Daily Rules, Proposed Rules, and Notices of the Federal Government
The preamble to this notice of final rulemaking is organized as follows:
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.
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).
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).
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 additional
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.
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.
This existing section provides the scope of these provisions, and remains unchanged from the current regulation. HHS received no comments on this section.
HHS amends a number of terms in the existing § 37.2 to reflect updated terminology and references.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Section 37.43 comprises the current requirements in existing § 37.42—Approval of roentgenographic facilities. HHS received no comments on § 37.43.
Section 37.44 establishes standards for the approval of radiographic facilities that use digital radiography systems. These standards mirror those for film-screen technology.
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).
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.
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.
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 37.53 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.
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.
Section 37.60 is essentially unchanged from existing § 37.60, which establishes the protocol for submitting radiographs. HHS received no comments on § 37.60.
This section is amended only to update terminology. HHS received no comments on § 37.70.
Section 37.80 remains unchanged from the existing requirement, although terminology in this section is updated. HHS received no comments on § 37.80.
Section 37.200 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 37.201 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 37.202 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 37.203 retains the existing standards establishing the manner in which autopsies are conducted. HHS received no comments on § 37.203.
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.
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 is
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.
The Regulatory Flexibility Act (RFA), 5 U.S.C. 601
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,
The Paperwork Reduction Act, 44 U.S.C. 3501
■ 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 Facility
As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531
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.
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.”
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.
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.
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.
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.
For the reasons discussed in the preamble, the Department of Health and Human Services amends 42 CFR part 37 as follows:
Sec. 203, 83 Stat. 763 (30 U.S.C. 843), unless otherwise noted.
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 to
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: