EPA Releasing Additional Data on the Ongoing Uses of Chrysotile Asbestos

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On March 17, 2023, EPA released additional data for public comment related to the proposed risk management rule for chrysotile asbestos. The proposed rule, introduced in April 2022, aims to prohibit the ongoing use of the only known form of asbestos currently imported into the United States, chrysotile asbestos. The Agency claims that if implemented, the rule will protect people from the unreasonable risk to human health presented by chrysotile asbestos. EPA evaluated human health risks for chrysotile asbestos in Part 1 of the Risk Evaluation for Asbestos; and is currently working on Part 2 of the Risk Evaluation for Asbestos. That document will evaluate legacy uses and associated disposals, including other types of asbestos fibers in addition to chrysotile.

EPA originally proposed that the prohibition on the commercial use of chrysotile asbestos would occur two years after the effective date of the final rule to give facilities time to transition away from asbestos technology. However, after the comment period, EPA received comments and met with stakeholders, including affected industry and other interested groups, about the use of chrysotile asbestos diaphragms in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. Raw chrysotile asbestos currently imported into the U.S. is used exclusively by the chlor-alkali industry. It is a main component of systems used for the disinfection of drinking water, but most chlor-alkali plants no longer use asbestos diaphragms, and alternatives are available.

Many commenters argued that the two-year timeline would not provide the chlor-alkali industry with a reasonable transition period and requested additional time to allow the industry to transition away from asbestos-containing diaphragms.  According to EPA, a letter from the Asbestos Disease Awareness Organization (ADAO) provides contrasting information that shows that the chlor-alkali industry has shut down a substantial portion of its asbestos diaphragm production capacity in the last three years and is in the process of transitioning to non-asbestos membrane technology.

EPA is seeking comments on how to consider the additional information received regarding maintaining the prohibition compliance dates, staggering the prohibition compliance dates, or establishing longer deadlines for the prohibition on processing, distribution in commerce, and commercial use of chrysotile asbestos. EPA also seeks comments on the new information provided regarding the practicability of measuring 0.005 fibers per cubic centimeter (f/cc) and 0.0025 f/cc for an eight-hour work shift by existing sampling and analytical protocols. Further, the Agency requests suggestions as to how EPA could effectively implement interim exposure reduction requirements in a way that they are compatible with Occupational Safety and Health Administration (OSHA) requirements and industrial hygiene practices.

EPA states that the Agency plans to use the data it collects during this comment period in the development of the final rule, including the proposed chrysotile asbestos prohibition compliance dates for these uses.

EPA Proposes PFAS Drinking Water Standard

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On March 14, EPA released a proposed rule establishing national drinking water standards for PFAS. The proposed rule is part of the Agency’s PFAS Strategic Roadmap. It seeks to regulate PFOA and PFOS as individual contaminants and four additional PFAS (PFNA, PFHxS, PFBS, and GenX chemicals) as mixtures. EPA intends to regulate PFOA and PFOS at the lowest level of which they can be reliably measured, which the Agency has determined to be 4 parts per trillion.

For the additional four PFAS, EPA proposed maximum concentration limits (MCLs) for any mixture containing one or more of these substances. This would require water systems to use an approach called Hazard Index Calculation to determine if the combined levels of these PFAS pose a potential risk. Hazard Indexing is a tool used to evaluate the health risks of simultaneous exposure to mixtures of related chemicals. To determine the Hazard Index for these four PFAS, water systems would  be required to monitor drinking water and compare the amount of each PFAS in the water to its associated Health-Based Water Concentration (HBWC). HBWCs are the levels at which no health effects are expected.

In remarks accompanying the Agency’s press release on the proposed rule, Administrator Michael S. Regan commented, “EPA’s proposal to establish a national standard for PFAS in drinking water is informed by the best available science and would help provide states with the guidance they need to make decisions that best protect their communities. This action has the potential to prevent tens of thousands of PFAS-related illnesses and marks a major step toward safeguarding all our communities from these dangerous contaminants.”

The proposed rule is causing great concern in the wastewater utility and chemicals industries.  They are apprehensive about the logistical and financial hurdles that  implementing the rule would entail. Both the American Chemistry Council and the National Association of Water Companies, a trade group representing investor-owned utilities, have voiced concerns, claiming that compliance with the rule will cost billions of dollars. The Agency is actively working with financial institutions to help utilities in vulnerable communities with limited resources comply with the rule and claims $9 billion is already earmarked for this purpose from bills approved by Congress since 2021.

Additional information can be found in EPA’s Proposal to Limit PFAS in Drinking Water Fact Sheet.

EPA Finds TCE as a Whole Chemical Substance an Unreasonable Risk to Human Health

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Earlier this year, EPA announced the final revision to the risk determination for trichloroethylene (TCE) risk evaluation issued under the Toxic Substances Control Act (“TSCA”). EPA found that TCE presents unreasonable risks to the health of workers, occupational non-users, consumers, and bystanders. The risks identified include adverse human health effects unrelated to cancer, such as neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposures to TCE and risks for cancer from chronic inhalation and dermal exposures to TCE. The revised risk determination supersedes the conditions of use (“COU”) specific “no unreasonable risk” determinations that the EPA previously issued in its 2020 TCE risk evaluation.

TCE is a volatile organic compound (“VOC”) used mostly in industrial and commercial processes. Consumer uses include cleaning and furniture care products, arts and crafts, spray coatings, and automotive care products like brake cleaners. EPA determined that 52 of the 54 COUs evaluated drive the unreasonable risk determination.

EPA states that it used the whole chemical risk determination approach for TCE because there are benchmark exceedances for multiple COUs spanning across most aspects of TCE’s life cycle, from manufacturing (including import), processing, commercial use, consumer use, and disposal for health of workers occupational non-users (workers nearby but not in direct contact with this chemical), consumers, and bystanders. EPA holds that this approach is appropriate because the health effects associated with TCE exposures are “severe and potentially irreversible,” including developmental toxicity, reproductive toxicity, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, and cancer. EPA notes that the revised risk determination for TCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE). EPA states that as it moves forward with a risk management rulemaking for TCE, it will “strive for consistency with existing OSHA requirements or best industry practices when those measures would address the identified unreasonable risk.

Additionally, EPA stated it is conducting a screening-level approach to assess potential risks from the air and water pathways for several of the first 10 risk evaluation chemicals, including TCE. The goal of the screening approach is to evaluate the surface water, drinking water, and ambient air pathways for TCE that were excluded from the 2020 risk evaluation and to determine if there are risks that were unaccounted for in that risk evaluation. EPA expects to describe its findings regarding the chemical-specific application of this screening-level approach in its proposed risk management rule for TCE.

EPA Releases Proposed Approach for Considering Cumulative Risks Under TSCA

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EPA recently released two documents regarding cumulative risk assessments under TSCA section 6, Draft Proposed Principles of Cumulative Risk Assessment Under the Toxic Substances Control Act, and Draft Proposed Approach for Cumulative Risk Assessment of High-priority Phthalates and Manufacturer-Requested Phthalate under the Toxic Substances Control Act. The first document details a set of principles for evaluating the cumulative risk of substances under TSCA; the second document presents a proposed approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals which are currently undergoing TSCA section 6 risk evaluation.

In the  Draft Proposed Principles of Cumulative Risk Assessment Under TSCA, EPA explained that it plans to alter its approach to individual substance evaluations under TSCA section 6 by taking a cumulative assessment approach when appropriate. Previously, the Agency looked at the risks posed by a single substance under its specific conditions of use. The Agency now intends to implement a new approach to evaluating human health effects, which it believes is more appropriate when considering human exposure to these substances. People are often exposed to many chemical substances with similar effects at the same time, and looking at the combined exposure health risk will paint a more complete picture. The Agency believes that this approach will allow for more effective mitigation of identified unreasonable risks and provide particularly useful information for communities that face higher than normal levels of chemical pollution.

Phthalates will be subjected to a cumulative risk assessment because the group of substances has similar effects on human health and has generally been found concurrently in the human body. The phthalates to be assessed as a group include DEHP, BBP, DBP, DIBP, DCHP, DINP, and DIDP. The chemical group is often used in industrial and consumer products to make plastics more flexible and durable. The draft proposal requests comment and peer review on its assessment that six phthalate substances are toxicologically similar, and the U.S. population is frequently co-exposed to these substances, making a cumulative risk assessment the most appropriate course of review action under TSCA.

The Agency is accepting comments on these documents through April 28, 2023.

EPA Issues SNUR for Inactive PFAS

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On January 26, 2023, EPA proposed a significant new use rule (SNUR) for PFAS substances that are currently classified as “inactive” on the TSCA Inventory. A substance is considered inactive on the TSCA Inventory when it has not been manufactured, imported, or processed in the U.S. since 2006. When the rule is finalized, anyone who wants to begin any manufacturing, importing, or processing activity involving any of these PFAS substances would be subject to the SNUR and would be required to obtain permission from EPA via a Significant New Use Notification (SNUN) at least 90 days before commencing the said activity. EPA would then review and make an affirmative determination as to whether the activity detailed in the SNUN presents an unreasonable risk to human health or the environment. EPA proposes some exceptions from the SNUR requirement, including when one of these PFAS are present as an impurity or byproduct and when the substances are imported or processed as part of an article.  Comments on the proposed rule are being accepted until March 27, 2023.

EPA to Begin Rulemaking to Regulate PFAS in Effluent Discharges

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EPA has announced that it will begin a rulemaking to regulate PFAS in landfill leachate discharges. Pursuant to the 2021 Preliminary Effluent Guidelines Program Plan, EPA has been collecting data on wastewater discharges from the Landfills Point Source Category (40 CFR part 445), with a focus on PFAS discharges. EPA refers to this data collection as the Landfill Leachate Detailed Study. The goals of the study were to understand the total number and location of landfills discharging leachate, characterize PFAS leachate effluent from regulated landfills, and identify current wastewater treatment technologies and management practices at these landfills.

Study results on effluent from 200 landfills revealed that 95 percent of the facilities discharged PFAS. The detections included 63 different PFAS with average concentrations for an individual compound as high as 14,000 part-per-trillion (ppt). This announcement was included in the Agency’s Effluent Guidelines Program Plan, which was released last month. The Effluent Guidelines Program Plan explains that

The details of the pending rulemaking and how the proposed rule could impact daily landfill operations are limited, but EPA commented that landfill operators are likely able to treat PFAS with technologies onsite. These technologies could include granular active carbon, ion exchange, and reverse osmosis. Further, the timing of the rule is uncertain as the Agency awaits other PFAS decisions, such as the anticipated regulation of PFAS designation as hazardous substances under RCRA and CERCLA.

Through the Effluent Guidelines Program Plan, the Agency is pursuing additional PFAS-related actions as well, including:

  • Data gathering on textile mills’ use and treatment of PFAS in the industry and associated PFAS discharges.
  • Initiation of a Publicly Owned Treatment Works (POTWs) Influent Study on PFAS, which will focus on gathering nationwide data on industrial discharges of PFAS to POTWs. The focus of the study will be to verify current sources of PFAS wastewater and document new PFAS water sources.
  • Continuing monitoring PFAS use and discharges from the Pulp, Paper, and Paperboard Category (40 CFR part 430).
  • Continuing monitoring of PFAS use and discharge at airports.

EPA Requests Comments on New Approach Methodologies (NAMs) White Paper

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EPA published a draft white paper, New Approach Methodologies (NAMs) in the Endocrine Disruptor Screening Program (EDSP) and is requesting public comment. The white paper was developed pursuant to the Federal Food, Drug, and Cosmetics Act (“FFDCA”), which requires EPA to develop a screening program to determine whether certain substances may have effects in humans that is similar to an effect produced by naturally occurring estrogen or other endocrine effects. The white paper states that some NAMs are acceptable alternatives for certain EDSP Tier 1 assays. Other NAMs may be useful for prioritization purposes and weight of evidence evaluations. The EPA press release discussing the draft white paper states that it will “reinvigorate [EPA’s] efforts to meet its requirement for EDSP screening of chemicals and continue to provide transparency of EDSP Tier 1 testing, which is the step in the EDSP that determines the potential for endocrine-disrupting effects and whether there is a need to obtain more data by requiring additional Tier 2 tests.” Tier 1 screenings are used to identify substances that have the potential to interact with the endocrine system, while Tier 2 screenings are used to identify adverse endocrine-related effects caused by a substance.

Currently, each chemical undergoing ESDP Tier 1 methods can take up to six years, and the cost to the industry of each chemical review is roughly $1 million, due significantly to vertebrate testing. Certain validated NAMs included in the white paper will allow EPA to use alternatives to vertebrate animal testing and other in vitro assays, ultimately allowing the Agency to review chemicals faster, more efficiently, and at a lower cost to the Agency.

EPA Releases PFAS Analytic Tools

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On January 5, EPA released its PFAS Analytic Tools database, a collection of PFAS information the Agency has brought together from internal Agency databases, other federal agencies, and state and tribal agencies. The data will be particularly useful to the Agency when it reviews submissions on  PFAS releases from the Toxics Release Inventory (“TRI”) reporting.  In addition, EPA expects that the database will benefit state, local, and tribal governments in navigating the PFAS-related requirements they are subject to.  The Agency also expects that the database will help communities gain a better understanding of local PFAS releases.

The database has 11 tabs that include:

  • An integrated map,
  • Drinking water contamination, production,
  • Wastewater and/or stormwater discharge monitoring,
  • Superfund sites,
  • Industry sectors in which PFASs were manufactured or used as raw materials, and
  • toxic releases.

In its press release on the database and on the database interface itself, the Agency identifies several data gaps. For example, the drinking water Unregulated Contaminant Monitoring Rule (“UCMR”) data was collected only between 2012 and 2015. EPA notes that state agencies and public water systems may have better data on PFAS levels in drinking water. Additionally, only a few states have set PFAS effluent limits for National Pollutant Discharge Elimination System (“NPDES”) permit holders, causing significant gaps in discharge monitoring. (The Agency has initiated rulemaking to increase monitoring effluent for PFAS.

Each tab identifies relevant data gaps and limitations.

The Agency is taking steps to fill these data gaps, including:

  • Initiating rulemaking to increase monitoring effluent for PFAS;
  • Publishing the fifth Unregulated Contaminant Monitoring Rule, which will significantly increase the number of drinking water samples collected by regulated entities (EPA predicts the number of samples collected will be in the millions);
  • EPA’s proposal to designate PFAS as hazardous substances under CERCLA; and
  • EPA’s recent proposal to change PFAS reporting requirements in the TRI data collection.

EPA recently held a webinar introducing the database and demonstrating its use.  A recording of the webinar is available here. A copy of the Agency’s presentation is available here.

EPA Issues Next Test Order Under National PFAS Testing Strategy — PFAS Used in Plastics at Issue

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EPA has issued its second round of Test Orders under its National PFAS Testing Strategy. The test orders require companies to conduct and submit testing on trifluoro (trifluoromethyl) oxirane (HFPO) (CASRN 428-59-1), a PFAS substance used in making plastics. According to EPA’s Chemical Data Reporting (CDR) database, more than 1,000,000 points of HFPO are manufactured each year. EPA has concluded, using existing hazard and exposure data, that HFPO may present an unreasonable risk of injury to health or the environment, finding that exposure may result in neurotoxicity, reproductive effects, and cancer. The Tier 1 testing will address human health from exposure via inhalation and hydrolysis. Tier 2 testing, if required, will look at reproductive toxicity, developmental neurotoxicity, and carcinogenicity.

The companies that are subject to the test order include The Chemours Company, DuPont De Nemours Inc., E.I. du Pont de Nemours and Company, and 3M Company. These companies are required to submit the results of testing data to EPA within 415 days of the effective date of the order. All data produced from this test order will subsequently be published on EPA’s website.

EPA Publishes Final IRIS Assessment of PFBA

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In December, EPA published the IRIS Toxicological Review of Perfluorobutanoic Acid and Related Salts. The Agency’s assessment addresses potential cancer and noncancer human health effects of exposure to perfluorobutanoic acid (PFBA) and its related salts. The most significant of the IRIS findings is that sufficient oral exposure to PFBA likely causes disruptions to normal thyroid hormone production, liver damage, and developmental effects. The Agency stated there was inadequate evidence to determine whether reproductive effects might represent a potential human health hazard following PFBA exposure.

PFBA and its related salts are members of the PFAS family.  It is a breakdown product of other PFAS that are used in a variety of products, including stain-resistant fabrics, carpets, and paper food packaging. PFBA can also be used in the manufacturing process of photo film and is used as a substitute for a type of PFAS, longer chain perfluoroalkyl carboxylic acids in consumer products. The substance can accumulate in agriculture crops, household dust, soils, food products, and surface, ground, and drinking water. Exposure to PFBA can occur through inhalation of indoor or outdoor air, ingesting contaminated drinking water and food, and dermal contact with PFBA-containing products.

As part of its PFAS Strategic Roadmap, EPA has been actively working on IRIS assessments for five PFAS: PFBA, PFHxA, PFHxS, PFNA, and PFDA. The PFBA IRIS is the first in this series to be released.