80 FR 78234 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 241 (December 16, 2015)

[Federal Register Volume 80, Number 241 (Wednesday, December 16, 2015)]
[Notices]
[Pages 78234-78236]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-31581]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

Centers for Disease Control and Prevention

[30Day-16-0048]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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, 
Washington, DC 20503 or by fax to (202) 395-5806. Written comments 
should be received within 30 days of this notice.

Proposed Project

    ATSDR Exposure Investigations (EIs) (OMB Control No. 0923-0048, 
Expiration Date 5/31/2016)--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.

[[Page 78235]]

    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, three of the EIs that ATSDR conducted in 
the past three years include the Colorado Smelter (CO--blood lead and 
urine arsenic), ASARCO Hayden Smelter Site (AZ--blood lead and urine 
arsenic), and Decatur (AL--perfluorochemicals [PFCs] in serum).

Example 1: Colorado Smelter Blood Lead and Urine Arsenic Sampling, CO

    The site is a former smelter located in Pueblo, Colorado. Past 
sampling found elevated levels of lead and arsenic in residential soils 
and a slag pile associated with the smelter. ATSDR sampled blood lead 
levels (BLLs) in children and adults and found seven children that had 
BLLs near or exceeding the level of 5 micrograms per deciliter (mg/
dL)(a level identified by ATSDR as a level of concern for lead effects 
in children). One adult had an elevated level of arsenic in their 
urine. Speciation of the sample determined that it was primarily 
organic arsenic, probably resulting from eating seafood.
     The local health department conducted a Healthy Homes 
Inspection for these families having children with elevated BLLs and 
ATSDR recommended that the children follow up with their primary care 
provider.
     On June 10, 2014, the local health department obtained a 
six year grant from the EPA Region 8 to conduct health education, BLL 
screening, assist in the coordination of developmental and cognitive 
evaluations in affected children from a designated area of Pueblo, and 
conduct other public health actions/investigations as stipulated in the 
grant.
     On December 11, 2014, EPA listed the Colorado Smelter site 
on the National Priority List (NPL).

Example 2: ASARCO Hayden Smelter Site, AZ

    The community is located in the vicinity of the ASARCO Hayden 
Smelter, which has been operating for 100 years as a copper ore 
processer. The processing has resulted in lead and arsenic 
contamination in the surrounding residential area and in tailing piles 
used for recreation. Limited sampling of the community in the past 
found elevated BLLs and arsenic in urine. Based on community concerns, 
EPA requested that ATSDR conduct an EI to assess potential exposure of 
the community to lead and arsenic.
     In April, 2015, ATSDR collected 83 BLL and 58 urine 
arsenic samples from the community.
     Participants have been notified of their results and the 
EI report is being prepared.

Example 3: Perfluorochemical Serum Sampling, Decatur, AL

    Perfluorochemicals (PFC) are a class of organofluorine compounds 
that are used in a variety of industrial and consumer products 
including fire-fighting foams; personal care and cleaning products; and 
oil, stain, grease, and water repellent coatings. These coatings are 
used on carpet, textiles, leather, ``non-stick'' cookware, and paper 
wrappers used on fast food items. As a result, United States (U.S.) 
general population exposure to PFCs is common.
    In 2007, PFCs were released by a chemical manufacturer near 
Decatur, AL, and impacted environmental media in the area. In 2010, 
ATSDR conducted an EI to assess exposure of residents to PFCs in blood. 
PFCs were found in the serum of people that regularly used the public 
water system in the area as their primary drinking water source.
    Recommendations of the EI included continued monitoring for PFCs in 
the public water supply and continued biological PFC testing in the 
community to determine if PFCs in the community had been reduced.
    Based on the results of the 2010 EI, ATSDR is preparing to conduct 
another EI at the site in 2016 (approved by OMB on 8/10/2015), 
including biological sampling of serum and urine to:
     Compare individuals' current serum PFC concentrations with 
their 2010 serum PFC concentrations.
     Compare individuals' serum PFC concentrations to the 
national population reference values (NHANES 2011-2012).
     Calculate the biological half-life for each PFC species 
using paired blood and urine PFC concentrations to improve the 
understanding of the pharmacokinetic behavior of these compounds in 
humans.
     Evaluate the potential existence of non-drinking water PFC 
exposure pathways through physiologically-based pharmacokinetic (PBPK) 
modeling.
    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
----------------------------------------------------------------------------------------------------------------
                                                                                   Number of     Average  burden
         Type of respondents                 Form name            Number of      responses per    per  response
                                                                 respondents       respondent       (in hrs.)
----------------------------------------------------------------------------------------------------------------
Exposure Investigation Participants.  Chemical Exposure                 1,200                1            30/60
                                       Questions.
----------------------------------------------------------------------------------------------------------------



[[Page 78236]]

Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific 
Integrity, Office of the Associate Director for Science, Office of the 
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-31581 Filed 12-15-15; 8:45 am]
BILLING CODE 4163-18-P