[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Page 39020]
[FR Doc No: 2021-15640]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OARM-2018-0065; FRL-8765-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Drug Testing for Contractor Employees
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Drug Testing for Contractor
Employees (EPA ICR No. 2183.08, OMB Control No. 2030-0044) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through September 30,
2021. Public comments were previously requested via the Federal
Register on March 8, 2021 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before August 23,
2021.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OARM-2018-0065, online using www.regulations.gov (our preferred
method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC
20460. EPA's policy is that all comments received will be included in
the public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI), or other
information whose disclosure is restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Thomas Valentino, Policy Training and
Oversight Division, Office of Acquisition Solutions (3802R),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: This ICR applies to contractors who perform response
services at sensitive sites with serious security concerns where the
Agency and public interest would best be protected through drug
testing. It requires the contractor to test its employees for the use
of marijuana, cocaine, opiates, amphetamines, phencyclidine (PCP), and
any other controlled substances. Only contractor employees who have
been tested within the previous 90 calendar days and have passing drug
test results may be directly engaged in on-site response work and/or
on-site related activities at designated sites with significant
security concerns. The Agency may request contractors responding to any
of these types of incidents to conduct drug testing and apply
Government-established suitability criteria in title 5 CFR 731.104,
Appointments subject to investigation, 732.201, Sensitivity level
designations and investigative requirements, and 736.102, Notice to
investigative sources, when determining whether employees are
acceptable to perform on given sites or on specific projects.
    Form numbers: None.
    Respondents/affected entities: Private contractors.
    Respondent's obligation to respond: Required to obtain a benefit
per title 5 CFR 731.104.
    Estimated number of respondents: 500 (total).
    Frequency of response: Annual.
    Total estimated burden: 1,125 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $133,010 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: There is no change in the hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2021-15640 Filed 7-22-21; 8:45 am]
BILLING CODE 6560-50-P


a. Primary calibration standards ( or sources) shall be obtained from suppliers maintaining a nationally accredited measurement program. When primary standards are not available, the standards used shall be correlated with primary standards obtained from a nationally accredited measurement program. The Hanford TRU Project defines " suppliers maintaining a nationally accredited measurement program" as associated with NDA and radioactive sources to include, but not be limited to, programs associated with or qualified by and in descending priority:

  National Institute of Standards and Technology ( NIST)   New Brunswick Laboratory ( NBL)   Sandia National Laboratory ( SNL)   Los Alamos National Laboratory ( LANL)

b. Primary calibration standards cannot exceed the authorization or approval for that organization as identified in the applicable measurement program ( e. g., relative to isotopes, matrix, form, DC voltage, etc.). Correlation to a primary standard must also be within the authorization or approval limitations for the primary standard( s) being used. The Hanford site defines " Primary calibration standards or sources" as being standards or sources for which the value of those standards or sources is certified directly by and in one of the programs identified in 4. a immediately above.

c. Correlation of standards must be documented, approved by the SQAO, and transmitted to the SPO. Equipment critical to the correlation of a standard to primary standards obtained from a nationally accredited measurement program must have been calibrated and maintained using standards that meet the same criteria. Standards used for correlation cannot be the same ones used for calibration of the equipment used to establish the correlation. The sources or standards must be at the same or higher level to which the correlation is being established.

5. Calibration Verification:

a. Notwithstanding the need to calibrate individual components after replacement, changes, or adjustments ( e. g., energy calibration of a detector), verification of the NDA system's calibration shall be performed after any one of the following occurs: HNF 2600, REV 15 Page 244 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN ( 1) Replacement of the measurement system's major components ( e. g., detector, neutron generator, or supporting electronic components that have the capacity to affect data),

( 2) Major system repairs and/ or modifications ( e. g., detector reconditioning or replacement of key mechanical components that have the capacity to affect data),

( 3) Significant changes to the system's software, or ( 4) Relocation of the system.

b. Calibration verification shall consist of demonstrating that the system is within the range of acceptable operation. Calibration verification is an overall performance check of the ability of the system as a whole to produce consistent results ( e. g., combined overall check of a gamma system's calibrations for energy, efficiency, etc.). Secondary standards can be used for the calibration verification if their performance has been correlated with the calibration standard ( see item 4, above). If a verification of the measurement system's calibration or other test demonstrates that the system's response has significantly changed, a recalibration of the system shall be performed. A system calibration may be performed in lieu of calibration verification.

c. Calibration verification is typically duplicate measurements of a single data point for each calibration. It is not always necessary to verify each concurrent calibration, or the calibration verification may be limited to that for the individual component( s).

( 1) When each calibration is not verified, the report of the calibration verification must include technical justification for any intentional omissions.

( 2) Examples of when such partial calibration verification would be appropriate include when only an energy calibration of a detector is required ( i. e., efficiency is not affected) or a hardware change that does not affect data calculation.

( 3) Examples of when a full calibration verification or when all concurrent calibrations are required to undergo calibration verification include software upgrade or replacement of components affecting data calculations.

d. Calibration verification shall be documented in a report to the SPO and approved by the SQAO. HNF 2600, REV 15 Page 245 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN 6. Calibration Confirmation: To confirm that the calibration of the NDA system was correctly established, the accuracy and precision of the system are determined after each calibration ( or recalibration) by performing replicate measurements of a non interfering matrix. Calibration confirmation replicate measurements shall be performed on containers of the same nominal size as those in which actual waste is assayed and according to approved waste assay procedures. The number of replicate measurements to be performed shall be documented and technically justified. The replicate measurements shall be performed using calibration standards or sources ( see above) that span the range of use. The calibration standards used for calibration confirmation shall not be the same as those used for the system calibration.

Accuracy is reported as percent recovery (% R). The acceptance criteria for accuracy shall be within ± 30 percent of nominal source strength in a noninterfering matrix. Normally, a minimum of two source strengths is required one from the lower one third of the range, and one from the upper one third of the range. A single source strength may be used only if the operating range is restricted to either small mass loadings ( i. e., a range of 0 20 g WG Pu) or the calibration range is small ( i. e., the range spans less than 20 g WG Pu). Precision is reported as percent relative standard deviation (% RSD). The % RSD shall not exceed the values listed in table E 2 for the corresponding number of replicate measurements in a non interfering matrix. Calibration confirmation shall be documented in a report to the SPO and approved by the SQAO.

Table E 2 Upper Limits for % RSD vs. Number of Replicates a Number of Replicates 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Max % RSD 1.8 6.6 10.0 12.3 14.0 15.2 16.2 17.1 17.7 18.3 18.8 19.3 19.7 20.0 a The values listed for maximum % RSD are derived from the measured standard deviation of the replicate measurements using the formula:

% 100 1 ) 292 . 0 ( % 100 2 1 , 05 . 0       <

n s n   µ where s is the measured standard deviation, n is the number of replicates, µ is the true value,  2 0.05, n 1 is the critical value for the upper 5% tail of a one sided chi squared distribution with n 1 degrees of freedom, and 0.292 corresponds to a 95% upper confidence bound on the true system precision limit of 29.2%. This formula may be used to calculate the maximum % RSD if more than 15 replicate analyses are performed. A minimum of 2 replicates must be analyzed and documented.

Use of alternate limits for accuracy and precision must be technically justified and approved by CBFO before certification of the waste. HNF 2600, REV 15 Page 246 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN E. 3 QUALITY CONTROL This appendix documents, defines, and describes the additional QA requirements for NDA that must be implemented by and in facility calibration and operating procedures. Each NDA technique used for NDA of TRU waste must be performed in accordance with calibration and operating procedures that have been written, approved, and controlled by the facility and the SPO. Procedures shall contain applicable quality controls as described below and must specify the qualitative and quantitative acceptance criteria and corrective action to take if these criteria are not met. In accordance with references E27 through E29, NDA personnel initiate a nonconformance report ( NCR) and/ or corrective action report ( CAR), as appropriate, if final reported background measurements, instrument performance measurements, interfering matrix checks, or trending analyses do not meet acceptance criteria. All background and instrument performance measurements shall be documented.

E. 3.1 General Requirements 1. NDA Training: Only appropriately trained and qualified personnel shall be allowed to perform NDA and data validation/ review. Standardized training requirements for NDA personnel shall be based upon existing industry standardized training requirements ( e. g., references E8 and E9) and shall meet the specifications in the reference E2. Qualification of NDA personnel shall be completed in accordance with references E23 and E24. Requalification shall be based upon evidence of continued satisfactory performance and must be performed at least every two years in accordance with references E23 and E24.

2. Software QC Requirements: Reference E25 describes the Hanford TRU Project's software QA program and incorporates requirements from references E2 ( QAPD, section 6.0) and E30.

3. Comparison Programs: Sites using NDA systems shall participate in any relevant measurement comparison program( s) sponsored or approved by the CBFO. Such programs may be conducted as part of the NDA performance demonstration program ( PDP) ( references E7 and E10) or through other third parties. Participation in a measurement comparison program is not required if CBFO has not sponsored or approved such a program for that waste matrix or configuration. Participation in the Calorimetry Exchange Program administered by NBL is not required from a WIPP perspective. However, if WIPP certified calorimeters participate in this program ( e. g., to meet safeguards or other business practice requirements), the results shall also be transmitted to TRU Project records to document participation in a measurement comparison program.

4. Control Limits: As recognized by reference E15, initial establishment of statistical control limits may have to be based upon a limited population of measurement results. Control limits should be updated as conditions warrant or change ( e. g., increase in sample population, changes over time, etc.). HNF 2600, REV 15 Page 247 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN 5. Definitions: The Hanford TRU Project uses the following definitions relative to performance of periodic QC related measurements:

Operational Day ( also " when in operation"): A 24 hour period in which the system is to be used to perform measurements for TRU wastes.

Operational Week: Seven consecutive days starting at 7 a. m. on Monday in which the system performed WIPP related measurements on one or more days in that week.

Six month period ( as used in interfering matrix checks): The six calendar months, through the last day of the sixth month, during which the system is used. This period starts the day of the first instrument performance measurement performed on or after May 17, 2002, the completion of the previous six month period, or placing the system in service, as appropriate. Once started, the sixmonth period cannot be extended due to periods of the system being out of service or inactive, although the facility may end the period earlier ( e. g., if a new system calibration is required, suspension of operations, etc.).

E. 3.2 NDA Quality Control Requirements for GEA Systems E. 3.2.1 Recommended Consensus Standards The assay procedures related requirements and guidance cited in certain American Society for Testing and Materials ( ASTM) and American National Standards Institute ( ANSI) standards ( references E8, E11, E13 and E15) and NRC standard practices and guidelines ( reference E16) as referenced in this appendix are recommended for use at all Hanford facilities. Since these consensus standards address a multitude of operating systems, environments, regulatory requirements, etc., it is not practical to accept any of these standards in their entirety.

E. 3.2.2 Quality Control Requirements The information below summarizes the minimum QC requirements related to GEA systems:

1. Background Measurements: Must be performed and recorded at least once per operational day unless specific approval for a less frequent period is obtained from CBFO. Contributions to background due to radiation from nearby radiation producing equipment, standards, or wastes must be carefully controlled. More frequent background measurements must be performed if the background will vary significantly within a single day or shift. Background measurements are not required when the system is out of service or for systems used solely for isotopic measurements.

Background measurements are normally performed before the first use of the system for WIPP related measurements on a given day. However, for measurements made during off hours, the period of validity of the background HNF 2600, REV 15 Page 248 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN measurement may carry over into the next calendar day, but only if the time elapsed from the last background measurement is less than 24 hours.

Individual ( i. e., daily or more frequent) background measurements shall be evaluated against acceptance limits established in facility procedures. Facility procedures shall also define the actions to take if background measurements result in data that are outside the acceptable range.

2. Instrument Performance Measurements: Instrument performance measurements on operable instruments or systems must be performed and recorded at least once per operational day. Instrument performance measurements for systems used for quantitative measurements shall include, but are not limited to, efficiency checks, matrix correction checks, peak position, and resolution checks, as applicable. Instrument performance measurements are not required when the system is out of service. Both radioactive sources and surrogate waste matrix containers ( both non interfering and interfering) may be used.

Instrument performance measurements are normally performed before the first use of the system for WIPP related measurements on a given day. However, for measurements made during off hours, the period of validity of the instrument performance measurements may carry over into the next calendar day, but only if the time elapsed from the last set of instrument performance measurements is less than 24 hours.

Individual ( i. e., daily or more frequent) instrument performance measurements, regardless of whether or not an interfering matrix is used for these measurements, shall be verified to be within acceptance limits in accordance with table E 3, below, before permitting any routine operations ( e. g., measurements for actual waste characterization). If instrument performance measurements result in data that are outside the acceptable range, the required responses in Table E 3 shall be followed.

Instrument performance measurements for gamma systems used solely for isotopic measurements ( e. g., to support calorimetry or neutron measurements) may consist of separate instrument performance measurements ( e. g., energy and resolution) or may be part of an overall combined system instrument performance measurement for the combined gamma calorimeter/ neutron system. Independent instrument performance measures are subject to the requirements and acceptance criteria of Table E 3, and combined instrument performance measurements are subject to the requirements from the applicable section ( e. g., section E. 3 or E. 4). HNF 2600, REV 15 Page 249 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN Table E 3 Control Limits ( Range of Applicability) for Instrument Performance Measurements of Gamma and Neutron Systems Category Acceptability Range a Required Actions d Acceptable | Result | c   2  b No action required. Warning 2  b < | Result | c   3  b The instrument performance measurement may be rerun no more than twice ( i. e., maximum of three total measurements). If a repeat instrument performance measurement results in data within ± 2 , the additional instrument performance measurement shall be documented and work may continue. If the system does not fall within ± 2  after a maximum of two reruns instrument performance measurements, then the required response for the Action Range shall be followed. Action | Result | c > 3  b Work shall stop, and the occurrence shall be documented as an NCR or CAR and appropriately dispositioned. The NDA system shall be removed from service pending successful resolution of all necessary actions, and all assays performed since the last acceptable instrument performance measurements are suspect, pending satisfactory resolution. If the corrective action includes the adjustment, maintenance, repair or replacement of any system component, recalibration or calibration verification is required before returning the system back to service. a Reference E15. Alternative control limits may be used only with prior approval by CBFO. bThe standard deviation (  ) is only based on the reproducibility of the data check measurements themselves. This is not TMU. The standard deviation may be periodically updated to account for changes in system response over time. The initial acceptability range and any subsequent changes shall be documented and transmitted to the SPO. If the standard deviation is not calculated as the square root of the variance as calculated from ANSI N15.36 1994 ( Annex A, Equation A. 1), the reference for the equation that is used must be provided to and approved by CBFO. When control limits are calculated using alternative methodologies, ± 2  corresponds to the calculated upper and lower warning limits and ± 3  corresponds to the calculated upper and lower action limits. Only the positive range for the warning and action are applicable for resolution control limits. cAbsolute Value dIf failure of an instrument performance check is due to a procedural noncompliance ( e. g., incorrect or no source used), a CAR will be issued. Additional instrument performance measurement( s) shall be performed in accordance with procedural requirements. If these additional instrument performance measurements meet the acceptance criteria, NDA operations may continue while the CAR is processed. HNF 2600, REV 15 Page 250 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN 3. Interfering Matrix Checks: In addition to the daily instrument performance measurements, at least once during the operational week an interfering matrix must be used to assess the long term stability of the NDA instrument's matrix correction. Surrogate waste containers must reflect the type of waste ( e. g., debris, ash) currently being assayed. Radioactivity standards and interfering matrices must be selected such that, over a six month period, the operating range of the assay system is tested in each applicable surrogate waste matrix. Interfering matrix checks are not required for gamma systems used solely for isotopic measurements to support calorimetry or neutron measurements.

An applicable surrogate waste matrix and activity range are defined to be that by the end of the six month period, the ranges of the matrices and activities that were measured during that period were addressed in the interfering matrix checks performed in the same period and are relative to the range spanned in the calibration of the system. It is not required to have performed an interfering matrix check for an activity range or matrix that was not analyzed during that sixmonth period.

Interfering surrogate matrix containers must be constructed in such a way that the waste characteristics do not change over time or are replaced before the characteristics significantly change.

Facility procedures shall define the means to ensure the interfering matrix checks satisfy the requirement to test the range of activity and matrices over a six month period.

The applicable combinations of matrices and activity ranges shall be technically justified and documented in a report to the SPO and approved by the SQAO. New waste matrices shall be evaluated as they arise. Minimum requirements are:

  The uppermost range of activity must be within the upper one third ( 1/ 3) of the applicable activity range for the system,   The lowermost range of activity must be within the lower one third ( 1/ 3) of the applicable activity range for the system,   The matrix is defined based upon density and the uppermost range shall be within the upper one third ( 1/ 3) of the applicable density range for the system, and   The lowermost range of density must be within the lower one third ( 1/ 3) of the applicable density range for the system.   If the range of activity and/ or density is relatively constant within the applicable six month period ( i. e., stays within the same third of the range), only a single range is required to be tested. For example, if all measurements performed during the applicable period fall in the lower one third of the calibration range, the activity used in the interfering matrix checks may be limited to the lower one third of the calibration range. HNF 2600, REV 15 Page 251 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN   For neutron systems, the matrix is characterized in terms of its absorption and moderation properties rather than its physical density.

The interfering matrix checks shall be reviewed and evaluated at least weekly by the cognizant engineer or an NDA scientist to determine continued acceptability of the assay system and to monitor for adverse trends. Facility procedures shall define trend acceptance criteria and acceptance criteria for interfering matrix checks. At a minimum, the following conditions require initiation of an NCR or CAR and investigation:

  Any individual measurement with accuracy (% R) not within ± 60 percent of stated source activity at time of measurement,   Six consecutive measurements with the accuracy (% R) increasing or decreasing, or   Indication of other abnormal trends or conditions.

4. Alternative Control Limits: With CBFO approval, alternative methodologies may be used to establish control limits. The student t distribution may be used to establish control limits for efficiency. Nonstatistical control limits may be used for other parameters such as energy and resolution provided they are technically justified. Facility procedures shall specify the methodology to establish these control limits.

E. 3.2.3 Evaluation Criteria for Trend Analysis 1. Successful performance of the daily background measurements ( i. e., results are within acceptance limits) satisfies weekly review requirements for background measurements.

2. Trending Criteria for Instrument Performance Measurements: Instrument performance measurements shall be reviewed and evaluated at least weekly by the cognizant engineer or an NDA scientist to determine continued acceptability of the assay system and to monitor for adverse trends. Facility procedures shall define trend acceptance criteria. At a minimum, if any of the conditions below occur, the facility shall notify the SQAO. An investigation shall be performed, documented, and approved by the SQAO before resuming routine operations. This investigation shall be discussed in or attached to affected NDA batch reports.

  For efficiency, six consecutive measurements all increasing or decreasing,   A detailed review of the results indicates other abnormal trends or conditions.

E. 3.2.4 Documenting Trend Analysis and Weekly Interfering Matrix Checks Unless specifically approved by the SPM, within one month of the close of the six month period, the facility shall document the results of the interfering matrix checks in a report to the SPM. HNF 2600, REV 15 Page 252 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN This report shall include the applicable ranges and matrices of wastes measured during that period, both for measurement of wastes and for the weekly interfering matrix checks that were performed.

E. 3.3 NDA Quality Control Requirements for Calorimetry Systems E. 3.3.1 Recommended Consensus Standards The assay procedures and related requirements and guidance cited in certain ASTM and ANSI standards ( references E9, E14, E15 and E17) and NRC standard practices and guidelines ( reference E16) as referenced in this appendix are recommended for use at all Hanford facilities. Since these consensus standards address a multitude of operating systems, environments, regulatory requirements, etc., it is not practical to accept any of these standards in their entirety.

E. 3.3.2 Quality Control Requirements The information below summarizes the minimum QC requirements related to NDA using calorimetry:

1. Baseline Measurements: Basepower or baseline measurements shall be conducted at a frequency ( typically weekly) specified in facility operating procedures and approved by CBFO. Table E 4 contains acceptance criteria for baseline or base power measurements.

2. Instrument Performance Measurements: Instrument performance measurements for calorimetry shall be performed with electrical and/ or heat standards traceable to a nationally accredited measurement program at a frequency determined by each facility, consistent with reference E17. These requirements shall be specified in facility operating procedures and must be approved by CBFO.

3. Acceptance Criteria: Individual basepower or baseline and instrument performance measurements shall be verified to be within acceptance limits before permitting any routine operations. Table E 4 contains acceptance criteria for instrument performance measurements. If the NDA system fails to meet acceptance criteria, the NDA system shall be removed from service pending successful resolution of all necessary actions, and all assays performed since the last acceptable instrument performance measurements are suspect, pending satisfactory resolution. HNF 2600, REV 15 Page 253 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN Table E 4 Control Limits ( Range of Applicability) for Base Power and Instrument Performance Measurements on Calorimeters Category Acceptability Range Required Actions c Acceptable | Result | b   2  a No action required. Warning 2  a < | Result | b   3  a The instrument performance measurement may be rerun no more than twice ( i. e., maximum of three total measurements). If a repeat instrument performance measurement results in data within ± 2 , the additional instrument performance measurement shall be documented and work may continue. If the system does not fall within ± 2  after a maximum of two reruns instrument performance measurements, then the required response for the Action Range shall be followed. Action | Result | b > 3  a As recommended by reference E17 section 8.4.2, if an instrument performance measurement for wattage exceeds 3 , a single confirmatory measurement shall be performed. These actions shall also be applied to basepower measurements.   If the result of this confirmatory measurement is   2 , no further action is required except to document both measurements.   If the result of this confirmatory instrument performance measurement is > 2  but   3 , the actions for exceeding the Warning Range shall continue with the initial and confirmatory instrument performance measurements being treated as two results within the Warning Range.   Otherwise, work shall stop, and the occurrence shall be documented as an NCR or CAR and appropriately dispositioned. The calorimeter shall be removed from service pending successful resolution of all necessary actions, and all assays performed since the last acceptable instrument performance measurements are suspect, pending satisfactory resolution. If the corrective action includes the adjustment, maintenance, repair, or replacement of any system component, recalibration or calibration verification is required before returning the calorimeter to service. a The standard deviation (  ) is only based on the reproducibility of the data check measurements themselves. This is not TMU. The standard deviation may be periodically updated to account for changes in system response over time. The initial acceptability range and any subsequent changes shall be documented and transmitted to the SPO. If the standard deviation is not calculated as the square root of the variance as calculated from ANSI N15.36 1994 ( Annex A, Equation A. 1), the reference for the equation that is used must be provided to and approved by CBFO. b Absolute Value c If failure of an instrument performance check is due to a procedural noncompliance ( e. g., incorrect or no source used), a CAR will be issued. Additional instrument performance measurement( s) shall be performed in accordance with procedural requirements. If these additional instrument performance measurements meet the acceptance criteria, NDA operations may continue while the CAR is processed.

Basepower or baseline and instrument performance measurements shall be reviewed and evaluated at least weekly by the cognizant engineer or an NDA scientist to determine continued acceptability of the calorimetry system and to monitor performance trends. Facility procedures shall define trend acceptance criteria. HNF 2600, REV 15 Page 254 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN 4. Isotopic Systems: Isotopic systems used solely in conjunction with calorimetry shall meet the applicable QC requirements from subsection E. 3.2 above. Facility operating procedures shall incorporate the applicable instrument performance measurement requirements. These instrument performance measurements may be performed independently of or in conjunction with the instrument performance measurements for calorimeters.

E. 3.4 NDA Quality Control Requirements for IPAN Systems E. 3.4.1 Recommended Consensus Standards The assay procedures related requirements and guidance cited in certain ASTM and ANSI standards ( references E12 and E15) and NRC standard practices and guidelines ( reference E16) as referenced in this appendix are recommended for use at all Hanford facilities. Since these consensus standards address a multitude of operating systems, environments, regulatory requirements, etc., it is not practical to accept any of these standards in their entirety.

E. 3.4.2 Quality Control Requirements The information below summarizes the minimum QC requirements related to IPAN systems:

1. Background Measurements: Must be performed and recorded at least once per operational day unless specific approval for a less frequent period is obtained from CBFO. Contributions to background due to radiation from nearby radiation producing equipment, standards, or wastes must be carefully controlled. More frequent background measurements must be performed if the background will vary significantly within a single day or shift. Background measurements are not required when the system is out of service.

Background measurements are normally performed before the first use of the system for WIPP related measurements on a given day. However, for measurements made during off hours, the period of validity of the background measurement may carry over into the next calendar day, but only if the time elapsed from the last background measurement is less than 24 hours.

Individual ( i. e., daily or more frequent) background measurements shall be evaluated against acceptance limits established in facility procedures. Facility procedures shall also define the actions to take if background measurements result in data that are outside the acceptable range.

2. Instrument Performance Measurements: Instrument performance measurements on operable systems must be performed and recorded at least once per operational day. Instrument performance measurements shall include, but are not limited to, efficiency checks and matrix correction checks ( if applicable). Instrument performance measurements are not required when the system is out of service. Both radioactive sources and surrogate waste matrix containers ( both noninterfering and interfering) may be used. HNF 2600, REV 15 Page 255 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN Instrument performance measurements are normally performed before the first use of the system for WIPP related measurements on a given day. However, for measurements made during off hours, the period of validity of the instrument performance measurements may carry over into the next calendar day, but only if the time elapsed from the last background and instrument performance measurement is less than 24 hours.

Individual ( i. e., daily or more frequent) instrument performance measurements, regardless of whether or not an interfering matrix is used for these measurements, shall be verified to be within acceptance limits per table E 3 above before permitting any routine operations ( e. g., for actual waste characterization). If instrument performance measurements result in data that are outside the acceptable range, the required responses in table E 3 shall be followed.

3. Interfering Matrix Checks: In addition to the daily instrument performance measurements, at least once during the operational week, an interfering matrix must be used to assess the long term stability of the system's operation and matrix correction. Surrogate waste containers must reflect the type of waste ( e. g., debris, sludge) currently being assayed. Radioactive standards and interfering matrices must be selected such that over a six month period the operating range of the assay system is tested in each applicable surrogate waste matrix.

An applicable activity range is defined to be that by the end of the six month period, the ranges and activities that were measured during that period were addressed in the interfering matrix checks performed in the same period and are relative to the range spanned in the calibration of the system. It is not required to have performed an interfering matrix check for an activity range or matrix that was not analyzed during that six month period.

Interfering surrogate matrix containers must be constructed in such a way that the waste characteristics do not change over time or are replaced before the characteristics significantly change.

Facility procedures shall define the means to ensure the interfering matrix checks satisfy the requirement to test the range of activity and matrices over a six month period.

The applicable combinations of matrices and activity ranges shall be technically justified and documented in a report to the SPO and approved by the SQAO. Minimum requirements are:

  The uppermost range of activity must be within the upper one third ( 1/ 3) of the applicable activity range for the system,   The lowermost range of activity must be within the lower one third ( 1/ 3) of the applicable activity range for the system, and HNF 2600, REV 15 Page 256 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN   If the range of activity is relatively constant within the applicable sixmonth period ( i. e., stays within the same third of the range), only a single range is required to be tested. For example, if all measurements performed during the applicable period fall in the lower one third of the calibration range, the activity used in the interfering matrix checks may be limited to the lower one third of the calibration range.

The interfering matrix checks shall be reviewed and evaluated at least weekly by the cognizant engineer or an NDA scientist to determine continued acceptability of the assay system and to monitor for adverse trends. Facility procedures shall define trend acceptance criteria and acceptance criteria for interfering matrix checks. At a minimum, the following conditions require initiation of an NCR or CAR and investigation:

  Any individual measurement with accuracy (% R) not within ± 60 percent of stated source activity at time of measurement,   Six consecutive measurements with the accuracy (% R) increasing or decreasing, or   A detailed review of the results indicates other abnormal trends or conditions.

E. 3.4.3 Evaluation Criteria for Trend Analysis 4. Successful performance of the daily background measurements ( i. e., results are within acceptance limits) satisfies weekly review requirements for background measurements.

5. Trending Criteria for Instrument Performance Measurements: Instrument performance measurements shall be reviewed and evaluated at least weekly by the cognizant engineer or an NDA scientist to determine continued acceptability of the assay system and to monitor for adverse trends. Facility procedures shall define trend acceptance criteria. At a minimum, if any of the conditions below occur, the facility shall notify the SQAO. An investigation shall be performed, documented, and approved by SQAO before resuming routine operations. This investigation shall be discussed in or attached to affected NDA batch reports.

  Six consecutive measurements all increasing or decreasing, or   A detailed review of the results indicates other abnormal trends or conditions.

E. 3.4.4 Documenting Trend Analysis Unless specifically approved by the SPM, within one month of the close of the six month period, the facility shall document the results of the interfering matrix checks in a report to the SPM. This report shall include the applicable ranges and matrices of wastes measured during that HNF 2600, REV 15 Page 257 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN period, both for measurement of wastes and for the weekly interfering matrix checks that were performed.

E. 3.5 NDA Quality Control Requirements for SuperHENC Systems E. 3.5.1 Recommended Consensus Standards The assay procedures related requirements and guidance cited in certain ASTM and ANSI standards ( references E15 and E33) and NRC standard practices and guidelines ( reference E16) as referenced in this appendix are recommended for use at all Hanford facilities. Since these consensus standards address a multitude of operating systems, environments, regulatory requirements, etc., it is not practical to accept any of these standards in their entirety.

E. 3.5.2 Quality Control Requirements The information below summarizes the minimum QC requirements related to SuperHENC systems:

1. Background Measurements: Must be performed and recorded at least once per operational day unless specific approval for a less frequent period is obtained from CBFO. Contributions to background due to radiation from nearby radiation producing equipment, standards, or wastes must be carefully controlled. More frequent background measurements must be performed if the background will vary significantly within a single day or shift. Background measurements are not required when the system is out of service.

Background measurements are normally performed before the first use of the system for WIPP related measurements on a given day. However, for measurements made during off hours, the period of validity of the background measurement may carry over into the next calendar day, but only if the time elapsed from the last background measurement is less than 24 hours.

Individual ( i. e., daily or more frequent) background measurements shall be evaluated against acceptance limits established in facility procedures. Facility procedures shall also define the actions to take if background measurements result in data that are outside the acceptable range.

2. Instrument Performance Measurements: Instrument performance measurements on operable systems must be performed and recorded at least once per operational day. Instrument performance measurements shall include, but are not limited to, efficiency checks and matrix correction checks. Instrument performance measurements are not required when the system is out of service. Both radioactive sources and surrogate waste matrix containers ( both non interfering and interfering) are used. The interfering matrix checks are discussed in E. 3.5.2( 3) below. HNF 2600, REV 15 Page 258 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN Instrument performance measurements are normally performed before the first use of the system for WIPP related measurements on a given day. However, for measurements made during off hours, the period of validity of the instrument performance measurements may carry over into the next calendar day, but only if the time elapsed from the last background and instrument performance measurement is less than 24 hours.

Individual ( i. e., daily or more frequent) instrument performance measurements, regardless of whether or not an interfering matrix is used for these measurements, shall be verified to be within acceptance limits per table E 3 above before permitting any routine operations ( e. g., for actual waste characterization). If instrument performance measurements result in data that are outside the acceptable range, the required responses in table E 3 shall be followed.

3. Interfering Matrix Checks: In addition to the daily instrument performance measurements, at least once during the operational week, an interfering matrix must be used to assess the long term stability of the system's operation and matrix correction. Surrogate waste containers must reflect the type of waste ( e. g., debris, sludge) currently being assayed. Radioactive standards and interfering matrices must be selected such that over a six month period the operating range of the assay system is tested in each applicable surrogate waste matrix.

An applicable activity range is defined to be that by the end of the six month period, the ranges and activities that were measured during that period were addressed in the interfering matrix checks performed in the same period and are relative to the range spanned in the calibration of the system. It is not required to have performed an interfering matrix check for an activity range or matrix that was not analyzed during that six month period.

Interfering surrogate matrix containers must be constructed in such a way that the waste characteristics do not change over time or are replaced before the characteristics significantly change.

Facility procedures shall define the means to ensure the interfering matrix checks satisfy the requirement to test the range of activity and matrices over a six month period.

The applicable combinations of matrices and activity ranges shall be technically justified and documented in a report to the SPO and approved by the SQAO. Minimum requirements are:

  The uppermost range of activity must be within the upper one third ( 1/ 3) of the applicable activity range for the system,   The lowermost range of activity must be within the lower one third ( 1/ 3) of the applicable activity range for the system, and HNF 2600, REV 15 Page 259 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN   If the range of activity is relatively constant within the applicable sixmonth period ( i. e., stays within the same third of the range), only a single range is required to be tested. For example, if all measurements performed during the applicable period fall in the lower one third of the calibration range, the activity used in the interfering matrix checks may be limited to the lower one third of the calibration range.

The interfering matrix checks shall be reviewed and evaluated at least weekly by the cognizant engineer or an NDA scientist to determine continued acceptability of the assay system and to monitor for adverse trends. Facility procedures shall define trend acceptance criteria and acceptance criteria for interfering matrix checks. At a minimum, the following conditions require initiation of an NCR or CAR and investigation:

  Any individual measurement with accuracy (% R) not within ± 60 percent of stated source activity at time of measurement,   Six consecutive measurements with the accuracy (% R) increasing or decreasing, or   A detailed review of the results indicates other abnormal trends or conditions.

E. 3.5.3 Evaluation Criteria for Trend Analysis 1. Successful performance of the daily background measurements ( i. e., results are within acceptance limits) satisfies weekly review requirements for background measurements.

2. Trending Criteria for Instrument Performance Measurements: Instrument performance measurements shall be reviewed and evaluated at least weekly by the cognizant engineer or an NDA scientist to determine continued acceptability of the assay system and to monitor for adverse trends. Facility procedures shall define trend acceptance criteria. At a minimum, if any of the conditions below occur, the facility shall notify the SQAO. An investigation shall be performed, documented, and approved by SQAO before resuming routine operations. This investigation shall be discussed in or attached to affected NDA batch reports.

  Six consecutive measurements all increasing or decreasing, or   A detailed review of the results indicates other abnormal trends or conditions.

E. 3.5.4 Documenting Trend Analysis Unless specifically approved by the SPM, within one month of the close of the six month period, the facility shall document the results of the interfering matrix checks in a report to the SPM. This report shall include the applicable ranges and matrices of wastes measured during that HNF 2600, REV 15 Page 260 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN period, both for measurement of wastes and for the weekly interfering matrix checks that were performed.

E. 4 DATA MANAGEMENT E. 4.1 Data Review and Validation All NDA data must be reviewed and approved by qualified personnel before being reported. At a minimum, the data must be reviewed by an independent technical reviewer, SQAO, and approved by the SPM. The validation process includes verification that the applicable quality controls specified in subsection E. 3 have been met.

Facility procedures shall specify the exact requirements for data validation, verification and review by an independent technical reviewer ( ITR).

In general, the requirements of section B3 10 of reference E21 shall be incorporated into the review requirements and combines the requirements for data generation level, independent technical review ( ITR), and technical supervisor review. Key issues to be reviewed include, but are not limited to:

  ITR review shall be documented in a checklist format,   Data generation and reduction have been performed in accordance with procedural requirements,   Verification of calculations or data entry as appropriate,   Instrument performance and background measurements for the affected period have been performed, documented, and meet acceptance criteria and have been evaluated for adverse trends. Appropriate corrective actions have been documented and successfully completed,   Batch data report is otherwise assembled and complete in accordance with facility procedures,   Data is technically correct and justified. All anomalies, error messages, warning flags, etc., have been corrected or justified in the report,   Analytical measurements are performed within any limits for activity, waste matrix, calibration range, etc.,   Report is complete ( through ITR) and data properly reported.

The ITR of NDA data for use in batch data reports is defined to be a person qualified to perform the work as NDA scientist ( analyst) who has not acted in the capacity of data analyst for any of the waste analyses contained in the affected NDA batch data report.

SPO procedures shall specify the review requirements for review, validation, and verification by SQAO. HNF 2600, REV 15 Page 261 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN In general, the requirements of section B3 10 of reference E21 shall be incorporated into the procedural requirements and combine the requirements for QA officer review and SQAO review. Key issues to be reviewed or incorporated include, but are not limited to:

  SQAO review shall be documented in a checklist format,   ITR review complete with any open issues satisfactorily resolved,   Background and instrument performance measurements for the applicable period are attached and meet acceptance criteria, including any trends,   Analytical measurements are performed within any limits for activity, waste matrix, calibration range, etc.,   Copies of any CAR or NCR affecting the data within the batch are attached,   Report is complete and data properly reported, and,   Any person qualified as SQAO may perform the SQAO review of an NDA batch data report.

SPM Approval:

  Any person qualified as SPM may perform the SPM approval of an NDA batch data report,   SPM approval demonstrates the ITR and SQAO reviews have been successfully completed with any and all problems or issues satisfactorily resolved and the associated checklists are complete,   Verifies the data is now acceptable to permit shipment to WIPP, and   A checklist is not required, although SPM signature and date is required, when approved.

E. 4.2 Data Reporting E. 4.2.1 NDA Batch Data Reports NDA data must be reported to the SPO on a batch basis. For the purpose of the Hanford TRU Project, batches are defined as a suite of waste containers undergoing NDA using the same system or equipment. A single batch report is limited to 20 waste containers excepting that the SPM may authorize a greater number on a case by case basis for batches assayed on or after May 17, 2002.

Each facility is required to submit batch data reports for each batch to the SPO on standard forms ( either hard copy or electronic equivalent), as provided in approved facility procedures. NDA batch data reports shall consist of the following:

  Facility name, batch number, container numbers included in that batch   Table of contents   Narrative or executive summary, including any explanation of issues or problems associated with the batch   Background and instrument performance measurement data or control charts for the relevant time period ( i. e., at least the duration over which the containers in that batch were assayed) HNF 2600, REV 15 Page 262 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN   Any NCR or CAR directly associated with NDA for that batch   For all NDA batch data reports with data collected before May 17, 2002, a statement that the data was collected before May 17, 2002 ( or effective date of CH WAC, reference E20) and the replicate analysis are substituted for the weekly interfering matrix checks   Identification of or reference to applicable calibration, TMU, and QAO reports ( QAO report applies to measurements performed but not validated before May 17, 2002)   Signed ITR and SQAO data validation checklists in accordance with reference E2 ( QAPD, section 5.3.2), applicable facility procedures, and reference E26   Separate report sheet( s) for each container in the batch that include, but are not limited to:

1. Title of " Radioassay Data Sheet"

2. Method used for NDA ( i. e., procedure identification)

3. Date of NDA 4. For batches with measurements obtained before May 17, 2002:

a. Positive identification of each replicate analysis b. Positive indication of whether or not the replicate analysis met the acceptance criteria 5. Activities and/ or masses of individual radioisotopes present, the associated TMUs and the confidence level for which the TMU was calculated ( curies and/ or grams). For the ten WIPP tracked isotopes results less than LLD shall be reported as "< LLD" ( zero shall be used if the isotope is documented in AK as not being present in the container)

6. Signature/ date of both analyst and reviewer 7. Other information or radiological properties shall be documented on the radioassay data sheet including, but not limited to:

a. Decay heat expressed in watts ( W) and its associated TMU b. Total 239Pu FGE expressed in grams ( g) and its associated TMU c. TRU alpha activity concentration expressed in curies/ gram ( Ci/ g) and associated TMU ; further TRU alpha activity is defined to be the sum of the activities of TRU isotopes that decay by alpha emission and have halflives greater than 20 years d. Total 239Pu equivalent activity expressed in curies ( PE Ci)

8. Reported analytical results or summaries including signatures/ dates of operator and analyst/ reviewer HNF 2600, REV 15 Page 263 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN 9. Sufficient information to permit the independent calculation of the activity of radionuclides that are scaled or correlated from the measured values for other radionuclides ( e. g., 90Sr calculated from measured 137Cs or 234U from 235U or 238U)

10. Radionuclides that are neither one of the ten WIPP tracked isotopes nor otherwise contribute to 95 percent of the total radiological hazard must have their activity/ mass reported if either of the below conditions are met. Reporting may be either on the radioassay data sheet or elsewhere within the report:

a. The radionuclide contributes to FGE or decay heat ( e. g., 241Pu, 237Np or 235U)

b. The radionuclide is used to scale one of the ten WIPP tracked isotopes.

11. Signature approval and release by SPM.

E. 4.2.2 Calibration Reports Calibration and recalibration reports prepared on or after May 17, 2002, shall include, but are not limited to, the following:

  System description, including modifications, major repairs, replacement of major components, etc., since last report   Range of operation for which the calibration is valid ( both activity and matrices)   Description of calibration methodology   Period for which calibration is applicable   Summary and description of the calibration confirmation   Results of calibration confirmation   Reports of all calibration parameters, components, functions calibrated   Supporting analytical results   System settings, operating parameters, etc.   Must be reviewed and approved by the SQAO.

E. 4.2.3 Total Measurement Uncertainty Reports TMU reports prepared on or after May 17, 2002, shall include, but are not limited to, the following requirements:

  Description of system( s), including modifications, major repairs, replacement of major components, etc., since last report   Identification of and technical justification for like or similar systems   Assumptions, limits, range, matrices, etc., to which the TMU is applicable   Evaluation of the individual contributing components to TMU   Total measurement uncertainty and equations for individual isotopes and parameters in accordance with reference E6   Must be reviewed and approved by the SQAO. HNF 2600, REV 15 Page 264 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN E. 4.2.4 Calibration Verification Reports Calibration verification reports prepared on or after May 17, 2002, shall include, but are not limited to, the following:

  System description, including modifications, major repairs, replacement of major components, etc., since last calibration or calibration verification report   Range of operation for which the calibration is valid ( both activity and matrices)   Period for which calibration is applicable   Summary and description of the calibration verification   Results of calibration verification   Supporting analytical results   Must be reviewed and approved by the SQAO.   Technical justification must also be included if only partial calibration verification is performed ( e. g., calibration verification does not test all concurrent calibrations or does not test the full system).

E. 4.3 Data and Records Retention The following records shall be forwarded to the SPO and shall be documented and retrievable by NDA batch number, in accordance with reference E2 ( QAPD):

  NDA batch reports   All raw data, including instrument readouts, calculation records, and NDA QC results ( both background or power baseline and instrument performance measurements). Raw data includes, but is not limited to, the original data collected for subsequent analysis   All instrument calibration reports, including the analysis of the associated standards and any confirmatory measurements performed to satisfy the calibration confirmation requirements. " Calibration reports" include the original analytical results collected to perform any and all portions of the calibration ( e. g., energy calibration, efficiency determination, system correction factor determination, calibration confirmation, etc.). HNF 2600, REV 15 Page 265 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN E. 4.4 Required Reports Table E 5 summarizes routinely generated reports required by this appendix. This list cannot be all inclusive and does not address special occurrences.

Table E 5 Summary of Required Reports Report Subject Frequency Comments Reference Section NDA Batch Data Reports As generated AK Summary Report As generated, updated as necessary As related to radionuclides present and their fractional abundances E. 2.2.1 E. 2.2.2 Acceptable Knowledge Source Document Deficiency As generated E. 2.2.3 Method to Quantify 234U and 90Sr As generated May need to update this on a waste stream basis E. 2.1 Calibration Report Following initial calibration Calibration confirmation also required E. 3 E. 5.2.2 Recalibration Report After each recalibration Calibration confirmation also required E. 3 E. 5.2.2 Calibration Confirmation Concurrent with each calibration or recalibration May be documented separately or included in calibration report E. 3 Calibration Verification As performed ( following system repair, modification, etc.) E. 3 E. 5.2.4 LLD Methodology As generated, updated as necessary Must include equivalent LLD for isotopes that cannot be measured ( e. g., 90Sr and 234U) E. 3 TMU Report As generated, updated as necessary Must be submitted to CBFO E. 3 E. 5.2.3 Methodology for Alternate Control Limits As needed Must be approved by CBFO before implementation of methodology E. 4.2.2 E. 4.4.2 CAR/ NCR As generated Various Interfering Matrix Checks and Trend Analysis 1 month after end of 6 month period E. 4.2.2 E. 4.3.2 E. 4.4.2 Correlation of Sources to Primary Standards When performed E. 3 Calibration Technique If not performed in accordance with consensus standards Requires pre approval by CBFO E. 3 Alternate Calibration Confirmation Accuracy and Precision Limits As needed Requires pre approval by CBFO E. 3 Calorimetry Baseline and Instrument Performance Measurement Frequency Prior to use and whenever updated Requires pre approval by CBFO and must include equivalent trending E. 4.3.2 Definition of applicable operating ranges for weekly interfering matrix checks Prior to use and whenever updated E. 4.2.2 E. 4.3.2 E. 4.4.2 HNF 2600, REV 15 Page 266 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN E. 5 QUALITY CHARACTERISTICS ASSESSMENT Per 40 CFR § 194.22( c), there are five " quality characteristics" that have to be assessed. These quality characteristics and the method by which they are assessed are described in the following sections.

E. 5.1 Data Accuracy Per 40 CFR § 194.22( c)( 1), Data Accuracy is defined as " the degree to which data agree with an acceptable reference or true value." For NDA methods, this quality characteristic is met and maintained as described in subsection E. 2.

E. 5.2 Data Precision Per 40 CFR § 194.22( c)( 2), Data Precision is defined as " a measure of the mutual agreement between comparable data gathered or developed under similar conditions expressed in terms of standard deviation." For NDA methods, this quality characteristic is met and maintained as described in subsection E. 2.

E. 5.3 Data Representativeness Per 40 CFR § 194.22( c)( 3), Data Representativeness is defined as " the degree to which data can accurately and precisely represent a characteristic of a population, a parameter, variations at a sampling point, or environmental conditions." For NDA this quality characteristic for the waste stream is met and maintained through 100 percent measurement confirmation on a payload container basis.

E. 5.4 Data Completeness Per 40 CFR § 194.22( c)( 4), Data Completeness is defined as " a measure of the amount of valid data obtained compared to the amount that was expected." For NDA methods, this quality characteristic is met and maintained by requiring 100 percent valid results. Any result indicating the NDA measurement was invalid requires re measurement.

E. 5.5 Data Comparability Per 40 CFR § 194.22( c)( 5), Data Comparability is defined as " a measure of confidence with which one data set can be compared to another." For NDA this quality characteristic is addressed by ensuring that all data are produced under the same system of controls. These controls apply to all aspects of the data generation process, including procurement of analytical instruments; calibration and operation of assay equipment according to industry standards; preparation and use of standardized instrument and data review procedures; and training of equipment operators and technical/ data review personnel to the QAPD, as specified in subsection E. 3.1. Additionally, comparison of measured data with AK derived or based values, as applicable, provides a means to assess comparability on a waste stream basis. Although no specific confidence level is specified, these controls provide comparability among all data HNF 2600, REV 15 Page 267 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN generated under this program. Sites using NDA systems shall participate in measurement comparison programs as specified in subsection E. 3.1.

E. 6 239PU EQUIVALENT ACTIVITY 239Pu equivalent activity ( PE Ci) is calculated and reported for each container of TRU waste. This calculation normalizes the activity for each TRU isotope to that of 239Pu. PE Ci is calculated for each and every TRU isotope regardless of half life ( t1/ 2) or method of decay and for 233U using the following formula:

 = =   k i i i WF A Ci PE 1 where: k   the number of TRU isotopes including 233U ( without regard to method of decay or t1/ 2) Ai   the activity ( in Curies) of TRU radionuclide i WFi   the weight factor ( WF) for TRU radionuclide i WF is defined to be the ratio of the 50 year effective whole body dose commitment due to the inhalation of 239Pu particulates with a 1.0 µ m activity median aerodynamic diameter ( AMAD) and a weekly pulmonary clearance class ( CEDEPu 239) to the 50 year effective whole body dose commitment due to the inhalation of radionuclide i particulates, with a 1.0 µ m activity median aerodynamic diameter and the pulmonary clearance class resulting in the highest 50 year effective whole body dose commitment ( CEDEi). The values of CEDEPu 239 and CEDEi are taken from DOE/ EH 0071 ( reference E18). Mathematically, this is expressed as:

i Pu i CEDE CEDE WF 239   =

Table E 6 contains the weighting factors for TRU isotopes listed in reference E18, section 1.3.7, that have a 50 year committed dose equivalent factor ( Ei as used in reference E20, CEDE as used on reference E19) identified in reference E19. HNF 2600, REV 15 Page 268 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN Table E 6 PE Ci Weighting Factors Isotope Atomic No. Class CEDE WF 1 / WF Comment U 233 92 Y 1.30E+ 02 3.9 0.3 Np 237 93 W 4.90E+ 02 1.0 1.0 Pu 236 94 W 1.60E+ 02 3.2 0.3 Pu 238 94 W 4.60E+ 02 1.1 0.9 Pu 239 94 W 5.10E+ 02 1.0 1.0 Pu 240 94 W 5.10E+ 02 1.0 1.0 Pu 241 94 W 1.00E+ 01 51.0 0.0 Pu 242 94 W 4.80E+ 02 1.1 0.9 Pu 244 94 W 4.80E+ 02 1.1 0.9 Am 241 95 W 5.20E+ 02 1.0 1.0 Am 242m 95 W 5.10E+ 02 1.0 1.0 Am 243 95 W 5.20E+ 02 1.0 1.0 Cm 242 96 W 1.70E+ 01 30.0 0.0 Cm 243 96 W 3.50E+ 02 1.5 0.7 Cm 244 96 W 2.70E+ 02 1.9 0.5 Cm 245 96 W 5.40E+ 02 0.9 1.1 Cm 246 96 W 5.40E+ 02 0.9 1.1 Cm 247 96 W 4.90E+ 02 1.0 1.0 Cm 248 96 W 1.90E+ 03 0.3 3.7 Cm 250 96 N/ A N/ A N/ A N/ A Not Listed in DOE/ EH 0071 Bk 250 97 W 6.90E 03 73913.0 0.0 Use with caution: may be a typo in DOE/ EH 0071 Cf 249 98 W 5.50E+ 02 0.9 1.1 Cf 250 98 W 2.20E+ 02 2.3 0.4 Cf 251 98 W 5.60E+ 02 0.9 1.1 Cf 252 98 Y 1.30E+ 02 3.9 0.3 Es 254 99 W 3.60E+ 01 14.2 0.1 E. 7 NDA RELATED PROCEDURES Table E 7 identifies procedures used specifically for or in the performance or documentation of NDA in the Hanford TRU Project. These procedures may also contain requirements for other aspects of the Hanford TRU Project. HNF 2600, REV 15 Page 269 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN Table E 7 NDA Implementing Procedures in the Hanford TRU Project Document number Title WMP 400, Section 1.2.1 TRU Training and Qualification Plan WMP 400, Section 1.2.2 Qualification of NDA, NDE, Visual Examination, Transportation, and Inspection and Test Personnel WMP 400, Section 1.3.2 TRU Nonconforming Item Reporting and Control WMP 400, Section 1.3.3 TRU Corrective Action Reporting and Control WMP 400, Section 1.5.1 TRU Records Management WMP 400, Section 3.1.2 Quality Assurance Reports to Management WMP 400, Section 6.1.1 TRU Software Quality Assurance WMP 350, Section 2.2 Calculation of Assay Results WMP 350, Section 2.3 Data Management WMP 350, Section 2.5 GEA Energy and Efficiency Setup and Baseline Establishment WMP 350, Section 2.8 WRAP NDA Measurement Control Program WMP 350, Section 2.9 Performing Calibration Verifications and Confirmations for NDA at WRAP WMP 350, Section 2.10 GEA Calibration Using NDA2000 WRP1 OP 0905 Imaging Passive/ Active Neutron Assay Operation WRP1 OP 0906 Gamma Energy Assay Operations WRP1 OP 0907 Gamma Energy Assay Operations Using NDA2000 TRU OP 002 Operation of the SuperHENC Assay System ZA 948 392 NDA Using NDA 2000 ZA 948 393 NDA Using the Room 172 ANTECH Calorimeters ZA 400 303 Energy and Efficiency Setup and Baseline Determination Using NDA 2000 HNF 2600, REV 15 Page 270 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN Table E 7 NDA Implementing Procedures in the Hanford TRU Project Document number Title ZA 400 304 ANTECH Calorimeter Calibration ZA 400 302 Calculation of Assay Results FSP PFP 5 8, Section 16.2 Data Management FSP PFP 5 8, Section 16.3 QC Criteria for Residues Project NDA Instruments FSP PFP 5 8, Section 16.4 Calibration Confirmation for Residues Project NDA Instruments E. 8 NDA SPECIFIC REFERENCES Hanford TRU Project NDA programs were developed using the following references:

E1 NUREG 1297, Peer Review for High Level Nuclear Waste Repositories, Office of Nuclear Material Safety and Safeguards, U. S. Nuclear Regulatory Commission, Washington D. C.

E2 DOE CBFO 94 1012, Quality Assurance Program Document, Carlsbad Field Office, U. S. Department of Energy, Carlsbad, New Mexico E3 Currie, Lloyd A., 1968, " Limits for Qualitative Detection and Quantitative Determination." Anal. Chem. 40: 586 93 E4 EPA 520/ 1 80 012, Upgrading Environmental Radiation Data, Office of Radiation Programs, U. S. Environmental Protection Agency, Washington D. C., 1980 E5 " Total Measurement Uncertainty Assessment for Transuranic Waste Shipments to the Waste Isolation Pilot Plant," K. C. Smith, R. A. Stroud, K. L. Coop, and J. F. Bresson, Proceedings of the 6th Nondestructive Assay Waste Characterization Conference, Salt Lake City, Utah, Nov. 17 19, 1998, pp. 21 37 E6 " Standardized Total Measurement Uncertainty Reporting for WIPP," K. L. Coop, J. F. Bresson, M. E. Doherty, B. M. Gillespie, and D. R. Davidson, Nondestructive Assay Interface Working Group, Salt Lake City, Utah, May 22, 2000 E7 DOE/ CBFO 01 1006, Performance Demonstration Program Plan for Nondestructive Assay of Boxed Wastes for the TRU Waste Characterization Program, Carlsbad Field Office, U. S. Department of Energy Carlsbad, New Mexico HNF 2600, REV 15 Page 271 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN E8 ASTM C1490, " Standard Guide for Selection, Training and Qualification of Nondestructive Assay ( NDA) Personnel, American Society for Testing and Materials," Philadelphia, Pennsylvania E9 ANSI N15.54, " Radiometric Calorimeters   Measurement Control Program," American National Standards Institute, Inc., New York, NY E10 DOE/ CBFO 01 1005, Performance Demonstration Program Plan for Nondestructive Assay of Drummed Wastes for the TRU Waste Characterization Program, Carlsbad Field Office, U. S. Department of Energy, Carlsbad, New Mexico E11 ASTM C1030 95, " Standard Test Method for Determination of Plutonium Isotopic Composition by Gamma Ray Spectrometry," American Society for Testing and Materials, Philadelphia, Pennsylvania E12 ASTM C1316 95, " Standard Test Method for Nondestructive Assay of Nuclear Material in Scrap and Waste by Passive Active Neutron Counting Using a 252Cf Shuffler," American Society for Testing and Materials, Philadelphia, Pennsylvania E13 ASTM C1133 96, " Standard Test Method for Nondestructive Assay of Special Nuclear Material in Low Density Scrap and Waste by Segmented Passive Gamma Ray Scanning," American Society for Testing and Materials, Philadelphia, Pennsylvania.

E14 ASTM C1458 00, " Standard Test Method for Nondestructive Assay of Plutonium, Tritium and 241 Am by Calorimetric Assay," American Society for Testing and Materials, Philadelphia, Pennsylvania.

E15 ANSI N15.36 1994, " Nondestructive Assay Measurement Control and Assurance," American National Standards Institute, Inc., New York, NY E16 Regulatory Guide 5.11, Nondestructive Assay of Special Nuclear Material Contained in Scrap and Waste, Office of Nuclear Regulatory Research, U. S. Nuclear Regulatory Commission, Washington, D. C.

E17 ANSI N15.22 1987, " Plutonium Bearing Solids Calibration Techniques for Calorimetric Assay," American National Standards Institute, Inc., New York, NY E18 Safety Analysis Report for the TRUPACT II Shipping Package, Westinghouse Electric Corporation, Waste Isolation Division, Carlsbad, New Mexico E19 DOE/ EH 0071, Internal Dose Conversion Factors for Calculation of Dose to the Public, U. S. Department of Energy, July 1988 E20 DOE/ WIPP 02 3122, Contact Handled Transuranic Waste Acceptance Criteria for the Waste Isolation Pilot Plant, Carlsbad Field Office, U. S. Department of Energy, Carlsbad, New Mexico HNF 2600, REV 15 Page 272 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN E21 HNF 2599, Hanford Site Transuranic Waste Characterization Quality Assurance Project Plan, Hanford TRU Project Office, Richland Operations Office, U. S. Department of Energy, Richland, Washington E22 Hanford TRU Procedure: WMP 400, Waste Isolation Pilot Plant ( WIPP) Procedures, Section 7.1.9, " Acceptable Knowledge Documentation Management"

E23 Hanford TRU Procedure: WMP 400, Section 1.2.1, TRU Training and Qualification Plan E24 Hanford TRU Procedure: WMP 400, Section 1.2.2, " Qualification of NDA, NDE, Visual Examination, Transportation, and Inspection and Test Personnel"

E25 Hanford TRU Procedure: WMP 400, Section 6.1.1, " TRU Software Quality Assurance"

E26 Hanford TRU Procedure: WMP 400, section 7.1.6, " TRU Waste Project Level Data Validation and Verification"

E27 Hanford TRU Procedure: WMP 400, Section 1.3.2, " TRU Nonconforming Item Reporting and Control"

E28 Hanford TRU Procedure: WMP 400, Section 1.3.3, " TRU Corrective Action Reporting and Control"

E29 Hanford TRU Procedure: WMP 400 Section 2.4.4, " TRU Control of Measuring, Testing and Data Collection Equipment"

E30 ASME NQA 2a 1990, Part 2.7, " Quality Assurance Requirements for Computer Software for Nuclear Facility Applications," American Society of Mechanical Engineers, New York, NY E31 HNF 11976, Interval Estimation for Statistical Control Limits E32 HNF 11977, Performance Control Limits for Gamma Assay Systems E33 ASTM C1207 03 " Standard Test Methods for Nondestructive Assay of Plutonium in Scrap and Waste by Passive Neutron Coincidence Counting," American Society for Testing and Materials, Philadelphia, Pennsylvania HNF 2600, REV 15 Page 273 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN APPENDIX F HYDROGEN/ METHANE SAMPLING AND ANALYSIS HNF 2600, REV 15 Page 274 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN HYDROGEN/ METHANE SAMPLING AND ANALYSIS The concentration of hydrogen/ methane in a waste container can be used to determine the required aspiration time prior to shipping waste. Sampling personnel will collect hydrogen/ methane in accordance with the requirements established in the HNF 2599, Hanford Site Transuranic Waste Characterization Quality Assurance Project Plan, Section B1 1. The analytical method used is based on ASTM Method D2650 83, using a gas chromatograph coupled with a thermal conductivity detector ( GC/ TCD).

The required quality control ( QC) samples associated with sampling and analysis for hydrogen/ methane are discussed in Section F1. The information obtained from the hydrogen/ methane analysis is used for meeting DOT requirements during shipment of containers, as described in Section <IP_ADDRESS> of the CH TRAMPAC.

The hydrogen/ methane data, report generation, review, and validation requirements are applicable, and those requirements are discussed in Sections F. 4 and F. 5.

F. 0 WASTE DRUM SAMPLING FOR HYDROGEN/ METHANE Data Quality Objectives HSG sampling of drums is described in HNF 2599, Section B1 1. Sampling for hydrogen/ methane can occur either just for hydrogen/ methane or combined with sampling for HSG analysis.

A field duplicate sample shall be sampled for each sampling batch. The result comparison from the drum sample and the field duplicate sample assesses the precision of the sampling process. The analysis of a field blank is not necessary.

Laboratory completeness will be expressed as the number of samples analyzed with valid results as a percent of the total number of samples submitted for analysis. Valid results are defined as results that meet the data usability criteria specified in Table F 1.

Table F 1 Hydrogen Analysis And Quality Assurance Objectives Compound CAS # Precision (% RPD) Accuracy (% R) MDL ( ppmv) PRQL (% vol) Complete  ness (%) Hydrogen 1333 74 0 < 25 70 130 30 0.1 90 Methane 74 82 8 < 25 70 130 30 0.1 90 1 % vol = 10,000ppmv RPD = relative percent difference % R = Percent recovery MDL = method detection limit PRQL = project required quantitation limit HNF 2600, REV 15 Page 275 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN Table F 2 lists the field QC samples and the frequency of taking these samples.

Table F 2 Summary Of Field QC Sample Frequencies QC Sample Direct Canister System On Line System Equipment Blank Once   Completed with HSG canister certification 1 per on line batch Field Reference Standard Once   Completed with HSG canister certification 1 per on line batch Field duplicate 1 per sampling batch 1 per on line batch Table F 3 provides the acceptance criteria for the field QC samples and corrective actions if acceptance criteria are not met.

Table F 3 Summary Of Sampling QC Sample Acceptance Criteria QC Sample Acceptance Criteria Corrective Action Equipment Blank Completed during HSG Certification N/ A Field Reference Standard Completed during HSG Certification N/ A Field duplicate RPD < 25% for detections in both samples > PRQL Nonconformance if RPD > 25% for detections in both samples HNF 2600, REV 15 Page 276 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN F. 1 METHOD REQUIREMENTS The analytical method in LA 523 426, " Determination of Permanent Gases in TRU Waste Container Headspace," is based on ASTM Method D2650 83. Analysis is performed by gas chromatography coupled with a thermal conductivity detector ( GC/ TCD). The minimum requirements of quality control and assurance are listed in Table F 4. Table F 4 Laboratory Quality Control Samples and Frequencies For Hydrogen Analysis QC Sample Minimum Frequency Acceptance Criteria Corrective Action Method performance samples Seven ( 7) samples initially and a minimum four ( 4) semiannually Meet method QAOs; 70 130% R for concentrations > lowest initial calibration standard Repeat until acceptable Field Duplicates One ( 1) per sampling batch RPD < 25% for detections in both samples > PRQL Nonconformance if RPD > 25% for detections in both samples Laboratory blanks One ( 1) per analytical batch Analyte amounts # 3 x MDLs from Table F 1 Nonconformance if analyte concentrations > 3 x MDLs from Table F 1 Laboratory control samples ( LCS/ LCSD) One set per analytical batch 70 130 % R; RPD   25 for LCS/ LCSD Nonconformance if % R < 70 or > 130 or if RDP > 25 for LCS/ LCSD Technique Procedure Frequency of Procedure Acceptance Criteria 3 pt initial calibration Initially, and as needed % RSD of response factor for each analyte < 30; correlation coefficient   0.995 Initial calibration verification ( ICV) Immediately following 3 pt calibration 70 130 % R Continuing calibration verification ( CCV) Every 12 hours, prior to laboratory blank and every 12 hour of analysis Peak must be within established RT window; % D of response factor   25 compared to ACF of the initial calibration GC/ TCD Laboratory blank Every 12 hours, after CCV, and every 12 hours of analysis Analyte concentration < 3 x MDL from Table F 1 QAO = Quality Assurance Objective % R = percent recovery % RPD = relative percent difference RT = retention time % D = percent difference MDL = method detection limit GC/ TCD = gas chromatograph/ thermal conductivity detector HNF 2600, REV 15 Page 277 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN F. 2 INSTRUMENT TESTING, INSPECTION AND MAINTENANCE REQUIREMENTS Analytical personnel test, inspect, and maintain analytical equipment to ensure that the QAOs in Table F 1 are met.

F. 3 REPORT GENERATION Hydrogen/ Methane Batch Data Report The Hydrogen/ Methane batch data reports will be generated following the requirements as identified in WMP 400, Section 8.1.8, " Data Management for Headspace Gas Sampling and Analytical Results."

Hydrogen/ methane batch data reports/ records are stored in accordance with WMP 400, Section 1.5.1, " TRU Records Management."

Hydrogen/ methane results are reported to WWIS in accordance with WMP 400, Section 7.1.5.

F. 4 DATA REVIEW, VALIDATION AND VERIFICATION Data Generation Level Data review requirements are included in the HNF 2599, Section B3 10, for verification and validation.

F. 5 CORRECTIVE ACTION The corrective action process is outlined in the HNF 2599, Section B3 13.

F. 6 RECORDS The hydrogen/ methane analysis generates the following records, which shall be transmitted to the SPO in accordance with procedure WMP 400, Section 1.5.1:

  Hydrogen/ Methane Batch Data Report F. 7 TRAINING The hydrogen/ methane personnel described in this appendix are trained in accordance with WMP 400, Section 1.2.1, " TRU Training and Qualification Plan," and WMP 400, Section 1.2.2, " Qualification of NDE, NDA, Visual Examination, Transportation, and Inspection and Test Personnel". HNF 2600, REV 15 Page 278 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN F. 8 PROCUREMENT Procurement of hydrogen/ methane equipment will be performed in accordance with WMP 400, Section 2.3.1, " TRU Procurement Planning" and WMP 400, Section 2.3.2 " TRU Procurement Document Control."

F. 9 SOFTWARE Software associated with hydrogen/ methane equipment and evacuation is controlled by WMP 400, Section 6.1.1, " TRU Software Quality Assurance." HNF 2600, REV 15 Page 279 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN F. 10 PROCEDURES PERTINENT TO THIS APPENDIX Table F 5 lists the implementing procedures pertinent to hydrogen sampling and analysis.

Table F 5 Hydrogen Sampling and Analysis Implementing Procedures Document number Title TRU OP 001 Headspace Gas Samples of TRU Waste Containers LA 523 426 Determination of Permanent Gases in Waste Container Headspace Gas Sampling LO 090 450 Sample Chain of Custody Acceptance and Disposal LO 080 407 Cleaning SUMMA   Canisters HNF 2599 Hanford Site TRU Waste Characterization Quality Assurance Project Plan WMP 400, Section 1.2.1 TRU Training and Qualification Plan WMP 400, Section 1.2.2 Qualification of NDE, NDA, Visual Examination, Transportation, and Inspection and Test Personnel WMP 400, Section 1.3.1 TRU Corrective Action Management WMP 400, Section 1.3.2 TRU Nonconforming Item Reporting and Control WMP 400, Section 1.3.3 TRU Corrective Action Reporting and Control WMP 400, Section 1.5.1 TRU Records Management WMP 400, Section 2.3.1 TRU Procurement Planning WMP 400, Section 2.3.2 TRU Procurement Document Control WMP 400, Section 2.3.3 TRU Control of Purchased Items and Services WMP 400, Section 6.1.1 TRU Software Quality Assurance WMP 400, Section 7.1.5 WIPP Waste Information System Data Entry and Reporting WMP 400, Section 7.1.7 TRU Waste Container Management Activities WMP 400, Section 8.1.1 Logkeeping Practices for Headspace Gas Sampling and Analysis WMP 400, Section 8.1.8 Data Management for Headspace Gas Sampling and Analysis Results HNF 2600, REV 15 Page 280 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN ABBREVIATIONS/ ACRONYMS CBFO Carlsbad Field Office CH TRAMPAC Contact Handled Transuranic Waste Authorized Methods for Payload Control DOE U. S. Department of Energy DQO Data quality objective GGTP Gas Generation Test Program ( the Program) ppm parts per million PRQL Program required quantitation limit QA Quality Assurance QAO Quality Assurance objective QAPD Quality Assurance Program Document QAPjP Quality Assurance Project Plan QAPP Quality Assurance Program Plan QC Quality Control TRUPACT II Transuranic Package Transporter II VOC Volatile organic compound DEFINITIONS Precision is a measure of mutual agreement among individual measurements of the same property, usually under prescribed similar conditions.

Accuracy is the degree of agreement between a measured value and an accepted reference or true value.

Representativeness is the degree to which sample data accurately and precisely represent a characteristic of a population, parameter variation at a sampling point, or an environmental condition.

Completeness is the percentage of measurements made that are judged to be valid measurements. The completeness goal is to generate a sufficient amount of valid data based on project needs.

Comparability is the degree to which one data set can be compared to another. Sample data should be comparable with other measurement data for similar samples and sample conditions. To evaluate comparability, the standards shall be analyzed to the same degree of accuracy and precision. HNF 2600, REV 15 Page 281 of 281 5/ 11/ 2005 HANFORD SITE TRANSURANIC WASTE CERTIFICATION PLAN APPENDIX G PAYLOAD MANAGEMENT OF TRU ALPHA ACTIVITY CONCENTRATION ( The Hanford site is not implementing this appendix at this time.)


[Federal Register Volume 84, Number 240 (Friday, December 13, 2019)]
[Rules and Regulations]
[Pages 68049-68050]
[FR Doc No: 2019-26686]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2019-0377; FRL-10002-93-Region 5]

Air Plan Approval; Indiana; Second Maintenance Plan for 1997
Ozone NAAQS

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: Pursuant to the Clean Air Act (CAA), the Environmental
Protection Agency (EPA) is approving as a revision to the Indiana State
Implementation Plan (SIP), the State's plan for maintaining the 1997
ozone National Ambient Air Quality Standards (NAAQS) through the end of
the second 10-year maintenance period. On June 20, 2019, the Indiana
Department of Environmental Management submitted the State's plan for
maintaining the 1997 ozone NAAQS for the Indianapolis, La Porte County,
and South Bend-Elkhart areas and the Indiana portions of the Chicago-
Gary-Lake County, IL-IN (Chicago), Cincinnati-Hamilton, OH-KY-IN
(Cincinnati), and Louisville, KY-IN (Louisville) multi-state areas. EPA
proposed to approve the submission on September 25, 2019, and received
no comments. This action makes certain commitments related to
maintenance of the 1997 ozone NAAQS in these areas federally
enforceable as part of the Indiana SIP.

DATES: This final rule is effective on January 13, 2020.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R05-OAR-2019-0377. All documents in the docket are listed on
the www.regulations.gov website. Although listed in the index, some
information is not publicly available, i.e., Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. Certain other material, such as copyrighted material, is
not placed on the internet and will be publicly available only in hard
copy form. Publicly available docket materials are available either
through www.regulations.gov or at the Environmental Protection Agency,
Region 5, Air and Radiation Division, 77 West Jackson Boulevard,
Chicago, Illinois 60604. This facility is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding Federal holidays. We recommend
that you telephone Charles Hatten, Environmental Engineer, at (312)
886-6031 before visiting the Region 5 office.

FOR FURTHER INFORMATION CONTACT: Charles Hatten, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, the terms ``we'',
``us'', and ``our'' refer to the EPA.

I. What is being addressed in this document?

    This rule approves Indiana's June 20, 2019 submission to provide
for maintenance of the 1997 ozone NAAQS for the Indianapolis, La Porte
County, and South Bend-Elkhart areas and the Indiana portions of the
Chicago, Cincinnati, and Louisville areas through the end of the second
10-year maintenance period. The background for this action is discussed
in detail in EPA's notice of proposed rulemaking (NPRM), dated
September 25, 2019 (84 FR 50354).

II. What comments did we receive on the proposed rule?

    In the NPRM, EPA provided a 30-day review and comment period for
the proposed rule. The comment period ended on October 25, 2019. We
received no comments on the proposed rule.

III. What action is EPA taking?

    EPA is approving, as a revision to the Indiana SIP, the State's
plan for maintaining the 1997 ozone NAAQS for the Indianapolis, La
Porte County, and South Bend-Elkhart areas and the Indiana portions of
the Chicago, Cincinnati, and Louisville areas through the end of the
second 10-year maintenance period.

VI. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because it is not a significant regulatory
action under Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Ozone,
Volatile organic compounds.

    Dated: November 25, 2019.
Cathy Stepp,
Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

0
2. In Sec.  52.770, the table in paragraph (e) is amended by:
0
a. Removing the entry for ``Cincinnati-Hamilton, OH-KY-IN 1997 8-hour
ozone maintenance plan'' and adding in its place the entry ``Ozone (8-
Hour, 1997): Cincinnati-Hamilton, OH-KY-IN (Dearborn County (part))'';
0
b. Removing the entry for ``Indianapolis Hydrocarbon Control Strategy''
and adding in its place the entry ``Ozone (8-Hour, 1997): Indianapolis,
IN (Boone, Hamilton, Hancock, Hendricks, Johnson, Madison, Marion,
Morgan, and Shelby Counties)'';
0
c. Removing the entry for ``Lake and Porter Counties 1997 8-hour ozone
maintenance plan'' and adding in its place the entry ``Ozone (8-Hour,
1997): Chicago-Gary-Lake County, IL-IN (Lake and Porter Counties)'';
0
d. Removing the entry for ``LaPorte Hydrocarbon Control Strategy'' and
adding in its place the entry ``Ozone (8-Hour, 1997): LaPorte CO., IN
(LaPorte County)'';
0
e. Removing the two entries for ``Louisville Hydrocarbon Control
Strategy'' and adding in their place the entry ``Ozone (8-Hour, 1997):
Louisville, KY-IN (Clark and Floyd Counties)''; and
0
f. Removing the entries for ``South Bend-Elkhart 1997 8-hour ozone
maintenance plan'' and ``South Bend-Elkhart Hydrocarbon Control
Strategy'' and adding in their place the entry ``Ozone (8-Hour, 1997):
South Bend-Elkhart, IN (Elkhart and St. Joseph Counties)''.
    The additions read as follows:

Sec.  52.770  Identification of plan.

* * * * *
    (e) * * *

                       EPA-Approved Indiana Nonregulatory and Quasi-Regulatory Provisions
----------------------------------------------------------------------------------------------------------------
                  Title                    Indiana date          EPA approval                 Explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Ozone (8-Hour, 1997): Cincinnati-              6/20/2019  12/13/2019, [insert         2nd maintenance plan.
 Hamilton, OH-KY-IN (Dearborn County                       Federal Register
 (part)).                                                  citation].

                                                  * * * * * * *
Ozone (8-Hour, 1997): Indianapolis, IN         6/20/2019  12/13/2019, [insert         2nd maintenance plan.
 (Boone, Hamilton, Hancock, Hendricks,                     Federal Register
 Johnson, Madison, Marion, Morgan, and                     citation].
 Shelby Counties).

                                                  * * * * * * *
Ozone (8-Hour, 1997): Chicago-Gary-Lake        6/20/2019  12/13/2019, [insert         2nd maintenance plan.
 County, IL-IN (Lake and Porter                            Federal Register
 Counties).                                                citation].

                                                  * * * * * * *
Ozone (8-Hour, 1997): LaPorte CO., IN          6/20/2019  12/13/2019, [insert         2nd maintenance plan.
 (LaPorte County).                                         Federal Register
                                                           citation].

                                                  * * * * * * *
Ozone (8-Hour, 1997): Louisville, KY-IN        6/20/2019  12/13/2019, [insert         2nd maintenance plan.
 (Clark and Floyd Counties).                               Federal Register
                                                           citation].

                                                  * * * * * * *
Ozone (8-Hour, 1997): South Bend-              6/20/2019  12/13/2019, [insert         2nd maintenance plan.
 Elkhart, IN (Elkhart and St. Joseph                       Federal Register
 Counties).                                                citation].

                                                  * * * * * * *
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[FR Doc. 2019-26686 Filed 12-12-19; 8:45 am]
 BILLING CODE 6560-50-P