Supporting Statement B

Attachment 2 Blood Lead and Urine Arsenic in Anaconda, MT EI: Supporting Statement B

Blood Lead and Urine Arsenic Levels in Anaconda, MT

Exposure Investigation

ATSDR Exposure Investigations (EI) Generic Information Collection Request

OMB No. 0923-0048

Attachment 2: Supporting Statement Part B

Submitted: January 20, 2021

Science Support Branch (SSB)

Division of Community and Health Investigations (DCHI)

Agency for Toxic Substances and Disease Registry (ATSDR)

Program Official:

Peter J. Kowalski, MPH, CIH

Lead, Exposure Investigations and Data Analysis Team

Science Support Branch

Division of Community Health Investigations

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

B. Collections of Information Employing Statistical Methods 3

B.1. Respondent Universe and Sampling Methods 3

B.2. Procedures for the Collection of Information 3

B.3. Methods to Maximize Response Rates and Deal with Non-response 4

B.4. Test of Procedures or Methods to be Undertaken 4

B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data 4

ATTACHMENTS

Attachments:

1. Supporting Statement A

2. Supporting Statement B

3. Anaconda, MT EI Parental Permission/Assent/Consent Forms

   1. Privacy Act Statement

   2. Adult Consent Form for Blood and Urine Testing

   3. Parental Permission Form for Blood and Urine Testing: Children younger than 18 years of age

   4. Assent Form for Blood and Urine Testing: Children between 7 and 17 years of age

4. Anaconda, MT EI Questionnaire

5. Anaconda, MT EI Research Determination

6. Anaconda, MT EI Sample Results Letter

7. Example of Prior EI Final Report

8. Privacy Impact Assessment Form

9. Anaconda EI Protocol

B. Collections of Information Employing Statistical Methods

This is no statistical methodology used for this investigation. Section B.1 of the submission (below) describes how the data will be collected.

B.1. Respondent Universe and Sampling Methods

Since the Agency for Toxic Substances and Disease Registry (ATSDR) does not use the exposure investigation (EI) results to generalize or estimate the total exposed population, the respondent universe and statistical methods for determining sample size are not a factor.

Past zinc smelting activity in the city of Anaconda resulted in lead and arsenic contamination in the soil and attic dust throughout the Anaconda area. EPA listed the site on the National Priority List (NPL) in 1983 and is in the process of remediating soil within the Anaconda area. The purpose of the Anaconda, MT EI is to sample blood lead and urine arsenic levels in residents in the Anaconda area. The results of the testing will be used to identify participants that may be recommended for follow-up that may include recommending case management (lead) and education regarding environmental exposure.

B.2. Procedures for the Collection of Information



Recruitment for the EI will be conducted in the fall of 2018 and will include:

• Sending a postcard providing information on the testing event and inviting residents to make an appointment to participate. Given community concerns about environmental contamination in the Anaconda area, all residents are invited to participate.

• Obtaining assistance from the Montana Department of Public Health and Human Services (MDPHHS) and the Anaconda Deer Lodge County (ADLC) Health Department including distributing recruitment materials (fact sheets and posters) and providing information on the EI on their social media accounts.

• Providing participants with a urine collection kit that will include instructions on how to obtain a first-morning urine sample, freeze it and transport it to the blood-collection location. ATSDR personnel will deliver the urine kits to participants and obtain consent to participate in the EI at that time (Attachment 3). All questions regarding participation in the EI will be answered.

On the day of the blood collection, participants will bring their frozen urine sample and will provide it to ATSDR personnel. A questionnaire will be administered (Attachment 4) and blood will be collected from participants. Blood samples will be obtained using certified phlebotomists at the blood collection center. ATSDR personnel will pack and ship all blood and urine samples overnight to the National Center for Environmental Health/Division of Laboratory Sciences (NCEH/DLS) for analysis. For arsenic, total urinary arsenic (creatinine- adjusted, as appropriate) and speciated arsenic will be analyzed.

Quality Control Procedures

Prior to the interviews, the EI team is trained on the site-specific questions to be asked (e.g., the purpose of each question, how to capture answers, place for comments, etc.). The list of questions and individual’s answers are stored in a secure database or locked filing cabinet.

Each participant is given information regarding the name of the EI, a telephone number to answer questions, and the address of the ATSDR website where they can find more information about the EI (Attachment 3). Each participant receives a copy of their personal results (sample results letters provided in Attachment 6). Individual results will be protected to the full extent provided by law and will not be shared publically in any published reports.

B.3. Methods to Maximize Response Rates and Deal with Non-response

ATSDR has a list of addresses in the area in the vicinity of the former Anaconda smelter, including the communities of Anaconda and Opportunity. A postcard with information on the EI and an invitation to participate will be provided in an attempt to notify all participants in the Anaconda area. In addition, fact sheets and posters will be distributed throughout the community by MCPHHS and the ADLC health department.

EPA is currently remediating residential soil and attic dust in Anaconda so it is anticipated that residents will be aware of the cleanup effort and be willing to be included in the EI. Even without 100% participation, we can interpret results because we are providing participants an individual result and are not attempting to determine population level exposures.

B.4. Test of Procedures or Methods to be Undertaken

The EI team will use the questions provided in Attachment 4.

B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Statistical calculations are not used to determine participation in EIs.

4