committed a series of FIFRA violations by selling or distributing a minimum of 23,000 unregistered, misbranded, or restricted use pesticide products.  DOJ also alleges 8,074 violations of a Stop Sale, Use, or Removal Order (SSURO) issued by EPA in 2020 (and amended in 2021), which identified some of these allegedly unlawful pesticide products.  Among the products sold in alleged violation of the SSURO was an insecticide containing dichlorvos, which DOJ characterizes as highly dangerous, and a “disinfection card” claiming to protect users from COVID-19 when worn around their neck.

Finally, eBay is being sued under TSCA for violating a 2019 rule prohibiting the manufacture, processing, and distribution of products containing methylene chloride for consumer paint and coating removal.  The TSCA section 6(a) rule was the result of EPA’s determination that those uses pose an unreasonable risk of injury to health due to methylene chloride’s acute human lethality.  According to the complaint, eBay has distributed over 5,600 items in violation of the rule.

The lawsuit seeks injunctive relief to prevent eBay from further selling products violating the CAA, FIFRA, and TSCA.  The complaint additionally requests civil penalties for each of the CAA violations, which could amount to $5,580 per violation.

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.

Environmental Groups Call on FDA to Revoke Approval of Fluorinated Plastic for Food Contact

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A coalition of environmental and health groups led by the Environmental Defense Fund have petitioned the Food and Drug Administration (FDA) to revoke approval of fluorinated polyethylene as an indirect food additive.  According to the petition, manufacture of fluorinated polyethylene produces PFAS, including harmful perfluoroalkyl carboxylic acids if water or oxygen is present.

FDA approved fluorinated polyethylene as an indirect food additive—a substance that comes into contact with food, but is not intended to be added directly to food—in 1983.  Since then, according to the petition, the dangers of even minimal exposures to PFAS have become clear, and studies have demonstrated that fluorinated polyethylene results in PFAS migration into food.

The petitioners argue that the substance can no longer be considered “safe” as defined at 21 CFR 170.3(i), which requires “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.”  The Agency must consider the following factors when determining whether this safety standard is met:

  • The probable consumption of the substance and any substance formed in or on food because of its use.
  • The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in the diet.
  • Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food ingredients, are generally recognized as appropriate.

The petitioners also claim that revoking approval for fluorinated polyethylene is the logical consequence of a previous FDA statement on the substance.  In a 2021 public letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles, the Agency stated that its regulations “[do] not authorize fluorination of polyethylene containers in the presence of water, oxygen, or gases other than nitrogen.”  The petition, however, alleges that all nitrogen gas contains water and oxygen as impurities.  “If FDA is serious about its claim that no oxygen or water may be present in the nitrogen gas, then the agency has effectively determined that the 1983 approval should be revoked,” the petitioners state.

The petition comes after a July 2022 FDA request for information on food contact uses of fluorinated polyethylene due to PFAS concerns.

DOD and FAA Approve Use of a PFAS-Free Fire Suppressant

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This September, the Department of Defense (DOD) announced the approval of the first PFAS-free foam for firefighting activities at military installations.  The approval is an important step in phasing out the use of PFAS-containing aqueous film forming foams (AFFFs), which are used to extinguish liquid fires.

The day after the foam received DOD approval, the Federal Aviation Administration (FAA) notified airports that they could use it.  FAA is not currently requiring exclusive use of the PFAS-free foam, however.

The transition away from PFAS-containing foams is required by section 322 of the 2020 National Defense Authorization Act.  Among other deadlines, the act prohibits DOD from purchasing fire-fighting foams containing more than 1 part per billion PFAS beginning October 1, 2023.

DOD issued a performance specification for PFAS-free (also known as fluorine-free) foams in January of this year.  According to DOD’s announcement, several other fluorine-free foams are currently being tested for conformance with the specifications.

 

 

EPA Settles with Kyocera After Self-Disclosure of TSCA Violations

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On September 5, 2023, EPA signed a consent agreement with Kyocera International, Inc. (“Kyocera”) over three alleged violations of the Toxic Substances Control Act (TSCA). Kyocera’s civil penalty was reduced to $105,937 because of EPA’s audit policy, which rewards companies that “voluntarily discover, promptly disclose and expeditiously correct” violations with reduced fines.

The alleged violations, which pertain to six unnamed chemicals (Chemicals A, B, C, D, E, and F), are as follows:

  1. Importation of Chemical A at least 12 times, Chemical B at least 21 times, and Chemical C at least 18 times without first filing a premanufacture notice (PMN) or an exemption to PMN requirements, in violation of TSCA section 5(a)(1);
  2. Failure to comply with recordkeeping requirements for Chemical D and E’s polymer exemptions to PMN requirements, in violation of TSCA section 5(a)(1); and
  3. Importation of Chemical A at least 12 times, Chemical B at least 21 times, and Chemical C at least 18 times without submission of proper certifications prior to the importation, and importation of Chemical F three times without providing a positive TSCA certification statement for each import, in violation of TSCA section 13(a)(1)(B).

The electronics manufacturer corrected the alleged violations by ceasing importation of Chemicals A, B, C, and D, submitting low-volume exemptions to PMN requirements for Chemicals B and C (which were granted by the Agency), and complying with the polymer exemption requirements for Chemical D. Under the terms of the settlement, EPA gave Kyocera permission to release its self-imposed quarantined stocks of Chemicals B, C, and D.

Kyocera self-disclosed the violations on June 23, 2021, with supplemental information provided in March 2023. The company disclosure and subsequent corrective action satisfied all of EPA’s audit policy conditions except the requirement that the violations be uncovered by “systematic discovery” and was therefore eligible for a 75% reduction in the gravity-based portion of the civil penalty.

The consent decree comes after a June 30, 2022, EPA Inspector General report which found that eDisclosure, EPA’s violation self-disclosure system, “does not have adequate internal controls in place to ensure that the EPA’s screening process is effective and that significant concerns . . . are identified and addressed.” EPA agreed with all four of the report’s recommendations and proposed corrective actions, including the development of national guidance and eDisclosure-specific training for EPA staff who monitor eDisclosure submissions.

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.

CPSC Publishes Request for Information Regarding PFAS in Consumer Products

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On September 20, 2023, the Consumer Product Safety Commission (CPSC) published a request for information (RFI) in the Federal Register for information on PFAS in consumer products. The RFI requests information from all stakeholders, including “consumers, manufacturers and importers, government agencies, non-governmental organizations, and researchers.”

The requested information falls into three categories:

  1. Use or potential use of PFAS in consumer products, including information about the definition of PFAS, identification of specific PFAS potentially used or present in consumer products, and information about which PFAS or consumer products CPSC should prioritize in future assessments, among other information;
  2. Potential human exposures to PFAS associated with consumer products use, including information about the potential for exposure and risk from the presence of PFAS in consumer products, among other information; and
  3. Potential adverse human health effects informed by toxicological data, including reports that could inform whether individual PFAS or categories of PFAS have the potential for adverse human health effects, and information on additional data sources that CPSC should consider.

The Federal Register notice also announced the availability of a contract report that CPSC commissioned to characterize the use of PFAS in consumer products, identify PFAS regulations and restrictions, and summarize recent hazard, exposure, and risk assessments on PFAS. The contract report ultimately identified 863 PFAS with reported use or detection in consumer products. The RFI instructs reporting entities to consider information already available to CPSC in the contract report when reporting information.

CPSC does not explicitly state what it plans to do with the collected data in the RFI but states that the contract report “identif[ies] possible next steps.” The next steps identified by the contract report include research (such as developing a consensus on the definition of PFAS), new regulations, and consumer awareness.

The RFI comes after Minnesota, Maine, and other states passed regulations limiting the use of PFAS in consumer products. CPSC will accept the requested information through November 20, 2023.