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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

TBD

2a Name:

12/11/23

Aerosols from cyanobacterial blooms: exposures and health effe
General Support System (GSS)
Major Application

3

The subject of this PIA is which of the following?

Minor Application (stand-alone)
Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Operations and Maintenance
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

Senior Environmental Epidemiolo

POC Name

Lorraine Backer

POC Organization DEHSP
POC Email

[email protected]

POC Phone

770.488.3426
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

9

Briefly explain why security authorization is not
required

The exposure study will utilize several CDC authorized systems
for data collection, storage, and processing.
PIA Validation (PIA
Refresh/Annual Review)
Anonymous to NonAnonymous
New Public Access
Internal Flow or Collection

Indicate the following reason(s) for updating this PIA.
Choose from the following options.

Significant System
Management Change
Alteration in Character of
Data
New Interagency Uses
Conversion

Commercial Sources
Other...
10

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

N/A

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Algal toxins from cyanobacterial harmful algal blooms
(CyanoHABs) include some of the most potent natural
chemicals. People and animals are at risk for exposure to toxins
produced by CyanoHABs in drinking water or in improperly
treated water used for medical purposes such as renal dialysis.
Additional potential exposure sources include contaminated
dietary supplements or fish harvested from lakes with ongoing
CyanoHABs.

11 Describe the purpose of the system.

Although outbreaks of human illness associated with
CyanoHABs have been sporadically recorded for decades,
information about clinical signs and symptoms from
cyanobacterial toxin poisonings is primarily from animal
poisonings and laboratory studies. Exposures to cyanobacterial
toxins produce a variety of symptoms and illnesses. The
primary effects include acute hepatotoxicity, acute
neurotoxicity, gastrointestinal symptoms, and respiratory,
dermatologic, and allergic reactions. Which, if any,
cyanobacterial toxins cause respiratory symptoms is not
known; however, cyanobacterial hepatotoxins or
lipopolysaccharide endotoxins may be associated with the
gastrointestinal disturbances.
The methods used for this study will be similar to those used in
CDC’s earlier studies of recreational exposure to CyanoHABs in
two lakes (see Backer et al., 2008; 2010). We will conduct a
study of 50 people highly exposed to CyanoHABs. Study
participants recruited from, for example, the Florida
Department of Environmental Protection (FL DEP) will serve as
their own controls. Bloom composition and the absence/
presence of toxins can vary over time during a bloom (Paerl
and Otten, 2013) and CDC is interested in not only exposure,
but also how exposure varies as the blooms develop, mature,
and die off. Therefore, we will collect baseline (control) data
before the blooms begin and then follow up to collect
additional data throughout the bloom season. The study will
be conducted on Lake Okeechobee, Florida, U.S.A. which has a
history of prolonged CyanoHAB events.
The two objectives of this study are to:
• Assess exposure to CyanoHAB aerosols, and to
• Determine if exposure is associated with health symptoms
and/or outcomes.

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The study will collect, maintain, and store the information
below:
Participant Contact Information (name, mailing address, email,
phone number)
Demographic Data (date of birth, sex, height)
Laboratory Results (liver enzyme and creatinine concentrations
in blood, cyanobacterial toxins in urine and on nasal swabs,
pulmonary function test results)
Surveys (employment, diet, lifestyle factors, exposure routes,
pre- and post-exposure symptoms, data on environmental
Describe the type of information the system will
conditions and where participants were during their study
collect, maintain (store), or share. (Subsequent
activities)
12
questions will identify if this information is PII and ask Other (StudyID)
about the specific data elements.)
The study will be sharing de-identified data with Florida
Department of Health (FLDoH), the state in which the study is
being conducted. FLDoH will use the data to support response
activities and to enter de-identified data (demographics,
laboratory results, survey results) into NCEZID's One Health
Harmful Algal Bloom System (OHHABS).
Authentication will be handled by NCEZID's RedCap system via
CDC's Secure Access Management System. CDC's Active
Directory will also be used for internal authentication. Both
systems have their own PIA.
The study will enroll participants with potential exposure to
toxic cyanobacterial blooms and assess whether exposure to
these toxins is associated with particular health outcomes.
Participants will be members of the public who are 18 years of
age and older and who likely have high exposures to
cyanobacterial blooms that occur in and around Lake
Okeechobee, Florida. Information that will be collected and
maintained about these participants include contact
information, demographic information, laboratory results, and
various surveys. All information (participant contact
information, demographic data, laboratory results, and
surveys) collected, stored, and shared in the study is
considered PII.
Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

Participant Contact Information (name, mailing address, email,
phone number)
Demographic Data (date of birth, sex, height)
Laboratory Results (liver enzyme and creatinine concentrations
in blood, cyanobacterial toxins in urine and on nasal swabs,
pulmonary function test results)
Surveys (employment, diet, lifestyle factors, exposure routes,
pre- and post-exposure symptoms, data on environmental
conditions and where participants were during their study
activities)
Other (StudyID)
Any information shared about the participants with the FLDoH
will be de-identified. Authentication will be handled by
NCEZID's RedCap system via CDC's Secure Access Management
System. CDC's Active Directory will also be used for internal
authentication. Both systems have their own PIA.

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Yes

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

No

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

Taxpayer ID

Sex

Employment

Height

Study ID

Other...

Employees
Public Citizens
16

Business Partners/Contacts (Federal, state, local agencies)

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

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)

<100
To contact study participants with reminders and information
about the study, for the informed consent process and to send
participants' their lab testing results.
NONE

20 Describe the function of the SSN.

N/A

20a Cite the legal authority to use the SSN.

N/A

21

Identify legal authorities governing information use Public Health Service Act, Section 301, “Research and
and disclosure specific to the system and program.
investigation,” (42 U.S.C. 241)

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.

SORN 09-20-0136 “Epidemiologic Studies and Su

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.

OMB Control No. 0920-1316, 01/31/2024
Yes

24 Is the PII shared with other organizations?

No
Within HHS
Other Federal
Agency/Agencies
State or Local
Agency/Agencies

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

Private Sector
Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
N/A
Understanding (MOU), or Information Sharing
Agreement (ISA)).
24c

Describe the procedures for accounting for
disclosures

N/A

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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

Participants sign a consent form on order to participate in the
study. The consent form notifies the individual that their
information will be collected, for what purpose, and
information they will receive back from the study.
Voluntary

Is the submission of PII by individuals voluntary or
mandatory?

Mandatory

Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
Individuals who wish to opt out may decline taking part in the
27
object to the information collection, provide a
study.
reason.
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.

NCEH will contact the study principal investigator (PI) (per
consent form) via email, telephone, and/or mail when major
changes to the study occur to obtain consent from the study
participants.
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 PI and data manager using
contact information in the study’s SORN or consent form.

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.

31

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

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 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

To contact study participants during
study activities and to provide

Administrators

To provide access to users as needed.

Developers
Contractors

Direct contractor will be engaged to
contact study participants during

Others
Describe the procedures in place to determine which
The study PI will determine the level of access for each user
32 system users (administrators, developers,
depending on their role in the study.
contractors, etc.) may access PII.
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.

Due to the small number of study participants, all users with
access to PII will have access to all study participants' PII.

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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.

Study staff will all go through annual security awareness
training.

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

We will provide instructions to users about how to manage
data security and privacy protections and will require all study
staff and direct contractors to receive training on their roles
and responsibilities, as outlined in the study's Manual of
Procedures. The study's 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
Record retention will be based on CDC\ATSDR Scientific and
Research Project Records Control Schedule known as “big
bucket.”
a. Long-Term ongoing Studies that contain cumulative
research data

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

Authorized Disposition: PERMANENT: Transfer “snapshot” copy
of data to the National Archives and Records Administration
(NARA) in 1 year intervals (or other time period established
with NARA); the first transfer to occur within the first year after
the approval of Records Control Schedule. Electronic media
will be transferred to NARA formatted in accordance with
current applicable regulations regarding transfer of electronic
records.
b. Completed Studies
Authorized Disposition: PERMANENT: Transfer to NARA a copy
of the completed database no longer than one year after the
end of the project. Electronic media will be transferred to
NARA formatted in accordance with current applicable
regulations regarding transfer of electronic records.

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

Administrative controls: consist of rules of behavior, annual
required privacy and security training, Manual of Procedures,
NDAs, and DUAs.
Technical controls: consist of file level and whole disk
encryption, e-Auth Level 3, and access control lists in multiple
authorized CDC IT systems.
Physical controls: consist of controlled physical access, security
guards, key card access, and locked rooms.

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

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Reviewer Questions

Answer

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

Reviewer
Notes

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Reviewer Questions
12

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

Answer
Yes
No

Reviewer
Notes

General Comments

OPDIV Senior Official
for Privacy Signature

Jarell
Oshodi -S

Digitally signed by Jarell
HHS Senior
Oshodi -S
Agency Official
Date: 2024.01.19
for Privacy
18:01:22 -05'00'

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