[Federal Register Volume 78, Number 47 (Monday, March 11, 2013)]
[Notices]
[Pages 15366-15367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05520]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-12RS]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to [email protected]. Send written comments
to 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
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
[[Page 15367]]
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 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, over a three-year period. 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 for the questionnaire and 20
minutes for the consent form. There are no costs to respondents other
than their time. The total estimated annual burden hours are 23.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondents Form name respondents responses per response (in
respondent hours)
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Nanomaterials Workers................. Questionnaire........... 33 1 22/60
Nanomaterials Workers................. Informed Consent........ 33 1 20/60
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Dated: February 28, 2013.
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. 2013-05520 Filed 3-8-13; 8:45 am]
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