[Federal Register Volume 77, Number 183 (Thursday, September 20, 2012)]
[Notices]
[Pages 58396-58397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23194]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-12-12RS]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-7570 or
send comments to Kimberly S. Lane, at 1600 Clifton Road, MS-D74,
Atlanta, GA 30333 or send an email to [email protected].
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; and (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. Written comments should be received
within 60 days of this notice.
Proposed Project
Exposure Assessment and Epidemiological Study of U.S. Workers
Exposed to Carbon Nanotubes and Carbon Nanofibers--New--National
Institute for Occupational Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The mission of the National Institute for Occupational Safety and
Health (NIOSH) is to promote safety and health at work for all people
through research and prevention. The Occupational Safety and Health Act
of 1970, Public Law 91-596 (Section 20[a][1] authorizes NIOSH to
conduct research to advance the health and safety of workers. In this
capacity, NIOSH will conduct an exposure assessment and epidemiological
study of U.S. carbon nanotube (CNT) and carbon nanofiber (CNF) workers.
At present, because of the newness of the technology, much of the
occupational exposure to engineered nanomaterials occurs at the
research and development (R&D) or pilot scale. There have been few
reliable surveys of the size of the workforce exposed to nanomaterials.
Health effects from exposure to nanomaterials are uncertain, but may be
more severe than from larger-sized particles of the same material. This
is due to the small size, high surface area per unit mass (i.e.,
specific surface area) or (in some cases) high aspect ratio of
nanomaterials. Carbon nanotubes and nanofibers are among the
nanomaterials of greatest interest from a public health perspective
because of their potentially asbestiform properties (e.g., high aspect
ratio) and toxicological evidence of possible fibrogenic, inflammatory,
and clastogenic damage resulting from exposures at occupationally
relevant levels. In addition, the useful properties of CNT and CNF have
rendered them among the first nanomaterials to be commercially
exploited in manufacturing settings. Thus, an epidemiologic study to
determine whether early or late health effects occur from occupational
exposure to CNT and CNF is warranted.
The proposed research is a cross-sectional study of the small
current U.S. workforce involved with CNT and CNF in manufacturing and
distribution, to be conducted in the following phases: 1) Industrywide
exposure assessment study to evaluate worker exposure and further
develop and refine measurement methods for CNT and CNF. This component
will refine sampling and analysis protocols previously developed for
the detection and quantification of CNT and CNF in US workplaces. 2) A
cross-sectional study relating the best metrics of CNT and CNF exposure
to markers of early pulmonary or cardiovascular health effects. After
the sampling and analysis protocols have been established to measure
CNT and CNF, an industrywide study of the association between exposure
and health effects will be conducted. Medical examinations will be
conducted and several biomarkers of early effect (for pulmonary
fibrosis, cardiovascular disease, and genetic damage) will be measured
in blood and sputum for workers exposed to a range of CNT and CNF
levels.
The study will include a questionnaire with a three-fold purpose:
(1) To determine whether study participants have any contraindications
for certain medical procedures to be conducted (spirometry and sputum
induction), (2) to assist in interpretation of the biomarker results,
and (3) to inquire about current and past exposure to CNT, CNF, and
other chemicals, dusts, and fumes. The questionnaire will be given by
NIOSH personnel as a computer-assisted personal interview (CAPI). After
administration of the CAPI, medical examinations will be conducted to
evaluate pulmonary function (via spirometry) and blood pressure, and
sputum and blood will be collected. Statistical analyses will be
conducted to determine the nature of the relation between exposure to
CNT
[[Page 58397]]
and CNF and these biomarkers of early effect, considering potential
confounding factors such as smoking, age, gender, and workplace co-
exposures, including non-engineered ultrafine particles.
The proposed project supports the NIOSH legislatively mandated
industrywide studies program that conducts epidemiological and exposure
assessment research studies to identify the occupational causes of
disease in the working population and their offspring and to
effectively communicate study results to workers, scientists, industry,
and the public.
The questionnaire will be administered one time only, at the
worksite, to 100 workers involved in the production and use of CNT or
CNT. The study will be carried out during the participants' regular
work shift. There is no cost to respondents or their employers other
than their time. We estimate that the average burden per response to be
22 minutes, and that the total burden to all respondents will be 37
hours (see table below).
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Respondents respondents responses per response (in (in hours)
respondent hours)
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Nanomaterials Workers........................... 100 1 22/60 37
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Total....................................... .............. .............. .............. 37
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Dated: September 14, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate
Director for Science (OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2012-23194 Filed 9-19-12; 8:45 am]
BILLING CODE 4163-18-P