Specifications for Medical Examinations of Coal Miners, 73270-73290 [2016-24405]

Download as PDF 73270 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations J. Plain Writing Act of 2010 DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Part 37 [Docket No. CDC–2014–0011; NIOSH–276] RIN 0920–AA57 Specifications for Medical Examinations of Coal Miners Centers for Disease Control and Prevention, HHS. ACTION: Final rule. AGENCY: With this action, the Department of Health and Human Services (HHS), in accordance with recent rulemaking by the Department of Labor’s Mine Safety and Health Administration (MSHA), finalizes amendments to Coal Workers’ Health Surveillance Program regulations to establish standards for the approval of facilities to conduct spirometry and requires that all coal mine operators submit a plan for the provision of spirometry testing and X-ray examinations to all surface and underground coal miners. DATES: This rule is effective on November 23, 2016. FOR FURTHER INFORMATION CONTACT: A. Scott Laney, Research Epidemiologist, Division of Respiratory Disease Studies, NIOSH, Centers for Disease Control and Prevention, 1095 Willowdale Road, MS HG900.2, Morgantown, WV 26505– 2888; (304) 285–5754 (this is not a tollfree number); alaney@cdc.gov. SUPPLEMENTARY INFORMATION: SUMMARY: sradovich on DSK3GMQ082PROD with RULES3 Table of Contents I. Public Participation II. Background A. History of Coal Workers’ Health Surveillance Program and Statutory Authority B. Need for Rulemaking III. Summary of Final Rule and Response to Public Comment A. Subpart—Chest Radiographic Examinations B. Subpart—Spirometry Examinations C. Subpart—General Requirements 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) VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 I. Public Participation Interested persons or organizations were invited to participate in this rulemaking by submitting written views, arguments, recommendations, and data. Comments were invited on any topic related to this rulemaking. HHS received submissions to the docket from two commenters, including a trade association representing coal mine operators and a spirometry expert. miners are to be given in accordance with specifications prescribed by the Secretary of Health and Human Services (30 U.S.C. 843(a)). The Mine Act also grants the Secretary, HHS general authority to issue regulations as is deemed appropriate to carry out provisions of the Act (30 U.S.C. 957), and grants NIOSH the authority to conduct activities in the field of coal mine health on behalf of the Secretary, HHS (30 U.S.C. 951(b)). II. Background B. Need for Rulemaking A. History of Coal Workers’ Health Surveillance Program and Statutory Authority 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 coal workers’ pneumoconiosis (pneumoconiosis), silicosis, and chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.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. 801 et seq.) (Mine Act). The National Institute for Occupational Safety and Health (NIOSH) Coal Workers’ Health Surveillance Program (CWHSP), also authorized by the Mine Act, was established to detect pneumoconiosis and prevent its progression in individual miners, while at the same time providing information for evaluation of temporal and geographic trends in pneumoconiosis. To inform each miner of his or her health status, the Act requires that coal mine operators provide each miner who begins work at a coal mine for the first time 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 a coal mine must be offered a chest radiograph approximately every 5 years. All chest radiographs and other supplemental tests deemed necessary to protect the health and safety of U.S. coal On May 1, 2014, the Mine Safety and Health Administration (MSHA) in the Department of Labor published a final rule amending existing health and safety standards in 30 CFR part 72 to improve health protections for coal miners, including the expansion of requirements for medical surveillance.2 The amendments added a new section, § 72.100, to require that both underground and surface coal mine operators provide to each miner chest Xrays and spirometry tests using facilities approved by NIOSH, as well as the documentation of occupational history and symptom assessment. The expansion of MSHA’s medical surveillance requirements caused HHS to amend regulations in 42 CFR part 37 pertaining to the CWHSP, thereby expanding the scope of the Program to include coal miners who work in surface coal mines and adding spirometry testing and symptom assessment for all miners. In response to MSHA’s rulemaking, NIOSH published an interim final rule on August 4, 2014 (August 2014 IFR) to expand the existing CWHSP to provide chest radiographic examinations to miners who work in surface coal mines and establish requirements for spirometry testing for all coal miners under part 37.3 This action finalizes those provisions promulgated by the August 2014 IFR. 1 Edward L Petsonk and John E Parker, Coal Workers’ Lung Diseases and Silicosis, in Fishman’s Pulmonary Diseases and Disorders, 967 (Alfred P. Fishman ed., McGraw-Hill, 4th ed., 2008). PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 III. Summary of Final Rule and Response to Public Comment This document finalizes the August 2014 IFR. The following section-bysection summary describes and explains the amendments to certain provisions of part 37. Public comments are also summarized and answered. The final regulatory text is provided in the last section of this document. 2 79 3 79 FR 24814. FR 45110. E:\FR\FM\24OCR3.SGM 24OCR3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations A. Subpart—Chest Radiographic Examinations sradovich on DSK3GMQ082PROD with RULES3 Section 37.1 Scope Section 37.1 provides the scope of the provisions in Subpart—Chest Radiographic Examinations, and is amended to clarify the purpose of this subpart. Under this subpart, coal mine operators are required to provide radiographic examinations to each current and new coal miner, using medical facilities approved by NIOSH according to the standards established in this subpart. Because no comments were submitted on this section and no changes are made to the regulatory text, this section is not included in the regulatory text below. Section 37.2 Definitions Section 37.2 contains definitions for terms that appear throughout this subpart and the new subparts (Subpart—Spirometry Testing and Subpart—General Requirements). The existing definitions of several terms are revised and a new definition of ‘‘B Reader’’ is added, as discussed below. The definition ‘‘Act,’’ which refers to the Federal Mine Safety and Health Act of 1977, is revised to include reference to the Public Law number and amendments. The definition ‘‘convenient time and place’’ is revised to strike the phrase ‘‘with respect to the conduct of any examination under this subpart,’’ because that phrase is not used in part 37. Additional language is added to clarify how this term is to be interpreted. Although this definition was not included in the August 2014 IFR, revising it to be consistent with the language in §§ 37.40 and 37.100 is thus a logical outgrowth of this rulemaking. The definition ‘‘digital radiography systems’’ is changed to replace the word ‘‘X-ray’’ with ‘‘radiographic.’’ Although this definition was not included in the August 2014 IFR, revising it is consistent with changes made to § 37.51 in this final action and is thus a logical outgrowth of this rulemaking. The definition ‘‘ILO Classification’’ is revised to clarify that using the term ‘‘digital chest image file’’ includes all electronic standard chest images included in the set of film radiographs provided by the International Labour Office (ILO) in the International Classification of Radiographs of Pneumoconioses. The definition is also revised to recognize that NIOSH must approve other sets of chest images files as equivalent to the ILO Classification. The ILO Classification is incorporated by reference into certain sections in part 37. Although this definition was not VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 included in the August 2014 IFR, revising it to recognize digitized image files is consistent with changes made to § 37.51 in this final action, and is thus a logical outgrowth of this rulemaking. The definition ‘‘NIOSH’’ is revised to replace the former name of the NIOSH division responsible for the CWHSP with its new name, Respiratory Health Division (RHD). RHD is the organizational unit within NIOSH responsible for administration of the CWHSP. The definition ‘‘Panel of B Readers’’ is revised to clarify that B Readers are certified by NIOSH and classify or otherwise evaluate radiographs for the CWHSP. The definition ‘‘radiologic technologist’’ is revised to clarify terminology by replacing ‘‘chest images’’ with ‘‘chest radiographs.’’ A new definition of ‘‘B Reader’’ is added to direct readers to § 37.52, which requires physicians who wish to evaluate and classify chest radiographs for pneumoconiosis to take and pass a specially designed proficiency examination given by NIOSH. This definition is predicated on existing language in § 37.52, and is thus a logical outgrowth of the August 2014 IFR. Finally, the definition ‘‘facility’’ is moved from § 37.91 and is unchanged. No comments were submitted on this section. Section 37.3 Chest Radiographs Required for Miners Section 37.3 requires mine operators to provide miners an opportunity to receive a chest radiograph. Paragraphs (a)(1) and (2), concerning the provision of each employed miner an opportunity for a chest radiograph at least 3.5 to 4.5 years after the previous period for the conduct of such examinations, are revised to eliminate redundancy and provide greater clarity regarding the deadlines for voluntary examinations. The sentence specifying that the period during which examinations must begin is removed because it does not provide any additional information and may be confusing. The example provided in paragraph (a)(2) is also removed for similar reasons. No changes are made to paragraph (b), which establishes the periodicity of three required initial chest radiographs. Paragraph (c), which establishes that NIOSH will notify the miner when it is time for a second or third radiography examination and will notify the operator under certain circumstances, is revised for clarity. Paragraph (d), concerning the availability of chest radiographs, is revised to replace ‘‘subpart’’ with ‘‘part’’ PO 00000 Frm 00003 Fmt 4701 Sfmt 4700 73271 to clarify that radiographs must be made available by an operator in accordance with a plan submitted and approved by NIOSH in accordance with this part. As discussed in the August 2014 IFR, the section requiring operator plans for medical examinations has been removed from this subpart and replaced in Subpart—General Requirements. One commenter asked that HHS require miners to submit to mandatory respiratory examinations. NIOSH does not have legal authority to require coal miners to submit to medical examinations. Although section 203(a) of the Mine Act (30 U.S.C. 843(a)) states that medical examinations shall be given to miners at certain intervals, it states elsewhere in that section that miners are to have ‘‘the opportunity’’ to have such examinations. Moreover, NIOSH concurs with MSHA’s position, as addressed in the agency’s May 1, 2014 final rule in response to public comment, that requiring miners to submit to medical examinations against their will would not be appropriate.4 No changes are made to the regulatory text in response to public comment. Section 37.4 Chest Radiographic Examinations Conducted by the Secretary Section 37.4 details the conditions under which the HHS Secretary will determine whether to conduct a chest radiographic examination. Paragraph (a), which details the circumstances under which the Secretary, HHS, will arrange for chest radiographs at a particular mine, is unchanged. ‘‘Shall’’ is replaced with ‘‘must,’’ in accordance with Federal plain language guidelines, in paragraph (b), which requires the operator to reimburse the Secretary or person, agency, or institution directed by the Secretary to conduct radiography examinations, and paragraph (c), which requires the examinations arranged by the Secretary to be given according to the periodicity requirements in § 37.3. Paragraph (d), which stipulates that operators participating in the National Study of Coal Workers’ Pneumoconiosis would not be responsible for assuming the cost of providing chest radiographs, is removed in its entirety because that study no longer exists. No comments were submitted on this section and no changes are made to the regulatory text. Section 37.10 Standards Incorporated by Reference Section 37.10 provides references to the standards incorporated by reference 4 See MSHA final rule, 79 FR 24814, at 24928 (May 1, 2014). E:\FR\FM\24OCR3.SGM 24OCR3 73272 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations into part 37. This section is amended slightly to update the name of the NIOSH Division of Respiratory Disease Studies, now known as the Respiratory Health Division. The link to the American College of Radiology publication has been updated. No public comment was received and no further edits are made to this section. Section 37.20 Miner Identification Document Section 37.20 requires the use of a Miner Identification Document as a component of the examination. Although this section was not amended by the August 2014 IFR, revising it here is consistent with the addition of spirometry to part 37, and is thus a logical outgrowth of this rulemaking. The text is revised slightly to reference both radiographic and spirometry examinations. The section is also changed to clarify that the form (CDC/ NIOSH 2.9) is required for both types of examination. sradovich on DSK3GMQ082PROD with RULES3 Section 37.40 General Provisions Section 37.40 outlines general provisions for chest radiographs. Paragraphs (a) and (c), which require that the radiographic examination must be given at a convenient time and place and performed in an approved facility, respectively, are unchanged. Paragraph (b) is revised to update the name of the completed form that must accompany the chest radiographic examination, the Chest Radiograph Classification Form (CDC/NIOSH 2.8). No comments were submitted on this section. Section 37.43 Approval of Radiographic Facilities That Use Film Radiography Systems Section 37.43 establishes standards for the approval of radiography facilities that use film. Although this section was not included in the August 2014 IFR, revisions are a logical outgrowth of other changes throughout the part. The section heading is revised to clarify that it applies to film radiography systems. Paragraph (a), concerning application to NIOSH for facility participation in the CWHSP, is unchanged except to divide it into smaller paragraphs for clarity. Paragraph (a)(1) concerns the submission of sample radiographs made on the equipment intended to be used to perform radiographs under this part; (a)(2) concerns the submission of sample radiographs within 15 days of being made; (a)(3) concerns the return of such radiographs submitted as a component of the A Reader approval process. The reference provided for those chest radiographs is corrected to read § 37.52(a)(2)(i). VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 The name of the form referenced in paragraph (b), the Radiographic Facility Certification Document, is updated to be consistent with updates in other sections of Part 37. Paragraphs (c), (d), and (f), concerning the evaluation of radiographs submitted with applications for NIOSH approval, the inspection of the applicant facility by NIOSH, and the establishment of a quality assurance program at the applicant facility, respectively, are unchanged. The name of the form referenced in paragraph (e), the Radiographic Facility Certification Document, is updated to be consistent with updates in other sections of part 37. The paragraph is also divided into smaller paragraphs for clarity. Paragraph (e)(1) now concerns the suspension or withdrawal of NIOSH approval of a radiograph facility; paragraph (e)(2) requires a copy of a withdrawal notice be displayed on the mine bulletin board. In paragraph (g), concerning the maintenance of records in accordance with Federal privacy laws, the word ‘‘interpretations’’ is replaced with ‘‘classifications,’’ to clarify that B Readers are responsible for recording classifications on the Chest Radiograph Classification Form (CDC/NIOSH 2.8). The term ‘‘classifications’’ describes surveillance activities, such as providing standardized descriptions of chest radiographs, while ‘‘interpretations’’ is a broader term meant to describe clinical activities, such as assessing radiographic findings and generating radiological differential diagnoses. This revision is consistent with similar changes in other sections of part 37. Section 37.44 Approval of Radiographic Facilities That Use Digital Radiography Systems Section 37.44 establishes standards for the approval of radiography facilities that use digital radiography. Although this section was not included in the August 2014 IFR, the new organization and content revisions are a logical outgrowth of other changes throughout the part. Paragraph (a), concerning application to NIOSH for facility participation in the CWHSP, is unchanged. Paragraph (a)(1), regarding the submission of digital radiographic image files with an application for facility approval, is redesignated as paragraph (a) and divided into smaller paragraphs for clarity. Paragraph (a)(1) now concerns the submission of image files; (a)(2) concerns the submission of images within 60 days of the application date; (a)(3) concerns the documentation that must accompany the image files; PO 00000 Frm 00004 Fmt 4701 Sfmt 4700 and (a)(4) concerns the orientation of submitted images. Paragraph (a)(2) is redesignated as paragraph (b). The name of the form referenced in paragraphs (b) and (e), the Radiographic Facility Certification Document, is updated to be consistent with updates in other section of part 37; similarly, the word ‘‘X-ray’’ is replaced with ‘‘radiograph’’ in paragraph (g)(2). Paragraphs (b), (c), (e), (f), and (h), concerning facility licensure, physical inspections by NIOSH, the medical physicist requirement, documentation of compliance, and maintenance of records in accordance with Federal privacy laws are redesignated as paragraphs (c), (d), (e), (f), and (i), respectively. Paragraph (g)(2), regarding radiation exposure parameters, is redesignated as paragraph (h)(2) and is divided into smaller paragraphs for clarity. Paragraph (h)(2)(i) now concerns the monitoring of radiological exposures; paragraph (h)(2)(ii) now concerns annual assessments of radiation exposures conducted by a medical physicist. The substance of paragraph (h) is otherwise unchanged. Section 37.50 Interpreting and Classifying Chest Radiographs—Film Radiography Systems Section 37.50 establishes procedures for the classification of film radiographs. The section heading is revised to clarify that the procedures herein apply specifically to film radiography systems. Paragraphs (a), which requires radiographs to be interpreted in accordance with the ILO Classification, and (c), which requires those interpreting chest radiographs to have a complete set of standard radiographs for use with the ILO Classification immediately available for reference, are unchanged. Paragraph (b) requires radiographs to be interpreted and classified by physicians who read chest radiographs in the normal course of practice and who have demonstrated proficiency in classifying pneumoconiosis in accordance with the standards in § 37.52. Non-substantive revisions to the regulatory text in paragraph (b)(1), which requires that interpretations of findings other than pneumoconiosis must be provided by a qualified physician who provides these services for the examining facility, clarify that the physician must have all required licensure and privileges and must interpret chest radiographs in the normal course of his or her practice. Paragraph (c), which requires all interpreters to have immediately available a set of standard radiographs E:\FR\FM\24OCR3.SGM 24OCR3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations for use with the ILO Classification, is unchanged. Paragraph (d), which establishes standards for view boxes, is revised to clarify that view boxes must comply with the requirements in paragraphs (d)(1)–(4). No comments were submitted on this section. sradovich on DSK3GMQ082PROD with RULES3 Section 37.51 Interpreting and Classifying Chest Radiographs—Digital Radiography Systems Section 37.51 establishes procedures for the classification of digital chest radiographs. Paragraph (a), which requires that significant abnormal findings other than pneumoconiosis must be initially interpreted and notification provided by a qualified physician, is not changed in this action. Paragraph (b), requiring that classifications be made by B Readers and recorded on a Chest Radiograph Classification form, is revised to clarify that physician readers who have demonstrated proficiency in the classification of pneumoconiosis in accordance with § 37.52(b) are B Readers. The paragraph is also changed to remove the term ‘‘interpretations,’’ for the reasons discussed above. Paragraph (c), which requires B Readers to have a complete set of NIOSH-approved standard digital radiographs for use with the ILO Classification immediately available for reference, is changed to clarify that NIOSH-approved digital standard images used for making classifications include all approved electronic standard chest images, thus encompassing the current digitized standard chest radiographs provided by ILO. This paragraph is also divided into smaller paragraphs to aid the reader; no substantive changes are made. Paragraph (c)(1) now concerns the use of only NIOSH-approved standard digital images for classification; (c)(2) prohibits the modification of the appearance of the standard images. Paragraphs (d) through (g), which concern viewing systems, quality control for display devices, use of soft copy images, and the impermissibility of classifications based on digitized copies of chest radiographs are also unchanged. No comments were submitted on this section. Section 37.52 Proficiency in the Use of Systems for Classifying the Pneumoconioses Section 37.52 establishes the A and B Reader approval programs. Paragraph (a) establishes standards for the approval of A Readers; paragraph (a)(1), which allows A Reader approvals to continue if established prior to October 15, 2012, VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 is changed to clarify that the approval continues indefinitely. Paragraph (a)(2) details the requirements for becoming a NIOSH-approved A Reader; paragraph (i), which requires the submission of six properly-classified sample radiographs, is revised to remove the word ‘‘interpretations’’ and replace it with ‘‘classifications,’’ and to update the name of the form to Chest Radiograph Classification Form (CDC/NIOSH 2.8), for the reasons discussed above. Paragraph (a)(2)(ii), requiring the completion of a NIOSH-approved ILO Classification course in lieu of the six sample radiographs referenced in paragraph (a)(2)(i), is unchanged. Paragraph (b), which establishes standards for the approval of B Readers, and paragraph (b)(1), which establishes that B Reader approvals received prior to October 1, 1976 are terminated, are unchanged. Paragraph (b)(2) requires that physicians pass a proficiency examination in order to be approved as a NIOSH B Reader and is revised to clarify that B Reader proficiency examinations are only given on behalf of or by NIOSH. This paragraph is also revised to divide the large paragraph into smaller paragraphs; no substantive revisions are made. Paragraph (b)(2)(i) now concerns the provision of a complete set of NIOSH-approved standard reference digital radiographs to physicians taking the B Reader exam; (b)(2)(ii) states that physicians who qualify as B Readers need not be qualified as A Readers. Paragraph (c) requires physicians who wish to participate in the CWHSP to apply to NIOSH. The name of the form is changed to Physician Application for Certification; the paragraph is otherwise unchanged. No comments were submitted on this section. Section 37.53 Method of Obtaining Definitive Chest Radiograph Classifications Section 37.53 establishes the method used by NIOSH to obtain definitive classifications of chest radiographs. For the reasons discussed above, the name of this section is revised to replace ‘‘interpretations’’ with ‘‘chest radiograph classifications,’’ to clarify that B Readers provide classifications according to the ILO system for classifying radiographs. Paragraph (a) establishes that radiographs will be independently classified by an A Reader and B Reader or two B Readers, or if agreement is lacking, NIOSH will obtain a third classification. This paragraph is revised to clarify that B Readers are qualified by NIOSH pursuant to § 37.52, and is also divided into smaller paragraphs to aid the reader. Paragraph PO 00000 Frm 00005 Fmt 4701 Sfmt 4700 73273 (a)(1) now concerns agreement among the two classifications; (a)(2) concerns the procedure NIOSH follows when agreement is lacking, and is further divided into smaller paragraphs. Paragraph (a)(2)(i) concerns agreement between two of three classifications resulting in a final determination; (a)(2)(ii) concerns lack of agreement among three classifications. No other changes are made to this paragraph. Paragraph (b), which establishes what NIOSH considers to be agreement between chest radiographs, is revised to clarify that two classifications are considered to be in agreement when they meet the standards now in paragraphs (b)(1), (2), and (3). Paragraph (b)(3), which contains the current standard for a determination of simple pneumoconiosis, is further divided into smaller paragraphs (i) and (ii) and is revised slightly to comport with the new structure. No comments were submitted on this section. Section 37.54 Notification of Abnormal Radiographic Findings Section 37.54 requires that findings of abnormalities identified by chest radiograph be communicated to the miner. Although this section was not included in the August 2014 IFR, the revisions discussed below are consistent with other changes in this final action. A new heading is added to clarify the intent of paragraph (a), which provides that findings suggesting heart abnormalities, tuberculosis, lung cancer, or any other significant health condition other than pneumoconiosis must be communicated to the miner or the miner’s designated physician. The paragraph is also rearranged to clarify that the first physician to interpret a miner’s radiograph must communicate the findings. A new heading is added to clarify the intent of paragraph (b), which provides that NIOSH will arrange for a physician to compare a recent radiograph found to show significant abnormal findings, including pneumoconiosis, with older images that NIOSH may have in its possession. The word ‘‘interpretation’’ is removed from this paragraph to clarify that NIOSH will arrange for a physician to compare the most recent image showing an abnormality to older images. This change is consistent with other similar changes throughout part 37, for the reasons discussed above. A new heading is added to paragraph (c), to clarify the intent of the paragraph regarding notice to the miner of eligibility for Part 90 transfer rights. The term ‘‘final findings’’ is replaced with ‘‘final determinations,’’ which are reported to the miner or the miner’s E:\FR\FM\24OCR3.SGM 24OCR3 sradovich on DSK3GMQ082PROD with RULES3 73274 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations designated physician by NIOSH, when such determinations provide evidence for the development of pneumoconiosis. Revisions also clarify that NIOSH will coordinate with MSHA regarding notification of part 90 eligibility. Finally, a heading is added to clarify the intent of paragraph (d), which states that NIOSH makes every effort to process pneumoconiosis determinations within 60 days of receipt of chest radiograph images and other documents. The paragraph is also divided into smaller paragraphs to aid the reader. Paragraph (d)(1) now concerns timely notice by MSHA; this paragraph is revised to clarify that NIOSH will work with MSHA to provide notice within the 60-day timeframe established in paragraph (d). Paragraph (d)(2) now states that examination results may not be processed by NIOSH if the examination was made within 6 months of the date of a prior acceptable examination. One public commenter recommended that this section be changed to allow the results of the radiography examinations and spirometry to be made available to a health professional designated by the mine operator. According to the commenter, because operators are required to establish a plan for the examinations and pay for them, they are entitled to have access to the results. The commenter argued that section 203 of the Mine Act (30 U.S.C. 843) does not support excluding mine operators from the notification requirements in this section or in the spirometry results notification requirements in the new § 37.97. According to the commenter, the decision to not provide examination results to mine operators is inconsistent with a 2006 NIOSH guidance document concerning refractory ceramic fibers and with the DOL Occupational Safety and Health Administration (OSHA) asbestos standards, both of which allow notification of employers. Further, according to the commenter, section 103(h) of the Mine Act provides for the sharing of reports and findings to any interested person. Finally, the commenter argued that sharing the examination findings with operators would allow the operators to provide health counseling and medical management to miners showing evidence of early disease. NIOSH declines to make results of radiography or spirometry available to either mine operators or health professionals designated by operators. Section 203 of the Mine Act specifically identifies the parties that must be notified of examination results (i.e., Secretary, DOL; Secretary, HHS; miner; and miner’s designated physician). VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 NIOSH is not authorized to expand notification to mine operators. Section 103 of the Mine Act, referenced by the commenter and described above, is not relevant to the matter of medical examinations of individual miners because it only addresses the conduct of mine inspections. Finally, NIOSH concurs with MSHA in its response to the question of providing examination results to operators, published in MSHA’s 2014 final rule on respirable coal mine dust, which explained that the individuals notified of the miner’s test results are limited in order to protect miners’ confidentiality and uphold Federal privacy laws.5 Section 37.60 Submitting Required Chest Radiographs and Miner Identification Documents Section 37.60 establishes the protocol for submitting radiographs to NIOSH. Paragraph (a) is revised to clarify that all submitted items, including each required chest radiograph, the Chest Radiograph Classification form, and the Miner Identification Document, become the property of NIOSH. Paragraph (a)(1) is further revised to remove the redundant sentence concerning the 14day deadline for submission of documents after the date of the radiographic examination. The sentence concerning NIOSH’s notification to the submitting facility of receipt of image files and forms is moved into paragraph (a)(2). Paragraph (b) is revised to clarify that the operator must arrange for reexamination at no expense to the miner, in the event that NIOSH finds any submission to be inadequate. Paragraph (c), which establishes that failure to comply with paragraph (a) or (b) may result in revocation of approval of a plan, is unchanged, as is paragraph (d), which states that chest radiographs and required forms must only be submitted for miners. Paragraph (e) is revised to replace ‘‘shall’’ with ‘‘must’’ or ‘‘will’’ throughout the paragraph in accordance with Federal plain language guidelines. References in this paragraph concerning the collection of Social Security numbers are revised slightly to clarify that only the last four digits are required by NIOSH; this change is not substantive and reflects current Program practice. No comments were submitted on this section. Section 37.70 Review of Classifications Section 37.70(a) establishes that a miner may request that NIOSH 5 See PO 00000 79 FR 24814, at 24928 (May 1, 2014). Frm 00006 Fmt 4701 Sfmt 4700 reevaluate a pneumoconiosis classification that the miner believes is in error. The section heading is changed to replace ‘‘interpretations’’ with ‘‘classifications,’’ consistent with previous edits discussed above. The paragraph is also divided into smaller paragraphs to aid the reader. Paragraph (a)(1) establishes that after a written request from a miner, NIOSH will obtain one or more additional classifications by B Readers if the contested classification was based on agreement between an A Reader and a B Reader, pursuant to § 37.53. A reference in this paragraph to the section in part 37 that addresses the transfer of miners to a less dusty area is corrected to read § 37.102. Paragraph (a)(2) establishes that a classification based on agreement between two or more B Readers will be considered final and will be not be reevaluated. No comments were submitted on this section and no other changes are made to the regulatory text. § 37.80 Availability of Records for Radiographs Section 37.80 requires that written consent be provided to NIOSH for the release of medical information and radiographs. This section was not included in the August 2014 IFR, but is revised in this final action to clarify that original film radiographs are available for examination at the NIOSH facility in Morgantown, WV. No comments were submitted on this section. B. Subpart—Spirometry Testing This subpart establishes standards for spirometry testing for all coal miners, working in both underground and surface mines. As discussed in the August 2014 IFR, the provisions in this subpart are consistent with MSHA regulations in 30 CFR 72.100, which requires that operators offer periodic spirometry and respiratory assessments to document miner respiratory symptoms and lung function. This is in addition to chest radiographic examinations and occupational history questionnaires. The subpart heading is revised to replace the word ‘‘examinations’’ with the word ‘‘testing,’’ and similar changes are made throughout the subpart to reflect the correct terminology for describing spirometry. Section 37.90 Scope Section 37.90 provides the scope of the provisions in Subpart—Spirometry Testing. The text of this section is changed slightly to clarify that operators are required to provide spirometry testing to both current and newly E:\FR\FM\24OCR3.SGM 24OCR3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations employed coal miners. No comments were submitted on this section. Section 37.91 Definitions Section 37.91 defines terms used in this subpart. Several revisions are made to this section. The definition ‘‘facility’’ is removed, unchanged, from this section and moved to the definitions section in § 37.2. The definition ‘‘FET’’ is revised to clarify that forced expiratory time is the time from the beginning of a forced exhalation maneuver to the end of the expiration. The definition ‘‘FEV1’’ is revised to clarify that forced expiratory volume in one second is the greatest volume of air that can be forcibly blown out within the first second after full inspiration. A new definition of the FEV1/FVC is added to mean the ratio between the largest acceptable FEV1 and the largest acceptable FVC following the forced vital capacity maneuver.6 Although this definition was not included in the August 2014 IFR, it is considered to be a logical outgrowth of this rulemaking. (See § 37.96(b)(1).) The existing definition of ‘‘FEV6’’ is revised to clarify that forced expiratory volume in six seconds is the greatest volume of air that can forcibly be blown out in six seconds after full inspiration. The existing definition of ‘‘FVC’’ is revised to clarify that forced vital capacity is the greatest volume of air that can forcibly be blown out after full inspiration. The existing definition of ‘‘PEF’’ is revised to clarify that peak expiratory flow is the maximal airflow generated during a forced vital capacity maneuver. No comments were submitted on this section. sradovich on DSK3GMQ082PROD with RULES3 Section 37.92 Spirometry Testing Required for Miners Section 37.92 requires coal mine operators to provide all miners an opportunity to receive spirometry testing. Paragraph (a), which requires that each operator must provide an opportunity for miners to perform spirometry testing at least once every 5 years, is unchanged except for the heading, in which ‘‘Voluntary examinations’’ is replaced with ‘‘Voluntary tests.’’ Paragraphs (b)(1), (2), and (3) establish the periodicity of initial, second, and third spirometry tests. The headings for the lower subparagraphs, ‘‘Initial spirometry examination,’’ ‘‘Second examination,’’ and ‘‘Third examination’’ 6 See Gregg L. Ruppel, Manual of Pulmonary Function Testing, 51 (St. Louis: Mosby Inc., 9th ed., 2009). VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 are removed to mirror the structure of § 37.3, ‘‘Chest radiographs required for miners.’’ The word ‘‘examination(s)’’ is replaced with ‘‘test(s)’’ throughout all three. Paragraph (b)(3) is revised to clarify that a third spirometry test and respiratory assessment will be provided if the second spirometry test results demonstrate more than a 15 percent age adjusted decline in the percent predicted FEV1 value since the initial baseline test. This paragraph is also divided into smaller paragraphs to aid the reader; the two new sub-paragraphs clarify how the percent predicted FEV1 value will be calculated (paragraph (b)(3)(i)) and the appropriate correction factor for calculating the percent predicted FEV1 for an individual of Asian descent (paragraph (b)(3)(ii)). One comment was received on paragraph (b)(3), supporting the decision to establish the 15 percent decline in the percent predicted FEV1 value. Paragraph (c) establishes notification requirements for second and third spirometry testing sessions. This paragraph is also divided into smaller paragraphs to aid the reader. Paragraph (c)(1) stipulates that the operator would be notified of a miner’s eligibility for a third spirometry test only with the consent of the miner. If the operator is notified, NIOSH will not specify the medical reason for the third test nor reveal that it is the miner’s third. Paragraph (c)(2) establishes that if the miner is notified of the time for a third test and the operator is not notified, provision for the test in the NIOSHapproved operator’s plan will constitute the operator’s compliance with this requirement; no changes are made to the text of this paragraph. No revisions are made to paragraph (d) and no other public comment was received on this section. Section 37.93 Approval of Spirometry Facilities Section 37.93 establishes standards by which NIOSH approves facilities that conduct spirometry tests, including ensuring that spirometry results are of adequate quality, and specifying programmatic approaches to quality assurance and addressing deficiencies. Paragraph (a) requires that NIOSHapproved facilities be able to provide spirometry of high technical quality by meeting the standards in this subpart. The paragraph is revised to replace the term ‘‘spirometry examinations’’ with the more common ‘‘spirometry testing,’’ and to remove the link to the Spirometry Facility Certification Document to avoid incorrect information if the NIOSH Web site is updated. PO 00000 Frm 00007 Fmt 4701 Sfmt 4700 73275 Paragraph (b) establishes that a spirometry quality assurance program must be in place at the facility to minimize the rate of invalid test results. Paragraph (b)(1) requires instrument calibration checks, performed in accordance with the 2005 ATS/ERS Standardisation of Spirometry guidelines. The regulatory text is revised to clarify that instrument calibration check records must be maintained by the facility and available for inspection by NIOSH, as deemed necessary. One public commenter stated that the calibration check procedures as described in the proposed rule were most relevant to volume spirometers, which are no longer being produced and are increasingly unavailable for purchase. In response to the public comment, the regulatory text in paragraph (b)(1) is revised and divided into smaller paragraphs to clarify which calibration check procedures are expected for volume spirometers (paragraph (b)(1)(i)) and flow-type spirometers (paragraph (b)(2)(ii)). These procedures are consistent with guidance cited by the commenter and published by the Occupational Safety and Health Administration.7 A new paragraph (b)(1)(iii) contains the existing sentence regarding the retention and maintenance of instrument calibration check records, and is changed to clarify that records will be available for inspection by NIOSH, as deemed necessary. Paragraph (b)(2) requires automated maneuver and test session qualitychecks. The paragraph is revised to clarify that the screen displayed error messages must alert the technician to maneuver acceptability and test session non-repeatability. The paragraph is also revised to clarify that each spirometry test session must have the goal of obtaining 3 acceptable with 2 repeatable forced vital capacity maneuvers. A public commenter also expressed concern that technicians understand that although the error messages referenced in paragraph (b)(2) are helpful, they are unreliable and cannot be relied on alone to evaluate and determine test validity. NIOSH agrees that technicians should not rely on the equipment alone to alert them of testing errors. Accordingly, § 37.95(a) requires all providers who collect spirometry data to successfully complete a NIOSHapproved spirometry training course. The spirometry course curriculum includes the identification and 7 Occupational Safety and Health Administration, U.S. Department of Labor, Spirometry Testing in Occupational Health Programs: Best Practices for Healthcare Professionals, OSHA 3637–03 2013, https://www.osha.gov/Publications/OSHA3637.pdf. E:\FR\FM\24OCR3.SGM 24OCR3 73276 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations correction of technical and subject performance errors.8 Course participants are given additional curriculum materials to use as guides for correcting these testing errors, which they can retain for future reference in their clinics.9 Paragraph (b)(2) is not changed in response to the public comment. Paragraph (b)(3) requires ongoing monitoring of spirometry test quality. The paragraph is revised to clarify that NIOSH may provide quality performance feedback to the spirometry technician(s). The word ‘‘examination,’’ used to characterize spirometry data, is removed from paragraph (b)(4), which concerns quality assurance audits. The word ‘‘as’’ is inserted into paragraph (c), which concerns noncompliance, to improve the first sentence; the word ‘‘examination’’ is removed, for the reasons discussed above. Paragraph (d), revocation of approval, is unchanged. Finally, in paragraph (e), references to chest radiographs are removed and/or changed to reference spirometry tests, in keeping with the theme of this subpart. These changes include replacing the term ’’medical examinations’’ with ‘‘spirometry tests’’ and removing the reference to radiograph examinations, classifications, and images. Section 37.94 Respiratory assessment form Section 37.94 requires that a respiratory assessment form must be completed for each miner upon testing. The link to the form on the NIOSH Web site is removed and the word ‘‘examination’’ is replaced with ‘‘testing.’’ No comments were submitted on this section. sradovich on DSK3GMQ082PROD with RULES3 Section 37.95 Specifications for Performing Spirometry Tests Section 37.95 establishes standards for the performance of spirometry tests; the term ‘‘examinations’’ is replaced with ‘‘tests’’ in the section heading. Paragraph (a) of this section requires that persons administering spirometry tests for the CWHSP demonstrate completion of NIOSH-approved spirometry training, and maintain their knowledge by periodically completing an approved refresher course. The paragraph is revised to remove the link 8 See Spirometry: What is the Design and Content of an Approved Course? http://www.cdc.gov/niosh/ topics/spirometry/content-approved-course.html. 9 See NIOSH, Get Valid Spirometry Results EVERY Time, DHHS (NIOSH) Publication No. 2011–135, March 2011, http://www.cdc.gov/niosh/ docs/2011-135/, and NIOSH, Spirometry Quality Assurance: Common Errors and Their Impact on Test Results, DHHS (NIOSH) Publication Number 2012–116, January 2012, http://www.cdc.gov/niosh/ docs/2012-116/default.html. VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 to the Spirometry Results Notification Form. Paragraph (b) establishes specifications for the spirometry testing equipment used to conduct tests pursuant to this Part. A public commenter recommended that the realtime displays should be large in order to allow the technician to quickly identify issues with the tests. NIOSH agrees with the commenter’s concern and has required that spirometry testing equipment conform with the 2005 ATS/ ERS Standardisation of Spirometry specifications for graphics (real-time displays and test reports), which should be a minimum size for the proper recognition of errors and acceptability of test maneuvers. As part of the approval process, clinics are required to provide information pertaining to spirometer manufacturer, model, and serial number for each spirometer used during miner testing. This spirometer information allows NIOSH to confirm that the system display meets minimum requirements. No changes are made to paragraph (b). Paragraph (c) specifies certain required documents and procedures during performance of spirometry testing, including the pre-test checklist, Respiratory Assessment form, collection of anthropometric and demographic information, and the spirometry procedure itself, which must be conducted in accordance with testing procedures described in the 2005 ATS/ ERS Standardisation of Spirometry and the 2010 Standardisation of Lung Function Testing, authors’ replies to readers’ comments, which are incorporated by reference. The paragraph is revised to include a new paragraph (c)(1), which clarifies that the Miner Identification Document described in § 37.20 must be completed for each miner at the facility where spirometry is performed; the remaining numbered paragraphs are re-numbered accordingly. In the paragraphs now designated (c)(2) and (3), which require completion of the pre-test checklist and the Respiratory Assessment form, respectively, the links to those documents are removed, for the reason discussed above. Paragraph (c)(4), which requires the collection of anthropometric and demographic information, is revised to clarify that the data must either be entered into the facility’s computer and transmitted electronically with the spirometry data file or submitted, if required under the facility’s approval, on the Spirometry Results Notification form. Language concerning spirometry equipment that does not permit electronic transfer of data files is removed because all PO 00000 Frm 00008 Fmt 4701 Sfmt 4700 facilities that are approved to participate in the CWHSP will submit spirometry data electronically, whether in the form of spirometry data files or in the form of a completed Spirometry Results Notification Form (CDC/NIOSH 2.15) accompanied by a spirometry report PDF that contains graphics for NIOSH inspection of FVC maneuver quality. The paragraph (c)(5) heading is revised to clarify that the topic of the paragraph is test procedures. Paragraph (d), concerning the submission of test results by the approved facility to NIOSH, is removed because it is redundant. Requirements for the submission of spirometry results to NIOSH are consolidated in § 37.96(c). No changes are made to former paragraph (e), now designated paragraph (d), concerning records retention, other than to substitute ‘‘test’’ and ‘‘sessions’’ for ‘‘examination’’ and ‘‘examinations,’’ and no other public comments were received on this section. Section 37.96 Spirometry Interpretations, Reports, and Submission Section 37.96 establishes requirements for the interpretation of spirometry test results, as well as specifications for the content, deletion, and transmission of test reports. The heading of this section is revised to replace the word ‘‘notifications’’ with ‘‘submission’’ to reflect a reorganization of this section, discussed below. Paragraph (a) of this section requires qualified health care professionals at the facilities to interpret results using a standardized approach, described in the 2005 ATS/ERS Interpretative Strategies for Lung Function Tests, and the 2014 Official ATS Standards: Spirometry in the Occupational Setting, which are incorporated by reference. No changes are made to paragraph (a). Paragraph (b) specifies the content of spirometry test reports and the deletion of files and forms associated with the testing. The title of paragraph (b) is edited for clarity, ‘‘Spirometry reports at NIOSH-approved spirometry facilities.’’ The phrase ‘‘at a minimum’’ is removed from paragraph (b)(1) to clarify that spirometry reports must contain the elements listed in this paragraph. Paragraph (b)(1) is also divided into smaller paragraphs to clarify the required elements, and revised by adding the word ‘‘threshold’’ to describe the lower limit of normal values required. Paragraph (b)(2) is unchanged. The language in paragraph (c), which requires that findings are communicated to the miner or the miner’s designated physician, is moved from § 37.96 to a new § 37.97; the existing section E:\FR\FM\24OCR3.SGM 24OCR3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES3 containing references to documents incorporated by reference into this subpart is renumbered § 37.98. The notifications to miners section, public comment, and NIOSH response to comment are discussed below. With the removal of the language in paragraph (c), paragraph (d), concerning the submission of spirometry results to NIOSH, is redesignated paragraph (c). The text in this paragraph is revised to clarify that each facility must submit spirometry results and completed forms to NIOSH within 14 days of a spirometry test. The link to the Spirometry Notification Form is removed, as discussed above, and the name of the form is corrected. This paragraph is divided into smaller paragraphs to aid clarity. Paragraph (c)(1) concerns the submission of spirometry test results in the form of an electronic data file. CWHSP prefers the submission of all test results and data points using CSV or XML files. The submission must be carried out as specified in the facility’s approval. Paragraph (c)(2) allows the submission of test results electronically using the Spirometry Results Notification form, when specified under a facility’s approval. Electronic submission of test results via ePDF is acceptable when facilities are otherwise unable to submit electronic files in CSV or XML format. These changes are not substantive. The final paragraph, concerning the confidentiality of test results, is redesignated paragraph (d). The word ‘‘examinations’’ is removed from the paragraph heading. The text in this paragraph is revised to clarify that medical records containing protected health information must be maintained pursuant to the requirements in § 37.93(e). Finally, paragraph (d) is divided into two smaller paragraphs for clarity. No public comment was received on this section. Section 37.97 Notification of Spirometry Results New § 37.97, concerning the notification to miners or the miner’s designated physician of spirometry results, comprises text that was located in § 37.96(c). It is moved to a new section to make information about notification procedures more accessible and to mirror the structure of the subpart concerning chest radiographs. The original text is revised slightly to clarify that a comparison between current and previously submitted spirometry tests will be provided by NIOSH to the miner if the results from more than one set of spirometry results are available. One public commenter recommended that the results of both VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 radiography and spirometry be made available to a health professional designated by the mine operator. NIOSH declines to adopt this recommendation; a summary of the public comment and NIOSH’s response is located above, in the discussion concerning § 37.54. Section 37.98 by Reference Standards Incorporated Existing § 37.97, concerning standards incorporated by reference into this subpart, is redesignated § 37.98. Paragraph (a) is revised to update the name of the NIOSH Respiratory Health Division, as discussed above. The link to the ATS Standardization of Spirometry; 1994 Update, is updated, as is the link to the 2005 ATS/ERS Standardisation of Spirometry. No comments were submitted on this section. C. Subpart—General Requirements This subpart establishes general requirements for all surface and underground coal mine operators. Section 37.100 Coal Mine Operator Plan for Medical Examinations Section 37.100 requires that all coal mine operators submit a plan for providing miners with radiography and spirometry examinations. Paragraph (a) requires operators to submit and receive NIOSH approval for a plan to provide the examinations, as well as occupational histories and respiratory assessments; it is unchanged. Paragraph (a)(1) specifies that on or after August 1, 2014, a person becoming a coal mine operator, for example by purchasing an existing mine or developing a new mine, or a mine operator without an approved plan must submit a plan within 60 days that provides for chest radiographs and occupational histories. The paragraph is revised, inserting the word ‘‘only,’’ to clarify that the provision of spirometry tests need not be included for a plan approved pursuant to this paragraph. Paragraph (a)(2) states that all operators with approved examination plans providing only for chest radiographs and occupational histories will be notified by MSHA when they are required to submit an amended plan that includes spirometry and respiratory assessments. In paragraph (b), which lists the required components of the operator’s plan, the term ‘‘X-ray’’ is replaced with ‘‘radiograph’’ and ‘‘tests’’ are replaced with ‘‘examinations’’ in paragraph (b)(4); ‘‘shall’’ is replaced with ‘‘must’’ or ‘‘will’’ in paragraph (b)(5) in PO 00000 Frm 00009 Fmt 4701 Sfmt 4700 73277 accordance with the Federal Plain Language Guidelines.10 Paragraph (c), which allows operators to provide for alternate examination facilities, is revised to clarify that the alternate facilities should be identified in the operator’s plans submitted to NIOSH for approval. ‘‘Shall’’ is also replaced by ‘‘must’’ and ‘‘shall be’’ is replaced with ‘‘is’’ in paragraph (d), which states that an approved plan remains in effect even when the mine operator has transferred responsibility for the mine to a new operator. Paragraph (e), concerning changes in mine plans, is unchanged. Paragraph (f), which requires the display of a proposed plan or a proposed change in plan, is revised slightly to clarify that only changes to a NIOSH-approved plan need be displayed. In paragraph (g), which requires that mine operators resubmit a plan for each mine upon notification from NIOSH, the word ‘‘will’’ is replaced with ‘‘must’’ in accordance with Federal Plain Language Guidelines. No public comment was received and no other changes are made to this section. Section 37.101 Approval of Plans Section 37.101 establishes that the operator’s plan will be approved by NIOSH if it is found to meet the requirements in this subpart. Paragraphs (a) and (b), concerning approval and denial of mine operator plans, are unchanged. Paragraph (c) is revised to clarify that NIOSH will inform MSHA if an operator’s plan is denied, in addition to the existing requirement for NIOSH to inform the operator. No comments were submitted on this section. Section 37.102 Transfer of Affected Miner to Less Dusty Area Section 37.102 requires that any miner who has evidence of the development of pneumoconiosis, as determined by NIOSH, must be given the option of transferring to a less dusty area of the mine. A public commenter recommended that transfer to a less dusty area should be mandatory for all miners with ILO classifications greater than or equal to category 2. According to the commenter, only 19 percent of over 3,000 miners who were offered an opportunity to transfer to a less dusty area since 1980 have exercised that option. Thus, the commenter thinks that the intervention program is ineffective ‘‘in preventing pulmonary function 10 See Federal Plain Language Guidelines, http:// www.plainlanguage.gov/howto/guidelines/ FederalPLGuidelines/index.cfm. E:\FR\FM\24OCR3.SGM 24OCR3 73278 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations loss,’’ and that ‘‘stronger measures must be put in place to increase the participation in the transfer option.’’ NIOSH cannot require transfer of a miner who demonstrates evidence of development of pneumoconiosis to a less dusty area. NIOSH concurs with MSHA’s position, as addressed in the agency’s May 1, 2014 final rule, that a mandatory transfer program would compromise the confidentiality of the CWHSP. In addition, section 203 of the Mine Act (30 U.S.C. 843) only speaks of optional transfers, and does not authorize mandatory transfers. No additional public comment was received, and no changes are made to the regulatory text. Section 37.103 Medical Examinations at Miner’s Expense Section 37.103 states that any miner who wishes to obtain a radiography examination or spirometry test at his or her own expense may do so. For clarity, the word ‘‘interpretation’’ is replaced with ‘‘evaluation of spirometry test results.’’ No public comment was received on this section. sradovich on DSK3GMQ082PROD with RULES3 General One commenter asserted that NIOSH must take into account the effects of cigarette smoking on the health outcomes of coal miners, particularly chronic obstructive pulmonary disease (COPD). The commenter referred to a 1995 NIOSH Criteria Document concerning occupational exposure to respirable coal mine dust, which recommended that underground and surface coal mine operators prohibit smoking in all mines and other work areas associated with mining, provide counseling to smokers about their increased risk of lung cancer and COPD, and encourage them to participate in a smoking cessation program.11 NIOSH acknowledges the effects of smoking and dust exposure on the development of occupational respiratory disease. Accordingly, NIOSH uses the Respiratory Assessment Form (CDC/ NIOSH 2.13) in the course of conducting a spirometry test; the form includes detailed questions designed to establish the miner’s smoking history.12 At the population level, this data collection will allow NIOSH to take smoking into account in evaluations of coal miners’ respiratory health and will assist NIOSH in developing interventions to benefit underground and surface coal miners. At the level of the individual miner, the 11 National Institute for Occupational Safety and Health, HHS, Criteria for a Recommended Standard: Occupational Exposure to Respirable Coal Mine Dust, DHHS (NIOSH) Publication No. VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 goal of the radiography and spirometry conducted pursuant to part 37 is to identify radiographic evidence of pneumoconiosis and spirometric evidence of respiratory impairment, not to establish disease causation. NIOSH lacks authority to prohibit smoking in underground and surface coal mines, but includes information about health effects of smoking in notifications to individual miners. Fortunately, many mines prohibit smoking onsite. 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 not being treated as a ‘‘significant’’ action under E.O. 12866. It finalizes and makes non-substantive revisions to those sections in 42 CFR part 37 which added requirements for mine operators to provide symptom assessment and spirometry testing for the surveillance of decreased lung function to all coal miners, and extended existing requirements to provide chest X-rays and occupational histories for underground coal miners to surface coal mine operators. The nonsubstantive revisions made in this final action to those sections of 42 CFR part 37 that were promulgated by interim final rule in August 2014 (79 FR 45110) will not result in costs to either the agency or its stakeholders. 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. 601 et seq., requires each agency to consider the potential impact of its regulations on small entities including small businesses, small governmental units, and small not-forprofit organizations. This rule 95–106, September 1995, http://www.cdc.gov/ niosh/docs/95-106/pdfs/95-106.pdf. 12 See Respiratory Assessment Form (CDC/NIOSH 2.13), questions 9, 9a, 9b, 9c, 9d, 10, 11, http:// PO 00000 Frm 00010 Fmt 4701 Sfmt 4700 establishes requirements for the provision of chest X-rays and spirometry tests to all coal miners, and sets standards for the approval of testing facilities and transmission of test data. The potential impact on small businesses has been analyzed by MSHA, in the Regulatory Economic Analysis published in support of that agency’s May 1, 2014 final rule (see http:// www.msha.gov/REGS/REA/ CoalMineDust2010.pdf). This final rule does not impose any new requirements on small radiographic or spirometry facilities that participate in the Coal Workers’ Health Surveillance Program administered by NIOSH under 42 CFR part 37. This final rule will not impose a significant economic burden on small coal mines. Accordingly, 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. C. Paperwork Reduction Act The Paperwork Reduction Act, 44 U.S.C. 3501 et 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 action continues to impose the same information collection requirements as under the August 2014 IFR, including the submission of the following forms: • Consent, Release, and History Form for Autopsy [CDC/NIOSH (M)2.6] • Chest Radiograph Classification Form [CDC/NIOSH 2.8] • Miner Identification Document [CDC/ NIOSH 2.9] • Coal Mine Operator’s Plan [CDC/ NIOSH (M)2.10] • Radiographic Facility Certification Document [CDC/NIOSH (M)2.11(E)] • Physician Application for Certification [CDC 2.12 (E)] • Respiratory Assessment Form [CDC/ NIOSH 2.13] • Spirometry Facility Certification [CDC/NIOSH 2.14] • Spirometry Results Notification Form [CDC/NIOSH 2.15] • Coal Contractor Plan [CDC/NIOSH (M) 2.18 (E)] These forms are approved by OMB for data collected under the National Coal Workers’ Health Surveillance Program (CWHSP) (OMB Control No. 0920–0020, expires June 30, 2018). HHS estimates that the paperwork burden associated with this rulemaking is 20,282 hours. www.cdc.gov/niosh/topics/surveillance/pdfs/ cwhsp-respiratoryassessment-2-13.pdf. E:\FR\FM\24OCR3.SGM 24OCR3 73279 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations Number of responses per respondent Number of respondents Average burden per response (in hours) Total burden hours Type of respondent Form name Coal Mine Operator ......................................... Coal Mine Contractor ...................................... Radiograph Facility Supervisor ....................... Coal Miner ....................................................... Coal Miner—Radiograph ................................. B Reader Physician ......................................... Physicians taking the B Reader Examination Spirometry Facility Supervisor ......................... Spirometry Facility Employee .......................... Spirometry Technician ..................................... Coal Mine—Spirometry ................................... Pathologist ....................................................... Pathologist ....................................................... 388 575 40 14,560 14,560 10 100 100 14,560 14,560 14,560 5 5 1 1 1 1 1 3014 1 1 1 1 1 1 1 30/60 30/60 30/60 20/60 15/60 3/60 10/60 30/60 5/60 20/60 15/60 5/60 5/60 194 288 20 4,854 3,640 1,507 17 50 1,214 4,854 3,640 1 1 Next-of-kin for deceased miner ....................... 2.10 .................................... 2.18 .................................... 2.11 .................................... 2.9 ...................................... No form required ............... 2.8 ...................................... 2.12 .................................... 2.14 .................................... 2.13 .................................... 2.15 .................................... No form required ............... Invoice—No standard form Pathology Report—No standard form. 2.6 ...................................... 5 1 15/60 2 Total .......................................................... ............................................ ........................ ........................ ........................ 20,282 D. Small Business Regulatory Enforcement Fairness Act has been reviewed carefully to eliminate drafting errors and ambiguities. the Federal Plain Writing Act guidelines. As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et 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. 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.’’ List of Subjects in 42 CFR Part 37 E. Unfunded Mandates Reform Act of 1995 Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et 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. sradovich on DSK3GMQ082PROD with RULES3 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 classifications 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 action affects radiographs submitted to DOL for the purpose of reviewing and administering those claims. This rule VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 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 drafting this final action consistent with PO 00000 Frm 00011 Fmt 4701 Sfmt 4700 Chronic obstructive pulmonary disease, Coal workers’ pneumoconiosis, Incorporation by reference, Lung diseases, Mine safety and health, Occupational safety and health, Pneumoconiosis, Respiratory and pulmonary diseases, Silicosis, Spirometry, Surface coal mining, Transfer rights, Underground coal mining, 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 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. 2. Amend § 37.2 by revising the introductory text and the definitions of ‘‘Act’’, ‘‘Convenient time and place’’, ‘‘Digital radiography systems’’, ‘‘ILO Classification’’, ‘‘NIOSH’’, ‘‘Panel of B Readers’’, and ‘‘Radiologic technologist’’ and by adding definitions of ‘‘B Reader’’ and ‘‘Facility’’ to read as follows: ■ § 37.2 Definitions. Any term defined in the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 801 et seq., Pub. L. 95–164, as amended) and not defined below will have the meaning given it in the Act. As used in this subpart: E:\FR\FM\24OCR3.SGM 24OCR3 sradovich on DSK3GMQ082PROD with RULES3 73280 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations Act means the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 801, et seq., Pub. L. 95–164, as amended). B Reader means a physician certified by NIOSH as able to classify chest radiographs using the ILO Classification system, pursuant to § 37.52(b). * * * * * Convenient time and place means that an examination conducted pursuant to this part 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 definition. Digital radiography systems, as used in this context, include both Digital Radiography (DR) and Computed Radiography (CR) systems. (1) Computed radiography (CR) is the term for digital radiographic image acquisition systems that detect radiographic signals using a cassettebased 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 radiographic image acquisition systems in which the radiographic signals received by the image detector are converted nearly instantaneously to electronic signals without movable cassettes. Facility means a facility or organization licensed to provide health care by the State or Territory in which services are provided, such as a hospital, a clinic, or other provider that performs medical examinations. ILO Classification means the classification of radiographs using the International Classification of Radiographs of Pneumoconioses, a 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 approved by NIOSH as equivalent. The ILO Classification is incorporated by reference into §§ 37.50(a) and (c) and 37.51(b). * * * * * NIOSH means the National Institute for Occupational Safety and Health VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 (NIOSH), located within the Centers for Disease Control and Prevention (CDC). Within NIOSH, the Respiratory Health Division (RHD), 1095 Willowdale Road, Morgantown, WV 26505, is the organizational unit that has programmatic responsibility for the Coal Workers’ Health Surveillance Program. * * * * * Panel of B Readers means the group of physicians that are currently certified by NIOSH as B Readers and who classify or otherwise evaluate radiographs for the Coal Workers’ Health Surveillance Program. * * * * * Radiologic technologist means an individual who has met the requirements for privileges to perform general radiographic procedures and for competence in using the equipment and software employed by the examining facility to obtain chest radiographs as specified by the State or Territory and examining facility in which such services are provided. Optimally, such an individual will 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 offered by the American Registry of Radiologic Technologists. * * * * * ■ 3. Revise § 37.3 to read as follows: § 37.3 Chest radiographs required for miners. (a) Voluntary examinations. Every operator must provide to each miner who is employed in or at any of its coal mines and who was employed in coal mining prior to December 30, 1969, or who has completed the required examinations under paragraph (b) of this section an opportunity for a chest radiograph at no cost to the miner in accordance with this subpart: (1) NIOSH will notify the operator of each coal mine of a period within which the operator may provide examinations to each miner employed at its coal mine. The period must begin no sooner than 3.5 years and end no later than 4.5 years subsequent to the ending date of the previous 6-month period specified for a coal mine either by the operator on an approved plan or by NIOSH if the operator did not submit an approved plan. Within the period specified for each mine, the operator may select a 6month period within which to provide examinations in accordance with a plan approved under § 37.101. (2) Within either the next or future period(s) specified to the operator for PO 00000 Frm 00012 Fmt 4701 Sfmt 4700 each of its coal mines, the operator of the coal mine may select a different 6month period for each of its mines within which to offer examinations. In the event the operator does not submit an approved plan, NIOSH will specify a 6-month period to the operator within which miners must have the opportunity for examinations. (b) Mandatory examinations. Every operator must provide to each miner who begins working in or at an underground coal mine for the first time after December 30, 1969 or in or at a surface coal mine for the first time after August 1, 2014: (1) An initial chest radiograph, as soon as possible, but in no event later than 30 days after commencement of employment or within 30 days of approval of a plan to provide chest radiographs. An initial chest radiograph given to a miner according to former regulations for this subpart prior to August 1, 2014 will also be considered as fulfilling this requirement. (2) A second chest radiograph, in accordance with this subpart, 3 years following the initial examination if the miner is still engaged in coal mining. A second radiograph given to a miner according to former regulations under this subpart prior to August 1, 2014 will be considered as fulfilling this requirement. (3) A third chest radiograph 2 years following the second chest radiograph if the miner is still engaged in coal mining and if the second radiograph shows evidence of category 1 (1/0, 1/1, 1/2), category 2 (2/1, 2/2, 2/3), category 3 (3/ 2, 3/3, 3/+) simple pneumoconiosis, or complicated pneumoconiosis (ILO Classification) or if the second spirometry examination specified in § 37.92(b)(2) shows evidence of decreased lung function to the extent specified in § 37.92(b)(3). (c) Notification. NIOSH will notify the miner when he or she is due to receive the second or third mandatory examination under paragraph (b) of this section. NIOSH will notify the coal mine operator when the miner is to be given a second examination. (1) The operator will be notified of a miner’s third examination only with the miner’s written consent. The notice to the operator will not state the medical reason for the examination or that it is the third examination in the series. (2) If the miner is notified by NIOSH that the third mandatory examination is due and the operator is not so notified, availability of the radiographic examination under the NIOSH-approved operator’s plan will constitute the operator’s compliance with the requirement to provide a third E:\FR\FM\24OCR3.SGM 24OCR3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations mandatory examination even if the miner refuses to take the examination. (d) Availability of chest radiographs. The opportunity for chest radiographs to be made available by an operator for purposes of this subpart must be provided in accordance with a plan that has been submitted and approved in accordance with this part. ■ 4. Revise § 37.4 to read as follows: § 37.4 Chest radiographic examinations conducted by the Secretary. (a) The Secretary will give chest radiographs or make arrangements with an appropriate person, agency, or institution to give the chest radiographs and with A or B Readers to interpret the radiographs required under this subpart in the locality where the miner resides, at the mine, or at a medical facility easily accessible to a mining community or mining communities, under the following circumstances: (1) Where, in the judgment of the Secretary, due to the lack of adequate medical or other necessary facilities or personnel at the mine or in the locality where the miner resides, the required radiographic examination cannot be given. (2) Where the operator has not submitted an approvable plan. (3) Where, after commencement of an operator’s program pursuant to an approved plan and after notice to the operator of his failure to follow the approved plan and, after allowing 15 calendar days to bring the program into compliance, the Secretary determines and notifies the operator in writing that the operator’s program still fails to comply with the approved plan. (b) The operator of the mine must reimburse the Secretary or other person, agency, or institution as the Secretary may direct, for the cost of conducting each examination made in accordance with this section. (c) All examinations given or arranged by the Secretary will comply with the time requirements of § 37.3. Whenever the Secretary gives or arranges for the examinations of miners at a time, a written notice of the arrangements will be sent to the operator who must post the notice on the mine bulletin board. ■ 5. Revise § 37.10 to read as follows: sradovich on DSK3GMQ082PROD with RULES3 § 37.10 Standards incorporated by reference. (a) Certain material is incorporated by reference into this subpart, Subpart— Chest Radiographic Examinations, with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, NIOSH must publish notice of VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 change in the Federal Register and the material must be available to the public. All approved material is available for inspection at NIOSH, Respiratory Health Division, 1095 Willowdale Road, Morgantown, WV 26505. To arrange for an inspection at NIOSH, call 304–285– 5749. Copies are also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030 or go to http://www.archives.gov/federal_ register/code_of_federal_regulations/ ibr_locations.html. (b) American Association of Physicists in Medicine, Order Department, Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI 53705, http:// www.aapm.org/pubs/reports: (1) AAPM On-Line Report No. 03, Assessment of Display Performance for Medical Imaging Systems, April 2005, into § 37.51(d) and (e). (2) AAPM Report No. 14, Performance Specifications and Acceptance Testing for X-Ray Generators and Automatic Exposure Control Devices, Report of the Diagnostic X-Ray Imaging Committee Task Group on Performance Specifications and Acceptance Testing for X-Ray Generators and Automatic Exposure Control Devices, published by the American Institute of Physics for AAPM, January 1985, into §§ 37.42(h) and 37.44(g). (3) AAPM Report No. 31, Standardized Methods for Measuring Diagnostic X-Ray Exposures, Report of Task Group 8, Diagnostic X-Ray Imaging Committee, published by the American Institute of Physics, July 1990, into § 37.44(g). (4) AAPM Report No. 74, Quality Control in Diagnostic Radiology, Report of Task Group 12, Diagnostic X-Ray Imaging Committee, published by Medical Physics Publishing for AAPM, July 2002, into §§ 37.42(h), 37.43(f), and 37.44(g). (5) AAPM Report No. 93, Acceptance Testing and Quality Control of Photostimulable Storage Phosphor Imaging Systems, October 2006, into §§ 37.42(i) and 37.44(g). (6) AAPM Report No. 116, An Exposure Indicator for Digital Radiography, Report of AAPM Task Group 116, published by AAPM, July 2009, into § 37.44(g). (c) American College of Radiology, 1891 Preston White Dr., Reston, VA 20191, http://www.acr.org: (1) ACR Practice Guideline for Diagnostic Reference Levels in Medical X-Ray Imaging, Revised 2008 (Resolution 3), into §§ 37.42(i) and 37.44(g). PO 00000 Frm 00013 Fmt 4701 Sfmt 4700 73281 (2) [Reserved] (d) International Labour Office, CH– 1211 Geneva 22, Switzerland, http:// www.ilo.org/publns: (1) Guidelines for the Use of the ILO International Classification of Radiographs of Pneumoconioses, Revised Edition 2011, into §§ 37.50(a), 37.50(c), and 37.51(b). (2) [Reserved] (e) National Council on Radiation Protection and Measurements, NCRP Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814–3095, Telephone (800) 229–2652, http:// www.ncrppublications.org: (1) NCRP Report No. 102, Medical Xray, Electron Beam, and Gamma-Ray Protection for Energies Up to 50 MeV (Equipment Design, Performance, and Use), issued June 30, 1989, into § 37.45. (2) NCRP Report No. 105, Radiation Protection for Medical and Allied Health Personnel, issued October 30, 1989, into § 37.45. (3) NCRP Report No. 147, Structural Shielding Design for Medical X-Ray Imaging Facilities, revised March 18, 2005, into § 37.45. (f) National Electrical Manufacturers Association, 1300 N. 17th Street, Rosslyn, VA 22209, http:// medical.nema.org: (1) DICOM Standard PS 3.3–2011, Digital Imaging and Communications in Medicine (DICOM) standard, Part 3: Information Object Definitions, copyright 2011, into § 37.42(i). (2) DICOM Standard PS3.4–2011, Digital Imaging and Communications in Medicine (DICOM) standard, Part 4: Service Class Specifications, copyright 2011, into § 37.42(i). (3) DICOM Standard PS 3.10–2011, Digital Imaging and Communications in Medicine (DICOM) standard, Part 10: Media Storage and File Format for Media Interchange, copyright 2011, into § 37.42(i). (4) DICOM Standard PS 3.11–2011, Digital Imaging and Communications in Medicine (DICOM) standard, Part 11: Media Storage Application Profiles, copyright 2011, into § 37.42(i). (5) DICOM Standard PS 3.12–2011, Digital Imaging and Communications in Medicine (DICOM) standard, Part 12: Media Formats and Physical Media for Media Interchange, copyright 2011, into §§ 37.42(i) and 37.44(a). (6) DICOM Standard PS 3.14–2011, Digital Imaging and Communications in Medicine (DICOM) standard, Part 14: Grayscale Standard Display Function, copyright 2011, into §§ 37.42(i)(5) and 37.51(d). (7) DICOM Standard PS 3.16–2011, Digital Imaging and Communications in Medicine (DICOM) standard, Part 16: E:\FR\FM\24OCR3.SGM 24OCR3 73282 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations Content Mapping Resource, copyright 2011, into § 37.42(i). ■ 6. Revise § 37.20 to read as follows: § 37.20 Miner identification document. As part of the examination, a Miner Identification Document (CDC/NIOSH (M)2.9) which includes an occupational history questionnaire must be completed for each miner at the facility where the examination is made (this document is required for both radiographic and spirometry examinations conducted pursuant to this part). ■ 7. Revise § 37.40 to read as follows: § 37.40 General provisions. (a) The chest radiographic examination must be given at a convenient time and place. (b) The chest radiographic examination consists of the chest radiograph, a completed Chest Radiograph Classification Form (CDC/ NIOSH 2.8), and a completed Miner Identification Document (CDC/NIOSH 2.9). (c) A radiographic examination must be made in a facility approved in accordance with § 37.43 or § 37.44. Chest radiographs of miners under this section must be performed: (1) By or under the supervision of a physician who makes chest radiographs in the normal course of practice and who has demonstrated ability to make chest radiographs of a quality to best ascertain the presence of pneumoconiosis; or (2) By a radiologic technologist as defined in § 37.2. ■ 8. Revise § 37.43 to read as follows: sradovich on DSK3GMQ082PROD with RULES3 § 37.43 Approval of radiographic facilities that use film radiography systems. (a) Facilities become eligible to participate in this program by demonstrating their ability to make high quality diagnostic chest radiographs by submitting to NIOSH six or more sample chest radiographs made and processed at the applicant facility and which are of acceptable quality to one or more individuals selected by NIOSH from the panel of B Readers. Applicants must also submit a radiograph of a plastic step-wedge object 1 or other test object (available on loan from NIOSH) that was made and processed at the same time with the same technique as the radiographs submitted and processed at the facility for which approval is sought. 1 The plastic step-wedge object is described in E. Dale Trout, John P. Kelley, A Phantom for the Evaluation of Techniques and Equipment Used for Roentgenography of the Chest, Amer J Roentgenol 1973;117(4):771–776. VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 (1) At least one chest radiograph and one test object radiograph must have been made with each unit to be used hereunder. (2) All radiographs must have been made within 15 calendar days prior to submission and must be marked to identify the facility where each radiograph was made, the X-ray machine used, and the date each was made. (3) The chest radiographs will be returned and may be the same radiographs submitted pursuant to § 37.52(a)(2)(i). (b) Each radiographic facility submitting chest radiographs for approval under this section must complete and include a Radiographic Facility Certification Document (CDC 2.11) describing each unit to be used to make chest radiographs under the Act. The form must include: (1) The date of the last radiation safety inspection by an appropriate licensing agency or, if no such agency exists, by a qualified expert as defined in NCRP Report No. 102 (incorporated by reference, see § 37.10); (2) The deficiencies found; (3) A statement that all the deficiencies have been corrected; and (4) The date of acquisition of the unit. To be acceptable, the radiation safety inspection must have been made within 1 year preceding the date of application. (c) Radiographs submitted with applications for approval under this section will be evaluated by one or more individuals selected by NIOSH from the panel of B Readers or by a qualified medical physicist or consultant. Applicants will be advised of any reasons for denial of approval. (d) NIOSH or its representatives may make a physical inspection of the applicant’s facility and any approved radiographic facility at any reasonable time to determine if the requirements of this subpart are being met. (e) NIOSH may require a facility periodically to resubmit radiographs of a test object, sample radiographs, or a Radiographic Facility Certification Document for quality control purposes. (1) Approvals granted hereunder may be suspended or withdrawn by notice in writing when in the opinion of NIOSH the quality of radiographs or information submitted under this section warrants such action. (2) A copy of a notice withdrawing approval will be sent to each operator who has listed the facility as its facility for giving chest radiographs and must be displayed on the mine bulletin board adjacent to the operator’s approved plan. The approved plan will be PO 00000 Frm 00014 Fmt 4701 Sfmt 4700 reevaluated by NIOSH in light of this change. (f) A formal written quality assurance program must be established at each facility addressing radiation exposures, equipment maintenance, and image quality, and must conform to the standards in AAPM Report No. 74, pages 1–19, 47–53, and 56 (incorporated by reference, see § 37.10). (g) In conducting medical examinations pursuant to this part, physicians and radiographic facilities must maintain the results and analysis of these examinations (including any hard copies or digital files containing individual data, classifications, and images) consistent with applicable statutes and regulations governing the handling and protection of individually identifiable health information, including, as applicable, the HIPAA Privacy and Security Rules (45 CFR part 160 and 45 CFR part 164, subparts A, C, and E). ■ 9. Revise § 37.44 to read as follows: § 37.44 Approval of radiographic facilities that use digital radiography systems. (a) Facilities seeking approval must demonstrate the ability to make high quality digital chest radiographs by submitting to NIOSH digital radiographic image files of a test object (e.g., a plastic step-wedge or chest phantom which will be provided on loan from NIOSH) as well as digital radiographic image files from six or more sample chest radiographs that are of acceptable quality to one or more individuals selected by NIOSH from the panel of B Readers and a qualified medical physicist or consultant, both designated by NIOSH. (1) Image files must be submitted on standard portable media (compact or digital video disc) and formatted to meet specifications of the Digital Imaging and Communications in Medicine (DICOM) standard PS 3.12–2011 (incorporated by reference, see § 37.10). Applicants will be advised of any reasons for denial of approval. (2) All submitted images must be made within 60 days prior to the date of application using the same technique, equipment, and software as will be used by the facility under the requested approval. At least six chest radiographs and one test object radiograph must have been made with each digital radiographic unit to be used by the facility under the requested approval. The corresponding radiographic image files must be submitted on standard portable media (compact or digital video disc) and formatted to meet specifications of the current DICOM Standard PS 3.12–2011. E:\FR\FM\24OCR3.SGM 24OCR3 sradovich on DSK3GMQ082PROD with RULES3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations (3) Documentation must include the following: the identity of the facility where each radiograph was made; the Xray machine used; and the model, version, and production date of each image acquisition software program and hardware component. (4) The submitted sample digital chest image files must include at least two taken with the detector in the vertical position and two in the horizontal position where the imaging system permits these positions, and at least two chest images must be from persons within the highest quartile of chest diameters (28 cm or greater). (b) Each radiographic facility submitting chest radiographic image files for approval under this section must complete and include an Radiographic Facility Certification Document (CDC 2.11) describing each system component, and the models and versions of image acquisition hardware and software to be used to make digital chest radiographs under the Act. The form must include: (1) A copy of a dated report signed by a qualified medical physicist, documenting the evaluation of radiation safety and performance characteristics specified in this section for each digital radiography system; (2) A copy of the report of the most recent radiation safety inspection by a licensing agency, if such agency exists; (3) A listing of all deficiencies noted in either of the reports; (4) A statement that all the listed deficiencies have been corrected; and (5) The names and relevant training and experience of facility personnel described in paragraphs (c), (e), and (f) of this section. To be acceptable, the report by the medical physicist and radiation safety inspection specified in this paragraph (b) must have been made within 1 year prior to the date of submission of the application. (c) Facilities must maintain ongoing licensure and certification under relevant local, State, and Federal laws and regulations for all digital equipment and related processes covered under this part. (d) NIOSH or its representatives may make a physical inspection of the applicant’s facility and any approved radiographic facility at any reasonable time to determine if the requirements of this subpart are being met. (e) NIOSH may periodically require a facility to resubmit radiographic image files of the NIOSH-supplied test object (e.g., step-wedge or chest phantom), sample radiographs, or a Radiographic Facility Certification Document. Approvals granted to facilities under this section may be suspended or VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 withdrawn by notice in writing when, in the opinion of NIOSH, deficiencies in the quality of radiographs or information submitted under this section warrant such action. A copy of a notice suspending or withdrawing approval will be sent to each operator that has listed the facility for its use under this part and must be displayed on the mine bulletin board adjacent to the operator’s approved plan. The operator’s approved plan may be reevaluated by NIOSH in response to such suspension or withdrawal. (f) A qualified medical physicist who is familiar with the facility hardware and software systems for image acquisition, manipulation, display, and storage, must be on site or available as a consultant. The physicist must be trained in evaluating the performance of radiographic equipment and facility quality assurance programs, and must be licensed/approved by a State or Territory of the United States or certified by a competent U.S. national board. (g) Facilities must document that testing performed by a qualified medical physicist has verified that performance of each image acquisition system for which approval is sought met initial specifications and standards of the equipment manufacturer and performance testing as required under paragraphs (c), (f), and (h) of this section. (h) A formal written quality assurance program must be established at each facility addressing radiation exposures, equipment maintenance, and image quality, and must conform to the standards in AAPM Report No. 74, pages 1–19, 47–53, and 56, and AAPM Report No. 116, sections VIII, IX, and X (incorporated by reference, see § 37.10). (1) Applications for facility approval must include a comprehensive assessment by a qualified medical physicist within 12 months prior to application addressing the performance of X-ray generators, automatic exposure controls, and image capture systems. The assessment must comply with the following guidelines: AAPM Report No. 93, pages 1–68; AAPM Report No. 74, pages 6–11; and AAPM Report No. 14, pages 1–96 (incorporated by reference, see § 37.10). (2) Radiographic technique charts must be used that are developed specifically for the radiography system and detector combinations used, indicating exposure parameters by anatomic measurements. If automated exposure control devices are used, calibration for chest imaging must be documented using the actual voltages and image capture systems. PO 00000 Frm 00015 Fmt 4701 Sfmt 4700 73283 (i) Radiological exposures resulting from at least ten (randomly selected) digital chest images obtained at the facility must be monitored at least quarterly to detect and correct potential dose creep, using methods specified in AAPM Report No. 31 (incorporated by reference, see § 37.10). Radiation exposures must be compared to a professionally accepted reference level published in the American College of Radiology (ACR) Practice Guideline for Diagnostic Reference Levels in Medical X-Ray Imaging, pages 1–6 (incorporated by reference, see § 37.10). (ii) The medical physicist must conduct an annual assessment of measured or estimated radiation exposures, with specific recommended actions to minimize exposures during examinations performed under this part. (3) For each digital radiography device and system, performance must be monitored annually in accordance with the recommendations of AAPM Report No. 93 (incorporated by reference, see § 37.10), except for the testing specifically excluded below. Documentation must be maintained on the completion of quality assurance testing, including the reproducibility of X-ray output, linearity and reproducibility of mA settings, accuracy and reproducibility of timer and kVp settings, accuracy of source-to-detector distance, and X-ray field focal spot size, selection, beam quality, congruence and collimation. For DR systems, the following tests listed in AAPM Report No. 93 are not required under this part: (i) Section 8.4.5: Laser beam function. (ii) Section 8.4.9: Erasure Thoroughness. (iii) Section 8.4.11: Imaging Plate (IP) Throughput. (4) Facilities must maintain documentation, available for inspection by NIOSH for 5 years, of the ongoing implementation of policies and procedures for monitoring and evaluating the effective management, safety, and proper performance of chest image acquisition, digitization, processing, compression, transmission, display, archiving, and retrieval functions of digital radiography devices and systems. (i) In conducting medical examinations pursuant to this part, physicians and radiographic facilities must maintain the results and analysis of these examinations (including any hard copies or digital files containing individual data, interpretations, and images) consistent with applicable statutes and regulations governing the handling and protection of individually identifiable health information, including, as applicable, the HIPAA E:\FR\FM\24OCR3.SGM 24OCR3 73284 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations Privacy and Security Rules (45 CFR part 160 and 45 CFR part 164, subparts A, C, and E). ■ 10. Revise § 37.50 to read as follows: § 37.50 Interpreting and classifying chest radiographs—film radiography systems. sradovich on DSK3GMQ082PROD with RULES3 (a) Chest radiographs must be interpreted and classified in accordance with the Guidelines for the Use of the ILO International Classification of Radiographs of Pneumoconioses (incorporated by reference, see § 37.10). Chest radiograph interpretations and classifications must be recorded on a paper or electronic Chest Radiograph Classification Form (CDC/NIOSH 2.8). (b) Radiographs must be interpreted and classified only by a physician who reads chest radiographs in the normal course of practice and who has demonstrated proficiency in classifying the pneumoconioses in accordance with § 37.52. (1) Initial clinical interpretations and notification of findings other than pneumoconiosis under paragraph (a) of this section must be provided by a qualified physician who provides these services for the examining facility. This physician must have all required licensure and privileges, and must interpret chest radiographs in the normal course of practice. (2) [Reserved] (c) All interpreters, whenever interpreting chest radiographs made under the Act, must have immediately available for reference a complete set of the standard radiographs for use with the Guidelines for the Use of the ILO International Classification of Radiographs of Pneumoconioses (incorporated by reference, see § 37.10). (d) View boxes used for making interpretations must comply with the following: (1) Fluorescent lamps must be simultaneously replaced with new lamps at 6-month intervals; (2) All the fluorescent lamps in a panel of boxes must have identical manufacturer’s ratings as to intensity and color; (3) The glass, internal reflective surfaces, and the lamps must be kept clean; (4) The unit must be so situated as to minimize front surface glare. ■ 11. Revise § 37.51 to read as follows: § 37.51 Interpreting and classifying chest radiographs—digital radiography systems. (a) For each chest radiograph obtained at an approved facility using a digital radiography system, a qualified and licensed physician who reads chest radiographs in the normal course of practice must provide an initial clinical VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 interpretation and notification, as specified in § 37.54, of any significant abnormal findings other than pneumoconiosis. (b) Chest radiographs must be classified for pneumoconiosis by physician readers (B Readers) who have demonstrated ongoing proficiency, as specified in § 37.52(b), in classifying the pneumoconioses in a manner consistent with the Guidelines for the Use of the ILO International Classification of Radiographs of Pneumoconioses (incorporated by reference, see § 37.10). Chest radiograph classifications must be recorded on a paper or electronic Chest Radiograph Classification Form (CDC/ NIOSH 2.8). (c) All B Readers, whenever classifying digitally-acquired chest radiographs made under the Act, must have immediately available for reference a complete set of NIOSH-approved standard digital chest radiographic images, including electronic images such as scanned images, provided for use with the Guidelines for the Use of the ILO International Classification of Radiographs of Pneumoconioses (incorporated by reference, see § 37.10). (1) Only NIOSH-approved standard digital (electronic) images may be used for classifying digital chest images for pneumoconiosis. (2) Modification of the appearance of the standard images using software tools is not permitted. (d) Viewing systems should enable readers to display the coal miner’s chest image at the full resolution of the image acquisition system, side-by-side with the selected NIOSH-approved standard images for comparison. (1)(i) Image display devices must be flat panel monitors displaying at least 3 MP at 10 bit depth. Image displays and associated graphics cards must meet the calibration and other specifications of the Digital Imaging and Communications in Medicine (DICOM) standard PS 3.14–2011 (incorporated by reference, see § 37.10). (ii) Image displays and associated graphics cards must not deviate by more than 10 percent from the grayscale standard display function (GSDF) when assessed according to the AAPM OnLine Report No. 03, pages 1–146 (incorporated by reference, see § 37.10). (2) Display system luminance (maximum and ratio), relative noise, linearity, modulation transfer function (MTF), frequency, and glare should meet or exceed recommendations listed in AAPM On-Line Report No. 03, pages 1–146 (incorporated by reference, see § 37.10). Viewing displays must have a maximum luminance of at least 171 cd/ m2, a ratio of maximum luminance to PO 00000 Frm 00016 Fmt 4701 Sfmt 4700 minimum luminance of at least 250, and a glare ratio greater than 400. The contribution of ambient light reflected from the display surface, after light sources have been minimized, must be included in luminance measurements. (3) Displays must be situated so as to minimize front surface glare. Readers must minimize reflected light from ambient sources during the performance of classifications. (4) Measurements of the width and length of pleural shadows and the diameter of opacities must be taken using calibrated software measuring tools. If permitted by the viewing software, a record must be made of the presentation state(s), including any noise reduction and edge enhancement or restoration functions that were used in performing the classification, including any annotations and measurements. (e) Quality control procedures for devices used to display chest images for classification must comply with the recommendations of the American Association of Physicists in Medicine AAPM On-Line Report No. 03, pages 1– 146 (incorporated by reference, see § 37.10). (1) If automatic quality assurance systems are used, visual inspection must be performed using one or more test patterns recommended by the medical physicist every 6 months, or more frequently, to check for defects that automatic systems may not detect. (2) [Reserved] (f) Classification of CR and DR digitally-acquired chest radiographs under this part must be performed based on the viewing of images displayed as soft copies using the viewing workstations specified in this section. Classification of radiographs must not be based on the viewing of hard copy printed transparencies of images that were digitally-acquired. (g) The classification of chest radiographs based on digitized copies of chest radiographs that were originally acquired using film-screen techniques is not permissible under this part. ■ 12. Revise § 37.52 to read as follows: § 37.52 Proficiency in the use of systems for classifying the pneumoconioses. (a) First or A Readers: (1) Approval of a physician as an A Reader continues indefinitely if established prior to October 15, 2012. (2) Physicians who desire to become A Readers must demonstrate their proficiency in classifying the pneumoconioses by either: (i) Submitting to NIOSH from the physician’s files six sample chest radiographs which are considered E:\FR\FM\24OCR3.SGM 24OCR3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations properly classified by one or more individuals selected by NIOSH from the panel of B Readers. The six radiographs must consist of two without pneumoconiosis, two with simple pneumoconiosis, and two with complicated pneumoconiosis (these may be the same radiographs submitted for facility approval pursuant to §§ 37.43 and 37.44). The films will be returned to the physician. The classifications must be on the Chest Radiograph Classification Form (CDC/ NIOSH 2.8); or (ii) Satisfactory completion, since June 11, 1970, of a course approved by NIOSH on the ILO International Classification of Radiographs of Pneumoconioses. (b) Final or B Readers: (1) Approval as a B Reader established prior to October 1, 1976, is hereby terminated. (2) Proficiency in evaluating chest radiographs for radiographic quality and in the use of the ILO Classification for interpreting chest radiographs for pneumoconiosis and other diseases must be demonstrated by those physicians who desire to be B Readers by taking and passing a speciallydesigned proficiency examination given on behalf of or by NIOSH at a time and place specified by NIOSH. (i) Each physician who desires to take the digital version of the examination will be provided a complete set of the current NIOSH-approved standard reference digital radiographs. (ii) Physicians who qualify under this provision need not be qualified under paragraph (a) of this section. (c) Physicians who wish to participate in the program must familiarize themselves with the necessary components for attainment of reliable classification of chest radiographs for the pneumoconioses2 and apply using a Physician Application for Certification Form (CDC 2.12(E)). ■ 13. Revise § 37.53 to read as follows: sradovich on DSK3GMQ082PROD with RULES3 § 37.53 Method of obtaining definitive chest radiograph classifications. (a) All chest radiographs which are first classified by an A or B Reader will be submitted by NIOSH to a B Reader qualified pursuant to § 37.52. (1) If there is agreement between the two classifications, as described in paragraph (b) of this section, the result will be considered final and reported to MSHA for transmittal to the miner. 2 NIOSH Safety and Health Topic, Chest Radiography: Radiographic Classification, http:// www.cdc.gov/niosh/topics/chestradiography/ radiographic-classification.html. VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 (2) When agreement is lacking, NIOSH must obtain a third classification from the panel of B Readers. (i) If any two of the three classifications demonstrate agreement, the result must be considered the final determination. (ii) If agreement is lacking among the three classifications, NIOSH will obtain independent classifications from two additional B Readers selected from the panel, and the final determination will be the median category derived from the total of five classifications. (b) Two classifications are considered to be in agreement when: (1) They are derived from complete classifications recorded using approved paper or electronic versions of the Chest Radiograph Classification Form (CDC/ NIOSH 2.8) and received by NIOSH; and (2) Both find either stage A, B, or C complicated pneumoconiosis; or, (3) For simple pneumoconiosis, are both in the same major category or are within one minor category (ILO Classification 12-point scale) of each other (subject to the exception in paragraph (b)(3)(ii) of this section). (i) The higher of the two classifications must be reported. (ii) The only exception to the one minor category principle is a reading sequence of 0/1, 1/0 or 1/0, 0/1, which are not considered agreement. ■ 14. Revise § 37.54 to read as follows: § 37.54 Notification of abnormal radiographic findings. (a) Significant abnormal findings other than pneumoconiosis. The first physician to interpret the radiograph must communicate findings of, or findings suggesting, abnormality of cardiac shape or size, tuberculosis, lung cancer, or any other significant abnormal findings other than pneumoconiosis to the miner indicated on the Miner Identification Document or to the miner’s designated physician. A notice of the communication must be submitted to NIOSH. When significant abnormal findings are reported, NIOSH will also notify the miner to contact his or her physician. (b) Significant changes or progression of disease. When NIOSH has more than one radiograph of a miner in its files and the most recent examination was found by the first physician to interpret the radiograph or subsequently by NIOSH B Readers to show an abnormality of cardiac shape or size, tuberculosis, cancer, complicated pneumoconiosis, and any other significant abnormal findings, NIOSH will arrange for a licensed physician to compare the most recent image to older images and NIOSH will inform the PO 00000 Frm 00017 Fmt 4701 Sfmt 4700 73285 miner of any significant changes or progression of disease or other findings. (c) Notice of eligibility for part 90 transfer option. All final determinations of radiographic classifications providing evidence for development of pneumoconiosis will be reported to the miner or to the miner’s designated physician by NIOSH. In addition, NIOSH will coordinate with MSHA to assure that such miners are notified of eligibility to transfer to a less dusty area, in accordance with section 203 of the Act (see 30 CFR part 90 and § 37.102). (d) Prompt dispatch of findings. NIOSH will make every reasonable effort to process the findings described in paragraph (c) of this section within 60 days of receipt of the information described in § 37.60 in a complete and acceptable form. (1) NIOSH will coordinate with MSHA to provide notice of eligibility for the part 90 transfer option within the same time frame. (2) The results of an examination may not be processed by NIOSH if the examination was made within 6 months of the date of a previous acceptable examination. ■ 15. Revise § 37.60 to read as follows: § 37.60 Submitting required chest radiograph classification and miner identification documents. (a) Each chest radiograph required to be made under this subpart, together with the completed Chest Radiograph Classification Form and the completed Miner Identification Document, must be submitted together for each miner to NIOSH within 14 calendar days after the radiographic examination is given. All submitted items become the property of NIOSH. (1) When the radiograph is digital, the image file for each radiograph, together with either hard copy or electronic versions of the completed Chest Radiograph Classification Form and the completed Miner Identification Document, must be submitted to NIOSH using the software and format specified by NIOSH either using portable electronic media, or a secure electronic file transfer. (2) NIOSH will notify the submitting facility when it has received the image files and forms from the examination. After this notification, the facility will permanently delete, or if this is not technologically feasible for the imaging system used, render permanently inaccessible all files and forms from its electronic and physical files. (b) If NIOSH deems any submission under paragraph (a) of this section inadequate, the operator will be notified of the deficiency. The operator must E:\FR\FM\24OCR3.SGM 24OCR3 73286 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations promptly make appropriate arrangements for the necessary reexamination at no expense to the miner. (c) Failure to comply with paragraph (a) or (b) of this section will be cause to revoke approval of a plan or any other approval as may be appropriate. An approval that has been revoked may be reinstated at the discretion of NIOSH after it receives satisfactory assurances and evidence that all deficiencies have been corrected and that effective controls have been instituted to prevent a recurrence. (d) Chest radiographs and other required documents must be submitted only for miners. (e) If a miner refuses to participate in all phases of the examination prescribed in this subpart, no report need be made. If a miner refuses to participate in any phase of the examination prescribed in this subpart, all forms must be submitted with his or her name and the last four digits of the Social Security number on each. If any form cannot be completed because of the miner’s refusal, it must be marked ‘‘Miner Refuses,’’ and submitted to NIOSH. No submission will be made, however, without a completed Miner Identification Document (CDC/NIOSH 2.9) containing the miner’s name, address, last four digits of the Social Security number and place of employment. ■ 16. Revise § 37.70 to read as follows: sradovich on DSK3GMQ082PROD with RULES3 § 37.70 Review of classifications. (a) Any miner who believes the classification for pneumoconiosis reported to him or her by MSHA is in error may file a written request with NIOSH that his or her radiograph be reevaluated. (1) If the classification was based on agreement between an A Reader and a B Reader, NIOSH will obtain one or more additional classifications by B Readers as necessary to obtain agreement in accordance with § 37.53, and MSHA must report the results to the miner together with notification from MSHA of any rights which may accrue to the miner in accordance with § 37.102. (2) If the reported classification was based on agreement between two (or more) B Readers, the reading will be accepted as conclusive and the miner must be so informed by MSHA. (b) Any operator who is directed by MSHA to transfer a miner to a less dusty atmosphere based on the most recent examination may file a written request with NIOSH to review its findings. The standards set forth in paragraph (a) of this section apply and the operator and VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 miner will be notified by MSHA whether the miner is entitled to the option to transfer. ■ 17. Revise § 37.80 to read as follows: § 37.80 Availability of records for radiographs. (a) Medical information and radiographs on miners will be released by NIOSH only with the written consent from the miner, or if the miner is deceased, written consent from the miner’s widow or widower, next of kin, or legal representative. (b) To the extent authorized, original film radiographs will be made available for examination only at the NIOSH facility in Morgantown, WV. ■ 18. Revise the subpart heading above § 37.90 to read as follows: Subpart—Spirometry Testing ■ 19. Revise § 37.90 to read as follows: § 37.90 Scope. Under this subpart, coal mine operators are required to provide spirometry testing to both current and newly employed coal miners, using medical facilities approved by NIOSH in accordance with standards established in this subpart. ■ 20. Revise § 37.91 to read as follows: § 37.91 Definitions. Definitions provided in § 37.2 will have the same meaning in this subpart. Any term defined in the Federal Mine Safety and Health Act of 1977 (Pub. L. 95–164, as amended) and not defined in § 37.2 or this section will have the meaning given it in the Act. As used in this subpart: ATS means American Thoracic Society. ERS means European Respiratory Society. FET means forced expiratory time, which is the time from the beginning of a forced exhalation (the backextrapolated ‘‘time zero’’) maneuver to the end of expiration. FEV1 means forced expiratory volume in one second, which is the greatest volume of air that can be forcibly blown out within the first second, after full inspiration. FEV1/FVC means the ratio between the largest acceptable FEV1 and the largest acceptable FVC following the forced vital capacity maneuver. It is usually reported as a percentage. FEV6 means forced expiratory volume in six seconds, which is the greatest volume of air that can forcibly be blown out in six seconds, after full inspiration. FVC means forced vital capacity, which is the greatest volume of air that PO 00000 Frm 00018 Fmt 4701 Sfmt 4700 can forcibly be blown out after full inspiration. PEF means peak expiratory flow, which is the maximal airflow generated during a forced vital capacity maneuver. Spirometry test means a pulmonary function test that measures expiratory volume and airflow rates and may determine the presence and severity of lung function impairments, if such are present. ■ 21. Revise § 37.92 to read as follows: § 37.92 Spirometry testing required for miners. (a) Voluntary tests. Each operator must provide to all miners who are employed in or at any of its coal mines the opportunity to have a spirometry test and a respiratory assessment at no cost to the miner at least once every 5 years in accordance with this subpart. The tests will be available during a 6month period that begins no less than 3.5 years and not more than 4.5 years from the end of the last 6-month period. (b) Mandatory tests. Every operator must provide to each miner who begins work in or at a coal mine for the first time on or after August 1, 2014, spirometry testing and respiratory assessment at no cost to the miner in accordance with this subpart. (1) Initial spirometry testing and respiratory assessment will be provided to all miners who begin work in or at a coal mine for the first time on or after August 1, 2014 within the first 30 days of their employment or within 30 days of approval of a plan to provide spirometry testing. (2) A follow-up second spirometry test and respiratory assessment will be provided to the miner no later than 3 years after the initial spirometry if the miner is still engaged in coal mining. (3) A third spirometry test and respiratory assessment will be provided no later than 2 years after the tests in paragraphs § 37.3(b)(2) and paragraph (b)(2) of this section if the chest radiograph shows evidence of pneumoconiosis as defined in § 37.3(b)(3) or if the second spirometry test results demonstrate a 15 percent or greater decline in the percent predicted FEV1 value since the initial (i.e., baseline) test. (i) Percent predicted FEV1 will be calculated according to prediction equations published in Spirometric Reference Values from a Sample of the General U.S. Population, American Journal of Respiratory and Critical Care Medicine, 159(1):179–187, January 1999 (incorporated by reference, see § 37.98). (ii) A correction factor to Caucasian reference values will be applied when testing individuals of Asian descent as E:\FR\FM\24OCR3.SGM 24OCR3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations specified in the ATS Technical Standards: Spirometry in the Occupational Setting, p. 987 (incorporated by reference, see § 37.98). (c) Notification. NIOSH will notify the miner when he or she is due to receive the second or third mandatory test under paragraph (b) of this section. NIOSH will notify the coal mine operator when the miner is to perform a second spirometry test. (1) The operator will be notified of a miner’s eligibility for a third test only with the miner’s written consent. The notice to the operator will not state the medical reason for the test or that it is the third test in the series. (2) If the miner is notified by NIOSH that the third mandatory test is due and the operator is not so notified, availability of spirometry testing under the NIOSH-approved operator’s plan will constitute the operator’s compliance with the requirement to provide a third spirometry test even if the miner does not take the test. (d) Availability of spirometry testing. The opportunity for spirometry to be available for purposes of this subpart must be indicated in an operator’s plan that has been submitted and approved in accordance with this subpart. ■ 22. Revise § 37.93 to read as follows: sradovich on DSK3GMQ082PROD with RULES3 § 37.93 Approval of spirometry facilities. (a) Application for facility approval. Facilities seeking approval to provide the spirometry testing specified under this subpart must have the ability to provide spirometry of high technical quality. Thus, NIOSH-approved facilities must meet the requirements specified in this subpart for the following activities: Training of technicians who perform the tests; conducting spirometry tests using equipment and procedures that meet required specifications; collecting the respiratory assessment form; transmitting data to NIOSH; and communicating with miners as required for scheduling, testing, and notification of results. Facilities seeking approval may apply to NIOSH using the Spirometry Facility Certification document (CDC/NIOSH 2.14). (b) Spirometry quality assurance. A spirometry quality assurance program must be in place to minimize the rate of invalid test results. This program must include all of the following components: (1) Instrument calibration checks. Testing personnel must fully comply with the 2005 ATS/ERS Standardisation of Spirometry guidelines for instrument calibration check procedures, pp. 322– 323, including Table 3 (incorporated by reference, see § 37.98). VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 (i) For volume spirometers, calibration check procedures must include daily (day of testing) leak and volume accuracy checks. In addition, volume linearity checks must be performed according to the frequency established by the 2005 ATS/ERS guidelines. (ii) For flow-type spirometers, calibration must be checked daily by injecting 3 liters of air from a calibration syringe at 3 different speeds (fast, medium, slow). Flow linearity must be checked weekly as established by the 2005 ATS/ERS guidelines. (iii) Instrument calibration check records must be maintained by the facility and available for inspection by NIOSH, as deemed necessary. (2) Automated maneuver and test session quality checks. The spirometer software must automatically perform quality assurance checks on expiratory maneuvers during each spirometry testing session. Screen displayed error messages must alert the technician to maneuver acceptability and test session non-repeatability. Each spirometry test session must have the goal of obtaining 3 acceptable with 2 repeatable forced vital capacity maneuvers, as defined by the 2005 ATS/ERS Standardisation of Spirometry, p. 325 (incorporated by reference, see § 37.98). (3) Ongoing monitoring of test quality. Facilities must submit spirometry results to NIOSH within 14 calendar days of testing as specified in § 37.96(c) to permit NIOSH to monitor test quality and provide a results report to each miner. NIOSH may provide quality performance feedback to the appropriate technician(s) along with suggestions for improvement. (4) Quality assurance audits. NIOSH may periodically conduct audits to review tests submitted by approved facilities and assess the quality of spirometry provided. Such audits may include a review of all spirometry data obtained during a specified time period or review of spirometry test data collected over time on selected miners. (c) Noncompliance. If NIOSH determines that a facility is not compliant with the policies and procedures specified in this subpart, or determines as the result of a quality assurance audit as specified in this section that a facility is not performing spirometry of adequate quality, the facility will be notified of the deficiency. The facility must promptly make appropriate arrangements for the deficiency to be rectified. (d) Revocation of approval. If a facility fails to rectify deficiencies within 60 days of notification, NIOSH approval of the facility may be revoked. PO 00000 Frm 00019 Fmt 4701 Sfmt 4700 73287 An approval which has been revoked may be reinstated at the discretion of NIOSH after it receives satisfactory assurances and evidence that all deficiencies have been corrected and that effective controls have been instituted by the facility to prevent a recurrence. (e) Maintenance of records. When conducting spirometry tests pursuant to this subpart, physicians and facilities must maintain the results and analyses of these tests (including any hard copies or digital files containing individual data, such as interpretations) in a manner consistent with applicable statutes and regulations governing the handling and protection of individually identifiable health information, including, as applicable, the HIPAA Privacy and Security Rules (45 CFR part 160 and 45 CFR part 164, subparts A, C, and E). ■ 23. Revise § 37.94 to read as follows: § 37.94 Respiratory assessment form. As part of the spirometry testing and concurrent with it, personnel at the facility must complete a Respiratory Assessment Form (CDC/NIOSH 2.13). ■ 24. Revise § 37.95 to read as follows: § 37.95 Specifications for performing spirometry tests. (a) Persons administering spirometry tests. Each person administering spirometry tests for the Coal Workers’ Health Surveillance Program must successfully complete a NIOSHapproved spirometry training course and maintain a valid certificate by periodically completing NIOSHapproved spirometry refresher training courses, identified on the NIOSH Web site at http://www.cdc.gov/niosh/. A copy of the certificate of completion from a NIOSH-approved spirometry training or refresher course, with validation dates printed on the document, must be available for inspection. NIOSH will assign each person administering spirometry tests a unique identification number, which must be entered into the spirometry system computer whenever instrument quality assurance or miner testing is done or on the Spirometry Results Notification Form (CDC/NIOSH 2.15). (b) Spirometer specifications. Spirometry testing equipment must meet the 2005 ATS/ERS Standardisation of Spirometry specifications for spirometer accuracy and precision and real-time display size and content, pp. 331–333, including Table 2 on p. 322 and Table 6 on p. 332 (incorporated by reference, see § 37.98). Facilities must make available for inspection written verification from a third-party testing E:\FR\FM\24OCR3.SGM 24OCR3 sradovich on DSK3GMQ082PROD with RULES3 73288 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations laboratory (not the manufacturer or distributor) that the model of spirometer being used has successfully passed its validation checks as required by the Standardization of Spirometry; 1994 Update protocol, Appendix B pp. 1126– 1134, including Table C1 (incorporated by reference, see § 37.98). Facilities may request such documentation from spirometer manufacturers. For each forced expiratory maneuver submitted for a miner under this part, the spirometry data file must retain a record of the parameters defined in the 2005 ATS/ERS Standardisation of Spirometry, p. 335 including Table 8 (incorporated by reference, see § 37.98). Spirometers that provide electronic transfer of spirometry data results files must use the format, content, and data structure specified by the 2005 ATS/ ERS Standardisation of Spirometry, p. 335, or a procedure for data transfer that is approved by NIOSH. (c) Spirometry procedures. Administration of spirometry must include the following: (1) Miner Identification Document. The Miner Identification Document (CDC/NIOSH (M)2.9), described in § 37.20, must be completed for each miner at the facility where spirometry is performed. (2) Pre-test checklist. The Spirometry Pre-Test Checklist portion of the Spirometry Results Notification Form (CDC/NIOSH 2.15) must be completed prior to each spirometry session to identify possible contraindications to testing, or factors that might affect results. (3) Respiratory Assessment Form. A standardized Respiratory Assessment Form (CDC/NIOSH 2.13) must be completed at the initial spirometry and repeated at each spirometry testing procedure. (4) Collection of anthropometric and demographic information. The miner’s standing height must be measured in stocking feet using a stadiometer (or equivalent device) each time the miner performs spirometry. The miner’s weight must also be measured (in stocking feet). The miner’s birth date, race, and ethnicity must also be recorded. These data will be entered into the spirometry system computer and transmitted with the spirometry data file or, if required under the facility’s approval, on the Spirometry Results Notification Form (CDC/NIOSH 2.15). (5) Test procedures. Spirometry will be conducted in accordance with test procedures defined in the 2005 ATS/ ERS Standardisation of Spirometry, pp. 323–326, and the Standardisation of Lung Function Testing, Replies to VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 Readers, pp. 1496–1498 (both incorporated by reference, see § 37.98). (i) The technician must be able to view real-time testing display screens as specified in the 2005 ATS/ERS Standardisation of Spirometry, p. 322 (incorporated by reference, see § 37.98). (ii) A miner will be tested in the standing position, but may be seated if he or she experiences lightheadedness or other signs or symptoms that raise a safety concern relating to the standing position during the spirometry test. (d) Records retention. On-site records of the results will include spirometry test reports and retention of all spirometry sessions, pre-test checklists, and standardized respiratory assessment results in electronic or printed format until notification to delete or render the information inaccessible, as described in § 37.100(b)(6)(ii), is received from NIOSH. ■ 25. Revise § 37.96 to read as follows: § 37.96 Spirometry interpretations, reports, and submission. (a) Interpretation of spirometry tests. Interpretations will be carried out by physicians or other qualified health care professionals with expertise in spirometry who have all required licensure and privileges to provide this service in their State or Territory. Interpretations must be carried out using procedures and criteria consistent with recommendations in the ATS Technical Standards: Spirometry in the Occupational Setting, pp. 987–990, and the ATS/ERS Interpretative Strategies for Lung Function Tests, p. 950, p. 956 including Table 5, and p. 957 including Table 6 (both incorporated by reference, see § 37.98). (b) Spirometry reports at NIOSHapproved spirometry facilities. (1) Spirometry test reports must contain the following: (i) The miner’s age, height, gender, race, and weight; (ii) Numerical values (FVC, FEV6, FEV1, FEV1/FVC, FEV1/FEV6, FET, and PEF) and volume-time and flow-volume spirograms for all recorded expiratory maneuvers; normal reference value set used; and the predicted, percent predicted, and lower limit of normal threshold values; (iii) Miner position during testing (standing or sitting); (iv) Dates of test and last calibration check; (v) Ambient temperature and barometric pressure (volume spirometers); and (vi) The technician’s unique identification number. (2) NIOSH will notify the submitting facility when to permanently delete or, PO 00000 Frm 00020 Fmt 4701 Sfmt 4700 if this is not technologically feasible for the spirometry system used, render permanently inaccessible all files and forms associated with a miner’s spirometry test from its electronic and physical files. (c) Submission of spirometry results. Facilities must submit results of spirometry tests electronically with content as specified in § 37.96(b), completed pre-test screening checklists (found in Spirometry Results Notification Form CDC/NIOSH 2.15), and completed Respiratory Assessment Form (CDC/NIOSH 2.13) within 14 calendar days of testing a miner. (1) Electronic spirometry test results. Submission of spirometry test results in the form of an electronic data file in a format approved by NIOSH is preferred. Facilities must utilize a secure internet data transfer site specified by NIOSH. Data submission must be performed as specified in the facility’s approval. The transmitted spirometry data files must include a variable length record providing all parameters in the format, content, and data structure described by the 2005 ATS/ERS Standardisation of Spirometry, p. 335 including Table 8 (incorporated by reference, see § 37.98), or an alternate data file that is approved by NIOSH. (2) Spirometry test results submitted using the Spirometry Results Notification form. If specified under a facility’s approval, spirometry results may be provided using the Spirometry Results Notification Form (CDC/NIOSH 2.15). The form must be completed and submitted electronically, accompanied by image files in a format approved by NIOSH that documents the flow-volume and volume-time curves for each trial reported on the form. The method of electronic submission must be approved by NIOSH and carried out securely as specified for electronic data files in § 37.96(c)(1). (d) Confidentiality of spirometry results. Individual medical information and spirometry results are considered protected health information under HIPAA and may only be released as specified by HIPAA or to NIOSH, as discussed in paragraph (d)(1) of this section, and maintained by the spirometry facility as specified in § 37.93(e). (1) Personally identifiable information in the possession of NIOSH will be released only with the written consent of the miner or, if the miner is deceased, the written consent of the miner’s next of kin or legal representative. (2) To provide on-site back-up and assure complete data transfer, facilities must retain the forms and results (in electronic or paper format) from a E:\FR\FM\24OCR3.SGM 24OCR3 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations miner’s test until instruction has been received from NIOSH to delete the associated files and forms or, if this is not technologically feasible, render the data permanently inaccessible. ■ 26. Revise § 37.97 to read as follows: § 37.97 Notification of spirometry results. (a) Findings must be communicated to the miner or, if requested by the miner, to the miner’s designated physician. The health care professional at the NIOSHapproved facility must inform the miner if the spirometry shows abnormal results or if the respiratory assessment suggests he or she may benefit from the medical follow-up or a smoking cessation intervention. (b) NIOSH will notify the miner of his or her spirometry test results, a comparison between current and previously submitted spirometry tests (if available), and will advise the miner to contact a health care professional as appropriate based on the results. ■ 27. Add § 37.98 to read as follows: sradovich on DSK3GMQ082PROD with RULES3 § 37.98 Standards incorporated by reference. (a) Certain material is incorporated by reference into this subpart, Subpart— Spirometry Testing, with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, NIOSH must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at NIOSH, Respiratory Health Division, 1095 Willowdale Road, Morgantown, WV 26505. To arrange for an inspection at NIOSH, call 304–285–5749. Copies are also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030 or go to http://www.archives.gov/federal_ register/code_of_federal_regulations/ ibv_locations.html. (b) American Journal of Respiratory and Critical Care Medicine, American Thoracic Society (ATS), 25 Broadway, 18th Floor, New York, NY 10004. Phone: (800) 635–7181, extension 8065. Email: Hope.Robinson@sheridan.com. http://www.atsjournals.org/action/ showHome: (1) Standardization of Spirometry; 1994 Update. Official Statement of the ATS, adopted November 11, 1994. American Journal of Respiratory and Critical Care Medicine 152(3):1107– 1136, September 1995, into § 37.95(b). This ATS Official Statement is also available at http://www.atsjournals.org/ doi/pdf/10.1164/ajrccm.152.3.7663792. VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 (2) Official American Thoracic Society Technical Standards: Spirometry in the Occupational Setting (‘‘ATS Technical Standards: Spirometry in the Occupational Setting’’). Redlich CA, Tarlo SM, Hankinson JL, Townsend MC, Eschenbacher WL, Von Essen SG, Sigsgaard T, and Weissman DN. American Journal of Respiratory and Critical Care Medicine 189(8):983–994, April 15, 2014, into §§ 37.92(b) and 37.96(a). (3) Spirometric Reference Values from a Sample of the General U.S. Population. Hankinson JL, Odencrantz JR, Fedan KB. American Journal of Respiratory and Critical Care Medicine, 159(1):179–187, January 1999, into § 37.92(b). (c) European Respiratory Journal, 442 Glossop Road, Sheffield, S10 2PX, UK. Phone: 44 114 267 28 60; Fax: 44 114 266 50 64. Email: info@ersj.org.uk. http://erj.ersjournals.com/. (1) Standardisation of Spirometry (‘‘2005 ATS/ERS Standardisation of Spirometry’’). ATS/ERS Task Force: Standardization of Lung Function Testing. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CPM, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, and Wanger J. European Respiratory Journal 26(2):319–338, August 2005, into §§ 37.93(b); 37.95(b) and (c); and 37.96(c). The ATS/ERS Standardisation of Spirometry is also available on the ATS Web site at https:// www.thoracic.org/statements/resources/ pfet/PFT2.pdf. (2) Interpretative Strategies for Lung Function Tests (‘‘ATS/ERS Interpretative Strategies for Lung Function Tests’’). ATS/ERS Task Force: Standardisation of Lung Function Testing. Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CPM, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, and Wanger J. European Respiratory Journal 26(5):948–968, November 2005, into § 37.96(a). The ATS/ERS Standardisation of Lung Function Testing is also available on the ATS Web site at http://www.thoracic.org/ statements/resources/pft/pft5.pdf. (3) Standardisation of Lung Function Testing, the Authors’ Replies to Readers’ Comments (‘‘Standardisation of Lung Function Testing, Replies to Readers’’). Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten C, Gustafsson P, Jensen R, MacIntyre N, McKay RT, Pedersen OF, Pellegrino R, Viegi G, and PO 00000 Frm 00021 Fmt 4701 Sfmt 4700 73289 Wanger J. European Respiratory Journal 36(6):1496–1498, December 2010, into § 37.95(c). The Standardisation of Lung Function Testing, Replies to Readers is also available on the ATS Web site at http://www.thoracic.org/statements/ resources/pft/clarification-12-2010.pdf. ■ 28. Revise § 37.100 to read as follows: § 37.100 Coal mine operator plan for medical examinations. (a) Each coal mine operator must submit and receive NIOSH approval of a plan for the provision of chest radiographs, occupational histories, spirometry tests, and respiratory assessments of miners, using the appropriate forms provided by NIOSH. (1) During the transition from August 1, 2014 until the time when spirometry facilities are approved by NIOSH, any person becoming a coal mine operator on or after August 1, 2014, or any coal mine operator without an approved plan as of that date must submit a plan within 60 days that provides for chest radiographs and occupational histories only. (2) Coal mine operators with previously approved plans for only chest radiographs and occupational histories, or with plans developed pursuant to paragraph (a)(1) of this section, will be notified by MSHA when the plans must be amended to include spirometry testing and respiratory assessments. Amendments must be submitted to NIOSH within 60 days of MSHA’s notification. (b) The coal mine operator’s plan must include: (1) The name, address, and telephone number of the operator(s) submitting the plan; (2) The name, MSHA identification number for respirable dust measurements, and address of the mine included in the plan; (3) The proposed beginning and ending date of the 6-month period(s) for voluntary radiography exams and spirometry tests (see §§ 37.3(a) and 37.92(a)), the estimated number of miners to be given or offered examinations during the 6-month period under the plan, and a roster specifying the names and current home mailing addresses of each miner covered by the plan; (4) The name and location of the approved radiograph and spirometry facility or facilities, and the approximate date(s) and time(s) of day during which the radiograph examination and spirometry will be given to miners to enable a determination of whether the examinations will be conducted at a convenient time and place; E:\FR\FM\24OCR3.SGM 24OCR3 sradovich on DSK3GMQ082PROD with RULES3 73290 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations (5) If a mobile medical examination facility is proposed to provide some or all of the surveillance tests specified in paragraph (a) of this section, the plan must provide that each miner be given adequate notice of the opportunity to have the examination and that no miner will have to wait for an examination more than 1 hour before or after his or her work shift. The plan must include: (i) The number of change houses at the mine. (ii) One or more alternate non-mobile approved medical examination facilities for the reexamination of miners and for the mandatory examination of miners when necessary (see §§ 37.3(b) and 37.92(b)), or an assurance that the mobile facility will return to the location(s) specified in the plan as frequently as necessary to provide for medical surveillance examinations in accordance with these regulations. (iii) The name and location of each change house at which examinations will be given. For mines with more than one change house, the examinations must be given at each change house or at a change house located at a convenient place for each miner. (6) Assurances that: (i) The operator will not solicit a physician’s spirometric, radiographic or other findings concerning any miner employed by the operator; (ii) Instructions have been given to the person(s) giving the examinations that duplicate spirograms or copies of spirograms (including copies of electronic files) and radiographs or copies of radiographs (including, for digital radiographs, copies of electronic files) will not be made, and to the extent that it is technically feasible all related electronic files must be permanently deleted from the facility records or rendered permanently inaccessible following the confirmed transfer of such data to NIOSH, and that (except as may be necessary for the purpose of this part) the physician’s spirometric, radiographic and other findings, as well as the occupational history and respiratory assessment information obtained from a miner will not be disclosed in a manner that would permit identification of the individual miner with his or her information; and (iii) The spirometry and radiographic examinations will be made at no charge to the miner. (c) Operators may provide for alternate spirometry or radiography facilities in plans submitted to NIOSH for approval. VerDate Sep<11>2014 18:21 Oct 21, 2016 Jkt 241001 (d) The change of operators of any mine operating under a plan approved pursuant to § 37.101(a) must not affect the plan of the operator which has transferred responsibility for the mine. Every plan is subject to revision in accordance with paragraph (e) of this section. (e) The operator must advise NIOSH of any change in its plan. Each change in an approved plan is subject to the same review and approval as the originally approved plan. (f) The operator must promptly display in a visible location on the bulletin board at the mine its proposed plan or proposed change in a NIOSHapproved plan when it is submitted to NIOSH. The proposed plan or change in a NIOSH-approved plan must remain posted in a visible location on the bulletin board until NIOSH either grants or denies approval at which time the approved plan or denial of approval must be permanently posted. In the case of an operator who does not have a bulletin board, such as an operator that is a contractor, the operator must otherwise notify its employees of the examination arrangements. Upon request, the contractor must show NIOSH written evidence that its employees have been notified. (g) Upon notification from NIOSH that sufficient time has elapsed since the previous period of examinations, the operator must resubmit a plan for each of its coal mines to NIOSH for approval for the next period of examinations (see §§ 37.3(a)(2) and 37.92(a)). The plan must include the proposed beginning and ending dates of the next period of examinations and all information required by paragraph (b) of this section. ■ 29. Revise § 37.101 to read as follows: § 37.101 Approval of plans. (a) If, after review of any plan submitted pursuant to this subpart, NIOSH determines that the action to be taken under the plan by the operator meets the specifications of this subpart and will effectively achieve its purpose, NIOSH will approve the plan and notify the operator submitting the plan of the approval. Approval may be conditioned upon such terms as the Secretary deems necessary to carry out the purpose of section 203 of the Act. (b) Where NIOSH has reason to believe that it will deny approval of a plan NIOSH will, prior to the denial, give notice in writing to the operator(s) of an opportunity to amend the plan. The notice must specify the ground(s) PO 00000 Frm 00022 Fmt 4701 Sfmt 9990 upon which approval is proposed to be denied. (c) If a plan is denied approval, NIOSH will advise the operator(s) in writing of the reasons for the denial and inform MSHA that the plan was denied. ■ 30. Revise § 37.102 to read as follows: § 37.102 Transfer of affected miner to less dusty area. (a) Any miner who, in the judgment of NIOSH, has evidence of the development of pneumoconiosis, must be afforded the option of transferring from his or her position to another position in an area of the mine where the concentration of respirable dust in the mine atmosphere is in compliance with the MSHA requirements in 30 CFR part 90. A classification of one or more of the miner’s chest radiographs as showing category 1 (1⁄0, 1⁄1, 1⁄2), category 2 (2⁄1, 2⁄2, 2⁄3), or category 3 (3⁄2, 3⁄3, 3/ +) simple pneumoconiosis, or complicated pneumoconiosis (ILO Classification) will be accepted as such evidence. NIOSH will, at its discretion, also accept other medical examinations provided to NIOSH for review, such as computed tomography scans of the chest or lung biopsies, as evidence of the development of pneumoconiosis. (b) Any transfer under this section shall be in accordance with the procedures specified in 30 CFR part 90. ■ 31. Revise § 37.103 to read as follows: § 37.103 Medical examination at miner’s expense. Any miner who wishes to obtain a medical examination at the miner’s own expense at an approved spirometry or radiography facility and to have the complete examination submitted to NIOSH may do so, provided that the examination is made no sooner than 6 months after the most recent examination of the miner submitted to NIOSH. NIOSH will provide radiographic classification, evaluation of spirometry test results, and reporting of the results of examinations made at the miner’s expense in the same manner as if they were submitted under an operator’s plan. Any change in the miner’s transfer rights under the Act that may result from this examination will be subject to the terms of § 37.102. Dated: October 4, 2016. Sylvia M. Burwell, Secretary, Department of Health and Human Services. [FR Doc. 2016–24405 Filed 10–21–16; 8:45 am] BILLING CODE 4163–19–P E:\FR\FM\24OCR3.SGM 24OCR3

Agencies

[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Rules and Regulations]
[Pages 73270-73290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24405]



[[Page 73269]]

Vol. 81

Monday,

No. 205

October 24, 2016

Part III





Department of Health and Human Services





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42 CFR Part 37





Specifications for Medical Examinations of Coal Miners; Final Rule

Federal Register / Vol. 81 , No. 205 / Monday, October 24, 2016 / 
Rules and Regulations

[[Page 73270]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 37

[Docket No. CDC-2014-0011; NIOSH-276]
RIN 0920-AA57


Specifications for Medical Examinations of Coal Miners

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Final rule.

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SUMMARY: With this action, the Department of Health and Human Services 
(HHS), in accordance with recent rulemaking by the Department of 
Labor's Mine Safety and Health Administration (MSHA), finalizes 
amendments to Coal Workers' Health Surveillance Program regulations to 
establish standards for the approval of facilities to conduct 
spirometry and requires that all coal mine operators submit a plan for 
the provision of spirometry testing and X-ray examinations to all 
surface and underground coal miners.

DATES: This rule is effective on November 23, 2016.

FOR FURTHER INFORMATION CONTACT: A. Scott Laney, Research 
Epidemiologist, Division of Respiratory Disease Studies, NIOSH, Centers 
for Disease Control and Prevention, 1095 Willowdale Road, MS HG900.2, 
Morgantown, WV 26505-2888; (304) 285-5754 (this is not a toll-free 
number); alaney@cdc.gov.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Public Participation
II. Background
    A. History of Coal Workers' Health Surveillance Program and 
Statutory Authority
    B. Need for Rulemaking
III. Summary of Final Rule and Response to Public Comment
    A. Subpart--Chest Radiographic Examinations
    B. Subpart--Spirometry Examinations
    C. Subpart--General Requirements
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

I. Public Participation

    Interested persons or organizations were invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments were invited on any topic related 
to this rulemaking.
    HHS received submissions to the docket from two commenters, 
including a trade association representing coal mine operators and a 
spirometry expert.

II. Background

A. History of Coal Workers' Health Surveillance Program and Statutory 
Authority

    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 coal workers' 
pneumoconiosis (pneumoconiosis), silicosis, and chronic obstructive 
pulmonary disease, including chronic bronchitis and emphysema.\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. 801 et seq.) (Mine Act).
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    \1\ Edward L Petsonk and John E Parker, Coal Workers' Lung 
Diseases and Silicosis, in Fishman's Pulmonary Diseases and 
Disorders, 967 (Alfred P. Fishman ed., McGraw-Hill, 4th ed., 2008).
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    The National Institute for Occupational Safety and Health (NIOSH) 
Coal Workers' Health Surveillance Program (CWHSP), also authorized by 
the Mine Act, was established to detect pneumoconiosis and prevent its 
progression in individual miners, while at the same time providing 
information for evaluation of temporal and geographic trends in 
pneumoconiosis. To inform each miner of his or her health status, the 
Act requires that coal mine operators provide each miner who begins 
work at a coal mine for the first time 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 a 
coal mine must be offered a chest radiograph approximately every 5 
years.
    All chest radiographs and other supplemental tests deemed necessary 
to protect the health and safety of U.S. coal miners are to be given in 
accordance with specifications prescribed by the Secretary of Health 
and Human Services (30 U.S.C. 843(a)). The Mine Act also grants the 
Secretary, HHS general authority to issue regulations as is deemed 
appropriate to carry out provisions of the Act (30 U.S.C. 957), and 
grants NIOSH the authority to conduct activities in the field of coal 
mine health on behalf of the Secretary, HHS (30 U.S.C. 951(b)).

B. Need for Rulemaking

    On May 1, 2014, the Mine Safety and Health Administration (MSHA) in 
the Department of Labor published a final rule amending existing health 
and safety standards in 30 CFR part 72 to improve health protections 
for coal miners, including the expansion of requirements for medical 
surveillance.\2\ The amendments added a new section, Sec.  72.100, to 
require that both underground and surface coal mine operators provide 
to each miner chest X-rays and spirometry tests using facilities 
approved by NIOSH, as well as the documentation of occupational history 
and symptom assessment.
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    \2\ 79 FR 24814.
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    The expansion of MSHA's medical surveillance requirements caused 
HHS to amend regulations in 42 CFR part 37 pertaining to the CWHSP, 
thereby expanding the scope of the Program to include coal miners who 
work in surface coal mines and adding spirometry testing and symptom 
assessment for all miners. In response to MSHA's rulemaking, NIOSH 
published an interim final rule on August 4, 2014 (August 2014 IFR) to 
expand the existing CWHSP to provide chest radiographic examinations to 
miners who work in surface coal mines and establish requirements for 
spirometry testing for all coal miners under part 37.\3\ This action 
finalizes those provisions promulgated by the August 2014 IFR.
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    \3\ 79 FR 45110.
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III. Summary of Final Rule and Response to Public Comment

    This document finalizes the August 2014 IFR. The following section-
by-section summary describes and explains the amendments to certain 
provisions of part 37. Public comments are also summarized and 
answered. The final regulatory text is provided in the last section of 
this document.

[[Page 73271]]

A. Subpart--Chest Radiographic Examinations

Section 37.1 Scope
    Section 37.1 provides the scope of the provisions in Subpart--Chest 
Radiographic Examinations, and is amended to clarify the purpose of 
this subpart. Under this subpart, coal mine operators are required to 
provide radiographic examinations to each current and new coal miner, 
using medical facilities approved by NIOSH according to the standards 
established in this subpart. Because no comments were submitted on this 
section and no changes are made to the regulatory text, this section is 
not included in the regulatory text below.
Section 37.2 Definitions
    Section 37.2 contains definitions for terms that appear throughout 
this subpart and the new subparts (Subpart--Spirometry Testing and 
Subpart--General Requirements). The existing definitions of several 
terms are revised and a new definition of ``B Reader'' is added, as 
discussed below.
    The definition ``Act,'' which refers to the Federal Mine Safety and 
Health Act of 1977, is revised to include reference to the Public Law 
number and amendments.
    The definition ``convenient time and place'' is revised to strike 
the phrase ``with respect to the conduct of any examination under this 
subpart,'' because that phrase is not used in part 37. Additional 
language is added to clarify how this term is to be interpreted. 
Although this definition was not included in the August 2014 IFR, 
revising it to be consistent with the language in Sec. Sec.  37.40 and 
37.100 is thus a logical outgrowth of this rulemaking.
    The definition ``digital radiography systems'' is changed to 
replace the word ``X-ray'' with ``radiographic.'' Although this 
definition was not included in the August 2014 IFR, revising it is 
consistent with changes made to Sec.  37.51 in this final action and is 
thus a logical outgrowth of this rulemaking.
    The definition ``ILO Classification'' is revised to clarify that 
using the term ``digital chest image file'' includes all electronic 
standard chest images included in the set of film radiographs provided 
by the International Labour Office (ILO) in the International 
Classification of Radiographs of Pneumoconioses. The definition is also 
revised to recognize that NIOSH must approve other sets of chest images 
files as equivalent to the ILO Classification. The ILO Classification 
is incorporated by reference into certain sections in part 37. Although 
this definition was not included in the August 2014 IFR, revising it to 
recognize digitized image files is consistent with changes made to 
Sec.  37.51 in this final action, and is thus a logical outgrowth of 
this rulemaking.
    The definition ``NIOSH'' is revised to replace the former name of 
the NIOSH division responsible for the CWHSP with its new name, 
Respiratory Health Division (RHD). RHD is the organizational unit 
within NIOSH responsible for administration of the CWHSP.
    The definition ``Panel of B Readers'' is revised to clarify that B 
Readers are certified by NIOSH and classify or otherwise evaluate 
radiographs for the CWHSP.
    The definition ``radiologic technologist'' is revised to clarify 
terminology by replacing ``chest images'' with ``chest radiographs.''
    A new definition of ``B Reader'' is added to direct readers to 
Sec.  37.52, which requires physicians who wish to evaluate and 
classify chest radiographs for pneumoconiosis to take and pass a 
specially designed proficiency examination given by NIOSH. This 
definition is predicated on existing language in Sec.  37.52, and is 
thus a logical outgrowth of the August 2014 IFR.
    Finally, the definition ``facility'' is moved from Sec.  37.91 and 
is unchanged. No comments were submitted on this section.
Section 37.3 Chest Radiographs Required for Miners
    Section 37.3 requires mine operators to provide miners an 
opportunity to receive a chest radiograph. Paragraphs (a)(1) and (2), 
concerning the provision of each employed miner an opportunity for a 
chest radiograph at least 3.5 to 4.5 years after the previous period 
for the conduct of such examinations, are revised to eliminate 
redundancy and provide greater clarity regarding the deadlines for 
voluntary examinations. The sentence specifying that the period during 
which examinations must begin is removed because it does not provide 
any additional information and may be confusing. The example provided 
in paragraph (a)(2) is also removed for similar reasons.
    No changes are made to paragraph (b), which establishes the 
periodicity of three required initial chest radiographs. Paragraph (c), 
which establishes that NIOSH will notify the miner when it is time for 
a second or third radiography examination and will notify the operator 
under certain circumstances, is revised for clarity.
    Paragraph (d), concerning the availability of chest radiographs, is 
revised to replace ``subpart'' with ``part'' to clarify that 
radiographs must be made available by an operator in accordance with a 
plan submitted and approved by NIOSH in accordance with this part. As 
discussed in the August 2014 IFR, the section requiring operator plans 
for medical examinations has been removed from this subpart and 
replaced in Subpart--General Requirements.
    One commenter asked that HHS require miners to submit to mandatory 
respiratory examinations. NIOSH does not have legal authority to 
require coal miners to submit to medical examinations. Although section 
203(a) of the Mine Act (30 U.S.C. 843(a)) states that medical 
examinations shall be given to miners at certain intervals, it states 
elsewhere in that section that miners are to have ``the opportunity'' 
to have such examinations. Moreover, NIOSH concurs with MSHA's 
position, as addressed in the agency's May 1, 2014 final rule in 
response to public comment, that requiring miners to submit to medical 
examinations against their will would not be appropriate.\4\ No changes 
are made to the regulatory text in response to public comment.
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    \4\ See MSHA final rule, 79 FR 24814, at 24928 (May 1, 2014).
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Section 37.4 Chest Radiographic Examinations Conducted by the Secretary
    Section 37.4 details the conditions under which the HHS Secretary 
will determine whether to conduct a chest radiographic examination. 
Paragraph (a), which details the circumstances under which the 
Secretary, HHS, will arrange for chest radiographs at a particular 
mine, is unchanged.
    ``Shall'' is replaced with ``must,'' in accordance with Federal 
plain language guidelines, in paragraph (b), which requires the 
operator to reimburse the Secretary or person, agency, or institution 
directed by the Secretary to conduct radiography examinations, and 
paragraph (c), which requires the examinations arranged by the 
Secretary to be given according to the periodicity requirements in 
Sec.  37.3.
    Paragraph (d), which stipulates that operators participating in the 
National Study of Coal Workers' Pneumoconiosis would not be responsible 
for assuming the cost of providing chest radiographs, is removed in its 
entirety because that study no longer exists. No comments were 
submitted on this section and no changes are made to the regulatory 
text.
Section 37.10 Standards Incorporated by Reference
    Section 37.10 provides references to the standards incorporated by 
reference

[[Page 73272]]

into part 37. This section is amended slightly to update the name of 
the NIOSH Division of Respiratory Disease Studies, now known as the 
Respiratory Health Division. The link to the American College of 
Radiology publication has been updated. No public comment was received 
and no further edits are made to this section.
Section 37.20 Miner Identification Document
    Section 37.20 requires the use of a Miner Identification Document 
as a component of the examination. Although this section was not 
amended by the August 2014 IFR, revising it here is consistent with the 
addition of spirometry to part 37, and is thus a logical outgrowth of 
this rulemaking. The text is revised slightly to reference both 
radiographic and spirometry examinations. The section is also changed 
to clarify that the form (CDC/NIOSH 2.9) is required for both types of 
examination.
Section 37.40 General Provisions
    Section 37.40 outlines general provisions for chest radiographs. 
Paragraphs (a) and (c), which require that the radiographic examination 
must be given at a convenient time and place and performed in an 
approved facility, respectively, are unchanged. Paragraph (b) is 
revised to update the name of the completed form that must accompany 
the chest radiographic examination, the Chest Radiograph Classification 
Form (CDC/NIOSH 2.8). No comments were submitted on this section.
Section 37.43 Approval of Radiographic Facilities That Use Film 
Radiography Systems
    Section 37.43 establishes standards for the approval of radiography 
facilities that use film. Although this section was not included in the 
August 2014 IFR, revisions are a logical outgrowth of other changes 
throughout the part. The section heading is revised to clarify that it 
applies to film radiography systems. Paragraph (a), concerning 
application to NIOSH for facility participation in the CWHSP, is 
unchanged except to divide it into smaller paragraphs for clarity. 
Paragraph (a)(1) concerns the submission of sample radiographs made on 
the equipment intended to be used to perform radiographs under this 
part; (a)(2) concerns the submission of sample radiographs within 15 
days of being made; (a)(3) concerns the return of such radiographs 
submitted as a component of the A Reader approval process. The 
reference provided for those chest radiographs is corrected to read 
Sec.  37.52(a)(2)(i).
    The name of the form referenced in paragraph (b), the Radiographic 
Facility Certification Document, is updated to be consistent with 
updates in other sections of Part 37.
    Paragraphs (c), (d), and (f), concerning the evaluation of 
radiographs submitted with applications for NIOSH approval, the 
inspection of the applicant facility by NIOSH, and the establishment of 
a quality assurance program at the applicant facility, respectively, 
are unchanged.
    The name of the form referenced in paragraph (e), the Radiographic 
Facility Certification Document, is updated to be consistent with 
updates in other sections of part 37. The paragraph is also divided 
into smaller paragraphs for clarity. Paragraph (e)(1) now concerns the 
suspension or withdrawal of NIOSH approval of a radiograph facility; 
paragraph (e)(2) requires a copy of a withdrawal notice be displayed on 
the mine bulletin board.
    In paragraph (g), concerning the maintenance of records in 
accordance with Federal privacy laws, the word ``interpretations'' is 
replaced with ``classifications,'' to clarify that B Readers are 
responsible for recording classifications on the Chest Radiograph 
Classification Form (CDC/NIOSH 2.8). The term ``classifications'' 
describes surveillance activities, such as providing standardized 
descriptions of chest radiographs, while ``interpretations'' is a 
broader term meant to describe clinical activities, such as assessing 
radiographic findings and generating radiological differential 
diagnoses. This revision is consistent with similar changes in other 
sections of part 37.
Section 37.44 Approval of Radiographic Facilities That Use Digital 
Radiography Systems
    Section 37.44 establishes standards for the approval of radiography 
facilities that use digital radiography. Although this section was not 
included in the August 2014 IFR, the new organization and content 
revisions are a logical outgrowth of other changes throughout the part. 
Paragraph (a), concerning application to NIOSH for facility 
participation in the CWHSP, is unchanged. Paragraph (a)(1), regarding 
the submission of digital radiographic image files with an application 
for facility approval, is redesignated as paragraph (a) and divided 
into smaller paragraphs for clarity. Paragraph (a)(1) now concerns the 
submission of image files; (a)(2) concerns the submission of images 
within 60 days of the application date; (a)(3) concerns the 
documentation that must accompany the image files; and (a)(4) concerns 
the orientation of submitted images.
    Paragraph (a)(2) is redesignated as paragraph (b). The name of the 
form referenced in paragraphs (b) and (e), the Radiographic Facility 
Certification Document, is updated to be consistent with updates in 
other section of part 37; similarly, the word ``X-ray'' is replaced 
with ``radiograph'' in paragraph (g)(2).
    Paragraphs (b), (c), (e), (f), and (h), concerning facility 
licensure, physical inspections by NIOSH, the medical physicist 
requirement, documentation of compliance, and maintenance of records in 
accordance with Federal privacy laws are redesignated as paragraphs 
(c), (d), (e), (f), and (i), respectively.
    Paragraph (g)(2), regarding radiation exposure parameters, is 
redesignated as paragraph (h)(2) and is divided into smaller paragraphs 
for clarity. Paragraph (h)(2)(i) now concerns the monitoring of 
radiological exposures; paragraph (h)(2)(ii) now concerns annual 
assessments of radiation exposures conducted by a medical physicist. 
The substance of paragraph (h) is otherwise unchanged.
Section 37.50 Interpreting and Classifying Chest Radiographs--Film 
Radiography Systems
    Section 37.50 establishes procedures for the classification of film 
radiographs. The section heading is revised to clarify that the 
procedures herein apply specifically to film radiography systems. 
Paragraphs (a), which requires radiographs to be interpreted in 
accordance with the ILO Classification, and (c), which requires those 
interpreting chest radiographs to have a complete set of standard 
radiographs for use with the ILO Classification immediately available 
for reference, are unchanged.
    Paragraph (b) requires radiographs to be interpreted and classified 
by physicians who read chest radiographs in the normal course of 
practice and who have demonstrated proficiency in classifying 
pneumoconiosis in accordance with the standards in Sec.  37.52. Non-
substantive revisions to the regulatory text in paragraph (b)(1), which 
requires that interpretations of findings other than pneumoconiosis 
must be provided by a qualified physician who provides these services 
for the examining facility, clarify that the physician must have all 
required licensure and privileges and must interpret chest radiographs 
in the normal course of his or her practice.
    Paragraph (c), which requires all interpreters to have immediately 
available a set of standard radiographs

[[Page 73273]]

for use with the ILO Classification, is unchanged.
    Paragraph (d), which establishes standards for view boxes, is 
revised to clarify that view boxes must comply with the requirements in 
paragraphs (d)(1)-(4). No comments were submitted on this section.
Section 37.51 Interpreting and Classifying Chest Radiographs--Digital 
Radiography Systems
    Section 37.51 establishes procedures for the classification of 
digital chest radiographs. Paragraph (a), which requires that 
significant abnormal findings other than pneumoconiosis must be 
initially interpreted and notification provided by a qualified 
physician, is not changed in this action.
    Paragraph (b), requiring that classifications be made by B Readers 
and recorded on a Chest Radiograph Classification form, is revised to 
clarify that physician readers who have demonstrated proficiency in the 
classification of pneumoconiosis in accordance with Sec.  37.52(b) are 
B Readers. The paragraph is also changed to remove the term 
``interpretations,'' for the reasons discussed above.
    Paragraph (c), which requires B Readers to have a complete set of 
NIOSH-approved standard digital radiographs for use with the ILO 
Classification immediately available for reference, is changed to 
clarify that NIOSH-approved digital standard images used for making 
classifications include all approved electronic standard chest images, 
thus encompassing the current digitized standard chest radiographs 
provided by ILO. This paragraph is also divided into smaller paragraphs 
to aid the reader; no substantive changes are made. Paragraph (c)(1) 
now concerns the use of only NIOSH-approved standard digital images for 
classification; (c)(2) prohibits the modification of the appearance of 
the standard images.
    Paragraphs (d) through (g), which concern viewing systems, quality 
control for display devices, use of soft copy images, and the 
impermissibility of classifications based on digitized copies of chest 
radiographs are also unchanged. No comments were submitted on this 
section.
Section 37.52 Proficiency in the Use of Systems for Classifying the 
Pneumoconioses
    Section 37.52 establishes the A and B Reader approval programs. 
Paragraph (a) establishes standards for the approval of A Readers; 
paragraph (a)(1), which allows A Reader approvals to continue if 
established prior to October 15, 2012, is changed to clarify that the 
approval continues indefinitely. Paragraph (a)(2) details the 
requirements for becoming a NIOSH-approved A Reader; paragraph (i), 
which requires the submission of six properly-classified sample 
radiographs, is revised to remove the word ``interpretations'' and 
replace it with ``classifications,'' and to update the name of the form 
to Chest Radiograph Classification Form (CDC/NIOSH 2.8), for the 
reasons discussed above. Paragraph (a)(2)(ii), requiring the completion 
of a NIOSH-approved ILO Classification course in lieu of the six sample 
radiographs referenced in paragraph (a)(2)(i), is unchanged.
    Paragraph (b), which establishes standards for the approval of B 
Readers, and paragraph (b)(1), which establishes that B Reader 
approvals received prior to October 1, 1976 are terminated, are 
unchanged. Paragraph (b)(2) requires that physicians pass a proficiency 
examination in order to be approved as a NIOSH B Reader and is revised 
to clarify that B Reader proficiency examinations are only given on 
behalf of or by NIOSH. This paragraph is also revised to divide the 
large paragraph into smaller paragraphs; no substantive revisions are 
made. Paragraph (b)(2)(i) now concerns the provision of a complete set 
of NIOSH-approved standard reference digital radiographs to physicians 
taking the B Reader exam; (b)(2)(ii) states that physicians who qualify 
as B Readers need not be qualified as A Readers.
    Paragraph (c) requires physicians who wish to participate in the 
CWHSP to apply to NIOSH. The name of the form is changed to Physician 
Application for Certification; the paragraph is otherwise unchanged. No 
comments were submitted on this section.
Section 37.53 Method of Obtaining Definitive Chest Radiograph 
Classifications
    Section 37.53 establishes the method used by NIOSH to obtain 
definitive classifications of chest radiographs. For the reasons 
discussed above, the name of this section is revised to replace 
``interpretations'' with ``chest radiograph classifications,'' to 
clarify that B Readers provide classifications according to the ILO 
system for classifying radiographs. Paragraph (a) establishes that 
radiographs will be independently classified by an A Reader and B 
Reader or two B Readers, or if agreement is lacking, NIOSH will obtain 
a third classification. This paragraph is revised to clarify that B 
Readers are qualified by NIOSH pursuant to Sec.  37.52, and is also 
divided into smaller paragraphs to aid the reader. Paragraph (a)(1) now 
concerns agreement among the two classifications; (a)(2) concerns the 
procedure NIOSH follows when agreement is lacking, and is further 
divided into smaller paragraphs. Paragraph (a)(2)(i) concerns agreement 
between two of three classifications resulting in a final 
determination; (a)(2)(ii) concerns lack of agreement among three 
classifications. No other changes are made to this paragraph.
    Paragraph (b), which establishes what NIOSH considers to be 
agreement between chest radiographs, is revised to clarify that two 
classifications are considered to be in agreement when they meet the 
standards now in paragraphs (b)(1), (2), and (3). Paragraph (b)(3), 
which contains the current standard for a determination of simple 
pneumoconiosis, is further divided into smaller paragraphs (i) and (ii) 
and is revised slightly to comport with the new structure. No comments 
were submitted on this section.
Section 37.54 Notification of Abnormal Radiographic Findings
    Section 37.54 requires that findings of abnormalities identified by 
chest radiograph be communicated to the miner. Although this section 
was not included in the August 2014 IFR, the revisions discussed below 
are consistent with other changes in this final action.
    A new heading is added to clarify the intent of paragraph (a), 
which provides that findings suggesting heart abnormalities, 
tuberculosis, lung cancer, or any other significant health condition 
other than pneumoconiosis must be communicated to the miner or the 
miner's designated physician. The paragraph is also rearranged to 
clarify that the first physician to interpret a miner's radiograph must 
communicate the findings.
    A new heading is added to clarify the intent of paragraph (b), 
which provides that NIOSH will arrange for a physician to compare a 
recent radiograph found to show significant abnormal findings, 
including pneumoconiosis, with older images that NIOSH may have in its 
possession. The word ``interpretation'' is removed from this paragraph 
to clarify that NIOSH will arrange for a physician to compare the most 
recent image showing an abnormality to older images. This change is 
consistent with other similar changes throughout part 37, for the 
reasons discussed above.
    A new heading is added to paragraph (c), to clarify the intent of 
the paragraph regarding notice to the miner of eligibility for Part 90 
transfer rights. The term ``final findings'' is replaced with ``final 
determinations,'' which are reported to the miner or the miner's

[[Page 73274]]

designated physician by NIOSH, when such determinations provide 
evidence for the development of pneumoconiosis. Revisions also clarify 
that NIOSH will coordinate with MSHA regarding notification of part 90 
eligibility.
    Finally, a heading is added to clarify the intent of paragraph (d), 
which states that NIOSH makes every effort to process pneumoconiosis 
determinations within 60 days of receipt of chest radiograph images and 
other documents. The paragraph is also divided into smaller paragraphs 
to aid the reader. Paragraph (d)(1) now concerns timely notice by MSHA; 
this paragraph is revised to clarify that NIOSH will work with MSHA to 
provide notice within the 60-day timeframe established in paragraph 
(d). Paragraph (d)(2) now states that examination results may not be 
processed by NIOSH if the examination was made within 6 months of the 
date of a prior acceptable examination.
    One public commenter recommended that this section be changed to 
allow the results of the radiography examinations and spirometry to be 
made available to a health professional designated by the mine 
operator. According to the commenter, because operators are required to 
establish a plan for the examinations and pay for them, they are 
entitled to have access to the results. The commenter argued that 
section 203 of the Mine Act (30 U.S.C. 843) does not support excluding 
mine operators from the notification requirements in this section or in 
the spirometry results notification requirements in the new Sec.  
37.97. According to the commenter, the decision to not provide 
examination results to mine operators is inconsistent with a 2006 NIOSH 
guidance document concerning refractory ceramic fibers and with the DOL 
Occupational Safety and Health Administration (OSHA) asbestos 
standards, both of which allow notification of employers. Further, 
according to the commenter, section 103(h) of the Mine Act provides for 
the sharing of reports and findings to any interested person. Finally, 
the commenter argued that sharing the examination findings with 
operators would allow the operators to provide health counseling and 
medical management to miners showing evidence of early disease.
    NIOSH declines to make results of radiography or spirometry 
available to either mine operators or health professionals designated 
by operators. Section 203 of the Mine Act specifically identifies the 
parties that must be notified of examination results (i.e., Secretary, 
DOL; Secretary, HHS; miner; and miner's designated physician). NIOSH is 
not authorized to expand notification to mine operators. Section 103 of 
the Mine Act, referenced by the commenter and described above, is not 
relevant to the matter of medical examinations of individual miners 
because it only addresses the conduct of mine inspections. Finally, 
NIOSH concurs with MSHA in its response to the question of providing 
examination results to operators, published in MSHA's 2014 final rule 
on respirable coal mine dust, which explained that the individuals 
notified of the miner's test results are limited in order to protect 
miners' confidentiality and uphold Federal privacy laws.\5\
---------------------------------------------------------------------------

    \5\ See 79 FR 24814, at 24928 (May 1, 2014).
---------------------------------------------------------------------------

Section 37.60 Submitting Required Chest Radiographs and Miner 
Identification Documents
    Section 37.60 establishes the protocol for submitting radiographs 
to NIOSH. Paragraph (a) is revised to clarify that all submitted items, 
including each required chest radiograph, the Chest Radiograph 
Classification form, and the Miner Identification Document, become the 
property of NIOSH. Paragraph (a)(1) is further revised to remove the 
redundant sentence concerning the 14-day deadline for submission of 
documents after the date of the radiographic examination. The sentence 
concerning NIOSH's notification to the submitting facility of receipt 
of image files and forms is moved into paragraph (a)(2).
    Paragraph (b) is revised to clarify that the operator must arrange 
for reexamination at no expense to the miner, in the event that NIOSH 
finds any submission to be inadequate.
    Paragraph (c), which establishes that failure to comply with 
paragraph (a) or (b) may result in revocation of approval of a plan, is 
unchanged, as is paragraph (d), which states that chest radiographs and 
required forms must only be submitted for miners.
    Paragraph (e) is revised to replace ``shall'' with ``must'' or 
``will'' throughout the paragraph in accordance with Federal plain 
language guidelines. References in this paragraph concerning the 
collection of Social Security numbers are revised slightly to clarify 
that only the last four digits are required by NIOSH; this change is 
not substantive and reflects current Program practice. No comments were 
submitted on this section.
Section 37.70 Review of Classifications
    Section 37.70(a) establishes that a miner may request that NIOSH 
reevaluate a pneumoconiosis classification that the miner believes is 
in error. The section heading is changed to replace ``interpretations'' 
with ``classifications,'' consistent with previous edits discussed 
above. The paragraph is also divided into smaller paragraphs to aid the 
reader. Paragraph (a)(1) establishes that after a written request from 
a miner, NIOSH will obtain one or more additional classifications by B 
Readers if the contested classification was based on agreement between 
an A Reader and a B Reader, pursuant to Sec.  37.53. A reference in 
this paragraph to the section in part 37 that addresses the transfer of 
miners to a less dusty area is corrected to read Sec.  37.102. 
Paragraph (a)(2) establishes that a classification based on agreement 
between two or more B Readers will be considered final and will be not 
be reevaluated. No comments were submitted on this section and no other 
changes are made to the regulatory text.
Sec.  37.80 Availability of Records for Radiographs
    Section 37.80 requires that written consent be provided to NIOSH 
for the release of medical information and radiographs. This section 
was not included in the August 2014 IFR, but is revised in this final 
action to clarify that original film radiographs are available for 
examination at the NIOSH facility in Morgantown, WV. No comments were 
submitted on this section.

B. Subpart--Spirometry Testing

    This subpart establishes standards for spirometry testing for all 
coal miners, working in both underground and surface mines. As 
discussed in the August 2014 IFR, the provisions in this subpart are 
consistent with MSHA regulations in 30 CFR 72.100, which requires that 
operators offer periodic spirometry and respiratory assessments to 
document miner respiratory symptoms and lung function. This is in 
addition to chest radiographic examinations and occupational history 
questionnaires. The subpart heading is revised to replace the word 
``examinations'' with the word ``testing,'' and similar changes are 
made throughout the subpart to reflect the correct terminology for 
describing spirometry.
Section 37.90 Scope
    Section 37.90 provides the scope of the provisions in Subpart--
Spirometry Testing. The text of this section is changed slightly to 
clarify that operators are required to provide spirometry testing to 
both current and newly

[[Page 73275]]

employed coal miners. No comments were submitted on this section.
Section 37.91 Definitions
    Section 37.91 defines terms used in this subpart. Several revisions 
are made to this section. The definition ``facility'' is removed, 
unchanged, from this section and moved to the definitions section in 
Sec.  37.2.
    The definition ``FET'' is revised to clarify that forced expiratory 
time is the time from the beginning of a forced exhalation maneuver to 
the end of the expiration.
    The definition ``FEV1'' is revised to clarify that forced 
expiratory volume in one second is the greatest volume of air that can 
be forcibly blown out within the first second after full inspiration.
    A new definition of the FEV1/FVC is added to mean the ratio between 
the largest acceptable FEV1 and the largest acceptable FVC following 
the forced vital capacity maneuver.\6\ Although this definition was not 
included in the August 2014 IFR, it is considered to be a logical 
outgrowth of this rulemaking. (See Sec.  37.96(b)(1).)
---------------------------------------------------------------------------

    \6\ See Gregg L. Ruppel, Manual of Pulmonary Function Testing, 
51 (St. Louis: Mosby Inc., 9th ed., 2009).
---------------------------------------------------------------------------

    The existing definition of ``FEV6'' is revised to clarify that 
forced expiratory volume in six seconds is the greatest volume of air 
that can forcibly be blown out in six seconds after full inspiration.
    The existing definition of ``FVC'' is revised to clarify that 
forced vital capacity is the greatest volume of air that can forcibly 
be blown out after full inspiration.
    The existing definition of ``PEF'' is revised to clarify that peak 
expiratory flow is the maximal airflow generated during a forced vital 
capacity maneuver.
    No comments were submitted on this section.
Section 37.92 Spirometry Testing Required for Miners
    Section 37.92 requires coal mine operators to provide all miners an 
opportunity to receive spirometry testing. Paragraph (a), which 
requires that each operator must provide an opportunity for miners to 
perform spirometry testing at least once every 5 years, is unchanged 
except for the heading, in which ``Voluntary examinations'' is replaced 
with ``Voluntary tests.''
    Paragraphs (b)(1), (2), and (3) establish the periodicity of 
initial, second, and third spirometry tests. The headings for the lower 
subparagraphs, ``Initial spirometry examination,'' ``Second 
examination,'' and ``Third examination'' are removed to mirror the 
structure of Sec.  37.3, ``Chest radiographs required for miners.'' The 
word ``examination(s)'' is replaced with ``test(s)'' throughout all 
three. Paragraph (b)(3) is revised to clarify that a third spirometry 
test and respiratory assessment will be provided if the second 
spirometry test results demonstrate more than a 15 percent age adjusted 
decline in the percent predicted FEV1 value since the initial baseline 
test. This paragraph is also divided into smaller paragraphs to aid the 
reader; the two new sub-paragraphs clarify how the percent predicted 
FEV1 value will be calculated (paragraph (b)(3)(i)) and the appropriate 
correction factor for calculating the percent predicted FEV1 for an 
individual of Asian descent (paragraph (b)(3)(ii)). One comment was 
received on paragraph (b)(3), supporting the decision to establish the 
15 percent decline in the percent predicted FEV1 value.
    Paragraph (c) establishes notification requirements for second and 
third spirometry testing sessions. This paragraph is also divided into 
smaller paragraphs to aid the reader. Paragraph (c)(1) stipulates that 
the operator would be notified of a miner's eligibility for a third 
spirometry test only with the consent of the miner. If the operator is 
notified, NIOSH will not specify the medical reason for the third test 
nor reveal that it is the miner's third. Paragraph (c)(2) establishes 
that if the miner is notified of the time for a third test and the 
operator is not notified, provision for the test in the NIOSH-approved 
operator's plan will constitute the operator's compliance with this 
requirement; no changes are made to the text of this paragraph.
    No revisions are made to paragraph (d) and no other public comment 
was received on this section.
Section 37.93 Approval of Spirometry Facilities
    Section 37.93 establishes standards by which NIOSH approves 
facilities that conduct spirometry tests, including ensuring that 
spirometry results are of adequate quality, and specifying programmatic 
approaches to quality assurance and addressing deficiencies. Paragraph 
(a) requires that NIOSH-approved facilities be able to provide 
spirometry of high technical quality by meeting the standards in this 
subpart. The paragraph is revised to replace the term ``spirometry 
examinations'' with the more common ``spirometry testing,'' and to 
remove the link to the Spirometry Facility Certification Document to 
avoid incorrect information if the NIOSH Web site is updated.
    Paragraph (b) establishes that a spirometry quality assurance 
program must be in place at the facility to minimize the rate of 
invalid test results. Paragraph (b)(1) requires instrument calibration 
checks, performed in accordance with the 2005 ATS/ERS Standardisation 
of Spirometry guidelines. The regulatory text is revised to clarify 
that instrument calibration check records must be maintained by the 
facility and available for inspection by NIOSH, as deemed necessary. 
One public commenter stated that the calibration check procedures as 
described in the proposed rule were most relevant to volume 
spirometers, which are no longer being produced and are increasingly 
unavailable for purchase. In response to the public comment, the 
regulatory text in paragraph (b)(1) is revised and divided into smaller 
paragraphs to clarify which calibration check procedures are expected 
for volume spirometers (paragraph (b)(1)(i)) and flow-type spirometers 
(paragraph (b)(2)(ii)). These procedures are consistent with guidance 
cited by the commenter and published by the Occupational Safety and 
Health Administration.\7\ A new paragraph (b)(1)(iii) contains the 
existing sentence regarding the retention and maintenance of instrument 
calibration check records, and is changed to clarify that records will 
be available for inspection by NIOSH, as deemed necessary.
---------------------------------------------------------------------------

    \7\ Occupational Safety and Health Administration, U.S. 
Department of Labor, Spirometry Testing in Occupational Health 
Programs: Best Practices for Healthcare Professionals, OSHA 3637-03 
2013, https://www.osha.gov/Publications/OSHA3637.pdf.
---------------------------------------------------------------------------

    Paragraph (b)(2) requires automated maneuver and test session 
quality-checks. The paragraph is revised to clarify that the screen 
displayed error messages must alert the technician to maneuver 
acceptability and test session non-repeatability. The paragraph is also 
revised to clarify that each spirometry test session must have the goal 
of obtaining 3 acceptable with 2 repeatable forced vital capacity 
maneuvers. A public commenter also expressed concern that technicians 
understand that although the error messages referenced in paragraph 
(b)(2) are helpful, they are unreliable and cannot be relied on alone 
to evaluate and determine test validity. NIOSH agrees that technicians 
should not rely on the equipment alone to alert them of testing errors. 
Accordingly, Sec.  37.95(a) requires all providers who collect 
spirometry data to successfully complete a NIOSH-approved spirometry 
training course. The spirometry course curriculum includes the 
identification and

[[Page 73276]]

correction of technical and subject performance errors.\8\ Course 
participants are given additional curriculum materials to use as guides 
for correcting these testing errors, which they can retain for future 
reference in their clinics.\9\ Paragraph (b)(2) is not changed in 
response to the public comment.
---------------------------------------------------------------------------

    \8\ See Spirometry: What is the Design and Content of an 
Approved Course? http://www.cdc.gov/niosh/topics/spirometry/content-approved-course.html.
    \9\ See NIOSH, Get Valid Spirometry Results EVERY Time, DHHS 
(NIOSH) Publication No. 2011-135, March 2011, http://www.cdc.gov/niosh/docs/2011-135/, and NIOSH, Spirometry Quality Assurance: 
Common Errors and Their Impact on Test Results, DHHS (NIOSH) 
Publication Number 2012-116, January 2012, http://www.cdc.gov/niosh/docs/2012-116/default.html.
---------------------------------------------------------------------------

    Paragraph (b)(3) requires ongoing monitoring of spirometry test 
quality. The paragraph is revised to clarify that NIOSH may provide 
quality performance feedback to the spirometry technician(s). The word 
``examination,'' used to characterize spirometry data, is removed from 
paragraph (b)(4), which concerns quality assurance audits.
    The word ``as'' is inserted into paragraph (c), which concerns 
noncompliance, to improve the first sentence; the word ``examination'' 
is removed, for the reasons discussed above. Paragraph (d), revocation 
of approval, is unchanged.
    Finally, in paragraph (e), references to chest radiographs are 
removed and/or changed to reference spirometry tests, in keeping with 
the theme of this subpart. These changes include replacing the term 
''medical examinations'' with ``spirometry tests'' and removing the 
reference to radiograph examinations, classifications, and images.
Section 37.94 Respiratory assessment form
    Section 37.94 requires that a respiratory assessment form must be 
completed for each miner upon testing. The link to the form on the 
NIOSH Web site is removed and the word ``examination'' is replaced with 
``testing.'' No comments were submitted on this section.
Section 37.95 Specifications for Performing Spirometry Tests
    Section 37.95 establishes standards for the performance of 
spirometry tests; the term ``examinations'' is replaced with ``tests'' 
in the section heading. Paragraph (a) of this section requires that 
persons administering spirometry tests for the CWHSP demonstrate 
completion of NIOSH-approved spirometry training, and maintain their 
knowledge by periodically completing an approved refresher course. The 
paragraph is revised to remove the link to the Spirometry Results 
Notification Form.
    Paragraph (b) establishes specifications for the spirometry testing 
equipment used to conduct tests pursuant to this Part. A public 
commenter recommended that the real-time displays should be large in 
order to allow the technician to quickly identify issues with the 
tests. NIOSH agrees with the commenter's concern and has required that 
spirometry testing equipment conform with the 2005 ATS/ERS 
Standardisation of Spirometry specifications for graphics (real-time 
displays and test reports), which should be a minimum size for the 
proper recognition of errors and acceptability of test maneuvers. As 
part of the approval process, clinics are required to provide 
information pertaining to spirometer manufacturer, model, and serial 
number for each spirometer used during miner testing. This spirometer 
information allows NIOSH to confirm that the system display meets 
minimum requirements. No changes are made to paragraph (b).
    Paragraph (c) specifies certain required documents and procedures 
during performance of spirometry testing, including the pre-test 
checklist, Respiratory Assessment form, collection of anthropometric 
and demographic information, and the spirometry procedure itself, which 
must be conducted in accordance with testing procedures described in 
the 2005 ATS/ERS Standardisation of Spirometry and the 2010 
Standardisation of Lung Function Testing, authors' replies to readers' 
comments, which are incorporated by reference. The paragraph is revised 
to include a new paragraph (c)(1), which clarifies that the Miner 
Identification Document described in Sec.  37.20 must be completed for 
each miner at the facility where spirometry is performed; the remaining 
numbered paragraphs are re-numbered accordingly. In the paragraphs now 
designated (c)(2) and (3), which require completion of the pre-test 
checklist and the Respiratory Assessment form, respectively, the links 
to those documents are removed, for the reason discussed above. 
Paragraph (c)(4), which requires the collection of anthropometric and 
demographic information, is revised to clarify that the data must 
either be entered into the facility's computer and transmitted 
electronically with the spirometry data file or submitted, if required 
under the facility's approval, on the Spirometry Results Notification 
form. Language concerning spirometry equipment that does not permit 
electronic transfer of data files is removed because all facilities 
that are approved to participate in the CWHSP will submit spirometry 
data electronically, whether in the form of spirometry data files or in 
the form of a completed Spirometry Results Notification Form (CDC/NIOSH 
2.15) accompanied by a spirometry report PDF that contains graphics for 
NIOSH inspection of FVC maneuver quality. The paragraph (c)(5) heading 
is revised to clarify that the topic of the paragraph is test 
procedures.
    Paragraph (d), concerning the submission of test results by the 
approved facility to NIOSH, is removed because it is redundant. 
Requirements for the submission of spirometry results to NIOSH are 
consolidated in Sec.  37.96(c).
    No changes are made to former paragraph (e), now designated 
paragraph (d), concerning records retention, other than to substitute 
``test'' and ``sessions'' for ``examination'' and ``examinations,'' and 
no other public comments were received on this section.
Section 37.96 Spirometry Interpretations, Reports, and Submission
    Section 37.96 establishes requirements for the interpretation of 
spirometry test results, as well as specifications for the content, 
deletion, and transmission of test reports. The heading of this section 
is revised to replace the word ``notifications'' with ``submission'' to 
reflect a reorganization of this section, discussed below.
    Paragraph (a) of this section requires qualified health care 
professionals at the facilities to interpret results using a 
standardized approach, described in the 2005 ATS/ERS Interpretative 
Strategies for Lung Function Tests, and the 2014 Official ATS 
Standards: Spirometry in the Occupational Setting, which are 
incorporated by reference. No changes are made to paragraph (a).
    Paragraph (b) specifies the content of spirometry test reports and 
the deletion of files and forms associated with the testing. The title 
of paragraph (b) is edited for clarity, ``Spirometry reports at NIOSH-
approved spirometry facilities.'' The phrase ``at a minimum'' is 
removed from paragraph (b)(1) to clarify that spirometry reports must 
contain the elements listed in this paragraph. Paragraph (b)(1) is also 
divided into smaller paragraphs to clarify the required elements, and 
revised by adding the word ``threshold'' to describe the lower limit of 
normal values required. Paragraph (b)(2) is unchanged.
    The language in paragraph (c), which requires that findings are 
communicated to the miner or the miner's designated physician, is moved 
from Sec.  37.96 to a new Sec.  37.97; the existing section

[[Page 73277]]

containing references to documents incorporated by reference into this 
subpart is renumbered Sec.  37.98. The notifications to miners section, 
public comment, and NIOSH response to comment are discussed below.
    With the removal of the language in paragraph (c), paragraph (d), 
concerning the submission of spirometry results to NIOSH, is 
redesignated paragraph (c). The text in this paragraph is revised to 
clarify that each facility must submit spirometry results and completed 
forms to NIOSH within 14 days of a spirometry test. The link to the 
Spirometry Notification Form is removed, as discussed above, and the 
name of the form is corrected. This paragraph is divided into smaller 
paragraphs to aid clarity. Paragraph (c)(1) concerns the submission of 
spirometry test results in the form of an electronic data file. CWHSP 
prefers the submission of all test results and data points using CSV or 
XML files. The submission must be carried out as specified in the 
facility's approval. Paragraph (c)(2) allows the submission of test 
results electronically using the Spirometry Results Notification form, 
when specified under a facility's approval. Electronic submission of 
test results via ePDF is acceptable when facilities are otherwise 
unable to submit electronic files in CSV or XML format. These changes 
are not substantive.
    The final paragraph, concerning the confidentiality of test 
results, is redesignated paragraph (d). The word ``examinations'' is 
removed from the paragraph heading. The text in this paragraph is 
revised to clarify that medical records containing protected health 
information must be maintained pursuant to the requirements in Sec.  
37.93(e). Finally, paragraph (d) is divided into two smaller paragraphs 
for clarity. No public comment was received on this section.
Section 37.97 Notification of Spirometry Results
    New Sec.  37.97, concerning the notification to miners or the 
miner's designated physician of spirometry results, comprises text that 
was located in Sec.  37.96(c). It is moved to a new section to make 
information about notification procedures more accessible and to mirror 
the structure of the subpart concerning chest radiographs. The original 
text is revised slightly to clarify that a comparison between current 
and previously submitted spirometry tests will be provided by NIOSH to 
the miner if the results from more than one set of spirometry results 
are available. One public commenter recommended that the results of 
both radiography and spirometry be made available to a health 
professional designated by the mine operator. NIOSH declines to adopt 
this recommendation; a summary of the public comment and NIOSH's 
response is located above, in the discussion concerning Sec.  37.54.
Section 37.98 Standards Incorporated by Reference
    Existing Sec.  37.97, concerning standards incorporated by 
reference into this subpart, is redesignated Sec.  37.98. Paragraph (a) 
is revised to update the name of the NIOSH Respiratory Health Division, 
as discussed above. The link to the ATS Standardization of Spirometry; 
1994 Update, is updated, as is the link to the 2005 ATS/ERS 
Standardisation of Spirometry. No comments were submitted on this 
section.

C. Subpart--General Requirements

    This subpart establishes general requirements for all surface and 
underground coal mine operators.
Section 37.100 Coal Mine Operator Plan for Medical Examinations
    Section 37.100 requires that all coal mine operators submit a plan 
for providing miners with radiography and spirometry examinations. 
Paragraph (a) requires operators to submit and receive NIOSH approval 
for a plan to provide the examinations, as well as occupational 
histories and respiratory assessments; it is unchanged. Paragraph 
(a)(1) specifies that on or after August 1, 2014, a person becoming a 
coal mine operator, for example by purchasing an existing mine or 
developing a new mine, or a mine operator without an approved plan must 
submit a plan within 60 days that provides for chest radiographs and 
occupational histories. The paragraph is revised, inserting the word 
``only,'' to clarify that the provision of spirometry tests need not be 
included for a plan approved pursuant to this paragraph.
    Paragraph (a)(2) states that all operators with approved 
examination plans providing only for chest radiographs and occupational 
histories will be notified by MSHA when they are required to submit an 
amended plan that includes spirometry and respiratory assessments.
    In paragraph (b), which lists the required components of the 
operator's plan, the term ``X-ray'' is replaced with ``radiograph'' and 
``tests'' are replaced with ``examinations'' in paragraph (b)(4); 
``shall'' is replaced with ``must'' or ``will'' in paragraph (b)(5) in 
accordance with the Federal Plain Language Guidelines.\10\
---------------------------------------------------------------------------

    \10\ See Federal Plain Language Guidelines, http://www.plainlanguage.gov/howto/guidelines/FederalPLGuidelines/index.cfm.
---------------------------------------------------------------------------

    Paragraph (c), which allows operators to provide for alternate 
examination facilities, is revised to clarify that the alternate 
facilities should be identified in the operator's plans submitted to 
NIOSH for approval.
    ``Shall'' is also replaced by ``must'' and ``shall be'' is replaced 
with ``is'' in paragraph (d), which states that an approved plan 
remains in effect even when the mine operator has transferred 
responsibility for the mine to a new operator.
    Paragraph (e), concerning changes in mine plans, is unchanged. 
Paragraph (f), which requires the display of a proposed plan or a 
proposed change in plan, is revised slightly to clarify that only 
changes to a NIOSH-approved plan need be displayed.
    In paragraph (g), which requires that mine operators resubmit a 
plan for each mine upon notification from NIOSH, the word ``will'' is 
replaced with ``must'' in accordance with Federal Plain Language 
Guidelines.
    No public comment was received and no other changes are made to 
this section.
Section 37.101 Approval of Plans
    Section 37.101 establishes that the operator's plan will be 
approved by NIOSH if it is found to meet the requirements in this 
subpart. Paragraphs (a) and (b), concerning approval and denial of mine 
operator plans, are unchanged. Paragraph (c) is revised to clarify that 
NIOSH will inform MSHA if an operator's plan is denied, in addition to 
the existing requirement for NIOSH to inform the operator. No comments 
were submitted on this section.
Section 37.102 Transfer of Affected Miner to Less Dusty Area
    Section 37.102 requires that any miner who has evidence of the 
development of pneumoconiosis, as determined by NIOSH, must be given 
the option of transferring to a less dusty area of the mine. A public 
commenter recommended that transfer to a less dusty area should be 
mandatory for all miners with ILO classifications greater than or equal 
to category 2. According to the commenter, only 19 percent of over 
3,000 miners who were offered an opportunity to transfer to a less 
dusty area since 1980 have exercised that option. Thus, the commenter 
thinks that the intervention program is ineffective ``in preventing 
pulmonary function

[[Page 73278]]

loss,'' and that ``stronger measures must be put in place to increase 
the participation in the transfer option.'' NIOSH cannot require 
transfer of a miner who demonstrates evidence of development of 
pneumoconiosis to a less dusty area. NIOSH concurs with MSHA's 
position, as addressed in the agency's May 1, 2014 final rule, that a 
mandatory transfer program would compromise the confidentiality of the 
CWHSP. In addition, section 203 of the Mine Act (30 U.S.C. 843) only 
speaks of optional transfers, and does not authorize mandatory 
transfers. No additional public comment was received, and no changes 
are made to the regulatory text.
Section 37.103 Medical Examinations at Miner's Expense
    Section 37.103 states that any miner who wishes to obtain a 
radiography examination or spirometry test at his or her own expense 
may do so. For clarity, the word ``interpretation'' is replaced with 
``evaluation of spirometry test results.'' No public comment was 
received on this section.
General
    One commenter asserted that NIOSH must take into account the 
effects of cigarette smoking on the health outcomes of coal miners, 
particularly chronic obstructive pulmonary disease (COPD). The 
commenter referred to a 1995 NIOSH Criteria Document concerning 
occupational exposure to respirable coal mine dust, which recommended 
that underground and surface coal mine operators prohibit smoking in 
all mines and other work areas associated with mining, provide 
counseling to smokers about their increased risk of lung cancer and 
COPD, and encourage them to participate in a smoking cessation 
program.\11\
---------------------------------------------------------------------------

    \11\ National Institute for Occupational Safety and Health, HHS, 
Criteria for a Recommended Standard: Occupational Exposure to 
Respirable Coal Mine Dust, DHHS (NIOSH) Publication No. 95-106, 
September 1995, http://www.cdc.gov/niosh/docs/95-106/pdfs/95-106.pdf.
---------------------------------------------------------------------------

    NIOSH acknowledges the effects of smoking and dust exposure on the 
development of occupational respiratory disease. Accordingly, NIOSH 
uses the Respiratory Assessment Form (CDC/NIOSH 2.13) in the course of 
conducting a spirometry test; the form includes detailed questions 
designed to establish the miner's smoking history.\12\ At the 
population level, this data collection will allow NIOSH to take smoking 
into account in evaluations of coal miners' respiratory health and will 
assist NIOSH in developing interventions to benefit underground and 
surface coal miners. At the level of the individual miner, the goal of 
the radiography and spirometry conducted pursuant to part 37 is to 
identify radiographic evidence of pneumoconiosis and spirometric 
evidence of respiratory impairment, not to establish disease causation.
---------------------------------------------------------------------------

    \12\ See Respiratory Assessment Form (CDC/NIOSH 2.13), questions 
9, 9a, 9b, 9c, 9d, 10, 11, http://www.cdc.gov/niosh/topics/surveillance/pdfs/cwhsp-respiratoryassessment-2-13.pdf.
---------------------------------------------------------------------------

    NIOSH lacks authority to prohibit smoking in underground and 
surface coal mines, but includes information about health effects of 
smoking in notifications to individual miners. Fortunately, many mines 
prohibit smoking onsite.

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 not being treated as a ``significant'' action 
under E.O. 12866. It finalizes and makes non-substantive revisions to 
those sections in 42 CFR part 37 which added requirements for mine 
operators to provide symptom assessment and spirometry testing for the 
surveillance of decreased lung function to all coal miners, and 
extended existing requirements to provide chest X-rays and occupational 
histories for underground coal miners to surface coal mine operators. 
The non-substantive revisions made in this final action to those 
sections of 42 CFR part 37 that were promulgated by interim final rule 
in August 2014 (79 FR 45110) will not result in costs to either the 
agency or its stakeholders.
    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. 601 et 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 requirements for the provision of chest X-rays and 
spirometry tests to all coal miners, and sets standards for the 
approval of testing facilities and transmission of test data.
    The potential impact on small businesses has been analyzed by MSHA, 
in the Regulatory Economic Analysis published in support of that 
agency's May 1, 2014 final rule (see http://www.msha.gov/REGS/REA/CoalMineDust2010.pdf). This final rule does not impose any new 
requirements on small radiographic or spirometry facilities that 
participate in the Coal Workers' Health Surveillance Program 
administered by NIOSH under 42 CFR part 37. This final rule will not 
impose a significant economic burden on small coal mines. Accordingly, 
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.

C. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et 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 action continues to 
impose the same information collection requirements as under the August 
2014 IFR, including the submission of the following forms:

 Consent, Release, and History Form for Autopsy [CDC/NIOSH 
(M)2.6]
 Chest Radiograph Classification Form [CDC/NIOSH 2.8]
 Miner Identification Document [CDC/NIOSH 2.9]
 Coal Mine Operator's Plan [CDC/NIOSH (M)2.10]
 Radiographic Facility Certification Document [CDC/NIOSH 
(M)2.11(E)]
 Physician Application for Certification [CDC 2.12 (E)]
 Respiratory Assessment Form [CDC/NIOSH 2.13]
 Spirometry Facility Certification [CDC/NIOSH 2.14]
 Spirometry Results Notification Form [CDC/NIOSH 2.15]
 Coal Contractor Plan [CDC/NIOSH (M) 2.18 (E)]

    These forms are approved by OMB for data collected under the 
National Coal Workers' Health Surveillance Program (CWHSP) (OMB Control 
No. 0920-0020, expires June 30, 2018). HHS estimates that the paperwork 
burden associated with this rulemaking is 20,282 hours.

[[Page 73279]]



----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent            Form name       respondents    responses per   response (in        hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Coal Mine Operator............  2.10............             388               1           30/60             194
Coal Mine Contractor..........  2.18............             575               1           30/60             288
Radiograph Facility Supervisor  2.11............              40               1           30/60              20
Coal Miner....................  2.9.............          14,560               1           20/60           4,854
Coal Miner--Radiograph........  No form required          14,560               1           15/60           3,640
B Reader Physician............  2.8.............              10            3014            3/60           1,507
Physicians taking the B Reader  2.12............             100               1           10/60              17
 Examination.
Spirometry Facility Supervisor  2.14............             100               1           30/60              50
Spirometry Facility Employee..  2.13............          14,560               1            5/60           1,214
Spirometry Technician.........  2.15............          14,560               1           20/60           4,854
Coal Mine--Spirometry.........  No form required          14,560               1           15/60           3,640
Pathologist...................  Invoice--No                    5               1            5/60               1
                                 standard form.
Pathologist...................  Pathology                      5               1            5/60               1
                                 Report--No
                                 standard form.
Next-of-kin for deceased miner  2.6.............               5               1           15/60               2
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............          20,282
----------------------------------------------------------------------------------------------------------------

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. 801 et 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. 1531 
et 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.

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 classifications 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 action affects 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 drafting this final action consistent with the Federal 
Plain Writing Act guidelines.

List of Subjects in 42 CFR Part 37

    Chronic obstructive pulmonary disease, Coal workers' 
pneumoconiosis, Incorporation by reference, Lung diseases, Mine safety 
and health, Occupational safety and health, Pneumoconiosis, Respiratory 
and pulmonary diseases, Silicosis, Spirometry, Surface coal mining, 
Transfer rights, Underground coal mining, 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 COAL MINERS

0
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.

0
2. Amend Sec.  37.2 by revising the introductory text and the 
definitions of ``Act'', ``Convenient time and place'', ``Digital 
radiography systems'', ``ILO Classification'', ``NIOSH'', ``Panel of B 
Readers'', and ``Radiologic technologist'' and by adding definitions of 
``B Reader'' and ``Facility'' to read as follows:


Sec.  37.2   Definitions.

    Any term defined in the Federal Mine Safety and Health Act of 1977 
(30 U.S.C. 801 et seq., Pub. L. 95-164, as amended) and not defined 
below will have the meaning given it in the Act. As used in this 
subpart:

[[Page 73280]]

    Act means the Federal Mine Safety and Health Act of 1977 (30 U.S.C. 
801, et seq., Pub. L. 95-164, as amended).
    B Reader means a physician certified by NIOSH as able to classify 
chest radiographs using the ILO Classification system, pursuant to 
Sec.  37.52(b).
* * * * *
    Convenient time and place means that an examination conducted 
pursuant to this part 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 
definition.
    Digital radiography systems, as used in this context, include both 
Digital Radiography (DR) and Computed Radiography (CR) systems.
    (1) Computed radiography (CR) is the term for digital radiographic 
image acquisition systems that detect radiographic 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 
radiographic image acquisition systems in which the radiographic 
signals received by the image detector are converted nearly 
instantaneously to electronic signals without movable cassettes.
    Facility means a facility or organization licensed to provide 
health care by the State or Territory in which services are provided, 
such as a hospital, a clinic, or other provider that performs medical 
examinations.
    ILO Classification means the classification of radiographs using 
the International Classification of Radiographs of Pneumoconioses, a 
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 approved by NIOSH as equivalent. The ILO 
Classification is incorporated by reference into Sec. Sec.  37.50(a) 
and (c) and 37.51(b).
* * * * *
    NIOSH means the National Institute for Occupational Safety and 
Health (NIOSH), located within the Centers for Disease Control and 
Prevention (CDC). Within NIOSH, the Respiratory Health Division (RHD), 
1095 Willowdale Road, Morgantown, WV 26505, is the organizational unit 
that has programmatic responsibility for the Coal Workers' Health 
Surveillance Program.
* * * * *
    Panel of B Readers means the group of physicians that are currently 
certified by NIOSH as B Readers and who classify or otherwise evaluate 
radiographs for the Coal Workers' Health Surveillance Program.
* * * * *
    Radiologic technologist means an individual who has met the 
requirements for privileges to perform general radiographic procedures 
and for competence in using the equipment and software employed by the 
examining facility to obtain chest radiographs as specified by the 
State or Territory and examining facility in which such services are 
provided. Optimally, such an individual will 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 offered by the American Registry of Radiologic 
Technologists.
* * * * *

0
3. Revise Sec.  37.3 to read as follows:


Sec.  37.3  Chest radiographs required for miners.

    (a) Voluntary examinations. Every operator must provide to each 
miner who is employed in or at any of its coal mines and who was 
employed in coal mining prior to December 30, 1969, or who has 
completed the required examinations under paragraph (b) of this section 
an opportunity for a chest radiograph at no cost to the miner in 
accordance with this subpart:
    (1) NIOSH will notify the operator of each coal mine of a period 
within which the operator may provide examinations to each miner 
employed at its coal mine. The period must begin no sooner than 3.5 
years and end no later than 4.5 years subsequent to the ending date of 
the previous 6-month period specified for a coal mine either by the 
operator on an approved plan or by NIOSH if the operator did not submit 
an approved plan. Within the period specified for each mine, the 
operator may select a 6-month period within which to provide 
examinations in accordance with a plan approved under Sec.  37.101.
    (2) Within either the next or future period(s) specified to the 
operator for each of its coal mines, the operator of the coal mine may 
select a different 6-month period for each of its mines within which to 
offer examinations. In the event the operator does not submit an 
approved plan, NIOSH will specify a 6-month period to the operator 
within which miners must have the opportunity for examinations.
    (b) Mandatory examinations. Every operator must provide to each 
miner who begins working in or at an underground coal mine for the 
first time after December 30, 1969 or in or at a surface coal mine for 
the first time after August 1, 2014:
    (1) An initial chest radiograph, as soon as possible, but in no 
event later than 30 days after commencement of employment or within 30 
days of approval of a plan to provide chest radiographs. An initial 
chest radiograph given to a miner according to former regulations for 
this subpart prior to August 1, 2014 will also be considered as 
fulfilling this requirement.
    (2) A second chest radiograph, in accordance with this subpart, 3 
years following the initial examination if the miner is still engaged 
in coal mining. A second radiograph given to a miner according to 
former regulations under this subpart prior to August 1, 2014 will be 
considered as fulfilling this requirement.
    (3) A third chest radiograph 2 years following the second chest 
radiograph if the miner is still engaged in coal mining and if the 
second radiograph shows evidence of category 1 (1/0, 1/1, 1/2), 
category 2 (2/1, 2/2, 2/3), category 3 (3/2, 3/3, 3/+) simple 
pneumoconiosis, or complicated pneumoconiosis (ILO Classification) or 
if the second spirometry examination specified in Sec.  37.92(b)(2) 
shows evidence of decreased lung function to the extent specified in 
Sec.  37.92(b)(3).
    (c) Notification. NIOSH will notify the miner when he or she is due 
to receive the second or third mandatory examination under paragraph 
(b) of this section. NIOSH will notify the coal mine operator when the 
miner is to be given a second examination.
    (1) The operator will be notified of a miner's third examination 
only with the miner's written consent. The notice to the operator will 
not state the medical reason for the examination or that it is the 
third examination in the series.
    (2) If the miner is notified by NIOSH that the third mandatory 
examination is due and the operator is not so notified, availability of 
the radiographic examination under the NIOSH-approved operator's plan 
will constitute the operator's compliance with the requirement to 
provide a third

[[Page 73281]]

mandatory examination even if the miner refuses to take the 
examination.
    (d) Availability of chest radiographs. The opportunity for chest 
radiographs to be made available by an operator for purposes of this 
subpart must be provided in accordance with a plan that has been 
submitted and approved in accordance with this part.

0
4. Revise Sec.  37.4 to read as follows:


Sec.  37.4  Chest radiographic examinations conducted by the Secretary.

    (a) The Secretary will give chest radiographs or make arrangements 
with an appropriate person, agency, or institution to give the chest 
radiographs and with A or B Readers to interpret the radiographs 
required under this subpart in the locality where the miner resides, at 
the mine, or at a medical facility easily accessible to a mining 
community or mining communities, under the following circumstances:
    (1) Where, in the judgment of the Secretary, due to the lack of 
adequate medical or other necessary facilities or personnel at the mine 
or in the locality where the miner resides, the required radiographic 
examination cannot be given.
    (2) Where the operator has not submitted an approvable plan.
    (3) Where, after commencement of an operator's program pursuant to 
an approved plan and after notice to the operator of his failure to 
follow the approved plan and, after allowing 15 calendar days to bring 
the program into compliance, the Secretary determines and notifies the 
operator in writing that the operator's program still fails to comply 
with the approved plan.
    (b) The operator of the mine must reimburse the Secretary or other 
person, agency, or institution as the Secretary may direct, for the 
cost of conducting each examination made in accordance with this 
section.
    (c) All examinations given or arranged by the Secretary will comply 
with the time requirements of Sec.  37.3. Whenever the Secretary gives 
or arranges for the examinations of miners at a time, a written notice 
of the arrangements will be sent to the operator who must post the 
notice on the mine bulletin board.

0
5. Revise Sec.  37.10 to read as follows:


Sec.  37.10  Standards incorporated by reference.

    (a) Certain material is incorporated by reference into this 
subpart, Subpart--Chest Radiographic Examinations, with the approval of 
the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR 
part 51. To enforce any edition other than that specified in this 
section, NIOSH must publish notice of change in the Federal Register 
and the material must be available to the public. All approved material 
is available for inspection at NIOSH, Respiratory Health Division, 1095 
Willowdale Road, Morgantown, WV 26505. To arrange for an inspection at 
NIOSH, call 304-285-5749. Copies are also available for inspection at 
the National Archives and Records Administration (NARA). For 
information on the availability of this material at NARA, call 202-741-
6030 or go to http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (b) American Association of Physicists in Medicine, Order 
Department, Medical Physics Publishing, 4513 Vernon Blvd., Madison, WI 
53705, http://www.aapm.org/pubs/reports:
    (1) AAPM On-Line Report No. 03, Assessment of Display Performance 
for Medical Imaging Systems, April 2005, into Sec.  37.51(d) and (e).
    (2) AAPM Report No. 14, Performance Specifications and Acceptance 
Testing for X-Ray Generators and Automatic Exposure Control Devices, 
Report of the Diagnostic X-Ray Imaging Committee Task Group on 
Performance Specifications and Acceptance Testing for X-Ray Generators 
and Automatic Exposure Control Devices, published by the American 
Institute of Physics for AAPM, January 1985, into Sec. Sec.  37.42(h) 
and 37.44(g).
    (3) AAPM Report No. 31, Standardized Methods for Measuring 
Diagnostic X-Ray Exposures, Report of Task Group 8, Diagnostic X-Ray 
Imaging Committee, published by the American Institute of Physics, July 
1990, into Sec.  37.44(g).
    (4) AAPM Report No. 74, Quality Control in Diagnostic Radiology, 
Report of Task Group 12, Diagnostic X-Ray Imaging Committee, published 
by Medical Physics Publishing for AAPM, July 2002, into Sec. Sec.  
37.42(h), 37.43(f), and 37.44(g).
    (5) AAPM Report No. 93, Acceptance Testing and Quality Control of 
Photostimulable Storage Phosphor Imaging Systems, October 2006, into 
Sec. Sec.  37.42(i) and 37.44(g).
    (6) AAPM Report No. 116, An Exposure Indicator for Digital 
Radiography, Report of AAPM Task Group 116, published by AAPM, July 
2009, into Sec.  37.44(g).
    (c) American College of Radiology, 1891 Preston White Dr., Reston, 
VA 20191, http://www.acr.org:
    (1) ACR Practice Guideline for Diagnostic Reference Levels in 
Medical X-Ray Imaging, Revised 2008 (Resolution 3), into Sec. Sec.  
37.42(i) and 37.44(g).
    (2) [Reserved]
    (d) International Labour Office, CH-1211 Geneva 22, Switzerland, 
http://www.ilo.org/publns:
    (1) Guidelines for the Use of the ILO International Classification 
of Radiographs of Pneumoconioses, Revised Edition 2011, into Sec. Sec.  
37.50(a), 37.50(c), and 37.51(b).
    (2) [Reserved]
    (e) National Council on Radiation Protection and Measurements, NCRP 
Publications, 7910 Woodmont Avenue, Suite 400, Bethesda, MD 20814-3095, 
Telephone (800) 229-2652, http://www.ncrppublications.org:
    (1) NCRP Report No. 102, Medical X-ray, Electron Beam, and Gamma-
Ray Protection for Energies Up to 50 MeV (Equipment Design, 
Performance, and Use), issued June 30, 1989, into Sec.  [thinsp]37.45.
    (2) NCRP Report No. 105, Radiation Protection for Medical and 
Allied Health Personnel, issued October 30, 1989, into Sec.  
[thinsp]37.45.
    (3) NCRP Report No. 147, Structural Shielding Design for Medical X-
Ray Imaging Facilities, revised March 18, 2005, into Sec.  
[thinsp]37.45.
    (f) National Electrical Manufacturers Association, 1300 N. 17th 
Street, Rosslyn, VA 22209, http://medical.nema.org:
    (1) DICOM Standard PS 3.3-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 3: Information Object Definitions, 
copyright 2011, into Sec.  37.42(i).
    (2) DICOM Standard PS3.4-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 4: Service Class Specifications, 
copyright 2011, into Sec.  37.42(i).
    (3) DICOM Standard PS 3.10-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 10: Media Storage and File Format 
for Media Interchange, copyright 2011, into Sec.  37.42(i).
    (4) DICOM Standard PS 3.11-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 11: Media Storage Application 
Profiles, copyright 2011, into Sec.  37.42(i).
    (5) DICOM Standard PS 3.12-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 12: Media Formats and Physical Media 
for Media Interchange, copyright 2011, into Sec. Sec.  37.42(i) and 
37.44(a).
    (6) DICOM Standard PS 3.14-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 14: Grayscale Standard Display 
Function, copyright 2011, into Sec. Sec.  37.42(i)(5) and 37.51(d).
    (7) DICOM Standard PS 3.16-2011, Digital Imaging and Communications 
in Medicine (DICOM) standard, Part 16:

[[Page 73282]]

Content Mapping Resource, copyright 2011, into Sec.  37.42(i).

0
6. Revise Sec.  37.20 to read as follows:


Sec.  37.20  Miner identification document.

    As part of the examination, a Miner Identification Document (CDC/
NIOSH (M)2.9) which includes an occupational history questionnaire must 
be completed for each miner at the facility where the examination is 
made (this document is required for both radiographic and spirometry 
examinations conducted pursuant to this part).

0
7. Revise Sec.  37.40 to read as follows:


Sec.  37.40  General provisions.

    (a) The chest radiographic examination must be given at a 
convenient time and place.
    (b) The chest radiographic examination consists of the chest 
radiograph, a completed Chest Radiograph Classification Form (CDC/NIOSH 
2.8), and a completed Miner Identification Document (CDC/NIOSH 2.9).
    (c) A radiographic examination must be made in a facility approved 
in accordance with Sec.  37.43 or Sec.  37.44. Chest radiographs of 
miners under this section must be performed:
    (1) By or under the supervision of a physician who makes chest 
radiographs in the normal course of practice and who has demonstrated 
ability to make chest radiographs of a quality to best ascertain the 
presence of pneumoconiosis; or
    (2) By a radiologic technologist as defined in Sec.  37.2.

0
8. Revise Sec.  37.43 to read as follows:


Sec.  37.43  Approval of radiographic facilities that use film 
radiography systems.

    (a) Facilities become eligible to participate in this program by 
demonstrating their ability to make high quality diagnostic chest 
radiographs by submitting to NIOSH six or more sample chest radiographs 
made and processed at the applicant facility and which are of 
acceptable quality to one or more individuals selected by NIOSH from 
the panel of B Readers. Applicants must also submit a radiograph of a 
plastic step-wedge object \1\ or other test object (available on loan 
from NIOSH) that was made and processed at the same time with the same 
technique as the radiographs submitted and processed at the facility 
for which approval is sought.
---------------------------------------------------------------------------

    \1\ The plastic step-wedge object is described in E. Dale Trout, 
John P. Kelley, A Phantom for the Evaluation of Techniques and 
Equipment Used for Roentgenography of the Chest, Amer J Roentgenol 
1973;117(4):771-776.
---------------------------------------------------------------------------

    (1) At least one chest radiograph and one test object radiograph 
must have been made with each unit to be used hereunder.
    (2) All radiographs must have been made within 15 calendar days 
prior to submission and must be marked to identify the facility where 
each radiograph was made, the X-ray machine used, and the date each was 
made.
    (3) The chest radiographs will be returned and may be the same 
radiographs submitted pursuant to Sec.  37.52(a)(2)(i).
    (b) Each radiographic facility submitting chest radiographs for 
approval under this section must complete and include a Radiographic 
Facility Certification Document (CDC 2.11) describing each unit to be 
used to make chest radiographs under the Act. The form must include:
    (1) The date of the last radiation safety inspection by an 
appropriate licensing agency or, if no such agency exists, by a 
qualified expert as defined in NCRP Report No. 102 (incorporated by 
reference, see Sec.  37.10);
    (2) The deficiencies found;
    (3) A statement that all the deficiencies have been corrected; and
    (4) The date of acquisition of the unit. To be acceptable, the 
radiation safety inspection must have been made within 1 year preceding 
the date of application.
    (c) Radiographs submitted with applications for approval under this 
section will be evaluated by one or more individuals selected by NIOSH 
from the panel of B Readers or by a qualified medical physicist or 
consultant. Applicants will be advised of any reasons for denial of 
approval.
    (d) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (e) NIOSH may require a facility periodically to resubmit 
radiographs of a test object, sample radiographs, or a Radiographic 
Facility Certification Document for quality control purposes.
    (1) Approvals granted hereunder may be suspended or withdrawn by 
notice in writing when in the opinion of NIOSH the quality of 
radiographs or information submitted under this section warrants such 
action.
    (2) A copy of a notice withdrawing approval will be sent to each 
operator who has listed the facility as its facility for giving chest 
radiographs and must be displayed on the mine bulletin board adjacent 
to the operator's approved plan. The approved plan will be reevaluated 
by NIOSH in light of this change.
    (f) A formal written quality assurance program must be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and must conform to the standards in AAPM Report No. 
74, pages 1-19, 47-53, and 56 (incorporated by reference, see Sec.  
37.10).
    (g) In conducting medical examinations pursuant to this part, 
physicians and radiographic facilities must maintain the results and 
analysis of these examinations (including any hard copies or digital 
files containing individual data, classifications, and images) 
consistent with applicable statutes and regulations governing the 
handling and protection of individually identifiable health 
information, including, as applicable, the HIPAA Privacy and Security 
Rules (45 CFR part 160 and 45 CFR part 164, subparts A, C, and E).

0
9. Revise Sec.  37.44 to read as follows:


Sec.  37.44  Approval of radiographic facilities that use digital 
radiography systems.

    (a) Facilities seeking approval must demonstrate the ability to 
make high quality digital chest radiographs by submitting to NIOSH 
digital radiographic image files of a test object (e.g., a plastic 
step-wedge or chest phantom which will be provided on loan from NIOSH) 
as well as digital radiographic image files from six or more sample 
chest radiographs that are of acceptable quality to one or more 
individuals selected by NIOSH from the panel of B Readers and a 
qualified medical physicist or consultant, both designated by NIOSH.
    (1) Image files must be submitted on standard portable media 
(compact or digital video disc) and formatted to meet specifications of 
the Digital Imaging and Communications in Medicine (DICOM) standard PS 
3.12-2011 (incorporated by reference, see Sec.  37.10). Applicants will 
be advised of any reasons for denial of approval.
    (2) All submitted images must be made within 60 days prior to the 
date of application using the same technique, equipment, and software 
as will be used by the facility under the requested approval. At least 
six chest radiographs and one test object radiograph must have been 
made with each digital radiographic unit to be used by the facility 
under the requested approval. The corresponding radiographic image 
files must be submitted on standard portable media (compact or digital 
video disc) and formatted to meet specifications of the current DICOM 
Standard PS 3.12-2011.

[[Page 73283]]

    (3) Documentation must include the following: the identity of the 
facility where each radiograph was made; the X-ray machine used; and 
the model, version, and production date of each image acquisition 
software program and hardware component.
    (4) The submitted sample digital chest image files must include at 
least two taken with the detector in the vertical position and two in 
the horizontal position where the imaging system permits these 
positions, and at least two chest images must be from persons within 
the highest quartile of chest diameters (28 cm or greater).
    (b) Each radiographic facility submitting chest radiographic image 
files for approval under this section must complete and include an 
Radiographic Facility Certification Document (CDC 2.11) describing each 
system component, and the models and versions of image acquisition 
hardware and software to be used to make digital chest radiographs 
under the Act. The form must include:
    (1) A copy of a dated report signed by a qualified medical 
physicist, documenting the evaluation of radiation safety and 
performance characteristics specified in this section for each digital 
radiography system;
    (2) A copy of the report of the most recent radiation safety 
inspection by a licensing agency, if such agency exists;
    (3) A listing of all deficiencies noted in either of the reports;
    (4) A statement that all the listed deficiencies have been 
corrected; and
    (5) The names and relevant training and experience of facility 
personnel described in paragraphs (c), (e), and (f) of this section. To 
be acceptable, the report by the medical physicist and radiation safety 
inspection specified in this paragraph (b) must have been made within 1 
year prior to the date of submission of the application.
    (c) Facilities must maintain ongoing licensure and certification 
under relevant local, State, and Federal laws and regulations for all 
digital equipment and related processes covered under this part.
    (d) NIOSH or its representatives may make a physical inspection of 
the applicant's facility and any approved radiographic facility at any 
reasonable time to determine if the requirements of this subpart are 
being met.
    (e) NIOSH may periodically require a facility to resubmit 
radiographic image files of the NIOSH-supplied test object (e.g., step-
wedge or chest phantom), sample radiographs, or a Radiographic Facility 
Certification Document. Approvals granted to facilities under this 
section may be suspended or withdrawn by notice in writing when, in the 
opinion of NIOSH, deficiencies in the quality of radiographs or 
information submitted under this section warrant such action. A copy of 
a notice suspending or withdrawing approval will be sent to each 
operator that has listed the facility for its use under this part and 
must be displayed on the mine bulletin board adjacent to the operator's 
approved plan. The operator's approved plan may be reevaluated by NIOSH 
in response to such suspension or withdrawal.
    (f) A qualified medical physicist who is familiar with the facility 
hardware and software systems for image acquisition, manipulation, 
display, and storage, must be on site or available as a consultant. The 
physicist must be trained in evaluating the performance of radiographic 
equipment and facility quality assurance programs, and must be 
licensed/approved by a State or Territory of the United States or 
certified by a competent U.S. national board.
    (g) Facilities must document that testing performed by a qualified 
medical physicist has verified that performance of each image 
acquisition system for which approval is sought met initial 
specifications and standards of the equipment manufacturer and 
performance testing as required under paragraphs (c), (f), and (h) of 
this section.
    (h) A formal written quality assurance program must be established 
at each facility addressing radiation exposures, equipment maintenance, 
and image quality, and must conform to the standards in AAPM Report No. 
74, pages 1-19, 47-53, and 56, and AAPM Report No. 116, sections VIII, 
IX, and X (incorporated by reference, see Sec.  37.10).
    (1) Applications for facility approval must include a comprehensive 
assessment by a qualified medical physicist within 12 months prior to 
application addressing the performance of X-ray generators, automatic 
exposure controls, and image capture systems. The assessment must 
comply with the following guidelines: AAPM Report No. 93, pages 1-68; 
AAPM Report No. 74, pages 6-11; and AAPM Report No. 14, pages 1-96 
(incorporated by reference, see Sec.  37.10).
    (2) Radiographic technique charts must be used that are developed 
specifically for the radiography system and detector combinations used, 
indicating exposure parameters by anatomic measurements. If automated 
exposure control devices are used, calibration for chest imaging must 
be documented using the actual voltages and image capture systems.
    (i) Radiological exposures resulting from at least ten (randomly 
selected) digital chest images obtained at the facility must be 
monitored at least quarterly to detect and correct potential dose 
creep, using methods specified in AAPM Report No. 31 (incorporated by 
reference, see Sec.  37.10). Radiation exposures must be compared to a 
professionally accepted reference level published in the American 
College of Radiology (ACR) Practice Guideline for Diagnostic Reference 
Levels in Medical X-Ray Imaging, pages 1-6 (incorporated by reference, 
see Sec.  37.10).
    (ii) The medical physicist must conduct an annual assessment of 
measured or estimated radiation exposures, with specific recommended 
actions to minimize exposures during examinations performed under this 
part.
    (3) For each digital radiography device and system, performance 
must be monitored annually in accordance with the recommendations of 
AAPM Report No. 93 (incorporated by reference, see Sec.  37.10), except 
for the testing specifically excluded below. Documentation must be 
maintained on the completion of quality assurance testing, including 
the reproducibility of X-ray output, linearity and reproducibility of 
mA settings, accuracy and reproducibility of timer and kVp settings, 
accuracy of source-to-detector distance, and X-ray field focal spot 
size, selection, beam quality, congruence and collimation. For DR 
systems, the following tests listed in AAPM Report No. 93 are not 
required under this part:
    (i) Section 8.4.5: Laser beam function.
    (ii) Section 8.4.9: Erasure Thoroughness.
    (iii) Section 8.4.11: Imaging Plate (IP) Throughput.
    (4) Facilities must maintain documentation, available for 
inspection by NIOSH for 5 years, of the ongoing implementation of 
policies and procedures for monitoring and evaluating the effective 
management, safety, and proper performance of chest image acquisition, 
digitization, processing, compression, transmission, display, 
archiving, and retrieval functions of digital radiography devices and 
systems.
    (i) In conducting medical examinations pursuant to this part, 
physicians and radiographic facilities must maintain the results and 
analysis of these examinations (including any hard copies or digital 
files containing individual data, interpretations, and images) 
consistent with applicable statutes and regulations governing the 
handling and protection of individually identifiable health 
information, including, as applicable, the HIPAA

[[Page 73284]]

Privacy and Security Rules (45 CFR part 160 and 45 CFR part 164, 
subparts A, C, and E).

0
10. Revise Sec.  37.50 to read as follows:


Sec.  37.50  Interpreting and classifying chest radiographs--film 
radiography systems.

    (a) Chest radiographs must be interpreted and classified in 
accordance with the Guidelines for the Use of the ILO International 
Classification of Radiographs of Pneumoconioses (incorporated by 
reference, see Sec.  37.10). Chest radiograph interpretations and 
classifications must be recorded on a paper or electronic Chest 
Radiograph Classification Form (CDC/NIOSH 2.8).
    (b) Radiographs must be interpreted and classified only by a 
physician who reads chest radiographs in the normal course of practice 
and who has demonstrated proficiency in classifying the pneumoconioses 
in accordance with Sec.  37.52.
    (1) Initial clinical interpretations and notification of findings 
other than pneumoconiosis under paragraph (a) of this section must be 
provided by a qualified physician who provides these services for the 
examining facility. This physician must have all required licensure and 
privileges, and must interpret chest radiographs in the normal course 
of practice.
    (2) [Reserved]
    (c) All interpreters, whenever interpreting chest radiographs made 
under the Act, must have immediately available for reference a complete 
set of the standard radiographs for use with the Guidelines for the Use 
of the ILO International Classification of Radiographs of 
Pneumoconioses (incorporated by reference, see Sec.  37.10).
    (d) View boxes used for making interpretations must comply with the 
following:
    (1) Fluorescent lamps must be simultaneously replaced with new 
lamps at 6-month intervals;
    (2) All the fluorescent lamps in a panel of boxes must have 
identical manufacturer's ratings as to intensity and color;
    (3) The glass, internal reflective surfaces, and the lamps must be 
kept clean;
    (4) The unit must be so situated as to minimize front surface 
glare.

0
11. Revise Sec.  37.51 to read as follows:


Sec.  37.51  Interpreting and classifying chest radiographs--digital 
radiography systems.

    (a) For each chest radiograph obtained at an approved facility 
using a digital radiography system, a qualified and licensed physician 
who reads chest radiographs in the normal course of practice must 
provide an initial clinical interpretation and notification, as 
specified in Sec.  37.54, of any significant abnormal findings other 
than pneumoconiosis.
    (b) Chest radiographs must be classified for pneumoconiosis by 
physician readers (B Readers) who have demonstrated ongoing 
proficiency, as specified in Sec.  37.52(b), in classifying the 
pneumoconioses in a manner consistent with the Guidelines for the Use 
of the ILO International Classification of Radiographs of 
Pneumoconioses (incorporated by reference, see Sec.  37.10). Chest 
radiograph classifications must be recorded on a paper or electronic 
Chest Radiograph Classification Form (CDC/NIOSH 2.8).
    (c) All B Readers, whenever classifying digitally-acquired chest 
radiographs made under the Act, must have immediately available for 
reference a complete set of NIOSH-approved standard digital chest 
radiographic images, including electronic images such as scanned 
images, provided for use with the Guidelines for the Use of the ILO 
International Classification of Radiographs of Pneumoconioses 
(incorporated by reference, see Sec.  37.10).
    (1) Only NIOSH-approved standard digital (electronic) images may be 
used for classifying digital chest images for pneumoconiosis.
    (2) Modification of the appearance of the standard images using 
software tools is not permitted.
    (d) Viewing systems should enable readers to display the coal 
miner's chest image at the full resolution of the image acquisition 
system, side-by-side with the selected NIOSH-approved standard images 
for comparison.
    (1)(i) Image display devices must be flat panel monitors displaying 
at least 3 MP at 10 bit depth. Image displays and associated graphics 
cards must meet the calibration and other specifications of the Digital 
Imaging and Communications in Medicine (DICOM) standard PS 3.14-2011 
(incorporated by reference, see Sec.  37.10).
    (ii) Image displays and associated graphics cards must not deviate 
by more than 10 percent from the grayscale standard display function 
(GSDF) when assessed according to the AAPM On-Line Report No. 03, pages 
1-146 (incorporated by reference, see Sec.  37.10).
    (2) Display system luminance (maximum and ratio), relative noise, 
linearity, modulation transfer function (MTF), frequency, and glare 
should meet or exceed recommendations listed in AAPM On-Line Report No. 
03, pages 1-146 (incorporated by reference, see Sec.  37.10). Viewing 
displays must have a maximum luminance of at least 171 cd/m2, a ratio 
of maximum luminance to minimum luminance of at least 250, and a glare 
ratio greater than 400. The contribution of ambient light reflected 
from the display surface, after light sources have been minimized, must 
be included in luminance measurements.
    (3) Displays must be situated so as to minimize front surface 
glare. Readers must minimize reflected light from ambient sources 
during the performance of classifications.
    (4) Measurements of the width and length of pleural shadows and the 
diameter of opacities must be taken using calibrated software measuring 
tools. If permitted by the viewing software, a record must be made of 
the presentation state(s), including any noise reduction and edge 
enhancement or restoration functions that were used in performing the 
classification, including any annotations and measurements.
    (e) Quality control procedures for devices used to display chest 
images for classification must comply with the recommendations of the 
American Association of Physicists in Medicine AAPM On-Line Report No. 
03, pages 1-146 (incorporated by reference, see Sec.  37.10).
    (1) If automatic quality assurance systems are used, visual 
inspection must be performed using one or more test patterns 
recommended by the medical physicist every 6 months, or more 
frequently, to check for defects that automatic systems may not detect.
    (2) [Reserved]
    (f) Classification of CR and DR digitally-acquired chest 
radiographs under this part must be performed based on the viewing of 
images displayed as soft copies using the viewing workstations 
specified in this section. Classification of radiographs must not be 
based on the viewing of hard copy printed transparencies of images that 
were digitally-acquired.
    (g) The classification of chest radiographs based on digitized 
copies of chest radiographs that were originally acquired using film-
screen techniques is not permissible under this part.

0
12. Revise Sec.  37.52 to read as follows:


Sec.  37.52  Proficiency in the use of systems for classifying the 
pneumoconioses.

    (a) First or A Readers:
    (1) Approval of a physician as an A Reader continues indefinitely 
if established prior to October 15, 2012.
    (2) Physicians who desire to become A Readers must demonstrate 
their proficiency in classifying the pneumoconioses by either:
    (i) Submitting to NIOSH from the physician's files six sample chest 
radiographs which are considered

[[Page 73285]]

properly classified by one or more individuals selected by NIOSH from 
the panel of B Readers. The six radiographs must consist of two without 
pneumoconiosis, two with simple pneumoconiosis, and two with 
complicated pneumoconiosis (these may be the same radiographs submitted 
for facility approval pursuant to Sec. Sec.  37.43 and 37.44). The 
films will be returned to the physician. The classifications must be on 
the Chest Radiograph Classification Form (CDC/NIOSH 2.8); or
    (ii) Satisfactory completion, since June 11, 1970, of a course 
approved by NIOSH on the ILO International Classification of 
Radiographs of Pneumoconioses.
    (b) Final or B Readers:
    (1) Approval as a B Reader established prior to October 1, 1976, is 
hereby terminated.
    (2) Proficiency in evaluating chest radiographs for radiographic 
quality and in the use of the ILO Classification for interpreting chest 
radiographs for pneumoconiosis and other diseases must be demonstrated 
by those physicians who desire to be B Readers by taking and passing a 
specially-designed proficiency examination given on behalf of or by 
NIOSH at a time and place specified by NIOSH.
    (i) Each physician who desires to take the digital version of the 
examination will be provided a complete set of the current NIOSH-
approved standard reference digital radiographs.
    (ii) Physicians who qualify under this provision need not be 
qualified under paragraph (a) of this section.
    (c) Physicians who wish to participate in the program must 
familiarize themselves with the necessary components for attainment of 
reliable classification of chest radiographs for the pneumoconioses\2\ 
and apply using a Physician Application for Certification Form (CDC 
2.12(E)).
---------------------------------------------------------------------------

    \2\ NIOSH Safety and Health Topic, Chest Radiography: 
Radiographic Classification, http://www.cdc.gov/niosh/topics/chestradiography/radiographic-classification.html.

0
13. Revise Sec.  37.53 to read as follows:


Sec.  37.53  Method of obtaining definitive chest radiograph 
classifications.

    (a) All chest radiographs which are first classified by an A or B 
Reader will be submitted by NIOSH to a B Reader qualified pursuant to 
Sec.  37.52.
    (1) If there is agreement between the two classifications, as 
described in paragraph (b) of this section, the result will be 
considered final and reported to MSHA for transmittal to the miner.
    (2) When agreement is lacking, NIOSH must obtain a third 
classification from the panel of B Readers.
    (i) If any two of the three classifications demonstrate agreement, 
the result must be considered the final determination.
    (ii) If agreement is lacking among the three classifications, NIOSH 
will obtain independent classifications from two additional B Readers 
selected from the panel, and the final determination will be the median 
category derived from the total of five classifications.
    (b) Two classifications are considered to be in agreement when:
    (1) They are derived from complete classifications recorded using 
approved paper or electronic versions of the Chest Radiograph 
Classification Form (CDC/NIOSH 2.8) and received by NIOSH; and
    (2) Both find either stage A, B, or C complicated pneumoconiosis; 
or,
    (3) For simple pneumoconiosis, are both in the same major category 
or are within one minor category (ILO Classification 12-point scale) of 
each other (subject to the exception in paragraph (b)(3)(ii) of this 
section).
    (i) The higher of the two classifications must be reported.
    (ii) The only exception to the one minor category principle is a 
reading sequence of 0[sol]1, 1[sol]0 or 1[sol]0, 0[sol]1, which are not 
considered agreement.

0
14. Revise Sec.  37.54 to read as follows:


Sec.  37.54  Notification of abnormal radiographic findings.

    (a) Significant abnormal findings other than pneumoconiosis. The 
first physician to interpret the radiograph must communicate findings 
of, or findings suggesting, abnormality of cardiac shape or size, 
tuberculosis, lung cancer, or any other significant abnormal findings 
other than pneumoconiosis to the miner indicated on the Miner 
Identification Document or to the miner's designated physician. A 
notice of the communication must be submitted to NIOSH. When 
significant abnormal findings are reported, NIOSH will also notify the 
miner to contact his or her physician.
    (b) Significant changes or progression of disease. When NIOSH has 
more than one radiograph of a miner in its files and the most recent 
examination was found by the first physician to interpret the 
radiograph or subsequently by NIOSH B Readers to show an abnormality of 
cardiac shape or size, tuberculosis, cancer, complicated 
pneumoconiosis, and any other significant abnormal findings, NIOSH will 
arrange for a licensed physician to compare the most recent image to 
older images and NIOSH will inform the miner of any significant changes 
or progression of disease or other findings.
    (c) Notice of eligibility for part 90 transfer option. All final 
determinations of radiographic classifications providing evidence for 
development of pneumoconiosis will be reported to the miner or to the 
miner's designated physician by NIOSH. In addition, NIOSH will 
coordinate with MSHA to assure that such miners are notified of 
eligibility to transfer to a less dusty area, in accordance with 
section 203 of the Act (see 30 CFR part 90 and Sec.  37.102).
    (d) Prompt dispatch of findings. NIOSH will make every reasonable 
effort to process the findings described in paragraph (c) of this 
section within 60 days of receipt of the information described in Sec.  
37.60 in a complete and acceptable form.
    (1) NIOSH will coordinate with MSHA to provide notice of 
eligibility for the part 90 transfer option within the same time frame.
    (2) The results of an examination may not be processed by NIOSH if 
the examination was made within 6 months of the date of a previous 
acceptable examination.

0
15. Revise Sec.  37.60 to read as follows:


Sec.  37.60  Submitting required chest radiograph classification and 
miner identification documents.

    (a) Each chest radiograph required to be made under this subpart, 
together with the completed Chest Radiograph Classification Form and 
the completed Miner Identification Document, must be submitted together 
for each miner to NIOSH within 14 calendar days after the radiographic 
examination is given. All submitted items become the property of NIOSH.
    (1) When the radiograph is digital, the image file for each 
radiograph, together with either hard copy or electronic versions of 
the completed Chest Radiograph Classification Form and the completed 
Miner Identification Document, must be submitted to NIOSH using the 
software and format specified by NIOSH either using portable electronic 
media, or a secure electronic file transfer.
    (2) NIOSH will notify the submitting facility when it has received 
the image files and forms from the examination. After this 
notification, the facility will permanently delete, or if this is not 
technologically feasible for the imaging system used, render 
permanently inaccessible all files and forms from its electronic and 
physical files.
    (b) If NIOSH deems any submission under paragraph (a) of this 
section inadequate, the operator will be notified of the deficiency. 
The operator must

[[Page 73286]]

promptly make appropriate arrangements for the necessary reexamination 
at no expense to the miner.
    (c) Failure to comply with paragraph (a) or (b) of this section 
will be cause to revoke approval of a plan or any other approval as may 
be appropriate. An approval that has been revoked may be reinstated at 
the discretion of NIOSH after it receives satisfactory assurances and 
evidence that all deficiencies have been corrected and that effective 
controls have been instituted to prevent a recurrence.
    (d) Chest radiographs and other required documents must be 
submitted only for miners.
    (e) If a miner refuses to participate in all phases of the 
examination prescribed in this subpart, no report need be made. If a 
miner refuses to participate in any phase of the examination prescribed 
in this subpart, all forms must be submitted with his or her name and 
the last four digits of the Social Security number on each. If any form 
cannot be completed because of the miner's refusal, it must be marked 
``Miner Refuses,'' and submitted to NIOSH. No submission will be made, 
however, without a completed Miner Identification Document (CDC/NIOSH 
2.9) containing the miner's name, address, last four digits of the 
Social Security number and place of employment.

0
16. Revise Sec.  37.70 to read as follows:


Sec.  37.70  Review of classifications.

    (a) Any miner who believes the classification for pneumoconiosis 
reported to him or her by MSHA is in error may file a written request 
with NIOSH that his or her radiograph be reevaluated.
    (1) If the classification was based on agreement between an A 
Reader and a B Reader, NIOSH will obtain one or more additional 
classifications by B Readers as necessary to obtain agreement in 
accordance with Sec.  37.53, and MSHA must report the results to the 
miner together with notification from MSHA of any rights which may 
accrue to the miner in accordance with Sec.  37.102.
    (2) If the reported classification was based on agreement between 
two (or more) B Readers, the reading will be accepted as conclusive and 
the miner must be so informed by MSHA.
    (b) Any operator who is directed by MSHA to transfer a miner to a 
less dusty atmosphere based on the most recent examination may file a 
written request with NIOSH to review its findings. The standards set 
forth in paragraph (a) of this section apply and the operator and miner 
will be notified by MSHA whether the miner is entitled to the option to 
transfer.

0
17. Revise Sec.  37.80 to read as follows:


Sec.  37.80  Availability of records for radiographs.

    (a) Medical information and radiographs on miners will be released 
by NIOSH only with the written consent from the miner, or if the miner 
is deceased, written consent from the miner's widow or widower, next of 
kin, or legal representative.
    (b) To the extent authorized, original film radiographs will be 
made available for examination only at the NIOSH facility in 
Morgantown, WV.

0
18. Revise the subpart heading above Sec.  37.90 to read as follows:

Subpart--Spirometry Testing

0
19. Revise Sec.  37.90 to read as follows:


Sec.  37.90  Scope.

    Under this subpart, coal mine operators are required to provide 
spirometry testing to both current and newly employed coal miners, 
using medical facilities approved by NIOSH in accordance with standards 
established in this subpart.

0
20. Revise Sec.  37.91 to read as follows:


Sec.  37.91  Definitions.

    Definitions provided in Sec.  37.2 will have the same meaning in 
this subpart. Any term defined in the Federal Mine Safety and Health 
Act of 1977 (Pub. L. 95-164, as amended) and not defined in Sec.  37.2 
or this section will have the meaning given it in the Act. As used in 
this subpart:
    ATS means American Thoracic Society.
    ERS means European Respiratory Society.
    FET means forced expiratory time, which is the time from the 
beginning of a forced exhalation (the back-extrapolated ``time zero'') 
maneuver to the end of expiration.
    FEV1 means forced expiratory volume in one second, which is the 
greatest volume of air that can be forcibly blown out within the first 
second, after full inspiration.
    FEV1/FVC means the ratio between the largest acceptable FEV1 and 
the largest acceptable FVC following the forced vital capacity 
maneuver. It is usually reported as a percentage.
    FEV6 means forced expiratory volume in six seconds, which is the 
greatest volume of air that can forcibly be blown out in six seconds, 
after full inspiration.
    FVC means forced vital capacity, which is the greatest volume of 
air that can forcibly be blown out after full inspiration.
    PEF means peak expiratory flow, which is the maximal airflow 
generated during a forced vital capacity maneuver.
    Spirometry test means a pulmonary function test that measures 
expiratory volume and airflow rates and may determine the presence and 
severity of lung function impairments, if such are present.

0
21. Revise Sec.  37.92 to read as follows:


Sec.  37.92  Spirometry testing required for miners.

    (a) Voluntary tests. Each operator must provide to all miners who 
are employed in or at any of its coal mines the opportunity to have a 
spirometry test and a respiratory assessment at no cost to the miner at 
least once every 5 years in accordance with this subpart. The tests 
will be available during a 6-month period that begins no less than 3.5 
years and not more than 4.5 years from the end of the last 6-month 
period.
    (b) Mandatory tests. Every operator must provide to each miner who 
begins work in or at a coal mine for the first time on or after August 
1, 2014, spirometry testing and respiratory assessment at no cost to 
the miner in accordance with this subpart.
    (1) Initial spirometry testing and respiratory assessment will be 
provided to all miners who begin work in or at a coal mine for the 
first time on or after August 1, 2014 within the first 30 days of their 
employment or within 30 days of approval of a plan to provide 
spirometry testing.
    (2) A follow-up second spirometry test and respiratory assessment 
will be provided to the miner no later than 3 years after the initial 
spirometry if the miner is still engaged in coal mining.
    (3) A third spirometry test and respiratory assessment will be 
provided no later than 2 years after the tests in paragraphs Sec.  
37.3(b)(2) and paragraph (b)(2) of this section if the chest radiograph 
shows evidence of pneumoconiosis as defined in Sec.  37.3(b)(3) or if 
the second spirometry test results demonstrate a 15 percent or greater 
decline in the percent predicted FEV1 value since the initial (i.e., 
baseline) test.
    (i) Percent predicted FEV1 will be calculated according to 
prediction equations published in Spirometric Reference Values from a 
Sample of the General U.S. Population, American Journal of Respiratory 
and Critical Care Medicine, 159(1):179-187, January 1999 (incorporated 
by reference, see Sec.  37.98).
    (ii) A correction factor to Caucasian reference values will be 
applied when testing individuals of Asian descent as

[[Page 73287]]

specified in the ATS Technical Standards: Spirometry in the 
Occupational Setting, p. 987 (incorporated by reference, see Sec.  
37.98).
    (c) Notification. NIOSH will notify the miner when he or she is due 
to receive the second or third mandatory test under paragraph (b) of 
this section. NIOSH will notify the coal mine operator when the miner 
is to perform a second spirometry test.
    (1) The operator will be notified of a miner's eligibility for a 
third test only with the miner's written consent. The notice to the 
operator will not state the medical reason for the test or that it is 
the third test in the series.
    (2) If the miner is notified by NIOSH that the third mandatory test 
is due and the operator is not so notified, availability of spirometry 
testing under the NIOSH-approved operator's plan will constitute the 
operator's compliance with the requirement to provide a third 
spirometry test even if the miner does not take the test.
    (d) Availability of spirometry testing. The opportunity for 
spirometry to be available for purposes of this subpart must be 
indicated in an operator's plan that has been submitted and approved in 
accordance with this subpart.

0
22. Revise Sec.  37.93 to read as follows:


Sec.  37.93  Approval of spirometry facilities.

    (a) Application for facility approval. Facilities seeking approval 
to provide the spirometry testing specified under this subpart must 
have the ability to provide spirometry of high technical quality. Thus, 
NIOSH-approved facilities must meet the requirements specified in this 
subpart for the following activities: Training of technicians who 
perform the tests; conducting spirometry tests using equipment and 
procedures that meet required specifications; collecting the 
respiratory assessment form; transmitting data to NIOSH; and 
communicating with miners as required for scheduling, testing, and 
notification of results. Facilities seeking approval may apply to NIOSH 
using the Spirometry Facility Certification document (CDC/NIOSH 2.14).
    (b) Spirometry quality assurance. A spirometry quality assurance 
program must be in place to minimize the rate of invalid test results. 
This program must include all of the following components:
    (1) Instrument calibration checks. Testing personnel must fully 
comply with the 2005 ATS/ERS Standardisation of Spirometry guidelines 
for instrument calibration check procedures, pp. 322-323, including 
Table 3 (incorporated by reference, see Sec.  37.98).
    (i) For volume spirometers, calibration check procedures must 
include daily (day of testing) leak and volume accuracy checks. In 
addition, volume linearity checks must be performed according to the 
frequency established by the 2005 ATS/ERS guidelines.
    (ii) For flow-type spirometers, calibration must be checked daily 
by injecting 3 liters of air from a calibration syringe at 3 different 
speeds (fast, medium, slow). Flow linearity must be checked weekly as 
established by the 2005 ATS/ERS guidelines.
    (iii) Instrument calibration check records must be maintained by 
the facility and available for inspection by NIOSH, as deemed 
necessary.
    (2) Automated maneuver and test session quality checks. The 
spirometer software must automatically perform quality assurance checks 
on expiratory maneuvers during each spirometry testing session. Screen 
displayed error messages must alert the technician to maneuver 
acceptability and test session non-repeatability. Each spirometry test 
session must have the goal of obtaining 3 acceptable with 2 repeatable 
forced vital capacity maneuvers, as defined by the 2005 ATS/ERS 
Standardisation of Spirometry, p. 325 (incorporated by reference, see 
Sec.  37.98).
    (3) Ongoing monitoring of test quality. Facilities must submit 
spirometry results to NIOSH within 14 calendar days of testing as 
specified in Sec.  37.96(c) to permit NIOSH to monitor test quality and 
provide a results report to each miner. NIOSH may provide quality 
performance feedback to the appropriate technician(s) along with 
suggestions for improvement.
    (4) Quality assurance audits. NIOSH may periodically conduct audits 
to review tests submitted by approved facilities and assess the quality 
of spirometry provided. Such audits may include a review of all 
spirometry data obtained during a specified time period or review of 
spirometry test data collected over time on selected miners.
    (c) Noncompliance. If NIOSH determines that a facility is not 
compliant with the policies and procedures specified in this subpart, 
or determines as the result of a quality assurance audit as specified 
in this section that a facility is not performing spirometry of 
adequate quality, the facility will be notified of the deficiency. The 
facility must promptly make appropriate arrangements for the deficiency 
to be rectified.
    (d) Revocation of approval. If a facility fails to rectify 
deficiencies within 60 days of notification, NIOSH approval of the 
facility may be revoked. An approval which has been revoked may be 
reinstated at the discretion of NIOSH after it receives satisfactory 
assurances and evidence that all deficiencies have been corrected and 
that effective controls have been instituted by the facility to prevent 
a recurrence.
    (e) Maintenance of records. When conducting spirometry tests 
pursuant to this subpart, physicians and facilities must maintain the 
results and analyses of these tests (including any hard copies or 
digital files containing individual data, such as interpretations) in a 
manner consistent with applicable statutes and regulations governing 
the handling and protection of individually identifiable health 
information, including, as applicable, the HIPAA Privacy and Security 
Rules (45 CFR part 160 and 45 CFR part 164, subparts A, C, and E).

0
23. Revise Sec.  37.94 to read as follows:


Sec.  37.94  Respiratory assessment form.

    As part of the spirometry testing and concurrent with it, personnel 
at the facility must complete a Respiratory Assessment Form (CDC/NIOSH 
2.13).

0
24. Revise Sec.  37.95 to read as follows:


Sec.  37.95  Specifications for performing spirometry tests.

    (a) Persons administering spirometry tests. Each person 
administering spirometry tests for the Coal Workers' Health 
Surveillance Program must successfully complete a NIOSH-approved 
spirometry training course and maintain a valid certificate by 
periodically completing NIOSH-approved spirometry refresher training 
courses, identified on the NIOSH Web site at http://www.cdc.gov/niosh/. 
A copy of the certificate of completion from a NIOSH-approved 
spirometry training or refresher course, with validation dates printed 
on the document, must be available for inspection. NIOSH will assign 
each person administering spirometry tests a unique identification 
number, which must be entered into the spirometry system computer 
whenever instrument quality assurance or miner testing is done or on 
the Spirometry Results Notification Form (CDC/NIOSH 2.15).
    (b) Spirometer specifications. Spirometry testing equipment must 
meet the 2005 ATS/ERS Standardisation of Spirometry specifications for 
spirometer accuracy and precision and real-time display size and 
content, pp. 331-333, including Table 2 on p. 322 and Table 6 on p. 332 
(incorporated by reference, see Sec.  37.98). Facilities must make 
available for inspection written verification from a third-party 
testing

[[Page 73288]]

laboratory (not the manufacturer or distributor) that the model of 
spirometer being used has successfully passed its validation checks as 
required by the Standardization of Spirometry; 1994 Update protocol, 
Appendix B pp. 1126-1134, including Table C1 (incorporated by 
reference, see Sec.  37.98). Facilities may request such documentation 
from spirometer manufacturers. For each forced expiratory maneuver 
submitted for a miner under this part, the spirometry data file must 
retain a record of the parameters defined in the 2005 ATS/ERS 
Standardisation of Spirometry, p. 335 including Table 8 (incorporated 
by reference, see Sec.  37.98). Spirometers that provide electronic 
transfer of spirometry data results files must use the format, content, 
and data structure specified by the 2005 ATS/ERS Standardisation of 
Spirometry, p. 335, or a procedure for data transfer that is approved 
by NIOSH.
    (c) Spirometry procedures. Administration of spirometry must 
include the following:
    (1) Miner Identification Document. The Miner Identification 
Document (CDC/NIOSH (M)2.9), described in Sec.  37.20, must be 
completed for each miner at the facility where spirometry is performed.
    (2) Pre-test checklist. The Spirometry Pre-Test Checklist portion 
of the Spirometry Results Notification Form (CDC/NIOSH 2.15) must be 
completed prior to each spirometry session to identify possible 
contraindications to testing, or factors that might affect results.
    (3) Respiratory Assessment Form. A standardized Respiratory 
Assessment Form (CDC/NIOSH 2.13) must be completed at the initial 
spirometry and repeated at each spirometry testing procedure.
    (4) Collection of anthropometric and demographic information. The 
miner's standing height must be measured in stocking feet using a 
stadiometer (or equivalent device) each time the miner performs 
spirometry. The miner's weight must also be measured (in stocking 
feet). The miner's birth date, race, and ethnicity must also be 
recorded. These data will be entered into the spirometry system 
computer and transmitted with the spirometry data file or, if required 
under the facility's approval, on the Spirometry Results Notification 
Form (CDC/NIOSH 2.15).
    (5) Test procedures. Spirometry will be conducted in accordance 
with test procedures defined in the 2005 ATS/ERS Standardisation of 
Spirometry, pp. 323-326, and the Standardisation of Lung Function 
Testing, Replies to Readers, pp. 1496-1498 (both incorporated by 
reference, see Sec.  37.98).
    (i) The technician must be able to view real-time testing display 
screens as specified in the 2005 ATS/ERS Standardisation of Spirometry, 
p. 322 (incorporated by reference, see Sec.  37.98).
    (ii) A miner will be tested in the standing position, but may be 
seated if he or she experiences lightheadedness or other signs or 
symptoms that raise a safety concern relating to the standing position 
during the spirometry test.
    (d) Records retention. On-site records of the results will include 
spirometry test reports and retention of all spirometry sessions, pre-
test checklists, and standardized respiratory assessment results in 
electronic or printed format until notification to delete or render the 
information inaccessible, as described in Sec.  37.100(b)(6)(ii), is 
received from NIOSH.

0
25. Revise Sec.  37.96 to read as follows:


Sec.  37.96  Spirometry interpretations, reports, and submission.

    (a) Interpretation of spirometry tests. Interpretations will be 
carried out by physicians or other qualified health care professionals 
with expertise in spirometry who have all required licensure and 
privileges to provide this service in their State or Territory. 
Interpretations must be carried out using procedures and criteria 
consistent with recommendations in the ATS Technical Standards: 
Spirometry in the Occupational Setting, pp. 987-990, and the ATS/ERS 
Interpretative Strategies for Lung Function Tests, p. 950, p. 956 
including Table 5, and p. 957 including Table 6 (both incorporated by 
reference, see Sec.  37.98).
    (b) Spirometry reports at NIOSH-approved spirometry facilities. (1) 
Spirometry test reports must contain the following:
    (i) The miner's age, height, gender, race, and weight;
    (ii) Numerical values (FVC, FEV6, FEV1, FEV1/FVC, FEV1/FEV6, FET, 
and PEF) and volume-time and flow-volume spirograms for all recorded 
expiratory maneuvers; normal reference value set used; and the 
predicted, percent predicted, and lower limit of normal threshold 
values;
    (iii) Miner position during testing (standing or sitting);
    (iv) Dates of test and last calibration check;
    (v) Ambient temperature and barometric pressure (volume 
spirometers); and
    (vi) The technician's unique identification number.
    (2) NIOSH will notify the submitting facility when to permanently 
delete or, if this is not technologically feasible for the spirometry 
system used, render permanently inaccessible all files and forms 
associated with a miner's spirometry test from its electronic and 
physical files.
    (c) Submission of spirometry results. Facilities must submit 
results of spirometry tests electronically with content as specified in 
Sec.  37.96(b), completed pre-test screening checklists (found in 
Spirometry Results Notification Form CDC/NIOSH 2.15), and completed 
Respiratory Assessment Form (CDC/NIOSH 2.13) within 14 calendar days of 
testing a miner.
    (1) Electronic spirometry test results. Submission of spirometry 
test results in the form of an electronic data file in a format 
approved by NIOSH is preferred. Facilities must utilize a secure 
internet data transfer site specified by NIOSH. Data submission must be 
performed as specified in the facility's approval. The transmitted 
spirometry data files must include a variable length record providing 
all parameters in the format, content, and data structure described by 
the 2005 ATS/ERS Standardisation of Spirometry, p. 335 including Table 
8 (incorporated by reference, see Sec.  37.98), or an alternate data 
file that is approved by NIOSH.
    (2) Spirometry test results submitted using the Spirometry Results 
Notification form. If specified under a facility's approval, spirometry 
results may be provided using the Spirometry Results Notification Form 
(CDC/NIOSH 2.15). The form must be completed and submitted 
electronically, accompanied by image files in a format approved by 
NIOSH that documents the flow-volume and volume-time curves for each 
trial reported on the form. The method of electronic submission must be 
approved by NIOSH and carried out securely as specified for electronic 
data files in Sec.  37.96(c)(1).
    (d) Confidentiality of spirometry results. Individual medical 
information and spirometry results are considered protected health 
information under HIPAA and may only be released as specified by HIPAA 
or to NIOSH, as discussed in paragraph (d)(1) of this section, and 
maintained by the spirometry facility as specified in Sec.  37.93(e).
    (1) Personally identifiable information in the possession of NIOSH 
will be released only with the written consent of the miner or, if the 
miner is deceased, the written consent of the miner's next of kin or 
legal representative.
    (2) To provide on-site back-up and assure complete data transfer, 
facilities must retain the forms and results (in electronic or paper 
format) from a

[[Page 73289]]

miner's test until instruction has been received from NIOSH to delete 
the associated files and forms or, if this is not technologically 
feasible, render the data permanently inaccessible.

0
26. Revise Sec.  37.97 to read as follows:


Sec.  37.97  Notification of spirometry results.

    (a) Findings must be communicated to the miner or, if requested by 
the miner, to the miner's designated physician. The health care 
professional at the NIOSH-approved facility must inform the miner if 
the spirometry shows abnormal results or if the respiratory assessment 
suggests he or she may benefit from the medical follow-up or a smoking 
cessation intervention.
    (b) NIOSH will notify the miner of his or her spirometry test 
results, a comparison between current and previously submitted 
spirometry tests (if available), and will advise the miner to contact a 
health care professional as appropriate based on the results.

0
27. Add Sec.  37.98 to read as follows:


Sec.  37.98  Standards incorporated by reference.

    (a) Certain material is incorporated by reference into this 
subpart, Subpart--Spirometry Testing, with the approval of the Director 
of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To 
enforce any edition other than that specified in this section, NIOSH 
must publish notice of change in the Federal Register and the material 
must be available to the public. All approved material is available for 
inspection at NIOSH, Respiratory Health Division, 1095 Willowdale Road, 
Morgantown, WV 26505. To arrange for an inspection at NIOSH, call 304-
285-5749. Copies are also available for inspection at the National 
Archives and Records Administration (NARA). For information on the 
availability of this material at NARA, call 202-741-6030 or go to 
http://www.archives.gov/federal_register/code_of_federal_regulations/ibv_locations.html.
    (b) American Journal of Respiratory and Critical Care Medicine, 
American Thoracic Society (ATS), 25 Broadway, 18th Floor, New York, NY 
10004. Phone: (800) 635-7181, extension 8065. Email: 
Hope.Robinson@sheridan.com. http://www.atsjournals.org/action/showHome:
    (1) Standardization of Spirometry; 1994 Update. Official Statement 
of the ATS, adopted November 11, 1994. American Journal of Respiratory 
and Critical Care Medicine 152(3):1107-1136, September 1995, into Sec.  
37.95(b). This ATS Official Statement is also available at http://www.atsjournals.org/doi/pdf/10.1164/ajrccm.152.3.7663792.
    (2) Official American Thoracic Society Technical Standards: 
Spirometry in the Occupational Setting (``ATS Technical Standards: 
Spirometry in the Occupational Setting''). Redlich CA, Tarlo SM, 
Hankinson JL, Townsend MC, Eschenbacher WL, Von Essen SG, Sigsgaard T, 
and Weissman DN. American Journal of Respiratory and Critical Care 
Medicine 189(8):983-994, April 15, 2014, into Sec. Sec.  37.92(b) and 
37.96(a).
    (3) Spirometric Reference Values from a Sample of the General U.S. 
Population. Hankinson JL, Odencrantz JR, Fedan KB. American Journal of 
Respiratory and Critical Care Medicine, 159(1):179-187, January 1999, 
into Sec.  37.92(b).
    (c) European Respiratory Journal, 442 Glossop Road, Sheffield, S10 
2PX, UK. Phone: 44 114 267 28 60; Fax: 44 114 266 50 64. Email: 
info@ersj.org.uk. http://erj.ersjournals.com/.
    (1) Standardisation of Spirometry (``2005 ATS/ERS Standardisation 
of Spirometry''). ATS/ERS Task Force: Standardization of Lung Function 
Testing. Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, 
Coates A, Crapo R, Enright P, van der Grinten CPM, Gustafsson P, Jensen 
R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino 
R, Viegi G, and Wanger J. European Respiratory Journal 26(2):319-338, 
August 2005, into Sec. Sec.  37.93(b); 37.95(b) and (c); and 37.96(c). 
The ATS/ERS Standardisation of Spirometry is also available on the ATS 
Web site at https://www.thoracic.org/statements/resources/pfet/PFT2.pdf.
    (2) Interpretative Strategies for Lung Function Tests (``ATS/ERS 
Interpretative Strategies for Lung Function Tests''). ATS/ERS Task 
Force: Standardisation of Lung Function Testing. Pellegrino R, Viegi G, 
Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten 
CPM, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, 
McKay R, Miller MR, Navajas D, Pedersen OF, and Wanger J. European 
Respiratory Journal 26(5):948-968, November 2005, into Sec.  37.96(a). 
The ATS/ERS Standardisation of Lung Function Testing is also available 
on the ATS Web site at http://www.thoracic.org/statements/resources/pft/pft5.pdf.
    (3) Standardisation of Lung Function Testing, the Authors' Replies 
to Readers' Comments (``Standardisation of Lung Function Testing, 
Replies to Readers''). Miller MR, Hankinson J, Brusasco V, Burgos F, 
Casaburi R, Coates A, Enright P, van der Grinten C, Gustafsson P, 
Jensen R, MacIntyre N, McKay RT, Pedersen OF, Pellegrino R, Viegi G, 
and Wanger J. European Respiratory Journal 36(6):1496-1498, December 
2010, into Sec.  37.95(c). The Standardisation of Lung Function 
Testing, Replies to Readers is also available on the ATS Web site at 
http://www.thoracic.org/statements/resources/pft/clarification-12-2010.pdf.

0
28. Revise Sec.  37.100 to read as follows:


Sec.  37.100  Coal mine operator plan for medical examinations.

    (a) Each coal mine operator must submit and receive NIOSH approval 
of a plan for the provision of chest radiographs, occupational 
histories, spirometry tests, and respiratory assessments of miners, 
using the appropriate forms provided by NIOSH.
    (1) During the transition from August 1, 2014 until the time when 
spirometry facilities are approved by NIOSH, any person becoming a coal 
mine operator on or after August 1, 2014, or any coal mine operator 
without an approved plan as of that date must submit a plan within 60 
days that provides for chest radiographs and occupational histories 
only.
    (2) Coal mine operators with previously approved plans for only 
chest radiographs and occupational histories, or with plans developed 
pursuant to paragraph (a)(1) of this section, will be notified by MSHA 
when the plans must be amended to include spirometry testing and 
respiratory assessments. Amendments must be submitted to NIOSH within 
60 days of MSHA's notification.
    (b) The coal mine operator's plan must include:
    (1) The name, address, and telephone number of the operator(s) 
submitting the plan;
    (2) The name, MSHA identification number for respirable dust 
measurements, and address of the mine included in the plan;
    (3) The proposed beginning and ending date of the 6-month period(s) 
for voluntary radiography exams and spirometry tests (see Sec. Sec.  
37.3(a) and 37.92(a)), the estimated number of miners to be given or 
offered examinations during the 6-month period under the plan, and a 
roster specifying the names and current home mailing addresses of each 
miner covered by the plan;
    (4) The name and location of the approved radiograph and spirometry 
facility or facilities, and the approximate date(s) and time(s) of day 
during which the radiograph examination and spirometry will be given to 
miners to enable a determination of whether the examinations will be 
conducted at a convenient time and place;

[[Page 73290]]

    (5) If a mobile medical examination facility is proposed to provide 
some or all of the surveillance tests specified in paragraph (a) of 
this section, the plan must provide that each miner be given adequate 
notice of the opportunity to have the examination and that no miner 
will have to wait for an examination more than 1 hour before or after 
his or her work shift. The plan must include:
    (i) The number of change houses at the mine.
    (ii) One or more alternate non-mobile approved medical examination 
facilities for the reexamination of miners and for the mandatory 
examination of miners when necessary (see Sec. Sec.  37.3(b) and 
37.92(b)), or an assurance that the mobile facility will return to the 
location(s) specified in the plan as frequently as necessary to provide 
for medical surveillance examinations in accordance with these 
regulations.
    (iii) The name and location of each change house at which 
examinations will be given. For mines with more than one change house, 
the examinations must be given at each change house or at a change 
house located at a convenient place for each miner.
    (6) Assurances that:
    (i) The operator will not solicit a physician's spirometric, 
radiographic or other findings concerning any miner employed by the 
operator;
    (ii) Instructions have been given to the person(s) giving the 
examinations that duplicate spirograms or copies of spirograms 
(including copies of electronic files) and radiographs or copies of 
radiographs (including, for digital radiographs, copies of electronic 
files) will not be made, and to the extent that it is technically 
feasible all related electronic files must be permanently deleted from 
the facility records or rendered permanently inaccessible following the 
confirmed transfer of such data to NIOSH, and that (except as may be 
necessary for the purpose of this part) the physician's spirometric, 
radiographic and other findings, as well as the occupational history 
and respiratory assessment information obtained from a miner will not 
be disclosed in a manner that would permit identification of the 
individual miner with his or her information; and
    (iii) The spirometry and radiographic examinations will be made at 
no charge to the miner.
    (c) Operators may provide for alternate spirometry or radiography 
facilities in plans submitted to NIOSH for approval.
    (d) The change of operators of any mine operating under a plan 
approved pursuant to Sec.  37.101(a) must not affect the plan of the 
operator which has transferred responsibility for the mine. Every plan 
is subject to revision in accordance with paragraph (e) of this 
section.
    (e) The operator must advise NIOSH of any change in its plan. Each 
change in an approved plan is subject to the same review and approval 
as the originally approved plan.
    (f) The operator must promptly display in a visible location on the 
bulletin board at the mine its proposed plan or proposed change in a 
NIOSH-approved plan when it is submitted to NIOSH. The proposed plan or 
change in a NIOSH-approved plan must remain posted in a visible 
location on the bulletin board until NIOSH either grants or denies 
approval at which time the approved plan or denial of approval must be 
permanently posted. In the case of an operator who does not have a 
bulletin board, such as an operator that is a contractor, the operator 
must otherwise notify its employees of the examination arrangements. 
Upon request, the contractor must show NIOSH written evidence that its 
employees have been notified.
    (g) Upon notification from NIOSH that sufficient time has elapsed 
since the previous period of examinations, the operator must resubmit a 
plan for each of its coal mines to NIOSH for approval for the next 
period of examinations (see Sec. Sec.  37.3(a)(2) and 37.92(a)). The 
plan must include the proposed beginning and ending dates of the next 
period of examinations and all information required by paragraph (b) of 
this section.

0
29. Revise Sec.  37.101 to read as follows:


Sec.  37.101  Approval of plans.

    (a) If, after review of any plan submitted pursuant to this 
subpart, NIOSH determines that the action to be taken under the plan by 
the operator meets the specifications of this subpart and will 
effectively achieve its purpose, NIOSH will approve the plan and notify 
the operator submitting the plan of the approval. Approval may be 
conditioned upon such terms as the Secretary deems necessary to carry 
out the purpose of section 203 of the Act.
    (b) Where NIOSH has reason to believe that it will deny approval of 
a plan NIOSH will, prior to the denial, give notice in writing to the 
operator(s) of an opportunity to amend the plan. The notice must 
specify the ground(s) upon which approval is proposed to be denied.
    (c) If a plan is denied approval, NIOSH will advise the operator(s) 
in writing of the reasons for the denial and inform MSHA that the plan 
was denied.

0
30. Revise Sec.  37.102 to read as follows:


Sec.  37.102  Transfer of affected miner to less dusty area.

    (a) Any miner who, in the judgment of NIOSH, has evidence of the 
development of pneumoconiosis, must be afforded the option of 
transferring from his or her position to another position in an area of 
the mine where the concentration of respirable dust in the mine 
atmosphere is in compliance with the MSHA requirements in 30 CFR part 
90. A classification of one or more of the miner's chest radiographs as 
showing category 1 (\1/0\, \1/1\, \1/2\), category 2 (\2/1\, \2/2\, \2/
3\), or category 3 (\3/2\, \3/3\, 3/+) simple pneumoconiosis, or 
complicated pneumoconiosis (ILO Classification) will be accepted as 
such evidence. NIOSH will, at its discretion, also accept other medical 
examinations provided to NIOSH for review, such as computed tomography 
scans of the chest or lung biopsies, as evidence of the development of 
pneumoconiosis.
    (b) Any transfer under this section shall be in accordance with the 
procedures specified in 30 CFR part 90.

0
31. Revise Sec.  37.103 to read as follows:


Sec.  37.103  Medical examination at miner's expense.

    Any miner who wishes to obtain a medical examination at the miner's 
own expense at an approved spirometry or radiography facility and to 
have the complete examination submitted to NIOSH may do so, provided 
that the examination is made no sooner than 6 months after the most 
recent examination of the miner submitted to NIOSH. NIOSH will provide 
radiographic classification, evaluation of spirometry test results, and 
reporting of the results of examinations made at the miner's expense in 
the same manner as if they were submitted under an operator's plan. Any 
change in the miner's transfer rights under the Act that may result 
from this examination will be subject to the terms of Sec.  37.102.

    Dated: October 4, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-24405 Filed 10-21-16; 8:45 am]
 BILLING CODE 4163-19-P