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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 37

[Docket No. CDC-2011-0013; NIOSH-225]

RIN 0920-AA21

Specifications for Medical Examinations of Underground Coal Miners

AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
ACTION: Final rule.
SUMMARY: This final rule modifies the Department of Health and Human Services (HHS) regulations for medical examinations of underground coal miners. Existing regulations established specifications for providing, interpreting, classifying, and submitting film-based roentgenograms (now commonly called chest radiographs or X-rays) of underground coal miners. The revised standards modify the requirements to permit the use of film-based radiography systems and add a parallel set of standards permitting the use of digital radiography systems. An additional amendment requires coal mine operators to provide the National Institute for Occupational Safety and Health (NIOSH) with employee rosters to assist the Coal Workers' Health Surveillance Program in improving participation by miners.
DATES: This final rule is effective October 15, 2012. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 15, 2012.
FOR FURTHER INFORMATION CONTACT: Anita Wolfe, Public Health Analyst, Division of Respiratory Disease Studies, National Institute for Occupational Safety and Health, 1095 Willowdale Road, MS B208, Morgantown, WV 26505, Telephone (888) 480-4042 (this is a toll-free number). Information requests can also be submitted by email tocwhsp@cdc.gov.
SUPPLEMENTARY INFORMATION:

The preamble to this notice of final rulemaking is organized as follows:

Table of Contents I. Public Participation II. Background A. Scope of Rulemaking B. Impact of Rulemaking III. Summary of Final Rule and Response to Public Comments A. Subpart—Chest Radiographic Examinations B. Subpart—Autopsies IV. Regulatory Assessment Requirements A. Executive Orders 12866 and 13563 B. Regulatory Flexibility Act C. Paperwork Reduction Act D. Small Business Regulatory Enforcement Fairness Act E. Unfunded Mandates Reform Act of 1995 F. Executive Order 12988 (Civil Justice) G. Executive Order 13132 (Federalism) H. Executive Order 13045 (Protection of Children From Environmental Health Risks and Safety Risks) I. Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) J. Plain Writing Act of 2010 V. Final Rule I. Public Participation

HHS received comments from 11 individuals and organizations. Four of the commenters are B Readers; two are West Virginia physicians; one is a private citizen; and one is a U.S. Senator. Comments were also submitted on behalf of the National Council on Radiation Protection and Measurements (NCRP), the American Society of Radiologic Technologists, and a law firm representing two coal companies and the West Virginia Coal Workers' Pneumoconiosis Fund.

II. Background

All mining work generates fine particles of dust in the air. Coal miners who inhale excessive dust are known to develop a group of diseases of the lungs and airways, including chronic bronchitis, emphysema, chronic obstructive pulmonary disease, silicosis, and coal workers' pneumoconiosis (CWP).1 To address such threats to the U.S. coal mining workforce, the Coal Mine Health and Safety Act was enacted in 1969 (Pub. L. 91-173) and amended by the Federal Mine Safety and Health Act of 1977 (Pub. L. 95-164, 30 U.S.C. 801et seq.) (Mine Act). The statutes included an enforceable 2 milligrams per cubic meter limit on respirable dust exposure during underground coal mine work (30 U.S.C. 842(b)(2)). The science available at that time indicated that enforcement of this limit would greatly reduce the development of CWP, but could not ensure that all miners would be protected from developing disabling or lethal disease.

1Petsonk EL, Parker JE [2008]. Coal workers' lung diseases and silicosis. In: Fishman AP, Elias J, Fishman J, Grippi M, Senior R, Pack A eds. Fishman's Pulmonary Diseases and Disorders. 4th ed. New York: McGraw-Hill, pp. 967-980.

The NIOSH Coal Workers' Health Surveillance Program (CWHSP), also mandated by the Mine Act, was developed to detect CWP and prevent progression in individual miners, while at the same time providing information for evaluation of temporal and geographic trends in pneumoconiosis. The Mine Act grants NIOSH general authority to issue regulations as the Institute deems appropriate in carrying out provisions of the Act and specifically directs that medical examinations for underground coal miners shall be given in accordance with specifications prescribed by NIOSH (30 U.S.C. 843(a), 957).

To inform each miner of his or her health status, the Act requires that underground coal mine operators offer new workers a chest roentgenogram (hereafter chest radiograph or X-ray) through an approved facility as soon as possible after employment starts. Three years later a miner must be offered a second chest radiograph. If this second examination reveals evidence of pneumoconiosis, the miner is entitled to a third chest radiograph 2 years after the second. Further, all miners working in an underground coal mine must be offered a chest radiograph approximately every 5 years. All chest radiographs are to be given in accordance with specifications prescribed by the Secretary of Health and Human Services (30 U.S.C. 843(a)).

Chest radiographs taken for the CWHSP are assessed by qualified and licensed physicians who are A or B Readers. A Readers are physicians who interpret chest radiographs for clinical purposes. They will have demonstrated knowledge of the International Labour Office (ILO) Classification of Radiographs of Pneumoconioses by completing a NIOSH-approved course or submitting six radiographs with satisfactory classifications, as specified in 42 CFR 37.51. B Readers are physicians who have demonstrated proficiency in the use of the ILO classification system by taking and passing a specially-designed proficiency examination offered by NIOSH, as specified in 42 CFR 37.51.

HHS proposed amendments to the existing part 37 regulations in a document published in January, 2012 (77 FR 1360, January 9, 2012).

A. Scope of Rulemaking

Existing regulations under 42 CFR part 37 provide rules and specifications for giving, interpreting, classifying, and submitting chest radiographs as required under section 203 of the Federal Mine Safety and Health Act of 1977, as amended (30 U.S.C. 843). Those rules will remain in effect. This rulemaking does not substantially alter the current standards.

Significantly, the new rule expands the availability of chest radiographic examinations by establishing additionaloptions for giving, interpreting, classifying, and submitting digitally-acquired radiographs under the same scope as the existing rule does for film radiographs. The final rule establishes the minimum specifications for methods, procedures, quality assurance, documentation, and equipment including computer software for facilities seeking approval to perform and submit digital radiographic examinations as well as the physician readers who interpret, classify, and submit reports using those radiographs. The final rule also makes limited changes to general requirements to reflect current terminology (such as the use of “radiograph” instead of “roentgenogram” which is no longer commonly used), practice or needs, such as requiring mine operators to provide a roster of current miners to NIOSH, which uses this information to promote miner participation in the Coal Workers' Health Surveillance Program. The final rule does not modify existing requirements for miner radiographic examinations, eligibility, or other rights, including transfer of affected miners in accordance with 30 CFR part 90.

B. Impact of Rulemaking

The U.S. Department of Labor (DOL) will likely amend its Black Lung Benefits Act (BLBA) program regulations to correspond with this final rule. The BLBA provides disability compensation and medical benefits to miners disabled by pneumoconiosis and monthly compensation to their eligible survivors (30 U.S.C. 901-944). Because DOL is required to consult with NIOSH on the development of criteria for medical tests for coal miners (30 U.S.C. 902(f)(1)(D)), DOL has modeled its technical requirements for chest radiographs on those adopted by NIOSH for the Coal Workers' Health Surveillance Program (see 20 CFR 718.102 and 20 CFR part 718 Appendix A). DOL's Occupational Safety and Health Administration (OSHA) might enable the use of digital chest images for medical surveillance under its asbestos regulations for general industry, shipyard employment, and construction (29 CFR 1910.1001 Appendix E, 29 CFR 1915.1001 Appendix E, and 29 CFR 1926.1101 Appendix E, respectively). OSHA's asbestos regulations include requirements for screening asbestos-exposed individuals using chest radiography. Enabling the use of modern digital chest imaging in that setting will involve similar technical considerations as are addressed in this final rule. However, OSHA's asbestos regulations are not linked by statute or regulation to this final rule.

The DOL standards refer to chest “roentgenograms,” an outdated term which NIOSH is replacing with the more contemporary “radiograph.” The DOL standards also rely upon the same ILO standards for the classification of radiographs, and might need to be amended to comport with the 2011 version of the ILO Classification, as referenced in this final rule. Finally, the DOL standards refer to film-based images and might need to be expanded to refer to digitally-acquired images in order to allow for such images to be used for purposes of determining eligibility for compensation.

III. Summary of Final Rule and Response to Public Comments

This final rule establishes new requirements for digital radiography under existing part 37 of 42 CFR—Specifications for Medical Examinations of Underground Coal Miners. The new provisions supplement and update the existing requirements for film-screen radiographs by establishing standards for digital radiographs. The following is a section-by-section introduction to each rule section, including a summary of the public comments and NIOSH responses to them. In general, the commenters are supportive of this rulemaking and welcome its implementation. Commenters offered thoughtful and practical suggestions for improvement of the final rule text, and HHS has adopted many of those suggestions.

Table 1 matches the current regulatory provisions with the corresponding final provisions. The final regulatory text is provided in the last section of this notice.

Table 1—Current and Final Provisions Current regulation Final regulation 37.2Definitions 37.2Definitions. 37.3Chest roentgenograms required for miners 37.3Chest radiographs required for miners. 37.4Plans for chest roentgenographic examinations 37.4Plans for chest radiographic examinations. 37.5Approval of plans 37.5Approval of plans. 37.6Chest roentgenographic examinations conducted by the Secretary 37.6Chest radiographic examinations conducted by the Secretary. 37.7Transfer of affected miner to less dusty area 37.7Transfer of affected miner to less dusty area. 37.8Roentgenographic examination at miner's expense 37.8Radiographic examination at miner's expense. 37.10Standards incorporated by reference. 37.20Miner identification document 37.20Miner identification document. 37.40General provisions 37.40General provisions. 37.41Chest roentgenogram specifications 37.41Chest radiograph specifications—film. 37.42Approval of roentgenographic facilities 37.42Chest radiograph specifications--digital radiography systems. 37.43Protection against radiation emitted by Roentgenographic equipment 37.43Approval of radiographic facilities that use film.
  • 37.44Approval of radiographic facilities that use digital radiography systems.
  • 37.45Protection against radiation emitted by radiographic equipment. 37.50Interpreting and classifying chest roentgenogram 37.50Interpreting and classifying chest radiographs—film. 37.51Proficiency in the use of systems for classifying the pneumoconioses 37.51Interpreting and classifying chest radiographs—digital radiography systems. 37.52Method of obtaining definitive interpretations 37.52Proficiency in the use of systems for classifying the pneumoconioses. 37.53Notification of abnormal roentgeno graphic findings 37.53Method of obtaining definitive interpretations. 37.54Notification of abnormal radiographic findings. 37.60 Submitting required chest roentgenograms and miner identification documents 37.60 Submitting required chest radiographs and miner identification documents. 37.70Review of interpretations 37.70Review of interpretations. 37.80Availability of records 37.80Availability of records. 37.200Scope 37.200Scope. 37.201Definitions 37.201Definitions. 37.202Payment for autopsy 37.202Payment for autopsy. 37.203Autopsy specifications 37.203Autopsy specifications. 37.204Procedure for obtaining payment 37.204Procedure for obtaining payment.
    Section 37.1Scope

    This existing section provides the scope of these provisions, and remains unchanged from the current regulation. HHS received no comments on this section.

    Section 37.2Definitions

    HHS amends a number of terms in the existing § 37.2 to reflect updated terminology and references.

    Comment:One commenter supports and agrees with the definition of “radiologic technologist” included in Section 37.2 but suggests that the definition contained in this section be amended torequirethe individual to have “completed a formal training program in radiography leading to a certificate, an associate degree, or a bachelor's degree and participated in the voluntary initial certification and annual renewal of registration for radiologic technologists in radiography offered by the American Registry of Radiologic Technologists.” The definition proposed by HHS would make those credentials “optimal,” but not required.

    HHS response:HHS considers the described training, certification, and ongoing renewals as optimum for radiologic technologists. However, because State and Territorial governments have regulatory authority for oversight of radiologic technologists, the Federal government cannot require such credentials. Accordingly, the commenter's suggestion cannot be implemented.

    Section 37.3Chest Radiographs Required for Miners

    This existing section requires mine operators to provide miners an opportunity to receive a chest radiograph. HHS amends this provision to delete and replace outdated text. HHS received no comments on § 37.3.

    Section 37.4Plans for Chest Radiographic Examinations

    This existing section requires that mine operators submit to NIOSH a Coal Mine Operator's Plan (Form CDC/NIOSH (M)2.10, OMB 0920-0020, exp. June 30, 2014) for chest radiographic examinations, including the beginning and ending dates of the 6-month period for voluntary examinations, and the name and location of the approved X-ray facility or facilities. HHS received no comments on § 37.4.

    Section 37.5Approval of Plans

    This existing section outlines the process undertaken by the Secretary of HHS to approve or deny approval of a Coal Mine Operator's Plan (Form CDC/NIOSH (M)2.10, OMB 0920-0020, exp. June 30, 2014). HHS amends this section to redact outdated text and to correct gender-exclusive language. HHS received no comments on § 37.5.

    Section 37.6Chest Radiographic Examinations Conducted by the Secretary

    This existing section details the conditions under which the HHS Secretary will determine whether to conduct a chest radiographic examination. HHS amends this section to replace outdated text with current terminology. HHS received no comments on § 37.6.

    Section 37.7Transfer of Affected Miner to Less Dusty Area

    Under 30 CFR part 90, miners whose radiographs show specific categories of pneumoconiosis are offered the right to frequent workplace dust monitoring, and transfer to another position in an area of the mine where the concentration of respirable dust in the mine atmosphere is in compliance with MSHA requirements in 30 CFR 90.3. HHS received no comments on § 37.7.

    Section 37.8Radiographic Examination at Miner's Expense

    This existing section provides for any miner who wishes to obtain a radiographic examination at his or her own expense. HHS received no comments on § 37.8.

    Section 37.10Standards Incorporated by Reference

    HHS has added § 37.10 to consolidate all of the standards incorporated by reference in Part 37. There are no substantive changes to the referenced standards.

    Section 37.20Miner Identification Document

    This existing section requires the completion of a Miner Identification Document (Form CDC/NIOSH (M)2.9, OMB 0920-0020, exp. June 30, 2014) for each miner when the chest radiograph is made. HHS received no comments on § 37.20.

    Section 37.40General Provisions

    This existing section outlines general provisions for chest radiographic examinations. HHS received no comments on § 37.40. However, paragraph (c) is edited to indicate that a radiograph may also be performed by a radiologic technologist to comport with the requirements in §§ 37.41 and 37.42.

    Section 37.41Chest Radiograph Specifications—Film

    This existing section establishes performance standards for the acquisition of chest radiographs using film-screen technology. HHS amends this section to update terminology and standards. In response to comments, discussed below, subsection (c) is amended to require that chest radiographs be performed by either a physician or a person working under the supervision of a physician, or by a radiologic technologist. Subsection (d) is amended in response to a comment to § 31.42, below, to specify that the size of the focal spot should be described as the measured size and not the nominal size. Subsection (n) is also amended in response to comments (see below) to require that each radiograph be marked with the miner's date of birth, in addition to the identification of the facility where it was made, the miner's Social Security number, and the date on which the X-ray was made.

    Comment:One commenter supports the change to subsection (c), requiring that a radiologic technologist perform chest radiography using film. According to the commenter, a registered radiologic technologist in radiography is educationally prepared and clinically competent to perform chest radiography. Several commenters do not approve of the proposed requirement, asserting that when radiographs of miners under this regulation are takenby State approved and licensed radiology facilities in a physician's office or clinic and that X-ray is performed under the direct supervision of a facility medical or osteopathic physician, it is not necessary to employ a radiology technician. Commenters state that allowing other trained professionals to make radiographs will improve the availability of surveillance health examination in mining regions.

    HHS response:The intent of the wording in this section is to assure that coal miners are provided high quality radiographic examinations using professionally-accepted methods that minimize radiation exposure. In order to optimize quality, safety, and accessibility goals, the wording of § 37.41(c) has been edited to indicate that the X-ray may be made either a physician or a person working under the supervision of a physician, or by a radiologic technologist.

    Comment:One commenter states that use of Social Security number as an identifier is increasingly difficult. The individual suggests that for examinations under this regulation, the image file or DICOM header include the date of birth of the individual whose chest is imaged.

    HHS response:HHS concurs and has accordingly modified the regulatory text in § 37.41(n) to require that the X-ray also be marked with the miner's date of birth.

    Section 37.42Chest Radiograph Specifications—Digital Radiography Systems

    This new section establishes performance standards for the acquisition of chest radiographs using digital radiography systems, including digital radiography and computed radiography. Section 37.42(b), (c), (d), and (i)(4) is amended in response to comments, as discussed below. Section 37.42(i)(5)(i)(A) is amended to include DICOM Standard PS 3.3-2001, Annex A, Computed Radiography Image Information Object Definition. This section title was inadvertently omitted, and references an image information object which was already a required component of older CR equipment models.

    Comment:One commenter notes that the regulations “do not require certification that the individual digital image taken both complied with the specifications of 42 CFR 37.42 and that the facility where the digital image was taken has been approved, and that its approval was current under 42 CFR 37.44, when the digital image was taken.” The comment suggests either the recording form be revised or alternatively, a web-based listing of NIOSH-approved radiographic facilities be made available.

    HHS response:CWHSP will continue to maintain a web-based listing of radiographic facilities that are NIOSH-approved under 42 CFR part 37, including directions and maps to locate approved facilities. (See,http://www.cdc.gov/niosh.)

    Comment:One commenter indicates that the size of the detector specified in § 37.42(b) would exclude one prominent equipment provider, and also would unnecessarily prohibit use of larger detectors. The commenter further suggests that the specification of a 5 megapixel matrix size be eliminated since the requirements for pixel pitch and detector size are sufficient, and these are not entirely consistent with the specified matrix size. The commenter further expresses concern that the requirement that “Spatial resolution shall be at least 2.4 line pair per millimeter” is not adequately defined. The commenter offers several methods to clarify the requirement, including the suggestion that the modulation transfer function be included in the system performance requirements in § 37.42(i)(4).

    HHS response:In response to this comment, the text of the final rule is modified to specify only pixel pitch and detector size, without a specific matrix size. Specifically, HHS has omitted the proposed maximum size for image detectors. The final rule text now specifies a minimum area and width for detectors which will accommodate the equipment mentioned in the comment (§ 37.42(b)). Per the commenter's suggestion, § 37.42(i)(4) is also amended to address the modulation transfer function (MTF). However, HHS reminds stakeholders that under § 37.42(i)(6), NIOSH retains the discretion to evaluate image quality by requiring the facility to include a test object on each X-ray.

    Comment:One commenter states that when radiographs of miners under this regulation are taken by State-approved and licensed radiology facilities in a physician's office or clinic and that X-ray is performed under the direct supervision of a facility medical or osteopathic physician, it is not necessary to employ a radiologic technologist (§ 37.42(c)).

    HHS Response:In order to optimize quality, safety, and accessibility goals, the wording of § 37.42(c) has been edited to indicate that the X-ray may be made by either a physician or a person working under the supervision of a physician, or by a radiologic technologist.

    Comment:A commenter suggests that, in relation to the specifications for X-ray generators in 37.42(d), the size of the focal spot should be described as the measured size and not the nominal size.

    HHS response:HHS has amended the final rule text to specify the measured, rather than nominal width of the focal point. A similar change is made to § 37.41(d), specifications for film radiographs.

    Comment:One commenter suggests that the application of edge enhancement techniques in image processing may result in inaccurate appearances and emphasizes the importance of using full uncompressed DICOM image files, and requiring medical grade monitors (§ 37.42(i)).

    HHS response:HHS concurs with the commenter and believes that the provisions in § 37.42(i) appropriately restrict use of edge enhancement techniques, require compression of DICOM image files to be fully reversible (lossless), and stipulate that the image display devices must meet the Grayscale Standard Display Function for diagnostic monitors specified in DICOM Part 14.

    Comment:One commenter recommends that § 37.42(i)(5)(ii)(A) be amended to require that the image file or DICOM header include the date of birth of the individual whose chest is imaged. Another commenter indicates that determining whether imaging parameters have been met will be difficult because only basic information is contained in the DICOM header, thus placing a burden on small hospitals attempting to comply with quality assurance standards.

    HHS response:HHS concurs that the miner's date of birth should be required for film radiographs. For digital radiographs, unique identification of each miner, chest image, facility, and date and time of the examination are encoded within the image information object according to Part 3 (PS 3.3-2009) of the DICOM standard, as specified in § 37.42. Accordingly, HHS has not amended the text of § 37.42(i)(5)(ii)(A).

    With regard to the quality assurance standards, since the inception of the Program, there has been a continuing concern for both safety and image properties, and quality assurance has always been a component of the 42 CFR Part 37 specifications. In this final rule, this professionally recommended and prudent element is being extended to cover the newly permitted digital imaging systems.

    Comment:A commenter expresses concern that images will be rejected and deleted even if, due to emergency situations, patients may be elderly, tooill for a high quality standard PA image, etc. The commenter further states that all images have useful information, and that no images should be discarded (§ 37.42(i)(11)).

    HHS response:The rule allows each physician reader to maintain his or her individual professional judgment in determining the quality of an image that is to be classified. The rule does not specifically require deletion of image files, but requires that when an image is deemed suboptimal and imaging is immediately repeated to obtain a better quality image, the original suboptimal file be fully deleted or rendered permanently inaccessible. The requirement to delete image files after they are transferred to NIOSH or if found substandard and thus immediately repeated is entirely analogous to the current rules regarding destruction of copies of film radiographs, and is only intended to assure maintenance of worker confidentiality for participants in the mandated Program. Approved facilities are permitted to forward to NIOSH all files of chest radiographic examinations that they have performed for any eligible coal miner, independent of image quality.

    Section 37.43Approval of Radiographic Facilities That Use Film

    Section 37.43 comprises the current requirements in existing § 37.42—Approval of roentgenographic facilities. HHS received no comments on § 37.43.

    Section 37.44Approval of Radiographic Facilities That Use Digital Radiography Systems

    Section 37.44 establishes standards for the approval of radiographic facilities that use digital radiography systems. These standards mirror those for film-screen technology.

    Comment:A commenter states that it is the position of the American Society of Radiologic Technologists that radiographic technique charts be used by persons performing radiography and that all health care facilities make radiographic technique charts available to persons performing radiography. The commenter is pleased to see this position reflected by the inclusion of the provision in § 37.44(g)(2) along with the requirement that facilities have in place a documented quality assurance program.

    HHS response:HHS appreciates this comment.

    Section 37.45Protection Against Radiation Emitted by Radiographic Equipment

    This provision requires that radiographic equipment conform to applicable State, territorial, and Federal regulations. Where no State, Territorial or Federal regulations apply, the section incorporates by reference the recommendations of the National Council on Radiation Protection and Measurements (NCRP).

    Comment:A commenter representing the NCRP provided updated references to the publications of his organization for the text of the regulation.

    HHS response:HHS appreciates the comment and has amended the final rule text accordingly.

    Section 37.50Interpreting and Classifying Chest Radiographs—Film

    Procedures for classifying radiographs are unchanged from the existing § 37.50, but for updating the requirement that images be interpreted and classified in accordance with the Guidelines for the Use of the ILO International Classification of Radiographs for Pneumoconioses, 2011 edition.2 HHS received no comments on § 37.50. HHS is changing the rule text in § 37.50(a) and (c) to clarify that the Guidelines are being incorporated by reference.

    2International Labour Office [2011]. Guidelines for the use of ILO International Classification of Pneumoconiosis, revised edition 2011). Geneva, Switzerland: International Labour Organization. Occupational Safety and Health Series No. 22 (Rev. 2011).

    Section 37.51Interpreting and Classifying Chest Radiographs—Digital Radiography Systems

    Section 37.51 establishes requirements for the classification of radiographs. Of note, the ILO has recently authorized the use of the ILO Classification for digital images and authorized a set of standard digital image files for use during classification. HHS is changing the rule text in § 37.51(b) and (c) to clarify that the Guidelines are being incorporated by reference.

    Comment:A commenter observes that it can be difficult for a reader to load the subject images on his or her picture archiving and communication (PACS) system, due to software issues from the system manufacturers. The commenter further states that that software in most PACS systems does not permit viewing of the miner radiograph side-by-side with another image folder, such as the ILO standard images.

    HHS response:NIOSH is aware of this concern, and has applied considerable resources and effort to make available a specific software package (NIOSH BViewer®) which is designed to address this issue (the BViewer software is available for free download athttp://www.cdc.gov/niosh/topics/chestradiography/digital-images.html). Although initially it is anticipated that some readers may have difficulty in displaying the standard ILO images along with the miner radiograph, over time, NIOSH believes that PACS manufacturers will incorporate software with functionality similar to B Viewer to further ameliorate this concern.

    Section 37.52Proficiency in the Use of Systems for Classifying the Pneumoconioses

    This section establishes the A and B Reader approval programs, and is modified from existing § 37.51 to make clarifications in the current requirements and update older terminology. HHS received no comments on § 37.52.

    Section 37.53Method of Obtaining Definitive Interpretations

    Section 37.53 maintains the standards in existing § 37.52, which establishes that radiographs will be independently interpreted by an A Reader and B Reader, or two B Readers, whose classifications must be in agreement as defined in § 37.53(b); if sufficient agreement is lacking, NIOSH will obtain a third interpretation.

    Comment:One commenter indicates that if the B Reader feels the image is satisfactory for identifying the abnormality, then it should not be disqualified if quality assurance standards have not been met. The commenter feels technical issues should not be used to disqualify evidence and therefore deny benefits if the individual is not able to return for repeat testing, and suggests that consensus among 2 or more B Readers be required where the quality of an image is in dispute.

    HHS response:A digital or screen film radiograph will not be disqualified for technical reasons if two or more B Readers do not find it unreadable and are able to classify it. The B Reader rates the quality of the image and classifies it for the presence and severity of findings associated with pneumoconiosis, but does not assess whether the facility making the image complied with the quality assurance specifications in Part 37. The rule does not constrain the reader in determining whether the image is either satisfactory or unreadable due to quality issues. Thus, responding to this comment does not necessitate a change to the rule text.

    Section 37.54Notification of Abnormal Radiographic Findings

    Section 37.54, redesignated from § 37.53, would be revised to update outdated terminology. The provision would also allow the first reader to communicate certain information directly to the miner, including abnormal findings other than pneumoconiosis. As discussed below, § 37.54(b) is amended in response to public comment.

    Comment:One commenter believes that the side-by-side review referenced in § 37.54(b) can be confusing to the miner, and that all information regarding X-ray results should be communicated at one time. The commenter suggests that because the evaluation of findings other than pneumoconiosis does not require a B Reader, this section should permit the comparisons to be done by any licensed physician, and/or that the miner be provided with copies of the relevant images so that their personal physician can perform the comparison. Finally, the commenter suggests that communication about health issues be to the miner, and not the designated physician to reduce the chance of failure of important communications. Another commenter recommends that NIOSH utilize available in-house medical expertise to complete the “side-by-side” readings. Outside consultation could still be obtained, where deemed useful or necessary.

    HHS response:HHS agrees with commenters that the use of a B Reader to interpret findings other than pneumoconiosis is unnecessary. In response to these comments, HHS has amended § 37.54(b) to indicate that, instead of a B Reader, NIOSH will arrange for a licensed physician to compare the most recent image and interpretation to older ones and inform the miner of any significant changes or progression of disease or other comments. The rule text is also changed to clarify that the Department means to refer to abnormal findings other than pneumoconiosis and substitutes the phrase “abnormality of cardiac shape or size” for “enlarged heart.”

    Section 37.60Submitting Required Chest Radiographs and Miner Identification Documents

    Section 37.60 is essentially unchanged from existing § 37.60, which establishes the protocol for submitting radiographs. HHS received no comments on § 37.60.

    Section 37.70Review of Interpretations

    This section is amended only to update terminology. HHS received no comments on § 37.70.

    Section 37.80Availability of Records for Radiographs

    Section 37.80 remains unchanged from the existing requirement, although terminology in this section is updated. HHS received no comments on § 37.80.

    Section 37.200Scope

    Section 37.200 remains unchanged from the existing explanation that provisions in this subpart establish conditions under which pathologists will be paid to conduct autopsies on deceased miners. HHS received no comments on § 37.200.

    Section 37.201Definitions

    Section 37.201 retains the existing definitions for Secretary, miner, and pathologist, but updates “ALFORD,” in the existing provision to “NIOSH.” HHS received no comments on § 37.201.

    Section 37.202Payment for Autopsy

    Section 37.202 retains the existing provision setting forth circumstances under which a pathologist may be paid by the Secretary for performing an autopsy. HHS received no comments on § 37.202.

    Section 37.203Autopsy Specifications

    Section 37.203 retains the existing standards establishing the manner in which autopsies are conducted. HHS received no comments on § 37.203.

    Section 37.204Procedure for Obtaining Payment

    Section 37.204 retains the existing procedure for submitting a claim for payment to NIOSH (“NIOSH” replaces “ALFORD” in the rule text). HHS has received no comments on § 37.204.

    IV. Regulatory Assessment Requirements A. Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

    This final rule is being treated as a “significant” action under E.O. 12866. It provides for the use of digital radiography systems in the Coal Workers' Health Surveillance Program (CWHSP) administered by NIOSH under 42 CFR part 37, in cooperation with coal mine operators, to monitor and protect the health of U.S. coal miners, particularly for the prevention of coal workers' pneumoconiosis. The current regulations at 42 CFR part 37 only allow for the use of film-screen radiography systems in this program. The addition of digital X-ray standards in part 37 does not require mine operators to change their plans to accommodate digital radiographs, but it is expected to substantially increase the amount of access miners will have to radiograph facilities because the use of film-screen radiography is declining markedly throughout the United States and specifically in areas where coal mining is located and where coal miners live. In fact, many clinics participating in the Program have indicated that they are maintaining their outdated X-ray film capabilities only because of Program requirements, and that they intend to switch to digital radiography when NIOSH allows its use by promulgating this final rule. In general, most health care facilities have abandoned the use of film-based X-rays. Mammography was the last mainstream radiology procedure that required use of film; many facilities made the final switch to digital several years ago when digital mammography systems became available.

    Increased access to radiograph facilities that offer digital X-rays is expected to result in cost savings to coal miners because they will not have to drive as far to visit an approved clinic.

    Digital radiographs are more cost-effective than their film-based counterparts because they do not require costly chemical processing, they eliminate the need for a separate device to develop the image, and they avoid costs associated with managing and archiving hard-copy images. Over the past 5 years approximately 100 clinics have submitted film-screen radiographs to CWHSP. NIOSH queried several clinics on the costs associated with film-screen radiography, including equipment maintenance, chemicals, film, and processing. Based on the responses, it is estimated that the cost to facilities of maintaining film X-ray technology to provide radiographs for approximately 2,500 coal miners is between $7,000 and $15,000 per clinic per year. Because NIOSH expects that most facilities participating in the Program will switch entirely to digital radiography when this rule ispromulgated, we estimate a first year cost savings to facilities that currently provide both film and digital radiographs of between $700,000 and $1,500,000 after they have discontinued the use of film radiographs.

    Although this rule does not require any facility to upgrade to digital technology, facilities that choose to do so will necessarily incur costs associated with its acquisition. HHS invited public comment on these estimates and received one comment asserting that meeting the rule's quality assurance standards will be prohibitively expensive for small facilities. As discussed here, HHS expects that facilities voluntarily upgrading to digital technology will necessarily incur costs associated with acquiring the technology and meeting regulatory standards. However, the quality assurance standards in this rule reflect standard industry practice and should not create burdens for small facilities already using, or planning to use, digital chest imaging and wishing to join the CWHSP.

    Furthermore, the final rule does not require any radiography facility to perform digital radiographs for this NIOSH program. Facilities may continue to perform film-screen radiography under the current requirements of Part 37 applicable to film-screen radiography, which would not be substantially changed by this final rule.

    The provisions for using the DICOM standard and incorporating by reference standard best practices for digital radiography used in lung imaging ensure that the final requirements reflect standard practice and technology. For these reasons, the rule provisions allowing for the use of digital radiography and specifying equipment and practice parameters would not impose any additional costs on coal mine operators who provide for their miners' participation in this program nor on the radiography facilities that serve the participating coal miners.

    The final rule establishes a new requirement for coal mine operators to provide to NIOSH a roster of current miners under § 37.4(a)(3). The provision of this roster to NIOSH is current practice by almost all of the approximately 500 U.S. underground coal mine operators; therefore codifying this practice in regulation will not result in any additional cost to mine operators. For these reasons, the final rule is not considered economically significant, as defined in sec. 3(f)(1) of E.O. 12866.

    The rule is consistent with the requirements of 42 U.S.C. 7384n(c). The rule does not interfere with State, local, or tribal governments in the exercise of their governmental functions.

    B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601et seq.,requires each agency to consider the potential impact of its regulations on small entities including small businesses, small governmental units, and small not-for-profit organizations. This rule establishes standards for the delivery of digitally-acquired chest radiographs for underground coal miners. It does not impose any new requirements on small radiographic facilities that participate in the Coal Workers' Health Surveillance Program (CWHSP) administered by NIOSH under 42 CFR part 37. These facilities may continue to exclusively use film-screen technology for radiography under provisions that would be essentially unchanged by this rulemaking. The rule will benefit these facilities by allowing and facilitating their transition to digital radiography for the purposes of this program. In this respect, the reliance in the rule on the DICOM standards, standard technology, and current best practices for lung imaging radiography ensure that the rule is consistent with current medical practices in digital radiography. It should also be noted that if this standard permits some facilities to switch entirely to digital imaging, rather than maintaining two duplicate technologies, the facilities may be able to achieve savings in radiography operating costs, as discussed in the Executive Orders 12866 and 13563 analysis above. The final rule also introduces a substantial benefit in allowing the participation in CWHSP of radiography facilities that solely use digital radiography; such facilities currently are prohibited from participation due to the current lack of digital radiography standards for CWHSP under part 37.

    This final rule is expected to increase access to medical facilities for small and larger coal mine operators, since many medical facilities exclusively use digital radiography or are transitioning to this technology. The rule may also decrease the cost to coal mine operators of providing X-ray screenings to miners. Lower cost is likely to be one of the factors in the trend among radiography facilities to adopt or switch entirely to digital radiography. In any event, allowing and facilitating the provision of digital radiography under part 37 will impose no new costs on small coal mine operators.

    The final rule establishes a new requirement for coal mine operators to provide to NIOSH a roster of current miners under § 37.4(a)(3). The provision of this roster to NIOSH is current practice by almost all coal mine operators. HHS estimates that, of 488 underground coal mines that can be considered small as of the first quarter of 2011,3 130 coal mine plans are submitted to the Agency annually. HHS further estimates that a clerical worker spends 0.5 hours per year preparing the roster. According to the Bureau of Labor Statistics, the average salary of a coal mine clerical worker is $17.38/hour; HHS estimates the annual cost for an individual coal mine operator to supply a roster to NIOSH is approximately $9 and the total cost to all coal mines combined amounts to approximately $1170 annually. In HHS's judgment, this $9 cost would not be significant for any coal mine operator. Therefore, a regulatory flexibility analysis as provided for under the RFA is not required. HHS certifies that this rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA.

    3U.S. Department of Labor, Mine Safety and Health Administration. Mining Industry Accident, Injuries, Employment, and Production Data—Address & Employment Self-Extracting Files.http://www.msha.gov/stats/part50/p50y2k/aetable.htm. Accessed June 26, 2012.

    C. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501et seq.,requires an agency to invite public comment on, and to obtain OMB approval of, any regulation that requires 10 or more people to report information to the agency or to keep certain records. This final rule continues to impose the same information collection requirements as under the current rule, including the submission of the following forms:

    ■ Roentgenographic Interpretation Form [CDC/NIOSH (M)2.8]

    ■ Miner Identification Document [CDC/NIOSH (M)2.9]

    ■ Coal Mine Operator's Plan [CDC/NIOSH (M)2.10]

    ■ Facility Certification Document [CDC/NIOSH (M)2.11]

    ■ Interpreting Physician Certification Document [CDC/NIOSH (M)2.12]

    ■ Consent, Release, and History Form [CDC/NIOSH (M)2.6]

    These forms are approved by OMB for data collected under the CWHSP (OMB Control No. 0920-0020, exp. June 30, 2014).

    The additional reporting burden associated with the Coal Mine Operator's Plan which requires underground coal mine operators to submit a roster of current employees (§ 37.4(a)(3)), and the FacilityCertification Document which is required of participating digital radiography facilities (§ 37.44(a)(2)), are both accounted for in the OMB information collection approval referenced above. There is no additional recordkeeping burden associated with the quality assurance program referenced in § 37.44(g) because this provision reflects standard industry practice and does not impose any new recordkeeping requirements.

    Type of respondent Form name and No. Number of
  • respondents
  • Number of
  • responses per respondent
  • Hours/
  • response
  • Response
  • burden
  • (in hrs)
  • Physicians (B Readers) Roentgenographic Interpretation Form—CDC/NIOSH (M) 2.8 10,000 1 3/60 500 Miners Miner Identification Document—CDC/NIOSH (M) 2.9 5,000 1 20/60 1,667 Coal Mine Operators Coal Mine Operator's Plan—CDC/NIOSH (M) 2.10 200 1 30/60 100 Super-visors at X-ray Facilities Facility Certification Document—CDC/NIOSH (M) 2.11 100 1 30/60 50 Physicians (B Readers) Interpreting Physician Certification Document—CDC/NIOSH (M) 2.12 300 1 10/60 50 Spirometry Test—Coal Miners No form involved 2,500 1 20/60 833 X-ray—Coal Miners No form involved 5,000 1 15/60 1250 Pathologist (Invoice) 50 1 5/60 4 Pathologist (Final diagnosis) 50 1 5/60 4 Next-of-Kin Consent, Release, and History Form—CDC.NIOSH (M) 2.6 50 1 15/60 13 Totals 23,250 4,471
    D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801et seq.), the Department will report the promulgation of this rule to Congress prior to its effective date. The report will state that the Department has concluded that this rule is not a “major rule” because it is not likely to result in an annual effect on the economy of $100 million or more.

    E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531et seq.) directs agencies to assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector “other than to the extent that such regulations incorporate requirements specifically set forth in law.” For purposes of the Unfunded Mandates Reform Act, this rule does not include any Federal mandate that may result in increased annual expenditures in excess of $100 million by State, local or tribal governments in the aggregate, or by the private sector. For 2012, the inflation adjusted threshold is $139 million.

    F. Executive Order 12988 (Civil Justice)

    This rule has been drafted and reviewed in accordance with Executive Order 12988, “Civil Justice Reform,” and will not unduly burden the Federal court system. Chest radiograph interpretations that result in a finding of pneumoconiosis may be an element in claim processing and adjudication conducted by DOL's Black Lung Compensation Program. This final rule would affect radiographs submitted to DOL for the purpose of reviewing and administering those claims. This rule has been reviewed carefully to eliminate drafting errors and ambiguities.

    G. Executive Order 13132 (Federalism)

    The Department has reviewed this rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” The rule does not “have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

    H. Executive Order 13045 (Protection of Children From Environmental Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the environmental health and safety effects of this rule on children. HHS has determined that the rule would have no effect on children.

    I. Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the effects of this rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect.

    J. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS has attempted to use plain language in promulgating the final rule consistent with the Federal Plain Writing Act guidelines.

    V. Final Rule List of Subjects in 42 CFR Part 37

    Black lung benefits, Incorporation by reference, Lung diseases, Mine safety and health, Occupational safety and health, Pneumoconiosis, Respiratory and pulmonary diseases, Underground coal mining, Workers' compensation, X-rays.

    Text of the Rule

    For the reasons discussed in the preamble, the Department of Health and Human Services amends 42 CFR part 37 as follows:

    PART 37—SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF UNDERGROUND COAL MINERS 1. The authority citation for part 37 continues to read as follows: Authority:

    Sec. 203, 83 Stat. 763 (30 U.S.C. 843), unless otherwise noted.

    Subpart—Chest Radiographic Examinations
    2. Revise § 37.1 to read as follows:
    § 37.1 Scope.

    The provisions of this subpart set forth the specifications for giving, interpreting, classifying, and submitting chest radiographs required by section 203 of the Act to be given tounderground coal miners and new miners.

    3. Revise § 37.2 to read as follows:
    § 37.2 Definitions.

    Any term defined in the Federal Mine Safety and Health Act of 1977 and not defined below will have the meaning given it in the Act. As used in this subpart:

    Actmeans the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 801,et seq.).

    Chest radiographmeans a single posteroanterior radiographic projection or radiograph of the chest at full inspiration recorded on either film or digital radiography systems.

    Convenient time and place with respect to the conduct of any examination under this subpartmeans that the examination must be given at a reasonable hour in the locality in which the miner resides or a location that is equally accessible to the miner. For example, examinations at the mine during, immediately preceding, or immediately following work and a “no appointment” examination at a medical facility in a community easily accessible to the residences of a majority of the miners working at the mine, will be considered of equivalent convenience for purposes of this paragraph.

    Digital radiography systems,as used in this context, include both Digital Radiography (DR) and Computed Radiography (CR).

    (1)Computed radiography (CR)is the term for digital X-ray image acquisition systems that detect X-ray signals using a cassette-based photostimulable storage phosphor. Subsequently, the cassette is processed using a stimulating laser beam to convert the latent radiographic image to electronic signals which are then processed and stored so they can be displayed.

    (2)Digital radiography (DR)is the term used for digital X-ray image acquisition systems in which the X-ray signals received by the image detector are converted nearly instantaneously to electronic signals without movable cassettes.

    ILO Classificationmeans the below-referenced classification of radiographs of the pneumoconioses system devised by an international committee of the International Labour Office (ILO), including a complete set of standard film radiographs or digital chest image files available from the ILO or other set of chest image files accepted by NIOSH as equivalent.

    MSHAmeans the Mine Safety and Health Administration, Department of Labor.

    Minermeans any individual including any coal mine construction worker who is working in or at any underground coal mine, but does not include any surface worker who does not have direct contact with underground coal mining or with coal processing operations.

    NIOSHmeans the National Institute for Occupational Safety and Health (NIOSH), located within the Centers for Disease