Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Agency for Toxic Substances and Disease Registry (ATSDR) has submitted the information collection request titled ATSDR Exposure Investigations (EIs) to the Office of Management and Budget (OMB) for review and approval. ATSDR previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on November 6, 2018 to obtain comments from the public and affected agencies. ATSDR did not receive comments related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

ATSDR will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) 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;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) 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 submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide written comments within 30 days of notice publication.

Proposed Project

ATSDR Exposure Investigations (EIs), (OMB Control No. 0923-0048, Expiration Date 3/31/2019)—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 Paperwork Reduction Act approval for the extension of the generic clearance titled ATSDR Exposure Investigations (OMB No. 0923-0048; OMB Exp. Date: 3/31/2019) 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, four of the EIs that ATSDR conducted in the past three years include the Anaconda Smelter (MT—blood lead and urine arsenic), Former United Zinc and Associated Smelters (KS—blood lead), Dimock Private Well Water Sampling (PA) and the Follow-up Arsenic Urine Testing in Hayden, Arizona.

Example 1: Anaconda Smelter Blood Lead and Urine Arsenic Sampling, MT

The site is a former smelter located in Anaconda, Montana. Past smelting activities resulted in high levels of heavy metals, primarily arsenic and lead, in community soil and in the slag piles. ATSDR sampled blood and urine in 191 community members to evaluate lead (blood) and arsenic (urine) in September 2018. Given community concern about contamination, all members of the community were invited to participate in the testing. Given community interest in the testing, an additional round of testing (177 participants) was completed in November 2018 that focused on residents that were not tested in the September event as well as young children and women of childbearing age, since they are the most impacted by lead exposure.

Urine samples were evaluated for total arsenic, speciated arsenic (organic and inorganic), creatinine and specific gravity. If arsenic is detected, speciation of the sample will determined whether the arsenic is organic (probably resulting from eating seafood) or inorganic (likely resulting from exposure to environmental arsenic). The results of the testing are currently being analyzed by the National Center for Environmental Health/Division of Laboratory Sciences (NCEH/DLS). For the initial testing event, participants have been notified of their results by mail; two adult participants with blood lead levels ≥5 µg/dL were also notified of their results by phone by the EI Medical Officer. Results for the follow-up testing will be sent individually to participants when the analysis is completed and a report will be prepared and presented to the community in a community meeting.

Example 2: Former United Zinc and Associated Smelters, Iola, Kansas

The community is located in the vicinity of the Former United Zinc and Associated Smelters in Iola, Kansas. The smelters operated from 1902 to 1925 and operations resulted in heavy metal contamination in community soils. Limited sampling of the community in the past found elevated blood lead levels (BLLs) in young children. The blood testing was completed in two phases: One in December of 2016 and one in August 2017 and a total of 61 participants were tested: 24 children younger than 6 years, 17 children aged 6-19 years and 20 adult women. One child younger than six years had a BLL greater than five micrograms of lead per deciliter of blood (µg/dL). The child's parents were notified by phone of the results by the ATSDR Medical Officer and follow-up was conducted by the local PEHSU (Pediatric Environmental Health Specialty Unit.

All participants received their results by mail and the EI report was released and presented to the community in a public meeting in August 2018.

Example 3: Private Well Water Sampling in Dimock, PA

Unconventional natural gas drilling activities have been conducted in the Dimock, PA area for approximately 10 years and local residents complain of poor water quality. In 2012, EPA sampled 64 private wells in the area for contaminants that may be present due to natural gas drilling activities. ATSDR assisted in the analysis of the 2012 data set and the following recommendations were made:

○ People with elevated levels of inorganic analytes in their well water should install a home treatment system, and

○ people with high levels of methane in their well water should vent their well and home and treat their water to eliminate potential buildup of explosive gases.

Additional water sampling was recommended and an EI was conducted in August 2017. For the EI, the 64 residents previously sampled were invited to have their private wells retested: 25 residences agreed participate in the EI sampling. Residents were provided the results of their sampling and an EI report is currently being prepared. It will be presented to the community in a public meeting when completed.

Example 4: Follow-Up Arsenic Urine Testing in Hayden, Arizona

ATSDR completed an EI in 2015 at the ASARCO Hayden Smelter Site in Hayden, AZ. The EI included blood lead and urine arsenic testing. Air monitoring determined that the smelter was not operating during the sample collection period and that, given the short half-life of arsenic in the body, the arsenic results may not be valid.

In 2017, ATSDR retested the participants from the 2015 EI to evaluate their urinary arsenic levels. It was determined that all urinary arsenic levels were below the follow-up level and air data indicate that air arsenic levels in the two weeks prior to testing were consistent with usual levels seen in the community. The EI report is being prepared and a community meeting will be held when the document is released.

All of ATSDR's targeted biological assessments (e.g., urine, blood) and some of the environmental investigations (e.g., air, water, soil, 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. 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.