Project Determination

Print Date: 6/14/22

Title:

Jasper and Newton Counties (JNC) Missouri Lead Exposure Investigation

Project Id:

0900f3eb81f160cd

Accession #:

NCEH-EIT-5/5/22-160cd

Project Contact:

Erin J Evans

Organization:

NCEH/ATSDR/OCHHA/WS

Status:

Pending Clearance

Intended Use:

Project Determination

Estimated Start Date:

05/26/2022

Estimated Completion Date:

03/31/2023

CDC/ATSDR HRPO/IRB Protocol #:
0923-0048

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

6/14/22

Davis_Stephanie I. (sgd8) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Environmental Sampling
Non-Epi Aids Investigations

PRA:
PRA Applies

6/14/22

Davis_Stephanie I. (sgd8) CIO OMB / PRA

Description & Funding
Description
Priority:

Urgent

Date Needed:

05/26/2022

Priority Justification:

The current extension ICR for #ATSDR Exposure Investigations# (OMB Control No. 0923-0048) will need to be extended until 6/30
/2022 by OMB. This requires urgent approval to meet summer deadlines.

Determination Start Date:

05/05/22

Description:

The EI will measure blood lead levels (BLLs) and lead in environmental samples in and around homes near the Oronogo-Duenweg
Mining Belt and Newton County Mine Tailings Superfund sites. ATSDR will compare the results with the CDC blood lead reference
values of 3.5 #g/dL for children and 5 #g/dL for adults, provide participants with their individual results and interpretation/
recommendations, and write a summary report (EI report). This EI will result in an increased education about preventing lead
exposure, improved access to recommendations for remedial or removal actions, and to the knowledge needed to guide future
remediation of lead in the area.

IMS/CIO/Epi-Aid/Lab-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

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The EI will measure blood lead levels (BLLs) in 225 children (<72 months) and 75 pregnant women or women of childbearing age
(15-44 years) near the Oronogo-Duenweg Mining Belt and Newton County Mine Tailings Superfund sites. EPA and MDHSS will
sample lead contamination in and around households to allow a better evaluation of BLLs. ATSDR will compare the results with the
CDC blood lead reference value of 3.5 #g/dL for children and 5 #g/dL for adults, provide participants with their individual results and
interpretation/ recommendations, and write a summary report (EI report). This EI will result in an increased education about
preventing lead exposure, improved access to recommendations for remedial or removal actions, and to the knowledge needed to
guide future remediation of lead in the area.

Objective:

The EI has the following objectives: 1. Evaluate BLLs in Jasper and Newton County residents, who are children (<72 months) and
women who are pregnant or of childbearing age (15-44 years) that participate in the investigation. 2. Review environmental
sampling data collected by state and federal partners. Samples will be taken from participating residents# indoor and outdoor
environments including soil, drinking water from private wells at the tap, public water collected at the tap, household dust, and
interior and exterior painted surfaces. 3. Administer a survey questionnaire to document demographic, behavioral, occupational, and
educational information of participants. Parents/guardians will complete the survey for the child participants. 4. Evaluate lead levels
in environmental samples and the association between environmental lead levels with BLLs. 5. Recommend ways to lower
environmental exposures to lead. 6. Provide an opportunity for all participants and parents/guardians of child participants to discuss
their blood lead findings with an ATSDR medical officer.

Does this project include interventions, services, or Yes
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Not Selected

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Yes

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Children ; Pregnant Women

Tags/Keywords:

Lead ; Mining ; Environmental Exposure

CDC's Role:

CDC employees or agents will obtain or use identifiable (including coded) private data or biological specimens

Method Categories:

Convenience Sample; Exposure Investigation; Health Education; Individual Interviews (Qualitative)
Participants for the EI will be recruited from the areas within the Oronogo-Duenweg Mining Belt and Newton County Mine Tailings
Superfund sites# boundaries. The EI will seek participants who reside in areas where soil lead contamination is highest or
suspected to be present. ATSDR will use site investigations and historic site sampling data provided by EPA Region 7 to identify
these areas. Up to 300 participants will be enrolled. Children < 72 months, pregnant women, and women of childbearing age will be
eligible for inclusion. ATSDR will also evaluate BLLs for minor siblings of participants ? 72 months, if requested by a parent or
guardian, as a public health service to the community. However, their results will not be evaluated as part of the EI, and they will not
be compensated as a eligible participant. ATSDR will perform the following recruitment activities: 1. ATSDR will create a mailing list
for the residents in Jasper and Newton Counties where lead contamination is known to be present or where environmental
investigations are pending. Contact information will be provided for participants to make appointments for testing. 2. Fact sheets,
fliers, and postcards providing information on testing will be prepared by ATSDR and provided to LPHAs, distributed to eligible
participants, and printed in local news publications and online outlets. 3. Digital recruitment material will be developed, and targeted
social media advertising will be purchased. Click and impression advertisements will be purchased through Facebook and
Instagram. Advertisements will target women with children, women who are pregnant, women of childbearing age, men with

Methods:

children, and grandparents. 4. ATSDR will develop a webpage to display information about the EI, eligibility criteria, and enrollment
information. 5. ATSDR will focus on daycares, preschools, and elementary schools in the area to request partnership to recruit from
client families. 6. ATSDR will recruit through established or newly created in-person connections with the community. Recruitment
will occur through local events or public information sessions aimed at community groups, religious organizations, or other influential
community members including elected officials. 7. ATSDR will work with LPHAs and local media outlets to broadcast recruitment
information via radio or local news channels. 8. ATSDR will work with MDHSS, LPHAs, and the PEHSU to provide recruitment
information and material to area PCPs, pediatricians, clinicians, and other area healthcare providers. 9. A $20 token of appreciation
in the form of a cash gift card will be provided to each eligible participant. Participants will receive the gift card at the time of blood
draw. 10. Recruitment efforts will stop once the participation goal of 225 children <72 months and 75 pregnant women or women of
childbearing age (15-44 years) has been met. Collection: 1. There will be two blood collection events. There will be one event at a
central location for each county, to reduce travel burden on participants (ATSDR). 2. Administer a questionnaire to document
demographic, behavioral, occupational, and educational information of participants (ATSDR). Parent/guardians will complete the
survey for child participants. 3. Environmental samples will be collected from participants# households within 90 days of blood
collection (EPA and MDHHS).

Collection of Info, Data or Biospecimen:

Blood will be collected from participants as well as environmental samples from in and around the house. Additional information will
be collected via questionnaire.

Expected Use of Findings/Results and their impact:

ATSDR and partners will evaluate blood lead levels and lead levels in environmental samples to determine the association between
environmental lead levels and BLLs. This EI will result in an increased education about preventing lead exposure, improved access
to recommendations for remedial or removal actions, and to the knowledge needed to guide future remediation of lead in the area.

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 (including
coded data)?:

Yes

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate
of Confidentiality (CoC)?

No

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

No

Funding

Funding Type

Funding Title

CDC Cooperative Agreement

APPLETREE

Funding #

Original Budget Yr

# Years Award

Budget Amount

Other-Funded by ATSDR operating funds

Staff Time Only

0.00

HSC Review

HSC Attributes
Environmental Sampling

Yes

Non-Epi Aids Investigations

Yes

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

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

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

Missouri Dept of Hlth & Senior Services

FWA00001948

07/28/25

Missouri Dept of Hlth & Senior Services IRB #1

03/10/24

U.S. Environmental Protection Agency

FWA00012755

06/08/22

Funding #

Staff
Staff
Member

SIQT
Exp. Date

CITI Biomedical
Exp. Date

Aaron
Young

04/26
/2025

04/29/2025

Cory Kokko

06/08
/2025

Erin Evans

CITI Social &
Behavioral Exp. Date

Phone

Organization

CoInvestigator

7704883745

EXPOSURE INVESTIGATIONS TEAM

05/12/2025

CoInvestigator

9135511312

WESTERN SECTION REGION 7

05/31
/2022

05/11/2025

Principal
Investigator

9135511311

WESTERN SECTION

Karen
Scruton

11/01
/2024

05/01/2017

Project
Coordinator

7704881325

OFFICE OF COMMUNITY HEALTH AND
HAZARD ASSESSMENT

Matthew
Ferguson

05/05
/2023

CoInvestigator

9135511310

WESTERN SECTION REGION 7

11/10/2024

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Michelle
Zeager

08/14
/2023

08/18/2023

CoInvestigator

4044983959

EXPOSURE INVESTIGATIONS TEAM

Peter
Kowalski

12/19
/2024

04/13/2025

Program
Official

7704880776

EXPOSURE INVESTIGATIONS SECTION

Data
DMP
Proposed Data Collection Start Date:

8/15/22

Proposed Data Collection End Date:

8/28/22

Proposed Public Access Level:

Public

Public Access Justification:

All identifying information will be removed , and the data will be summarized and included in a final report.

How Access Will Be Provided for Data:

The final report will be available on the ATSDR website as a health consultation. No identifying information will be included in the
report.

Plans for Archival and Long Term Preservation:

Spatiality
Country

State/Province

County/Region

United States

Missouri

Newton County

United States

Missouri

Jasper County

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...

Supporting Info
Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Davis_Stephanie
I. (sgd8)
CIO OMB / PRA

06/14/2022

GenIC files for ICRO review and
submission to OMB

Paperwork Reduction Act Form

JNCEI OMB 6-14-2022 to ICRO.zip

Young_Aaron
(wrh6)
CIO HSC

06/13/2022

Complete OMB submission clean
documents

Other

JNCEI OMB 6-13-2022 final.zip

Young_Aaron
(wrh6)
CIO HSC

06/13/2022

This file only has new documents
and those with revisions

Other

JNC EI OMB 6-13-2022 Revisions with Track Changes.
zip

Davis_Stephanie
I. (sgd8)
CIO HSC

06/04/2022

GenIC files in zipfile with OS edits
and comments to be addressed

Paperwork Reduction Act Form

Files rev OS 20220604.zip

Young_Aaron
(wrh6)
CIO HSC

06/01/2022

Complete OMB package

Other

JNC EI OMB 6-1-2022.zip

Young_Aaron
(wrh6)
CIO HSC

05/13/2022

Zip file of all attachments
combined for Jasper and Newton
County EI OMB

Other

Final OMB Jasper and Newton County EI.zip

Young_Aaron
(wrh6)
CIO HSC

05/13/2022

This is the Project Determination
file with your most recent comment
addressed. All changes have been
updates in the SGTARS system.

Other

eClearance Project Determination 5-11.docx

Davis_Stephanie
I. (sgd8)
CIO HSC

05/11/2022

Zipfile of GenIC files with OS
review comments

Paperwork Reduction Act Form

Files rev OS.zip

Current

Young_Aaron
(wrh6)
Project Contact

05/09/2022

Attachment 2 Supporting
Statement B updated

Other

Att2_Jasper and Newton County SupStatement B - 09230048_5-9-22.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/09/2022

Gen IC Submission updated 5-922

Other

Jasper and Newton County GenIC Submittal 5-9-22.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/09/2022

Updated Supporting Statement A 59-22

Other

Att1_Jasper and Newton MO EI SupStatement A_5-9-22.
docx

Li_Zheng (kzl4)
Office Approver
Projects

05/06/2022

SSA with OCHHA/ADS comments
/edits.

Paperwork Reduction Act Form

Att1_Jasper and Newton MO EI SupStatement A_ks zl.
docx

Li_Zheng (kzl4)
Office Approver
Projects

05/06/2022

SSB with OCHHA/ADS comments
/edits.

Paperwork Reduction Act Form

Att2_Jasper and Newton County SupStatement B - 09230048_ks zl.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 1 Supporting
Statement A

Other-Supporting Statement A

Att1_Jasper and Newton MO EI SupStatement A_ks .docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 4: EI participant
questionnaire

Data Collection Form

Att4 JNC Questionaire JNC EI 0923_0048.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment2: Supporting
Statement B

Other-Supporting Statement B

Att2_Jasper and Newton County SupStatement B - 09230048_ks.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 7 Prior EI Final report

Other-Example of Prior EI Final
Report

Att7 EX EI report_Anaconda_Co_Smelter_.pdf

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 6: Sample Results
Letter (Attachment 5 is the
autogenerated research
determination form)

Other-Sample Results Letter to
Participants

Att6 JNC Sample Results Letters0923-0048.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 8: Privacy Impact
Assessment Form

Other-Privacy Impact Assessment
Form

Att8_PIA_Requests_JNC.pdf

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 3B: Adult Consent
Form

Consent Form

Att3B_Adult Consent JNC EI 0923-0048.docx

Young_Aaron

Current

(wrh6)
Project Contact

05/05/2022

Attachment 3C: Parental
Permission form

Consent Form

Att3C parental perm JNC E 0923-0048I.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 3D: Missouri
Department of Health and Senior
Services consent form

Consent Form

Att3D MDHSS consent form JNC EI 0923-0048.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 9: Protocol for the
proposed EI that has been through
the eClearance process.

Protocol

Att9 JNC EI Protocol 0923-0048.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 3E: Environmental
Protection Agency consent form

Consent Form

Att3E EPA consent form JNC EI 0923-0048.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Generic Information Collection
Form

Other-Generic Information
Collection Submittal Form

Jasper and Newton County GenIC Submittal 5_3_22.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 3: All Privacy and
consent forms (3A-3E)

Consent Form

Att3 JNC privacy and consent forms 0923-0048.docx

Current

Young_Aaron
(wrh6)
Project Contact

05/05/2022

Attachment 3A: Privacy Statement

Consent Form

Att3A JNC privacy stmt 0923-0048.docx