Proposed Data Collection Submitted for Public Comment and Recommendations

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

3. Enhance the quality, utility, and clarity of the information to be collected;

4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Proposed Project

ATSDR Exposure Investigations (EIs) (OMB Control No. 0923-0048, Exp. 6/30/2025)—Extension—Agency for Toxic Substances and Disease Registry (ATSDR).

Background and Brief Description

The Agency for Toxic Substances and Disease Registry (ATSDR) is requesting a three-year Extension of this Generic Clearance to allow the agency to conduct Exposure Investigations (EIs), through methods developed by ATSDR. After a chemical release or suspected release into the environment, EIs are usually requested by officials of a state health agency, county health departments, the Environmental Protection Agency (EPA), the general public, and ATSDR staff.

EI results are used by public health professionals, environmental risk managers, and other decision makers to determine if current conditions warrant intervention strategies to minimize or eliminate human exposure. For example, an EI that ATSDR previously conducted during included environmental sampling to evaluate non-drinking water exposure to per- and polyfluoroalkyl substances (PFAS) in two communities that were shown to be exposed to PFAS in their drinking water.

During the most recent clearance period (4/30/2022-present) a single Generic Exposure Investigation information collection request (ICR) was submitted. The EI conducted under this clearance period was an EI in Jasper and Newton Counties, Missouri to evaluate exposure to lead in a former mining community. ATSDR collected blood samples from community members most vulnerable to the impacts of lead exposure: children five years old and younger along with pregnant women and women of childbearing age. ATSDR partnered with the U.S. Environmental Protection Agency (EPA) and the Missouri Department of Health and Senior Services (MDHSS) who collected environmental samples, including soil, dust wipes, drinking water and paint, along with the results of the blood sampling. Appropriate EI procedures, including use of consent forms and questionnaires were used in the EI. The environmental sampling was submitted under this OMB Control Number with a burden of 426 hours.

All of ATSDR's targeted biological assessments ( e.g., urine, blood) and some of the environmental investigations ( e.g., air, water, soil, dust, or food sampling) involve participants to determine whether they are or have been exposed to unusual levels of pollutants at specific locations ( e.g., where people live, spend leisure time, or anywhere they might come into contact with contaminants under investigation). Questionnaires, appropriate to the specific contaminant, are generally needed in about half of the EIs (at most approximately 12 per year) to assist in interpreting the biological or environmental sampling results. ATSDR collects contact information ( e.g., name, address, phone number) to provide the participant with their individual results. ATSDR also collects information on other possible confounding sources of chemical(s) exposure such as medicines taken, foods eaten, hobbies, jobs, etc. In addition, ATSDR asks questions on recreational or occupational activities that could increase a participant's exposure potential. That information represents an individual's exposure history.

The number of questions can vary depending on the number of chemicals being investigated, the route of exposure ( e.g., breathing, eating, touching), and number of other sources of the chemical(s) ( e.g., products used, jobs). We use approximately 12-20 questions about the pertinent environmental exposures per investigation. A question bank is available for health assessors to use as a basis of questions to be asked during the EI, but EI-specific questions may be included as appropriate. Typically, the number of participants in an individual EI ranges from 10 to 100. Participation is completely voluntary, and there are no costs to participants other than their time. Based on a maximum of 12 EIs per year and 100 participants each, the estimated annualized burden hours are 600.