[47 Pa.B. 2722]
[Saturday, May 13, 2017]
[Continued from previous Web Page]
Subchapter E. ENFORCEMENT AND DECERTIFICATION § 240.401. Inspection.
(a) The Department and its agents and [employes] employees will:
* * * * * (b) The Department, its agents and [employes] employees may conduct inspections of a building, property, premises or place of business of a person who conducts radon-related activities if a person presents information to the Department or the Department has access to information which gives it reason to believe that one of the following exists:
* * * * * (c) An agent or [employe] employee of the Department may not enter a private residence for the purpose of conducting an inspection under this section without a search warrant or without the consent of the occupant.
* * * * *
Subchapter F. [INTERIM CERTIFICATION] (Reserved) § 240.501. [Scope] (Reserved).
[This subchapter applies to persons certified in accordance with the Department's interim certification program as required under section 11 of the act (63 P.S. § 2011).]
§ 240.502. [Reapplication when this chapter is adopted as final] (Reserved).
[A person granted interim certification by the Department shall reapply for certification under this chapter. If a person fails to apply for certification within 60 days of Departmental notification, the interim certification automatically lapses and is void.]
(Editor's Note: The following subchapter is proposed to be added and printed in regular type to enhance readability.)
Subchapter G. QA REQUIREMENTS Sec.
240.601. Scope. 240.602. General requirements. 240.603. QA program. 240.604. QA requirements for testing using primary devices. 240.605. QA requirements for testing using secondary devices. 240.606. QA requirements for laboratories. § 240.601. Scope.
(a) This subchapter applies to QA requirements for:
(1) Persons conducting radon testing and radon laboratory analysis activities.
(2) Testing devices listed with the Department on the individual's certification.
(b) The subchapter does not apply to tests performed for the sole purpose of diagnostic testing.
§ 240.602. General requirements.
(a) The certified individual is responsible for all requirements in this subchapter, including when QA activity is performed by others.
(b) QA requirements and corrective actions in this section shall be documented and the records retained for a minimum of 5 years.
§ 240.603. QA program.
A person conducting radon testing or radon laboratory analysis activities shall have a QA program to ensure the measurements are accurate and errors are controlled. The program must ensure that testing devices are routinely and properly calibrated. The program shall provide the information related to all of the following activities:
(1) Organization and responsibilities.
(2) Sampling procedures.
(3) Detector custody.
(4) Analytical procedures.
(5) Data reduction, validation and reporting.
(6) Corrective action.
(7) QA reports to management.
§ 240.604. QA requirements for testing using primary devices.
(a) CRMs for primary testers.
(1) Calibration. Each Department-listed CRM must have a current calibration. To have a current calibration, the CRM shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the CRM.
(2) Background measurements. Background measurements shall be performed and documented after every 1,000 hours of operation of scintillation cell-type CRM. These background measurements shall be checked by purging the unit with clean, aged air or nitrogen in accordance with the manufacturer's instructions. For all CRMs, the background shall be monitored in accordance with the manufacturer's instructions.
(3) Check source counting. For a CRM with a check source, check source counting shall be documented and completed with that check source prior to each test.
(4) Routine instrument checks. Before and after each measurement, the CRM shall be checked according to the manufacturer's instructions. For each check, all of the following shall be verified:
(i) The correct input parameters and the unit's clock or timer are set properly.
(ii) The pump's flow rates are within the range of the manufacturer's specifications.
(5) Data collection log.
(i) CRM data shall be tracked on a form that contains all of the following:
(A) The CRM serial number.
(B) The exposure dates and times.
(C) The test result.
(D) The address of the building tested.
(E) The test location in the building.
(F) The name of the tester who placed the CRM.
(G) The name of the tester who retrieved the CRM.
(H) The calibration, repair and Department listing dates.
(ii) For a CRM without a radioactive check source, the data collection log must also contain all of the following intercomparison measurement information:
(A) The intercomparison devices' serial numbers.
(B) The RPD value.
(C) The intercomparison measurements results.
(6) Intercomparison measurements. An intercomparison measurement shall be performed for each CRM without a radioactive check source.
(i) Intercomparison measurements shall be made at least every tenth test with another Department-listed passive device that is analyzed by a Department-certified laboratory or with another CRM with a hard copy printout. The intercomparison measurements shall be distributed systematically throughout the entire population of test locations. Original printouts or Department-certified laboratory results, or both, shall be kept for each intercomparison. Each intercomparison measurement must be performed with the devices side by side for the measurement for at least 48 hours.
(ii) For intercomparison measurements, the RPD shall be used to track performance. The RPD value shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(iii) If the RPD value exceeds the control limit, the CRM may not be used for radon measurements until the problem is identified and corrected. If the RPD value exceeds the warning level, the criteria in ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be followed.
(iv) In addition to the control charts, intercomparison measurements shall be documented on the CRM data collection log.
(b) CWLMs for primary testers.
(1) Calibration. Each Department-listed CWLM must have a current calibration. To have a current calibration, the CWLM shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the CWLM.
(2) Background measurements. CWLM background measurements shall be performed and documented at least every 168 hours of operation and when the unit is calibrated.
(3) Routine instrument checks. Routine instrument checks for each CWLM shall be documented and performed before and after each test by using an Am-241 or similar energy check source. Pumps and flow meters shall be checked in accordance with the manufacturer's instructions and documented. The pump and flow meter check shall be performed with a dry-gas meter or other flow measurement device of traceable accuracy.
(4) Data collection log.
(i) CWLM data shall be tracked on a form that contains all of the following:
(A) The CWLM serial number.
(B) The exposure dates and times.
(C) The test result.
(D) The address of the building tested.
(E) The test location in the building.
(F) The name of the tester who placed the CWLM.
(G) The name of the tester who retrieved the CWLM.
(H) The calibration, repair and Department listing dates.
(ii) For CWLMs without a radioactive check source, the data collection log must also contain all of the following intercomparison measurement information:
(A) The intercomparison devices' serial numbers.
(B) The RPE value or RPD value.
(C) The intercomparison measurement results.
(5) Intercomparison measurements. An intercomparison measurement shall be performed for each CWLM monitor without a radioactive check source.
(i) A CWLM without radioactive check source capability must have an informal intercomparison measurement made with another CWLM with a hard copy printout at least every tenth test. This printout shall be retained for each intercomparison. The intercomparison measurements shall be distributed systematically throughout the entire population of test locations. Each intercomparison measurement must be performed with the devices side by side for the measurement for at least 48 hours.
(ii) Each intercomparison shall be documented on the data collection log.
(iii) For intercomparison measurements the RPD shall be used to track performance. The RPD value shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(iv) If the RPD value exceeds the control limit, the CWLM may not be used for radon measurements until the problem is identified and corrected. If the RPD value exceeds the warning level, the criteria in ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be followed.
(c) Electret ion chambers for primary testers.
(1) Calibration. Each Department-listed electret reader must have a current calibration. To have a current calibration, the electret reader shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the electret reader. Each electret reader shall be calibrated simultaneously with its corresponding reference electret's recertification.
(2) Data collection log. Electret custody shall be tracked on a form that contains all of the following:
(i) The electret serial number.
(ii) The electret chamber serial number.
(iii) The initial voltage reading.
(iv) The final voltage reading.
(v) The exposure dates and times.
(vi) The test result.
(vii) The serial number of duplicate electret.
(viii) The RPD value.
(ix) The address of the building tested.
(x) The test location in the building.
(xi) The name of the tester who placed the electret.
(xii) The name of the tester who retrieved the electret.
(3) Known exposure measurements (spikes).
(i) Spikes shall be conducted at a rate of 3 for each 100 test devices deployed, with a minimum of 3 spikes for each certification year when tests were conducted in the certification year, and with a maximum of 6 spikes each month.
(ii) Spikes shall be analyzed in the same manner as all other testing.
(iii) Spikes shall be monitored using a means control chart. The means control chart must be established as follows:
(A) Using an RPE value of plus and minus 10%, which corresponds to the 1 sigma level.
(B) A warning level of the RPE of plus and minus 20%, which corresponds to the 2 sigma warning level.
(C) Control limits of the RPE of plus and minus 30%, which corresponds to the 3 sigma control level.
(iv) The control and warning levels identified in subparagraph (iii) shall be adjusted when the RPE of at least 20 spike results has been calculated. The standard deviation of the 20 or more RPE values shall also be calculated and the warning and control limits shall be re-established on new control charts.
(v) Each RPE value shall be plotted on the means control chart within 1 week of return of the device from the chamber. If the RPE value is outside the 3 sigma control level, all measurements shall cease until the problem is evaluated and corrected. All evaluations shall be documented.
(vi) In addition to the means control chart, all spikes shall be documented on a form that contains all of the following:
(A) The radon chamber name.
(B) The electret serial numbers.
(C) The electret chamber serial numbers.
(D) The RV from radon chamber.
(E) The measured spike value or values.
(F) The individual RPE results.
(G) The certification year beginning date and end date.
(H) The exposure dates.
(4) Duplicate measurements.
(i) Duplicates shall be made in at least 10% of the total number of test devices deployed each month, or 50 each month, whichever is smaller.
(ii) The RPD shall be calculated for all duplicate results with an average of greater than or equal to 2.0 pCi/L. Two control charts shall be constructed to monitor duplicate precision:
(A) One for duplicates when the average is greater than or equal to 4.0 pCi/L.
(B) One for duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L.
(iii) Each RPD value shall be plotted on the control chart within 1 week of performing the duplicate measurement.
(iv) The RPD shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(v) For duplicates when the average is greater than or equal to 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 14%.
(B) The warning level shall be set at an RPD of 28%.
(C) The control limit shall be set at an RPD of 36%.
(vi) For duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 25%.
(B) The warning level shall be set at an RPD of 50%.
(C) The control limit shall be set at an RPD of 67%.
(vii) If the plotted RPD result falls outside of the control limit, the measurements shall cease until the problem is identified and corrected.
(viii) If the plotted RPD result falls outside of the warning level, ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be used to determine the action to be taken.
(ix) Documentation of duplicates must include all of the following:
(A) The device serial numbers.
(B) The exposure dates.
(C) Each duplicate measurement result.
(D) The RPD results.
(5) Electret voltage drift. The tester shall maintain documentation that electret voltage drift testing has been performed as follows:
(i) For each new shipment of 20 electrets or fewer, a minimum of 1 electret shall be set aside from each new shipment and evaluated for voltage drift.
(ii) For each new shipment of more than 20 electrets, a minimum of 5% of the electrets or 10 electrets, whichever number is smaller, shall be evaluated for voltage drift.
(iii) Electrets shall be covered with protective caps in a low-radon environment.
(iv) For short-term and long-term electrets, an initial and a final voltage reading shall be made.
(A) For short-term electrets the final voltage reading shall be made at 4 weeks.
(B) For long-term electrets the final voltage reading shall be made at 3 months.
(v) If the short-term voltage loss is greater than 6 volts per month or if the long-term voltage loss is greater than 12 volts over a 3-month period, testing with this shipment may not occur until the voltage loss is corrected.
(vi) Documentation of electret voltage drift must include all of the following:
(A) Whether it is a short-term or long-term electret.
(B) The date of receipt of the new shipment.
(C) The electret serial number.
(D) Initial voltages and dates.
(E) Final voltages and dates.
(F) The reader serial number.
(G) Corrective actions performed.
(6) Voltmeter routine instrument checks.
(i) Proper operation of the surface voltmeter shall be monitored following the manufacturer's procedures for analyzing the reference electrets and zeroing the voltmeter.
(ii) A voltage reading of a reference electret difference of more than 2 volts from the reference electret specified value shall be considered a wrong reading. The second reference electret in the set shall be read to determine whether the wrong reading is in the first reference electret or in the reader. Corrective action shall be taken in consultation with the manufacturer.
(iii) When zeroing the reader, if the voltmeter displays more than (±) 3 volts, corrective action shall be taken in consultation with the manufacturer.
(iv) Voltmeter checks shall be conducted at least once each week while the voltmeter is in use and shall be documented. Documentation of routine instrument checks must include all of the following:
(A) The reader serial number.
(B) The date of analysis.
(C) Zero value.
(D) The reference electret values.
(E) Corrective actions performed.
§ 240.605. QA requirements for testing using secondary devices.
(a) CRMs for secondary testers.
(1) Calibration. Each Department-listed CRM must have a current calibration. To have a current calibration, the CRM shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the CRM. A current calibration certificate shall be retained for each monitor.
(2) Check source counting. For a CRM with a check source, check source counting shall be documented and completed with that check source prior to each test.
(3) Routine instrument checks. Before and after each measurement, the CRM shall be checked according to the manufacturer's instructions. For each check, all of the following shall be verified:
(i) The correct input parameters and the unit's clock or timer are set properly.
(ii) The pump's flow rates are within the range of the manufacturer's specifications.
(4) Data collection log.
(i) CRM data shall be tracked on a form that contains all of the following:
(A) The CRM serial number.
(B) The exposure dates and times.
(C) The test result.
(D) The address of the building tested.
(E) The test location in the building.
(F) The name of the tester who placed the CRM.
(G) The name of the tester who retrieved the CRM.
(H) The calibration, repair and Department listing dates.
(ii) For a CRM without a radioactive check source, the data collection log must also contain all of the following intercomparison measurement information:
(A) The intercomparison device serial number.
(B) The RPE value or RPD value.
(C) The intercomparison measurement result.
(5) Intercomparison measurements. An intercomparison measurement shall be performed for each CRM without a radioactive check source.
(i) Intercomparison measurements shall be made at least every tenth test with another Department-listed passive device that is analyzed by a Department-certified laboratory or with another CRM with a hard copy printout. The intercomparison measurements shall be distributed systematically throughout the entire population of test locations. Original printouts or Department-certified laboratory results, or both, shall be kept for each intercomparison. Each intercomparison measurement must be performed with the devices side by side for the measurement for at least 48 hours.
(ii) When performing intercomparison measurements, the RPD shall be used to track performance. The RPD value shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(iii) If the RPD value exceeds the control limit, the CRM may not be used for radon measurements until the problem is identified and corrected. If the RPD value exceeds the warning level, the criteria in the ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be followed.
(iv) In addition to the control charts, intercomparison measurements shall be documented on the CRM data collection log.
(b) CWLM for secondary testers.
(1) Calibration. Each Department-listed CWLM must have a current calibration. To have a current calibration, the CWLM shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the CWLM. A current calibration certificate shall be retained for each monitor.
(2) Data collection log.
(i) CWLM data shall be tracked on a form that contains all of the following:
(A) The CWLM serial number.
(B) The exposure dates and times.
(C) The test result.
(D) The address of the building tested.
(E) The test location in the building.
(F) The name of the tester who placed the CWLM.
(G) The name of the tester who retrieved the CWLM.
(H) The calibration, repair and Department listing dates.
(ii) For CWLMs without a radioactive check source, the data collection log must also contain all of the following intercomparison measurement information:
(A) The intercomparison device serial number.
(B) The RPD value.
(C) The intercomparison measurement result.
(3) Intercomparison measurements. An intercomparison measurement shall be performed for all CWLM monitors without a radioactive check source.
(i) A CWLM without radioactive check source capability shall have an informal intercomparison measurement made with another CWLM with a hard copy printout at least every tenth test. This printout shall be retained for each intercomparison. The intercomparison measurements shall be distributed systematically throughout the entire population of test locations. Each intercomparison measurement must be performed with the devices side by side for the measurement for at least 48 hours.
(ii) Each intercomparison shall be documented on the data collection log.
(iii) When performing intercomparison measurements, the RPD shall be used to track performance. The RPD value shall be tracked using control charts from ''Protocols for Radon and Radon Decay product measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(iv) If the RPD value exceeds the control limit, the CWLM may not be used for radon measurements until the problem is identified and corrected. If the RPD value exceeds the warning level, the criteria in the ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be followed.
(c) Electret ion chambers for secondary testers.
(1) Data collection log. Electret data shall be tracked on a form that contains all of the following:
(i) The electret serial number.
(ii) The electret chamber serial number.
(iii) The initial voltage reading.
(iv) The final voltage reading.
(v) The exposure dates and times.
(vi) The test results.
(vii) The serial number of duplicate electret.
(viii) The RPD value.
(ix) The address of the building tested.
(x) The test location in the building.
(xi) The name of the tester who placed the electret.
(xii) The name of the tester who retrieved the electret.
(2) Known exposure measurements (spikes).
(i) Spikes shall be conducted at a rate of 3 for each 100 test devices deployed, with a minimum of 3 spikes for each certification year when tests were conducted in the certification year, and with a maximum of 6 spikes each month.
(ii) Spikes shall be submitted to a Department-certified laboratory labeled as QA. The RV of the spiked device may not be revealed to the laboratory prior to analysis.
(iii) Spikes shall be monitored using a means control chart. The means control chart must be established as follows:
(A) Using an RPE value of plus and minus 10%, which corresponds to the 1 sigma level.
(B) A warning level of the RPE of plus and minus 20%, which corresponds to the 2 sigma warning level.
(C) Control limits of the RPE of plus and minus 30%, which correspond to the 3 sigma control level.
(iv) The control and warning levels identified in subparagraph (iii) shall be adjusted when the RPE of at least 20 spike results have been calculated. The standard deviation of the 20 or more RPE values shall also be calculated and the warning and control limits shall be re-established on new control charts.
(v) Each RPE value shall be plotted on the means control chart within 1 week of return of the device from the chamber. If the RPE value is outside the 3 sigma control level, all measurements shall cease until the problem is evaluated and corrected. All evaluations shall be documented.
(vi) In addition to the means control chart, all spikes shall be documented on a form that contains all of the following:
(A) The radon chamber name.
(B) The electret serial numbers.
(C) The electret chamber serial numbers.
(D) The RV from radon chamber.
(E) The measured spike value or values.
(F) The individual RPE results.
(G) The certification year beginning date and end date.
(H) The exposure dates.
(3) Duplicate measurements.
(i) Duplicates shall be made in at least 10% of the total number of test devices deployed each month, or 50 each month, whichever is smaller.
(ii) The RPD shall be calculated for all duplicate results with an average of greater than or equal to 2.0 pCi/L. Two control charts shall be constructed to monitor duplicate precision:
(A) One for duplicates when the average is greater than or equal to 4.0 pCi/L.
(B) One for duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L.
(iii) Each RPD value shall be plotted on the control chart within 1 week of performing the duplicate measurement.
(iv) The RPD shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(v) For duplicates when the average is greater than or equal to 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 14%.
(B) The warning level shall be set at an RPD of 28%.
(C) The control limit shall be set at an RPD of 36%.
(vi) For duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 25%.
(B) The warning level shall be set at an RPD of 50%.
(C) The control limit shall be set at an RPD of 67%.
(vii) If the plotted RPD result falls outside of the control limit, the measurements shall cease until the problem is identified and corrected.
(viii) If the plotted RPD result falls outside of the warning level, ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be used to determine the action to be taken.
(ix) Documentation of duplicates must include all of the following:
(A) The device serial numbers.
(B) The exposure dates.
(C) Each duplicate measurement result.
(D) The RPD results.
(d) LS, AC and ATs for secondary testers.
(1) Data collection log. Detector data shall be tracked on a form that contains all of the following:
(i) The device serial number.
(ii) The serial number of duplicate devices.
(iii) The serial number of spiked devices.
(iv) The exposure dates and times.
(v) The test results.
(vi) The RPE value or RPD value.
(vii) The address of the building tested.
(viii) The test location in the building.
(ix) The name of the tester who placed the device.
(x) The name of the tester who retrieved the device.
(xi) The name of the laboratory to which device was sent.
(2) Known exposure measurements (spikes).
(i) Spikes shall be conducted at a rate of 3 for each 100 test devices deployed, with a minimum of 3 spikes for each certification year when tests were conducted in the certification year, and with a maximum of 6 spikes each month.
(ii) Spikes shall be submitted to a Department-certified laboratory labeled as QA. The RV of the spiked device may not be revealed to the laboratory prior to analysis.
(iii) Spikes shall be monitored using a means control chart. The means control chart must be established as follows:
(A) Using an RPE value of plus and minus 10%, which corresponds to the 1 sigma level.
(B) A warning level of the RPE of plus and minus 20%, which corresponds to the 2 sigma warning level.
(C) Control limits of the RPE of plus and minus 30%, which correspond to the 3 sigma control level.
(iv) The control and warning levels identified in subparagraph (iii) shall be adjusted when the RPE of at least 20 spike results has been calculated. The standard deviation of the 20 or more RPE values shall also be calculated and the warning and control limits shall be re-established on new control charts.
(v) Each RPE value shall be plotted on the means control chart within 1 week of receiving the result from the laboratory. If the RPE value is outside the 3 sigma control level, all measurements shall cease until the problem is evaluated and corrected. All evaluations shall be documented.
(vi) In addition to the means control chart, all spikes shall be documented on a form that contains all of the following:
(A) The radon chamber name.
(B) The device serial numbers.
(C) The RV from radon chamber.
(D) The measured spike value or values.
(E) The individual RPE results.
(F) The certification year beginning date and end date.
(G) The exposure dates.
(3) Duplicate measurements.
(i) Duplicates shall be made in at least 10% of the total number of test devices deployed each month, or 50 each month, whichever is smaller.
(ii) The RPD shall be calculated for all duplicate results with an average of greater than or equal to 2.0 pCi/L. Two control charts shall be constructed to monitor duplicate precision:
(A) One for duplicates when the average is greater than or equal to 4.0 pCi/L.
(B) One for duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L.
(iii) Each RPD value shall be plotted on the control chart within 1 week of performing the duplicate measurement.
(iv) The RPD shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(v) For duplicates when the average is greater than or equal to 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 14%.
(B) The warning level shall be set at an RPD of 28%.
(C) The control limit shall be set at an RPD of 36%.
(vi) For duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 25%.
(B) The warning level shall be set at an RPD of 50%.
(C) The control limit shall be set at an RPD of 67%.
(vii) If the plotted RPD result falls outside of the control limit, the measurements shall cease until the problem is identified and corrected.
(viii) If the plotted RPD result falls outside of the warning level, ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, shall be used to determine the action to be taken.
(ix) Documentation of duplicates must include all of the following:
(A) The device serial numbers.
(B) The exposure dates.
(C) Each duplicate measurement result.
(D) The RPD results.
(4) Field blanks.
(i) Field blank results shall be monitored and recorded. Field blanks shall be performed at a rate of 5% of the devices that are deployed each month, or 25 each month, whichever is smaller, or a minimum of 1 per certification year, unless tests are not performed. These devices shall be set aside, kept in a low-radon environment and labeled as QA when submitted to the laboratory.
(ii) If a field blank has a concentration greater than the lowest level of detection (LLD) as established by the laboratory, all of the following shall occur:
(A) The occurrence shall be documented and reported to the laboratory.
(B) The cause shall be investigated in conjunction with the laboratory and documented.
(iii) Documentation of field blanks must include all of the following:
(A) The device serial numbers.
(B) The date submitted to laboratory.
(C) The measurement results.
(D) The laboratory's reported LLD.
§ 240.606. QA requirements for laboratories.
(a) CRMs for laboratories.
(1) Calibration. Each Department-listed CRM must have a current calibration. To have a current calibration, the CRM shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the CRM. A current calibration certificate shall be retained for each monitor. Analysis may not be performed on a monitor that was not calibrated during any portion of the testing period.
(2) Data collection log. CRM data shall be tracked on a form that contains all of the following:
(i) The CRM serial number.
(ii) The exposure dates and times.
(iii) The test result.
(iv) The address of the building tested.
(v) The test location in the building.
(vi) The name of the tester who placed the CRM.
(vii) The name of the tester who retrieved the CRM.
(viii) The calibration, repair and Department listing dates.
(b) CWLM for laboratories.
(1) Calibration. Each Department-listed CWLM must have a current calibration. To have a current calibration, the CWLM shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the CWLM. A current calibration certificate shall be retained for each monitor. Analysis may not be performed on a monitor that was not calibrated during any portion of the testing period.
(2) Data collection log. CWLM data shall be tracked on a form that contains all of the following:
(i) The CWLM serial number.
(ii) The exposure dates and times.
(iii) The test result.
(iv) The address of the building tested.
(v) The test location in the building.
(vi) The name of the tester who placed the CWLM.
(vii) The name of the tester who retrieved the CWLM.
(viii) The calibration, repair and Department listing dates.
(c) Electret ion chamber for laboratory analysis.
(1) Calibration. Each Department-listed electret reader shall have a current calibration. To have a current calibration, the electret reader shall be calibrated in a Department-approved calibration facility within 1 year from the date of the previous calibration and when alterations or repairs are made to the electret reader. Each electret reader shall be calibrated simultaneously with its corresponding reference electret's recertification.
(2) Voltmeter routine instrument checks.
(i) Proper operation of the surface voltmeter shall be monitored following the manufacturer's procedures for zeroing the voltmeter and analyzing the reference electrets.
(ii) A voltage reading of a reference electret difference of more than 2 volts from its specified value shall be considered a wrong reading and corrective action shall be taken.
(iii) If the voltmeter displays more than (±) 3 volts, corrective action shall be taken.
(iv) Voltmeter checks shall be conducted at least once each week while the voltmeter is in use and shall be documented. Documentation of routine instrument checks must include all of the following:
(A) The reader serial number.
(B) The date of analysis.
(C) Zero value.
(D) The reference electret values.
(E) Corrective actions performed.
(3) Known exposure measurements (spikes).
(i) Spikes shall be conducted at a rate of 3 for each 100 test devices deployed, with a minimum of 3 spikes for each certification year when tests were conducted in the certification year, and with a maximum of 6 spikes each month.
(ii) Spikes shall be analyzed in the same manner as all other testing.
(iii) Spikes shall be monitored using a means control chart. The means control chart must be established as follows:
(A) Using an RPE value of plus and minus 10%, which corresponds to the 1 sigma level.
(B) A warning level of the RPE of plus and minus 20%, which corresponds to the 2 sigma warning level.
(C) Control limits of the RPE of plus and minus 30%, which correspond to the 3 sigma control level.
(iv) The control and warning levels identified in subparagraph (iii) shall be adjusted when the RPE of at least 20 spike results has been calculated. The standard deviation of the 20 or more RPE values shall also be calculated and the warning and control limits shall be re-established on new control charts.
(v) Each RPE value shall be plotted on the means control chart within 1 week of return of the device from the radon chamber. If the RPE value is outside the 3 sigma control level, all measurements shall cease until the problem is evaluated and corrected. All evaluations shall be documented.
(vi) In addition to the means control chart, all spikes shall be documented on a form that contains all of the following:
(A) The radon chamber name.
(B) The electret serial numbers.
(C) The RV from the radon chamber.
(D) The measured spike value or values.
(E) The individual RPE results.
(F) The certification year beginning date and end date.
(G) The exposure dates.
(4) Duplicate measurements.
(i) Duplicates shall be made in at least 10% of the total number of test devices deployed each month, or 50 each month, whichever is smaller.
(ii) The RPD shall be calculated for all duplicate results with an average of greater than or equal to 2.0 pCi/L. Two control charts shall be constructed to monitor duplicate precision:
(A) One for duplicates when the average is greater than or equal to 4.0 pCi/L.
(B) One for duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L.
(iii) Each RPD value shall be plotted on the control chart within 1 week of performing the duplicate measurement.
(iv) The RPD shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(v) For duplicates when the average is greater than or equal to 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 14%.
(B) The warning level shall be set at an RPD of 28%.
(C) The control limit shall be set at an RPD of 36%.
(vi) For duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 25%.
(B) The warning level shall be set at an RPD of 50%.
(C) The control limit shall be set at an RPD of 67%.
(vii) If the plotted RPD result falls outside of the control limit, the measurements shall cease until the problem is identified and corrected.
(viii) If the plotted RPD result falls outside of the warning level, ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be used to determine the action to be taken.
(ix) Documentation of duplicates must include all of the following:
(A) The device serial numbers.
(B) The exposure dates.
(C) Each duplicate measurement result.
(D) The RPD results.
(5) Electret voltage drift.
(i) For shipments of 20 electrets or fewer, a minimum of 1 electret shall be set aside from each new shipment and evaluated for voltage drift.
(ii) For shipments of more than 20 electrets, a minimum of 5% of the electrets or 10 electrets, whichever number is smaller, shall be evaluated for voltage drift.
(iii) Electrets shall be covered with protective caps in a low-radon environment.
(iv) For short-term and long-term electrets, an initial and a final voltage reading shall be made.
(A) For short-term electrets the final voltage reading shall be made at 4 weeks.
(B) For long-term electrets the final voltage reading shall be made at 3 months.
(v) If the short-term voltage loss is greater than 6 volts per month or if the long-term voltage loss is greater than 12 volts over a 3-month period, testing with this shipment may not occur until the voltage loss is corrected.
(vi) Documentation of electret voltage drift must include all of the following:
(A) Whether it is a short-term or long-term electret.
(B) The date of receipt of the new shipment.
(C) The electret serial number.
(D) Initial voltages and dates.
(E) Final voltages and dates.
(F) The reader serial number.
(G) Corrective actions performed.
(d) AC and LS.
(1) Calibration. All AC or LS laboratory systems shall be calibrated at least once every 12 months, when alterations or repairs are made to the system, or when a new batch of charcoal is received. This requires a determination of calibration factors for AC and LS devices by the exposure of these devices to a known concentration of radon in a Department-approved radon chamber. Calibration factors shall be determined for a range of exposure times and humidity levels.
(2) Laboratory control devices. The laboratory background level for each batch of AC and LS devices shall be established by each laboratory. Laboratories shall measure the background of at least 5% of unexposed AC and LS devices that have been processed according to their standard operating procedures (laboratory blanks).
(3) Routine counting system checks. Daily counting of a reference source shall be performed and documented. The characteristics of the check source (geometry, type of radiation emitted, and the like) must be similar to the samples to be analyzed. The count rate of the check sources must be high enough to yield reliable counting statistics in a short period of time, such as 1,000 to 10,000 counts per minute, to provide a maximum random uncertainty of 5%.
(4) Known exposure measurements (spikes).
(i) Spikes shall be conducted at a rate of 3 for each 100 test devices deployed, with a minimum of 3 spikes for each certification year when tests were conducted in the certification year, and with a maximum of 6 spikes each month.
(ii) Spikes shall be analyzed in the same manner as all other testing.
(iii) Spikes shall be monitored using a means control chart. The means control chart must be established as follows:
(A) Using an RPE value of plus and minus 10%, which corresponds to the 1 sigma level.
(B) A warning level of the RPE of plus and minus 20%, which corresponds to the 2 sigma warning level.
(C) Control limits of the RPE of plus and minus 30%, which correspond to the 3 sigma control level.
(iv) The control and warning levels identified in subparagraph (iii) shall be adjusted when the RPE of at least 20 spike results has been calculated. The standard deviation of the 20 or more RPE values shall also be calculated and the warning and control limits shall be re-established on new control charts.
(v) Each RPE value shall be plotted on the means control chart within 1 week of receiving the result from the laboratory. If the RPE value is outside the 3 sigma control level, all measurements shall cease until the problem is evaluated and corrected. All evaluations shall be documented.
(vi) In addition to the means control chart, all spikes shall be documented on a form that contains all of the following:
(A) The radon chamber name.
(B) The device serial numbers.
(C) The RV from the radon chamber.
(D) The measured spike value or values.
(E) The individual RPE results.
(F) The certification year beginning date and end date.
(G) The exposure dates.
(5) Duplicate measurements.
(i) Duplicates shall be made in at least 10% of the total number of test devices deployed each month, or 50 each month, whichever is smaller.
(ii) The RPD shall be calculated for all duplicate results with an average of greater than or equal to 2.0 pCi/L. Two control charts shall be constructed to monitor duplicate precision:
(A) One for duplicates when the average is greater than or equal to 4.0 pCi/L.
(B) One for duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L.
(iii) Each RPD value shall be plotted on the control chart within 1 week of performing the duplicate measurement.
(iv) The RPD shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(v) For duplicates when the average is greater than or equal to 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 14%.
(B) The warning level shall be set at an RPD of 28%.
(C) The control limit shall be set at an RPD of 36%.
(vi) For duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 25%.
(B) The warning level shall be set at an RPD of 50%.
(C) The control limit shall be set at an RPD of 67%.
(vii) If the plotted RPD result falls outside of the control limit, the measurements shall cease until the problem is identified and corrected.
(viii) If the plotted RPD result falls outside of the warning level, ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, shall be used to determine the action to be taken.
(ix) Documentation of duplicates must include all of the following:
(A) The device serial numbers.
(B) The exposure dates.
(C) Each duplicate measurement result.
(D) The RPD results.
(e) ATs.
(1) Calibration. All AT laboratory systems shall be calibrated at least once every 12 months, when alterations or repairs are made to the system, or when each new batch or sheet of detector material is received. This requires a determination of calibration factors for AT devices by the exposure of these devices to different concentrations of radon in a Department-approved radon chamber.
(2) Laboratory control detectors. Laboratory control detectors for each batch of ATs shall be established and documented. Each laboratory shall measure the background of a statistically significant number of unexposed ATs. The laboratory control background value shall be subtracted from the field readings to produce a final result.
(3) Known exposure measurements (spikes).
(i) Spikes shall be conducted at a rate of 3 for each 100 test devices deployed, with a minimum of 3 spikes for each certification year when tests were conducted in the certification year, and with a maximum of 6 spikes each month.
(ii) Spikes shall be analyzed in the same manner as all other testing. The RV of a spike may not be revealed to the laboratory prior to analysis.
(iii) Spikes shall be monitored using a means control chart. The means control chart must be established as follows:
(A) Using an RPE value of plus and minus 10%, which corresponds to the 1 sigma level.
(B) A warning level of the RPE of plus and minus 20%, which corresponds to the 2 sigma warning level.
(C) Control limits of the RPE of plus and minus 30%, which correspond to the 3 sigma control level.
(iv) The control and warning levels identified in subparagraph (iii) shall be adjusted when the RPE of at least 20 spike results has been calculated. The standard deviation of the 20 or more RPE values shall also be calculated and the warning and control limits shall be re-established on new control charts.
(v) Each RPE value shall be plotted on the means control chart within 1 week of receiving the result from the laboratory. If the RPE value is outside the 3 sigma control level, all measurements shall cease until the problem is evaluated and corrected. All evaluations shall be documented.
(vi) In addition to the means control chart, all spikes shall be documented on a form that contains all of the following:
(A) The radon chamber name.
(B) The device serial numbers.
(C) The RV from radon chamber.
(D) The measured spike value or values.
(E) The individual RPE results.
(F) The certification year beginning date and end date.
(G) The exposure dates.
(4) Duplicate measurements.
(i) Duplicates shall be made in at least 10% of the total number of test devices deployed each month, or 50 each month, whichever is smaller.
(ii) The RPD shall be calculated for all duplicate results with an average of greater than or equal to 2.0 pCi/L. Two control charts shall be constructed to monitor duplicate precision:
(A) One for duplicates when the average is greater than or equal to 4.0 pCi/L.
(B) One for duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L.
(iii) Each RPD value shall be plotted on the control chart within 1 week of performing the duplicate measurement.
(iv) The RPD shall be tracked using control charts from ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibits B-2 and B-3.
(v) For duplicates when the average is greater than or equal to 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 14%.
(B) The warning level shall be set at an RPD of 28%.
(C) The control limit shall be set at an RPD of 36%.
(vi) For duplicates when the average is greater than or equal to 2.0 pCi/L and less than 4.0 pCi/L, all of the following apply:
(A) The control level shall be set at an RPD of 25%.
(B) The warning level shall be set at an RPD of 50%.
(C) The control limit shall be set at an RPD of 67%.
(vii) If the plotted RPD result falls outside of the control limit, the measurements shall cease until the problem is identified and corrected.
(viii) If the plotted RPD result falls outside of the warning level, ''Protocols for Radon and Radon Decay Product Measurements in Homes,'' EPA 402-R-92-003, May 1993, Appendix B, Exhibit B-5, shall be used to determine the action to be taken.
(ix) Documentation of duplicates shall include all of the following:
(A) The device serial numbers.
(B) The exposure dates.
(C) Each duplicate measurement result.
(D) The RPD results.
(Editor's Note: Appendices B and C are proposed to be added and printed in regular type to enhance readability.)
Appendix B. Non-interference Agreement for Real Estate Radon Testing Property name:
Property address:
Property city, state, zip:
Dates of test:I hereby agree to abide by the following conditions to ensure a valid radon test result:
1) I will maintain closed-house conditions during the entire test period, and for 12 hours prior to any test of less than 96 hours, by doing the following:
• Continuing normal operation of permanently installed HVAC systems.
• Minimizing operation of dryers, range hoods, bathroom fans and other mechanical systems, understanding that drawing air out of the building may adversely affect the test results.
• In buildings having permanently installed radon mitigation systems, keeping the mitigation system functioning during the testing interval.
• Operating window air conditioning systems if set to recycle interior air.
• Keeping all windows closed.
• Keeping all external doors closed except for normal entry and exit.
• Not operating whole-house fans. Removing portable window fans from the window or covering and sealing the window fan.
• Not operating fireplaces, wood/coal stoves or combustion appliances, except water heaters and cooking appliances, unless they are the primary sources of heat for the building.
• Not operating ceiling fans, portable dehumidifiers, portable humidifiers, portable air filters and window air conditioners within 20 feet of the detector.
2) I will not interfere with or move the radon test device.
If the certified tester determines that these conditions were not maintained, this test will be deemed invalid.
_________________ _________________ ______
Signature of Person Printed Name of Person Date
in Control of Property in Control of Property
Appendix C. Radon Exposure Tracking Record Name ___________________________ Month(s) ______
Company Name _____________________________________
Employee ID Number ___________________________ Year ______
Date Job Site Radon Level (pCi/L) Working Level (WL) Hrs. of Exposure Working Level Month
(WLM)Cumulative Exposure(1) (WLM) Method used to assess Exposure(2) __________ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ ____ ______ _____ ÷200= ______ × ______ ÷170= _____ ______ ______ 1. Based upon an annual recommended health and safety limit of 4 working level months (4 WLM) 2. Highest Premitigation Level (a) or On-site Measurement (b) WL = (pCi/L)/200 (assuming 50% ER)
[Pa.B. Doc. No. 17-811. Filed for public inspection May 12, 2017, 9:00 a.m.]
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