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Regulatory Summary for Per- And Poly-
Fluoroalkyl Substances (PFAS)
1 INTRODUCTION
This fact sheet is one of six developed by the Interstate Technology and Regulatory Council
(ITRC) to provide an overview of the current regulations of per- and poly-fluoroalkyl substances
(PFAS) in the United States and worldwide. The fact sheets are tailored to the needs of state
regulatory program personnel who are tasked with making informed and timely decisions regarding
PFAS-impacted sites. The content is also useful to consultants and parties responsible for the
release of these contaminants, as well as public and tribal stakeholders. The information in this
fact sheet is supplemented by others in the series: Nomenclature Overview and Physical and
Chemical Properties; History and Use; Environmental Fate and Transport (to be published late
2017); Site Characterization Tools, Sampling Techniques, and Laboratory Analytical Methods (to
be published late 2017); and Remediation Technologies and Methods (to be published late 2017).
The purpose of this fact sheet is to:
• Provide a brief overview of background scientific information on PFAS that is important
to the understanding of their regulations, including an overview of PFAS sources to the
environment, and the health effects of PFAS on humans and other biota.
• Describe the primary state and U.S. programs that are being used to regulate PFAS.
• Summarize current regulatory values for PFAS in groundwater, drinking water, surface
water/effluent, and soil (Tables 4-1 and 4-2).
• Provide information (summarized in Tables 5-1 and 5-2) regarding the basis for differences
between various U.S. federal and state drinking water criteria for perfluorooctanoic acid
(PFOA) and perfluorooctane sulfonate (PFOS).
1.1 What are PFAS?
PFAS are a complex family of more than 3,000 manmade fluorinated organic chemicals (Wang
et al. 2017). These substances have a carbon chain structure containing at least one totally
fluorinated carbon atom. PFAS include both per- and poly -fluorinated chemicals. Perfluorinated
chemicals, such as perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), are a
subset of PFAS with carbon chain atoms that are totally fluorinated, while polyfluorinated
chemicals have at least one carbon chain atom that is not totally fluorinated (Buck et al. 2011).
Due to unique physical and chemical properties (for example, surfactant, oil -repelling, water -
repelling), PFAS have been extensively manufactured and used worldwide. Some PFAS
molecules are environmentally stable, mobile, persistent, and bioaccumulative. Further
discussion is in the Nomenclature Overview and Physical and Chemical Properties and History
and Use Fact Sheets.
Commented [LHW1]:Need todouble check -should --
Polyfluoroalkyl have a dash or not when they are mentioned
together?
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1.2 Why Are PFAS Important?
July 2017
The scientific community is rapidly recognizing and evolving its understanding of PFAS in the
environment. PFAS in the environment are considered to be contaminants of emerging concern
(CECs). CFCs are those chemicals that present known or potentially unacceptable human health
effects, or environmental risks, and either: (i) do not have regulatory cleanup standards, or (ii)
the regulatory standards are evolving due to new science, detection capabilities, or pathways, or
both (USDOD 2009).
PFAS are found globally in both remote and urban environments, and are present in various
matrices including: human blood (whole, plasma and serum), sediments, surface and
groundwater, and wildlife (Kannan et al. 2004, Yamashita et al. 2005, Higgins et al. 2005,
Rankin et al. 2016). Due to their widespread uses in many common products, ability to bind to
blood proteins, and long half-life in humans, scientists routinely find PFAS in the blood and
serum of both occupationally and non -occupationally exposed people (Kannan et al. 2004,
Kamnan et al. 2006, Olsen et al. 2003). Both laboratory studies using animals and
epidemiological studies of human show that exposure to some PFAS maybe associated with a
wide range of adverse health effects.
1.3 Regulation of PFAS
Although PFAS were not regulated during most of the last 50-60 years, the past few years have
seen federal, state, and international authorities establish a number of health -based regulatory
values and evaluation criteria. The terms `regulatory' or `regulation' are used in this fact sheet to
refer to guidance and advisories, as well as to standards identified under local, state, federal, or
international programs.
The heightened public and scientific interest in the health effects of PFAS that has followed
recognition of their widespread distribution, persistence, human exposure, and association with a
range of adverse health effects has caused an increased pace of criteria development and
regulation. A recent analysis of data acquired under the USEPA's unregulated contaminants
monitoring rule (UCMR) program found that approximately six million residents of the United
States have drinking water with PFOA or PFOS concentrations, or both, above the USEPA's
lifetime health advisory (HA) of 70 parts per trillion (Hu et al. 2016, see also Section 3.1.2 of
this fact sheet)
Human health protection is the primary focus of the PFAS criteria and regulations developed to
date. The regulatory criteria vary widely, with differences between criteria due to the selection
and interpretation of different key PFAS toxicity studies, choice of uncertainty factors, and
approach used for animal -to -human extrapolation. The choice of exposure assumptions,
including the life stage used as the basis and the percentage of exposure assumed to come from
non -drinking water sources, may also differ among regulatory criteria (see Table 5-1).
In addition to regulations that specify health -based PFAS concentration limits, agencies have
used various tools and strategies to limit the use and release of PFAS. For example, the USEPA
worked with 3M to achieve the company's voluntary phase -out and elimination of PFOS
(USEPA 2000), and with the eight primary U.S. manufacturers of PFOA to eliminate PFOA and
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many PFOA precursors by 2015 (USEPA 2017). Additionally, the Organisation for Economic
Cooperation and Development OECD (2015) has described the various internationally
implemented policies, voluntary initiatives, biomonitoring, and environmental monitoring
programs to control PFAS. More information is in the History and Use Fact Sheet.
1.4 PFAS in the Environment
First discovered in the late 1930s and initially produced in the 1940s and 1950s, many thousands
of PFAS have been synthesized and used in a diverse suite of industrial and consumer
applications (Lindstrom et at. 2011, Kirsch 2013). Some of the more important uses include
processing aids in the production of fluoropolymers, fire -fighting foams, metal plating and
finishing, textile coatings, paper packaging, cleaning produ' ts,"adhesives, and personal care
products (see History and Use Fact Sheet). PFAS enter the enronment following (1) release
from industrial processes; (2) fire suppression and training activities; (3) the use and disposal of
industrial and consumer articles; and (4) the discharge of treated min cipal effluent and biosolids
(UNEP 2015).
Due to the strength of the carbon -fluorine bond, PFAS are highly resistant to physical or
biological degradation, and long -chain PFAS persist indefinitely in the environment (ATSDR
2015, CONCAWE 2016). PFCAs and,PFSAs tend to ionize in both biota and in the environment,
and thus are relatively soluble in water and blood (CONCAWE 2016). If released directly to the
air, PFAS bind to particulates, eventuaiiy depositing to soil or surface water (USEPA 2014).
Because they exist as ions, PFCAs and PVSAs are-fittt volatile, but move readily from soil to
groundwater (USEPA 2014).
PFAS have been detected worldwide in humans and in multiple species of wildlife, as well as in
surface water, drinking water, groundwater, oceans, soils, sediments, and air (ATSDR 2015).
Long -chain PFAS can bioeoncentrate (increase in concentration in an organism relative to the
concentration in the aquatic environment), bioaccumulate (increase in concentration within a
trophic level), and can biomagnify (increase in concentration across trophic levels) (Conder et al.
2008, OECD 2002, 2013, UNEP 2015). PFOS is the most frequently detected PFAS in both
humans and other biota, and "is the primary PFAS found in all species and locations around the
world (Butts et al, 2010, also see review by Houde et al. 2011).
2 EXPOSURE AND HEALTH EFFECTS
There are both similarities and differences among PFAS compounds in their physical and
chemical properties, effects to human health and wildlife, and environmental fate and transport
relevant to human and ecological exposure. Additionally, the amount of relevant scientific data
that is available varies widely among PFAS. The remainder of this section is intended to provide
a generalized overview of potential exposure pathways and health effects of PFAS.
2.1 Human Exposures
Terminal PFAS (long -chain PFCAs and PFSAs) are not metabolized. Half-lives have been
documented in humans for PFOS (4.5-7.4 years), PFOA (2.3-10.1 years), and perfluorohexane
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sulfonate (PFHxS) (8.5 years), while human half-lives are much shorter for shorter chain PFAS
such as perfluorobutanoic acid (PFBA), perfluorobutane sulfonate (PFBS), and perfluorohexane
sulfonate (PFHxS) (see reviews by ATSDR, 2015, Lau 2015, also Tatum -Gibbs et al. 2011,
Ohmori et al. 2003). Because of their slow excretion rate, levels of long -chain PFAS in blood
serum do not fluctuate in the short term and are a stable measure of long term exposure. For
other species, the rate and extent of elimination vanes widely depending on the individual PFAS,
the species, and gender (see reviews in ATSDR, 2015, Lau 2015, USEPA 2016c, 2016d).
A recent National Health and Nutrition Examination Survey (NHANES 2013-2014, CDC 2017)
found detectable levels of PFOA, PFOS, PFNA and PFHxS in, the low parts per billion range in
nearly all samples of blood serum in the U.S. population. Most studies indicate levels of PFOA
and PFOS in humans appear to be decreasing over time, particularly in Western nations where
their production and use have been largely phased -out (Olsen et al. 2017), while trends for other
PFAS are less clear and some may even be increasing in prevalence (Okada et al. 2013, Eriksson
et al. 2017, O'Brien et al. 2016). Workers in industries that manufacture or use products
containing PFAS may be exposed to higher levels than the general public. The prevalence and
persistence of long -chain PFAS in humans and wildlife underscore the need to elucidate the
relationship between exposure to these chemicals and the potential for adverse effects on health
and populations.
There is a growing body of information suggesting that PFAS impacts to groundwater and other
environmental media are widespread. In some states,, the consumption of certain types of fish and
shellfish caught from contaminated bodies of water has led to public health advisories for some
PFAS, particularly PFOS (see summary in USEPA 2016, ATSDR March 2017).
2.1.1 Exposure Routes and Target Populations'
There are different populations that can be exposed via various routes. These populations
include:
• Workers in industries that manufacture or use products containing PFAS
• Adults and older children (general population)
• Toddlers and younger children (general population)
• Fetuses and infants. (general population)
Exposures to these populations are described below.
The primary potential human exposure pathways for PFAS include ingestion of food, dust, or
water. Drinking contaminated water, even at relatively low concentrations (below the USEPA
Health Advisory (HA) of 70 ng/L for PFOA and PFOS), is potentially a major source of human
exposure in areas where groundwater or surface water has been impacted by PFAS release (see
reviews in Lindstrom et al. 2011, DWQI, 2017). Additionally, Hu et al's (2016) analysis of the
UCMR3 data indicates that although a relatively small portion of U.S. drinking water supplies
are impacted by PFAS, approximately 6 million U.S. residents have drinking water with PFOA
and/or PFOS above the EPA HA of 70 ng/L. Workers in industries that manufacture or use
products containing PFAS may be exposed to higher levels than the general public (for example,
Costa et al. 2009, Freburg et al. 2010).
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Consumer products containing PFAS may potentially contribute to exposures prevalent in the
general population, as PFAS may be released during the use or disposal of these products. The
list of consumer products containing PFAS is extensive and includes certain types of food
packaging (Schaider et al. 2017) and other products, such as cleaning agents and cookware used
in and around the home. For example, fast food wrappers or microwave popcorn bags have the
potential to leach PFAS into food, although recently, certain PFAS compounds (diethanolamine
salts of mono- and bis-phosphates, pentanoic acid, 4,4-bis derivatives and perfluoroalkyl
substituted phosphate ester acids) have been phased out of food -packaging materials (United
States Food and Drug Administration [USFDA], 2016). Other potential sources of exposure
from consumer products include stain -resistant coatings used on carpets, upholstery and other
fabrics, water-resistant clothing, some personal hygiene products, and non-stick cookware
(ATSDR May 2017, EPA May & July 2016) (see History and Use Fact Sheet).
The inhalation of dust and indoor air in spaces with -carpets, textiles, or other consumer products
treated with PFAS may also contribute to the exposures prevalent in the general population.
Potential hand-to-mouth transfer from surfaces'treated with PFAS-containing stain protectants
has also been reported (Trudel et al. 2008). This,behavior is more common in toddlers and
young children as they spend time playing or crawling on floors, and may result in higher
exposures of this age. (ATSDR September 2016). Additionally, certain airborne PFAS
precursors such as the fluorotelomer alcohols can be metabolized to terminally -stable PFAS in
the body, thus representing a potentially significant portion 6f.PFAS exposure (Makey et al.
2017). However, it has been shown that dermal exposure to PFAS is typically not significant;
studies indicate that only limited absorption of PFAS occurs through the skin. (ATSDR 2015,
2017).
Fetuses can be exposed to PFAS during pregnancy, although the placental barrier has varying
levels of permeability to different OAS. Newborns can be exposed through the. ingestion of
breast milk, though the level of exposure depends on the PFAS concentration in the mother's
body and the duration of breastfeeding. Infants may also be exposed through ingestion of
formula prepared with PFAS-containinated water. Due to their higher water consumption based
on body weight, infants have a higher exposure to long -chain PFAS compared to older children
(USEPA 2011).
Some PFAS compounds can accumulate in the body. The accumulation and removal rate may
vary considerably depending on the individual PFAS, the exposure duration, and the dose.
Biological half-life data are available for only a small fraction of the PFAS group; however, in
general, long -chain PFAS are known or estimated to have relatively long half-lives (for example,
several years or more) in humans (ATSDR 2015, Lau 2015).
2.1.2 Health Effects
Numerous animal and human studies have evaluated both non -cancer and cancer health effects
related to exposure for a limited number of PFAS. Other PFAS have been studied but have less
data; and little to no health -effects data are available for many PFAS compounds. There is an
extensive database of toxicological information, including both animal and human
epidemiological studies, for PFOA and PFOS.
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In animal studies, PFOA has been found to cause developmental effects. Male rodents sustained
liver and kidney effects, increased body weight in adulthood, and reduced fertility. Their
offspring also endured health effects including low birth weight, delays in reaching
developmental markers, delayed mammary gland development, altered onset of puberty, and
behavioral changes. (see summary of original research results in USEPA 2016c). Effects on the
liver and low birth weight have also been shown in other animal studies (see summary of original
research in USEPA 2016d). There is also evidence that both PFOA and PFOS cause immune
system effects, including suppression of antibody response and reduced disease resistance
(National Toxicology Program [NTP], 2016). Both PFOA and PFOS caused tumors in chronic
rat studies (USEPA 2016c, d).
Some of these effects have also been associated with PFAS exposure to humans, including in the
general population as seen in the NHANES, and in communities exposed through drinking water
(USEPA 2016). The number of epidemiological studies`that have been conducted and the
consistency of the results vary among the health endpoints that have been evaluated. The "C8"
science panel (C8SP) conducted a series of 11 individual epidemiological studies that evaluated
the relationship between PFOA exposure of workers and residents in a West Virginia community
impacted by soil and drinking water contamination from industrial releases of PFOA. The Panel
determined that there were "probable links" between PFOA exposure and high cholesterol,
ulcerative colitis, thyroid disease, and pregnancy -induced hypertension (see Probable Links
reports available from the C8SP website [C8SP, 2017])). Other studies have linked PFOA
exposure to adverse non -cancer effects on the developing fetus and child and decreased fertility,
and have associated both PFOA and PFOS exposure to immune system effects. (ATSDR 2016,
USEPA 2016 c, d, NTP, 2016).
The International Agency for Research on Cancer (IARC) concluded that PFOA is "possibly
carcinogenic to humans (Group 2B)", based on a positive association of PFOA exposure and
testicular and kidney cancers in humans, and "limited evidence" of carcinogenicity in
experimental animals (IARC 2016). The C8 SP also found a probable link between PFOA
exposure and testicular and kidney cancers (C8SP 2017). The USEPA concluded that there is
suggestive evidence of carcinogenic potential of both PFOA and PFOS in humans (USEPA 2016
c, d)•
2.2 Environmental and Ecological Exposures
Some PFAS have been globally detected in aquatic mammals and other organisms, with much of
the data from studies in Asia, Europe, the United States, and the Canadian Arctic (see reviews of
Houde et al. 2011 and Butts' et al. 2010, Kelly et al. 2009). Some PFAS, particularly the long -
chain compounds, may bioaccumulate or biomagnify, and PFAS accumulation in wildlife is
well -documented (see review of Houde et al. 2011). PFOA and PFOS have been found to
bioaccumulate in marine mammals in the Arctic and other remote environments (reviewed in
Houde et al. 2011). The presence of these PFAS, far from known sources, has been attributed to
the release of precursor compounds which degrade to form terminally stable HAS such as PFOS
and PFOA (Young et al. 2007, Stock et al. 2007).
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Little is known about the potential impacts of PFAS to wildlife, although a handful of studies
have linked tissue concentrations in beluga whales and sea otters to adverse health effects (Kelly
et al. 2009, Kalman et al. 2006). A selection of available ecotoxicity information for PFAS have
been prepared by the FluoroCouncil (ENVIRON 2014), the European Union (PFOS
Environmental Quality Standards Dossier, European Union 2011), and the Conservation of
Clean Air and Water in Europe (CONCAWE 2016).
Experimental data from tests of PFOA and PFOS in invertebrates, aquatic plants, and fish
indicate that PFOS is moderately acute and slightly chronically toxic to aquatic organisms,
(Giesy et al. 2010) while PFOA appears to be less of an acute toxicant than PFOS to aquatic
organisms (CONCAWE 2016). The majority of aquatic toxicity studies have not evaluated the
effects of long-term (chronic) exposure. Studies also suggest that marine invertebrate species are
more sensitive than freshwater invertebrates. Flourinated carbon chain length, functional group,
and dose have been found to determine the toxicity of PFAS to ecological receptors (Hekster et
al. 2002, Geisy et al. 2010). Potential human health risks are the driver for regulatory and public
health action, and more research on the potential effects of long -chain PFAS exposure to
ecological receptors is needed.
3 REGULATORY PROGRAMS
Authority for regulating HAS is derived from a number of federal and state statutes, regulations,
and policy initiatives. This section provides a brief overview of the major federal legislative
statutes and regulatory programs that govern PFAS, along with examples of representative state
regulatory programs.
3.1 Federal PFAS Regulations
3.1.1 Toxic Substances and Control Act (TSCA)
The TSCA authorizes the USEPA to require reporting, record keeping, and testing of chemicals
and chemical mixtures that may pose a risk to health or the environment. Section 5 of TSCA
allows the USEPA to issue significant new use rules (SNURs) to limit the use of chemical(s)
when it identifies a new chemical, or a significant new use of an existing chemical, before it is
allowed into the marketplace (USEPA 2017a). The USEPA has applied the SNUR to PFOS in
four separate actions and to 277 chemically related PFAS (USEPA 2017b). Collectively, these
SNURs placed significant restrictions on the use and import of PFAS, allowing only limited uses
in select industries and for certain applications. In addition, one of the rules required companies
to report all new uses in the manufacture, import, or processing of certain PFOA-related
chemicals for use in carpets or for aftermarket treatment. �k proposed (but not yet finalized)
SNUR (USEPA 2015) would designate the manufacture, import, and processing of certain PFOA
and PFOA-related chemicals (long -chain perfluoroalkyl carboxylates [LCPFACs]) as a
significant new use The significant new use would angly for any use that is not ongoing after
December 31, 2015. and for all other LCPFACs for which there is currently no ongoing use.
Commented [a2]: A tittle confused as to what this is trying to
say. What constitutes "ongoing use?"
Commented [LH W3R2]: I separated this into 2 sentence and
added few small changes. Is this still accurate & possibly more
clear. It seemed like it was just a long sentence.
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3.1.2 Safe Drinking Water Act (SDWA)
July 2017
The SDWA is the federal law that protects public drinking water supplies throughout the nation
(USEPA 1974). Under the SDWA, the USEPA has authority to set enforceable maximum
contaminant levels (MCLs) for specific chemical substances, and to require testing of public
water supplies. The SDWA applies to all public water systems in the United States, but does not
apply to private drinking water supplies or to water that is not being used for drinking.
USEPA has not established an MCL for any PFAS. However, in May 2016, USEPA established
a Lifetime Health Advisory (HA) for PFOA and PFOS (individually or combined) in public
drinking water (USEPA 2016c). The Lifetime HA supersedes USEPA's 2009 short-term (week
to months) provisional Health Advisories (USEPA 2009), which were intended for use as interim
guidelines while USEPA developed the Lifetime HA. The Lifetime HA for PFOA and PFOS is
advisory in nature - it is not a legally enforceable federal standard and is subject to change as
new information becomes available (USEPA 2016c).
Much of the data now available regarding PFASoccurrence in public drinking water was
generated by USEPA under its third Unregulated Contaminant Monitoring Rule (UCMR3).
USEPA uses the Unregulated Contaminant Monitoring Rule (UCMR) to collect data for
chemicals that are suspected to be present in drinking water, but do not have health -based
standards set under the Safe Drinking Water Act. The third round of this monitoring effort, or
UCMR3, included six PFAS:
• perfluorooctanesulfonic acid (PFOS)
• perfluorooctanoic acid (PFOA)
• perfluorononanoic acid (PFNA)
• perfluorohexanesulfonic acid (PFHxS)
• perfluoroheptanoic acid (PFHpA)
• perfluorobutanesulfonic acid (PFBS)
All large public drinking water systems (serving more than 10,000 people) and a limited number
of smaller systems were monitored for these PFAS in a 12-month period between 2013 and
2015. In the 4,920 public drinking water supplies tested, PFAS were reported in 194 water
supplies (about 4% of those tested), serving about 16.5 million people in 36 states and territories
(Hu et al. 2016). Approximately 2.5% of the tested systems exceeded the Lifetime HA; 46
supplies (0.9%) exceeded the HA for PFOS; 13 (0.3%) exceeded the HA for PFOA; and 63
(1.3%) exceeded the combined PFOA and PFOS HA (USEPA 2016 and 2017).
Occurrence data produced by the UCMR program are used by the USEPA (and some states) to
help determine which substances to consider for regulation. All of the data from the UCMR
program are published in the National Contaminant Occurrence Database NCOD and available Commented ILHw41: Link added
for download from USEPA's web site.
When the USEPA determines that there may be an imminent and substantial endangerment from
a contaminant that is present in or likely to enter a public water supply, Section 1431 of the
SDWA authorizes USEPA to issue Emergency Administrative Orders (EAOs) to take any action
necessary to protect human health, if state and local authorities have not acted (42 U.S.C. §300i).
In several instances, USEPA has issued EAOs related to PFAS-contaminated public water
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systems in order to require treatment (or replacement) of those supplies along with actions to
identify, investigate, and address the contaminant sources. At least two such EAOs have been
issued to the United States Air Force related to past use of aqueous film forming foams (AFFF)
for firefighting and in fire training exercises at bases in New Hampshire and Pennsylvania
(USEPA 2015a, USEPA 2015b).
3.1.3 Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA)
PFAS, including PFOA and PFOS, are not listed as CERCLA hazardous substances, but may be
addressed as CERCLA pollutants or contaminants (40 CFR 3005). CERCLA investigations are
beginning to include PFAS where supported by the conceptual site model. For example, the
USEPA has proposed adding the St. Gobain Performance, Plastics site in Hoosick Falls, NY to
the federal Superfund list based. in part. on detections of k6kiln groundwater (USEPA, 2016).
PFAS have been reported for 14 CERCLA sites during" =year reviews (USEPA 2014).
CERCLA does not contain chemical -specific standards. Instead th ERLCA process is
designed to rely on the identification of other federal and state standarc} , to determine the degree
of cleanup. The lead agency, with regulatory input, identifies potential appicable or relevant and
appropriate requirements (ARARs) and to -be -considered values (TBCs). Risk -based goals may
be calculated when chemical-specifiE ARARs are not available, or are determined not to be
protective (USEPA 1997).
3.1.3.1 CERCLA Protection of.
At this time, there are no potential federal ARARs foi'PFAS. The tables in Section 4 include
current state regulatory and guidance values for PFAS. These values are not automatically
recognized as ARARs. A multi -step process is used to identify potential ARARs and TBCs on a
site -specific basis. Determining if a state requirement is promulgated and substantive are initial
steps in that process (40 CFR 300.5, 40 CFR 300.400(g), USEPA, 1988, USEPA, 1991).
Risk -based cleanup goals are calculated when chemical -specific ARARs are not available or are
determined not to be protective (USEPA 1997). The USEPA's Regional Screening Level
Generic Tables (RSLs — USEPA 2016e) and the RSL online calculator (USEPA 2017) provide
screening levels and preliminary remedial goals. These goals are based on calculations
incorporating toxicity values that have been selected in accordance with the USEPA's published
hierarchy (USEPA NO). Currently, PFBS is the only PFAS listed in the RSL generic tables. For
PFBS, the generic tables provide anon-cancer reference dose, screening levels for soil and tap
water, and soil screening levels for the protection of groundwater. The RSL calculator supports
site -specific calculations for PFBS, PFOA, and PFOS in tap water and soil. Non -cancer reference
doses are provided for PFOA and PFOS. A cancer ingestion slope factor is also provided for
PFOA, but the screening levels are based on the non -cancer endpoint. Although less frequently
used, the USEPA also provides tables and a calculator for Removal Management Levels
(RMLs). In general, RMLs are not final cleanup levels, but can provide a reference level when
considering the need for a removal action (for example, drinking water treatment or replacement)
(USEPA 2016c).
Because RSLs and RMLs are periodically updated, they should be reviewed for revisions and
additions before using them. RSLs and RMLs are not ARARs, but they may be evaluated as
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TBCs. The USEPA has emphasized that RSLs are not cleanup standards (USEPA 2016f) and
suggests that final remedial goals be derived using the RSL calculator, so that site -specific
information can be incorporated.
3.1.3.2 CERCLA Protection of the Environment
CERCLA requires that remedies also be protective of the environment. Risk -based remedial
goals that are protective of the environment are site -specific and dependent on the identification
of the ecological receptors to be protected. At this time, there are no PFAS ARARs for the
protection of the environment.
3.1.4 Other Federal Programs
PFAS are not currently regulated under the Resource Conservation and Recovery Act (RCRA),
the Clean Water Act (CWA), or the Clean Air Act (CAA).
3.2 State PFAS Regulations
States have been actively involved with addressing -air, water; and soil -related PFAS
contamination across multiple state regulatory programs. Examples of keystate programs for
water, soil, hazardous waste, and consumer products are described belowAt the present time, no
state programs regulate PFAS lri air. commented (a51: Tiny bit confusing wasidering it just said that
----'--^------------------._...---- --- -"-- ---- -- "states are actively involved with air" Ask Ginny about VT and air
Involvement
3.2.1 Product Labeling and Consumer Products Laws
Commented [LHW6R5]: Air was deleted from the first
sentence because it was a bit confusing. LS this OK now?
PFOS, PFOA, and their salts are under consideration for `Listing' as potential Developmental
Toxicants under California's Proposition 65 (Office of Environmental Health Hazard
Assessment [OEHHA], 2016). If finalized, the listing will likely impose reporting requirements
on manufacturers, distributors, and retailers, and will prohibit companies from discharging these
PFAS to sources of drinking water. Washington has required the reporting of PFOS in children's
products since 2011 (Washington State, 2008); proposed rules would require reporting of PFOA
in children's products starting in January 2019. Washington also tests products for chemicals to
ensure manufacturers are reporting accurate information.
3.2.2 Chemical Action Plans
Washington prepares chemical action plans (CAPs) under an administrative rule that addresses
persistent, bioaccumulative, and toxic (PBT) chemicals (Washington State, 2006). These CAPs
are used to identify, characterize, and evaluate uses and releases of specific PBTs or metals.
Washington is currently preparing a PFAS CAP that is expected to be completed in 2018.
3.2.3 Hazardous Substance Designation
Hazardous waste regulations that target select PFAS have been promulgated in Vermont and
New York, and are under development in several other states. Vermont regulates PFOA and
PFOS as hazardous wastes when present in a liquid at a concentration > 20 parts per trillion, but
allows exemptions for: (1) consumer products that were treated with PFOA and are not specialty
10
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products; (2) remediation wastes managed under an approved chemical action plan or disposal
plan; and (3) sludge from wastewater treatment facilities, residuals from drinking water supplies,
or leachate from landfills when managed under an approved plan (Vermont DEC 2016).
In 2017, the New York State Department of Environmental Conservation (NYDEC) finalized
regulations that identify PFOA, ammonium perfluorooctanoate, PFOS (the acid) and its salt,
perfluorooctane sulfonate, as hazardous substances that may be found in Class B firefighting
foams (NYDEC 2017). The regulations specify storage and registration requirements for Class B
foams that contain at least 1 % by volume of one or more of these four PFAS, and prohibit the
release of one pound or more of each of these PFAS into the environment during the use of
firefighting foams. If a release exceeds the one pound threshold, it is considered a hazardous
waste spill and must be reported; cleanup may be required under the State's Superfund or
Brownfields programs (NYDEC 2017).
3.2.4 Drinking Water, Groundwater, Surface Wate 4nd Remediation Programs
Several states have developed standards and guidance values for PFAS in drinking water and
groundwater (see Section 4 tables). Many states have either adopted the USEPA HAs for PFOA
and PFOS, or selected the same health -based valuees; choosing,to use the concentrations as
advisory, non -regulated levels to guide the interpretation of PFOA and PFOS detections. Other
states, such as Vermont, Minnesota, and New Jersey, have developed more stringent levels based
on their own analysis of the scientific data. Michigan is currently the only state that regulates
certain PFAS in surface water, although Minnesota has established enforceable water -body
specific PFAS discharge limits. New Jersey has adopted an Interim Ground Water Quality
Standard for PFNA,,and its drinking water advisory body has recommended proposed MCLs for
PFOA and PFNA. While several states have adopted enforceable ground water standards for
PFOA and PFOS, no state other than New Jersey currently has MCLs (or proposed MCLs) for
PFAS.
In California, when evaluating the discharge or cleanup of pollutants, the Regional Water
Quality Control Boards(RWQCB) are required "to initially evaluate setting the effluent limitation
or cleanup standard at the background concentration of each pollutant. This is done regardless of
whether there is a drinking water standard or other health -based value available. For
anthropogenic chemicals such as PFAS, the initial value would be the analytical detection limit
in water. Generally, technical and economic considerations, along with available health -based
criteria, are considered (for example, RWQCB, 2016).
Various states address the remediation of PFAS in groundwater and soil; compliance with
remediation standards is typically mandatory once a site or facility meets state -specific criteria
for environmental mitigation (see Section 4 tables).
4 AVAILABLE STANDARDS AND GUIDELINES
Standards or guidance values have been established for PFOS, PFOA, as well as several other
PFAS in environmental media as well as various terrestrial biota, fish, and finished products. The
tables, provided as a separate Excel file, are intended to represent available U.S. and
international standards and guidelines for groundwater, drinking water, surface water, effluent
11
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July 2017
(Table 4-1). and soil (Table 4-2). The available standards list is changing rapidly, so these tables
will be updated periodically by ITRC. The fact sheet user should visit the ITRC web site
(www.itrcweb.org) to determine the current version of the tables.
Table 4-1 presents the available PFAS water standards or guidance established by the USEPA,
each pertinent state, and international country. The specific agency or department is listed with
the year it was published, the acronym used, the type of media (groundwater, drinking water,
surface water, or effluent), as well as whether it was published as guidance or as promulgated
leTo date---------'-----------14 - -- eeua_ __
Table 4-2 presents the available HAS soil standards or guidance established by the USEPA,
each pertinent state, and international country. Both soil screening levels for groundwater
protection and human health are presented. The specific agency or department is listed with the
year the standard or guidance was published, and the acronym used. Five states and
Tables are provided in a keparate Excel file _
5 BASIS OF STANDARDS AND GUIDANCE
As shown in tables 4-1 and 4-2, regulatory values for PFAS in drinking water or groundwater
vary across the U.S. Most of these values are based on non -cancer toxicological effects. The
tables provided summarize the differences in the regulatory values for PFOA (Table 5-1) and
PFOS (Table 5-2), demonstrating that they are attributable to differences in the selection and
interpretation of key toxicity data, choice of uncertainty factors, and the approach used for
animal -to -human extrapolation. Differences in regulatory values are also due to the choice of
exposure assumptions, including the life stage used, and the percentage of exposure assumed to
come from non -drinking water sources. The available information is growing rapidly, so these
tables will be updated periodically by ITRC. The fact sheet user should visit the ITRC web site
(www;itrcweb.org) to determine the current version of the tables.
The values listed in these tables reflect the various divergent science and science policy
decisions. Note, some state values may not be listed because they have adopted the USEPA HAs,
as well as the USEPA's interpretation of PFOA and PFOS toxicology and exposure parameters.
Only the agencies that have used science or science policy decisions that are different from those
of the USEPA HAs are shown. Additionally, guidance on implementation for stakeholders is a
data gap for future evaluation.
Tables are provided in a keparate Excel file
12
Commented [LHW7]: I deleted these statements about numbers,
because they will go out of date
Commented [LHW8]: In the final fact sheets these will be
linked to a location on the rrRC web site.
Commented [LHW9]: In the final fact sheets these will be
linked to a location on the rlRC web site.
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6 OFERENCEO ---- ,_
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13
Commented [LNW 0]: Consider removing the links (keep the
" full citations) and making a more general links page that will be
easier to keep updated. We can probably leave these like this for the
review, but then when we publish the fact sheets consolidate the
links.
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USEPA. 2017c. "Regional Screening Level (RSL) Calculator." Accessed 26 May 2017. https://epa-
prgs ornl qov/cqi-bin/chemicals/csl search
USEPA. 2017. Fact Sheet: 2010/2015 PFOA Stewardship Program. https•//www epa gov/assessing-and-
managing chemicals under tsca/fact-sheet-20102015-pfoa-stewardship-program. Updated April 6
2017
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ITRC Draft Materia4 do not cite or quote July 2017
USHHS (United States Department of Health and Human Services). 2017. Fourth National Report on
Human Exposure to Environmental Chemicals. Updated Tables. Centers for Disease Control and
Prevention (CDC), Volume One. January.
https://www.cdc.gov/biomonitorinq/pdf/FourthReport UpdatedTables Volumel Jan2017.adf
WA ECY (Washington Department of Ecology). 2017. "The Reporting List of Chemicals of High Concern
to Children (CHCC)." hftp://Www.ecy.wa.gov/programs/hwtr/RTT/cspa/chcc.htmI
Washington State Legislature. 2006. "Persistent Bioaccumulative Toxins." Washington Administrative
Code 173-333. httr)://apps.lea.wa.gov/wac/default.aspx?cite=173-333
Washington State Legislature. 2008. "Identification of high priority chemicals —Report." RCW 70.240.030.
hftp://ai)ps.leg.wa.gov/RCW/default.aspx?cite=70.240.030
Vermont DEC (Department of Environmental Conservation). 2016. Emergency Rule Coversheet: Vermont
Hazardous Waste Regulations.
http://dec.vermont.gov/sites/dec/files/documents/2016 04 140/o20VHWMR%20Signed%20APA%20f
orms.pdf April 14 2016. See also http://www vectogether org/w"ontenVuploads/2013/10/Moran-
Matt-VEC. Presentation. pdf
Yamashita, N., K. Kannan, S. Taniyasu, Y. Horii, G. Petrick, T. Gamo. 2005. "A Global Survey of
Perfluorinated Acids in Oceans," Maritime Pollution Bulletin 51 (8el2), 658-668.
Young, C., V. Furdui, J. Franklin, R. Koerner, D. Muir, and S. Mabury. 2007 "Perfluorinated Acids in Arctic
Snow: New Evidence for Atmospheric Formation.' Environmental Science and Technology. 41: 3455-
3461. DOI: 10.1021/es0626234.
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