Summary of Public Comments

Version 12 Oct 2018, 1245

Attachment 2a: Agency Responses to Public Comments

Submitter
Anonymous Anonymous

Comment
The submitter commented on
issues associated with the impacts
of wildfire on wildlife.

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

Vicki Quint

The submitter commented on
testing drinking water and
groundwater for PFAS.

Vicki Quint

The submitter commented on
issues associated with exposure of
First Responders to PFAS during
firefighting activities.

International
Association of Fire
Fighters

The submitter encouraged ATSDR
to include fire fighters and other
workers in its data collection to
determine the relative risk to

The Agency appreciates the comment from
Vicki Quint. The exposure assessments focus
on human exposure to PFAS from drinking
water. While the presence of PFAS in
groundwater indicates contamination, it does
not necessarily signal that people have been
exposed. The exposure assessments will
investigate PFAS exposure among
communities in which there is evidence of
PFAS drinking water contamination. In
addition, ATSDR will conduct drinking water
testing at a subset of households to assess
current levels of PFAS and advise appropriate
mitigation, if necessary.
The Agency appreciates the comment from
Vicki Quint. The Exposure Assessments are
designed to characterize exposure to the
general population rather than worker
exposures. In order to generate results
representative of the community,
participants will be selected at random from
all people in the defined study areas.
Randomly selected individuals will be eligible
to participate in the investigation if they
meet all three inclusion criteria: are three
years of age or older, have lived in the
community for at least one year, and do not
have a bleeding disorder and is not anemic. If
first responders, including fire fighters, live in
the study area and are selected through the
random process, they will be included in the
exposure assessment. In the current work we
cannot target specific subpopulations (like
first responders or fire fighters) and still
generate results that will be valid for the
community as a whole.
The Agency appreciates the comment from
the International Association of Fire Fighters.
The Exposure Assessments are designed to
characterize exposure to the general

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workers as opposed to other
individuals at military bases.

Integral Consulting Inc.

The submitter requested that
ATSDR release additional details
on study design and protocol for
public review and comment.

Integral Consulting Inc.

The submitter requested that
ATSDR conduct analysis and
reporting of results on an
individual basis, not just by
composite summary statistics. The
submitter requested that deidentified individual results (both
questionnaire and biological
sampling) be released to the
public.

population rather than worker exposures. In
order to generate results representative of
the community, participants will be selected
at random from all people in the defined
study areas. Randomly selected individuals
will be eligible to participate in the
investigation if they meet all three inclusion
criteria: are three years of age or older, have
lived in the community for at least one year,
and do not have a bleeding disorder and is
not anemic. If fire fighters live in the study
area and are selected through the random
process, they will be included in the exposure
assessment. In the current work we cannot
target specific subpopulations (like fire
fighters) and still generate results that will be
valid for the community as a whole.
The Agency appreciates the comment from
Integral Consulting, Inc. The document
“Exposure Assessment Protocol: Biological
and Environmental Sampling of Per- and
Polyfluoroalkyl Substances (PFAS)” was
submitted with the Federal Register Notice
announcing the project and was available for
review during the 60-day comment period.
This document contains detailed information
on the design of the exposure assessments.
The Agency appreciates the comment from
Integral Consulting, Inc. As described in the
document, “Exposure Assessment Protocol:
Biological and Environmental Sampling of
Per- and Polyfluoroalkyl Substances (PFAS),”
ATSDR will conduct individual-level analyses
using biological, environmental, and
questionnaire data to explore relative source
contributions, including that of drinking
water, as well as factors that might influence
this relationship. Regarding data release,
public health and scientific advancements are
best served when data are shared for public
health purposes while ensuring the privacy of
participants is well protected. Investigators
will comply with all applicable laws and
regulations related to privacy protection and
human subjects research protection such as
the Privacy Act, the Common Rule at 45 CFR
46, etc. The investigators will also follow
CDC/ATSDR’s Policy on Public Health
Research and Non-research Data
Management and Access to make de-

Version 12 Oct 2018, 1245
identified data available to external
organizations and researchers at the
appropriate access level(s) as approved in the
study data management plan.
Diane Cotter

The submitter commented about
concentrations of PFAS in fire
fighter PPE.

Diane Cotter

The submitter commented about
concentrations of PFAS measured
in drinking water at fire training
centers and fire stations across
the United States. The submitter
commented that with no
regulations, the Department of
Defense was able to advise
Okinawa Prefecture Group they
need not pursue PFOA/PFOS
contamination any further as it
was not regulated.

Diane Cotter

The submitter attached a letter to
her submitted comments dated
September 12, 2018 and signed by
Robert A. Bilott, Taft Stettinius &
Hollister LLP.
Select comments from the
submitted letter pertain to this
docket, including the suggestion
to include fire fighters in exposure
assessments, the critique that the

Robert A. Bilott, Taft
Stettinius & Hollister LLP

The Agency appreciates the comments from
Diane Cotter. The Exposure Assessments are
designed to characterize exposure to the
general population rather than worker
exposures. In order to generate results
representative of the community,
participants will be selected at random from
all people in the defined study areas.
Randomly selected individuals will be eligible
to participate in the investigation if they
meet all three inclusion criteria: are three
years of age or older, have lived in the
community for at least one year, and do not
have a bleeding disorder and is not anemic. If
fire fighters live in the study area and are
selected through the random process, they
will be included in the exposure assessment.
In the current work we cannot target specific
subpopulations (like fire fighters) and still
generate results that will be valid for the
community as a whole.
The Agency appreciates the comment from
Diane Cotter. ATSDR is aware of concerns
about PFAS contamination around fire
training centers and fire stations. The 2018
National Defense Authorization Act requires
no less than eight exposure assessments be
conducted at current or former domestic
military installations. ATSDR is considering
locations for the exposure assessments on a
site-by-site basis, taking into account a
variety of factors. Because ATSDR and CDC
are non-regulatory agencies, the comments
regarding PFAS regulations are outside the
scope of this docket.
Please refer to the Agency responses to
comments submitted by Robert A. Bilott.

The Agency appreciates the comments from
Robert A. Bilott. The Exposure Assessments
are designed to characterize exposure to the
general population rather than worker
exposures. In order to generate results

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exposure assessments will not
enroll sufficient numbers of
participants to derive conclusions
about health effects, and whether
data from the exposure
assessments would be combined
with data from the proof of
concept study.

Stephen Risotto,
American Chemistry
Council

The submitter requested that
ATSDR: release additional details
on study design and protocol for
public review and comment;
explain the approach taken to
choose sites; list the PFAS species
that will be analyzed; explain the
use of questionnaire and
laboratory data to estimate
exposure; increase dust and tap
water collection to 100% of
households; and release deidentified, individual-level data.

representative of the community,
participants will be selected at random from
all people in the defined study areas.
Randomly selected individuals will be eligible
to participate in the investigation if they
meet all three inclusion criteria: are three
years of age or older, have lived in the
community for at least one year, and do not
have a bleeding disorder and is not anemic. If
fire fighters live in the study area and are
selected through the random process, they
will be included in the exposure assessment.
In the current work we cannot target specific
subpopulations (like fire fighters) and still
generate results that will be valid for the
community as a whole. Regarding the
comment on numbers of participants in the
exposure assessments hindering an analysis
of health effects, the exposure assessments
are not intended to study exposure-outcome
relationships. Lastly, given that data from the
exposure assessments will not include
information on health outcomes, combining
it with health-related data from the proof of
concept would not yield additional insights
on exposure-outcome relationships. The
remaining comments in the letter are outside
the scope of this docket.
The Agency appreciates the comments from
Stephen Risotto. The document “Exposure
Assessment Protocol: Biological and
Environmental Sampling of Per- and
Polyfluoroalkyl Substances (PFAS)” was
submitted with the Federal Register Notice
announcing the project and was available for
review during the 60-day comment period.
This document contains detailed information
on the design of the exposure assessments
and the planned data analyses. ATSDR is in
the process of evaluating sites for inclusion in
the exposure assessments. ATSDR is
considering locations on a site-by-site basis,
taking into account a variety of factors. The
approach taken will be shared publicly once
the selections have been made. Though
collection of environmental samples from
100% of households would increase
statistical power, the decision to sample a
10% subset was informed by logistics and
resource availability. Regarding data release,

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Jessica Bowman,
FluoroCouncil

The submitter commented that
collecting data on flooring type is
immaterial to estimates of PFAS
exposure through drinking water
and recommended removing
questions about flooring from the
questionnaire. The submitter
recommended that individuallevel and paired data be analyzed
to understand 1) relative source
contributions, and 2) human
elimination kinetics and human
serum to water slope factors.

public health and scientific advancements are
best served when data are shared for public
health purposes while ensuring the privacy of
participants is well protected. Investigators
will comply with all applicable laws and
regulations related to privacy protection and
human subjects research protection such as
the Privacy Act, the Common Rule at 45 CFR
46, etc. The investigators will also follow
CDC/ATSDR’s Policy on Public Health
Research and Non-research Data
Management and Access to make deidentified data available to external
organizations and researchers at the
appropriate access level(s) as approved in the
study data management plan.
The Agency appreciates the comments from
Jessica Bowman. Information on flooring type
will help ATSDR accomplish its third
objective, as defined in the document
“Exposure Assessment Protocol: Biological
and Environmental Sampling of Per- and
Polyfluoroalkyl Substances (PFAS)”: to
investigate environmental determinants of
PFAS concentrations in blood and urine.
There is reasonable evidence to suggest that
flooring type might impact PFAS dust levels
(Wilkens, K. et al. Environ Int. 2018 Oct;
119:493-502). ATSDR will conduct individuallevel analyses using biological,
environmental, and questionnaire data to
explore, when feasible, relative source
contributions, elimination kinetics, and
serum to water slope factors. Regarding data
release, public health and scientific
advancements are best served when data are
shared for public health purposes while
ensuring the privacy of participants is well
protected. Investigators will comply with all
applicable laws and regulations related to
privacy protection and human subjects
research protection such as the Privacy Act,
the Common Rule at 45 CFR 46, etc. The
investigators will also follow CDC/ATSDR’s
Policy on Public Health Research and Nonresearch Data Management and Access to
make de-identified data available to external
organizations and researchers at the
appropriate access level(s) as approved in the
study data management plan.

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