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Pursuing the PFAS Problem

by Michael Schubert, PhD | Sep 27, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Legislation-dtet, Testing Trends-dtet

Tackling the challenges of “forever chemicals” in the diagnostics industry.

From sweeping regulations to new billing codes for clinical testing, attention on per- and polyfluoroalkyl substances (PFAS) is on the rise. Known as “forever chemicals” for their stability and persistence, our understanding of these substances’ toxicity to humans is steadily growing—as are restrictions on their use and legislative actions against those responsible for environmental contamination and negative human health consequences. So, what should laboratory professionals and administrators know about PFAS?

A Brief Introduction to PFAS

PFAS are synthetic chemicals with at least one perfluorinated methyl or methylene group (without a hydrogen, chlorine, bromine, or iodine atom attached). These substances were—and, in many cases, still are—in use across a wide range of products due to their protective characteristics and lack of reactivity. Unfortunately, the stability their carbon-fluorine bonds offers doesn’t just make them valuable components in everything from household goods to laboratory supplies; it also makes them highly persistent in the environment—and in human tissues.

Today, PFAS are used in everything from cookware to carpets and from surgical stents to centrifuge tubes.^1,2 They’re ubiquitous in items intended for human consumption, too. Though it’s hard to estimate the levels of PFAS in food, which requires further study, it’s known many types of food packaging contain these chemicals, as do fish,³ dairy products,⁴ meat, shellfish, some grains,⁵ and even microwave popcorn.⁶ Even canned or bottled drinks often contain measurable levels, with PFAS in sparkling water reaching concentrations as high as nearly 10 parts per trillion.⁷

Currently, the majority of PFAS production worldwide comes from just 12 companies: AGC, Arkema, Chemours, Daikin, 3M, Solvay, Dongyue, Archroma, Merck, Bayer, BASF, and Honeywell.⁸ Although manufacturers in many areas must now test their products for PFAS content prior to distribution and use, such testing is not a universal requirement—and, with the discovery that major producers were aware of PFAS toxicity as early as the 1970s,⁹ these companies are seeing legal issues arise as a result of their PFAS use and pollution.¹⁰

The Dark Side of PFAS

As PFAS studies proliferate, evidence of their negative health effects mounts, with associations identified between PFAS and immunotoxicity, nephrotoxicity, hepatotoxicity, respiratory issues, endocrine issues, and more.¹¹ Some examples of these substances’ effects on the immune system include decreased antibody response to vaccines,¹² hypersensitivity,¹³ and autoimmunity.¹⁴ Exposure is also a concern for maternal-fetal medicine because PFAS can potentially lead to issues from pre-eclampsia¹⁵ to miscarriage,¹⁶ as well as long-term physical¹⁷ and developmental¹⁸ effects on the children of exposed parents. Finally, certain PFAS are classified as possible human carcinogens due to associations with higher rates of kidney and testicular cancers¹⁹ and ongoing investigations into links with other cancers.²⁰

Why haven’t more people heard about these concerns? Much of the research into PFAS effects receives little attention; additionally, many health effects have been identified via epidemiological studies and require additional research to establish a causal relationship. Even so, the ubiquitous presence and long half-lives of these chemicals means that people who are exposed—whether due to their location, occupation, or use or consumption of contaminated materials—are increasingly reporting deleterious effects and seeking legal and regulatory resolutions.

PFAS Testing and Its Challenges

Although PFAS testing is not a routine component of clinical care, large-scale studies indicate that most of the United States population has measurable levels of PFAS in their blood,²¹ and that hundreds of millions of people in the US alone receive drinking water with PFAS levels above 1 ng/mL.²² The U.S. Environmental Protection Agency has issued interim health advisory levels for PFAS ranging from 0.004 ppt for perfluorooctanoic acid to 2,000 ppt for perfluorobutane sulfonate²³—meaning that drinking water might contain up to hundreds of millions of times the safe limit.

But few people ever receive clinical PFAS testing, despite recommendations from both the Committee on the Guidance on PFAS Testing and Health Outcomes and the Agency for Toxic Substances and Disease Registry for testing in patients with a likely history of elevated exposure or other risk factors.^24,25 This is due to multiple factors: a lack of education around PFAS and exposure, a dearth of clinical labs offering testing, challenges and costs of the testing, complex and varying regulatory requirements, and difficulty in obtaining coverage or reimbursement.

In the US, for instance, clinical laboratory testing has few compliance requirements. According to the Committee on the Guidance on PFAS Testing and Health Outcomes, “Unlike most clinical laboratories, laboratories that offer PFAS testing are not subject to measurement standardization through external proficiency testing programs that evaluate laboratory performance against preestablished criteria. Laboratories that offer PFAS testing also need not comply with clinical certification, such as Clinical Laboratory Improvement Amendments (CLIA) certification, for reporting of results to patients.”²⁴ However, the group does recommend that labs providing clinical PFAS testing have rigorous quality assurance and quality control programs, report traceable data,²⁶ and employ methods whose standard deviations and limits of detection are consistent with those of the CDC and other relevant laboratories.^27,28

Because most providers are unfamiliar with PFAS testing, finding the right diagnostic and billing codes can present another challenge. Here are the most common ICD-10 diagnostic codes:²⁹

- Z77.11 (contact with and suspected exposure to environmental pollution)

- Z77.111 (contact with and suspected exposure to water pollution)

- Z77.29 (contact with and suspected exposure to other hazardous substances)

Z13.88 (encounter for screening for disorder due to exposure to contaminants)

For billing purposes, the most common CPT codes used are 82542 (column chromatography/mass spectrometry, analyte not elsewhere specified; quantitative, single stationary and mobile phase)²⁹ and 83921 (chemistry procedures; organic acid, single, quantitative).³⁰ However, the Centers for Medicare & Medicaid Services recently added a new code effective July 1, 2023—CPT code 0394U (perfluoroalkyl substances, 16 PFAS compounds by liquid chromatography with tandem mass spectrometry, plasma or serum, quantitative).³¹ In addition, health screenings for potential health effects of PFAS exposure can be billed according to standard procedures; these may include lipid panels, thyroid function testing, screenings for autoimmune diseases and cancers, and pregnancy-related health assessments.

Currently, several laboratories in the US regularly offer clinical PFAS testing (see Table 1).

Options for Clinical PFAS Testing
Laboratory	Sample Type	Cost	Turnaround Time	Link
empowerDX	Blood (finger-prick)	$249	4–5 weeks³⁶	https://is.gd/empowerdx
Eurofins Scientific SE	Serum	Not provided	5 days	https://is.gd/eurofinsserum
Eurofins Scientific SE	Blood (finger-prick)	Not provided	15–20 days	https://is.gd/eurofinsblood
NMS Labs	Serum/plasma	$470	7–14 days	https://is.gd/nmslabs
Quest Diagnostics	Serum/plasma³⁷	Not provided	Not provided	https://is.gd/questdx
SGS AXYS	Blood/serum	$420–570	30 days	https://is.gd/sgsaxys

Table 1. Laboratories offering clinical PFAS testing. Data from PFAS-REACH (2022),³⁵ empowerDX (2023),³⁶ and Quest Diagnostics (2019).³⁷ Originally published in Today’s Clinical Lab.

Eliminating PFAS Exposure

True to their nickname, “forever chemicals,” PFAS have long half-lives, which makes exposure reduction a difficult prospect—and one so far-reaching that governments and regulatory bodies may need to lead the charge. The European Chemicals Agency, for instance, recently published a proposal to restrict approximately 10,000 long-lived PFAS.³² After the six-month open consultation period, the feedback will be evaluated, opinions adopted, and recommendations sent to the European Commission regarding the proposal. In Canada, several of these chemicals are prohibited, protective guidelines are in place to manage PFAS in soil and water, and a risk management scope document proposes adding PFAS as a class to the government’s List of Toxic Substances.³³ However, in the United States, PFAS regulation varies by state, with some states having few controls and others banning the use of these chemicals in products such as food packaging and feminine hygiene products.³⁴

Until such broad-spectrum bans are in place, laboratories can reduce PFAS exposure and contamination by minimizing their use and disposal of these substances. For laboratory administrators, this may include providing PFAS-free personal protective equipment, purchasing PFAS-free reagents and consumables wherever possible, filtering water (for both drinking and experimental use), and taking a proactive approach to PFAS testing and routine health monitoring where needed. As regulators increasingly focus on restricting and managing PFAS, clinical and environmental labs are stepping up their PFAS testing volume—offering new opportunities for labs to contribute to the health and safety of both their staff and the populations they serve.

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