[Federal Register Volume 80, Number 65 (Monday, April 6, 2015)]
[Notices]
[Pages 18427-18429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07814]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Docket Number CDC-2015-0008; NIOSH-282]


International Labour Office (ILO) Reference Radiographs

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Request for information and comment.

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

SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease and Prevention is collaborating with 
the Labour Inspection, Labour Administration and Occupational Safety 
and Health Branch of the International Labour Office (ILO) in 
developing a set of digital reference radiographs for the ILO 
International Classification of Radiographs of Pneumoconiosis (ILO 
Classification). The current ILO Classification depends on 22 standard 
reference radiographs that are used to formally identify and 
characterize pneumoconiosis and related pulmonary abnormalities arising 
from occupational exposure. The original standards were based on film 
radiography, but the advent of digital radiography has led to the need 
for reference standards based on digitally-acquired images. NIOSH is 
assisting the ILO in the process of identifying such digital images.
    For this purpose, NIOSH is requesting trained users of the ILO 
Classification (e.g., NIOSH B-Readers [1] and other such experts) to 
submit comments regarding any of the current standard reference images 
that are felt to be deficient and for which improvements could be made. 
The current structure and format of the ILO Classification is to remain 
unchanged at the present time. NIOSH is not soliciting comments on the 
ILO Classification itself. Comments received on the ILO Classification 
will be considered irrelevant to the purpose of this docket.

DATES: Electronic or written comments must be received by June 5, 2015.

ADDRESSES: You may submit comments, identified by CDC-2015-0008 and 
docket number NIOSH-282, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: National Institute for Occupational Safety and 
Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, 
OH 45226-1998.
    Instructions: All information received in response to this notice 
must include the agency name and docket number (CDC-2015-0008; NIOSH-
282). All relevant comments received will be posted without change to 
www.regulations.gov, including any personal information provided. All 
electronic comments should be formatted as Microsoft Word. For access 
to the docket to read background documents or comments received, go to 
www.regulations.gov. All information received in response to this 
notice will also be available for public examination and copying at the 
NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 
45226.

FOR FURTHER INFORMATION CONTACT: Michael Attfield, 1095 Willowdale 
Road, Morgantown, WV 26505-2888, telephone (304) 285-5737 (this is not 
a toll free number).

SUPPLEMENTARY INFORMATION:

Table of Contents

 Background
 Information Needs
 References
    Background: Chest radiographs (X-Rays) provide critical medical 
information for the assessment of the pneumoconioses and related 
disorders in individuals, for example, those caused by inhaling coal, 
silica, and asbestos dusts [2]. Prior to 1950, the information evident 
on a radiograph could only be interpreted qualitatively. However in 
1950, the International Labour Office (ILO) established a more 
quantitative system whereby the various parenchymal and pleural changes 
could be formally recognized and categorized.

[[Page 18428]]

The quantitative system is not intended for the medical diagnosis of 
the pneumoconioses and related occupational diseases, but has proved 
invaluable for the accurate and reliable identification and 
characterization of such diseases and disorders in many scientific and 
administrative applications, including research into disease causation, 
evaluation of risk in terms of dust exposure, disease surveillance, 
disease prevention, and worker compensation. The ILO has periodically 
held meetings of experts with the intent of improving and refining the 
original classification scheme. The current edition is the 
International Classification of Radiographs of Pneumoconiosis, Revised 
Edition 2011 [3].
    The ILO Classification, as of the 2000 revision, consists of 22 
standard reference radiographic films. These films were selected to 
demonstrate a variety of types and severities of lung abnormalities 
that frequently arise from occupational dust exposure. Proper use of 
the classification involves a visual comparison of the test subject's 
X-Ray film side-by-side with the standards. The test subject is 
assigned the classification pertaining to the standard radiograph or 
radiographs to which it is most similar in appearance, i.e., Category 
0/0, 1/1, 2/2, or 3/3; and the types p/p, q/q, r/r, s/s, t/t, or u/u, 
where applicable. The person undertaking the classification, typically 
a physician formally trained in the use of the ILO Classification, 
completes a data entry sheet where they record their classifications of 
each of the various abnormalities. In addition, ancillary information 
on the quality of the radiograph and the presence of other medical 
findings is noted.
    The ILO classification was developed and used for over 50 years 
solely in conjunction with film radiography. In recent years 
radiographic technology has advanced to digital imaging. This poses 
severe problems for the use of the ILO Classification since the test 
subject's image must be viewed on a computer terminal screen while the 
standards can only be seen on a separate film viewing box. This results 
in the process being extremely cumbersome, while intrinsic differences 
in the appearance of film versus digital images interfere with the 
proper assessment of abnormality. To minimize these problems, the ILO 
released a set of digitized images in 2011. These images are digitized 
views of the existing film images, obtained by formally scanning each 
film to a digital file image.
    While digitizing the current standard reference films removed the 
need to employ a light box, as both images could now be viewed on the 
same computerized image display system alongside that showing the 
subject's radiograph, it did not eliminate the problems arising from 
different inherent appearances between the original film and the 
digital test images, since those still remained in the digitized 
versions. Ultimately, the best means to remove the potentially 
interfering visual differences from the comparison between the 
digitally-acquired chest radiographic image and the reference image is 
to select new digitally-acquired reference images.
    NIOSH is collaborating with and assisting the ILO in identifying a 
set of 22 digital images, each of which is intended to mimic as closely 
as possible the type and severity of abnormality evident on each of the 
current standard films/digitized images. There is no intention to 
modify or alter the underlying structure or format of the existing ILO 
Classification. The final outcome of this exercise will simply be an 
additional set of standard reference images, derived from digitally-
acquired images.
    In pursuing this objective both NIOSH and the ILO are aware that 
users of the classification may feel that one or more of the existing 
standard references do not optimally demonstrate the specified 
parenchymal or pleural findings. Appendix C of the manual that 
accompanies the ILO Classification [2] provides comments on each of the 
current standard radiographs. Comments range from issues of quality 
(e.g., unsharp, overexposed), excluded regions (e.g., costrophenic 
angles), and other factors. In addition, there is no category 1/1 s/s 
standard as there should be. Instead a 1/1 s/t is used. Moreover, only 
single quadrant views are available for all of the u/u type small 
opacity severities when individual full chest image standards would be 
better. To the extent possible, it is hoped to correct these known 
issues during the identification of new digital images.
    In addition to the published issues, regular users of the ILO 
Classification may feel that certain of the standard reference 
radiographs are sub-optimal in some way or another. For example, 
perhaps the appearances of a particular standard are generally felt to 
be at variance with its formally-designated degree of abnormality. In 
addition, there may be other factors where there are opportunities for 
improvement.
    NIOSH and the ILO, in selecting the new digital standard images, 
wish to correct any technical issues affecting the current standard 
reference radiographs. To be able to do this, they require access to 
information on perceived problems with the current standards. This 
docket is a request for information from interested parties on 
perceived issues with any of the current standards. This request in no 
way involves comment on the structure and content of the ILO 
Classification per se. NIOSH and the ILO will summarize the comments 
received on each of the standard radiographs, and employ that 
information in the derivation of the new digital standard reference 
radiographs.
    Information Needs: NIOSH is seeking additional data and information 
to ensure that generally perceived technical issues affecting any of 
the current ILO Classification standard radiographs are addressed in 
the development of a set of digital standard radiographs. Information 
is particularly needed for:
    (1) The standard reference title to which your submitted comments 
apply. For small opacities please state `small opacities' and the 
profusion (0/0, 1/1, 2/2, or 3/3, and the type (p/p, q/q, r/r, s/s, t/
t, or u/u, where applicable) for which you are supplying comments. For 
large opacities please state `large opacities' and the stage (A, B, C). 
For pleural abnormalities, please state `pleural'.
    (2) For radiographs concerning small opacities, please note whether 
the standard radiograph shows appearances consistent with its 
designated profusion, and if not, what profusion you believe it shows.
    (3) For radiographs concerning small opacities, please note whether 
the standard radiograph shows appearances consistent with its 
designated type, and if not, what type you believe it shows.
    (4) For large opacities, please note whether the standard 
radiograph shows appearances consistent with its designated stage, and 
if not, what stage you believe it shows.
    (5) For the composite radiograph showing pleural abnormalities, 
please note your concerns with each segment.
    (6) For all, please note any problems associated with other factors 
that impact its optimal reliability as a standard, indicate their 
effect on classification, and suggest a solution for improvement.

References

1. NIOSH [2012]. Chest Radiography: The NIOSH B Reader Program. http://www.cdc.gov/niosh/topics/chestradiography/breader.html.
2. NIOSH [2011]. Chest Radiography: Evaluating Occupational Lung 
Disorders. http://www.cdc.gov/niosh/topics/chestradiography/default.html.

[[Page 18429]]

3. ILO [2011]. The ILO International Classification of Radiographs of 
Pneumoconioses. http://www.ilo.org/safework/info/WCMS_108548/lang_en/
index.htm.

    Dated: March 30, 2015.
John Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2015-07814 Filed 4-3-15; 8:45 am]
BILLING CODE 4163-19-P