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given to a miner according to former August 1, 1978, becomes an operator of regulations under this subpart prior to a mine for which no plan has been apAugust 1, 1978 will be considered as ful- proved, that person shall submit a plan filling this requirement.

within 60 days after such event occurs. (3) A third chest roentgenogram 2 A separate plan shall be submitted by years following the second chest roent

the operator and by each construction genogram if the miner is still engaged

contractor for each underground coal in underground coal mining and if the

mine which has a MSHA identification second roentgenogram shows evidence

number. The plan shall include: of category 1, category 2, category 3

(1) The name, address, and telephone simple pneumoconioses, or complicated pneumoconioses (ILO Classification).

number of the operator(s) submitting

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

(2) The name, MSHA identification second or third mandatory examina

number for respirable dust measuretion under (b) of this section. Simi

ments, and address of the mine inlarly, ALOSH will notify the coal mine

cluded in the plan; operator when the miner is to be given (3) The proposed beginning and enda second examination. The operator ing date of the 6-month period for volwill be notified concerning a miner's untary examinations (see $37.3(a)) and third examination only with the min- the estimated number of miners to be er's written consent, and the notice to given or offered examinations during the operator shall not state the med- the 6-month period under the plan; ical reason for the examination nor

(4) The name and location of the apthat it is the third examination in the

proved X-ray facility or facilities, and series. If the miner is notified by

the approximate date(s) and time(s) of ALOSH that the third mandatory ex- day during which the roentgenograms amination is due and the operator is

will be given to miners to enable a denot so notified, availability of the

termination of whether the examinaroentgenographic examination under

tions will be conducted at a convenient the operator's plan shall constitute the

time and place; operator's compliance with the require

(5) If a mobile facility is proposed, ment to provide a third mandatory ex

the plan shall provide that each miner amination even if the miner refuses to

be given adequate notice of the opportake the examination. (d) The opportunity for chest roent

tunity to have the examination and

that no miner shall have to wait for an genograms to be available by an operator for purposes of this subpart shall

examination more than 1 hour before

or after his or her work shift. In addibe provided in accordance with a plan which has been submitted and approved

tion, the plan shall include: in accordance with this subpart.

(i) The number of change houses at (e) Any examinations conducted by

the mine. the Secretary in the National Study of (ii) One or more alternate nonmobile Coal Workers' Pneumoconiosis after approved facilities for the reexaminaJanuary 1, 1977, but before August 1, tion of miners and for the mandatory 1978 shall satisfy the requirements of

examination of miners when necessary this section with respect to the specific (see $37.3(b)), or an assurance that the examination given (see $37.6(d)).

mobile facility will return to the loca(43 FR 33715, Aug. 1, 1978; 43 FR 38830, Aug. 31,

tion(s) specified in the plan as fre1978, as amended at 49 FR 7563, Mar. 1, 1984)

quently as necessary to provide for ex

aminations in accordance with these 837.4 Plans

for

chest regulations. roentgenographic examinations.

(iii) The name and location of each (a) Every plan for chest change house at which examinations roentgenographic examinations of min- will be given. For mines with more ers shall be submitted on forms pre- than one change house, the examinascribed by the Secretary to ALOSH tions shall be given at each change within 120 calendar days after August house or at a change house located at 1, 1978. In the case of a person who after a convenient place for each miner.

or

ments. 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 $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)

(6) The name and address of the “Aor “B” reader who will interpret and classify the chest roentgenograms.

(7) Assurances that: (i) The operator will not solicit a physician's roentgenographic 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 “Aor “B” readers in plans submitted for approval.

(c) The change of operators of any mine operating under a plan approved pursuant to $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 arrange

$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.

837.6 Chest roentgenographic exami

nations 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:

ring 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/m3 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/m3 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)

(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 $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.

837.8 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 837.7.

$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

837.7 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 transfer

[blocks in formation]

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

(c) A roentgenographic examination shall be made in a facility approved in accordance with 837.42 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.

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 $37.42 of this subpart.

(g) Roentgenograms shall be given only with equipment having a beamlimiting 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 posteroanterior, the exposure may be increased to not more than 110 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

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;

837.41 Chest roentgenogram specifica

tions. (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 m. 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

cm.

are

(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.

() 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.

(1) 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) $ 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 $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

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