June 10, 2019
VIA ELECTRONIC FILING
Stiven Foster
Office of Land and Emergency Management
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460
RE:

Draft Interim Recommendations for Addressing Groundwater Contaminated with
PFOA and PFOS; Docket No. EPA-HQ-OLEM-2019-0229

Dear Mr. Foster:
We, the undersigned organizations (collectively, the Associations), write to you to express
our concerns regarding the U.S. Environmental Protection Agency’s (EPA or Agency) draft set of
recommendations for mitigating groundwater contaminated with perfluorooctanoic acid (PFOA)
and/or perfluorooctane sulfonate (PFOS).1
The Associations understand the importance of responsibly managing water resources and
have been working to protect clean water for decades. Many of the Associations’ members have
manufactured or used products containing PFOS and/or PFOA in the past when they were
previously in the U.S. stream of commerce, and we recognize the need for an appropriate risk-based
federal approach to regulating these two chemicals that is based on the best available science and
data. The Associations applaud EPA for recognizing that the government should not regulate PFAS
as a class, and that PFAS is a broad family of chemicals with varying properties.
The risk evaluations used to develop the draft interim recommendations would be improved
substantially by including the best available scientific data regarding PFOA and PFOS. As discussed
further below, recent studies demonstrate that EPA’s draft recommendations are overly
conservative and would likely lead to cleanups that take longer to complete and have more
expensive outcomes without improved public health and safety benefits.
Per- and polyfluoroalkyl substances (PFAS) are a broad class of chemical substances used
across a wide-cross section of industries, including aerospace, automotive, construction, electronics,
energy, first responder services, healthcare, and telecommunications. Beneficial products enabled by
PFAS technologies include semiconductors, solar panels, high performance electronics, medical
garments, and fuel-efficient automobiles, and certain fluorinated firefighting foams that are still
needed for emergency response operations.
U.S. ENVTL. PROT. AGENCY, USEPA Draft Interim Recommendations to Address Groundwater Contaminated with
Perfluorooctanoic Acid and Perfluorooctane Sulfonate (Apr. 25, 2019), available at
https://www.epa.gov/sites/production/files/201904/documents/draft_interim_recommendations_for_addressing_groundwater_contaminated_with_pfoa_and_pfos_pub
lic_comment_draft_4-24-19.508post.pdf.
1

 U.S. Environmental Protection Agency
June 10, 2019
Page 2 of 6
EPA and other federal agencies are advancing additional options to assess and regulate
specific PFAS chemistries, including PFOA and PFOS. In May 2018, EPA hosted a National
Leadership Summit to address PFAS in the environment.2
EPA used this summit to share information on ongoing efforts to: (1) characterize risks
from PFAS and develop monitoring and treatment/cleanup techniques; (2) identify specific nearterm actions, beyond those already underway, that are needed to address challenges currently facing
states and local communities; and (3) develop risk communication strategies that will help
communities to address public concerns with PFAS.3 A variety of stakeholders from both the state
and federal level attended the summit to provide their perspectives on the issue at hand.4
EPA then conducted a series of community engagement events over the course of the
summer in localities affected by PFAS contamination.5 These events provided EPA with the
opportunity to hear directly from the public as to how to best help states and communities that have
been directly impacted by PFAS. EPA also opened a public docket for those stakeholders unable to
attend an event to submit additional information for the Agency to consider.
These events, coupled with the information that EPA received electronically from
stakeholders, helped inform EPA’s “PFAS Action Plan.”6 The PFAS Action Plan “represents the
first time the EPA has built a national, multi-media, multi-program, research, management, and risk
communication plan to address emerging chemicals of concern within a class like PFAS.”7 The
PFAS Action Plan identifies a host of short-term solutions and long-term strategies for addressing
PFAS contamination.8
See U.S. ENVTL. PROT. AGENCY, PFAS National Leadership Summit and Engagement, available at
https://www.epa.gov/pfas/pfas-national-leadership-summit-and-engagement.
2

3

Id.

See U.S. ENVTL. PROT. AGENCY, PFAS National Leadership Summit List of Confirmed Organizations (May 22, 2018), available
at https://www.epa.gov/sites/production/files/201805/documents/pfas_summit_list_of_confirmed_organizations_5.22.18.pdf.
4

See U.S. ENVTL. PROT. AGENCY, PFAS Community Engagement, available at https://www.epa.gov/pfas/pfascommunity-engagement (EPA conducted community engagement events in: Exeter, New Hampshire; Horsham,
Pennsylvania; Colorado Springs, Colorado; Fayetteville, North Carolina; Leavenworth, Kansas; and Spokane,
Washington).
5

U.S. ENVTL. PROT. AGENCY, EPA’s Per- and Polyfluoroalkyl Substances (PFAS) Action Plan (Feb. 2019), available at
https://www.epa.gov/sites/production/files/2019-02/documents/pfas_action_plan_021319_508compliant_1.pdf.
6

Examining PFAS Chemicals and their Risks, Hearing Before the Subcomm. on Environment of the H. Comm. on Oversight and
Reform, 116th Cong. (Mar. 6, 2019) (statement of David P. Ross, Assistant Adm’r., EPA Office of Water, 4-5), available at
https://www.epa.gov/sites/production/files/2019-03/documents/epa_ross_hor_pfas_testimony__final_for_march_6.pdf.
7

8

Id. at 5.

 U.S. Environmental Protection Agency
June 10, 2019
Page 3 of 6
One of the short-term priority actions laid out in the PFAS Action Plan is for EPA to
provide guidance for groundwater cleanup actions at contaminated sites.9 These recommendations
will “provide a starting point for making site-specific cleanup decisions,” and, according to the
Agency, “may be considered for federal facility and private-party cleanup” under the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA or Superfund),10 corrective
action programs under the Resource Conservation and Recovery Act (RCRA),11 and, where
appropriate, state cleanup programs.12
The April 25, 2019 draft interim guidance provides recommendations on screening levels, as
well as preliminary remediation goals (PRGs), which are initial targets for cleanup and may be
adjusted on a site-specific basis as more information becomes available. Specifically, the draft
interim guidance recommends:
1. Screening sites using a level set to a hazard quotient of 0.1 for PFOA or PFOS
individually, which is currently 40 ng/L or parts per trillion (ppt);
2. Using the PFOA and PFOS hazard advisories of 70 ppt as the PRG for groundwater
that is a current or potential source of drinking water, where no state or tribal
maximum contaminant level (MCL) or other applicable or relevant and appropriate
requirements (ARARs) exist; and
3. Addressing levels of PFOA and/or PFOS over 70 ppt in situations where
groundwater is being used for drinking water.13
The Associations have concerns regarding EPA’s draft interim recommendations for
addressing groundwater contaminated with PFOA and PFOS. In general, the Agency should not set
groundwater cleanup levels to mirror a drinking water advisory level, given that they are two
separate environmental media with different exposure profiles, and the standards have different
purposes. Extending the orders of magnitude built into the drinking water advisory level to
groundwater cleanup levels would result in a level of conservativism that would lead to unachievable
standards, unrealistic expectations on the part of the community, and unreasonable costs to the
public.

9

EPA’s PFAS Action Plan, supra note 6, at 3.

10

42 U.S.C. § 9601, et seq.

11

Id. at § 6901, et seq.

12

Supra note 9.

13

Draft Interim Recommendations, supra note 1, at 1-2.

 U.S. Environmental Protection Agency
June 10, 2019
Page 4 of 6
It is imperative that any regulatory action, including the development of interim guidance,
taken to address any PFAS is based on the latest, evidence-based, peer-reviewed science. Agencies
should identify sources of uncertainty and the research needed to reduce those uncertainties, and
policies and guidance should remain flexible to accommodate emerging science.
EPA has taken extensive steps to develop its current scientific understanding of the toxicity
of PFOA and PFOS. Beginning in 2009, EPA developed provisional lifetime Hazard Assessments
(HA) for these PFAS based on a thorough evaluation of peer-reviewed science and literature on
human health effects associated with those two chemicals.14 EPA issued draft chronic health effects
support documents in 2014 and later finalized a lifetime drinking water HA of 70 ppt for the
individual or combined concentrations of PFOA and PFOS in 2016.15 Lifetime drinking water
health advisories are premised on the assumption that all water consumed every day – including
drinking water, and water used to prepare coffee, tea, soups, and other food – contains PFOA
and/or PFOS. In reality, only a subset of the water consumed by an individual is likely to come
from a single source, such as groundwater, and, therefore, this assumption is overly conservative.
Additional new information also demonstrates that the 70 ppt levels are overly
conservative, and would lead to unnecessarily stringent requirements without any additional human
or public health benefits. For example, EPA should use information from the 2018 clinical trials
conducted with ammonium perfluorooctanoate that would provide better estimates of PFOA halflife in humans.16 This is very important for predicting appropriate risk-based drinking water values
as there are large pharmacokinetic differences between humans and animals for PFOA and PFOS
that are highly dose dependent and show non-linear toxicokinetics.
Consequently, a modeled delivered dose can be much higher for humans predicted at a high
external dose but lower when applying a human relevant dose. For example, a recent Health Canada
evaluation correcting for this important observation showed that EPA underestimated the human
clearance rate that results in a resulting human equivalent dose up to 500 times lower than what is
currently predicted in the EPA HA and relevant supporting animal data that indicates that the
proposed PRG and Hazard Quotients (HQ) are based on data that over-predicts responses in
humans.17
A key element of any preliminary remediation goal should include a discussion of the
uncertainties in the calculations. By setting the HQ at 0.1, the EPA’s Office of Land and
Emergency Management (OLEM) is essentially saying that screening needs to begin with the
14

Draft Interim Recommendations, supra note 1, at 2.

15

Id.

See M. Covertino, T.R. Church, G.W. Olsen, et al., Stochastic Pharmacokinetic-Pharmacodynamic Modeling for Assessing the
Systemic Health Risk of Perfluorooctanoate (PFOA), Toxicological Sciences, 163(1), 293-306 (2018).
16

See HEALTH CANADA, Water Quality – Reports and Publications, available at https://www.canada.ca/en/healthcanada/services/environmental-workplace-health/reports-publications/water-quality.html.
17

 U.S. Environmental Protection Agency
June 10, 2019
Page 5 of 6
assumption that 10 times more groundwater could be consumed than already considered in the
lifetime drinking water HA for PFOA and PFOS, which is highly unlikely. This is, in effect,
applying a 10-fold additional and unnecessary uncertainty factor on top of those conservative
assumptions already built into the HA level derived by EPA’s Office of Water (OW).
EPA has the opportunity to review additional scientific information to further understand
the health effects, analytical methodologies, and treatment technologies associated with drinking
water contaminated with PFOA or PFOS, and should consider revising the HAs, screening levels,
and PRGs in a manner that reflects the best available science, consistent with Agency guidance
documents and tools supporting these efforts.18
Additionally, the Associations believe that the Agency should clarify the applicability
of these recommendations with respect to potential sources of drinking water. The science
behind health effects related situations in which groundwater is used for drinking water is
still emerging, and it is unclear what EPA considers to be a “potential source” and how they
would be defined. On its face, the April 2019 draft interim recommendations appear to
contradict EPA’s 2016 memorandum, “Clarification about the Appropriate Application of
the PFOA and PFOS Drinking Water Health Advisories.”19 That memorandum from OW
excludes application to non-drinking water (secondary) pathways and reiterates that these
HAs identify the concentration of PFOA and PFOS in drinking water at which adverse health
effects are not anticipated to occur in a lifetime.20
For consistency with the EPA methodology for calculating other preliminary remediation
goals and risk-based screening levels used nationwide, exposure assumptions (including groundwater
ingestion rates) should be standardized and correspond to actual consumption. The HA Basis
should be reexamined in light of the November 15, 2016, EPA memorandum that clarifies the strict
applicability of the drinking water HA, and that outlines the many conservative assumptions already
inherent in the HA methodology for PFOA and PFOS, thus obviating the need to effectively add an
additional “safety factor” of 10 by requiring a screening hazard quotient of 0.1.
Finally, EPA should clarify that levels of PFOA and PFOS in water used for drinking should
be compared to lifetime HA levels addressed at the point of use, rather than at the raw source, as
HA are intended for finished drinking water, not raw source water prior to disinfection or any other
transport or treatment.

18

Draft Interim Recommendations, supra note 1, at 2.

U.S. ENVTL. PROT. AGENCY, Memorandum from Dr. Peter C. Grevatt, Director of EPA Office of Groundwater and Drinking
Water, to Regions I – X Water Division Directors, Clarification about the Appropriate Application of the PFOA and PFOS Drinking
Water Health Advisories (Nov. 15, 2016), available at https://www.epa.gov/sites/production/files/201611/documents/clarification_memo_pfoapfos_dw_has.pdf.
19

20

Id.

 U.S. Environmental Protection Agency
June 10, 2019
Page 6 of 6
The Associations appreciate EPA’s efforts to set recommendations for cleaning up
groundwater contaminated with PFOA and/or PFOS, the opportunity to comment on this
important matter, and suggest that the Agency further update the guidance to reflect the most recent
scientific evidence.
Sincerely,
U.S. Chamber of Commerce
American Forest & Paper Association
American Fuel & Petrochemical Manufacturers
American Petroleum Institute