[Federal Register Volume 78, Number 47 (Monday, March 11, 2013)]
[Notices]
[Pages 15366-15367]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05520]


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

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 omb@cdc.gov. 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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondents                   Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Nanomaterials Workers.................  Questionnaire...........              33               1           22/60
Nanomaterials Workers.................  Informed Consent........              33               1           20/60
----------------------------------------------------------------------------------------------------------------


    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]
BILLING CODE 4163-18-P