80 FR 58735 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 189 (September 30, 2015)

Page Range		58735-58736
FR Document		2015-24719

The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed extension of the information collection entitled ``ATSDR Exposure Investigations (EIs)'' (OMB Control No. 0923-0048, Expiration Date 5/ 31/2016). EIs are used by ATSDR as part of its Public Health Assessment (PHA) process to identify whether exposure to contaminants have occurred in communities and to make recommendations for how to lower or eliminate exposure.

Federal Register, Volume 80 Issue 189 (Wednesday, September 30, 2015)

[Federal Register Volume 80, Number 189 (Wednesday, September 30, 2015)]
[Notices]
[Pages 58735-58736]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-24719]



[[Page 58735]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[60Day-15-0048; Docket No. ATSDR-2015-0006]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Centers for Disease Control and Prevention (CDC), Department of Health 
and Human Services (HHS)

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
as part of its continuing efforts to reduce public burden and maximize 
the utility of government information, invites the general public and 
other Federal agencies to take this opportunity to comment on proposed 
and/or continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
extension of the information collection entitled ``ATSDR Exposure 
Investigations (EIs)'' (OMB Control No. 0923-0048, Expiration Date 5/
31/2016). EIs are used by ATSDR as part of its Public Health Assessment 
(PHA) process to identify whether exposure to contaminants have 
occurred in communities and to make recommendations for how to lower or 
eliminate exposure.

DATES: Written comments must be received on or before November 30, 
2015.

ADDRESSES: You may submit comments, identified by Docket No. ATSDR-
2015-0006 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted 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 the 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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to a collection of 
information, to search data sources, to complete and review the 
collection of information; and to transmit or otherwise disclose the 
information.

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.
    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

[[Page 58736]]

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
                                                            Number of     responses    burden per   Total burden
        Type of respondents               Form name        respondents       per      response (in    (in hrs.)
                                                                         respondent       hrs.)
----------------------------------------------------------------------------------------------------------------
Exposure Investigation              Chemical Exposure            1,200             1         30/60           600
 Participants.                       Questions.
                                                         -------------------------------------------------------
    Total.........................  ....................  ............  ............  ............           600
----------------------------------------------------------------------------------------------------------------


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. 2015-24719 Filed 9-29-15; 8:45 am]
 BILLING CODE 4163-18-P

58736 Federal Register / Vol. 80, No. 189 / Wednesday, September 30, 2015 / Notices

children from a designated area of population exposure to PFCs is determine whether they are or have
Pueblo, and conduct other public health common. been exposed to unusual levels of
actions/investigations as stipulated in In 2007, PFCs were released by a pollutants at specific locations (e.g.,
the grant. chemical manufacturer near Decatur, where people live, spend leisure time,
• On December 11, 2014, EPA listed AL, and impacted environmental media or anywhere they might come into
the Colorado Smelter site on the in the area. In 2010, ATSDR conducted contact with contaminants under
National Priority List (NPL). an EI to assess exposure of residents to investigation).
PFCs in blood. PFCs were found in the Questionnaires, appropriate to the
Example 2: ASARCO Hayden Smelter
serum of people that regularly used the specific contaminant, are generally
Site, AZ
public water system in the area as their needed in about half of the EIs (at most
The community is located in the primary drinking water source. approximately 12 per year) to assist in
vicinity of the ASARCO Hayden Recommendations of the EI included interpreting the biological or
Smelter, which has been operating for continued monitoring for PFCs in the environmental sampling results. ATSDR
100 years as a copper ore processer. The public water supply and continued collects contact information (e.g., name,
processing has resulted in lead and biological PFC testing in the community address, phone number) to provide the
arsenic contamination in the to determine if PFCs in the community participant with their individual results.
surrounding residential area and in had been reduced. ATSDR also collects information on
tailing piles used for recreation. Limited Based on the results of the 2010 EI, other possible confounding sources of
sampling of the community in the past ATSDR is preparing to conduct another chemical(s) exposure such as medicines
found elevated BLLs and arsenic in EI at the site in 2016 (approved by OMB taken, foods eaten, hobbies, jobs, etc. In
urine. Based on community concerns, on 8/10/2015), including biological addition, ATSDR asks questions on
EPA requested that ATSDR conduct an sampling of serum and urine to: recreational or occupational activities
EI to assess potential exposure of the • Compare individuals’ current serum that could increase a participant’s
community to lead and arsenic. PFC concentrations with their 2010 exposure potential. That information
• In April, 2015, ATSDR collected 83 serum PFC concentrations. represents an individual’s exposure
BLL and 58 urine arsenic samples from • Compare individuals’ serum PFC
history.
the community. concentrations to the national
• Participants have been notified of population reference values (NHANES The number of questions can vary
their results and the EI report is being 2011–2012). depending on the number of chemicals
prepared. • Calculate the biological half-life for being investigated, the route of exposure
each PFC species using paired blood (e.g., breathing, eating, touching), and
Example 3: Perfluorochemical Serum and urine PFC concentrations to number of other sources of the
Sampling, Decatur, AL improve the understanding of the chemical(s) (e.g., products used, jobs).
Perfluorochemicals (PFC) are a class pharmacokinetic behavior of these We use approximately 12–20 questions
of organofluorine compounds that are compounds in humans. about the pertinent environmental
used in a variety of industrial and • Evaluate the potential existence of exposures per investigation.
consumer products including fire- non-drinking water PFC exposure Typically, the number of participants
fighting foams; personal care and pathways through physiologically-based in an individual EI ranges from 10 to
cleaning products; and oil, stain, grease, pharmacokinetic (PBPK) modeling. 100. Participation is completely
and water repellent coatings. These All of ATSDR’s targeted biological voluntary, and there are no costs to
coatings are used on carpet, textiles, assessments (e.g., urine, blood) and participants other than their time. Based
leather, ‘‘non-stick’’ cookware, and some of the environmental on a maximum of 12 EIs per year and
paper wrappers used on fast food items. investigations (e.g., air, water, soil, or 100 participants each, the estimated
As a result, United States (U.S.) general food sampling) involve participants to annualized burden hours are 600.

ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per Total burden
Type of respondents Form name respondents per response (in hrs.)
respondent (in hrs.)

Exposure Investigation Participants .............. Chemical Exposure Questions ..... 1,200 1 30/60 600

Total ....................................................... ....................................................... ...................... ...................... ...................... 600

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
mstockstill on DSK4VPTVN1PROD with NOTICES

Prevention.
[FR Doc. 2015–24719 Filed 9–29–15; 8:45 am]
BILLING CODE 4163–18–P

VerDate Sep<11>2014 18:27 Sep 29, 2015 Jkt 235001 PO 00000 Frm 00035 Fmt 4703 Sfmt 9990 E:\FR\FM\30SEN1.SGM 30SEN1

Document Created: 2015-12-15 09:31:39
Document Modified: 2015-12-15 09:31:39

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice with comment period.
Dates		Written comments must be received on or before November 30, 2015.
Contact		To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the 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]
FR Citation		80 FR 58735

80 FR 58735 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Toxic Substances and Disease Registry

Federal Register Volume 80, Issue 189 (September 30, 2015)

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