[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Notices]
[Pages 55543-55545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24234]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substance and Disease Registry

[60Day-19-0048; Docket No. ATSDR-2018-0009]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substance and Disease Registry, Department of 
Health and Human Services (HHS)

ACTION: Notice with comment period.

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SUMMARY: The Agency for Toxic Substance and Disease Registry, as part 
of its continuing effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ATSDR Exposure Investigations 
(EIs) (OMB Control No. 0923-0048, Expiration Date 3/31/2019)--
Extension--Agency for Toxic Substances and Disease Registry (ATSDR). To 
evaluate public health issues at a site resulting from environmental 
exposure, ATSDR EIs fill data gaps by conducting environmental and 
biological sampling.

DATES: CDC must receive written comments on or before January 7, 2019.

[[Page 55544]]


ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2018-0009 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE, MS-D74, Atlanta, Georgia 30329.
    Instructions: All submissions received must include the agency name 
and Docket Number. CDC will post, without change, all relevant comments 
to Regulations.gov.
    Please note: Submit all comments through the Federal eRulemaking 
portal (regulations.gov) or by U.S. mail to the address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact Jeffrey M. Zirger, Information Collection 
Review Office, Centers for Disease Control and Prevention, 1600 Clifton 
Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: 
[email protected].

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; and
    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.
    5. Assess information collection costs.

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 
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 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 community members to evaluate lead (blood) 
and arsenic (urine). Given community concern about contamination, all 
members of the community were invited to participate in the testing.
    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). 
Results 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 Blood Lead 
Testing, 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 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 6 years had a BLL greater than 5 [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, Pennsylvania

    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.

[[Page 55545]]

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 2 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.
    Additional water sampling was recommended and an EI was conducted 
in August in 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.
    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    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
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Exposure Investigation          Chemical                   1,200               1           30/60             600
 Participants.                   Exposure
                                 Questions.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             600
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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. 2018-24234 Filed 11-5-18; 8:45 am]
 BILLING CODE 4163-18-P