Appendix E: Privacy Impact Assessment

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

ATSDR

2

PIA Unique Identifier:

CDC ID No. 0923-18AUZ

2a Name:

07/25/19

Human health effects of drinking water exposures to per- and p
General Support System (GSS)
Major Application

3

Minor Application (stand-alone)

The subject of this PIA is which of the following?

Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Test
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

No
Yes
No
Agency
Contractor
POC Title

Principal Investigator

POC Name

Marian Pavuk

POC Organization ATSDR Division of Toxicology and
POC Email

[email protected]

POC Phone

770-488-3671
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

Briefly explain why security authorization is not
required

This data collection does not have a single dedicated IT system.
It uses various authorized CDC IT systems for the collection,
processing, analysis, and storage of the data .

10

Describe in further detail any changes to the system
that have occurred since the last PIA.

Not applicable.

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Per- and polyfluoroalkyl substances (PFAS) are a family of
chemicals used in industrial applications and consumer
products. PFAS contamination of drinking water is widespread
in the U.S. Some estimates indicate that at least sixty million
residents were served by 66 public water supplies that had at
least one sample at or above the US Environmental Protection
Agency (EPA) Lifetime Health Advisory for perfluorooctanoic
acid (PFOA) and perfluorooctane sulfonic acid (PFOS)
(individually or combined), which is 70 nanograms per liter
(ng/L) of water. Industrial facilities that manufacture or use
PFAS have contaminated drinking water in surrounding
communities in several states. In addition, PFOS, PFOA,
perfluorohexane sulfonic acid (PFHxS) and other PFAS
chemicals are constituents in aqueous film-forming foam
(AFFF), used to extinguish flammable liquid fires. The use of
AFFF at military bases and other sites may have resulted in the
migration of PFAS chemicals through soils to ground water
and/or surface water sources of drinking water for the bases
and/or surrounding communities around the country.

11 Describe the purpose of the system.

In response to growing awareness of the extent of PFAS
contamination across the U.S., the Section 316(a) of the 2018
National Defense Authorization Act (P.L. 115-91) as amended
by Section 315 of the John S. McCain National Defense
Authorization Act for Fiscal Year 2019 (Pub. L. 115-232)
authorized the Agency for Toxic Substances and Disease
Registry (ATSDR) to conduct a study on the human health
effects of PFAS contamination in drinking water.
Consequently, ATSDR is requesting a three-year Paperwork
Reduction Act (PRA) clearance for the Multi-site Study. The
Multi-site Study will build on the preceding proof-of-concept
study at the Pease International Tradeport in Portsmouth, New
Hampshire (OMB Control No. 0923-xxxx; expiration date mm/
dd/yyyy). ATSDR will conduct this research using a cooperative
agreement titled “Multi-site Study of the Health Implications of
Exposure to PFAS-Contaminated Drinking Water” (Notice of
Funding Opportunity [NOFO] No. CDC-RFA-TS-19-002). The
expected number of research recipients (e.g., entities selected
for funding) is six. The program will be administered by the
CDC Extramural Research Program Office (ERPO) at the
National Center for Injury Prevention and Control (NCIPC).
The research under this cooperative agreement will be a twopart program. First, a mandatory core research protocol for all
recipients is designed to aggregate data across all sites and
designed to compare data between sites. Next, each recipient
will have the option to propose additional investigatorinitiated research questions and hypotheses related to the
overall goals of this NOFO. The main goal of this cross-sectional
multi-site study is to evaluate associations between measured
and reconstructed historic serum levels of PFAS including
PFOA, PFOS, and PFHxS, and selected health outcomes.

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Study recipients will collect participant information, survey
responses, special educational records, and medical records
from the study participants and transfer them them to CDC to
be aggregated.
Categories of data and examples of the data elements to be
collected are:
Participant Information (name, Social Security Number [SSN],
date of birth, race, sex, address, email, phone number, etc.)
Survey Information (consent forms, exposure routes, water
consumption/source, medial history, education, occupation,
etc.)
Lab Test Results (per- and polyfluoroalkyl substances [PFAS]
concentration values in blood and urine, lipids, liver function
Describe the type of information the system will
test, kidney function test, thyroid hormones, sex hormones,
collect, maintain (store), or share. (Subsequent
immune function, anti-body response, etc.)
12
questions will identify if this information is PII and ask Children's schools will complete a form about diagnosed
about the specific data elements.)
learning disabilities and behavioral problems.
Medical providers will complete a form about conditions the
participants have been diagnosed with.
CDC will provide recipients with all lab test data to provide the
results to study participants. Recipient will maintain collected
information on site-specific participants for contact
information for result reporting and future contact.
CDC will maintain all-site aggregated data and share with the
study recipients for statistical analyses of multi-site outcomes.
All systems used by this study at CDC will authenticate users
via CDC's Active Directory or Secure Access Management
System (SAMS). Both are systems with their own PIA.

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The Multi-site Study will be cross-sectional in design.
Statistical sampling methods (e.g., a two-stage cluster sample)
may be used for recruitment of study participants if all the
affected households can be enumerated. If enumeration of all
households is not feasible, or if participation rates are expected
to be low, then the recipient can consider non-probabilistic
sampling approaches such as “judgment” and “snowball”
sampling approaches.

Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

ATSDR and recipients will collect information in several modes:
(1) hardcopy and then entered into data bases (informed
consent, update contact information, several forms to collect
study data during the appointment, neurobehavioral test
battery results); and (2) through electronic means using an
approved survey/data collection tool - eligibility screening
scripts, appointment reminder telephone calls, adult and child
questionnaires.
Data collected, shared and stored about adults will be
participant information, surveys, and lab test results. In
addition, the study will collect educational records about
school age children.
This data will be shared outside CDC using approved data use
agreements with outside investigators for approved research
purposes.
Yes

14 Does the system collect, maintain, use or share PII?

Indicate the type of PII that the system will collect or
15
maintain.

No
Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number

Taxpayer ID
Lab Test Results

Other...
Other...
Other...

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Employees
Public Citizens
16

Indicate the categories of individuals about whom PII
is collected, maintained or shared.

Business Partners/Contacts (Federal, state, local agencies)
Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?

5,000-9,999

18 For what primary purpose is the PII used?

ATSDR needs up-to-date PII for the informed consent process
and to send participants' their lab testing results.

Describe the secondary uses for which the PII will be
19
used (e.g. testing, training or research)

ATSDR will keep participant PII, including SSN, for future
studies, which will include longitudinal data collections. This
will require the linking of participant study identity and results
from Study A to Study B, etc.

20 Describe the function of the SSN.

SSN will be collected at enrollment for linkage to medical
records and school records. Once the linkage has occurred, the
SSN will be kept with other PII in a separate access-restricted
and encrypted secure share site. ATSDR will use SSN for
tracking and tracing Multi-site Study participants for
enrollment in future longitudinal studies.

20a Cite the legal authority to use the SSN.

Superfund Amendments and Reauthorization Act of 1986
(SARA).

21

Identify legal authorities governing information use Section 316(a) of the 2018 National Defense Authorization Act
and disclosure specific to the system and program.
(P.L. 115-91).

22

Are records on the system retrieved by one or more
PII data elements?

Yes
No
Published:

Identify the number and title of the Privacy Act
System of Records Notice (SORN) that is being used
22a
to cover the system or identify if a SORN is being
developed.

09-19-0001 ATSDR “Records of Persons Exposed

Published:
Published:
In Progress

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Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources
23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a

Identify the OMB information collection approval
number and expiration date.

CDC ID No. is 0923-18AUZ; OMB Control No. 0923-NEW
Yes

24 Is the PII shared with other organizations?

No
Within HHS

Identify with whom the PII is shared or disclosed and
24a
for what purpose.

Other Federal
Agency/Agencies
State or Local
ATSDR will obtain consent to retrieve
Agency/Agencies
Private Sector

ATSDR will obtain consent to
retrieve medical records information

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As part of the required "Data Management Plan," ATSDR will
share data sets with external entities via data use agreements
(DUA) with each data recipient.
The data use agreement (DUA) will be prepared, detailing the
condition of use of the data and proposed analyses for each
Describe any agreements in place that authorizes the outside project.
information sharing or disclosure (e.g. Computer
One of the Multi-site study investigators must be a co24b Matching Agreement, Memorandum of
investigator on any outside research project to guarantee
Understanding (MOU), or Information Sharing
adherence to the agreed conditions of use.
Agreement (ISA)).
After the approved project with the researchers outside of
Multi-site study group is completed, further or secondary
analyses of electronic datasets can only be undertaken with
additional approval(s) from ATSDR. Written confirmation of
understanding the conditions of use will be required from the
lead scientist and institution.
Describe the procedures for accounting for
24c
disclosures

Procedures for accounting for disclosures are detailed in the
study's manual of procedures. Typically, this will be a manual
process where the program keeps track of disclosures in a
spreadsheet.

Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.

ATSDR has a Privacy Act Statement that will be part of the
informed consent package. The Privacy Act Statement specifies
the ATSDR purpose for collecting PII, including SSN. The
informed consent information will be mailed in advance to
persons who are willing to take part in an Appointment Packet
for them to read in advance and to keep for their records. In
addition, ATSDR will use these forms and materials at
enrollment during their actual informed consent to obtain
signatures.

26

Is the submission of PII by individuals voluntary or
mandatory?

Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
27
object to the information collection, provide a
reason.

Voluntary
Mandatory
Individuals who wish to opt out may decline taking part in the
study. Additionally, if participants decide at a later date that
they would like to opt out of potential recontact for future
studies, they can contact the Principal Investigators at the
number provided on the consent form.

Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
ATSDR will contact individuals via email, telephone, and/or
28 and/or data uses have changed since the notice at
mail (if available) when major changes to the study occur to
the time of original collection). Alternatively, describe obtain consent from the study participants.
why they cannot be notified or have their consent
obtained.

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Individuals that have a concern that their PII has been
inappropriately used, obtained, or disclosed, OR that their PII is
inaccurate should contact the study Principal Investigator (PI)
and data manager using contact information in the study’s
consent form or System of Records Notice (SORN).
Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.

Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

The individual may be directed to contact the PI or data
manager to identify the record and specify the information
being contested, the corrective action sought, and the reasons
for requesting the correction, along with supporting
information to show how the record is inaccurate, incomplete,
untimely, or irrelevant. If an incident has occurred, the PI or
data manager will report the potential incident to the CDC
Security Incident Response Team and the Privacy Officer. The
data manager will serve as the point of contact (POC) to resolve
the individual's concerns.
There is no process in place for periodic reviews of the PII.
Once laboratory results are reported to the study participants,
data will be de-identified and used for analysis.
Users
Administrators

31

Identify who will have access to the PII in the system
and the reason why they require access.

Study PIs and trained study staff to
obtain informed consent and to relink
Study PIs will be responsible for
setting parameters allowing access to

Developers
Contractors
Others

Per the Multi-site Study Rules of Behavior, the data manager, in
Describe the procedures in place to determine which consultation with the study PI, will determine which users will
be able to access the data and the specific data they will need
32 system users (administrators, developers,
based on their role and research goals/priorities. Procedures
contractors, etc.) may access PII.
for PII access are documented in detail in the study Manual of
Procedures.

Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.

The data access request will be approved by the PI on a need
to know basis. When the access is no longer needed, the data
manager will be responsible for removing or terminating user's
access. Least privilege access will be employed, and users will
only be given access to the minimum data required for their
particular analysis. The study data manager will make this
determination.

Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.

Personnel are required to complete CDC security awareness
training.

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Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

ATSDR will require all study staff and direct contractors to
receive training on their roles and responsibilities, as outlined
in the Multi-site Study Manual of Procedures. All research staff
must have ethics training and possess certification of such
training. All research staff must sign an agreement
acknowledging their responsibilities to protect participants'
privacy and confidentiality. The Multi-site Study Rules of
Behavior will be signed and reviewed by all research staff.

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?

Yes
No

Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

PII data files collected in this study will be stored in a dedicated
CDC encrypted multi-user share with file level encryption. The
study will use a CDC approved software tool (currently it is PGP
Shredder) to dispose the PII data files when directed by the PI
and according to the appropriate records control schedule.
The approved records control schedule for this study is CDC/
ATSDR Records Control Schedule, Part 7: ATSDR, 5-13. Any
records sent to the Federal Records Center (FRC) will be deidentified as per the consent form. No PII will be disclosed to
the FRC.

Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

The PII will be secure in the system using: 1. Administrative
controls such as Rules of Behavior, Manual of Procedures, Nondisclosure Agreements (NDA), and Data User Agreements
(DUA); 2. Technical controls including the file level, column,
and whole disk encryption, e-Auth Level 3 external file share
with encryption, access control lists in multiple authorized CDC
IT systems, and routine daily backup of study data; and 3.
Physical controls including controlled physical access, guards,
key card access, locked rooms, as well as locked cabinets for
hardcopy of documents with PII.

REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.

Reviewer Questions
1

Are the questions on the PIA answered correctly, accurately, and completely?

Answer
Yes
No

Reviewer
Notes
2

Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?

Yes

Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?

Yes

No

Reviewer
Notes
3

No

Reviewer
Notes

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Reviewer Questions
4

Does the PIA appropriately describe the PII quality and integrity of the data?

Answer
Yes
No

Reviewer
Notes
5

Is this a candidate for PII minimization?

Yes
No

Reviewer
Notes
6

Does the PIA accurately identify data retention procedures and records retention schedules?

Yes
No

Reviewer
Notes
7

Are the individuals whose PII is in the system provided appropriate participation?

Yes
No

Reviewer
Notes
8

Does the PIA raise any concerns about the security of the PII?

Yes
No

Reviewer
Notes
9

Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?

Yes
No

Reviewer
Notes
10

Is the PII appropriately limited for use internally and with third parties?

Yes
No

Reviewer
Notes
11

Does the PIA demonstrate compliance with all Web privacy requirements?

Yes
No

Reviewer
Notes
12

Were any changes made to the system because of the completion of this PIA?

Yes
No

Reviewer
Notes

General Comments

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OPDIV Senior Official
for Privacy Signature

Jarell
Oshodi -S

Digitally signed by Jarell
HHS Senior
Oshodi -S
Agency Official
Date: 2019.07.29
for Privacy
07:14:53 -04'00'

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