The Environmental Protection Agency in mid-March announced its first set of federal limits on the presence of per- and polyfluoroalkyl substances (PFAS) in drinking water. Recent headlines show why the EPA is taking a clean drinking water approach to how PFAS is regulated in the United States.
That said, the EPA’s proposed limits, which are essentially near zero, no more than 4 parts per trillion for both perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS), are a radical departure from the limits established by other health agencies and are at odds with the Food and Drug Administration’s assessment on PFAS exposure.
Take, for example, how the EPA’s new limits compare to New York state, the World Health Organization, or the Canadian government, none known for being reckless regarding health guidelines and precautions. New York’s guidelines for PFAS exposure and drinking water, at 10 parts per trillion, is 2.5 times higher than the EPA’s new limit. The World Health Organization’s proposed limit is 25 times higher than the EPA at 100 parts per trillion. At the same time, Canada’s guidelines are 50 times higher for PFOA and 150 times higher for PFOS.
The huge variations in exposure guidelines suggest there is much work to be done when it comes to what the appropriate thresholds are to ensure that drinking water is safe. And unfortunately, that confusion only worsens when you factor in how the FDA perceives PFAS exposure and its associated risks.
The FDA, the regulatory body responsible for ensuring that pharmaceuticals and medical devices work and that their health benefits outweigh their known risks, has continuously approved both drugs and devices containing PFAS.
Most don’t know that the medical community relies heavily on PFAS products. Take, for example, medical implants like vascular grafts, stent grafts, surgical meshes, catheter tubes/wire and heart patches. It is estimated that 8 percent to 10 percent of Americans have implantable medical devices, many of which rely on PFAS and are approved by the FDA. In fact, the implantable medical devices market, valued at $72.2 billion, is expected to grow significantly as the American population ages.
Drugs containing PFAS, again approved by the FDA, include but are not limited to tachyarrhythmias (flecainide), antidepressants (fluoextine), non-steroidal anti-inflammatories (celecoxib), antibiotics (levofloxacin), rheumatoid arthritis therapeutics (leflunomide), cholesterol-lowering agents (atorvastin) and COVID-19 antivirals such as Paxlovid.
For all those drugs and devices, the notoriously over-cautious FDA has clearly stated that whatever PFAS exposure exists with these products, they are safe to the point where the benefits far outweigh the risks. Simply put, the presence of PFAS for these drugs and devices passes a safety check and a cost-benefit analysis.
This leads to some serious questions regarding how the EPA arrived at its near-zero threshold and why its assessment is at odds with other government agencies, global health bodies and their colleagues at the FDA.
And that doesn’t even address the externalities of hard-line policies on PFAS. The EPA’s guidelines, alongside legislative efforts like the PFAS Action Act, could seriously jeopardize American capacity to produce lifesaving drugs and devices and seriously undercut the United States’ ability to domestically produce semiconductors. These chemicals are vital for the production of semiconductors, predominantly the use of coolant, and if the EPA and Congress continue down this path, consumers will be in a world of trouble.
We know this is a predictable outcome because this is precisely what happened in Europe, where officials in Belgium paused production at a chemical plant in response to the tightening of environmental regulations. Reporting by Business Korea highlighted that semiconductor producers had only 30 to 90 days of coolant inventory left before they would encounter serious production problems.
For reference, the chip shortage of 2021 cost auto manufacturers $210 billion in lost revenue as cars sat in lots waiting for chips to be installed. Given that these chips are used in computers, smartphones, consumer electronics, appliances and medical equipment, an actual national shortage would be an economic disaster. If any conflict arises in Taiwan, a global producer of semiconductors, the U.S. economy would grind to a halt.
Rather than doing what appears to be guesswork on safe levels of PFAS exposure, the EPA should instead consult its colleagues domestically and abroad, come to a clear consensus on where and when risks may arise, and regulate from there, taking into account the costs and benefits of their policy suggestions.
