Non-Research Determination

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Print Date: 11/17/20

Title:

Exposure to arsenic and uranium from private wells in Connecticut, New Hampshire and New Mexico

Project Id:

0900f3eb81bd1920

Accession #:

NCEH-HST-9/1/20-d1920

Project Contact:

Backer_Lorraine (lfb9)

Organization:

NCEH/ATSDR/DEHSP/EMRCB/HST

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

02/05/2021

Estimated Completion Date:

09/30/2022

CDC/ATSDR HRPO/IRB Protocol #:

NA

OMB Control #:

GenIC under: 0929-1173

Determinations
Determination

Completed

Entered By & Role

9/8/20

Davis_Stephanie I. (sgd8) CIO HSC

PRA:
PRA Applies

9/9/20

Davis_Stephanie I. (sgd8) CIO OMB / PRA

ICRO:
Returned with No
Decision

9/9/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

HSC:
Does NOT Require HRPO
Review

Justification
Not Research / Other
45 CFR 46.102(l)
Non-Epi Aids Investigations

Description & Funding
Description
Priority:

Urgent

Date Needed:

09/04/2020

Priority Justification:

We need to get the approved protocol back to Connecticut so that their IRB can complete their review in
September.

Determination Start Date:

09/01/20

Description:

The purpose of this investigation is to respond to three states (Connecticut, New Hampshire, and New Mexico) that
have requested assistance with assessing potential exposure to naturally-occurring arsenic and uranium in drinking
water from private wells in areas (one area for each state) where there are no data about arsenic and uranium
concentrations in ground water (Ayotte et al, 2017). The new information obtained from these investigations will be
the description of exposure to contaminants in drinking water from private wells within a well-defined time period
and geographic distribution. This information will be used by the requesting agencies to target their respective
existing public health intervention activities to reduce exposures.

IMS/CIO/Epi-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

We will collect new data on the concentrations of arsenic and uranium in private well source water, household tap
water, and urine as well as information from private well owners that will allow us to comprehensively assess
exposures to these contaminants.

Objective:

Collect new data on arsenic and uranium concentrations in private well water in areas where there are no data.
Use biomonitoring and an individual exposure survey data to assess the association between concentrations of
arsenic and uranium in drinking water obtained from a private well and levels of arsenic and uranium in urine.
Use water quality testing, biomonitoring, and exposure survey results to support state-based outreach, education,
and mitigation efforts.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be
Included/Represented:

General US Population

Tags/Keywords:

Water quality, Arsenic, uranium, Drinking Water

CDC's Role:

CDC employees or agents will obtain or use identifiable (including coded) private data or biological specimens, CDC
employees will participate as co-authors in presentation(s) or publication(s), CDC employees will provide
substantial technical assistance or oversight, CDC is providing funding

Method Categories:

Convenience Sample

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Methods:

For this project, we will assess exposure to arsenic and uranium in private well water in areas of concern to our
public health partners. We will collect new data on the concentrations of arsenic and uranium in private well source
water, household tap water, and urine as well as obtain information about potential exposure to arsenic and
uranium by asking participants to complete a food log and an exposure survey. Three public health partners (the
state health/environmental protection agencies of Connecticut, New Hampshire, and New Mexico) have identified
areas where there are no data describing the concentrations of arsenic and uranium in ground water that is the
source for private wells (see Attachment A, Letters of Collaboration). We will create a grid across each area and
randomly choose 100 cells from each grid. We will collaborate with our public health partners to identify households
with private wells within the selected cells and obtain contact information for private well owners. If there are no
households identified in a cell, we will skip the cell and add a household from the neighboring cell to supplement
the absence of a household in the selected cell. A combination of Google & ESRI geolocation services & base maps,
E-911 GIS files, and tax assessors’ maps where available are used to identify household addresses. These are run
inside of an ArcGIS program such as ArcMap and more currently ArcPro for a few reasons. First, the tool that is run
to grid geographic areas and generate points within grid cells runs in ArcGIS. Second, most of the identification of
homes is visual – more likely than not, the point that the program generates is not going to be sitting on the
house. It is then up to the user to visually determine the nearest eligible household. The user must try to
determine if the structure seen on the map is a household or a business, on public water or private, and abandoned
or inhabited. An alternative approach would be to feed a fixed list of possible sites into the program, but this is
generally not recommended because these lists are often incomplete and often have incorrectly geolocated points,
which spatially biases the program. USGS reports that they recruit about 30% to 50% of people who receive
notification of an upcoming water quality investigation like this. Thus, we will send out letters and prepaid
postcards to a random sample of 200-300 households within the chosen cells in each state (see Attachment B,
Invitation Letter) in order to enroll 100 households with private wells from each state (one household per cell). We
will ask interested people to verify their name, address, and contact information and mail the prepaid postcard
back to us. From the postcards, we will create a database to facilitate contacting potential recruits to conduct a
brief telephone screening survey and, if appropriate, enroll them in the investigation. We will enroll 100 participants
in each state (see Attachment C, Screening Survey). At enrollment, we will make arrangements to send
participants a 3-day Food Log and materials to collect a urine specimen. We will also schedule appointments to visit
the households where we will do the following: 1. Obtain a signed consent form 2. Collect well water and tap water
samples 3. Collect the urine specimen 4. Review and collect the Food Log 5. Conduct the exposure survey with one
adult in each household (see Attachments D, E, F, G; Consent Form, Food Log, Urine

Collection of Info, Data or Biospecimen:

We will collect new data on the concentrations of arsenic and uranium in private well source water, household tap
water, and urine as well as information from private well owners that will allow us to comprehensively assess
exposures to these contaminants. At enrollment, we will make arrangements to send participants a 3-day Food Log
and materials to collect a urine specimen. We will also schedule appointments to visit the households where we will
do the following: 1. Obtain a signed consent form 2. Collect well water and tap water samples 3. Collect the urine
specimen 4. Review and collect the Food Log 5. Conduct the exposure survey with one adult in each household see
Attachments D, E, F, G; Consent Form, Food Log, Urine Collection Directions, and Exposure Survey, respectively).
We will not ask questions about symptoms or health status. We will ask you about medications you take because
that is important in helping us interpret exposure information. Project staff will provide investigation participants
with their well water sample and urine specimen test results and information about exposure reduction when
appropriate.

Expected Use of Findings/Results:

The primary audience for the results of this project is state public health partners responsible for private wells in
their own jurisdictions. They will use their data to inform decisions about ongoing and future efforts in outreach,
education, and mitigation for private well owners. We will share the protocol and associated documents for their
review and comment.

Could Individuals potentially be identified
based on Information Collected?

Yes

Will PII be captured (including coded data)? Yes
Does CDC have access to the identifiers?

Yes

Is an assurance of confidentiality in place or No
planned?
Is a certificate of confidentiality in place or
planned?

No

Is there a formal written agreement
prohibiting the release of identifiers?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

Other-Interagency agreement

14FED406345-001

$99,035.00

2020

2

HSC Review

HSC Attributes
Non-Epi Aids Investigations

Yes

Additional Ethical
Considerations
This activity is non-research. The methods
described are systematic, yet the results for each
site are not intended to be generalizable beyond
the geographic boundaries of the investigation
area of private wells identified by each state
health department. Data will be analyzed for each
state, and will not be aggregated across the three
states.

Regulation and Policy

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Do you anticipate this project will be
submitted to the IRB office

No

Estimated number of study participants

Population - Children
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors
Suggested level of risk to subjects Do you anticipate this project will be exempt research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA
Privacy Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from
target language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing
those bested about HIV serostatus

No Selection

Human genetic testing is planned now or in
the future

No Selection

Involves long-term storage of identfiable
biological specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New
Drug exemption or Investigational Device
Exemption

No Selection

Institutions & Staff
Institutions
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

USGS

$99,035.00

Staff
Staff
Member

SIQT Exp.
Date

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

Diana Diaz

09/02/2023

Kristin
Marks

07/16/2023

08/29/2022

02/04/2023

Lorraine
Backer

05/18/2021

04/12/2020

12/21/2021

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Co-Investigator

[email protected]

404-4983060

HEALTH
STUDIES

08/29/2022

Co-Investigator

[email protected]

770-4883414

HEALTH
STUDIES

04/13/2020

Principal
Investigator

[email protected]

770488-6

HEALTH
STUDIES

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Data
DMP
Proposed Data Collection Start Date:

2/5/21

Proposed Data Collection End Date:

9/30/22

Proposed Public Access Level:

Public

Public Access Justification:

Private well water analysis results will be made available by USGS on their website. Well locations will be masked
using GIS to ensure that wells and well owners cannot be identified.

How Access Will Be Provided for Data:

Private well water analysis results will be made available by USGS on their website. Well locations will be masked
using GIS to ensure that wells and well owners cannot be identified. Data including study participant survey
responses will only be available in aggregated form in a peer-reviewed publication.

Plans for Archival and Long Term
Preservation:

We will use only investigation IDs when communicating with laboratories for water testing and biomonitoring
results. The ID key will be kept separately from the investigation data and will be destroyed once all the data have
been analyzed, or by December 31, 2030.

Spatiality
Country

State/Province

United States

Connecticut

United States

New Hampshire

United States

New Mexico

County/Region

Dataset
Dataset
Title

Dataset
Description

Data
Publisher/Owner

Public
Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection
End Date

Dataset yet to be added...

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