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

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

§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 §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 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 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 difEficulty in obtaining a high-quality roentgenogram, a suitable filter or purification system shall be used.

1

(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.

(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 Emarked 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

inspection by an appropriate licensing agency or, if no such agency exists, by a qualified expert as defined in NCRP Report No. 33 (see §37.43); (2) the deficiencies found; (3) a statement that all the deficiencies have been corrected; and (4) the date of acquisition of the Xray 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.

or

a

(f) ALOSH may require a facility periodically to resubmit roentgenograms of a plastic step-wedge object, sample roentgenograms, 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]

$37.43 Protection against radiation emitted by roentgenographic equip

ment.

Except as otherwise specified in § 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 equip

ment, 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 MeVEquipment 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

§ 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 in classifying the proficiency pneumoconioses in accordance with § 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]

§ 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 pneumoconioses by either:

the

(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 §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]

§ 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 §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

(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 §37.60 in a complete and acceptable form. The infor

mation 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.

§ 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.