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ATSDR Exposure Investigations (EIs)

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Attachment 1. Blood Lead Levels in JNC EI: Supporting Statement A


Jasper and Newton Counties Missouri Lead Exposure Investigation


Oronogo-Duenweg Mining Belt Superfund Site

Newton County Mine Tailings Superfund Site

Jasper and Newton Counties, Missouri


Facility IDs MOD980686281/MOD981507585



ATSDR Exposure Investigations (EI) Generic Information Collection (GenIC)

under

OMB No. 0923-0048

Expiration Date: 06/30/2022



Supporting Statement Part A



Submitted: June 13, 2022




Exposure Investigation (EI)

Office of Community Health and Hazard Assessment (OCHHA)

Agency for Toxic Substances and Disease Registry (ATSDR)





Program Official:

Peter J. Kowalski, MPH, CIH

Lead, Exposure Investigations and Data Analysis Team

Office of Community Health and Hazard Assessment

Agency for Toxic Substances and Disease Registry

4770 Buford Hwy NE, MS F59
Atlanta, GA 30341

Phone: 770-488-0776

Fax: 770-488-1542

Email: [email protected]


Table of Contents





Shape1

Goal of the study: The Jasper and Newton County Exposure Investigation (JNC 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.

Intended use of the resulting data: The data will inform the extent of lead exposure in the community and help develop future recommendations and actions to reduce exposure to lead.

Methods to be used to collect: Participants for the EI will be recruited from the areas within the Oronogo-Duenweg Mining Belt and Newton County Mine Tailings Superfund sites’ boundaries through convenient sampling. Recruitment priority will be given to area residents where lead contamination is highest or suspected.

Subpopulation to be studied: Children (<72 months) and pregnant women or women of childbearing age (15-44 years) living near the sites.

How data will be analyzed: Data analysis will be performed using R, SPSS, SAS, and/or Prism software. Descriptive analyses, including the various BLLs and environmental data, broken down by age, sex, status on known lead exposures, comparison to NHANES, etc., will be provided and presented via distinctive and clear figures along with descriptions in text. ATSDR statisticians will compare the measured BLL to the current BLRV and incorporate multivariate regression analysis to determine the association between BLL and lead measured in the surrounding environment,





A. Justification

A.1 Circumstances Making the Collection of Information Necessary


This data collection is being conducted using the Generic Information Collection mechanism of the Agency for Toxic Substances and Disease Registry (ATSDR) Exposure Investigations (EIs) – OMB Control No.0923-0048, expiration date 6/31/2022. The data collection for the Jasper and Newton County Exposure Investigation (JNC EI) aligns with the agency’s mission.


The data collection is authorized by the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), commonly known as the “Superfund” Act, as amended by the Superfund Amendments and Reauthorization Act (SARA) of 1986.


ATSDR Public Health Assessment Process and the Role of the Exposure Investigation


The EI will measure lead in the blood of children (<72 months) and pregnant women or women of childbearing age (15-44 years) near the Oronogo-Duenweg Mining Belt and Newton County Mine Tailings Superfund sites. In addition, federal and state partners will measure lead contamination in and around households to better inform potential lead exposure to participants. The EI will evaluate the association between BLLs and environmental lead levels. The Oronogo-Duenweg Mining Belt and the Newton County Mine Tailings Superfund sites are listed on the EPA National Priorities List (NPL) and are part of the Tri-State Mining District (TSMD). The TSMD encompasses approximately 2,500 square miles of land in Kansas, Missouri, and Oklahoma.

The TSMD was one of the foremost lead-zinc mining areas of the world. Lead and zinc ores were actively mined, milled, and smelted for over 100 years. Historic mining activities generated millions of tons of waste (described in the Protocol) that contaminated soil, groundwater, and sediments with lead and other metals.

ATSDR released a Preliminary Public Health Assessment for the Oronogo-Duenweg Mining Belt in 1990 and a Public Health Assessment for the Newton County Mine Tailings Site in 2006. Public Health Assessments evaluate hazardous waste sites to determine whether people could be harmed by coming into contact with site-related substances. Both assessments concluded that the sites posed a public health concern due to human exposure to metals via ingestion and inhalation of contaminated groundwater, soil, sediment, and air [ATSDR 1990, 2006].

Given CDC’s changes to the blood-lead reference value (BLRV), in October 2021, EPA asked for ATSDR’s assistance in conducting a blood lead assessment for the Oronogo-Duenweg Mining Belt and Newton County Mine Tailings Superfund sites [EPA 2017, EPA 2019].


Blood Lead Levels in JNC, MO Exposure Investigation


The EI team evaluated the following four questions to determine whether an EI is appropriate to fill a data gap for the Oronogo-Duenweg Mining Belt and Newton County Mine Tailings Superfund sites.

  1. Can an exposed population be identified?



Yes. EPA has conducted extensive soil sampling and found high levels of lead throughout the impacted areas within both Jasper and Newton Counties. Sensitive populations could be at risk for exposure to harmful levels of lead in this community, specifically children < 72 months (i.e., younger than 6 years old) and women who are pregnant or of child-bearing age.



  1. Does a data gap exist that affects the ability to determine if a health hazard exists?



Yes. Communities near the Oronogo-Duenweg Mining Belt and Newton County Mine Tailings sites have been shown to have historic exposure to lead. While extensive response actions have been taken to reduce exposure, lead contamination remains present in soils at varying levels and some areas have yet to be investigated. It is unknown how historic and ongoing exposure to lead may be associated with BLLs.



  1. Can an exposure investigation be designed that will address this data gap?



Yes. The EI will focus on participants across both sites where contamination from historic mining activities is highest. EPA environmental sampling data and site investigation information will be used to identify areas where lead contamination is known or suspected to be present. Blood lead results will be compared to BLRVs and interpreted using levels of lead found in the households of participants. EPA and MDHSS will collect samples from soil, drinking water, house dust, and interior and exterior paint in homes of EI participants.



  1. How will the EI results impact the public health decision(s) for the site?

The results of the EI will allow ATSDR to measure and compare BLLs and environmental levels and to provide recommendations on how to reduce exposure. The results may lead to an increase in education about exposure and prevention and recommendations for remedial or removal actions. The results may also help inform future clean-up work.



Once the EI data collection and the EI report is complete, the ATSDR Team will conduct a public availability session for participants in the EI and for the community as a whole to discuss recommendations to reduce exposure and potential health concerns related to lead.

A.2. Purpose and Use of Information Collection


The objectives of the EI in JNC include:

  1. Evaluate BLLs for Jasper and Newton counties’ residents who are < 72 months, women who are pregnant, or women of childbearing age (15-44 years) that participate in the investigation.

    • Minor siblings > 72 months may also have their BLLs evaluated for participating families at the parent/guardian’s request.

    • Recommend case management for child participants with BLLs ≥ 3.5 µg/dL and adult participants with BLLs ≥ 5 µg/dL [CDC 2021b].

    • Recommend follow-up evaluation and retesting with a Primary Care Provider (PCP), obstetrician-gynecologist (OB/GYN), pediatrician, or health department.

    • Recommend screening for developmental and behavioral issues in children. Refer children with developmental and behavioral issues, as needed.

    • Provide information on nutrition that may help to decrease the absorption of lead into the body [CDC 2002].

  1. Review environmental sampling data collected by state and federal partners from participating residents’ indoor and outdoor environments.

  2. Administer a questionnaire to document demographic, behavioral, occupational, and educational information of participants. Parent/guardians will complete the survey for child participants.

  3. Evaluate lead levels in environmental samples and the association between environmental lead levels and BLLs.

  4. Recommend ways to lower environmental exposures to lead.

  5. Provide the opportunity for all participants and parents/guardians of child participants to discuss their blood lead findings with an ATSDR medical officer.

Data from ATSDR’s JNC EI report may also be used by public health professionals, environmental risk managers, and other decision makers in determining the source and extent of the exposures. ATSDR will produce this needed information to support public health action. Further, the results of this EI are not intended to be generalized and are applicable only to the participants. ATSDR only collects information that will help us interpret the laboratory data and recognize likely exposure scenarios. Once we conduct an EI, we match the unique answers given by participants with their laboratory results or environmental samples to determine whether intervention is needed on an individual level. The information collection is therefore inherently person- or location-specific.


Data are treated to protect privacy; access to computer files is password-protected and access is limited to authorized EI personnel. All staff working on the project agrees to safeguard the data and not to make unauthorized disclosures. Published reports will present responses in aggregate form and no individuals are identified by name.


A.3. Use of Improved Information Technology and Burden Reduction


ATSDR will conduct personal interviews at the sample collection location using a hard-copy questionnaire with the participants. The information will be entered electronically and validated on a laptop computer by staff members.

A.4. Efforts to Identify Duplication and Use of Similar Information


ATSDR released a Preliminary Public Health Assessment for the Oronogo-Duenweg Mining Belt in 1990 and a Public Health Assessment for the Newton County Mine Tailings Site in 2006. Public Health Assessments evaluate hazardous waste sites to determine whether people could be harmed by coming into contact with site-related substances. Both assessments concluded that the sites posed a public health concern due to human exposure to metals via ingestion and inhalation of contaminated groundwater, soil, sediment, and air [ATSDR 1990, 2006].

In 1991, ATSDR, in partnership with the Missouri Department of Health (MDOH) now known as the MDHSS, initiated a lead and cadmium exposure study to determine if residents living in the Jasper County Superfund site area had blood lead and urine cadmium levels higher than residents living in a comparison area. The final report, published in 1995, found that BLLs were significantly higher in the exposed group. Urine cadmium levels did not significantly differ between the control and study populations. Environmental exposure to the area soil was the most important factor influencing the distribution of BLLs [ATSDR 1995].

EPA implemented major interventions in response to the 1995 report. By June 2000, they had remediated 2,288 residential yards. In 2000, ATSDR and MDOH conducted a follow-up lead exposure study to determine whether the interventions had been effective in reducing the mean BLLs of children residing in the area. The final follow-up study report, published in 2002, found that educational and environmental interventions were effective in reducing mean BLLs [ATSDR 2002]. The findings and conclusions of these studies are described in the JNC EI Protocol Appendix A.

The CDC has updated recommendations on children’s BLLs over time as science and understanding of the health impacts of lead have evolved. Until 2012, children were identified as having a blood lead “level of concern” if the blood lead test result was greater than or equal to (≥)10 micrograms per deciliter (µg/dL). CDC no longer uses the term “level of concern” and instead uses a BLRV to identify children who have more lead in their blood than most children. In 2012, CDC began using a BLRV of 5 µg/dL and in 2021 lowered the BLRV to 3.5 µg/dL (described further in the next section) [CDC 2021b].

Given CDC’s changes to the BLRV, in October 2021, EPA asked for ATSDR’s assistance in conducting a blood lead assessment for the Oronogo-Duenweg Mining Belt and Newton County Mine Tailings Superfund sites [EPA 2017, EPA 2019]. There are concerns that historic residential soil clean up levels may not remain sufficiently protective. Blood lead testing and environmental sampling has not been conducted since the most recent changes to the BLRV and this EI will produce new information that can be used to direct future efforts in the community to reduce exposure to lead.


A.5. Impact on Small Businesses or Other Small Entities


The only small businesses that may be included in the JNC EI include daycare centers and preschool/elementary schools. These facilities will be approached for recruitment of children that attend the facility.

A.6. Consequences of Collecting the Information Less Frequently


This request is for a one-time data collection in the summer of 2022. There are no legal obstacles to reduce the burden. ATSDR’s Health and Safety plan for the EI is provided in Protocol Appendix G.

A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5


There are no special circumstances associated with this data collection. The data collection will fully comply with the guidelines of 5 CFR 1320.5 and will be voluntary.


A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency


This data collection is being conducted using the Generic Information Collection mechanism for Exposure Investigations – OMB Control No. 0923-0048 (expiration date: 06/30/2025). A 60-day Federal Register Notice was published in the Federal Register, Vol. 86, No. 154 on Wednesday, August 13, 2021. No comments were received.


This EI is a collaborative project between ATSDR, Centers for Disease Control and Prevention (CDC) Division of Laboratory Sciences (DLS), U.S. Environmental Protection Agency (EPA), Missouri Department of Health and Senior Services (MDHSS), Jasper County Health Department, Newton County Health Department, Joplin City Health Department, and the Mid-America Pediatric Environmental Health Specialty Unit (PEHSU). ATSDR will work collaboratively with all partners throughout this process and provide assistance as needed.


A.9. Explanation of Any Payment or Gift to Respondents


Each eligible participant will receive free blood lead testing with explanation of results and a $20 gift card for their participation. The gift cards will be provided to participants at the time of blood draw.

A.10. Protection of the Privacy and Confidentiality of Information Provided by Respondents


ATSDR/NCEH Information Systems Security officer (ISSO) has determined that the Privacy Act does apply for the JNC EI. The relevant Privacy Act System of Records Notice (SORN) for this EI is Privacy Act System Notice 09-19-0001, Records of Persons Exposed or Potentially Exposed to Toxic or Hazardous Substances (HHS/ATSDR). A Privacy Act Statement is included in the consent package (Appendix D1).


A Privacy Impact Assessment (PIA) form provides information on information that will be collected from respondents and how it will be secured (Attachment 6).


Data obtained during the EI will be treated in a secure manner and will not be disclosed, unless otherwise compelled by law. Missouri Open Record Laws require openness in government, which may result in personal identification being accessible by the general public. The EI will comply with all appropriate requirements.


A.10.1. Privacy Impact Assessment Information


The JNC EI will involve up to 300 participants, including children and adults. ATSDR provides participants with information on the EI process and what it can and cannot determine. ATSDR factsheets about the EI and other recruitment material is provided in Protocol Appendix C. After providing the participants this information, ATSDR will ask for parental permission or adult consent to participate in the EI (Protocol Appendices D2-D4). Participation is completely voluntary; participants can stop participating in the EI at any time.


Overview of the Data Collection System


The primary objective of the information collected for the JNC EI is to assess exposures to environmental lead. Data obtained during this EI will include analytical measures of lead in blood and environmental samples collected in and around the home as well as an administered questionnaire. Information obtained from the participants assists the team in determining if exposure has occurred or is occurring. For this EI, a data collection system will include all of the measurements and procedures that are proposed to address data gaps in the blood sampling.


The data collection system for this EI will be characterized by the following:


  1. Who will use the EI Data Collection System?

The OCHHA EI Team and the ATSDR Region 7 staff will use the Data Collection System to perform the blood collection and laboratory analysis during the JNC EI.


  1. Who can be included as part of the EI Generic Clearance?

Children < 72 months, pregnant women, and women of childbearing age will be eligible for inclusion in the EI. 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.


  1. What types of questions may be asked as part of the EI Generic Clearance?

For the JNC EI, the media of concern are water, soil and dust contaminated with lead. The Protocol Appendix E contains all ATSDR data collection forms: E1 is the questionnaire used to evaluate lead exposure of EI participants, and E2 is the tracking form used during blood collection. Data collection forms used by MDHHS and USEPA are provided in the Protocol Appendix I.


Items of Information to be Collected


Collecting identifying information is necessary to facilitate personal contact with participants, to obtain their parental permission /consent to participate and to provide them with results. The information is also used by ATSDR to better interpret the results of the sampling. ATSDR uses the information only to contact respondents. Data is treated in a private manner, unless otherwise compelled by law.


ATSDR collects contact information (e.g., name, address, phone number, email address) to provide the participant with their individual results. General information, which includes age/date of birth, race, gender, etc., will be collected since we are recruiting specific age groups in the EI.


ATSDR will ask participants questions about their recreational activities that could increase their potential exposure to lead in environmental media. Only questions needed to determine the extent of exposure in a particular situation will be asked. The questions are intended to estimate how long and how frequently participants may have contact with soil around their homes.


In addition, ATSDR will also collect information on other possible sources of lead exposure such as age and construction characteristics of the home, foods eaten, hobbies, time spent outdoors, etc. That information represents their individual exposure history.


The blood collection will be overseen by ATSDR personnel, obtained by trained phlebotomists, and shipped directly to the CDC National Center for Environmental Health (NCEH) laboratory in Atlanta for analysis. Appropriate Quality Assurance Plans will be prepared and implemented by ATSDR. Blood lead samples will be collected at a central location within the community.


An example of a completed Exposure Investigation is provided as Attachment 4 and the final JNC Protocol is provided as Attachment 7.


Sharing and Purpose of Collected Information


The information collected for the EI will be used to evaluate whether participants may have been exposed to lead in JNC from former mining activities. Participants will be notified of their individual results and an EI report will be prepared that will present the results of the investigation.


Securing of Collected Information


ATSDR only collects information that will help us interpret the laboratory data and recognize likely exposure scenarios. Once we conduct an EI, we match the unique answers given by participants with their laboratory results or environmental samples to determine whether intervention is needed on an individual level. The information collection is therefore inherently person- or location-specific.


Data are treated to protect privacy; access to computer files is password-protected and access is limited to authorized EI personnel, including contractors. All staff working on the project agree to safeguard the data and not to make unauthorized disclosures. Published reports may present responses in aggregate form and no individuals are identified by name.


Data are treated in a private manner, unless otherwise compelled by law. Paper documents containing personal identifiers are kept in locked file cabinets at ATSDR. ATSDR computers comply with the HHS Standard 2008-0007.001S for encryption in accordance with information systems security requirements for safeguarding personally identifiable information. Access to computer files is password-protected and access is limited to authorized EI personnel. That information is stored in a secure database along with the laboratory results.



Applicability of the Privacy Act


A. The Privacy Act is applicable. The applicable System of Records Notice (SORN) is No. 09-19-0001, “Records of Persons Exposed or Potentially Exposed to Hazardous or Toxic Substances.”


B. Identifying information such as name, address, phone number and email are collected. ATSDR uses the information only to contact respondents. Identifying information is necessary to facilitate the personal contact with respondents to conduct the questionnaire, to obtain consent to participate, and to provide them their results.


All identifying information maintained by the agency will be managed by ATSDR and is subject to the ATSDR Comprehensive Record Control Schedule (CRCS), B-371, which contains authorized disposition instructions for ATSDR's administrative and program records.


C. Respondent Consent –ATSDR will require that EI participants be fully informed of the potential risks and benefits of their participation and that the privacy of the participants’ information will be protected. The parental permission, and adult consent forms for the JNC EI include all appropriate information from the Privacy Act including authority and purpose for collecting the data, with whom identifiable information will be shared, the voluntary nature of the information collection and the effect upon the respondent for not participating (Appendices D1-D4). Missouri Sunshine Laws require openness in government and will be followed. The EI will comply with all appropriate requirements.


D. Voluntary Nature - Respondents are told that their participation in the EI is voluntary and they may refuse to answer any of the questions.


A.11. Institutional Review Board (IRB) and Justification for Sensitive Questions


Federal Regulations for Protection of Human Subjects (45 CFR 46) state that “research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” In contrast, this EI is intended to be a systematic investigation but is not designed to develop or contribute to generalizable knowledge. The JNC EI is a nonresearch activity and human subjects review by an Institutional Review Board (IRB) is not required. The EI was reviewed by the NCEH/ATSDR Human Subjects Coordinator, and the Project Determination is included as Attachment 8.


ATSDR will gather information about individual characteristics (e.g., gender, age, ethnicity, and race) to assist with interpretation for biological samples. For example, the individual’s laboratory results are compared to similar ethnicity and race results in the National Report on Human Exposure to Environmental Chemicals (http://www.cdc.gov/exposurereport/). Beyond that, questions of a sensitive nature will not be asked.


We will not ask questions on symptoms, medical outcomes, or drug and medication use. For the JNC EI, ATSDR will ask questions pertaining to recent or current pregnancy status because pregnancy makes a woman and her unborn child more vulnerable to the effects of lead.


Social security numbers are not needed nor will they be requested.

A.12. Estimates of Annualized Burden Hours and Costs

A.12.1. Estimates of Annualized Burden Hours


The estimate for burden hours for the JNC EI is based on similar EIs that the EI team has conducted in the past. A typical questionnaire may include up to 60 questions, taking approximately 20 minutes to complete. Blood draw is estimated to take 10 minutes for a total of 30 minutes per respondent. We are limiting the number of EI participants a maximum of 300. If the goal of 300 participants is not met, ATSDR will offer to 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 included as part of the EI report, and they will not be compensated.


Environmental sampling inside the home (dust wipes and public water samples), collected by MDHHS, will take approximately 30 minutes to collect. Environmental sampling outside the home (soil and private water samples), collected by the EPA will also take 30 minutes. Environmental sampling protocols are provided in the JNC EI Protocol Appendix F.


The maximum estimated time burden is 426 hours. This maximum value is based on the assumption that each participant will have a separate sampling event for indoor dust and outdoor soil. The total will likely be less due to multiple participants that will require one household set of environmental samples.


Estimated Annualized Burden Hours


Type of Respondents

Name of Form

No. of Respondents

No. of Responses per Respondent

Average Burden per Response

(in hours)

Total Burden (in Hours)

Parent Proxy for Children under 6

Participant Questionnaire

225

1

20/60

75

Adult EI Participants

Participant Questionnaire

75

1

20/60

25

Children under 6 and minors from 6-17 when applicable

Blood Collection

225

1

10/60

38

Adult EI Participants

Blood Collection

75

1

10/60

13

Head of Household

Home Schematic (Form 100)

300

1

5/60

25

Interior Environmental Paint Assessment (Form 110)

300

1

10/60

50

External Environmental Paint Assessment (Form 120)

300

1

5/60

25

Dust Wipe Collection (Form 200)

300

1

10/60

50

Soil Composite Sample Collection (Form 300)

300

1

20/60

100

Private Well Water Collection (Form 400) a

60 a

1

5/60

5

Public Water Kitchen Tap Collection (Form 500) a

240 a

1

5/60

20

Total





426 b

a Each of the 300 participants will have their water sampled. Water sampling will require no more than 5 minutes of time for either public or private sources. ATSDR anticipates homes will only use water from one source and that no more than 20% of the participants will have private wells. The true number of participants with private and public sources may change, but the total will still equal 300, and the burden will not change.


bThis maximum value assumes that each participant will have a separate sampling event for indoor dust and outdoor soil. The total will likely be less due to multiple participants that will require one household set of environmental samples.

A.12.2. Annualized Cost to Respondents


Using a mean hourly rate of $28.01/hour for adults, parent proxies, and heads of households (for all occupations) and a minimum wage of $7.25 for children, the annualized cost to respondents for the hour burdens for the collection of information is $11,125.76. The hourly wage rate is based on the U.S. Department of Labor, Bureau of Labor Statistics’ most current statistics [May 2021 National Occupational Employment and Wage Estimates United States, http://www.bls.gov/oes/current/oes_nat.htm#00-0000] and the U.S. Department of Labor Minimum Wage website, https://www.dol.gov/general/topic/wages/minimumwage.


Estimated Annualized Burden Costs


Type of Respondents

Name of Form

No. of Respondents

No. of Responses per Respondent

Average Burden per Response

(in hours)

Hourly Wage Rate

Total Respondent Cost

Parent Proxy for children under 6

Participant Questionnaire

225

1

20/60

$28.01

$2,100.75

Adult EI Participants

Participant Questionnaire

75

1

20/60

$28.01

$700.25

Children under 6 and minors from 6-17 when applicable

Blood Collection

225

1

10/60

$7.25

$271.88

Adult EI Participants

Blood Collection

75

1

10/60

$28.01

$350.13

Head of Household

Home Schematic (Form 100)

300

1

5/60

$28.01

$700.25

Interior Environmental Paint Assessment (Form 110)

300

1

10/60

$28.01

$1,400.50

External Environmental Paint Assessment (Form 120)

300

1

5/60

$28.01

$700.25

Dust Wipe Collection (Form 200)

300

1

10/60

$28.01

$1,400.50

Soil Composite Sample Collection (Form 300)

300

1

20/60

$28.01

$2,801.00

Private Well Water Collection (Form 400)

60a

1

5/60

$28.01

$140.05

Public Water Kitchen Tap Collection (Form 500)

240a

1

5/60

$28.01

$560.20

Total






$11,125.75 b

a Each of the 300 participants will have their water sampled. Water sampling will require no more than 5 minutes of time for either public or private sources. ATSDR anticipates homes will only use water from one source and that no more than 20% of the participants will have private wells. The true number of participants with private and public sources may change, but the total will still equal 300 and the burden will not change.


b This maximum value assumes that each participant will have a separate sampling event for indoor dust and outdoor soil. The total will likely be less due to multiple participants that will require one household set of environmental samples.


A.13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers


There will be no direct costs to the participants other than their time to participate in the EI.


A.14. Annualized Cost to the Government


Costs for ATSDR personnel are estimated based on experience with previous EI activities.


Staff (FTE)

Average Hours per Collection

Average Hourly Rate

Average Cost

Medical Officer (GS-14)

300

$54.24

$16,272.00

Headquarters Health Scientist (GS-13)

750

$45.90

$34,425.00

Regional Representative (Health Scientist – GS-13)

400

$45.90

$18,360.00

Estimated Total Personnel Cost of Exposure Investigation

$69,057.00


Non-Personnel

Cost

Travel costs



Atlanta Personnel

$8,418.00


Regional Personnel

$12,466.00

Laboratory costs


$24,000.00

Shipping supplies and samples


$1,250.00

Phlebotomist cost


$2,400.00

Gift Cards


$6,000

Facility Rental


$1,000

Estimated Total Non-personnel Cost of Exposure Investigation

$55,534.00

Total EI Cost (Personnel + Non-personnel costs)

$124,591.00


The travel costs include the following:

  • Travel to the site from Atlanta (2 person) for two weeks

  • Travel to site from Kansas City, MO (3 person) for two weeks

  • Travel to the site from Atlanta (1-2 person ), Kansas City (1-3 person ) to provide the results to the community


A.15. Explanation for Program Changes or Adjustments


This is a new data collection.


A.16. Plans for Tabulation and Publication and Project Time Schedule


A.16.1 Project Time Schedule


The project Time Schedule for the JNC EI is as follows:


Activity Time Schedule


EI Recruitment………………………………………………….. Immediately after OMB approval

Schedule Phlebotomist…………………………………………..6 weeks after OMB approval

Start of data collection and field work .....………………..……12 weeks after OMB approval

Data and laboratory analysis………………………………......... 15-21 weeks after OMB approval

Conduct Environmental Sampling…………………………15 to 28 weeks after OMB approval

Analyze Environmental Data and questionnaire…….………28 to 36 weeks after OMB approval

Respond to participants …………………………….…................36 weeks after OMB approval

Written report released….……………………….…...................40-64 - based on clearance process


Response letters to the participants will be sent to all participants (sample letters are provided in Protocol Appendices H1 & H2). If a participant has an elevated BLL, they will be notified by phone immediately to allow assistance to begin as soon as possible. Language from cleared ATSDR factsheets on reducing exposure to lead will be used to tailor the results letters to the participant’s measured lead concentrations and answers on the questionnaire. ATSDR factsheets on reducing lead exposure are provided in attachments 5A-5E. An example of a prior Exposure Investigation report is provided as Attachment 4.

A.17. Reason(s) Display of OMB Expiration Date is Inappropriate


We are not requesting an exemption.


A.18. Exceptions to Certification for Paperwork Reduction Act Submissions


There are no exceptions to certification for Paperwork Reduction Act.


References


[ATSDR 1990] Agency for Toxic Substances and Disease Registry. 1990. Preliminary health assessment for Oronogo-Duenweg mining belt. Atlanta GA.

[ATSDR 1995] Agency for Toxic Substances and Disease Registry. 1995. Jasper County, Missouri superfund site lead and cadmium exposure study. Atlanta GA.

[ATSDR 2002] Agency for Toxic Substances and Disease Registry. 2002. Jasper County, Missouri superfund site childhood 2000 lead exposure study. Atlanta GA.

[ATSDR 2006] Agency for Toxic Substances and Disease Registry. 2006. Public health assessment for Newton County mine tailings site. Atlanta GA.

[ATSDR 2020] Agency for Toxic Substances and Disease Registry. 2020. Toxicological profile for lead. Atlanta GA.

Brink LL, Talbot EO, Sharma RK, March GM, Wu WC, Rager JR, Strosnider HM (2013). Do U.S. Ambient Air Lead Levels Have a Significant Impact on Childhood Blood Lead Levels: Result of a National Study. J. Environ and Public Health. Available at: http://www.hindawi.com/journals/jeph/2013/278042/.

[CDC 2021b] Centers for Disease Control and Prevention. 2021. Blood lead reference value. Atlanta, GA [reviewed 2021 October 27; accessed 2021 November 22]. Available from: https://www.cdc.‌gov/nceh/lead/data/blood-lead-reference-value.htm.


[EPA 2017] U.S. Environmental Protection Agency. 2017. Fourth five-year review report for Oronogo-Duenweg mining belt superfund site Jasper County, Missouri. Lenexa KS.

[EPA 2018] U.S. Environmental Protection Agency. 2018. Generic quality assurance project plan for Region 7’s Superfund lead-contaminated sites. Lenexa KS.

[EPA 2019] U.S. Environmental Protection Agency. 2019. First five-year review report for Newton County mine tailings superfund site Newton County, Missouri. Lenexa KS.


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File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
File TitleAttachment 1. Blood Lead Levels in JNC EI: Supporting Statement A
AuthorCDC User
File Modified0000-00-00
File Created2023-08-31

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