PFAS Regulatory Standards: Water, Soils, Consumer Products.
June 11, 2024
Strict clean-up standards are starting to emerge.
The regulatory landscape for per- and polyfluoroalkyl substance (PFAS) standards had been in flux for years on both the Federal (i.e., the United States Environmental Protection Agency [EPA]) and state levels, a bit of the Wild West. Recently, however, cleanup standards have been starting to coalesce, skewing toward the strict end of the spectrum — good for overall public health and the environment, no-so-good for the private sector responsible party pocketbook.
First, a bit of regulatory standards history.
General regulatory background.
One of the problems with regulating 'PFAS compounds' on the Federal, or individual state level, is that there are simply too many of them.
The number of carbon-fluorine compounds that fall under the umbrella term 'PFAS' number between 5,000 and 12,000, depending upon who is counting; no one knows the exact number, as new ones are created in labs every day. Of this total, it is believed about 600 or so are actually commercially used (in over 40,000 places of business); the rest technically 'exist', but are not manufactured/used in any appreciable quantity. And while there has been ample press regarding the effects of PFAS (there have been 300+ published studies by a whole host of organizations), in reality, meaningful toxicological testing has been limited to only about 5 of the most commonly used compounds; the balance of hundreds of PFAS compounds have never been tested in any real capacity, and their production and use remains largely unregulated across the country.
So when we talk about the health and environmental effects of PFAS, we are really only talking about 5 compounds, primarily: PFOA, PFOS, and PFNA, and secondarily: GenX and PFHxS. The other 595 or so PFAS in use have not been rigorously tested for their effects on humans and the environment, either in the short-term or via long-term exposure; therefore, their effects are largely unknown, other than the fact that most long-chained (and even shorter-chained) carbon-fluorine synthetic compounds have similar deleterious effects on animals and people when any meaningful testing has been undertaken. Therefore, in the future, if/as the 5 listed compounds above are replaced by any of the many other PFAS compounds waiting in the wings (with all the desirable qualities they possess, which make our collective lives easier), it is expected the inherent health risks will largely remain — that risk simply seems to come with the PFAS benefits package.
So, what is a safe PFAS level to ingest?
The answer is. . . we simply don’t know.
As of 2009, the EPA declared the 'safe level' was in the hundreds of parts per trillion (ppt); only 13 years later, in 2022, the EPA declared, in effect, that there is no documented safe level that they have identified; the safe level is actually zero until proven otherwise. This safe PFAS level issue has been an ever-moving target, moving in an ever-more-conservative direction as further testing is conducted.
The primary PFAS intake mechanism for humans is ingesting liquids; hence many of the regulatory standards focus on drinking water PFAS levels, and correspondingly, groundwater levels. 80% of all drinking water in the United States is derived from public water supply systems, and over 2,800 of them have identified PFAS in the supply. Almost 50% of all water supplies for Americans (public systems and private wells) contain some level of PFAS — the issue is widespread and knows no geographic boundaries.
But there are also concerns about PFAS in soils (i.e., if PFAS is in the soil, it could leach into the groundwater/drinking water supply) and a whole subset of regulations regarding PFAS use in everyday consumer products. Namely, the regulatory framework is looking to crimp the use of PFAS on the front end (i.e., don't expose them to us to begin with) and on the back end (i.e., if they are already in the ecosystem, what levels can we live with, versus what levels need to be removed).
Finally, the regulatory framework (to keep people and the environment safe) has to be weighed against the economic impacts of compliance — overly broad restrictions harm economic growth, jobs, product access, and even national security (e.g., the semiconductor industry in particular). As with any environmental standard, there is a health/natural resources/economic impact dynamic that needs to be balanced, and that is rarely easy to accomplish.
With that groundwork laid, below is a historic summary of regulatory standards at the Federal and New Jersey state levels for waters and soils, followed by some state-specific consumer product regulations.
EPA, a Summary of Federal PFAS Regulations.
2001
The EPA was reportedly advised by Robert Bilott, Esq., the lead attorney representing a class action of plaintiffs against DuPont in the first large PFAS case in Parkersburg, West Virginia (the lawsuit began in 1998), of the dangerous effects of this class of synthetic, carbon-fluorine chemicals. Despite the warning, no meaningful PFAS enforcement action was implemented by the EPA at that time, or for years thereafter.
2009
Eight years later, the EPA first posts non-enforceable 'preliminary health advisory levels' for two of the most commonly used PFAS compounds, PFOA and PFOS. PFOA was earmarked at 400 parts per trillion (ppt) in drinking water; PFOS at 200 ppt. In retrospect, these first EPA advisory levels were exceedingly high (when viewed through a 2024 lens).
2013
The EPA required public water systems with greater than 10,000 customers to begin testing for select PFAS compounds, even though they hadn't implemented regulatory standards upon which action was required. This was more of a data-gathering exercise, to determine baseline PFAS levels and to quantify the extent of impacts. It soon became clear the impacts were nationwide, with elevated PFAS levels both near, and quite distant from, common sources of PFAS contamination (e.g., military bases, firehouses, airports, chemical plants, etc.).
2016
After 7 years, the EPA significantly dropped its 'health advisory levels' for PFOA and PFOS in drinking water to 70 ppt, combined. However, even this much-reduced level was higher than the PFOA/PFOS levels enacted in many individual states, which generally ranged from 10 to 20 ppt.
2018
The Agency for Toxic Substance and Disease Registry (ATSDR), a federal public health agency within the Department of Health and Human Services (DHHS), focuses on minimizing human health risk issues associated with hazardous substances. The ATSDR determined the draft minimum PFAS risk levels that people should eat/drink/breathe each day should be limited to 21 ppt for both PFOA and PFNA and 14 ppt for PFOS, all lower than EPA guidelines in place at the time. Despite this ATSDR recommendation, the EPA did not change their 2016 health advisory level of 70 ppt for PFOA and PFOS, in the aggregate.
2020
In February, the EPA adopted a 'PFAS Action Plan', a largely qualitative, cross-agency program to address and help states and local communities address emerging PFAS issues and encourage limiting the manufacture of new PFAS products, without prior regulatory review. The EPA also implemented a voluntary compliance program for industry to reduce PFAS use in existing product lines; this program was developed/rolled out in conjunction with the Food and Drug Administration (FDA), which was working with manufacturers to voluntarily remove PFAS from food packaging over the ensuing 3 years.
2021
In October, the EPA developed what they termed a 3-year 'PFAS Strategic Roadmap', stating, in essence, that the agency needed to do 'more research' to determine actual PFAS usage guidelines.
2022
21 years after the notification to the EPA from Mr. Bilott regarding the dangers of PFAS, more concrete regulations seemed to be heating up at the EPA, as opposed to conducting continuous PFAS research studies and issuing additional, non-enforceable advisories.
June 2022
The EPA set 'safe consumption levels' in drinking water. These levels were not enforceable, but were meant to give States guidance; they were also used by plaintiffs in a variety of active lawsuits. These targeted PFAS levels represented a seismic shift by the EPA; the proffered PFAS levels were so low that no analytical laboratories across the country had testing equipment that was sophisticated enough to even detect them. The PFOA level was set at 0.004 ppt (or almost 20,000 times lower than their prior health advisory level of 70 ppt); the PFOS level was 0.02 ppt, (3,500 times lower). These were both characterized as lifetime exposure thresholds. GenX was listed at 10 ppt (there were no prior guidelines) and PFBS was listed at 2,000 ppt.
August 2022
Just two months later, the EPA announced they would 'soon' be earmarking two PFAS compounds as 'hazardous substances' under the Federal Superfund law; to this date, no PFAS compounds were designated as hazardous by the EPA. The designation would not 'ban' the use of the chemicals, but it clearly was a shot across the bow, a portend of things to come. By designating some PFAS compounds as hazardous, it would allow the EPA to require more extensive use-reporting by the regulated community, open-up Superfund program tools to mandate PFAS-related remediation to occur and to aide in fostering private party cost-recovery for PFAS cleanups.
December 2022
The EPA announced a proposal 'in the coming months' for formal drinking water standards for certain PFAS compounds — it would require treatment via filter system installations on water supply systems with elevated PFAS levels. The EPA also publicly acknowledged that PFAS compounds were much more dangerous than they previously thought. The EPA, throughout 2022, continued to work diligently with the private sector to encourage them to voluntarily reduce/abate PFAS use in existing product lines. The EPA also earmarked $1 billion in funding to 'address PFAS contamination'; EPA Administrator Mike Regan stated that PFAS was now a 'top priority' for the EPA.
2023
February 2023
The EPA decision on PFAS hazardous substance designation was again delayed; it was still subject to 'internal review', according to the Agency.
March 2023
EPA proposed drinking water standards for PFOA and PFOS, both to be set at 4 ppt, likely going into effect by the end of 2023. These results were surprising to the regulated community (not-so-happy) and environmental groups (largely happy), since they were set lower than most PFAS standards in place in proactive State-level environmental agencies across the country, including New Jersey, that had already established PFAS compliance programs. The EPA alluded that the standards would have been set even lower, but the 4 ppt level is the lowest generally achievable detection level in the current commercial laboratory industry. And even then, there are only a limited number of labs that have sophisticated enough equipment to meet these levels, resulting in long PFAS testing turnaround timeframes (many weeks, in most situations), and expensive analytical costs on a per-sample basis (e.g., commonly $500+ per sample, with surcharges for quicker turnaround times, if even available). The EPA stated there would likely be an aggregate standard for GenX (used to largely replace PFOA), PFBS (used to largely replace PFOS), PFNA, and PFHxS. The EPA expected water utility compliance to run about $722 million annually, but result in $1.2 billion in annual medical savings (namely preventing certain cancers, post-natal care and cardiovascular diseases); industry groups predictably disputed both dollar figures — the former being too low and the latter being too high.
2024
March 2024
According to the FDA and their work with manufacturers beginning in 2020, PFAS was supposed to be removed from all food packaging by this time; however, the FDA was still working on testing validation methods to ensure manufacturers had complied. This is a critical step in curtailing the flow of PFAS into the environment and people's bodies.
April 2024
The EPA finally designated PFOA and PFOS as hazardous substances and published their first enforceable drinking water limits for select PFAS compounds, in what the EPA has characterized as its most important PFAS-related action to date. The EPA specifically chose the following chemicals: PFOA (4 ppt), PFOS (4 ppt), as well as GenX, PFNA, and PFHxS (any two of these three compounds/groups can't exceed 10 ppt in the aggregate) to target. The EPA's health-based goal for all the compounds was still 0 ppt — meaning no level of PFAS exposure was without risk. These levels were largely hailed by environmental groups and admonished by both industry groups and the utilities tasked with paying for meeting the new guidelines. Atypically, these EPA standards are actually stricter than the handful of environmentally progressive states, New Jersey included, which are usually enforcing contaminant standards below federal levels.
The EPA also proposed designating seven additional PFAS compounds as hazardous substances; this would allow the EPA to further expand the assessment of PFAS contamination at certain hazardous waste treatment, storage, and disposal facilities.
To assist in lessening the financial compliance blow to water companies, the EPA has provided said utilities 5 years to comply with the aforementioned standards (i.e., 3 years to sample and establish PFAS levels/baselines and another 2 years to install treatment systems to remove elevated PFAS levels). The projected annual utility company compliance cost was upped by the EPA from $722 million to $1.5 billion; industry groups still say it will likely be more than double the updated EPA dollar projections. The affected utilities provide drinking water to over 100 million citizens in our country. The EPA has earmarked $1 billion in grants to these water providers, part of the $9 billion Bipartisan Infrastructure Law; the EPA will also be implementing a Water Technical Assistance Program for small and disadvantaged rural community water supply systems, by providing guidance in securing federal funding and developing an overall compliance plan.
New Jersey PFAS Regulations.
Since a majority of our firm's Clients are New Jersey-based, we have also provided a chronology of major New Jersey Department of Environmental Protection (NJDEP)-related milestones below. These are primarily drinking water-related standards, but New Jersey is also one of about half the States in the country that have enacted complementary PFAS soil standards.
2006
New Jersey conducted its first statewide study of PFAS in groundwater; the study concluded that 65% of the State's water supply contained PFOA and 30% contained PFOS. However, the sample size was small (only 23 locations sampled), so the results may have been skewed. Regardless, this data certainly inferred that PFAS had infiltrated into a significant percentage of the public water supply statewide.
2007
A preliminary drinking water guidance level for PFOA was set at 40 ppt; this was ten times lower than the first EPA PFOA advisory level of 400 ppt, proffered 2 years later, in 2009.
2015
The Drinking Water Quality Institute (DWQI), an advisory board to the NJDEP that is responsible for developing maximum contaminant levels (MCLs) and/or standards for hazardous compounds in drinking water, opined that the NJDEP should set the action levels for PFNA at 13 ppt; PFNA experienced heavy usage in New Jersey and was one of the more prominent PFAS contaminants found in the water supply early in the testing regime. The NJDEP set an interim groundwater quality standard (GWQS) for PFNA at 10 ppt, which was less than the 13 ppt DWQI recommendation for drinking water.
2017
The PFOA drinking water standard was set at 14 ppt; the PFOS drinking water standard was set at 13 ppt; the same levels as recommended by the DWQI.
2018
PFNA was formally deemed a hazardous substance. Testing by the NJDEP determined that 43% of all private water supply wells had elevated PFAS levels and fish from a variety of water bodies across the State contained elevated levels of PFAS.
2019
As of January 1, 2019, PFNA testing of public community water systems serving 10,000 people, or less (with groundwater as the source), was required. PFOA and PFOS were both deemed hazardous substances. The NJDEP set a PFOS and PFOA interim GWQS of 10 ppt.
2020
As of January 1, 2020, PFNA testing of all other public community water systems was required. Both the drinking water and groundwater quality standards were set at the same levels; the levels were: PFOA (14 ppt); PFOS (13 ppt) and PFNA (13 ppt). They have remained at these levels to date.
2021
As of January 1, 2021, PFOA and PFOS needed to be monitored in public community water supply systems quarterly. As of December, PFOA, PFOS, and PFNA testing was to be included as part of the Private Well Testing Act (PWTA) sampling regime.
2022
In October, the NJDEP set interim PFAS-related soil standards, to be effective immediately, for PFOA, PFOS, PFNA, and GenX. There are a variety of standards set for residential, non-residential, and migration-to-groundwater situations and each site must be assessed by the Licensed Site Remediation Professional (LSRP) to opine as to whether PFAS were known, or likely to have been, used onsite. These soil action levels, each in the low to fractional parts per million (ppm) range, have already had far-reaching and expensive impacts on environmental assessment and remediation project throughout New Jersey. This is a huge game-changer for New Jersey landowners and responsible parties, who many times are surprised at the existence of PFAS in soils on their properties, as well as the accompanying expense to address same. Landowners commonly get caught in this PFAS soils-related money pit by allowing their consultants to sample without first developing defensible positions to avoid such sampling, if technically defensible to do so. PFAS-in-soils is a cutting-edge issue that landowners/responsible parties need to discuss in detail with their consultants and counsel pre-sampling, before generating data that might never have been required, but, once voluntarily generated, cannot be ignored.
What's Next?
Our fourth, and final near-term PFAS-related blog will discuss existing, as well as new/innovate, ways to remediate the PFAS that is in the groundwater and/or drinking water you consume. Current methods tend to be costly and inefficient; novel technologies offer more promise, but have not yet been implemented on a commercial scale. Given the extent of the PFAS problem, many research and development dollars are being expended on practical solutions — chaos begets huge economic opportunity in the world of PFAS remediation.
Stay tuned for our next blog.
A look at some of our past FPAS articles.
In 2020 and again over the last month, we penned other articles on this emerging group of contaminants, per- and polyfluoroalkyl substances, better known by the umbrella name PFAS. You can access them below:
PFAS Litigation: Where it’s Gone & Where it’s Going
A PFAS Update: The Forever Chemicals
Please note, the information provided in this newsletter relating to PFAS and associated compounds is strictly for informational purposes only and should not be construed as recommendations or advice on how to treat, remediate or handle PFAS in any manner; our firm assumes no liability of any kind regarding same.