EPA Issues First PFAS Test Order

WEDNESDAY, JUNE 8, 2022


On Monday (June 6), the U.S. Environmental Protection Agency issued its first Toxic Substances Control Act test order under the National Testing Strategy for per- and polyfluoroalkyl substances found in commercial fire fighting foam and other uses.

The PFAS testing strategy was recently released to help identify PFAS data needs and requires testing to fill those gaps. The initiative is part of the EPA’s PFAS Strategic Roadmap, which sets timelines from 2021 to 2024 to take specific actions and commit to bolder new policies to safeguard public health, protect the environment and hold polluters accountable.

“For far too long, families across America, especially those in underserved communities, have suffered from PFAS. High-quality, robust data on PFAS helps EPA to better understand and ultimately reduce the potential risks caused by these chemicals,” said EPA Administrator Michael S. Regan. “Our communities deserve transparency from the companies that use or produce these substances about their potential environmental and human health impacts.”

PFAS Testing Background

In October 2020, the Center for Environmental Health, Cape Fear River Watch, Clean Cape Fear, Democracy Green, Toxic Free NC, and the NC Black Alliance submitted a petition asking EPA to require health and environmental impact testing on 54 chemical substances that the petition identifies as PFAS manufactured by The Chemours Company in Fayetteville, North Carolina.

While the previous Administration has denied the petition in January 2021, the petitioners reissued their request and asked that the Administration reconsider in March of that same year. By September, the EPA reported that it had agreed to reconsider the petition in light of the change in administration and in policy priorities concerning PFAS.

The following month, the EPA announced a National PFAS Testing Strategy which identifies priority substances for the first of several described phases of an iterative testing approach based on the grouping of chemicals by chemistry features and available toxicity data.

In the PFAS National Testing Strategy, EPA assigned 6,504 PFAS into smaller categories based on similarities in structure, physical-chemical properties, and existing toxicity data. Of these categories, EPA identified 24 that lack toxicity data to inform EPA’s understanding of the potential human health effects and contain PFAS with at least one identifiable manufacturer to whom EPA could issue a test order.

As EPA continues to further develop the National PFAS Testing Strategy and following the review of some stakeholder feedback, the agency also plans to increase the weight it places on the potential for exposures when identifying the representative PFAS for each category.

These substances include many of the chemicals identified in the petition, in addition to other PFAS that are slated to inform a wider universe of categories of PFAS where key data is lacking. The information from these initial orders will provide the agency with critical information on more than 2,000 similar PFAS that fall within these categories.

In the future, the EPA plans to require PFAS manufacturers to provide the agency with toxicity data and information on categories of PFAS. The EPA expects to exercise its TSCA section 4 order authority to require recipients of test orders to conduct and fund the studies.

The collection of PFAS data will help the Agency to better understand the impacts of PFAS, including potential hazards, thus helping the EPA to continue to take action to protect human health and the environment.

On Dec. 28, 2021, the EPA granted the petition and agreed to exercise its TSCA authorities to compel development of information on PFAS. In summary:

  • Near-Term Testing Covers 30 of 54 Petition Chemicals – Under the Testing Strategy, EPA’s first test orders for 24 categories of PFAS about which the least is known will provide human health hazard data that cover 30 of the 54 petition chemicals.
  • Subsequent Testing May Cover nine of 54 Petition Chemicals – An additional nine PFAS identified in the petition belong to one other category included in the Testing Strategy. EPA is conducting more in-depth analyses of the sufficiency of the existing data, which will inform later phases of testing.
  • Remaining 15 of 54 Petition Chemicals – 15 chemicals identified in the petition do not fit the definition of PFAS used in developing the Testing Strategy. EPA has determined that there is robust data on some of them available to the Agency. EPA is conducting more in-depth analyses of the existing data, which will inform later phases of testing.
  • Mixtures Studies – EPA will address PFAS mixtures by using the toxicity of the individual substances to predict the toxicity of the mixture, an approach which is consistent with the current state-of-science on PFAS. EPA is proceeding with development and peer review of these methods as specifically applied to PFAS.
  • Human Studies – EPA is contributing to and reviewing numerous existing ongoing human studies, including studies on potentially exposed workers and communities in North Carolina, and is evaluating how to further advance and expand on these efforts. These include studies of health outcomes for people in communities impacted by industrial PFAS releases, as well studies that explore the connection between chronic health outcomes and PFAS exposures in North Carolina.
  • Analytical Standards – EPA does not believe it is appropriate to require the development or submission of analytical standards with the initial test orders that will be issued under the Testing Strategy and lacks the ability to order the submission of all analytical standards in the manner requested. Nonetheless, EPA has requested comment on whether to require the submission of existing analytical methods for PFAS under a separate rulemaking that the Agency expects to finalize next year.

Testing Commercial Fire Fighting Foam and Other Uses

For the first order issued in relation to the National PFAS Testing Strategy, the EPA selected 6:2 fluorotelomer sulfonamide betaine (CASRN 34455-29-3), a chemical substance surfactant used to make commercial fire-fighting foams and can also be found in certain floor finishes.

According to TSCA Chemical Data Reporting (CDR) rule reports, 6:2 fluorotelomer sulfonamide betaine has been manufactured (defined to include importing) in significant quantities (more than 25,000 pounds in a given year) and could be exposed to at least 500 workers in a given year.

Although there is some hazard and exposure information about this PFAS, the EPA found there is insufficient data to determine the effects on human health associated with the inhalation route of exposure. This test order will address this data need.

The Chemours Company, DuPont De Nemours Inc., National Foam Inc. and Johnson Controls Inc. are the recipients of this first test order. The TSCA requires a tiered testing process that covers the testing of physical-chemical properties and health effects following inhalation. Companies also have the option of providing the EPA with existing information that they believe EPA did not identify in its search for existing information.

The results of all the first-tier testing are required to be submitted to the EPA within 400 days of the effective date of the order and will inform the decision as to whether additional tests are necessary.

The orders and any data submitted in response to these orders that are not subject to a valid confidentiality claim will be made publicly available on the EPA’s website and in applicable dockets on www.regulations.gov.

The agency plans to issue the additional Phase I orders in the coming months.

Based on available information and predictive models, testing on 6:2 fluorotelomer sulfonamide betaine will also inform the agency’s understanding of the human health effects of 503 additional PFAS with similar structures as detailed in the Testing Strategy.

Recent PFAS Discoveries

In March, the Organization for Economic Cooperation and Development (OECD) released a report on the commercial availability and current uses of PFAS found in various paints, coatings and varnishes.

The OECD is an intergovernmental organization where representatives of 38 industrialized countries in North and South America, Europe and the Asia and Pacific region, as well as the European Commission, meet to coordinate and compile policies, discuss issues of mutual concern and work together to respond to international problems.

Most work carried out by the OECD is completed by more than 200 specialized committees and working groups. For the PFAS study, titled “Per- and Polyfluoroalkyl Substances and Alternatives in Coatings, Paints and Varnishes,” the organization looked at coatings used for cables, wires, solar panels, homes, bridges and other materials.

The establishment of the OECD/UNEP Global PFC Group was noted by the Strategic Approach to International Chemicals Management Framework in 2012 and has since been requested to facilitate the exchange of information on PFAS and support a global transition towards safer alternatives.

According to the report, in order to assess the uses of PFAS and their alternatives in CPVs, the OECD was required to go into sufficient detail to understand the function of PFAS in specific applications, rather than generalizing at the sector or market segment level.

In making this observation, coatings for cables and wiring, coatings used on the front and backsheets of solar panel, and household and architectural paints were examined more closely, with the majority identifying as fluoropolymers.

Additional findings in the OECD report included:

  • Although the majority of PFAS identified in the named applications are fluoropolymers (FPs), an exception was that short-chain PFAS, which are fluorosurfactants, are used in household paints and function as levelling, wetting and anti-blocking agents.
  • In coatings for cables and wiring, FPs are the choice of material if a high performance is required over a wide range of parameters, including fire safety. However, most of the cable and wire applications do not require such high performance, hence alternative materials such as polyurethane (PU), polyethylene and polyvinylchloride are used instead.
  • Some FPs perform well in front and backsheet materials for solar panels and some continue doing so for 10 years plus. Other FPs perform well on key parameters such as UV light and corrosion resistance, are lightweight and flexible, but tend to fail over longer periods.
  • FP-based paints are available for use on bridges and from the evidence reviewed in the report, their weatherability and durability performance is superior to that of alternatives. FP-based paints are significantly more expensive at the outset, although after 30 years PU coatings are more expensive than PFAS coatings because they require more frequent recoating, with associated labor, stoppage and material costs. In some cases, national specifications or legislative requirements regulate the use of both PFAS and alternatives for bridge protection paints.

In numerical findings, such as use and market data, the report found that aerospace equipment and other high-performance products use the chemicals on products such as cables and wires about 10% of the time. Additionally, there is a significant cost differential between using FPs or alternatives, and FPs are chosen only as a last resort where performance requirements necessitate their use.

Looking at PFAS in solar coatings, the report noted that available alternative chemicals and materials, such as glass, polyester, polyamides and polyethylene terephthalate, don’t perform as well. Publicly available market penetration data had not been identified, however.

And, in further observing infrastructure and architecture PFAS coatings, the OECD found that overall market penetration for FPs in architectural protective coatings is very low, reporting approximately 1% compared to alternatives at 99%.

As a result of the findings, the OECD concludes that more information on the markets for these chemicals and their risks is needed and has recommended the following:

  • International organizations and national governments conduct further work to understand the health and environmental risks of PFAS and non-PFAS alternatives used in CPVs;
  • The consideration of a systematic collection of market data by countries on the use of PFAS and alternatives in CPVs;
  • Industry associations and specific sectors of industry release more information on the human health and environmental risks of these chemicals and their alternatives; and
  • Manufacturers participate in future policy initiatives by providing information, such as a collection of market data.

A copy of the full report can be viewed here.

   

Tagged categories: Chemours; Coating Materials - Commercial; Construction chemicals; DuPont; Environmental Protection; Environmental Protection Agency (EPA); Floor coatings; Flooring system; Good Technical Practice; Government; hazardous materials; Health & Safety; Health and safety; NA; North America; Project Management; Regulations; Resinous flooring; Safety; Spray foam; Testing + Evaluation; Toxicity

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