GenIC request for approval

Generic Information Collection (GenIC) Submittal Form for

OMB Review of ATSDR Exposure Investigations (EIs) (0923-0048)

PROJECT TITLE: Drinking Water Exposure Investigation Dimock, PA

SITE LOCATION: Dimock, Pennsylvania

REQUESTED BURDEN HOURS: 30

PROJECT SUMMARY

Principal Investigator(s):	Robert Helverson (ATSDR Region 3) Karen Scruton (ATSDR Headquarters) Lora Werner (ATSDR Region 3)
Technical Assistance:	Region 3 Environmental Protection Agency (EPA) Pennsylvania Department of Environmental Protection (PADEP) Pennsylvania Department of Health (PADOH) Eastern Research Group (ERG) - Contractor
Source of Request (state, petition, etc.):	The Agency for Toxic Substances and Disease (ATSDR) exposure investigation (EI) will be conducted in coordination with EPA.
Project Goals:	The goals for the Drinking Water Exposure Investigation (EI) in Dimock, PA are to test residential well water, bulk water sources and indoor air to assess ingestion and inhalation exposure pathways at specific Dimock residences. ATSDR will perform the following actions: Test private well water (at the tap and raw groundwater), as well as supplied bulk water sources, for a list of contaminants associated with natural gas drilling methods. Monitor indoor air for total volatile organic compounds and combustible gas during water testing due to the presence of methane gas in samples tested by the U.S. Environmental Protection Agency (EPA) in 2012. Test water and indoor air for radon.
Project Objectives:	The objectives of the EI at Dimock, PA are to determine whether constituents associated with natural gas drilling activities may be present in drinking water at levels that may result in health effects (chemical or radon exposure) or safety concerns (methane). Levels of concern are identified as levels of a contaminant that exceed ATSDR comparison values (CVS) or other contaminant-specific screening criteria. If this is the case, ATSDR will make the following recommendations to residents: install a home water treatment system to address chemicals and methane in water or obtain an alternative source of drinking water, and install a radon treatment system if radon levels are found to be above the action level. Data from ATSDR’s Dimock EI report (sample in Attachment 7) may 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.
Environmental Sampling to be Completed:	Testing drinking water, raw groundwater and bulk water for constituents associated with natural gas drilling activities. In addition, testing radon in water and indoor air.
Biological Sampling to be Completed:	No biological testing will be completed for the EI.
Data Collection and Analysis Procedures:	Recruitment of Participants: Supporting Statements A and B are provided in Attachments 1 and 2. The Supporting Statements outline the EI data collection and analysis procedures. Recruitment: EI participants will be selected from the 64 residences tested by EPA in 2012 with a maximum of 20 homes being included in the EI. An invitation letter and fact sheet will be sent to the 64 potential participants that outlines the EI objectives. The invitation letter and EI fact sheet are provided in Attachment 9. The residences to be included in the EI will be identified using the following criteria: Residences included in the 2012 EPA testing event that have private well water identified as a health hazard in the 2016 HC that continues to be used as a source of potable water in the home, or an existing concern about the quality of their water, e.g., detections near or exceeding level of concern, discoloration or bubbling of water, and proximity of well to natural gas production wells. If greater than 20 residences meet the criteria, participants will be selected based on the results of the 2012 EPA testing: Those with well water with the highest number and/or concentration of contaminants of concern will be given priority for inclusion in the EI. Contaminants will be evaluated using ATSDR comparison values and other contaminant-specific screening criteria. Collection: All participants will be provided a consent form (Attachment 3) to sign to allow ATSDR to conduct the testing. Participants will be asked questions to allow a better interpretation of testing results. The questionnaire to be used in the EI is attached (Attachment 4), and is estimated to take 20 minutes to complete. The human subjects determination is provided in Attachment 8. The EI is not considered a research study; its primary intent is to provide a public health service for the community. Analysis: The samples will be analyzed by TestAmerica (constituents in water), Microbac (bacteria in water) and AccuStar Labs (radon test kits) using state-of-art laboratory methods.
Information Collection Mode (in-person or remote):	In-person
Plans for Payment to Participant (if applicable):	Not Applicable
Privacy Protections:	Privacy will be protected to the fullest extent of the law. The consent forms contain information about privacy protections.
Other Ethical Concerns/Issues:	Water and indoor air samples will be obtained from residents in the Dimock community. No ethical concerns or issues are identified.
Projected Time Frame:	The EI will be conducted in two phases: ATSDR will conduct a site visit prior to the testing to accomplish the following: Obtain written consent for accessing and testing water at the residence (Attachment 3). The consent includes granting permission to share de-identified well water and indoor air monitoring results with Pennsylvania state agencies and other federal agencies, Assess the accessibility at the residence to test raw water if a treatment system is in place, and Complete a site-specific questionnaire about water quality in the home to assist in the sampling effort. The questionnaire is provided in Attachment 4. Completion of the consent form and questionnaire will take approximately 20 minutes. ATSDR will conduct the testing over a period of one week and samples will be sent to accredited laboratories for analysis.
Plans for Publication and Dissemination of Results:	Water and radon results will be provided to participants within 12 weeks of sampling. The EI report will be prepared, cleared and released as soon as possible.
Burden Hours Requested:	30 hours 20 participants x 90 minutes per participant

Attachments:

1. Supporting Statement A

2. Supporting Statement B

3. Dimock EI Consent Form

4. Dimock EI Questionnaire

5. Dimock EI Protocol

6. Dimock EI Sample Results Letter

7. Example of Prior EI Final Report

8. Dimock EI Research Determination

9. Dimock EI Letter of invitation to participate and fact sheet