45110 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 

rulemaking. This action may not be 

challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2).) 

List of Subjects 

40 CFR Part 52 

Environmental protection, Air 

pollution control, Air quality, 

Prevention of significant deterioration, 

Incorporation by reference, Particulate 

matter, Reporting and recordkeeping 

requirements. 

40 CFR Part 70 

Administrative practice and 

procedure, Air pollution control, 

Intergovernmental relations, Operating 

permits, Reporting and recordkeeping 

requirements. 

Dated: July 21, 2014. 

Mike Brincks, 

Acting Regional Administrator, Region 7. 

For the reasons stated in the 

preamble, the Environmental Protection 

Agency is amending 40 CFR parts 52 

and 70 as set forth below: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et. seq. 

Subpart CC—Nebraska 

■ 2. In § 52.1420 the table in paragraph 

(c) is amended by revising the entries 

for 129–1, 129–17, and 129–19 to read 

as follows: 

§ 52.1420 Identification of plan. 

* * * * * 

(c) * * * 

EPA-APPROVED NEBRASKA REGULATIONS

Nebraska 

citation Title State effective date EPA approval date Explanation 

STATE OF NEBRASKA 

Department of Environmental Quality 

Title 129—Nebraska Air Quality Regulations 

129–1 ...... Definitions ....................................................................... 4/1/2012 8/4/2014 [Insert Federal 

Register citation].

*******

129–17 .... Construction Permits—When Required ......................... 4/1/2012 8/4/2014 [Insert Federal 

Register citation].

Approval does not include 

Nebraska’s revisions to 

sections 001.02T and 

013.04T pertaining to 

ethanol production facilities, which were not submitted by the State. 

129–19 .... Prevention of Significant Deterioration of Air Quality .... 4/1/2012 8/4/2014 [Insert Federal 

Register citation].

Provisions of the 2010 

PM2.5 PSD—Increments, 

SILs and SMCs rule (75 

FR 64865, October 20, 

2010) relating to SILs 

and SMCs that were affected by the January 

22, 2013 U.S. Court of 

Appeals decision are not 

SIP approved. 

* * * * * * * 

* * * * * 

PART 70—STATE OPERATING 

PERMITS PROGRAMS 

■ 3. The authority citation for part 70 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

■ 4. Appendix A to Part 70 is amended 

by adding, in alphabetical order, new 

paragraph (l) under the heading 

‘‘Nebraska; City of Omaha; LincolnLancaster County Health Department’’ 

to read as follows: 

Appendix A to Part 70—Approval 

Status of State and Local Operating 

Permits Programs 

* * * * * 

Nebraska; City of Omaha; Lincoln-Lancaster 

County Health Department 

* * * * * 

(l) The Nebraska Department of 

Environmental Quality approved a revision 

to NDEQ Title 129, Chapter 1 on December 

1, 2011, which became effective April 1, 

2012. This revision was submitted on 

February 13, 2013. We are approving this 

program revision effective October 3, 2014. 

* * * * * 

[FR Doc. 2014–18257 Filed 8–1–14; 8:45 am] 

BILLING CODE 6560–50–P 

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: Interim final rule. 

SUMMARY: With this action, the 

Department of Health and Human 

Services (HHS), in accordance with a 

final rule recently published by the 

Department of Labor’s Mine Safety and 

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Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 45111 

1Petsonk EL, Parker JE [2008]. Coal workers’ lung 

diseases and silicosis. In: Fishman AP, Elias J, 

Fishman J, Grippi M, Senior R, Pack A eds. 

Fishman’s Pulmonary Diseases and Disorders. 4th 

ed. New York: McGraw-Hill, pp. 967–980. 

2The Mine Safety and Health Administration 

(MSHA) published a final rule lowering the existing 

exposure limit from 2.0 mg/m3 to 1.5 mg/m3 in 

underground and surface coal mines (79 FR 24814, 

May 1, 2014). 3 30 U.S.C. 843(b). 

Health Administration (MSHA), is 

amending its regulations to establish 

standards for the approval of facilities 

that conduct spirometry examinations 

and to require that all coal mine 

operators submit a plan for the 

provision of spirometry and X-ray 

examinations to all surface and 

underground coal miners. 

DATES: This rule is effective on August 

4, 2014. Comments must be received by 

October 3, 2014. The incorporation by 

reference of certain publications listed 

in the rule is approved by the Director 

of the Federal Register as of August 4, 

2014. 

ADDRESSES: You may submit comments, 

identified by ‘‘RIN 0920–AA57,’’ by any 

of the following methods: 

• Internet: Access the Federal erulemaking portal at http://

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: NIOSH Docket Office, 1090 

Tusculum Avenue, MS C–34, 

Cincinnati, OH 45226–1998. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 

relevant comments will be posted 

without change to http://

www.regulations.gov including any 

personal information provided. For 

detailed instructions on submitting 

comments and additional information 

on the rulemaking process, see the 

‘‘Public Participation’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

www.regulations.gov. 

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: 

Table of Contents 

I. Public Participation 

II. Background 

A. History of Coal Workers’ Health 

Surveillance Program 

B. Need for Rulemaking 

C. Statutory Authority 

III. Issuance of an Interim Final Rule with 

Immediate Effective Date 

IV. Summary of Interim Final Rule 

A. Subpart—Chest Radiographic 

Examinations 

B. Subpart—Spirometry Examinations 

C. Subpart—General Requirements 

V. 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 

VI. Interim Final Rule 

I. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

arguments, recommendations, and data. 

Comments are invited on any topic 

related to this rulemaking. 

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 silicosis, and 

Coal Workers’ Pneumoconiosis (CWP), 

and the 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 statutes included an 

enforceable 2 milligrams per cubic 

meter limit on respirable dust exposure 

during underground coal mine work (30 

U.S.C. 842(b)(2)).2 The science available 

at that time indicated that enforcement 

of this limit would greatly reduce the 

development of CWP, but could not 

ensure that all miners would be 

protected from developing disabling or 

lethal disease. 

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 CWP and prevent 

its progression in individual miners, 

while at the same time providing 

information for evaluation of temporal 

and geographic trends in CWP. The 

Mine Act grants the HHS Secretary 

general authority to issue regulations as 

is deemed appropriate to carry out 

provisions of the Act and specifically 

directs that medical examinations for 

coal miners shall be given in accordance 

with specifications prescribed by the 

Secretary (30 U.S.C. 843(a), 957), and 

grants NIOSH the authority to conduct 

activities in the field of coal mine health 

on behalf of the Secretary (30 U.S.C. 

951(b)). 

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 CWP, 

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 are to be given in 

accordance with specifications 

prescribed by the Secretary of Health 

and Human Services (30 U.S.C. 843(a)). 

Under NIOSH supervision, a 

summary report based on the readings 

of the periodic chest radiograph is sent 

to each participating coal miner, who 

then has the opportunity to take action 

to reduce further dust exposure if early 

dust-induced lung disease is detected. 

Miners with evidence of CWP have 

specific rights under 30 CFR Part 90 3 to 

transfer to jobs with lower dust levels 

(see also 42 CFR 37.7). The combined 

results of these radiographic 

examinations of miners (radiographic 

surveillance) also enable NIOSH to track 

rates and patterns of CWP among the 

participating miners, to evaluate 

whether the implemented dust controls 

are effective in controlling CWP. 

B. Need for Rulemaking 

On May 1, 2014, the Mine Safety and 

Health Administration (MSHA) in the 

Department of Labor published a final 

rule revising 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 [79 FR 24814]. 

Section 72.100(a) of the MSHA final 

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45112 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 

rule requires 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. Section 72.100(c) of the rule 

prescribes an initial examination to be 

provided no later than 30 days after a 

miner begins employment at a coal mine 

for the first time, a follow-up exam no 

later than 3 years after the first, and 

another no later than 2 years after the 

second if the second test shows 

evidence of pneumoconiosis or the 

spirometry test shows evidence of 

reduced lung function. In addition to 

the mandatory exams, § 72.100(b) 

requires operators to provide each miner 

with an opportunity to have an X-ray 

and spirometry examination at least 

every 5 years. Section 72.100(a)(2) 

specifies that test results are to be 

furnished to the Secretary of Health and 

Human Services, and, at the request of 

the miner, to the miner’s designated 

physician. Section 72.100(d) of the 

MSHA final rule requires each coal 

mine operator to develop a plan for 

providing X-rays, spirometry, symptom 

assessment, and occupational history 

and submit it to NIOSH for approval; 

operators must also submit a roster of 

each miner covered by the plan. The 

MSHA final rule’s expansion of that 

agency’s medical surveillance 

requirements causes HHS to amend its 

regulations in 42 CFR Part 37 pertaining 

to the Coal Workers’ Health 

Surveillance Program, 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. 

C. Statutory Authority 

As discussed above, § 203 of the Mine 

Act directs the HHS Secretary to 

prescribe time intervals and 

specifications for the provision of chest 

X-rays, and standards for the reading, 

classification, and submission of the 

films [30 U.S.C. 843(a)]. The Secretary is 

also authorized to supplement the 

required X-rays with additional tests as 

deemed necessary to protect the health 

and safety of U.S. coal miners. 

III. Issuance of an Interim Final Rule 

With Immediate Effective Date 

Rulemaking under the Administrative 

Procedure Act (APA) generally requires 

a public notice and comment period and 

consideration of the submitted 

comments prior to promulgation of a 

final rule (5 U.S.C. 553). However, the 

APA provides for exceptions to its 

notice and comment procedures when 

an agency finds that there is good cause 

for dispensing with such procedures on 

the basis that they are impracticable, 

unnecessary, or contrary to the public 

interest. In accordance with the 

provisions in 5 U.S.C. 553(b)(3)(B), HHS 

finds good cause to waive the use of 

prior notice and comment procedures 

for this interim final rule (IFR) and to 

make this action effective immediately. 

This IFR amends 42 CFR Part 37 to 

allow coal miners who work in surface 

mines to participate in the CWHSP and 

to expand the Program to include 

spirometry testing to detect decreased 

lung function among both underground 

and surface coal miners. HHS has 

determined that it is impracticable to 

use prior notice and comment 

procedures for this IFR because the 

effective date of the final rule published 

by MSHA on May 1, 2014, requiring that 

NIOSH establish standards to provide 

spirometry testing, occupational history, 

and symptom assessment for all 

underground and surface coal miners, is 

August 1, 2014. NIOSH is committed to 

expanding the existing health 

surveillance program to provide 

spirometry testing to all coal miners as 

soon as possible, and believes that it 

would be contrary to the public interest 

to delay those individuals’ eligibility for 

inclusion in the program beyond the 

August 1, 2014 effective date. Thus, 

HHS is waiving the prior notice and 

comment procedures in the interest of 

protecting the health of all coal miners 

and allowing them to participate in the 

CWHSP as soon as possible. 

Stakeholders were given 

opportunities to participate in MSHA’s 

proposed rulemaking during seven 

public hearings held between December 

2010 and February 2011. The public 

comment period for the proposed rule 

was extended three times since the 

proposed rule was published on October 

19, 2010. MSHA received public 

comments on the provision related to 

NIOSH, 30 CFR 72.100, and 

summarized them in the preamble to the 

final rule (79 FR 24814, 24927–24929). 

Commenters were overall supportive of 

the provision, and MSHA was 

responsive to those comments that 

expressed concern or were critical of the 

measure. 

Under 5 U.S.C. 553(d)(3), HHS finds 

good cause to make this IFR effective 

immediately. As stated above, in order 

to protect the health of miners in both 

underground and surface coal mines, it 

is necessary that HHS act quickly to 

amend the existing standards in 42 CFR 

Part 37 to include surface miners and to 

establish criteria for the provision of 

spirometry testing. While amendments 

to Part 37 are effective on the date of 

publication of this IFR, they are interim 

and will be finalized following the 

receipt of any substantive public 

comments. (See Section I. Public 

Participation, above.) 

IV. Summary of Interim Final Rule 

This interim final rule expands the 

existing Coal Workers’ Health 

Surveillance Program to provide chest 

radiographic examinations to miners 

who work in surface coal mines and 

establishes new requirements for 

spirometry testing for all coal miners 

under existing Part 37 of 42 CFR— 

Specifications for Medical Examinations 

of Underground Coal Miners. The title 

of the Part is amended to read 

Specifications for Medical Examinations 

of Coal Miners. 

The following is a section-by-section 

summary which describes and explains 

the amended provisions of Part 37. The 

public is invited to provide comment on 

any aspect of the interim final rule. The 

amended regulatory text is provided in 

the last section of this notice. 

A. Subpart—Chest Radiographic 

Examinations 

Section 37.1 Scope 

Existing § 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 X-ray 

examinations to each current and new 

coal miner, using medical facilities 

approved by NIOSH according to the 

standards established in this subpart. 

Section 37.2 Definitions 

Existing § 37.2 contains definitions for 

terms that appear throughout this 

subpart and the new Subparts 

(Subpart—Spirometry Examinations and 

Subpart—General Requirements). In this 

section, the definition of ‘‘miner’’ is 

amended to remove language excluding 

surface coal miners from coverage under 

this part. ‘‘NIOSH’’ is amended to 

update the address of the Division of 

Respiratory Disease Studies and to 

reflect that programmatic responsibility 

is expanded to include medical 

examinations other than chest 

radiographs, and to clarify that the 

program also includes medical 

surveillance activities. The definition of 

‘‘operator’’ is amended to mirror the 

definition in the Mine Act, and to reflect 

the inclusion of surface coal miners in 

the medical examination and 

surveillance program. 

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Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 45113 

Section 37.3 Chest Radiographs 

Required for Miners 

Existing § 37.3 requires mine 

operators to provide miners an 

opportunity to receive a chest 

radiograph. This section is amended to 

remove the word ‘‘underground’’ and 

remove obsolete dates and examples. 

The section is also amended to specify 

that evidence of decreased lung function 

demonstrated by a spirometry exam 

conducted pursuant to § 37.92(b)(2) may 

trigger a third chest radiograph. 

Section 37.4 Plans for Chest 

Radiographic Examinations 

Existing § 37.4 requires that mine 

operators submit to NIOSH a plan for 

chest radiographic examinations, 

including the beginning and ending 

dates of the 6-month period for 

voluntary examinations, and the name 

and location of the approved X-ray 

facility or facilities. A form for the 

documentation of the plan is available 

on the CWHSP Web site at http://www.

cdc.gov/niosh/topics/surveillance/ords/

CoalWorkersHealthSurvProgram.html. 

This section is removed from this 

subpart and moved to new § 37.100; 

specific amendments are discussed 

below. 

Section 37.5 Approval of Plans 

Existing § 37.5 outlines the process 

undertaken by the Secretary of HHS to 

approve or deny approval of an 

operator’s plan for chest radiographs. 

This section is removed from this 

subpart and moved to new § 37.101; 

specific amendments are discussed 

below. 

Section 37.6 Chest Radiographic 

Examinations Conducted by the 

Secretary 

Existing § 37.6 details the conditions 

under which the HHS Secretary will 

determine whether to conduct a chest 

radiographic examination. This section 

is amended to change the section 

number to § 37.4 and to replace 

outdated text with current terminology. 

Section 37.7 Transfer of Affected 

Miner to Less Dusty Area 

Existing § 37.7 specifies that any 

miner who exhibits evidence of the 

development of CWP may transfer from 

his or her position to another position 

in the mine with a lower concentration 

of respirable dust, as compliant with the 

recently-updated 30 CFR 90.3. This 

section is removed from this subpart 

and moved to new § 37.102; specific 

amendments are discussed below. 

Section 37.8 Radiographic 

Examination at Miner’s Expense 

Existing § 37.8 allows that the miner 

may pay for an X-ray exam himself or 

herself, and NIOSH will provide the 

classification and report as if the exam 

was conducted pursuant to a mine 

operator’s plan. This section is removed 

from this subpart and moved to new 

§ 37.103; specific amendments are 

discussed below. 

Section 37.40 General Provisions 

Existing § 37.40 outlines general 

provisions for chest X-rays. This section 

is amended to update the terminology. 

Section 37.50 Interpreting and 

Classifying Chest Radiographs—Film 

Existing § 37.50 establishes 

procedures for the classification of film 

X-rays. It is amended slightly to update 

terminology. 

Section 37.51 Interpreting and 

Classifying Chest Radiographs—Digital 

Radiography Systems 

Existing § 37.51 establishes 

procedures for the classification of 

digital X-rays. It is amended slightly to 

update terminology. 

Section 37.52 Proficiency in the Use of 

Systems for Classifying the 

Pneumoconioses 

Existing § 37.52 establishes the A and 

B Reader approval programs. This 

section is amended to update 

terminology. 

Section 37.53 Method of Obtaining 

Definitive Classifications 

Existing § 37.53 establishes that 

radiographs will be independently 

classified by an A Reader and B Reader, 

or two B Readers, whose classifications 

must be in agreement as defined in 

§ 37.53(b); if sufficient agreement is 

lacking, NIOSH shall obtain a third 

classification. The section is amended to 

clarify that the section addresses 

radiographic classifications rather than 

interpretations, and to update 

terminology. 

Section 37.60 Submitting Required 

Chest Radiographs and Miner 

Identification Documents 

Existing § 37.60 establishes the 

protocol for submitting radiographs to 

NIOSH. This section is amended to 

update terminology. 

Section 37.70 Review of 

Classifications 

Existing § 37.70(a) establishes that a 

miner may request that NIOSH 

reevaluate a CWP interpretation that the 

miner believes is in error. The section 

heading and paragraph (a) are amended 

to replace the words ‘‘interpretation’’ 

and ‘‘interpretations’’ with 

‘‘classification’’ and ‘‘classifications.’’ 

Paragraph (b) is amended to strike an 

obsolete reference to standards 

established in 1978. 

B. Subpart—Spirometry Examinations 

This subpart is added to Part 37 and 

establishes standards for spirometry 

testing for all coal miners, working in 

both underground and surface mines. 

The new MSHA rule reduces 

permissible exposure and increases 

requirements for dust monitoring, 

however MSHA acknowledges that in 

spite of these changes, both surface and 

underground coal miners remain 

exposed to hazardous levels of 

respirable dust that can result in serious 

and fatal lung diseases. To facilitate 

early detection of lung injury and 

thereby provide an additional level of 

secondary health protection to miners, 

MSHA now requires that mine operators 

offer a periodic spirometry examination 

and symptom assessment, to document 

respiratory symptoms and lung 

function, in addition to the previous 

requirement for providing chest 

radiographic examinations and 

obtaining occupational histories. 

Section 37.90 Scope 

New § 37.90 provides the scope of the 

provisions in Subpart—Spirometry 

Examinations, and is amended to clarify 

the purpose of this subpart. Under this 

subpart, coal mine operators are 

required to provide spirometry 

examinations to each current and new 

coal miner, using medical facilities 

approved by NIOSH according to the 

standards established in this subpart. 

Section 37.91 Definitions 

New § 37.91 defines terms used in 

this subpart. The following new terms 

are added in this rulemaking: ‘‘ATS,’’ 

‘‘ERS,’’ ‘‘facility,’’ ‘‘FET,’’ ‘‘FEV1,’’ 

‘‘FEV6,’’ ‘‘FVC,’’ ‘‘PEF,’’ and 

‘‘spirometry examination.’’ 

Section 37.92 Spirometry 

Examinations Required for Miners 

New § 37.92 requires coal mine 

operators to provide all miners an 

opportunity to receive a spirometry 

examination. Paragraph (a) of this 

section specifies the timing and the new 

content for the miners’ ongoing 

voluntary periodic health examination, 

as required under the revised MSHA 

rule. The examination now includes a 

respiratory assessment and spirometry 

testing in addition to the previouslyrequired chest radiograph and 

occupational history. Underground coal 

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45114 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 

mines with previously-existing mine 

surveillance plans will continue on 

their already-established schedules for 

offering periodic health surveillance. 

Periodic surveillance schedules for 

mines that are new to health 

surveillance, primarily surface mines, 

will be established by NIOSH in 

conjunction with approval of mine 

plans. 

Paragraph (b) of this section specifies 

the timing and content of the respiratory 

assessment for newly hired miners. To 

record and provide accurate and timely 

recognition of important lung functional 

losses that have been documented to 

occur during the early years of mining, 

an initial test is specified within each 

new miner’s first 30 days of 

employment and a second test after 

three years of work. If an accelerated 

loss of function is recognized after three 

years, then a third test after two 

additional years is offered to the miner, 

to determine whether the rate of decline 

has stabilized. These early examinations 

are intended to record any early changes 

in symptoms and spirometry and also 

provide a more stable baseline for 

assessing trends in lung function over 

the miner’s subsequent career. The 

mandatory examinations specified in 

paragraph (b) are targeted to miners who 

begin work at a coal mine for the first 

time. The first spirometry test for 

experienced miners will be provided 

when they participate in the next 

scheduled voluntary examination (as 

provided in paragraph (a) of this 

section). For underground coal mines, 

examinations will be provided 

according to the already-established 5 

year cycle. For surface mines that are 

new to surveillance, initial voluntary 

examinations will be provided over the 

first 5 years after implementation of 

expanded surveillance under the IFR at 

times established by NIOSH when mine 

plans are approved. This staged 

approach is necessary to effectively 

manage services to the more than 90,000 

existing U.S. coal miners. 

Paragraph (c) explains that NIOSH 

will notify the miner when he or she is 

due to receive a second or third 

examination, and clarifies that a miner 

must provide written authorization for 

NIOSH to notify the coal operator of 

when a third examination is due. 

However, even if the miner does not 

complete the examination, the 

availability of the examination will 

constitute operator compliance with the 

plan. This procedure parallels the long 

established approach to offering third 

chest radiographs to new miners. 

Paragraph (d) states that the 

availability of spirometry testing must 

be indicated in the operator’s plan 

required by § 37.100. 

Section 37.93 Approval of Spirometry 

Facilities 

New § 37.93 establishes standards by 

which NIOSH will approve facilities 

that conduct spirometry tests, including 

ensuring that spirometry results are of 

adequate quality, and specifying 

programmatic approaches to quality 

assurance and addressing deficiencies. 

High quality spirometry is essential for 

the test results to provide information 

that can be useful in protecting miners’ 

lung health. Professional organizations 

have recognized that to optimize the 

utility of test results, close attention 

must be paid to a number of important 

factors. These factors include the type 

and performance of the testing 

equipment, the specific training and 

experience of the test providers, specific 

testing procedures, programmatic 

attention to test quality, and the specific 

approaches to data management and 

interpretation of results. The approval of 

facilities that are authorized to provide 

spirometry under this subpart provides 

a mechanism to document the specific 

services offered and the approaches 

taken by each facility to address these 

important technical factors. 

Paragraph (b) describes the factors 

considered important in assuring 

quality spirometry testing for miners 

covered by this program. Pursuant to the 

standards established in the 2005 

American Thoracic Society (ATS) and 

European Respiratory Society (ERS) 

consensus statement, Standardisation of 

Spirometry, which is incorporated by 

reference, testing instruments must be 

capable of demonstrating calibration, 

accuracy, and freedom from leaks as 

required on a daily basis, and results 

documented. Spirometers must provide 

an ongoing automatic assessment of test 

quality during testing, to permit 

immediate feedback to the technologist 

and miner. Results of each miner’s tests 

will be provided to NIOSH within 14 

calendar days, which will facilitate 

timely feedback with suggestions for 

quality improvement. NIOSH may 

periodically conduct audits to evaluate 

the quality of spirometry produced by 

the facility. Records pertaining to the 

provisions in this section are 

maintained by NIOSH under CDC/

ATSDR Privacy Act System of Records 

Notice 0920–0149, Morbidity Studies in 

Coal Mining, Metal and Non-Metal 

Mining and General Industry. As 

specified in § 37.96(e), 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. 

Paragraphs (c) and (d) state that if a 

facility is found to be noncompliant 

with the regulations in this subpart or 

if a quality assurance audit finds the 

facility to be under-performing, the 

facility will be notified. Facility 

approvals can be revoked if facilities 

show deficiencies that are not rectified 

in a timely manner, within 60 days of 

notification. 

Paragraph (e) requires the 

confidentiality of protected information. 

Section 37.94 Respiratory Assessment 

Form 

New § 37.94 requires that a 

respiratory assessment form must be 

completed for each miner upon 

examination. The form is required in 

order to provide recording of respiratory 

symptoms and certain other information 

relevant to miner lung health using a 

valid, concise, and consistent format. 

Section 37.95 Specifications for 

Performing Spirometry Examinations 

New § 37.95 establishes standards for 

the performance of spirometry tests. As 

discussed in § 37.93, if validated and 

standardized approaches are not taken, 

there can be no assurance of providing 

accurate and consistent test results. 

Paragraph (a) of this section requires 

that persons administering the 

spirometry testing demonstrate 

completion of NIOSH-approved 

spirometry training, and maintain their 

knowledge by periodically completing 

an approved refresher course. NIOSH 

approves sponsors to provide 

spirometry training courses. A listing of 

current courses is maintained on the 

NIOSH Web site (http://www.cdc.gov/

niosh). Private courses may also be 

available that are not listed on the 

NIOSH Web site. Stakeholders are 

encouraged to contact NIOSH if they 

have questions about spirometry 

training opportunities. 

Paragraph (b) of this section requires 

that testing performed under this 

subpart utilize equipment complying 

with standards published in the 2005 

ATS/ERS Standardisation of Spirometry 

for size of display, precision, and 

accuracy as verified by an independent 

testing laboratory. Requirements for 

validation checks are established in the 

ATS Standardization of Spirometry: 

1994 Update, which is incorporated by 

reference. These requirements are met 

by many of the spirometers that are 

currently marketed. Although not 

required, spirometers may also export 

results electronically if they meet an 

available industry standard for the file 

specification, or if the data file content, 

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format, and approach to the transfer is 

approved by NIOSH. 

Paragraph (c) of this section specifies 

certain required procedures during 

performance of testing, including testing 

procedures delineated 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. If the 

spirometer model does not support an 

approved approach to exporting data 

files, then certain numerical results 

must be entered into an electronic 

Spirometry Results Form (Form CDC/

NIOSH (M)2.17) and transmitted to 

NIOSH, accompanied by images of the 

three spirometry flow volume and 

volume time curves reported using a 

secure internet transfer site. 

Section 37.96 Spirometry 

Interpretations, Reports, and 

Notifications 

New § 37.96 establishes requirements 

for the interpretation of spirometry test 

results, as well as specifications for the 

content, deletion, and transmission of 

test reports. This section also addresses 

the notification of miners of the test 

results and their confidentiality. 

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. 

Paragraph (b) specifies the content of 

spirometry test reports and the deletion 

of files and forms associated with the 

examination. The requirement for 

deletion of these files and forms is 

included to help protect the 

confidentiality of this personal 

information. 

Paragraph (c) requires that findings 

are communicated to the miner or the 

miner’s designated physician. 

Paragraphs (d) and (e) of this section 

further specify the responsibilities of 

approved facilities to assure the 

confidentiality of all personal 

identifying information associated with 

testing performed under this subpart, to 

transfer all completed forms and 

spirometry results to NIOSH, and after 

NIOSH has indicated successful receipt 

of the data, to delete the records, to the 

extent feasible. Requirements for the 

transmission of spirometry data files are 

specified in the 2005 ATS/ERS 

Standardisation of Spirometry, which is 

incorporated by reference. NIOSH will 

send complete reports of spirometry 

examinations to the miner, along with 

any recommendations for follow-up. 

Section 37.97 Standards Incorporated 

by Reference 

New § 37.97 identifies standards 

incorporated by reference throughout 

this subpart. 

C. Subpart—General Requirements 

This new subpart establishes general 

requirements for all surface and 

underground coal mine operators. 

Section 37.100 Coal Mine Operator 

Plan for Medical Examinations 

New § 37.100 requires that all coal 

mine operators submit a plan for 

providing miners with X-ray and 

spirometry exams, occupational 

histories, and respiratory assessment. 

Paragraph (a)(1) of this section 

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 

coal mine operator without an approved 

plan must submit a plan within 60 days 

that provides for chest radiographs and 

occupational histories. 

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 

examination plan that includes 

spirometry and respiratory assessments. 

Such plans must be submitted to NIOSH 

within 60 days of that MSHA 

notification. New plans submitted from 

this time forward will provide covered 

workers with chest radiographs, 

spirometry tests, respiratory 

assessments, and occupational histories 

as specified in the IFR. 

Paragraph (b) lists the required 

components of the operator’s plan, 

including the identification of the 

medical facilities that will conduct the 

spirometry and X-ray exams, and the 

approximate dates and times during 

which the test will be provided. The 

plan must also provide assurances that 

operators will not solicit medical results 

or findings from miners; will instruct 

facilities about management of data as 

specified; and that examinations will be 

made at no charge to the miner. 

Paragraph (c) of this section specifies 

that operators may provide for alternate 

medical testing facilities and personnel. 

Paragraph (d) specifies that a change 

of operators does not affect the existing 

plan. 

Paragraph (e) specifies that the 

operator must advise NIOSH of any 

change in its plan and that the change 

is subject to the same review and 

approval as the original plan. 

Paragraph (f) specifies requirements 

for notifying employees of proposed 

mine plans or proposed changes to mine 

plans. 

Paragraph (g) notes requirements for 

periodic resubmission of plans. 

Section 37.101 Approval of Plans 

New § 37.101 establishes that the 

operator’s plan will be approved by 

NIOSH if it is found to meet the 

requirements in this subpart. Where an 

approval is denied, NIOSH will give 

notice in writing to the operator, who 

may amend the plan. 

Section 37.102 Transfer of Affected 

Miner to Less Dusty Area 

New § 37.102 establishes the 

evidentiary threshold required for a 

miner who is thought to be developing 

pneumoconiosis related to coal mine 

dust exposure to request transfer to a 

less dusty environment in the mine. 

Section 37.103 Medical Examinations 

at Miner’s Expense 

New § 37.103 states that any miner 

who wishes to obtain an X-ray or 

spirometry exam at his or her own 

expense may do so. NIOSH will provide 

an interpretation and report as if the 

results were submitted under an 

operator’s plan. 

V. 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 interim final rule is not being 

treated as a ‘‘significant’’ action under 

E.O. 12866. It amends existing 

regulations in 42 CFR Part 37 to add 

new requirements on mine operators to 

provide symptom assessment and 

spirometry testing for the surveillance of 

decreased lung function to all coal 

miners, and to extend existing 

requirements to provide chest X-rays 

and occupational histories for 

underground coal miners to surface coal 

mine operators. The amendments to Part 

37 described in this action are made 

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45116 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 

pursuant to the MSHA final rule 

published on May 1, 2014 (79 FR 24814) 

which requires the expansion of the 

scope and content of current respiratory 

health surveillance, and are part of that 

agency’s efforts to reduce lung disease 

among coal miners. MSHA estimated 

this expanded respiratory health 

surveillance would result in annualized 

costs to underground mines of $173,500 

per year and for surface mines of 

$559,900 per year. The Department of 

Labor has determined that its rule 

fulfills the requirements of E.O. 12866 

for this rule and provides estimates of 

the aggregate cost of benefits and costs 

of expanding the CWHSP administered 

by NIOSH under its rule (see MSHA’s 

Regulatory Economic Analysis at http:// 

www.msha.gov/rea.htm). 

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 

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/CoalMine

Dust2010.pdf). This interim 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 interim 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 interim final rule 

continues to impose the same 

information collection requirements as 

under the existing rule, including the 

submission of the following forms: 

• Chest Radiograph Classification Form 

[CDC/NIOSH (M)2.8] 

• Miner Identification Document [CDC/ 

NIOSH (M)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/NIOSH (M)2.12(E)] 

• Consent, Release, and History Form 

[CDC/NIOSH (M)2.6] 

These forms were previously 

approved by OMB for data collected 

under the National Coal Workers’ X-Ray 

Surveillance Program (CWXSP)— 

Federal Mine Safety and Health Act of 

1977 (42CFR37) (OMB Control No. 

0920–0020, exp. May 31, 2017), 

although the addition of surface coal 

miners to the CWHSP increases the 

burden. 

The expansion of the CWHSP in 

accordance with this rulemaking will 

result in the participation of additional 

coal miner operators, coal miners, and 

physicians. The provisions in this 

interim final rule that contain data 

collection requirements are: 

Section 37.100 Coal mine operator 

plan for medical examinations. Every 

operator must submit a mine plan (Form 

CDC/NIOSH (M)2.10 or (M)2.18) every 3 

to 4 years, providing information on 

how they plan to notify their miners of 

the opportunity to obtain the chest 

radiographic examination. Completing 

this form with all requested information 

(including a roster of current 

employees) is estimated to take 

approximately 30 minutes. 

Section 37.43 Approval of 

radiographic facilities that use film and 

Section 37.44 Approval of 

radiographic facilities that use digital 

radiography systems. X-ray facilities 

seeking NIOSH approval to provide 

miner X-rays under the CWHSP must 

complete an approval packet, including 

a Radiographic Facility Certification 

Document (Form CDC/NIOSH (M)2.11). 

The forms associated with this approval 

process require approximately 30 

minutes for completion. This form has 

been revised since the last OMB 

approval. A space has been added for 

the room number in which each X-ray 

unit listed for approval is located. This 

is needed to identify the location of the 

X-ray unit in hospitals and distinguish 

between units that may be identical 

except for the serial number. The serial 

number is not readily visible, so this 

will aid in identifying individual X-ray 

units. No additional burden to the 

facility is anticipated. 

Section 37.20 Miner identification 

document. Miners who elect to 

participate in the CWHSP must fill out 

the Miner Identification Document 

(Form CDC/NIOSH (M)2.9) which 

requires approximately 20 minutes to 

complete. This document records 

demographic and occupational history, 

as well as information required under 

the regulations from X-ray facilities in 

relation to coal miner examinations. In 

addition to completing this form, 

acquiring the chest image takes 

approximately 15 minutes. 

Section 37.50 Interpreting and 

classifying chest radiographs—film and 

Section 37.51 Interpreting and 

classifying chest radiographs—digital 

radiography systems. NIOSH utilizes a 

radiographic classification system 

developed by the International Labour 

Office (ILO), in the determination of 

pneumoconiosis among coal miners. 

Physicians (A and B Readers) fill out the 

Chest Radiograph Classification Form 

(Form CDC/NIOSH (M)2.8) regarding 

their classification of the X-rays (each Xray has at least two separate 

classifications). As stated above, this 

form has been revised since the last 

OMB approval. Based on prior practice 

it takes the physician approximately 3 

minutes to complete each form. No 

additional burden to the physician is 

anticipated. 

Section 37.52 Proficiency in the use 

of systems for classifying the 

pneumoconiosis. Physicians taking the 

B Reader Examination are asked to 

complete the Physician Application for 

Certification (Form CDC/NIOSH 

(M)2.12), which is a registration form 

that takes approximately 10 minutes to 

complete. This form has been revised 

since the last OMB approval. No 

additional burden to the physician is 

anticipated. 

Section 37.93 Approval of 

spirometry facilities. Spirometry 

facilities seeking NIOSH approval to 

provide spirometry examinations under 

the CWHSP must complete an approval 

packet, including a Spirometry Facility 

Certification Document (Form CDC/ 

NIOSH (M)2.14). The form and 

gathering supporting documentation 

associated with this approval process 

requires approximately 30 minutes to 

complete. 

Section 37.95 Specifications for 

performing spirometry examinations. 

Clinic personnel are required to 

complete the Spirometry Pre-Test 

Checklist form (Form CDC/NIOSH 

(M)2.15) for each miner prior to 

administering the spirometry test. This 

information is used by the clinic 

personnel to determine if the miner can 

perform the spirometry test safely and 

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identify any factors that may affect the 

spirometry results. Completion of the 

form will take approximately 5 minutes. 

Section 37.96 Spirometry 

interpretations, reports, and 

notifications. Spirometry facilities that 

do not submit spirometry results using 

a NIOSH-approved electronic database 

will submit the Spirometry Results 

Form (Form CDC/NIOSH (M)2.17) for 

each miner. This information allows 

NIOSH to identify the miner, conduct 

quality assurance audits, and interpret 

results. It will take approximately 10 

minutes to complete the form. 

Section 37.96 Spirometry 

interpretations, reports, and 

notifications. Spirometry facilities must 

submit the Spirometry Notification 

Form (Form CDC/NIOSH (M)2.16) to 

NIOSH upon completion of a spirometry 

examination. Miners must fill out their 

mailing address for notification of 

results; this will take approximately 2 

minutes. The remainder of the 

information documents that the facility 

completed and transmitted the required 

components of the spirometry 

examination. Completion of the entire 

form will require 10 minutes. 

Section 37.94 Respiratory 

assessment form. The Respiratory 

Assessment Form (Form CDC/NIOSH 

(M)2.13) is designed to assess 

respiratory symptoms and certain 

medical conditions and risk factors. 

Completion of the entire form will 

require 5 minutes. 

Section 37.202 Payment for autopsy. 

The Pathologist Invoice submitted by 

the pathologist must contain a statement 

that the pathologist is not receiving any 

other compensation for the autopsy. 

Each participating pathologist may use 

their individual invoice as long as this 

statement is added. It is estimated that 

only 5 minutes is required for the 

pathologist to add this statement to the 

standard invoice that they routinely use. 

Section 37.203 Autopsy 

specifications. The pathologist must 

submit information found at autopsy, 

slides, blocks of tissue, and a final 

diagnosis indicating presence or 

absence of pneumoconiosis. The format 

of the autopsy reports are variable 

depending on the pathologist 

conducting the autopsy. Since an 

autopsy report is routinely completed 

by a pathologist, the only additional 

burden is the specific request for a 

clinical abstract of terminal illness and 

final diagnosis relating to 

pneumoconiosis. Therefore, only 5 

minutes of additional burden is 

estimated for the pathologist’s report. 

There is no additional recordkeeping 

burden associated with the quality 

assurance programs referenced in 

§ 37.43 Approval of radiographic 

facilities that use film, § 37.44 Approval 

of radiographic facilities that use digital 

radiography systems, and § 37.93 

Approval of spirometry facilities, 

because these provisions reflect 

standard industry practice and do not 

impose any new recordkeeping 

requirements. 

HHS estimates that the paperwork 

burden associated with this rulemaking 

will be 16,358 hours. 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden/ 

response 

(hours) 

Total burden 

(hours) 

Coal mine operators ................................. Form 2.10 and Form 2.18 ............ 958 1 30/60 480 

X-ray facility supervisor ............................ Form 2.11 ..................................... 40 1 30/60 20 

Coal miner ................................................ Form 2.9 ....................................... 10,383 1 20/60 3,461 

B Reader physicians ................................ Form 2.8 ....................................... 200 104 3/60 1,040 

Physicians taking B reader examination .. Form 2.12 ..................................... 50 1 10/60 8 

Next-of-kin of deceased miner ................. Form 2.6 ....................................... 5 1 15/60 1 

Spirometry facility employee .................... Form 2.13 ..................................... 10,383 1 5/60 865 

Spirometry facility supervisor ................... Form 2.14 ..................................... 200 1 30/60 100 

Spirometry technician ............................... Form 2.15 ..................................... 10,383 1 5/60 865 

Spirometry facility employee .................... Form 2.16 ..................................... 10,383 1 10/60 1,730 

Spirometry technician ............................... Form 2.17 ..................................... 10,383 1 10/60 1,730 

X-ray—Coal Miners .................................. No form required .......................... 10,383 1 15/60 2,596 

Spirometry Test—Coal Miners ................. No form required .......................... 10,383 1 20/60 3,461 

Pathologist—Invoice ................................. No form required .......................... 5 1 5/60 0.4 

Pathologist—Report .................................. No form required .......................... 5 1 5/60 0.4 

Total ................................................... ....................................................... ........................ ........................ ...................... 16,358 

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. For 2014, the 

inflation-adjusted threshold is $152 

million. 

F. Executive Order 12988 (Civil Justice) 

This rule has been drafted and 

reviewed in accordance with Executive 

Order 12988, ‘‘Civil Justice Reform,’’ 

and will not unduly burden the Federal 

court system. Chest radiograph 

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 interim 

final rule 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. 

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45118 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 

G. Executive Order 13132 (Federalism) 

The Department has reviewed this 

rule in accordance with Executive Order 

13132 regarding federalism, and has 

determined that it does not have 

‘‘federalism implications.’’ The rule 

does not ‘‘have substantial direct effects 

on the States, on the relationship 

between the national government and 

the States, or on the distribution of 

power and responsibilities among the 

various levels of government.’’ 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

In accordance with Executive Order 

13045, HHS has evaluated the 

environmental health and safety effects 

of this rule on children. HHS has 

determined that the rule would have no 

effect on children. 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

In accordance with Executive Order 

13211, HHS has evaluated the effects of 

this rule on energy supply, distribution 

or use, and has determined that the rule 

will not have a significant adverse 

effect. 

J. Plain Writing Act of 2010 

Under Public Law 111–274 (October 

13, 2010), executive Departments and 

Agencies are required to use plain 

language in documents that explain to 

the public how to comply with a 

requirement the Federal Government 

administers or enforces. HHS has 

attempted to use plain language in 

promulgating the interim final rule 

consistent with the Federal Plain 

Writing Act guidelines. 

VI. Interim Final Rule 

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, Part 90 

miner, Part 90 transfer rights, 

Pneumoconiosis, Respiratory and 

pulmonary diseases, Silicosis, 

Spirometry, Surface coal mining, 

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. 

Subpart—Chest Radiographic 

Examinations 

■ 2. Revise the heading of the first 

subpart to read as set forth above. 

■ 3. Revise § 37.1 to read as follows: 

§ 37.1 Scope. 

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 in 

accordance with standards established 

in this subpart. 

■ 4. Amend § 37.2 by revsing the 

definitions of ‘‘miner’’, ‘‘NIOSH’’ and 

‘‘operator’’ to read as follows: 

§ 37.2 Definitions. 

* * * 

Miner means any individual working 

in a coal or other mine. 

NIOSH means the National Institute 

for Occupational Safety and Health 

(NIOSH), located within the Centers for 

Disease Control and Prevention (CDC). 

Within NIOSH, the Division of 

Respiratory Disease Studies (DRDS), 

1095 Willowdale Road, Morgantown, 

WV 26505, formerly called the 

Appalachian Laboratory for 

Occupational Safety and Health, is the 

organizational unit that has 

programmatic responsibility for the 

medical examination and surveillance 

program. 

* * * * * 

Operator means any owner, lessee, or 

other person who operates, controls, or 

supervises a coal or other mine or any 

independent contractor performing 

services or construction at such mine. 

* * * * * 

■ 5. 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 § 37.3(b) 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 

October 15, 2012, and end no later than 

a date specified by NIOSH separately for 

each coal mine. Within the period 

specified by NIOSH for each mine, the 

operator may select a 6-month period 

within which to provide examinations 

in accordance with a plan approved 

under § 37.101. 

(2) For all voluntary examinations, 

NIOSH will notify the operator of each 

coal mine when sufficient time has 

elapsed since the end of the previous 6- 

month period of examinations. NIOSH 

will specify to the operator of each mine 

a period within which the operator may 

provide examinations to its miners 

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 by NIOSH for each 

mine, the operator may select a 6-month 

period within which to provide 

examinations in accordance with a plan 

approved under § 37.101. 

Example: NIOSH finds that examinations 

were previously provided to miners 

employed at mine Y in a 6-month period 

from July 1, 2013, to December 31, 2013. 

NIOSH notifies the operator at least 3 months 

before July 1, 2017 (3.5 years after December 

31, 2013) that the operator may select and 

designate on its plan the next 6-month period 

within which to offer examinations to its 

miners employed at mine Y. The 6-month 

period must be scheduled between July 1, 

2017, and July 1, 2018 (between 3.5 and 4.5 

years after December 31, 2013). 

(3) Within either the next or future 

period(s) specified by NIOSH 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 

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Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 45119 

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 pneumoconioses, or 

complicated pneumoconioses (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 (b) of this section. 

Similarly, NIOSH will notify the coal 

mine operator when the miner is to be 

given a second examination. The 

operator will be notified concerning a 

miner’s third examination only with the 

miner’s written consent, and the notice 

to the operator must not state the 

medical reason for the examination or 

that it is the third examination in the 

series. 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 

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 subpart. 

§ 37.4 [Removed] 

■ 6. Remove § 37.4. 

§ 37.5 [Removed] 

■ 7. Remove § 37.5. 

§ 37.6 [Redesignated as § 37.4] 

■ 8. Redesignate § 37.6 as § 37.4 and in 

the section heading and in paragraph 

(a)(1) remove the word 

‘‘roentgenographic’’ and add in its place 

‘‘radiographic’’. 

§ 37.7 [Removed] 

■ 9. Remove § 37.7. 

§ 37.8 [Removed] 

■ 10. Remove § 37.8. 

■ 11. Amend § 37.10 in paragraph (a) by 

revising the first sentence to read as 

follows: 

§ 37.10

(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. * * * 

* * * * * 

§ 37.40 [Amended] 

■ 12. Amend § 37.40 in paragraph (b) by 

removing the word ‘‘Roentgenographic’’ 

and adding in its place ‘‘Radiographic’’. 

§ 37.50 [Amended] 

■ 13. Amend § 37.50 in paragraph (a) by 

removing the phrase ‘‘Roentgenographic 

Interpretation’’ and adding in its place 

‘‘Chest Radiograph Classification’’. 

§ 37.51 [Amended] 

■ 14. Amend § 37.51 in paragraph (b) by 

removing the phrase ‘‘Roentgenographic 

Interpretation’’ and adding in its place 

‘‘Chest Radiograph Classification’’. 

§ 37.52 [Amended] 

■ 15. Amend § 37.52 in paragraph 

(a)(2)(i) by removing the phrase 

‘‘Roentgenographic Interpretation’’ and 

adding in its place ‘‘Radiographic 

Interpretation’’. 

§ 37.53 [Amended] 

■ 16. Amend § 37.53 by removing the 

terms ‘‘interpreted’’, ‘‘interpretation’’, 

and ‘‘interpretations’’ and adding in 

their place ‘‘classified’’, ‘‘classification’’, 

and ‘‘classifications’’, respectively, 

wherever they occur, and in paragraph 

(b) by removing the phrase 

‘‘Roentgenographic Interpretation’’ and 

adding in its place ‘‘Chest Radiograph 

Classification’’. 

§ 37.60 [Amended] 

■ 17. Amend § 37.60 in the section 

heading and paragraphs (a) introductory 

text and (a)(1) by removing the phrase 

‘‘Roentgenographic Interpretation’’ and 

add in its place ‘‘Chest Radiograph 

Classification’’. 

§ 37.70 [Amended] 

■ 18. Amend § 37.70 in paragraph (a) by 

removing the terms ‘‘interpretation’’ and 

‘‘interpretations’’ and adding in their 

place ‘‘classification’’ and 

‘‘classifications’’, respectively, wherever 

they occur, and in paragraph (b) by 

removing the phrase ‘‘made subsequent 

to August 1, 1978,’’. 

■ 19. Add a subpart, titled Spirometry 

Examinations, after the undesignated 

center heading ‘‘Review and 

Availability of Records’’ to read as 

follows: 

Subpart—Spirometry Examinations 

Sec. 

37.90 Scope. 

37.91 Definitions. 

37.92 Spirometry examinations required for 

miners. 

37.93 Approval of spirometry facilities. 

37.94 Respiratory assessment form. 

37.95 Specifications for performing 

spirometry examinations. 

37.96 Spirometry interpretations, reports, 

and notifications. 

37.97 Standards incorporated by reference. 

§ 37.90 Scope. 

Under this subpart, coal mine 

operators are required to provide 

spirometry examinations to each current 

and new coal miner, using medical 

facilities approved by NIOSH in 

accordance with standards established 

in this subpart. 

§ 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 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. 

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 spirometry examinations. 

FET means forced expiratory time, 

which is the time from the beginning of 

exhalation (the back-extrapolated ‘‘time 

zero’’) to the end of the expiratory 

maneuver. 

FEV1 means forced expiratory volume 

in the first second, which is the volume 

of air that can forcibly be blown out in 

one second, after full inspiration. 

FEV6 means forced expiratory volume 

in the first six seconds, which is the 

volume of air that can forcibly be blown 

out in six seconds, after full inspiration. 

FVC means forced vital capacity, 

which is the volume of air that can 

forcibly be blown out after full 

inspiration. 

PEF means peak expiratory flow, 

which is the maximal airflow during a 

forced expiratory maneuver. 

Spirometry examination means a 

pulmonary function test that measures 

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expiratory volume and airflow rates and 

may determine the presence and 

severity of lung function impairments, if 

such are present. 

§ 37.92 Spirometry examinations required 

for miners. 

(a) Voluntary examinations. Each 

operator must provide to all miners who 

are employed in or at any of its coal 

mines the opportunity to have a 

spirometry examination and a 

respiratory assessment at no cost to the 

miner at least once every 5 years in 

accordance with this subpart. The 

examinations 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 examinations. 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, 

a spirometry examination and 

respiratory assessment at no cost to the 

miner in accordance with this subpart. 

(1) Initial spirometry examination. An 

initial spirometry examination 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 examinations. 

(2) Second examination. A follow-up 

second spirometry examination and 

respiratory assessment will be provided 

to the miner no later than 3 years after 

the initial spirometry examination if the 

miner is still engaged in coal mining. 

(3) Third examination. A third 

spirometry examination and respiratory 

assessment will be provided no later 

than 2 years after the examinations 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 more than a 15 

percent decline in the value of percent 

predicted FEV1 since the initial test. 

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 

§ 37.97). A correction factor to 

Caucasian reference values will be 

applied when testing individuals of 

Asian descent as specified in the ATS 

Technical Standards: Spirometry in the 

Occupational Setting, p. 987 

(incorporated by reference, see § 37.97). 

(c) Notification. NIOSH will notify the 

miner when he or she is due to receive 

the second or third mandatory 

examination under (b) of this section. 

Similarly, NIOSH will notify the coal 

mine operator when the miner is to be 

given a second examination. The 

operator will be notified concerning a 

miner’s third examination only with the 

miner’s written consent, and the notice 

to the operator must not state the 

medical reason for the examination or 

that it is the third examination in the 

series. If the miner is notified by NIOSH 

that the third mandatory examination is 

due and the operator is not so notified, 

availability of the spirometry 

examination under the NIOSH-approved 

operator’s plan will constitute the 

operator’s compliance with the 

requirement to provide a third 

mandatory examination even if the 

miner does not take the examination. 

(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. 

§ 37.93 Approval of spirometry facilities. 

(a) Facilities seeking approval to 

provide the spirometry examinations 

specified under this subpart must have 

the ability to provide spirometry of high 

technical quality. Thus, NIOSHapproved facilities must meet the 

requirements specified in this subpart 

for the following activities: Training 

technicians to 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 (Form CDC/NIOSH (M)2.14), 

available at http://www.cdc.gov/niosh/

topics/surveillance/ords/CoalWorkers

HealthSurvProgram.html. 

(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 § 37.97). Calibration check 

procedures must include daily (day of 

testing) leak and volume accuracy 

checks and linearity checks according to 

the frequency established by the 2005 

ATS/ERS guidelines. Instrument 

calibration check records must be 

maintained by the facility and available 

for inspection. 

(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. Messages must alert the 

technician to maneuver acceptability 

errors and test session non-repeatability. 

Each spirometry test session must have 

the goal of obtaining 3 acceptable with 

2 repeatable forced expiratory 

maneuvers, as defined by the 2005 ATS/ 

ERS Standardisation of Spirometry, p. 

325 (incorporated by reference, see 

§ 37.97). 

(3) Ongoing monitoring of test quality. 

Facilities must submit spirometry 

results to NIOSH within 14 calendar 

days of testing as specified in § 37.95(d) 

to permit NIOSH to monitor test quality 

and provide a report to the miner. 

NIOSH may provide feedback to the 

appropriate technician(s) along with 

suggestions for improvement. 

(4) Quality assurance audits. NIOSH 

may periodically conduct audits to 

review examinations submitted by 

approved facilities and assess the 

quality of spirometry provided. Such 

audits may include a review of all 

spirometry examination 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 specified in this section 

that a facility is not performing 

spirometry examinations 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. In 

conducting medical examinations 

pursuant to this part, physicians and 

radiographic facilities must maintain 

the results and analyses of these 

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examinations (including any hard 

copies or digital files containing 

individual data, interpretations, 

classifications, and images) in a manner 

consistent with applicable statutes and 

regulations governing the treatment 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). 

§ 37.94 Respiratory assessment form. 

As part of the spirometry examination 

and concurrent with it, personnel at the 

facility must complete a Respiratory 

Assessment form (Form CDC/NIOSH 

(M)2.13), available at http://www.cdc.

gov/niosh/topics/surveillance/ords/Coal

WorkersHealthSurvProgram.html, for 

the miner. 

§ 37.95 Specifications for performing 

spirometry examinations. 

(a) Persons administering the 

spirometry examination. Each person 

administering spirometry examinations 

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 

examinations 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 form (Form CDC/NIOSH 

(M)2.17), available at http://www.cdc.

gov/niosh/topics/surveillance/ords/Coal

WorkersHealthSurvProgram.html. 

(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 § 37.97). Facilities must 

make available for inspection written 

verification from a third-party testing 

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 § 37.97). 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 § 37.97). 

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 examination 

procedures. Administration of 

spirometry examinations must include 

the following: 

(1) Pre-test checklist. A short 

Spirometry Pre-Test Checklist (Form 

CDC/NIOSH (M) 2.15), available at 

http://www.cdc.gov/niosh/topics/

surveillance/ords/CoalWorkersHealth

SurvProgram.html, must be 

administered prior to each spirometry 

examination to identify possible 

contraindications to testing, or factors 

that might affect results. 

(2) Respiratory assessment. A 

standardized Respiratory Assessment 

form (Form CDC/NIOSH (M)2.13), 

available at http://www.cdc.gov/niosh/

topics/surveillance/ords/CoalWorkers

HealthSurvProgram.html, must be 

completed at the initial spirometry 

examination and repeated at each 

spirometry examination. 

(3) 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 

has a spirometry test. 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. For facilities with spirometers 

that do not permit electronic transfer of 

data files as specified in § 37.96(d), the 

Spirometry Results form (Form CDC/

NIOSH (M) 2.17), available at http://

www.cdc.gov/niosh/topics/surveillance/

ords/CoalWorkersHealthSurv

Program.html, will be completed for 

each miner tested, and will report the 

numerical results of the highest and 

second highest results for the FVC and 

FEV1 and the highest PEF from at least 

three maximal, acceptable expiratory 

maneuvers (also called trials), as well as 

the FEV6 derived from those maneuvers 

reported. 

(4) Examination. The spirometry 

examination 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 § 37.97). 

(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 § 37.97). 

(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) Submission of test results. NIOSHapproved facilities must submit results 

of spirometry examinations 

electronically with content as specified 

in § 37.96(b), pre-test screening 

checklists, and standardized respiratory 

assessments within 14 calendar days of 

testing a miner. 

(e) Records retention. On-site records 

of the results will include spirometry 

examination reports and retention of all 

spirometry examinations, 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. 

§ 37.96 Spirometry interpretations, 

reports, and notifications. 

(a) Interpretation of spirometry 

examinations. 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 § 37.97). 

(b) Spirometry test reports at the 

facilities. (1) Spirometry test reports 

must contain, at a minimum, the 

miner’s age, height, gender, race, and 

weight, 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, the predicted, percent predicted 

and lower limit of normal values, miner 

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45122 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 

position during testing (standing or 

sitting), dates of test and last calibration 

check, ambient temperature and 

barometric pressure (volume 

spirometers), and 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 examination from its 

electronic and physical files. 

(c) Notifying miners of spirometry 

examination results. (1) 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 examination shows 

abnormal results or if the respiratory 

assessment suggests he or she may 

benefit from the medical follow-up or a 

smoking cessation intervention. 

(2) NIOSH will notify the miner of his 

or her spirometry examination results 

and the results of a comparison between 

current and previously submitted 

spirometry examinations and will 

advise the miner to contact a health care 

professional as appropriate based on the 

results. 

(d) Submission of results. Each facility 

must submit spirometry results and 

completed forms to NIOSH within 14 

days after a miner has received an 

examination under this subpart. If 

specified under a facility’s approval, it 

must submit spirometry results and the 

completed Respiratory Assessment 

Form (Form CDC/NIOSH (M)2.13) and 

Spirometry Notification Form (Form 

CDC/NIOSH (M)2.16), available at 

http://www.cdc.gov/niosh/topics/

surveillance/ords/CoalWorkersHealth

SurvProgram.html, via electronic 

transmission. Facilities must utilize a 

secure internet data transfer site 

specified by NIOSH. 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 § 37.97), 

or an alternate data file that is approved 

by NIOSH. If electronic transmission of 

spirometry results is not possible, for 

example if a facility’s spirometer does 

not provide an approved electronic 

transfer of spirometry files, then the 

miner’s Spirometry Results Form (Form 

CDC/NIOSH (M)2.17), available at 

http://www.cdc.gov/niosh/topics/

surveillance/ords/CoalWorkersHealth

SurvProgram.html, must be completed 

and submitted accompanied by image 

files documenting the flow-volume and 

volume time curves for each trial 

reported on the Results Form. Such 

facilities must also send a completed 

Respiratory Assessment Form (Form 

CDC/NIOSH (M)2.13) and Spirometry 

Notification Form (Form CDC/NIOSH 

(M)2.16). Data submission to NIOSH by 

such a facility must be carried out as 

specified in the facility’s approval. 

(e) Confidentiality of spirometry 

examinations. 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 

specified in §§ 37.93 and 37.96 of this 

subpart. 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. To provide on-site backup and assure complete data transfer, 

facilities will retain the forms and 

results (in electronic or paper format) 

from a miner’s examination 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. 

§ 37.97 Standards incorporated by 

reference. 

(a) Certain material is incorporated by 

reference into this subpart, Subpart— 

Spirometry 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, Division of 

Respiratory Disease Studies, 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/show

Home: 

(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.thoracic.org/

statements/resources/archive/201.pdf. 

(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(d). The ATS/ERS 

Standardisation of Spirometry is also 

available on the ATS Web site at 

https://foundation.thoracic.org/

statements/resources/pft/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. 

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Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 45123 

(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 

§ 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. 

■ 20. Add a subpart, titled General 

Requirements, after Subpart— 

Spirometry Examinations to read as 

follows: 

Subpart—General Requirements 

Sec. 

37.100 Coal mine operator plan for medical 

examinations. 

37.101 Approval of plans. 

37.102 Transfer of affected miner to less 

dusty area. 

37.103 Medical examination at miner’s 

expense. 

§ 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 examinations, 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. 

(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 examinations 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 and spirometry 

examinations (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 X-ray and spirometry facility 

or facilities, and the approximate date(s) 

and time(s) of day during which the 

radiographs and spirometry tests will be 

given to miners to enable a 

determination of whether the 

examinations will be conducted at a 

convenient time and place; 

(5) If a mobile medical examination 

facility is proposed to provide some or 

all of the surveillance tests specified in 

paragraph § 37.100(a), the plan shall 

provide that each miner be given 

adequate notice of the opportunity to 

have the examination and that no miner 

shall have to wait for an examination 

more than 1 hour before or after his or 

her work shift. In addition, the plan 

shall 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 

shall 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 

with their 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 for 

approval. 

(d) The change of operators of any 

mine operating under a plan approved 

pursuant to § 37.101(a) shall not affect 

the plan of the operator which has 

transferred responsibility for the mine. 

Every plan shall be 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 plan when 

it is submitted to NIOSH. The proposed 

plan or change in plan must remain 

posted in a visible location on the 

bulletin board until NIOSH either grants 

or denies approval of it 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 will resubmit its 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. 

§ 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 

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45124 Federal Register / Vol. 79, No. 149 / Monday, August 4, 2014 / Rules and Regulations 

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 

§ 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. 

§ 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 Part 90 

of title 30, Code of Federal Regulations. 

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 pneumoconioses, 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. 

§ 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 

interpretation and radiographic 

classification 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: July 30, 2014. 

Sylvia M. Burwell, 

Secretary. 

[FR Doc. 2014–18336 Filed 8–1–14; 8:45 am] 

BILLING CODE 4162–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 447 

Payments for Services 

CFR Correction 

■ In Title 42 of the Code of Federal 

Regulations, Parts 430 to 481, revised as 

of October 1, 2013, on page 403, remove 

the undesignated center heading above 

§ 447.88. 

[FR Doc. 2014–18426 Filed 8–1–14; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2014–0002] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street SW., Washington, DC 20472, 

(202) 646–4064, or (email) 

Luis.Rodriguez3@fema.dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Associate 

Administrator for Mitigation has 

resolved any appeals resulting from this 

notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in floodprone areas in 

accordance with 44 CFR part 60. 

Interested lessees and owners of real 

property are encouraged to review the 

proof Flood Insurance Study and FIRM 

available at the address cited below for 

each community. 

The BFEs and modified BFEs are 

made final in the communities listed 

below. Elevations at selected locations 

in each community are shown. 

National Environmental Policy Act. 

This final rule is categorically excluded 

from the requirements of 44 CFR part 

10, Environmental Consideration. An 

environmental impact assessment has 

not been prepared. 

Regulatory Flexibility Act. As flood 

elevation determinations are not within 

the scope of the Regulatory Flexibility 

Act, 5 U.S.C. 601–612, a regulatory 

flexibility analysis is not required. 

Regulatory Classification. This final 

rule is not a significant regulatory action 

under the criteria of section 3(f) of 

Executive Order 12866 of September 30, 

1993, Regulatory Planning and Review, 

58 FR 51735. 

Executive Order 13132, Federalism. 

This final rule involves no policies that 

have federalism implications under 

Executive Order 13132. 

Executive Order 12988, Civil Justice 

Reform. This final rule meets the 

applicable standards of Executive Order 

12988. 

List of Subjects in 44 CFR Part 67 

Administrative practice and 

procedure, Flood insurance, Reporting 

and recordkeeping requirements. 

Accordingly, 44 CFR part 67 is 

amended as follows: 

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