Pia

Att5 PIA_PFAS EA signed OCISO 20181001.pdf

Per- or Polyfluoroalkyl Substances Exposure Assessments (PFAS EAs)

PIA

OMB: 0923-0059

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

ATSDR/NCEH

2

PIA Unique Identifier:

0923-18AJK

2a Name:

PFAS Exposure Assessments
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.

Planning
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

Medical Epidemiologist

POC Name

Matt Karwowski

POC Organization ATSDR/DCHI/SSB
POC Email

[email protected]

POC Phone

404-718-5867
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

Not applicable

10

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

Not applicable

11 Describe the purpose of the system.

The goal of this information collection is to address the
requirements for completing exposure assessments (EAs) for
per- or polyfluoroalkyl substances (PFAS). The Agency for Toxic
Substances and Disease Registry and the National Center for
Environmental Health (ATSDR/NCEH) will use statistical
methods to recruit respondents at a minimum of eight current
or former domestic military installations known to have PFAS
contamination in drinking water, groundwater or other water
sources. Respondents may include both on-site and off-site
residents. ATSDR will collect biological and environmental
samples to evaluate exposure at the installations.

The types of information to be collected, maintained, and
shared include name, date of birth, mailing address, Email
Describe the type of information the system will
address, phone numbers, household demographic history,
collect, maintain (store), or share. (Subsequent
residential history, occupational history, drinking water source
12
questions will identify if this information is PII and ask and household filtration system, household dust and tap water
about the specific data elements.)
lab results, age, activity patterns, basic health status
information (e.g., kidney disease, pregnancy status, etc.),
medical notes, and blood and urine samples.

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

All information collected, maintained, and/or shared is needed
to allow participants' blood results to be assessed and
interpreted. It is also needed to share the information with
federal and state partners, and for participants to be contacted
after the EA for potential participation in a national multi-site
study for PFAS. Results of the EA will be used to inform the
multi-site study.
Questionnaires will be administered in person to participants
by the Centers for Disease Control and Prevention (CDC) and
ATSDR personnel or their contractors.
PII data will be retrieved routinely by respondents' names,
mailing addresses, phone numbers, and/or Email addresses to
allow CDC/ATSDR and its contractors to provide respondents
with their individual sampling results.

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

Yes
No

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15

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

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
Household dust and tap
water lab results

Taxpayer ID
Blood and urine lab results

Household demographics

Occupational information

Other...

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?
18 For what primary purpose is the PII used?

19

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

500-4,999
The primary purpose for collecting PII is to provide participants
their individual biological and environmental sampling results.
The secondary use of PII will be to contact a select number of
participants about involvement in a subsequent national multisite study of PFAS.

20 Describe the function of the SSN.

Not applicable

20a Cite the legal authority to use the SSN.

Not applicable

ATSDR, in general, is authorized to conduct exposure
assessments under the ‘Comprehensive Environmental
Identify legal authorities governing information use Response, Compensation, and Liability Act of 1980’’ as
21
amended by ‘‘Superfund Amendments and Reauthorization
and disclosure specific to the system and program.
Act of 1986’’ (42 U.S.C. 9601, 9604); and the ‘Resource
Conservation and Recovery Act of 1976’’ as amended in 1984
(42 U.S.C. 6901).
22

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

Yes
No

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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.

09-19-001 Records of Persons Exposed or Potent

Published:
Published:
In Progress
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. 0923-18AJK; 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
Federal Agencies may assist with
Agency/Agencies the EAs. The agencies may use PII if
State or Local
State Agencies may assist with the EA
Agency/Agencies
Private Sector

Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
An MOU with federal or state partners will be created for each
24b Matching Agreement, Memorandum of
specific EA location.
Understanding (MOU), or Information Sharing
Agreement (ISA)).

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24c

Describe the procedures for accounting for
disclosures

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.

26

Is the submission of PII by individuals voluntary or
mandatory?

As appropriate, PII will be shared with federal and state
partners in accordance with the MOU(s). Disclosures are
accounted for according to the SORN. Disclosures not
accounted for in the SORN will be managed and the
procedures established by the system manager. Typically, this
procedure involves a manually updated tracking spreadsheet.
Disclosure of PII to entities outside of CDC must be approved in
writing and then logged in a spreadsheet. Disclosures should
not be made without a fully executed data use agreement
(DUA). The DUA and disclosure spreadsheet are maintained by
a principal investigator and data manager. No data will be
disclosed to an outside entity unless controls exist to protect
the data in transit.
Participants will sign consent forms or parental permission
assent forms if a participant is younger than 18 years old. The
forms have a provision that will request permission to allow
CDC/ATSDR to share participants' PII with federal and state
partners, as appropriate, as well as to be contacted after the EA
for potential participation in a national multi-site study for
PFAS. A Privacy Act Statement (PAS) is included as part of the
consent information. The PAS also is mentioned to participants
as part of an eligibility screener.
Voluntary
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.

Participants may opt-out of the study entirely by non-response,
non-consent, or stated refusal. Also, the consent forms and
parental permission/assent forms include a provision for
individuals to opt-out of the sharing of their PII with partners.

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
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.

If a major change to the information collection occurs,
participants will be notified by phone, Email, and/or mail using
information participants provided during the consent process.
Participants will be asked to consent to the change in writing.
Individuals should reasonably identify the record, contact CDC/
ATSDR personnel, specify the information being contested,
state the corrective action sought, and state the reasons for
requesting the correction. They also should provide supporting
information to show how the record is inaccurate, incomplete,
untimely, or irrelevant.

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 If an individual is concerned that their PII has been used
inappropriately and communicates that to the CDC, the matter
why not.
will be reported to and evaluated by CDC/ATSDR personnel
within 48 hours. Any inquiries from individuals related to their
PII also will be reviewed by the PFAS Data Manager. The Data
Manager will decide what action to take and communicate that
decision to the individual within 60 days.

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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.

For each EA, CDC/ATSDR personnel will determine whether the
PII data are accurate.
Participants will be provided CDC/ATSDR contact information
to allow them to inform CDC/ATSDR if their contact
information changes.
Users
Administrators

31

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

CDC/ATSDR personnel will have access
to PII to report individual results to
CDC/ATSDR administrators will be
responsible for allowing access to PII

Developers
Contractors

ATSDR will use contractors to collect
PII, perform testing during the EAs,

Others
Access to PII will be limited to those with a need to know the
Describe the procedures in place to determine which data; individuals will be assigned roles based on their function
in the study. Roles will determine the type and amount of PII
32 system users (administrators, developers,
individuals will be able to access. Additionally, roles and
contractors, etc.) may access PII.
accesses will be reassessed periodically by CDC/ATSDR
administrators, reestablishing permissions accordingly.

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.

CDC/ATSDR personnel and contractors will access PII when
they are recruiting participants and providing biological and
environmental sampling results to participants. Field data
collectors will only have access to the information they are
collecting. They will not have permissions to access any IT
resources from the study other than the laptops they use for
data collection.
Once data have been collected, system managers will
implement role-based access controls on share drives such that
only designated staff may access PII. Data aggregators and deidentifiers will be the only users with access to aggregated PII.
Access to the de-identified data will be handled by the
National Environmental Public Health Tracking Network
(NEPHTN).

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.

All EA personnel handling PII will have completed appropriate
privacy training and obtained a Scientific Ethics Verification
(SEV) number prior to January 2019 or CITI Human Subjects
Training Certification as required by January 2019.

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

All users must read and sign PFAS EA Rules of Behavior for Data
Access and Use, a document that provides guidance for data
access. System managers continuously monitor system
activities to ensure compliance with security requirements.

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

Yes
No

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

Records are retained and disposed of in accordance with the
ATSDR Comprehensive Records Control Schedule (B-371).
Current procedures allow the system manager to keep the
records for 20 years unless needed for further study. Registry
records will be actively maintained as long as funding is
provided for by legislation. Records may be transferred to a
Federal Records Center for storage when no longer needed for
evaluation or analysis. Disposal methods include the paper
recycling process, burning or shredding hard copy records, and
erasing computer files.
Administrative: All users with access to study data will be
required to read, agree to, and sign the PFAS EA Rules of
Behavior for Data Access and Use. CDC/ATSDR and contractors
who maintain records are instructed to protect the security of
records, and are to check with the system manager prior to
making disclosure of data. CDC/ATSDR and contractor sites are
restricted to authorized personnel only. Appropriate Privacy
Act provisions are included in contracts, and CDC/ATSDR
Project Director, contract officers, and project officers oversee
compliance with these requirements. Upon completion of the
contract, all data will be either returned to CDC/ATSDR or
destroyed, as specified by the contract. PII and non-PII will be
stored separately; a unique study ID will be used to link data
when necessary (i.e., to provide participants their results).

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

Technical: PII will be collected on computers lacking Internet
access. The disclosure spreadsheet, DUA, and any related
disclosure documentation will be stored in an encrypted
administrator folder for this study. Protection for computerized
records includes programmed verification of valid user
identification code and password, periodic password changes,
limited log-ins, virus protection, and user rights/file attribute
restrictions. Each user name is assigned limited access rights to
files and directories at varying levels to control file sharing. A
log will be kept of all changes to each file and all persons
reviewing files. Additional safeguards may also be built into the
program by the system analyst as warranted by the sensitivity
of the specific data set (i.e., encryption). Questionnaire and
laboratory results will be recorded electronically, and its data
will be securely transferred via CDC's Secure Access
Management System (SAMS) server(s). SAMS has its own
Privacy Impact Assessment.
Physical: Consent and assent forms, log books, and other
source data are maintained in locked cabinets in locked rooms.
Site security guards screen personnel and visitors. Access to
facilities and computer rooms is controlled by a card key
system. Computer workstations, lockable personal computers,
and automated records are located in secured areas.

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

Answer

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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
4

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

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

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Reviewer Questions

Answer

Reviewer
Notes
12

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

Yes
No

Reviewer
Notes

General Comments

OPDIV Senior Official
for Privacy Signature

Beverly E.
Walker -S

Digitally signed by
Beverly E. Walker -S
Date: 2018.10.01
15:32:55 -04'00'

HHS Senior
Agency Official
for Privacy

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