[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68780-68782]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27835]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-13-13BF]


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 
and send comments to Ron Otten, at CDC 1600 Clifton Road, MS-D74, 
Atlanta, GA 30333 or send an email to omb@cdc.gov.
    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

    Spectrum of Flavoring Chemical-Related Lung Disease--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

[[Page 68781]]

and prevention. The Occupational Safety and Health Act, Public Law 91-
596 (section 20[a][1]), authorizes NIOSH to conduct research to advance 
the health and safety of workers. NIOSH is proposing to conduct a study 
characterizing the nature of restrictive lung disease occurring in 
flavoring and microwave popcorn workers.
    Preliminary evidence suggests that flavorings exposures may be 
associated with restrictive lung disease in exposed workers. In two 
previous NIOSH health hazard evaluations, we found excesses of 
restrictive spirometry among workers in a flavoring manufacturing plant 
and a flavoring-exposed food production plant. There was virtually no 
obstructive lung disease in either of these health hazard evaluations. 
Over the course of eight cross-sectional studies at a microwave popcorn 
plant, we also found strong relationships between decreases in FEV1 and 
cumulative exposure estimates, without differentiating between 
obstructive and restrictive abnormalities.
    NIOSH requests OMB approval to collect additional information on a 
subset of participants from previous NIOSH studies to determine if 
restrictive lung disease is occurring among flavoring and popcorn 
workers. Diagnostic methods for restrictive lung disease will be 
applied in field settings. This will include spirometry, lung volume 
testing such as total lung capacity (TLC) and diffusing capacity of the 
lung to carbon monoxide (DLCO), as well as high resolution computed 
tomography (HRCT), which can detect lung abnormalities consistent with 
interstitial lung disease. These medical tests are critical to 
establishing lung disease of a fibrotic or inflammatory nature in 
persons with spirometric restriction.
    Recent literature has demonstrated that bronchiolitis obliterans 
and obstructive lung disease are related to flavoring exposures in an 
exposure-dependent way. However, secondary prevention of further 
impairment among flavoring workers with spirometric restriction and 
excessive declines in lung function of a restrictive nature is not 
occurring. Flavoring workers with restrictive abnormalities are not 
identified as having possible occupational lung disease, are not 
removed from further flavorings exposure, are not counseled about 
respiratory protection and work practices, and are unlikely to be 
successful in claims for work-related lung disease and medical 
expenses. These cases of restrictive spirometric abnormality do not 
motivate employers to implement controls to prevent lung injury to co-
workers or to enhance medical surveillance programs.
    Results from this study will benefit many stakeholders, including 
physicians who can appropriately manage workers with restrictive lung 
disease with consideration of enhanced respiratory protection or 
reassignment; workers who can make decisions regarding continued 
exposures and apply for compensation if warranted; companies who can 
set data driven priorities for preventive interventions; and policy 
makers who can recommend measures to prevent flavoring-related lung 
diseases.
    For this study, we will recruit participants from two study 
populations: approximately 100 workers from a flavorings plant for whom 
we have spirometry data and 130 workers that had abnormal spirometry on 
any test from a previous NIOSH health hazard evaluation at a microwave 
popcorn plant. Thirty additional workers from the microwave popcorn 
plant who had normal spirometry on their last test also will be chosen 
at random.
    NIOSH anticipates that information collection will begin during the 
summer of 2013 for the microwave popcorn workers and for the flavorings 
workers in the summer of 2014. Both study populations will be offered a 
questionnaire, spirometry, TLC test, DLCO, and HRCT of the chest. Those 
with abnormal spirometry will also be offered a bronchodilator test. 
Testing is expected to take between 3 to 3.25 hours per respondent. All 
testing will be conducted by trained NIOSH personnel, except for the 
HRCT chest scan, which will be done at a local hospital or radiology 
clinic. Participants will receive a letter which will explain their 
testing results. All study results will be stored at NIOSH.
    The total estimated burden for the one-time collection of data is 
822 hours. This is an overestimate of the actual burden to account for 
any possible waiting at the radiology clinic. Participation in this 
study is voluntary, and there are no costs to respondents other than 
their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
      Type of respondents            Testing         Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)         hours
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Popcorn workers with normal     Questionnaire                 30               1            3                 90
 spirometry.                     Spirometry DLCO
                                 TLC HRCT.
Popcorn workers with abnormal   Questionnaire                130               1            3.25             423
 spirometry.                     Spirometry DLCO
                                 TLC HRCT
                                 Bronchodilator
                                 test.
Flavoring workers with normal   Questionnaire                 64               1            3                192
 spirometry.                     Spirometry DLCO
                                 TLC HRCT.
Flavoring workers with          Questionnaire                 36               1            3.25             117
 abnormal spirometry.            Spirometry DLCO
                                 TLC HRCT
                                 Bronchodilator
                                 test.
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............             822
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[[Page 68782]]

    Dated:November 2, 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. 2012-27835 Filed 11-15-12; 8:45 am]
BILLING CODE 4163-18-P