0923-0048 GenIC Submission Form

Generic Information Collection (GenIC) Submittal Form for

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

PROJECT TITLE: Supplemental Exposure Investigation at Select PFAS Exposure Assessment Sites

SITE LOCATION: Hampden County, MA and New Castle County, DE

REQUESTED BURDEN HOURS: 350

PROJECT SUMMARY

Principal Investigator(s):	Karen Scruton (ATSDR Headquarters) Peter Kowalski (ATSDR Headquarters) Elaine Hubal (EPA ORD) Kent Thomas (EPA ORD)
Technical Assistance:	Region 1 ATSDR Region 3 ATSDR Laboratory (TBD)
Source of Request (state, petition, etc.):	ATSDR EI will be conducted in collaboration with EPA ORD.
Project Goals:	From 2019 to 2020, CDC/ATSDR conduced eight statistically based biomonitoring exposure assessments (EAs) domestic military installations that have or have had documented exposures to Per- and Polyfluoroalkyl Substances (PFAS) in drinking water. The intention of the EAs was to determine how exposure to PFAS in drinking water in communities nearby the military installations may have impacted levels of PFAS in serum and urine. In addition to serum and urine testing, tap water and indoor dust were also sampled in a subset of homes. Exposure to PFAS can result from exposure to both drinking water and non-drinking water sources. Although there is information indicating additional sources of exposure to PFAS, information on the contribution of these sources to PFAS body burden levels is sparse. Under CERCLA, CDC/ATSDR and EPA are conducting this environmental sampling exposure investigation (EI) to identify potential non-drinking water contributors to PFAS body burdens at two PFAS EA communities. This EI will include sampling environmental media at the homes of a sub-set of EA participants who had agreed to future recontact. The EI will include the sampling of additional environmental media and the administration of appropriate consent forms and questionnaires to evaluate non-drinking water exposure to PFAS. The goals of this environmental sampling EI are to evaluate: Whether PFAS are detectable in various non-drinking water environmental media; If detectable, what the levels of PFAS in environmental media are; and Whether these detectable levels of PFAS may be associated with the existing measured body burden levels of PFAS identified during the EA.
Project Objectives:	This environmental sampling exposure investigation will recruit former EA participants at two locations: 80 households from the Hampden County, MA community and 40 households from the New Castle County, DE community, which represent approximately 30% of the EA households. The households will be sampled for additional environmental media to evaluate levels of PFAS in the various media. The prior EA serum PFAS results will be further evaluated with the results of the environmental sampling as well as the results of the questionnaires administered during both the EA and this environmental sampling EI. Participants will receive their household sampling results and an EI report will be prepared at each location and presented to the community in a public meeting.
Environmental Sampling to be Completed:	All households will be sampled for indoor dust (filtered sample) and will be administered a household and exposure questionnaire. In addition, 20 homes at each location will also be sampled for: indoor air, bulk dust (from a vacuum cleaner bag), indoor wipe samples, and soil. Personal exposure to PFAS will be evaluated by having one participant in each of the 20 households wear a silicone wristband. In addition, outdoor air samples will be taken at a central location within the community and samples of locally-grown produce will be collected and analyzed for PFAS.
Biological Sampling to be Completed:	None. The existing serum PFAS results from the prior EA, the current environmental EI sampling results, and the prior and current questionnaire responses will be evaluated.
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 Recruitment for the EI will be conducted in the summer of 2021 and will include: Sending a letter to former EA participants in MA and DE inviting them to participate. The EA participants agreed to allow the results of the biological (serum, urine) and environmental sampling (tap water, dust) along with the EA questionnaire to be used for future PFAS evaluation in the community. They also agreed to allow ATSDR to retain their contact information and contact them in the future for PFAS work within the community. There are 247 households in MA and 134 households in DE that will be sent an invitation letter. Participants are asked in the letter to call to make an appointment on a first-come-first-served basis: participation will be limited to 80 households in MA and 40 households in DE. Of the households to be sampled, 20 at each location will be identified for more robust sampling (indoor air, bulk dust, indoor wipes, soil, silicone wristbands) on a first-come-first serve basis; the remaining households will be have a filtered dust sample collected and all households will complete appropriate consent forms and questionnaires. Households will be sent an appointment verification letter which will include appropriate consent forms and questionnaires for former EA participants that live in the household. Sending the forms prior to the sampling will allow some participants to complete consents and questionnaires without being required to be at home for the environmental sampling. The EI participant who will be responding for the household will need to be present for the environmental sampling. Sampling On the day of the environmental sampling, the completeness of the consent forms and questionnaires will be verified, and sampling will be completed per the Sampling and Analysis Plan. Samples will be sent to an accredited laboratory for analysis and participants will be sent their sampling results. ATSDR will complete a location-specific EI report that will be presented to each community. Human Subject Determination The human subjects determination is provided in Attachment 8. The EI is not considered a research study; its primary intent is to provide or improve a public health program or service for the community. Analysis: The environmental samples will be analyzed by an accredited laboratory using state-of-art laboratory methods.
Information Collection Mode (in-person or remote):	In-person. EI consent forms and questionnaires will be provided to invited participants prior to the sampling. This will allow all former EA participants living in the household to be able to complete them and to be included in the EI. When the sampling is conducted at the participants’ homes, the consent and questionnaire forms will be evaluated for completeness. COVID precautions to be undertaken in the field are described in the Sampling and Analysis Plan.
Plans for Payment to Participant (if applicable):	ATSDR will provide incentives to participants in appreciation for the time it will take to allow ATSDR to conduct the environmental sampling. A gift card will be provided when the sampling is conducted: $20 per household per appointment. Those homes that have the additional sampling requiring two appointments will receive a total of $40 for participating.
Privacy Protections:	Privacy will be protected to the fullest extent allowable by law. The consent forms contain information about privacy protections.
Other Ethical Concerns/Issues:	None
Projected Time Frame:	The EI is expected to be conducted in the summer of 2021 and to be completed by September 30, 2021, the end of fiscal year 2021. The sampling effort at each location is expected to take approximately 2 weeks. The laboratory is expected to take 3 months to analyze the samples.
Plans for Publication and Dissemination of Results:	The participants will be provided their household results of the environmental sampling approximately 4-6 months after sample collection since the laboratory is expected to take 3 months to analyze the samples. The EI report will be prepared, cleared, and released to each community as soon as possible.
Burden Hours Requested:	351 hours – per the burden hours outlined in Supporting Statement A

List of Attachments:

Att1_PFAS Environmental Sampling EI SSA 0923-0048

Att2_PFAS Environmental Sampling EI SSB 0928-0048

Att3_STARS Determination Form

Att4_Example EI Report

Att5_PFAS Environmental Sampling EI Protocol Text

Att6_Apx A1_Household Recruitment Letter

Att7_Apx A2_Recruitment Scripts

Att8_Apx A3_Appointment Verification Letter

Att9_Apx B1_Privacy Act Statement

Att10_Apx B2_Adult Consent1 - Sampling and Questionnaire

Att11_Apx B3_Adult Consent2 Questionnaire only

Att12_Apx B4_Parental Permission Form

Att13_Apx B5_Assent Form

Att14_ApxC1_Household Questionnaire

Att15_ApxC2_Personal Exposure Questionnaire - Adult

Att16_ApxC3_Personal Exp Questionnaire - Child

Att17_ApxD_Sampling and Analysis Plan

Att18_Apx D1_PFAS Sampling Collection Form (Dust Only)

Att19_Apx D2_PFAS Sampling Collection Form (Robust Sampling)

Att20_Apx E _Health and Safety Plan

Att21_Apx F1_Results Letter- Dust only

Att22_ApxF2_Results Letter-Robust Sampling