Attmt 3- 42 CFR Part 37 4

ATTACHMENT 3

42 CFR Part 37

PART 37--SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF UNDERGROUND COAL MINERS Subpart – Chest Roentgenographic Examinations
		Sec. 37.1	Scope.
		37.2	Definitions.
		37.3	Chest roentgenograms required for miners.
		37.4	Plans for chest roentgenographic examinations.
		37.5	Approval of plans.
		37.6	Chest roentgenographic examinations conducted by the Secretary.
		37.7	Transfer of affected miner to less dusty area.
		37.8	Roentgenographic examination at miner's expense.
		37.20	Miner identification document.

Specifications For Performing Chest Roentgenographic Examinations

		37.40	General provisions.
		37.41	Chest roentgenogram specifications.
		37.42	Approval of roentgenographic facilities.
		37.43	Protection against radiation emitted by roentgenographic equipment.

Specifications for interpretation, classification, and submission of chest roentgenograms

		37.50	Interpreting and classifying chest roentgenograms.
		37.51	Proficiency in the use of systems for classifying the pneumoconioses.
		37.52	Method of obtaining definitive interpretations.
		37.53	Notification of abnormal roentgenographic findings.
		37.60	Submitting required chest roentgenograms and miner identification documents.
		37.70	Review of interpretations.
		37.80	Availability of records.

Subpart - Autopsies

		37.200	Scope.
		37.201	Definitions.
		37.202	Payment for autopsy.
		37.203	Autopsy specifications.
		37.204	Procedure for obtaining payment.

AUTHORITY: Sec. 203, 83 Stat. 763; 30 U.S.C. 343, unless otherwise noted.

SOURCE: 43 FR 33715, Aug. 1, 1978, unless other wise noted.

Subpart--Chest Roentgenographic Examinations

Sec. 37.1 Scope.

The provisions of this subpart set forth the specifications for

giving, interpreting, classifying, and submitting chest roentgenograms

required by section 203 of the act to be given to underground coal

miners and new miners.

Sec. 37.2 Definitions.

Any term defined in the Federal Mine Safety and Health Act of 1977

and not defined below shall have the meaning given it in the act. As

used in this subpart:

(a) Act means the Federal Mine Safety and Health Act of 1977 (30

U.S.C. 801, et seq.).

(b) ALOSH means the Appalachian Laboratory for Occupational Safety

and Health, Box 4258, Morgantown, WV 26505. Although the Division of

Respiratory Disease Studies, National Institute for Occupational Safety

and Health, has programmatic responsibility for the chest

roentgenographic examination program, the Institute's facility in

Morgantown--ALOSH--is used throughout this subpart in referring to the

administration of the program.

(c) Chest roentgenogram means a single posteroanterior

roentgenographic projection or radiograph of the chest at full

inspiration recorded on roentgenographic film.

(d) Convenient time and place with respect to the conduct of any

examination under this subpart means that the examination must be given

at a reasonable hour in the locality in which the miner resides or a

location that is equally accessible to the miner. For example,

examinations at the mine during, immediately preceding, or immediately

following work and a ``no appointment'' examination at a medical

facility in a community easily accessible to the residences of a

majority of the miners working at the mine, shall be considered of

equivalent convenience for purposes of this paragraph.

(e) Institute and NIOSH mean the National Institute for Occupational

Safety and Health Center for Disease Control, Public Health Service,

Department of Health and Human Services.

(f) ILO-U/C Classification means the classification of radiographs

of the pneumoconioses devised in 1971 by an international committee of

the International Labor Office and described in ``Medical Radiography

and Photography,'' volume 48, No. 3, December 1972. ``ILO

Classification'' means the classification of radiographs of the

pneumoconioses revised in 1980 by an international committee of the

International Labor Office and described in ``Medical Radiography and

Photography'' volume 57, No. 1, 1981, and in ILO publication 22 (revised

1980) from the ILO Occupational Safety and Health Series.

(g) Miner means any individual including any coal mine construction

worker who is working in or at any underground coal mine, but does not

include any surface worker who does not have direct contact with

underground coal mining or with coal processing operations.

(h) Operator means any owner, lessee, or other person who operates,

controls, or supervises an underground coal mine or any independent

contractor performing services or construction at such mine.

(i) Panel of `B' Readers means the U.S. Public Health Service

Consultant Panel of ``B'' Readers, c/o ALOSH, P.O. Box 4258, Morgantown,

WV 26505.

(j) Preemployment physical examination means any medical examination

which includes a chest roentgenographic examination given in accordance

with the specifications of this subpart to a person not previously

employed by the same operator or at the same mine for which that person

is being considered for employment.

(k) Secretary means the Secretary of Health and Human Services and

any other officer or employee of the Department of Health and Human

Services to whom the authority involved may be delegated.

(l) MSHA means the Mine Safety and Health Administration, Department

of Labor.

[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7563, Mar. 1, 1984]

Sec. 37.3 Chest roentgenograms required for miners.

(a) Voluntary examinations. Every operator shall provide to each

miner who is employed in or at any of its underground coal mines and who

was employed in underground coal mining prior to December 30, 1969, or

who has completed the required examinations under Sec. 37.3(b) an

opportunity for a chest roentgenogram in accordance with this subpart:

(1) Following August 1, 1978 ALOSH will notify the operator of each

underground coal mine of a period within which the operator may provide

examinations to each miner employed at its coal mine. The period shall

begin no sooner than the effective date of these regulations and end no

later than a date specified by ALOSH separately for each coal mine. The

termination date of the period will be approximately 5 years from the

date of the first examination which was made on a miner employed by the

operator in its coal mine under the former regulations of this subpart

adopted July 27, 1973. Within the period specified by ALOSH for each

mine, the operator may select a 6-month period within which to provide

examinations in accordance with a plan approved under Sec. 37.5.

Example: ALOSH finds that between July 27, 1973, and March 31, 1975,

the first roentgenogram for a miner who was employed at mine Y and who

was employed in underground coal mining prior to December 30, 1969, was

made on January 1, 1974. ALOSH will notify the operator of mine Y that

the operator may select and designate on its plan a 6-month period

within which to offer its examinations to its miners employed at mine Y.

The 6-month period shall be scheduled between August 1, 1978 and January

1, 1979 (5 years after January 1, 1974).

(2) For all future voluntary examinations, ALOSH will notify the

operator of each underground coal mine when sufficient time has elapsed

since the end of the previous 6-month period of examinations. ALOSH 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 shall begin no sooner than 3\1/2\ years and end no later than

4\1/2\ 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 ALOSH if the operator did not submit an approved plan. Within

the period specified by ALOSH for each mine, the operator may select a

6-month period within which to provide examinations in accordance with a

plan approved under Sec. 37.5.

Example: ALOSH finds that examinations were previously provided to

miners employed at mine Y in a 6-month period from July 1, 1979, to

December 31, 1979. ALOSH notifies the operator at least 3 months before

July 1, 1983 (3\1/2\ years after December 31, 1979) 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 shall be scheduled between July 1, 1983, and July 1, 1984

(between 3\1/2\ and 4\1/2\ years after December 31, 1979).

(3) Within either the next or future period(s) specified by ALOSH 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, ALOSH will specify a 6-month period to the operator

within which miners shall have the opportunity for examinations.

(b) Mandatory examinations. Every operator shall provide to each

miner who begins working in or at a coal mine for the first time after

December 30, 1969:

(1) An initial chest roentgenogram as soon as possible, but in no

event later than 6 months after commencement ofemployment. A preemployment

physical examination which was made within the 6 months prior to the date on

which the miner started to work will be considered as fulfilling this

requirement. An initial chest roentgenogram given to a miner according to

former regulations for this subpart prior to August 1, 1978 will also be

considered as fulfilling this requirement.

(2) A second chest roentgenogram, in accordance with this subpart, 3

years following the initial examination if the miner is still engaged in

underground coal mining. A second roentgenogram given to a miner

according to former regulations under this subpart prior to August 1,

1978 will be considered as fulfilling this requirement.

(3) A third chest roentgenogram 2 years following the second chest

roentgenogram if the miner is still engaged in underground coal mining

and if the second roentgenogram shows evidence of category 1, category

2, category 3 simple pneumoconioses, or complicated pneumoconioses (ILO

Classification).

(c) ALOSH will notify the miner when he or she is due to receive the

second or third mandatory examination under (b) of this section.

Similarly, ALOSH 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 shall not state the medical reason for the

examination nor that it is the third examination in the series. If the

miner is notified by ALOSH that the third mandatory examination is due

and the operator is not so notified, availability of the

roentgenographic examination under the operator's plan shall constitute

the operator's compliance with the requirement to provide a third

mandatory examination even if the miner refuses to take the examination.

(d) The opportunity for chest roentgenograms to be available by an

operator for purposes of this subpart shall be provided in accordance

with a plan which has been submitted and approved in accordance with

this subpart.

(e) Any examinations conducted by the Secretary in the National

Study of Coal Workers' Pneumoconiosis after January 1, 1977, but before

August 1, 1978 shall satisfy the requirements of this section with

respect to the specific examination given (see Sec. 37.6(d)).

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978, as amended at 49

FR 7563, Mar. 1, 1984]

Sec. 37.4 Plans for chest roentgenographic examinations.

(a) Every plan for chest roentgenographic examinations of miners

shall be submitted on forms prescribed by the Secretary to ALOSH within

120 calendar days after August 1, 1978. In the case of a person who

after August 1, 1978, becomes an operator of a mine for which no plan

has been approved, that person shall submit a plan within 60 days after

such event occurs. A separate plan shall be submitted by the operator

and by each construction contractor for each underground coal mine which

has a MSHA identification number. The plan shall 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 for

voluntary examinations (see Sec. 37.3(a)) and the estimated number of

miners to be given or offered examinations during the 6-month period

under the plan;

(4) The name and location of the approved X-ray facility or

facilities, and the approximate date(s) and time(s) of day during which

the roentgenograms 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 facility is proposed, 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 nonmobile approved facilities for the

reexamination of miners and for the mandatory examination of miners when

necessary see Sec. 37.3(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 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) The name and address of the ``A'' or ``B'' reader who will

interpret and classify the chest roentgenograms.

(7) Assurances that: (i) The operator will not solicit a physician's

roentgenographic or other findings concerning any miner employed by the

operator,

(ii) Instructions have been given to the person(s) giving the

examinations that duplicate roentgenograms or copies of roentgenograms

will not be made and that (except as may be necessary for the purpose of

this subpart) the physician's roentgenographic and other findings, as

well as the occupational history information obtained from a miner

unless obtained prior to employment in a preemployment examination, and

disclosed prior to employment, will not be disclosed in a manner which

will permit identification of the employee with the information about

him, and

(iii) The roentgenographic examinations will be made at no charge to

the miner.

(b) Operators may provide for alternate facilities and ``A'' or

``B'' readers in plans submitted for approval.

(c) The change of operators of any mine operating under a plan

approved pursuant to Sec. 37.5 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 (d) of this section.

(d) The operator shall advise ALOSH 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.

(e) The operator shall 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 ALOSH. The proposed plan or change in plan shall

remain posted in a visible location on the bulletin board until ALOSH

either grants or denies approval of it at which time the approved plan

or denial of approval shall be permanently posted. In the case of an

operator who is a construction contractor and who does not have a

bulletin board, the construction contractor must otherwise notify its

employees of the examination arrangements. Upon request, the contractor

must show ALOSH written evidence that its employees have been notified.

(f) Upon notification from ALOSH that sufficient time has elapsed

since the previous period of examinations, the operator will resubmit

its plan for each of its coal mines to ALOSH for approval for the next

period of examinations (see Sec. 37.3(a)(2)). The plan shall include the

proposed beginning and ending dates of the next period of examinations

and all information required by paragraph (a) of this section.

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978]

Sec. 37.5 Approval of plans.

(a) Approval of plans granted prior to August 1, 1978 is no longer

effective.

(b) If, after review of any plan submitted pursuant to this subpart,

the Secretary 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, the Secretary will approve the plan and

notify the operator(s) submitting the plan of the approval. Approval may

be conditioned upon such terms as the Secretary deems necessary to carry

out the purpose of section 203 of the act.

(c) Where the Secretary has reason to believe that he will deny

approval of a plan he will, prior to the denial, give reasonable notice

in writing to the operator(s) of an opportunity to amend the plan. The

notice shall specify the ground upon which approval is proposed to be

denied.

(d) If a plan is denied approval, the Secretary shall advise the

operator(s) in writing of the reasons for the denial.

Sec. 37.6 Chest roentgenographic examinations conducted by the Secretary.

(a) The Secretary will give chest roentgenograms or make

arrangements with an appropriate person, agency, or institution to give

the chest roentgenograms and with ``A'' or ``B'' readers to interpret

the roentgenograms required under this subpart in the locality where the

miner resides, at the mine, or at a medical facility easily accessible

to a mining community or mining communities, under the following

circumstances:

(1) Where, in the judgment of the Secretary, due to the lack of

adequate medical or other necessary facilities or personnel at the mine

or in the locality where the miner resides, the required

roentgenographic examination cannot be given.

(2) Where the operator has not submitted an approvable plan.

(3) Where, after commencement of an operator's program pursuant to

an approved plan and after notice to the operator of his failure to

follow the approved plan and, after allowing 15 calendar days to bring

the program into compliance, the Secretary determines and notifies the

operator in writing that the operator's program still fails to comply

with the approved plan.

(b) The operator of the mine shall reimburse the Secretary or other

person, agency, or institution as the Secretary may direct, for the cost

of conducting each examination made in accordance with this section.

(c) All examinations given or arranged by the Secretary will comply

with the time requirements of Sec. 37.3. Whenever the Secretary gives or

arranges for the examinations of miners at a time, a written notice of

the arrangements will be sent to the operator who shall post the notice

on the mine bulletin board.

(d) Operators of mines selected by ALOSH to participate in the

National Study of Coal Workers' Pneumoconiosis (an epidemiological study

of respiratory diseases in coal miners) and who agree to cooperate will

have all their miners afforded the opportunity to have a chest

roentgenogram required hereunder at no cost to the operator. For future

examinations and for mandatory examinations each participating operator

shall submit an approvable plan.

Sec. 37.7 Transfer of affected miner to less dusty area.

(a) Any miner who, in the judgment of the Secretary based upon the

interpretation of one or more of the miner's chest roentgenograms, shows

category 1 (1/0, 1/1, 1/2), category 2 (2/1, 2/2, 2/3), or category 3

(3/2, 3/3, 3/4) simple pneumoconioses, or complicated pneumoconioses

(ILO Classification) shall 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 not more than

1.0 mg/m\3\ of air, or if such level is not attainable in the mine, to a

position in the mine where the concentration of respirable dust is the

lowest attainable below 2.0 mg/m\3\ of air.

(b) Any transfer under this section shall be in accordance with the

procedures specified in part 90 of title 30, Code of Federal

Regulations.

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978, as amended at 44

FR 23085, Apr. 18, 1979; 49 FR 7563, Mar. 1, 1984]

Sec. 37.8 Roentgenographic examination at miner's expense.

Any miner who wishes to obtain an examination at his or her own

expense at an approved facility and to have submitted to NIOSH for him

or her a complete examination may do so, provided that the examination

is made no sooner than 6 months after the most recent examination of the

miner submitted to ALOSH. ALOSH will provide an interpretation and

report of the examinations made at the miner's expense in the same

manner as if it were submitted under an operator's plan. Any change in

the miner's transfer rights under the act which may result from this

examination will be subject to the terms of Sec. 37.7.

Sec. 37.20 Miner identification document.

As part of the roentgenographic examination, a miner identification

document which includes an occupational history questionnaire shall be

completed for each miner at the facility where the roentgenogram is made

at the same time the chest roentgenogram required by this subpart is given.

Specifications for Performing Chest Roentgenographic Examinations

Sec. 37.40 General provisions.

(a) The chest roentgenographic examination shall be given at a

convenient time and place.

(b) The chest roentgenographic examination consists of the chest

roentgenogram, and a complete Roentgenographic Interpretation Form (Form

CDC/NIOSH (M) 2.8), and miner identification document.

(c) A roentgenographic examination shall be made in a facility

approved in accordance with Sec. 37.42 by or under the supervision of a

physician who regularly makes chest roentgenograms and who has

demonstrated ability to make chest roentgenograms of a quality to best

ascertain the presence of pneumoconiosis.

Sec. 37.41 Chest roentgenogram specifications.

(a) Every chest roentgenogram shall be a single posteroanterior

projection at full inspiration on a film being no less than 14 by 17

inches and no greater than 16 by 17 inches. The film and cassette shall

be capable of being positioned both vertically and horizontally so that

the chest roentgenogram will include both apices and costophrenic

angles. If a miner is too large to permit the above requirements, then

the projection shall include both apices with minimum loss of the

costophrenic angle.

(b) Miners shall be disrobed from the waist up at the time the

roentgenogram is given. The facility shall provide a dressing area and

for those miners who wish to use one, the facility shall provide a clean

gown. Facilities shall be heated to a comfortable temperature.

(c) Roentgenograms shall be made only with a diagnostic X-ray

machine having a rotating anode tube with a maximum of a 2 mm. source

(focal spot).

(d) Except as provided in paragraph (e) of this section,

roentgenograms shall be made with units having generators which comply

with the following: (1) The generators of existing roentgenographic

units acquired by the examining facility prior to July 27, 1973, shall

have a minimum rating of 200 mA at 100 kVp.; (2) generators of units

acquired subsequent to that date shall have a minimum rating of 300 mA

at 125 kVp.

Note: A generator with a rating of 150 kVp. is recommended.

(e) Roentgenograms made with battery-powered mobile or portable

equipment shall be made with units having a minimum rating of 100 mA at

110 kVp. at 500 Hz, or of 200 mA at 110 kVp. at 60 Hz.

(f) Capacitor discharge and field emission units may be used if the

model of such units is approved by ALOSH for quality, performance, and

safety. ALOSH will consider such units for approval when listed by a

facility seeking approval under Sec. 37.42 of this subpart.

(g) Roentgenograms shall be given only with equipment having a beam-

limiting device which does not cause large unexposed boundaries. The

beam limiting device shall provide rectangular collimation and shall be

of the type described in part F of the suggested State regulations for

the control of radiation or (for beam limiting devices manufactured

after August 1, 1974) of the type specified in 21 CFR 1020.31. The use

of such a device shall be discernible from an examination of the

roentgenogram.

(h) To insure high quality chest roentgenograms:

(1) The maximum exposure time shall not exceed \1/20\ of a second

except that with single phase units with a rating less than 300 mA at

125 kVp. and subjects with chests over 28 cm. posteroanterior, the

exposure may be increased to not more than \1/10\ of a second;

(2) The source or focal spot to film distance shall be at least 6

feet;

(3) Medium speed film and medium speed intensifying screens are

recommended. However, any film-screen combination, the rated ``speed''

of which is at least 100 and does not exceed 300, which produces

roentgenograms with spatial resolution, contrast, latitude and quantum

mottle similar to those of systems designated as ``medium speed'' may be

employed;

(4) Film-screen contact shall be maintained and verified at 6 month

or shorter intervals;

(5) Intensifying screens shall be inspected at least once a month

and cleaned when necessary by the method recommended by the

manufacturer;

(6) All intensifying screens in a cassette shall be of the same type

and made by the same manufacturer;

(7) When using over 90 kV., a suitable grid or other means of

reducing scattered radiation shall be used;

(8) The geometry of the radiographic system shall insure that the

central axis (ray) of the primary beam is perpendicular to the plane of

the film surface and impinges on the center of the film;

(9) A formal quality assurance program shall be established at each

facility.

(i) Radiographic processing:

(1) Either automatic or manual film processing is acceptable. A

constant time-temperature technique shall be meticulously employed for

manual processing.

(2) If mineral or other impurities in the processing water introduce

difficulty in obtaining a high-quality roentgenogram, a suitable filter

or purification system shall be used.

(j) Before the miner is advised that the examination is concluded,

the roentgenogram shall be processed and inspected and accepted for

quality by the physician, or if the physician is not available,

acceptance may be made by the radiologic technologist. In a case of a

substandard roentgenogram, another shall be immediately made. All

substandard roentgenograms shall be clearly marked as rejected and

promptly sent to ALOSH for disposal.

(k) An electric power supply shall be used which complies with the

voltage, current, and regulation specified by the manufacturer of the

machine.

(l) A densitometric test object may be required on each

roentgenogram for an objective evaluation of film quality at the

discretion of ALOSH.

(m) Each roentgenogram made hereunder shall be permanently and

legibly marked with the name and address or ALOSH approval number of the

facility at which it is made, the social security number of the miner,

and the date of the roentgenogram. No other identifying markings shall

be recorded on the roentgenogram.

[43 FR 33715, Aug. 1, 1978, as amended at 52 FR 7866, Mar. 13, 1987]

Sec. 37.42 Approval of roentgenographic facilities.

(a) Approval of roentgenographic facilities given prior to January

1, 1976, shall terminate upon August 1, 1978 unless each of the

following conditions have been met:

(1) The facility must verify that it still meets the requirements

set forth in the regulations for the second round of roentgenographic

examinations (38 FR 20076) and it has not changed equipment since it was

approved by NIOSH.

(2) From July 27, 1973, to January 1, 1976, the facility submitted

to ALOSH at least 50 roentgenograms which were interpreted by one or

more ``B'' readers not employed by the facility who found no more than 5

percent of all the roentgenograms unreadable.

(b) Other facilities will be eligible to participate in this program

when they demonstrate their ability to make high quality diagnostic

chest roentgenograms by submitting to ALOSH six or more sample chest

roentgenograms made and processed at the applicant facility and which

are of acceptable quality to the Panel of ``B'' readers. Applicants

shall also submit a roentgenogram of a plastic step-wedge object

(available on loan from ALOSH) which was made and processed at the same

time with the same technique as the roentgenograms submitted and

processed at the facility for which approval is sought. At least one

chest roentgenogram and one test object roentgenogram shall have been

made with each unit to be used hereunder. All roentgenograms shall have

been made within 15 calendar days prior to submission and shall be

marked to identify the facility where each roentgenogram was made, the

X-ray machine used, and the date each was made. The chest roentgenograms

will be returned and may be the same roentgenograms submitted pursuant

to Sec. 37.51.

Note: The plastic step-wedge object is described in an article by E. Dale

Trout and John P. Kelley appearing in ``The American Journal of Roentgenology,

Radium Therapy and Nuclear Medicine,'' Vol. 117, No. 4, April 1973.

(c) Each roentgenographic facility submitting chest roentgenograms

for approval under this section shall complete and include an X-ray

facility document describing each X-ray unit to be used to make chest

roentgenograms under the act. The form shall include: (1) The date of

the last radiation safety inspection by an appropriate licensing agency

or, if no such agency exists, by a qualified expert as defined in NCRP

Report No. 33 (see Sec. 37.43); (2) the deficiencies found; (3) a

statement that all the deficiencies have been corrected; and (4) the

date of acquisition of the X-ray unit. To be acceptable, the radiation

safety inspection shall have been made within 1 year preceding the date

of application.

(d) Roentgenograms submitted with applications for approval under

this section will be evaluated by the panel of ``B'' Readers or by a

qualified radiological physicist or consultant. Applicants will be

advised of any reasons for denial of approval.

(e) ALOSH or its representatives may make a physical inspection of

the applicant's facility and any approved roentgenographic facility at

any reasonable time to determine if the requirements of this subpart are

being met.

(f) ALOSH may require a facility periodically to resubmit

roentgenograms of a plastic step-wedge object, sample roentgenograms, or

a Roentgenographic Facility Document for quality control purposes.

Approvals granted hereunder may be suspended or withdrawn by notice in

writing when in the opinion of ALOSH the quality of roentgenograms or

information submitted under this section warrants such action. A copy of

a notice withdrawing approval will be sent to each operator who has

listed the facility as its facility for giving chest roentgenograms and

shall be displayed on the mine bulletin board adjacent to the operator's

approved plan. The approved plan will be reevaluated by ALOSH in light

of this change.

[43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31, 1978]

Sec. 37.43 Protection against radiation emitted by roentgenographic equipment.

Except as otherwise specified in Sec. 37.41, roentgenographic

equipment, its use and the facilities (including mobile facilities) in

which such equipment is used, shall conform to applicable State and

Federal regulations (See 21 CFR part 1000). Where no applicable

regulations exist, roentgenographic equipment, its use and the

facilities (including mobile facilities) in which such equipment is used

shall conform to the recommendations of the National Council on

Radiation Protection and Measurements in NCRP Report No. 33 ``Medical X-

ray and Gamma-Ray Protection for Energies up to 10 MeV--Equipment Design

and Use'' (issued February 1, 1968), in NCRP Report No. 48, ``Medical

Radiation Protection for Medical and Allied Health Personnel'' (issued

August 1, 1976), and in NCRP Report No. 49, ``Structural Shielding

Design and Evaluation for Medical Use of X-rays and Gamma Rays of up to

10 MeV'' (issued September 15, 1976). These documents are hereby

incorporated by reference and made a part of this subpart. These

documents are available for examination at ALOSH, 944 Chestnut Ridge

Road, Morgantown, WV 26505, and at the National Institute for

Occupational Safety and Health, 5600 Fishers Lane, Rockville, MD 20857.

Copies of NCRP Reports Nos. 33, 48, and 49 may be purchased for $3,

$4.50, and $3.50 each, respectively, from NCRP Publications, P.O. Box

30175, Washington, DC 20014.

Specifications for Interpretation, Classification, and Submission of

Chest Roentgenograms

Sec. 37.50 Interpreting and classifying chest roentgenograms.

(a) Chest roentgenograms shall be interpreted and classified in

accordance with the ILO Classification system and recorded on a

Roentgenographic Interpretation Form (Form CDC/NIOSH (M)2.8).

(b) Roentgenograms shall be interpreted and classified only by a

physician who regularly reads chest roentgenograms and who has

demonstrated proficiency in classifying the neumoconioses in accordance

with Sec. 37.51.

(c) All interpreters, whenever interpreting chest roentgenograms

made under the Act, shall have immediately available for reference a

complete set of the ILO International Classification of Radiographs for

Pneumoconioses, 1980.

Note: This set is available from the International Labor Office,

1750 New York Avenue, NW., Washington, DC 20006 (Phone: 202/376-2315).

(d) In all view boxes used for making interpretations:

(1) Fluorescent lamps shall be simultaneously replaced with new

lamps at 6-month intervals;

(2) All the fluorescent lamps in a panel of boxes shall have

identical manufacturer's ratings as to intensity and color;

(3) The glass, internal reflective surfaces, and the lamps shall be

kept clean;

(4) The unit shall be so situated as to minimize front surface

glare.

[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7564, Mar. 1, 1984]

Sec. 37.51 Proficiency in the use of systems for classifying the pneumoconioses.

(a) First or ``A'' readers:

(1) Approval as an ``A'' reader shall continue if established prior

to (insert) effective date of these regulations).

(2) Physicians who desire to be ``A'' readers must demonstrate their

proficiency in classifying the pneumoconioses by either:

(i) Submitting to ALOSH from the physician's files six sample chest

roentgenograms which are considered properly classified by the Panel of

``B'' readers. The six roentgenograms shall consist of two without

pneumoconiosis, two with simple pneumoconiosis, and two with complicated

pneumoconiosis. The films will be returned to the physician. The

interpretations shall be on the Roentgenographic Interpretation Form

(Form CDC/NIOSH (M) 2.8) (These may be the same roentgenograms submitted

pursuant to Sec. 37.42), or;

(ii) Satisfactory completion, since June 11, 1970, of a course

approved by ALOSH on the ILO or ILO-U/C Classification systems or the

UICC/Cincinnati classification system. As used in this subparagraph,

``UICC/Cincinnati classification'' means the classification of the

pneumoconioses devised in 1968 by a Working Committee of the

International Union Against Cancer.

(b) Final or ``B'' readers:

(1) Approval as a ``B'' reader established prior to October 1, 1976,

shall hereby be terminated.

(2) Proficiency in evaluating chest roentgenograms for

roentgenographic quality and in the use of the ILO Classification for

interpreting chest roentgenograms for pneumoconiosis and other diseases

shall be demonstrated by those physicians who desire to be ``B'' readers

by taking and passing a specially designed proficiency examination given

on behalf of or by ALOSH at a time and place specified by ALOSH. Each

physician must bring a complete set of the ILO standard reference

radiographs when taking the examination. Physicians who qualify under

this provision need not be qualified under paragraph (a) of this

section.

(c) Physicians who wish to participate in the program shall make

application on an Interpreting Physician Certification Document (Form

CDC/NIOSH (M) 2.12).

[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7564, Mar. 1, 1984]

Sec. 37.52 Method of obtaining definitive interpretations.

(a) All chest roentgenograms which are first interpreted by an ``A''

or ``B'' reader will be submitted by ALOSH to a ``B'' reader qualified

as described in Sec. 37.51. If there is agreement between the two

interpreters as defined in paragraph (b) of this section the result

shall be considered final and reported to MSHA for transmittal to the

miner. When in the opinion of ALOSH substantial agreement is lacking,

ALOSH shall obtain additional interpretations from the Panel of ``B''

readers. If interpretations are obtained from two or more ``B'' readers,

and if two or more are in agreement then the highest major category

shall be reported.

(b) Two interpreters shall be considered to be in agreement when

They both find either stage A, B, or C complicated pneumoconiosis, or their

findings with regard to simple pneumoconiosis are both in the same major

category, or (with one exception noted below) are within one minor

category (ILO Classification 12-point scale) of each other. In the last

situation, the higher of the two interpretations shall be reported. The

only exception to the one minor category principle is a reading sequence

of 0/1, 1/0, or 1/0, 0/1. When such a sequence occurs, it shall not be

considered agreement, and a third (or more) interpretation shall be

obtained until a consensus involving two or more readings in the same

major category is obtained.

[43 FR 33715, Aug. 1, 1978, as amended at 49 FR 7564, Mar. 1, 1984; 52

FR 7866, Mar. 13, 1987]

Sec. 37.53 Notification of abnormal roentgenographic findings.

(a) Findings of, or findings suggesting, enlarged heart,

tuberculosis, lung cancer, or any other significant abnormal findings

other than pneumoconiosis shall be communicated by the first physician

to interpret and classify the roentgenogram to the designated physician

of the miner indicated on the miner's identifcation document. A copy of

the communication shall be submitted to ALOSH. ALOSH will notify the

miner to contact his or her physician when any physician who interprets

and classifies the miner's roentgenogram reports significant abnormal

findings other than pneumoconiosis.

(b) In addition, when ALOSH has more than one roentgenogram of a

miner in its files and the most recent examination was interpreted to

show enlarged heart, tuberculosis, cancer, complicated pneumoconiosis,

and any other significant abnormal findings, ALOSH will submit all of

the miner's roentgenograms in its files with their respective

interprtations to a ``B'' reader. The ``B'' reader will report any

significant changes or progression of disease or other comments to ALOSH

and ALOSH shall submit a copy of the report to the miner's designated

physician.

(c) All final findings regarding pneumoconiosis will be sent to the

miner by MSHA in accordance with section 203 of the act (see 30 CFR part

90). Positive findings with regard to pneumoconiosis will be reported to

the miner's designated physician by ALOSH.

(d) ALOSH will make every reasonable effort to process the findings

described in paragraph (c) of this section within 60 days of receipt of

the information described in Sec. 37.60 in a complete and acceptable

form. The information forwarded to MSHA will be in a form intended to

facilitate prompt dispatch of the findings to the miner. The results of

an examination made of a miner will not be processed by ALOSH if the

examination was made within 6 months of the date of a previous

acceptable examination.

Sec. 37.60 Submitting required chest roentgenograms and miner identification documents.

(a) Each chest roentgenogram required to be made under this subpart,

together with the completed roentgenographic interpretation form and the

completed miner identification document, shall be sumitted together for

each miner to ALOSH within 14 calendar days after the roentgenographic

examination is given and become the property of ALOSH.

(b) If ALOSH deems any part submitted under paragraph (a) of this

section inadequate, it will notify the operator of the deficiency. The

operator shall promptly make appropriate arrangements for the necessary

reexamination.

(c) Failure to comply with paragraph (a) or (b) of this section

shall be cause to revoke approval of a plan or any other approval as may

be appropriate. An approval which has been revoked may be reinstated at

the discretion of ALOSH after it receives satisfactory assurances and

evidence that all deficiencies have been corrected and that effective

controls have been instituted to prevent a recurrence.

(d) Chest roentgenograms and other required documents shall be

submitted only for miners. Results of preemployment physical

examinations of persons who are not hired shall not be submitted.

(e) If a miner refuses to participate in all phases of the

examination prescribed in this subpart, no report need be made. If a miner

refuses to participate in any phase of the examination prescribed in this

subpart, all the forms shall be submitted with his or her name and social

security account number on each. If any of the forms cannot be completed

because of the miner's refusal, it shall be marked ``Miner Refuses,'' and

shall be submitted. No submission shall be made, however, without a completed

miner identification document containing the miner's name, address, social

security number and place of employment.

Review and Availability of Records

Sec. 37.70 Review of interpretations.

(a) Any miner who believes the interpretation for pneumoconiosis

reported to him or her by MSHA is in error may file a written request

with ALOSH that his or her roentgenogram be reevaluated. If the

interpretation was based on agreement between an ``A'' reader and a

``B'' reader, ALOSH will obtain one or more additional interpretations

by ``B'' readers as necessary to obtain agreement in accord with

Sec. 37.52(b), and MSHA shall report the results to the miner together

with any rights which may accrue to the miner in accordance with

Sec. 37.7. If the reported interpretation was based on agreement between

two (or more) ``B'' readers, the reading will be accepted as conclusive

and the miner shall be so informed by MSHA.

(b) Any operator who is directed by MSHA to transfer a miner to a

less dusty atmosphere based on the most recent examination made

subsequent to August 1, 1978, may file a written request with ALOSH to

review its findings. The standards set forth in paragraph (a) of this

section apply and the operator and miner will be notified by MSHA

whether the miner is entitled to the option to transfer.

Sec. 37.80 Availability of records.

(a) Medical information and roentgenograms on miners will be

released by ALOSH only with the written consent from the miner, or if

the miner is deceased, written consent from the miner's widow, next of

kin, or legal representative.

(b) To the extent authorized, roentgenograms will be made available

for examination only at ALOSH.

Sec. 37.200 Scope.

Authority: Sec. 508, 83 Stat. 803; 30 U.S.C. 957.

Source: 36 FR 8870, May 14, 1971, unless otherwise noted.

The provisions of this subpart set forth the conditions under which

the Secretary will pay pathologists to obtain results of autopsies

performed by them on miners.

Sec. 37.201 Definitions.

As used in this subpart:

(a) Secretary means the Secretary of Health and Human Services.

(b) Miner means any individual who during his life was employed in

any underground coal mine.

(c) Pathologist means

(1) A physician certified in anatomic pathology or pathology by the

American Board of Pathology or the American Osteopathic Board of

Pathology,

(2) A physician who possesses qualifications which are considered

``Board of eligible'' by the American Board of Pathology or American

Osteopathic Board of Pathology, or

(3) An intern, resident, or other physician in a training program in

pathology who performs the autopsy under the supervision of a

pathologist as defined in paragraph (c) (1) or (2) of this section.

(d) ALFORD means the Appalachian Laboratory for Occupational

Respiratory Diseases, Public Health Service, Department of Health and

Human Services, Post Office Box 4257, Morgantown, WV 26505.

Subpart--Autopsies

Sec. 37.202 Payment for autopsy.

(a) The Secretary will pay up to $200 to any pathologist who, after

the effective date of the regulations in this part and with legal

consent:

(1) Performs an autopsy on a miner in accordance with this subpart; and

(2) Submits the findings and other materials to ALFORD in accordance

with this subpart within 180 calendar days after having performed the

utopsy; and

(3) Receives no other specific payment, fee, or reimbursement in

connection with the autopsy from the miner's widow, his family, his

estate, or any other Federal agency.

(b) The Secretary will pay to any pathologist entitled to payment

under paragraph (a) of this section and additional $10 if the

pathologist can obtain and submits a good quality copy or original of a

chest roentgenogram (posteroanterior view) made of the subject of the

autopsy within 5 years prior to his death together with a copy of any

interpretation made.

[35 FR 13206, Aug. 19, 1970, as amended at 38 FR 16353, June 22, 1973]

Sec. 37.203 Autopsy specifications.

(a) Every autopsy for which a claim for payment is submitted

pursuant to this part:

(1) Shall be performed consistent with standard autopsy procedures

such as those, for example, set forth in the ``Autopsy Manual'' prepared

by the Armed Forces Institute of Pathology, July 1, 1960. (Technical

Manual No. 8-300. NAVMED P-5065, Air Force Manual No. 160-19.) Copies of

this document may be borrowed from ALFORD.

(2) Shall include:

(i) Gross and microscopic examination of the lungs, pulmonary

pleura, and tracheobronchial lymph nodes;

(ii) Weights of the heart and each lung (these and all other

measurements required under this subparagraph shall be in the metric

system);

(iii) Circumference of each cardiac valve when opened;

(iv) Thickness of right and left ventricles; these measurements

shall be made perpendicular to the ventricular surface and shall not

include trabeculations or pericardial fat. The right ventricle shall be

measured at a point midway between the tricuspid valve and the apex, and

the left ventricle shall be measured directly above the insertion of the

anterior papillary muscle;

(v) Size, number, consistency, location, description and other

relevant details of all lesions of the lungs;

(vi) Level of the diaphragm;

(vii) From each type of suspected pneumoconiotic lesion,

representative microscopic slides stained with hematoxylin eosin or

other appropriate stain, and one formalin fixed, paraffin-impregnated

block of tissue; a minimum of three stained slides and three blocks of

tissue shall be submitted. When no such lesion is recognized, similar

material shall be submitted from three separate areas of the lungs

selected at random; a minimum of three stained slides and three formalin

fixed, paraffin-impregnated blocks of tissue shall be submitted.

(b) Needle biopsy techniques shall not be used.

Sec. 37.204 Procedure for obtaining payment.

Every claim for payment under this subpart shall be submitted to

ALFORD and shall include:

(a) An invoice (in duplicate) on the pathologist's letterhead or

billhead indicating the date of autopsy, the amount of the claim and a

signed statement that the pathologist is not receiving any other

specific compensation for the autopsy from the miner's widow, his

surviving next-of-kin, the estate of the miner, or any other source.

(b) Completed PHS Consent, Release and History Form (See Fig. 1).

This form may be completed with the assistance of the pathologist,

attending physician, family physician, or any other responsible person

who can provide reliable information.

(c) Report of autopsy:

(1) The information, slides, and blocks of tissue required by this

subpart.

(2) Clinical abstract of terminal illness and other data that the

pathologist determines is relevant.

(3) Final summary, including final anatomical diagnoses, indicating

presence or absence of simple and complicated pneumoconiosis, and

correlation with clinical history if indicated.

Figure 1

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service--National Coal Workers' Autopsy Study

Consent, Release, and History Form Federal Coal Mine Health and Safety

Act of 1969

I, ------------------, (Name) ------------ (Relationship) of ------

------------, (Name of deceased miner) do hereby authorize the

performance of an autopsy (------------------) (Limitation, if any, on

autopsy) on said deceased. I understand that the report and certain

tissues as necessary will be released to the United States Public Health

Service and to ------------------ (Name of Physician securing autopsy)

I understand that any claims in regard to the deceased for which I may

sign a general release of medical information will result in the release

of the information from the Public Health Service. I further understand

that I shall not make any payment for the autopsy.

Occupational and Medical History

1. Date of Birth of Deceased ------------. (Month, Day, Year)

2. Social Security Number of Deceased ------------------.

3. Date and Place of Death ------------, (Month, Day, Year) --------

---------- (City, County, State).

4. Place of Last Mining Employment:

Name of Mine____________________________________________________________

Name of Mining Company__________________________________________________

Mine Address____________________________________________________________

5. Last Job Title at Mine of Last Employment

(e.g., Continuous Miner Operator, motorman, foreman, etc.)

6. Job Title of Principal Mining Occupation (that job to which miner

devoted the most number of years)

(e.g., Same as above)

7. Smoking History of Miner:

(a) Did he ever smoke cigarettes? Yes

No______________________________________________________________________

(b) If yes, for how many years?------------

Years.

(c) If yes, how many cigarettes per day did he smoke on the

average?----------------

(Number of)

Cigarettes per day.

(d) Did he smoke cigarettes up until the time of his death? Yes ----

-- No ------

(e) If no to (d), for how long before he died had he not been

smoking cigarettes?

8. Total Years in Surface and Underground Employment in Coal Mining,

by State (If known) ------, (Years) ------------ (State).

9. Total Years in Underground Coal Mining Employment, by State (If

known) ------, (Years) ------------ (State).

________________________________________________________________________

(Signature)

________________________________________________________________________

(Address)

________________________________________________________________________

(Date)

Interviewer:____________________________________________________________

PART 38 – DISASTER ASSISTANCE FOR CRISIS COUNSELING AND TRAINING

Sec.

1. Purpose; coordination.

2. Definitions.

3. Assistance; procedures, limitations.

4. Contracts.

5. Grant assistance.

6. Nondiscrimination.

7. Nonliability.

8. Criminal and civil penalties.

9. Federal audits.

Authority: Sec. 413, Pub. L. 93-288. The Disaster Relief Act of 1974,

88 Stat. 157, 42 U.S.C. 5183, EO 11795, 39 FR 25939, as amended by EO 11910,

41 FR 15681

Source: 41 FR 52052, Nov. 26, 1976, unless otherwise noted.