[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3454-3455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[30Day-19-0048]


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 [email protected]. 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 
[micro]g/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

[[Page 3455]]

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 ([micro]g/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:
    [cir] People with elevated levels of inorganic analytes in their 
well water should install a home treatment system, and
    [cir] 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.

                                        Estimated Annualized Burden Hours
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                                                                                     Number of    Average burden
        Type of respondents                   Form name              Number of     responses per   per response
                                                                    respondents     respondent       (in hrs.)
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Exposure Investigation Participants  Chemical Exposure Questions           1,200               1           30/60
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Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2019-01993 Filed 2-11-19; 8:45 am]
 BILLING CODE 4163-18-P