Appendix 9. Quality Assurance Project Plan (QAPP)

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1 Appendix 9 Quality Assurance Project Plan (QAPP)

2 DRAFT Quality Assurance Project Plan: The University of Michigan Dioxin Exposure Study Revised: February 2005 Adopted by: Title: Adopted by: Title: Adopted by: Title: Adopted by: Title: Date: Date: Date: Date:

3 Quality Assurance Project Plan Page i TABLE OF CONTENTS 1 INTRODUCTION Project Organization Project Team Responsibilities UMDES Principal Investigator (PI) Soil Sampling Program Manager/College of Engineering Principal Investigator Soil Sampling Supervisor Program Coordinators Soil Sampling Technician Responsibilities Contractor Responsibilities Problem Definition/Background Project/Task Description Blood Collection Household Dust Sampling Soil Sampling Sample Analysis Quality Objectives and Criteria Accuracy Precision Completeness Representativeness Comparability Method Detection Limits Bias Special Training/Certification Project Staff Field Staff Laboratory Staff DATA GENERATION AND ACQUISITION Sampling Process Design Overview Sampling Methods Sample Collection Cleaning of Equipment and Materials Sample Handling and Custody Field Sample Custody Chain-of-Custody Forms Sample Packing and Shipping Requirements Laboratory Sample Custody Sample Receipt and Maintenance of Custody Sample Storage Sample Tracking Analytical Methods Parameter Specific Information Laboratory Chain of Custody Procedures... 23

4 Quality Assurance Project Plan Page ii Analytical Records Quality Control Instrument/Equipment Testing, Inspection, and Maintenance Prevention Maintenance Procedures Schedules Records Instrument/Equipment Calibration and Frequency Inspection/Acceptance of Supplies and Consumables DATA MANAGEMENT Purpose/Background Data Recording Field Data Recording Laboratory Data Reporting Data Verification Data Transmittal Data Tracking Field Documents Soil Compositing Laboratory Data Storage and Retrieval Electronic Data Management ASSESSMENT AND OVERSIGHT Assessment and Response Actions Field Measurements Blood Sampling Household dust sampling Analytical Laboratory Measurements System Audits and Technical Reviews Alta Laboratory Audits Corrective Action Reports to Management DATA REVIEW, VERIFICATION AND VALIDATION Data Verification Data Review Requirements Data Validation Reconciliation with User Requirements REFERENCES... 40

5 Quality Assurance Project Plan Page iii LIST OF APPENDICES Appendix A Appendix B Appendix C Appendix D Appendix E Appendix F Appendix G Blood Collection and Analysis Household Dust Sampling Protocol Soil Sampling Protocol Analytical Laboratory Quality Assurance Program Method detection limit study results Document Checkout Form Corrective Action Request Form

6 Quality Assurance Project Plan Page iv AP ASTM COC CoE CSCAR DQO EWRE FEMA GC GIS GPS HASP HRGC HRMS ICAL IDL ISR LCS MCL MDEQ MDL MMMC/ML MMR mg ml MS/MSD OPR PARCCS PCBs PCDD/F PI ppt QA QAPP QAU QC RL RPD SOP SPH SRM UM USEPA DEFINITIONS AND ACRONYMS Analytical Procedure American Society for Testing and Materials Chain-of-custody College of Engineering Center for Statistical Consulting and Research (University of Michigan) Data quality objective Environmental and Water Resource Engineering (University of Michigan) Federal Emergency Management Agency Gas chromatograph Geographic Information Systems Global Positioning Satellite Health and safety plan High resolution gas chromatography High resolution mass spectroscopy Internal calibration Instrument detection limit Institute for Social Research (University of Michigan) Laboratory control samples Maximum contaminant levels Michigan Department of Environmental Quality Method detection limit MidMichigan Medical Center/Midland Laboratory Mobile Medical Response Milligram Milliliter Matrix spike/matrix spike duplicate Ongoing precision and recovery Precision accuracy representativeness comparability completeness sensitivity Polychlorinated biphenyls Polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans Principal investigator Part per trillion Quality assurance Quality Assurance Project Plan Quality Assurance Unit Quality control Reporting limit Relative percent difference Standard operating procedure School of Public Health (University of Michigan) Standard reference material University of Michigan United States Environmental Protection Agency

7 Quality Assurance Project Plan Page 5 1 Introduction The University of Michigan Dioxin Exposure Study (UMDES) is a collaborative effort within the University of Michigan between the School of Public Health, the Center for Statistical Consultation and Research, the College of Engineering, and the Institute for Social Research. This QAPP applies only to the sample collection and analysis programs associated with UMDES specifically the collection and analysis of blood, household dust, and soil. The interview and statistical analysis portions of UMDES will not be addressed in this document. The purpose of this QAPP is to document the necessary procedures required to assure that the project is executed in a manner consistent with generally accepted and approved quality assurance objectives. This QAPP is organized in accordance with the basic groups and subgroup elements discussed in the United States Environmental Protection Agency (USEPA) guidance for QAPPs. The four basic groups include project management; data generation and acquisition; assessment and oversight; and data validation and usability activities. The groups are subdivided into elements covering specific topics related to each group. This QAPP provides guidance and specifications to assure that: Proper preventive maintenance, equipment calibration, and approved analytical protocols will be implemented so that all field measurements and sampling analytical results will be valid; Sampling will be conducted using sample tracking systems and chain-of-custody procedures which properly identify samples being collected and insure the control of those samples from field collection through analysis and data reduction; Records will be produced and retained to document the quality of samples collected and analyzed, the validity of applied procedures, and the completeness of the investigation in relation to the approved scope of the project; Generated data will be validated; and Calculations, evaluations, and decisions completed or deduced during the execution of the study will be accurate, appropriate, and consistent with the objectives of the work plans. The requirements of this QAPP are applicable to the sample collection and analysis activities of all participants in the investigation. Section 1 of this QAPP summarizes project management activities and Section 2 presents QA/QC elements pertaining specifically to monitoring activities for the project. 1.1 Project Organization The University of Michigan staff members report to their team leader and the project manager for technical and administrative direction. Each staff member has responsibility for performance of assigned quality control duties in the course of accomplishing identified sub-tasks. The quality control duties include: Completing the assigned task on or before schedule and in a quality manner in accordance with established procedures; and Ascertaining that the work performed is technically correct and meets all aspects of the QAPP.

8 Quality Assurance Project Plan Page Project Team Responsibilities The University of Michigan (UM) is responsible for development and implementation of the UMDES Protocol and this QAPP. The UMDES sample collection and analysis effort can be divided into three programs: blood, household dust, and soil. The relationship of the University of Michigan personnel subcontractors that will work on the three UMDES programs are illustrated in the following figure: Figure 1: Personnel Blood collection and analysis Household dust sampling and analysis Dr. David Garabrant UMDES PI Dr. David Garabrant UMDES PI Beth Hedgeman Blood Collection Program Coordinator Mobile Medical Response Blood collection coordination MidMichigan Medical Center Phlebotomy services and blood sample processing Alta Analytical Laboratory Chemical analysis of blood Lynn Zwica Household Dust Sampling Program Coordinator ENVIRON Household dust sampling Alta Analytical Laboratory Chemical analysis of household dust

9 Quality Assurance Project Plan Page 7 Soil sampling and analysis Dr. Peter Adriaens Soils Sampling Program Manager/CoE-PI Dr. Avery Demond Soil Sampling Supervisor Tim Towey Soil Sampling Program Coordinator Soil Sampling Technicians UM students and staff Alta Analytical Laboratory Chemical analysis of soil ENVIRON Soil sampling audit function In addition to the responsibilities delineated in the following section, all UMDES and subcontractor personnel will comply with all confidentiality agreements specified by the University of Michigan UMDES Principal Investigator (PI) The Principal Investigator is responsible for the overall administration and staffing of the project. As part of the QA/QC responsibilities, the Principal Investigator will: Provide for overall direction of project objectives and activities as defined in the study protocol; Serve as Program Manager for the blood and household dust sampling programs; and Assure corrective actions are taken for deficiencies noted during household dust and blood sampling programs.

10 Quality Assurance Project Plan Page Soil Sampling Program Manager/College of Engineering Principal Investigator The program manager is responsible for maintaining a clear definition of and adherence to the scope, schedule, and budget of the project. As a part of this responsibility, the Soil Sampling Program Manager will: Direct all work performed by the UM and its subcontractors related to soil sampling activities; Assure corrective actions are taken for quality assurance deficiencies noted during soil sampling activities; and Be responsible for communicating changes in protocol and personnel to the Principal Investigator inasmuch as they impact the scope and schedule of the project Soil Sampling Supervisor The Soil Sampling Supervisor is responsible for the implementation of field activities, initial data acquisition, health and safety aspects of soil sampling activities, and for the proper selection and execution of procedures that have been accepted for use in the investigation. As part of the QA/QC responsibilities, the Soil Sampling Field Supervisor will: Supervise soil sampling technicians in the execution of data gathering tasks; Supervise the collection of samples so that sampling remains representative of actual field conditions; Supervise the regular maintenance of equipment to prevent unnecessary equipment failures and project delays caused thereby; and Assist in the maintenance of the schedule surveillance Program Coordinators The Program Coordinators are responsible for assisting in the implementation of field activities, data acquisition, health and safety aspects of field activities, and for the proper selection and execution of procedures that have been accepted for use in the investigation. As part of the QA/QC responsibilities, the Program Coordinators will: Perform data gathering, compilation, and management tasks; Serve as primary contacts with the analytical laboratory; Assist in supervising samplers and any additional technicians or subcontractors; Assist in reviewing the effectiveness of procedures and suggest changes that will enhance or more efficiently accomplish the objectives of the study protocol; Review the collection of samples and sample protocol so that sampling remains representative of actual field conditions; Schedule appointments for field sampling activities; and Assist in the preparation and review reports, submittals, and presentations to assure that data and conclusions accurately reflect observed conditions in the field Soil Sampling Technician Responsibilities The soil sampling technicians have the responsibility of collecting and compositing the soil samples from each eligible respondent s residence. Their responsibilities include:

11 Quality Assurance Project Plan Page 9 Perform sampling and compositing in adherence to the specified protocol; Perform self-verification on all documentation completed in the field and compositing laboratory; Submit field documentation to the Soil Sampling Program Coordinator; and Notify the Soil Sampling Program Coordinator in the case of any deviations from the protocols Contractor Responsibilities MidMichigan Medical Center/Midland Laboratory Responsibilities of MidMichigan Medical Center/Midland Laboratory (MMMC/ML) include: Provide service for phlebotomy (blood draw) requests for respondents living in Midland County and some of Bay County. Send nurse phlebotomists to the homes of UMDES respondents to complete the blood draws; Process and store the blood sample at the MMMC/ML; Express mail the blood sample to Alta Laboratories for analysis; and Maintain appropriate records of completed blood draws. MMMC/ML team leaders will be identified for coordination with Blood Collection Program Manager. The team leaders will contact the Blood Collection Program Manager immediately regarding any problems or concerns Mobile Medical Response Responsibilities of Mobile Medical Response (MMR), Inc. include: Serve as the data coordination center that will receive phone calls and documentation from the University of Michigan field interviewers who have identified study participants consenting to blood collection; Provide service for phlebotomy (blood draw) requests for respondents living in Saginaw County and some of Bay County; Send nurse phlebotomists to the homes of UMDES respondents to complete the blood draws; Deliver the blood sample for processing to the MMMC/ML; and Maintain appropriate records of completed blood draws. MMR team leaders will be identified for coordination with Blood Collection Program Manager. The team leaders will contact the Blood Collection Program Manager immediately regarding any problems or concerns ENVIRON International Corporation Responsibilities of ENVIRON International Corporation (ENVIRON) include:

12 Quality Assurance Project Plan Page 10 Collect household dust samples and maintain chain-of-custody of samples; Submit dust samples to analytical laboratory; Provide an internal consulting function for the data management of blood, household dust, and soil sampling programs; Provide an internal audit function for all aspects of the soil sampling program, including the collection, submittal to the analytical laboratory, and reporting of the results of QA/QC samples of UM laboratories involved in the study; Adhere to all protocols in the QAPP; and Notify the appropriate Program Coordinator in advance of any deviations from protocols. ENVIRON managers and team leaders will be identified for coordination with appropriate Program Managers and Coordinators. ENVIRON field staff will be responsible for collection of household dust samples and submittal to the analytical laboratory. ENVIRON will also conducting the QA/QC audit samples of the compositing laboratory at the University of Michigan Alta Laboratories Responsibilities and duties of the analytical laboratory include the following: Perform analytical procedures in adherence to the specified methods; Supply sampling containers and shipping cartons; Report results of analysis to appropriate program coordinator; Maintain laboratory custody of samples; Strictly adhere to all protocols in the Analytical Procedures; and Notify the appropriate Program Coordinator in advance of any deviations from QA protocols. The Alta Laboratory Technical Director will be the main point of contact for coordinating all sample submissions. The Laboratory Technical Director will be assisted by the Laboratory QA/QC Manager in performing the review and validation of all data generated to assure all data quality objectives have been met. The Technical Director or QA/QC Manager will contact the appropriate Program Coordinator immediately regarding any problems with samples that are noted during log in or with analysis. 1.3 Problem Definition/Background The UMDES is a collaborative effort within the University of Michigan between the School of Public Health, the Center for Statistical Consultation and Research, the College of Engineering, and the Institute for Social Research. This study is being undertaken in response to concerns among the population of Midland and Saginaw Counties that dioxins from the Dow Chemical Company facilities in Midland may have resulted in contamination of areas of the City of Midland and have contaminated the sediments in the Tittabawassee River flood plain. There is concern that resident s body burdens of dioxins are elevated due to environmental

13 Quality Assurance Project Plan Page 11 contamination. A central goal of the study is to explain the variability of blood serum dioxins as a function of a number of factors and to quantify how much variation each factor explains. Those factors include: soil dioxin concentrations on the resident s property, house dust dioxin concentrations within the resident s dwelling, proximity and duration of residence to the Tittabawassee River and Dow facilities in Midland, MI, consumption of fish and game from the Tittabawassee River and flood plain, past occupations, age, sex, and race. A personal interview will be conducted with each study participant. Additionally, measurement of the World Health Organization identified 29 specific congeners of dioxins, furans, and coplanar PCBs (the analytes ) will be conducted on the blood serum, house dust, and soil from consenting participants. This QAPP refers to the blood, household dust, and soil sampling procedures associated with the UMDES. Additional information on the scope and background of this project can be found within the study protocol (The University of Michigan Dioxin Exposure Study, 2004). 1.4 Project/Task Description Sampling in the UMDES will involve the collection of samples from four sample populations as follows: 1) Approximately 175 residents of Midland and Saginaw Counties who reside in the FEMA-defined 100-year flood plain of the Tittabawassee River between the Dow Chemical plant in Midland and the confluence of the Tittabawassee and Shiawassee Rivers in Saginaw 2) Approximately 175 residents of Midland, Saginaw, and Bay Counties who reside in census blocks adjacent to the FEMA-defined 100-year flood plain of the Tittabawassee River between the Dow Chemical plant in Midland and the confluence of the Tittabawassee and Shiawassee Rivers in Saginaw 3) 175 residents of Midland, Saginaw, and Bay Counties who do not reside in the flood plain of the Tittabawassee or Saginaw Rivers or the confluence flood plain of the Shiawassee River, and 4) 175 residents of Jackson and Calhoun Counties. From each participant, the following samples will be procured: blood, household dust, and soil samples. The specifics of each type of sample are described in the following paragraphs Blood Collection Each participant will be asked to provide an 80 ml sample of blood. Blood samples will be collected and handled by a professional phlebotomy service. Mobile and fixed locations phlebotomy options will be offered to each respondent. Blood will be allowed to clot, will be centrifuged and the serum will be decanted. Serum will be frozen at -20 C and will be shipped on dry ice to the analytic laboratory Household Dust Sampling Household dust sample collection will be performed utilizing the High Volume Small Surface Sampler (HVS3). The HVS3 is a vacuum cleaner equipped with a cyclone and a fine-particle filter capable of capturing 99.95% of particles above 0.3 µm aerodynamic mean diameter. The

14 Quality Assurance Project Plan Page 12 particulate matter collected in the catch bottle and on the fine-particle filter will be combined and sent to the laboratory for analysis for the specified analytes Soil Sampling Up to 7 stations at each residence will be identified depending on whether the residence resides within the floodplain (up to 6 stations if outside the floodplain). From each station 3 equally spaced cores will be collected using single-use Lexan push samplers or stainless steel push samplers, depending on the soil conditions. All sealed sample cores will be stored on ice before transport to the University of Michigan Environmental and Water Resources Engineering (EWRE) laboratories. At the EWRE labs, the samples will be stratified and composited before submission to the laboratory for analysis for the specified analytes Sample Analysis Blood, house dust, and soil samples will be analyzed for the identified World Health Organization identified 29 dioxin, furan, and PCB congeners. Analysis will be performed by Alta Analytical Laboratory (Alta) using internal modifications of USEPA methods 8290 (US EPA, 1994) and 1668 (US EPA, 1999). These modified methods or Analytical Procedures (AP) are prepared, issued and revised in accordance with the applicable Standard Operating Procedures (SOPs) at Alta. The methods that will be used in order to analyze the samples received for UMDES are listed in Table 2 below. Table 1: List of laboratory procedures. Title USEPA Method 8290 Modified method 8290 Modified Method 1668 Extraction & analysis of PCDD/F in soils and dust Extraction & analysis of PCDD/F in Human Plasma Extraction & analysis of coplanar PCBs in soils and dust The blood collection and analysis, household dust sampling, and soil sampling protocols are included in Appendices A, B, and C respectively. Alta has its own quality assurance program for UMDES, which can be found in Appendix D. 1.5 Quality Objectives and Criteria The data obtained from the UMDES field investigation will be compared with the defined quality assurance objectives and criteria for precision, accuracy, representativeness, completeness, and comparability (PARCC) as well as bias and sensitivity outlined in this section. The primary goal of these procedures is to ensure that the data reported are representative of actual conditions at the sites. This data assessment activity is an on-going coordinated process with data production and is intended to assure that all data produced during the UMDES acceptable for use in subsequent

15 Quality Assurance Project Plan Page 13 evaluations. Both statistical and qualitative evaluations will be used to assess the quality of the data. The primary evaluation of the data will be based upon the control samples described in Section 4. Table 3, located in Section 4, contains a summary of data acceptance criteria and the corresponding corrective action Accuracy Accuracy is the measure of the agreement between an observed value and an accepted reference value or true value. The accuracy of an analytical procedure can be determined by analyzing a sample containing a known quantity of material, and is expressed as the percent (%) of the known quantity which is recovered or measured. The concentration of the analyte relative to the detection limit of the analytical method is also a major factor in determining the accuracy of the measurement. Concentrations of analytes that are close to the detection limits are less accurate because they are more affected by such factors as instrument "noise". Higher concentrations will not be as affected by instrument noise or other variables and thus will be more accurate. Accuracy will be assessed by determining recoveries from spiked laboratory control samples and by comparing values obtained from reference samples. The %R utilizing laboratory control samples are calculated as follows: %R = ( C M ) ( C ) A x 100 where: C M = measured concentration of control sample C A = actual concentration of control sample Three types of control samples will be used to evaluate laboratory accuracy: internal standards, native standards, and performance evaluation samples. An internal standard is a reference substance that is an isotopically labeled analyte which is added to the sample prior to extraction and used in the quantitation and identification of native analytes. A native standard is a reference substance that is non-isotopically labeled. A performance evaluation sample is a standard reference material of known concentration, submitted to the lab in a blind manner. Performance evaluation samples will be submitted for soil samples. The measurement quality objective for HRGC/HRMS analysis is that the %R for 90% of the analytes for the standards falls within the following limits: % for natives blood standards; % for internal blood standards; % for natives dust/soil samples; % for internal standards for dust/soil samples; and % for performance evaluation standards for soil.

16 Quality Assurance Project Plan Page Precision Precision is a measure of the agreement between two or more measurements. Precision is usually stated in terms of standard deviation, but other estimates such as the coefficient of variation (relative standard deviation), range (maximum value minus minimum value), relative range, and relative percent difference (RPD) are common. The precision of the laboratory analysis is assessed by the comparison duplicate samples or by comparison of matrix spikes (MS) and matrix spike duplicates (MSD), if required by the analytical method. The RPD between the analyte levels measured in the MS sample and the MSD sample is calculated as follows: where C MS C MSD RPD = ( C MS + C MSD ) C MS = measured concentration of the matrix spike C MSD = measured concentration of the matrix spike duplicate Precision is measured by subdividing samples, preserving and numbering each split separately and sending the samples to the analysis laboratory as blind duplicates. In this study, soil samples will be homogenized, composited and subdivided in a strictly controlled, clean laboratory environment. Therefore, the Sample Preparation Laboratory will prepare duplicate composite soil samples on 5% of the samples analyzed. These blind duplicates will be used to assess variability arising from the sample homogenization, compositing, aliquotting, shipping and laboratory analysis processes. The measurement quality objective of this assessment is that 90% of these duplicate composite pairs agree within +50% for each congener in congener specific analysis. It is not anticipated that sufficient blood or dust sample will be available for creating duplicate samples Completeness Completeness is a measure of the amount of valid data obtained from the sampling program compared to the amount of data that were expected. Events that may contribute to reduction in measurement completeness include sample container breakage, inadequate sample volume, hemolysis (blood), and laboratory equipment failures. The percent completeness (%C) is determined as follows: ( M V ) ( M ) % C = 100 P where M V = number of valid measurements M P = number of planned measurements If the completeness objectives are not achieved for any particular category of data, the appropriate program coordinator will provide documentation why the objective was not met and how the lower percentage may impact the overall study objectives. Resampling of the blood, dust, or soil for UMDES would require additional respondent consent and is not planned at this

17 Quality Assurance Project Plan Page 15 time. An extra soil composite sample from each strata of each soil set from each respondent will be archived to avoid the need for resampling. The completeness objective for all measurements is 90% Representativeness Representativeness is the degree to which data accurately and precisely represent a characteristic of a population, parameter variations at a sampling point, a process condition, or an environmental condition. For sample collection, representativeness will be assured by following the work plans and applying proper collection techniques including the proper sample sizes and volumes, and sampling locations. In the laboratory, representativeness will be ensured by using the appropriate sample preparation techniques, by following appropriate analytical procedures, and by meeting the recommended sample holding times. Representativeness is a qualitative parameter, which is most concerned with the proper design of the sampling program (USEPA, 1987). Samples must be representative of the environmental media being sampled. Selection of sample locations and sampling procedures will be taken into consideration to obtain the most representative sample possible. Field and laboratory procedures will be performed in such a manner as to ensure, to the degree that is technically possible, that the data derived represents the in-place quality of the material sampled. Every effort will be made to ensure chemical compounds will not be introduced into the sample via sample containers, handling, and analysis. Laboratory sample containers will be thoroughly cleaned in accordance with procedures outlined in Appendix D. Analysis of equipment rinsate blanks will be performed to monitor for potential sample contamination from field and laboratory procedures. The assessment of representativeness also must consider the degree of heterogeneity in the material from which the samples will be collected. Sampling heterogeneity will be evaluated during data validation through the analysis of coded field duplicate samples. The analytical laboratory will also follow acceptable procedures to assure the samples are adequately homogenized prior to taking aliquots for analysis, so the reported results are representative of the sample received Comparability The objective for data comparability is to generate data for each parameter that are comparable between sampling locations and comparable over time. Data comparability will be promoted by: Using standard approved methods, wherever possible; Consistently following the sampling methods detailed in the SOPs; Consistently following the analytical methods detailed in the QAPP; Achieving the required detection limits detailed in the QAPP; Using identified standard methods for both sampling and analysis phases of this project;

18 Quality Assurance Project Plan Page 16 Requiring traceability of all analytical standards and/or source materials to the USEPA or National Institute of Standards and Technology (NIST); Requiring that all calibrations be verified with an independently prepared standard from a source other than that used for calibration (if applicable); Using standard reporting units and reporting formats including the reporting of QC data; Performing a complete data validation on a representative fraction of the analytical results, including the use of data qualifiers in all cases where appropriate; and Requiring that all validation qualifiers be used any time an analytical result is used for any purpose. These steps will ensure all future users of either the data or the conclusions drawn from them will be able to judge the comparability of these data and conclusions Method Detection Limits The expected achievable method detection limits (MDL) for tissue (blood) and solids (dust and soil) from congener specific analysis are provided in Table 2. The expected MDLs are based on studies performed by Alta Laboratories. The full results of those studies are contained in Appendix E. Table 2 Method Detection Limits Tissue MDL (parts per trillion) Solids MDL (parts per trillion) Chemical 2,3,7,8-TetraCDD ,2,3,7,8-PentaCDD ,2,3,4,7,8-HexaCDD ,2,3,6,7,8-HexaCDD ,2,3,7,8,9-HexaCDD ,2,3,4,6,7,8-HeptaCDD OctaCDD ,3,7,8-TetraCDF ,2,3,7,8-PentaCDF ,3,4,7,8-PentaCDF ,2,3,4,7,8-HexaCDF ,2,3,6,7,8-HexaCDF ,3,4,6,7,8-HexaCDF ,2,3,7,8,9-HexaCDF ,2,3,4,6,7,8-HeptaCDF ,2,3,4,7,8,9-HeptaCDF PCB-77 33'44'-TetraCB PCB '5-TetraCB PCB '44'-PentaCB PCB '5-PentaCB PCB '44'5-PentaCB PCB-123 2'344'5-PentaCB PCB '44'5-PentaCB PCB '44'5-HexaCB PCB '44'5'-HexaCB PCB '44'55'-HexaCB PCB '44'55'-HexaCB PCB '44'55'-HeptaCB

19 Quality Assurance Project Plan Page Bias Bias is the systematic distortion of a measurement process that causes errors in one direction. In this study, bias from the sampling design will be minimized by randomly sampling among the test population for the potentially contaminated regions of interest. Additionally, background samples will be taken of a test area that is similar to Midland and Saginaw Counties in terms of sex, age, and race distribution, proportion employed in manufacturing industries, a comparable mixture of urban and rural communities, and access to rivers and lakes for recreational use. 1.6 Special Training/Certification Special training/certification needed for project, field, and laboratory staff to successfully complete project work is discussed in this section Project Staff All UM project personnel will be trained in the Program for Education and Evaluation in Responsible Research and Scholarship (PEERRS). This is a web-based certification program for those members of the University of Michigan community involved in research activities. The intent of this training is to educate all personnel in the procedures, regulations, and responsibilities of those involved in human subjects research. Additionally, all sample collection staff will participate in an 8-hour training conducted by the Institute for Social Research and the appropriate Program Coordinator. The Sample Collection Teams Training will address subjects including the following: Introduction to UMDES; Community sentiment regarding the dioxin issue; Interacting with the public; and Protecting respondent confidentiality Field Staff Blood sampling personnel will be employees of MMMC/ML or MMR. MMMC/ML personnel who participate in blood collection will be trained, registered nurses. MMR phlebotomists are registered EMT paramedics. Training records for blood collection personnel will be maintained by their employer. Dust sampling personnel will be employees of ENVIRON. ENVIRON employees are trained in Hazardous Waste Operations and Emergency Response (HAZWOPER) according to the Occupational Safety and Health Administration s (OSHA) regulations (i.e., 29 OFR ). Additionally, ENVIRON personnel are trained in first aid and CPR. Household dust collection training will be provided prior to the initiation of field activities. All dust sampler training records will be maintained in personnel files at ENVIRON.

20 Quality Assurance Project Plan Page 18 Soil sampling personnel are employees of the UM and are also trained HAZWOPER trained according to OSHA regulations. Additionally, UM graduate student soil samplers have been trained in a one-credit course at the University of Michigan, conducted on May 10-15, The field course was tailored specifically to address the soil sampling procedures associated with the University of Michigan Dioxin Exposure Study. The course addressed topics including: sampling methods, sample handling, chain of custody, and field documentation procedures. All UM soil sampling personnel training records will be maintained by the soil sampling program coordinator Laboratory Staff Laboratory staff at Alta Analytical Laboratory may include biologists, microbiologists, chemists, and technicians with specific experience in sampling analysis. All laboratory personnel receive training and have proven proficiency in their designated analytical procedures. Laboratory personnel have been provided copies of the appropriate SOPs, which will be available at all times. The main objectives of the laboratory training are summarized below. Initial On-Site Training: The training requirement of each employee will be assessed periodically to ensure the competency of their job responsibilities, that career development objectives are being met, and that general-purpose educational opportunities are being utilized. The training program shall be relevant to the present and anticipated tasks of the laboratory. Manuals, texts, SOPs, journals, analytical methods and in-house Analytical Procedures are available for any new trainees, with on the job training performed by senior staff. Training Programs: Job related training at Alta will be provided through regularly scheduled in-house seminars and courses, university courses, conferences and seminars as well as one-onone on the job tutorials. Specified performance criteria must be successfully met while under supervision before personnel will be made responsible for activities that affect the quality objectives of the company. Training Documentation: Training records for Alta employees are maintained in each individual s training file. These records will be readily available to supervisors to ensure that employees have demonstrated capability prior to performing activities for which they are responsible. Employees are responsible for keeping their training file up-to-date. The training files shall maintain records of competence, education and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel.

21 Quality Assurance Project Plan Page 19 2 Data Generation and Acquisition The U.S. EPA QAPP Guidance Group B Data Generation and Acquisition elements (B1-B10) are addressed below. 2.1 Sampling Process Design Overview Four populations will be identified for study and a random sample of adults from each of these populations will be selected. The four populations are: Residents of Midland and Saginaw Counties who reside in the FEMA-defined 100- year flood plain of the Tittabawassee River between the Dow Chemical plant in Midland and the confluence of the Tittabawassee and Shiawassee Rivers in Saginaw Residents of Midland, Saginaw, and Bay Counties who reside in census blocks adjacent to the FEMA-defined 100-year flood plain of the Tittabawassee River between the Dow Chemical plant in Midland and the confluence of the Tittabawassee and Shiawassee Rivers in Saginaw Residents of Midland, Saginaw, and Bay Counties who do not reside in the flood plain of the Tittabawassee or Saginaw Rivers or the confluence flood plain of the Shiawassee River, and Residents of Jackson and Calhoun Counties. From each participant, the following samples will be procured: blood, household dust, and soil samples. The population that resides in the Tittabawassee River floodplain between the Dow Chemical plant in Midland and the confluence of the Tittabawassee and Saginaw rivers in Saginaw is of interest because it is believed that contamination of the Tittabawassee River flood plain by dioxin-like compounds is appreciable downstream and is not appreciable upstream of the Dow plant in Midland. Soil samples collected by the Michigan Department of Environmental Quality (MDEQ) in the sediments of the Chippewa River, Pine River, and Tittabawassee River above Midland, Michigan are in the range of 2-9 ppt TEQ. These levels are believed to be in the background range typically seen in many areas of Michigan. Sediment samples below Midland have highly variable dioxin, furan and PCB levels indicating contamination from Midland downstream to Saginaw. The choice of the confluence of the Tittabawassee and Shiawassee rivers in Saginaw as the lower end of the floodplain is based on information from the MDEQ that flood waters from the Shiawassee River do not travel upstream in the Tittabawassee River beyond this point. In addition, the congener profiles of soils from the north side of the Tittabawassee River at the confluence are similar to those found on the Tittabawassee River upstream of the confluence. Thus, sediments upstream of this point are believed to represent contaminants that have come downstream and are unlikely to be combined with contaminants that have originated from other sources. The sub-population that resides in Saginaw County, Midland County, and part of Bay County who do not reside in the floodplains of the Tittabawassee or Saginaw Rivers or the confluence

22 Quality Assurance Project Plan Page 20 floodplain of the Shiawassee River was chosen to provide a comparison group that is believed to have had the opportunity for dioxin exposure that is typical for residents of this region of Michigan. This population is believed to represent a range of dioxin, furan and PCB exposures including those who have background exposures that are typical of Michigan residents, those whose properties may have received fill dirt from the flood plain, those who have worked at Dow, those who recreate in the flood plains of the local rivers, those who eat sport fish from the local rivers, and those who live in areas downwind of Dow operations. The eligible population will be residents of Saginaw County and Midland County who reside on properties that are outside of the FEMA 100-year flood plain of the Tittabawassee River (below the point where the Chippewa River joins), the Saginaw River and its tributaries (Shiawassee, Flint, and Cass Rivers), and Saginaw Bay. In addition, the southwest corner of Bay County (Williams Township and City of Auburn) will also be included in this population because these areas are geographically close to the Tittabawassee River. It is anticipated that 10% of the participants will reside in the City of Midland, 18% in the City of Saginaw, and the remaining 72% in the surrounding areas of Saginaw County, Midland County, and the eligible part of Bay County. The population of Michigan outside of Saginaw and Midland counties will be chosen from Jackson and Calhoun counties. These counties are similar to Midland and Saginaw counties in terms of age, sex, and race distribution, proportion employed in manufacturing industries, a comparable mix of urban and rural communities, and access to rivers and lakes for recreational use (see Appendix 2). The purpose of including this population is to provide a referent group that is believed to have had background dioxin, furan and PCB exposures that are typical for residents of Michigan who live in areas that are not believed to be contaminated by dioxin-like compounds from Dow. All four populations will be sampled using a two-stage area probability household sample design. In the first stage, U.S Census blocks will be selected using probabilities proportionate to the number of households in the block. The second stage will select households using probabilities inversely proportionate to size. This design yields an equal chance of selection for households across the two stages. Within each sample household, a roster of eligible household members will be prepared, and one eligible household member will be selected at random. The random selection of a single eligible adult in each household will yield a sample that over-represents persons living in households with fewer eligible persons. This over-representation will be compensated in analysis using survey design weights. In order to be eligible for participation in the survey, subjects must be age 18 years or older and must have lived in the residence at least five years. They must also meet the eligibility criteria for having their blood drawn. 2.2 Sampling Methods Standard operating procedures (SOPs) will be employed to provide consistency and reproducibility to the sampling methods used by field personnel. The following sections present or reference the detailed methods for performing sampling activities including related support procedures for equipment cleaning, field measurements, and calibration and maintenance of field instruments. Sample custody procedures are presented in the sample handling and custody section of this QAPP. For all sampling related procedures, personnel will use personal

23 Quality Assurance Project Plan Page 21 protective equipment as required by the Health and Safety Plan (HASP) Sample Collection Blood collection will be performed by trained phlebotomists according to the protocol in Appendix A. Household dust samples will be procured by University of Michigan subcontractor ENVIRON using the HVS3 vacuum cleaner equipped with a fine-particle filter according to the protocol in Appendix B. Soil samples will be procured by University of Michigan personnel using hand-driven Lexan or stainless-steel samplers according to the protocol in Appendix C Cleaning of Equipment and Materials All reusable equipment and materials used during the field activities will be cleaned prior to use at the site and at specified intervals during the field activities. Cleaning will be performed according to the procedures specified in the appropriate protocol (Appendices B and C) to avoid the introduction of any chemical constituents or cross-contamination. A designated cleaning or decontamination area will be used or constructed, if necessary, so that all water and solvent generated during cleaning operations will be contained for proper disposal. 2.3 Sample Handling and Custody Proper sample handling and custody procedures will be employed as discussed in the following subsections of this QAPP Field Sample Custody The objective of field sample custody is to assure that samples are traceable and are not tampered with between sample collection and receipt by the analytical laboratory. Authorized persons will have custody of a sample when the samples are: In their physical possession; In their view after being in their possession; In their personal possession and secured to present tampering; and In a restricted area accessible only to authorized personnel. Field custody documentation will consist of both field log books and chain of custody forms Chain-of-Custody Forms Completed chain-of-custody forms will be required for all samples to be analyzed. Chain-ofcustody forms will be completed by the field sampling crew during each sample collection event. The chain-of-custody form will contain a sample s: Unique identification number; Sample date; Sample description; Sample type; and Analyses required. The original chain-of-custody form will accompany the samples to the laboratory. Copies will be made prior to shipment for separate field documentation. The chain-of-custody forms will

24 Quality Assurance Project Plan Page 22 remain with the samples at all times. The samples and signed chain-of-custody form will remain in the possession of the sampling crew until the samples are delivered to the express carrier (e.g., Federal Express) Sample Packing and Shipping Requirements Sample packaging and shipping procedures are designed to ensure that the samples and the chain-of-custody forms will arrive at the laboratory intact and together. Samples will be properly packaged for shipment according to the procedures presented in the appropriate protocols for blood, dust, and soil sampling (Appendices A-C) and submitted to the appropriate laboratory for analysis. Shipping containers will be secured with strapping tape and custody seals, if required, for shipment to the laboratory. The preferred procedure includes use of a custody seal attached to the front right and back left of the cooler. The custody seals are covered with clear plastic tape. The cooler is strapped shut with strapping tape in at least two locations. All shipments will be accompanied by the chain-of-custody form identifying the contents. A separate chain-of-custody form is required for each shipping container and should be placed inside the container. The original form will accompany the shipment and copies will be retained by the sampler for the sampling office records. If sample containers are sent by common carrier (i.e., by Federal Express or United Parcel Service), the carrier need not sign the chain-of-custody form. In such cases, the chain-ofcustody form should be sealed inside the sample container. The bill of lading (i.e., Federal Express label) serves as the custody documentation for the shipment so long as the container remains unopened until arrival at the laboratory. Copies of the bill of lading should be retained as part of the permanent documentation of the project Laboratory Sample Custody The laboratories will have written standard operating procedures (SOPs) for sample custody including: Sample receipt and maintenance of custody; Sample storage; and Sample tracking. In addition, the laboratory has written SOPs for laboratory safety, cleaning of analytical glassware, and traceability of standards used in sample analysis QA/QC Sample Receipt and Maintenance of Custody The laboratories shall have a designated sample custodian responsible for receipt of samples and have written SOPs describing duties and responsibilities. The laboratories shall have written SOPs for receiving and logging in of the samples. The procedures shall include but not be limited to documenting the following information: Presence or absence of chain-of-custody forms;

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