Summary of Public Comments and Response

Appendix B1. Public Comments and Agency Responses
Docket No. ATSDR-2018-0008 - Proposed Data Collection Submitted for Public Comment and Recommendations
“Human Health Effects of Drinking Water Exposures to Per- and Polyfluoroalkyl Substances (PFAS) at Pease International Tradeport, Portsmouth, NH
(The Pease Study)”
No.

Comment No.

B1a

ATSDR-2018-0008-0002

Anonymous

Mode of
Submission
online

B1b
B1c
B1d

ATSDR-2018-0008-0003
ATSDR-2018-0008-0004
ATSDR-2018-0008-0005

Karandeep Lachhar
Karandeep Lachhar
Jimmy Chuong

online
online
online

Submitted by:

Agency Response
ATSDR appreciates the comments from the submitter. The comments are
outside the scope of this docket.
ATSDR appreciates the comments of Karandeep Lachhar.
Posted in duplicate
ATSDR appreciates the comments from Jimmy Chuong. The purpose of
including a Portsmouth area referent group in this study is to provide
information on background PFAS serum levels as well as background levels of
effect biomarkers (e.g., liver, kidney, thyroid and immune function) among
those unexposed to PFAS-contaminated drinking water. Medical records will
not provide this information.
According to consumer confidence reports, the Pease Tradeport and City of
Portsmouth drinking water systems have been in compliance with EPA safe
drinking water regulations, so there are no other toxic chemicals of concern in
the water supply besides PFAS. It is possible that study participants may be
exposed to other toxic chemicals at their residences or workplaces, but
confounding should be minimal because these other exposures will likely not be
associated with PFAS serum levels. The questionnaire does obtain occupational
history so that occupational exposures can be taken into account in the
analyses. Analyses will be adjusted for age of the participant. The study will
obtain medical history including dates of diagnosis and the use of medications.

B1e

ATSDR-2018-0008-0006

Robert Bilott

letter

A study of mother-infant pairs is beyond the scope of the Pease study. This
requires a special study design.
ATSDR appreciated the comments from Robert Bilott. In November 2017,
ATSDR published a feasibility assessment for epidemiological studies at Pease
International Tradeport that provided sample size calculations for a wide range
of diseases and effect biomarkers. The assessment concluded that a children’s
study at Pease that included 350 exposed and 175 referents would have
sufficient statistical power to effectively
1

evaluate lipids, kidney function, growth hormone deficiency and obesity. Other
outcomes that might be effectively evaluated included thyroid function, sex
hormones, neurobehavioral effects, asthma, and rhinitis. An adult study that
included 1,000 exposed at Pease could effectively evaluate lipids, kidney
function, cardiovascular disease, and osteoarthritis. The assessment clearly
stated that health outcomes in children such as ADHD, thyroid disease and
cancers, and health outcomes in adults such as kidney and liver disease,
ulcerative colitis, and cancers, could not be effectively evaluated in a study
limited to the Pease population but would require a multi-site study.
Nevertheless, the Pease study will collect information on these outcomes. As a
“proof of concept”, a key purpose of the Pease study is to evaluate procedures
that will also be used in a multi-site study, so that any problems that may arise
can be identified and resolved prior to conducting the multi-site study.
Unlike the exposure assessments, the Pease proof of concept is an
epidemiological study whose findings can be generalized to other sites where
exposures to PFAS- contaminated drinking water occurred. Moreover, since the
study will evaluate specific PFAS serum levels, the results will also be relevant
to anyone with similar PFAS serum levels. The data from the Pease study will be
integrated in a database with data from the other sites included in the multisite epidemiological study. The proposed multi-site study will include data from
a total of at least 2,000 children and 6.000 adults.
The sites that will be included in the multi-site will not necessarily be the sites
included in the EA. With a sample size of at least 6,000 adults and categorizing
PFAS serum levels into exposure quartiles, there would be sufficient statistical
power to detect the relative risk for ulcerative colitis observed in the C8 study.
The multi-site study proposal will be submitted to the Federal Register for a
60-day public comment period in 2019.
ATSDR is aware of concerns about PFAS contamination around fire training
centers and fire stations, and recognizes that firefighters and emergency
responders are at risk of PFAS exposures due to the use of AFFF and possibly
through protective equipment treated with chemicals that include PFAS.
However, the Pease Proof of Concept Study is focused on PFAS exposures via
the consumption of contaminated drinking water at the Pease International
Tradeport.

2

The study will be estimating cumulative PFAS serum levels, as was done in the
C8 studies. By evaluating estimated PFAS serum levels in addition to measured
PFAS serum levels, the study can avoid issues such as confounding and reverse
causation that can occur when factors that affect a specific health outcome (or
the outcome itself) also affect measured PFAS serum levels. Moreover, the
estimation of PFAS serum levels facilitates the evaluation of specific periods of
exposure (exposure windows) as well as lagged exposures (e.g., to account for
latency periods). Estimating cumulative PFAS serum levels using
pharmacokinetic models and the historical reconstruction of the Pease drinking
water contamination will be difficult but doable for PFOA, PFOS and possibly
PFHxS. However, without detailed information about PFAS exposures that
occurred via occupation as a firefighter or to a worker in an industrial process
that uses or manufactures PFAS, it would be impossible in this study to factor
these occupational PFAS exposures into the estimates of cumulative PFAS
serum levels.
Additionally, it is likely that the firefighters also experienced occupational
exposures to other toxic substances that would be difficult to take into account
in the analyses, such as PAHs, benzene, asbestos, formaldehyde, cadmium,
dioxins, and PCBs. Firefighters at airports and military bases may also have been
exposed to high levels of jet fuel (JP-4). These confounding variables make it
difficult to determine whether the health outcome is related to PFAS exposure
or exposure to a different substance.
B1f
B1g

ATSDR-2018-0008-0007
ATSDR-2018-0008-0008

Robert Bilott
Diane Cotter

letter
email

Posted in duplicate
The Agency appreciates the comment from Diane Cotter. ATSDR is aware of
concerns about PFAS contamination around fire training centers and fire
stations, and recognizes that firefighters and emergency responders are at risk
of PFAS exposures due to the use of AFFF and possibly through protective
equipment treated with chemicals that include PFAS. However, the Pease Proof
of Concept Study is focused on PFAS exposures via the consumption of
contaminated drinking water at the Pease International Tradeport.
The study will be estimating cumulative PFAS serum levels, as was done in the
C8 studies. By evaluating estimated PFAS serum levels in addition to measured
PFAS serum levels, the study can avoid issues such as confounding and reverse
causation that can occur when factors that affect a specific health outcome (or
the outcome itself) also affect measured PFAS serum levels. Moreover, the
estimation of PFAS serum levels facilitates the evaluation of specific periods of
3

exposure (exposure windows) as well as lagged exposures (e.g., to account for
latency periods). Estimating cumulative PFAS serum levels using
pharmacokinetic models and the historical reconstruction of the Pease drinking
water contamination will be difficult but doable for PFOA, PFOS and possibly
PFHxS. However, without detailed information about PFAS exposures that
occurred via occupation as a firefighter or to a worker in an industrial process
that uses or manufactures PFAS, it would be impossible in this study to factor
these occupational PFAS exposures into the estimates of cumulative PFAS
serum levels.
Additionally, it is likely that the firefighters also experienced occupational
exposures to other toxic substances that would be difficult to take into
account in the analyses, such as PAHs, benzene, asbestos, formaldehyde,
cadmium, dioxins, and PCBs. Firefighters at airports and military bases may
also have been exposed to high levels of jet fuel (JP-4). These confounding
variables make it difficult to determine whether the health outcome is related
to PFAS exposure or exposure to a different substance.
B1h

ATSDR-2018-0008-0009

Martha Roy

online

Comments also Included in ATSDR-2018-0008-0013. Please see below for
responses.

B1i

ATSDR-2018-0008-0010

Bryan Lindauer

online

ATSDR appreciates the comments of Bryan Lindauer and agrees that exposure
to PFAS is a public health concern.

B1j

ATSDR-2018-0008-0011

Anonymous

online

ATSDR appreciates the comments from the submitter. The comments are
outside the scope of this docket.

4

B1k

ATSDR-2018-0008-0012

Steve Risotto

online

The Agency appreciates the comments from Stephen Risotto. In November
2017, ATSDR published a feasibility assessment for epidemiological studies at
Pease International Tradeport that provided sample size calculations for a wide
range of diseases and effect biomarkers. The assessment concluded that a
children’s study at Pease that included 350 exposed and 175 referents would
have sufficient statistical power to effectively evaluate lipids, kidney function,
growth hormone deficiency and obesity. Other outcomes that might be
effectively evaluated included thyroid function, sex hormones, neurobehavioral
effects, asthma, and rhinitis. An adult study that included 1,000 exposed at
Pease could effectively evaluate lipids, kidney function, cardiovascular disease,
and osteoarthritis. The assessment clearly stated that health outcomes in
children such as ADHD, thyroid disease and cancers, and health outcomes in
adults such as kidney and liver disease, ulcerative colitis, and cancers, could not
be effectively evaluated in a study limited to the Pease population but would
require a multi-site study. Nevertheless, the Pease study will collect
information on these outcomes. As a “proof of concept”, a key purpose of the
Pease study is to evaluate procedures that will also be used in a multi-site

5

study, so that any problems that may arise can be identified and resolved prior
to conducting the multi-site study.
Analyses for specific diseases will be restricted to those self-reported cases that
are confirmed by medical records. To minimize recall bias, analyses internal to
the Pease population will be conducted as well as analyses comparing Pease to
the referent group. However, the key outcomes are the effect biomarkers (e.g.,
lipids, kidney, liver, thyroid and immune function) that are not affected by recall
biases and do not require medical record confirmation.
The Pease study will incorporate age-, sex- and calendar year-specific historical
background PFAS serum levels from NHANES for the historical reconstruction of
PFAS serum levels in the Pease population. This approach will take into account
PFAS sources other than the Pease drinking water. ATSDR has extensive
experience conducting groundwater fate and transport modeling of
contaminants (e.g., the Camp Lejeune study) as well as drinking water
distribution system modeling (Toms River, NJ and Camp Lejeune studies) and
historical reconstruction of drinking water exposures based on very limited
contaminant sample data (Camp Lejeune study). The protocol for the Pease
study has completed an independent peer review process and ATSDR intends
to consult with independent experts to determine the best approach to
historically reconstructing the PFAS concentrations in the Pease drinking water
system.
In addition to reconstruction of PFAS drinking water concentrations, ATSDR
intends to estimate historical PFAS serum concentrations in participants. This
approach was successfully implemented in the C8 study using historically
reconstructed PFOA drinking water concentrations. PBPK models exist for
PFOS, so it is also possible to historically reconstruct PFOS serum levels from
PFOS drinking water concentrations. Currently, PBPK approaches for PFHxS are
limited but ATSDR intends to consult with independent experts to determine
the best approach to estimating PFHxS serum levels from PFHxS concentrations
in drinking water.
The study questionnaire includes a medical history, occupational history, and
lifestyle/demographic questions. The information from the questionnaire can
be used in the analyses to adjust for possible confounding. In addition,
“negative controls” (i.e., diseases not known to be associated with PFAS

6

bias and confounding. Confounding will also be minimized by conducting
analyses internal to the Pease population since it is unlikely that PFAS serum
levels will be associated with possible confounding factors. Finally, conducting
analyses using estimating PFAS serum levels will avoid biases such as reverse
causation and confounding due to factors (including the outcome under
evaluation) that might affect measured PFAS serum levels.
The document, “Human health effects of drinking water exposures to perand polyfluoroalkyl substances (PFAS) at Pease International Tradeport,
Portsmouth, NH” was submitted with the Federal Register Notice
announcing the project and was available for review during the 60-day
comment period. This document contains a detailed list of the PFAS to be
studied in the project.

7

B1l

ATSDR-2018-0008-0013

Martha Roy

online

ATSDR appreciates the comments from Martha Roy, Town Administrator, and the
Newington Selectmen.
In the study recruitment’s second wave, letters of invitation will be sent out to
those eligible for the study, including Newington households served by private
wells with measured PFOA + PFOS ≥70 parts per trillion (ppt). The recruitment’s
first wave will include those who participated in the NH DHHS Pease
biomonitoring program because they have PFAS concentration available close to
the time when wells were shut down. It is unlikely that the sample size goals will
be achieved after completion of wave one recruitment, so Newington community
members with private well contamination that exceeds the EPA Lifetime Health
Advisory for PFOA + PFOS will likely be recruited during wave two. The time
period of 2004-May 2014 is relevant to the Pease Tradeport. Newington residents
with PFAS-contaminated private wells above the EPA advisory will be eligible for
wave 2 recruitment if they were exposed anytime from 2004 onward. Newington
residents who did not use private wells will be eligible for the referent group if
they never consumed drinking water at the Pease Tradeport. Newington
residents will be recruited for the referent group in a similar fashion as others in
the Portsmouth area who never drank Pease drinking water.
For adults, the study procedures should take about one hour plus time to review
and sign a consent form to participate. For children, the study procedures will
take about 2 hours and 30 minutes plus time for reviewing and signing a consent
form.
All participants will be asked to provide a blood and urine sample. Once all the
PFAS analyses are completed, ATSDR will provide each participant with his/her
PFAS results. While we understand community members’ concerns about their
individual PFAS serum levels, due to the study design participants should expect
that it may take a year or longer from the time they provided the blood sample
to the time they receive their PFAS results.

8