(a) General requirement. Continuous Personal Dust Monitors (CPDMs) shall be designed and constructed for coal miners to wear and operate without impeding their ability to perform their work safely and effectively, and shall be sufficiently durable to perform reliably in the normal working conditions of coal mines.
(b) Ergonomic design testing. Prior to submitting an application under § 74.13, the applicant shall develop a testing protocol and test the CPDM to assure that the device can be worn safely, without discomfort, and without impairing a coal miner in the performance of duties throughout a full work shift. The results of the test shall also demonstrate that the device will operate consistently throughout a full work shift under representative working conditions of underground coal miners, including representative types and durations of physical activity, tasks, and changes in body orientation.
(1) The testing protocol shall specify that the tests be conducted in one or more active mines under routine operating conditions during production shifts.
(2) The applicant shall submit the testing protocol, in writing, to NIOSH for approval prior to conducting such testing.
(3) The applicant shall include the testing protocol and written test results in the application submitted to NIOSH as specified in § 74.13.
(4) NIOSH will advise and assist the applicant, as necessary, to develop a testing protocol and arrange for the conduct of testing specified in this paragraph.
(5) NIOSH may further inspect the device or conduct such tests as it deems necessary to assure the safety, comfort, practicality, and operability of the device when it is worn by coal miners in the performance of their duties.
(6) NIOSH may waive the requirement for the applicant to conduct testing under paragraph (b) of this section if NIOSH determines that such testing is unnecessary to assure the safety, comfort, practicality, and operability of the device when it is worn by coal miners in the performance of their duties.
(c) Maximum weight. A CPDM shall not add more than 2 kg to the total weight carried by the miner. CPDMs that are combined with other functions, such as communication or illumination, may exceed 2 kg provided that the total added weight carried by the miner does not exceed 2 kg.
(d) Dust concentration range. The CPDM shall measure respirable coal mine dust concentrations accurately, as specified under § 74.8, for an end-of-shift average measurement, for concentrations within a range from 0.2 to 4.0 mg/m
3 for respirable coal mine dust. For end-of-shift average concentrations exceeding 4.0 mg/m
3, the CPDM shall provide a reliable indication that the concentration exceeded 4.0 mg/m
3.
(e) Environmental conditions. The CPDM shall operate reliably and accurately as specified under § 74.8, under the following environmental conditions:
(1) At any ambient temperature and varying temperatures from minus 30 to plus 40 degrees centigrade;
(2) At any atmospheric pressure from 700 to 1000 millibars;
(3) At any ambient humidity from 10 to 100 percent relative humidity; and
(4) While exposed to water mists generated for dust suppression and while monitoring atmospheres including such water mists.
(f) Electromagnetic interference. The CPDM shall meet the following standards for control of and protection from electromagnetic interference.
(1) For emissions control, operators must follow: IEEE Std C95.1-2005, (IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz) and 47 CFR 15.1 through 15.407 (FCC Radio Frequency Devices). Persons must proceed in accordance with IEEE Std C95.1-2005 (IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz).
(i) The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Persons may obtain a copy from: American National Standards Institute (ANSI), 25 West 43rd Street, New York, NY 10036. http://www.ansi.org.
(ii) Persons may inspect a copy at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Arlington, VA 22202-5452, 202-693-9440, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(2) For immunity/susceptibility protection, operators must follow: IEC 61000-4-6, International Standard (Electromagnetic compatibility—Part 4-6: Testing and measurement techniques—Immunity to conducted disturbances, induced by radio-frequency fields), Edition 3.0, 2008-10. Persons must proceed in accordance with IEC 61000-4-6, International Standard (Electromagnetic compatibility—Part 4-6: Testing and measurement techniques—Immunity to conducted disturbances, induced by radio-frequency fields), Edition 3.0, 2008-10. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
(i) Persons may obtain a copy from the International Electrotechnical Commission at the address provided below:
International Electrotechnical Commission, IEC Central Office, 3, rue de Varembé, P.O. Box 131, CH-1211 GENEVA 20, Switzerland. http://www.standardsinfo.net.
(ii) Persons may inspect a copy at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Arlington, VA 22202-5452, 202-693-9440, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(g) Durability testing. The CPDM shall be designed and constructed to remain safe and measure respirable coal mine dust concentrations accurately, as specified under § 74.8 of this section after undergoing the following durability tests, which NIOSH will apply to test devices prior to their use in further testing under § 74.8 of this-subpart:
| Vibration | Mil-Std-810F, 514.5 | U.S. Highway Vibration, Restrained Figure 514.5C-1 | 1 Hours/Axis, 3 Axis; Total Duration = 3 Hrs, equivalent to 1,000 miles.
|
| Drop | 3-foot drop onto bare concrete surface | In standard in-use configuration | 1 drop per axis (3 total). |
(1) Persons must proceed in accordance with Mil-Std-810F, 514.5, Department of Defense Test Method for Environmental Engineering Considerations and Laboratory Tests, 1 January 2000. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Persons may obtain a copy from the U.S. Department of Defense at the address provided below.
ASC/ENOI, Bldg. 560, 2530 Loop Road West, Wright-Patterson AFB OH 45433-7101. http://www.dtc.army.mil/navigator/.
(2) Persons may inspect a copy at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Arlington, VA 22202-5452; 202-693-9440; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(h) Reporting of monitoring results. (1) The CPDM shall report continuous monitoring results legibly or audibly during use. A digital display, if used, shall be illuminated and shall provide a minimum character height of 6 millimeters. Other forms of display (e.g., analogue) must provide comparable visibility. Auditory reporting, if used, shall be clear, have adjustable volume, and provide means for the user to obtain data reports repetitively. The CPDM shall also report end-of-shift results using computer software compatible with current, commonly used personal computer technology.
(2) The CPDM shall report results as cumulative mass concentration in units of mass per volume of air (mg/m
3) with two significant figures of accuracy rounded as customary.
(i) Power requirements. The power source of the CPDM shall have sufficient capacity to enable continuous sampling for 12 hours in a coal mine dust atmosphere of up to 4.0 mg/m
3. If the CPDM uses a rechargeable battery, the battery charger shall be operated from a 110 (VAC) (nominal), 60 Hz power line.
(j) Flow stability and calibration of pump. If a pump is used, the flow shall not vary more than ±5 percent of the calibrated flow for 95 percent of samples taken for any continuous duration for up to 12 hours. The flow calibration maintenance interval to assure such performance shall be specified in the calibration instructions for the device.
(k) Battery check. If the CPDM uses a rechargeable battery, the CPDM shall have a feature to indicate to the user that the device is sufficiently charged to operate and provide accurate measurements for an entire shift of 12 hours under normal conditions of use.
(l) Integration with other personal mining equipment. (1) If the CPDM is integrated or shares functions with any other devices used in mines, such as cap lights or power sources, then the applicant shall obtain approvals for such other devices, prior to receiving final certification of the CPDM under this section.
(2) A CPDM that is integrated with another device shall be tested, according to all the requirements under this part, with the other device coupled to the CPDM and operating.
(m) Tampering safeguards or indicators. The CPDM shall include a safeguard or indicator which either prevents intentional or inadvertent altering of the measuring or reporting functions or indicates that the measuring or reporting functions have been altered.
(n) Maintenance features. The CPDM shall be designed to assure that the device can be cleaned and maintained to perform accurately and reliably for the duration of its service life.
[75 FR 17523, Apr. 6, 2010, as amended at 80 FR 52990, Sept. 2, 2015]
(a) Breathing zone measurement requirement. The CPDM shall be capable of measuring respirable dust within the personal breathing zone of the miner whose exposure is being monitored.
(b) Accuracy. The ability of a CPDM to determine the true concentration of respirable coal mine dust at the end of a shift shall be established through testing that demonstrates the following:
(1) For full-shift measurements of 8 hours or more, a 95 percent confidence that the recorded measurements are within ±25 percent of the true respirable dust concentration, as determined by CMDPSU reference measurements, over a concentration range from 0.2 to 4.0 mg/m
3; and
(2) For intra-shift measurements of less than 8 hours, a 95 percent confidence that the recorded measurements are within ±25 percent of the true respirable dust concentration, as determined by CMDPSU reference measurements, over the concentration range equivalent to 0.2 to 4.0 mg/m
3 for an 8-hour period.
1
1 The equivalent dust concentration range to the 8-hour range of 0.2 − 4 mg/m
3 is calculated by multiplying this 8-hour range by the dividend of eight hours divided by the duration of the intrashift measurement specified in units of hours. For example, for a measurement taken at exactly one hour into the shift, the 8-hour equivalent dust concentration range would be a one-hour average concentration range of: 8 hours/1 hour × (0.2 − 4 mg/m
3) = 1.6 − 32 mg/m
3; for a two-hour measurement, the applicable concentration range would be calculated as: 8 hours/2 hours × (0.2 − 4 mg/m
3) = 0.8 − 16 mg/m
3; for a 4-hours measurement, the equivalent range would be: 0.4 − 8 mg/m
3; * * * etc. A CPDM must perform accurately, as specified, for intrashift measurements within such equivalent concentration ranges.
(c) Reliability of measurements. The CPDM shall meet the accuracy requirements under paragraph (b) of this section, regardless of the variation in density, composition, size distribution of respirable coal mine dust particles, and the presence of water spray mist in coal mines.
(d) Precision. The precision of the CPDM shall be established through testing to determine the variability of multiple measurements of the same dust concentration, as defined by the relative standard deviation of the distribution of measurements. The relative standard deviation shall be less than 0.1275 without bias for both full-shift measurements of 8 hours or more, and for intra-shift measurements of less than 8 hours within the dust concentration range equivalent to 0.2 to 4.0 mg/m
3 for an 8-hour period, as specified under paragraph (b)(2) of this section.
(e) Bias. The bias of the CPDM measurements shall be limited such that the uncorrectable discrepancy between the mean of the distribution of measurements and the true dust concentration being measured during testing shall be no greater than 10 percent. Bias must be constant over the range of dust concentration levels tested, 0.2 to 4.0 mg/m
3 for an 8-hour sampling period.
(f) Testing conditions. Laboratory and mine testing of the CPDM for accuracy, precision, bias, and reliability under diverse environmental conditions (as defined under § 74.7(e) and (g)) shall be determined using the NIOSH testing procedure, “Continuous Personal Dust Monitor Accuracy Testing,” June 23, 2008, available at: http://www.cdc.gov/niosh/mining/pubs/pubreference/outputid3076.htm. All testing results shall be submitted to NIOSH in writing on the application filed under § 74.11.
(1) Persons must proceed in accordance with NIOSH testing procedure “Continuous Personal Dust Monitor Accuracy Testing,” June 23, 2008. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Persons may obtain a copy at the address below: NIOSH-Publications Dissemination, 4676 Columbia Parkway, Cincinnati, OH 45226. http://www.cdc.gov/niosh/mining.
(2) Persons may inspect a copy at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Arlington, VA 22202-5452; 202-693-9440; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
[75 FR 17523, Apr. 6, 2010, as amended at 80 FR 52990, Sept. 2, 2015]
(a) General requirements. The applicant shall establish and maintain a quality control system that assures that CPDM devices produced under the applicant's certificate of approval meet the required specifications and are reliable, safe, effective, and otherwise suitable for their intended use. To establish and to maintain an approval under this part, the applicant shall:
(1) Submit a copy of the most recent registration under ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements, published by ISO:
(i) With the application for approval under § 74.13 of this part; and
(ii) Upon request by NIOSH, subsequent to the approval of a CPDM under this part.
(2) Persons must proceed in accordance with ISO Q9001-2000, American National Standard, Quality Management Systems-Requirements. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Persons may obtain a copy from the International Organization for Standardization at the address provided below.
International Organization for Standardization, ISO Central Secretariat, 1, ch. de la Voie-Creuse, Case Postale 56, CH-1211 GENEVA 20, Switzerland. http://www.standardsinfo.net.
(3) Persons may inspect a copy at MSHA, Office of Standards, Regulations, and Variances, 201 12th Street South, Arlington, VA 22202-5452; 202-693-9440; or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(b) Quality management audits. Upon request, applicants or approval holders must allow NIOSH to inspect the quality management procedures and records, and to interview any employees who may be knowledgeable of quality management processes associated with the production of the CPDM. Audits may be conducted either on an occasional or periodic basis or in response to quality-related complaints or concerns.
(c) Applicant remediation of quality management deficiencies. An applicant or approval holder must correct any quality management deficiency identified by an audit within a reasonable time as determined by NIOSH. Failure to correct a deficiency may result in NIOSH disapproval of a pending application or, in the case of an approved device, revocation of approval until NIOSH determines that the deficiency is corrected.
[75 FR 17523, Apr. 6, 2010, as amended at 80 FR 52990, Sept. 2, 2015]
(a) Contents. The manufacturer must include operating and storage instructions and a maintenance and service life plan with each new CPDM device sold. These documents must be clearly written.
(1) Operating and storage instructions must include:
(i) An explanation of how the CPDM works;
(ii) A schematic diagram of the CPDM;
(iii) Procedures for wearing and use of the CPDM;
(iv) A one page “quick start guide” that will enable a novice to start and operate the CPDM.
(v) Procedures for calibration of the CPDM;
(vi) Procedures for inspecting the operating condition of the CPDM;
(vii) Procedures and conditions for storage, including the identification of any storage conditions that would likely impair the effective functioning of the CPDM; and
(viii) Procedures and conditions of use, including identification of any conditions of use that would likely impair the effective functioning of the CPDM.
(2) The maintenance and service life plan must address:
(i) Conditions that should govern the removal from service of the CPDM; and
(ii) Procedures that a user or others should follow when inspecting, performing maintenance and calibration, and determining when the CPDM should be removed from service.
(b) Submission to NIOSH for approval. A copy of the instructions and plan under paragraph (a) of this section shall be submitted to NIOSH with the application for approval of the CPDM and if substantive changes are made to the approved device or approved instructions.