RESPONSE MEASURES WORK PLAN VOLUME II

\jAVTEX RBERS FRONT ROYAL INC.

AVTEX RBERS SITE

RESPONSE MEASURES WORK PLANVOLUME II

ADMINISTRATIVE ORDERDocket No. III-90-010-DC

Prepared for U. S. Environmental Protection AgencyHazardous Waste Management Division

Region III

November 7,1989

AVTEX FIBeB FRONT ROYAL INC.KMdridcUnoP.O. Box 1168

Frort Royil, Virginia 22630

AVTEX FIBERS FRONT ROYAL INC,AVTEX FIBERS SITE

. ,- .SECTJON 10QUALITY CONTROL/QUALITYASSURANCE PROGRAM PLAN

ADMINISTRATIVE ORDERDocket Ho. III-90-01-DC

Prepared for U.S. Environmental Protection AgencyHazardous Watte Management Division

Eegion III

November 7, 1989

AVTEX FIBERS FRONT ROYAL INC.Kendrick LaneP.O. Box 1169

Front Royal» Virginia 22630

SECTION 10

QUALITY CONTROL/QUALITY ASSURANCE PROGRAM PLAN

This section contains quality control and quality assurance plans for thosecontractors engaged in sampling and analysis activities. Plans from thefollowing contractors are included in this section.

Alliance Technologies* metaTrace

GET- S.D. Myers

BiosphericsChemical Waste Management

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ALLIANCE•«w. -rt !JSS® P9'es Corporationi§QgS4-:H v''"4aS li"J. -r-. -'

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QUAUTY ASSURANCE / QUALITY CONTROLIn compliance with ScctionX, 10.1, AcopyofADMI>flSnUTIVEORDERI>)ckctiii-90-01-DCwasprovided to each contractor, sob-contractor, laboratory, andconsnltantetfcctive november 3,1989,byamcndingtheprchascagrccmcm\rtthcachvcndof toindodctte ThetennBcf thepurchase onfcr it quiielnalaflwoiiperfonnedbe in compHanceworder and that each vendor use quality assnrance, quality control, sjiddiainrfcnstoo haccordancen&tt*mEPA NA1CPOJQES AND PROCEDURES MANUAL'tetedmsyimtKvidtdnovember 1984, EPAdocmem330/9-78-001-R> 'INTERIM GUIDELINES AND

1980,QAMS-OOS/80.Quality assnrance/qnality control poUdesand_pirx)edure8mfliinalsareprovidedfOTlhe3majorcontractors. ThemannalsforALlJANCBTEClHNOlXKJIESINC.aAppendix R ThentanoalforCH£MICALWASTBMANAOEM£I INC,isindiided\nthLheir

5. D. MYERSINC, isincludedin their wodcplanfor identification, segregation, and disposal ofwaste generated during the clean-lip of the pcb sites*The QA/QCmannalforBIOSPHERICSINC. Is included in this flection.

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Region HI

AVTEX FIBERS FRCNT ROYAL INC.KentidcLm

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September 1,1989

Dear Prospective Client,

Biospherics' goal is to provide our clients with fully dependable, responsive, highquality service at an economical cost, while maintaining flexibility to accommodatespecialized projects. Our diversified customer base is our best business reference andevidences our success in achieving that goal Over the past 20 years, the scope ofBiospherics' services has expanded rapidly in response to the demands of ever-increasing environmental regulations and the public's growing interest in safety andhealth.

This Statement of Qualifications wfll acquaint you with the analytical servicesoffered by the Laboratory Division. Personnel profiles, facility descriptions,instrumentation lists, and copies of certifications are provided for your evaluation.Project descriptions were chosen to show the array of our general experience; however,the list is not totally inclusive of our capabilities. If we have not addressed yourspecific need or application, please contact our Technical Sales and Customer Servicestaff for further information. They will be happy to answer your questions, and helpyou determine the most cost effective approach to satisfy your analytical requirements.They can also schedule an appointment for you to visit our laboratory, or for atechnical representative to call on you.

You may also have a need for Biospherics' other divisions: EnvironmentalServices, Information Services, and BioTech Programs. BSD offers asbestos analysis,asbestos removal training, and indoor-air-quality studies. ISD operates telephone hot*lines and provides data-base management programs. Biotech specializes in wastewatertreatment and specialty chemical development Statements of Qualifications for theother divisions are available upon request

Thank you for your interest in Biospherics. We welcome your inquiries and lookforward to working with you.

Sincerely,

Robert G. Edwards, Ph.D.Vice President for Science Service*

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CORPORATE OVERVIEW OF BIOSPHERICS

Biospherics Incorporated, a District of Columbia corporation, was founded In 1967 to provideservices and products in environmental engineering, public health, and biotechnology. The company hasdeveloped into a diversified scientific and technological firm with an established position in the Nation'senvironmental and health fields. It provides a feroad range of environmental health and Information servicesto private industry as well as Federal, State, and local government agencies. The business Is structuredaround three operating divisions and a corporate product development group: the Laboratory Division, theEnvironmental Services Division, the Information Services Division, and the Biotech Programs group.

The Laboratory Division provides complete analytical testing and field investigation services forthe identification, measurement, and control of pollutants In the environment, as well as full laboratorysupport services for the registration of pesticides. The Environmental Services Division (ESD) providesIndustrial hygiene consultation and analytical services to Identify, evaluate, monitor and eliminate hazardsin the work place. ESD specializes In indoor-air quality studies. PCB and asbestos monitoring, and asbestosworker training. The Information Services Division (ISD) operates federally and commercially funded freetelephone information services on health care, pharmaceutical, and other programs for the public TlieBiotech Programs group represents the R&D arm of the Company and Is primarily dedicated to thedevelopment of proprietary products and processes.

The Laboratory Division, ESD and, at times, ISD combine personnel talents to providecomprehensive services (environmental analytical, Industrial hygiene, field sampling, and Information) forcommercial and government projects. The staff are fully experienced with EPA. NIOSH and "Standard. Methods' methodologies, and with the Individual requirements of RCRA, CERCLA, OSHA, New JerseyECRA. the Clean Water Act. the Safe Drinking Water Act and other Federal and State legislation. Theyadhere to Good Laboratory Practices (GLP) for work performed under FIFRA. The laboratory is AIHA-

\. j accredited, and also certified In several states including New Jersey, New York. Maryland. Virginia,- Pennsylvania, and Delaware. Chemists, technicians and support staff provide analyses of soil, sludge,

sediment, wastewater, drinking water, ground water, air, hazardous waste, and other sample matrices. ESD• and the laboratory Ground Water Program staffs have extensive experience surveying, monitoring, andsampling for Indoor and outdoor environmental hazards with emphasis on asbestos, PCB's, solvents, fuels,pesticides and leaking underground storage tanks. ISD and the Laboratory Division also pool resources forproviding manufacturers with Information hotlines on chemical products. The highly qualified staff ofchemists, engineers, food technologists, library specialists and the like in Biotech Programs are readilyavailable to consult with or otherwise assist the Laboratory Division.

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DIRECTORS AND OFFICERS

Board o f Directors . . . . . . . . . .

Lionel V. Baldwin, Ph.D., President, National Technological University, Fort Collins, Colorado.

Richard D. Brown, Vice President, Finance, and Chief Financial Officer, Cornel Federal Systems, Chantllly,Virginia.

A. Brace Cleveland, President and founder of the GIT Investment Funds group of mutual funds and BankersFinance Investment Management Corporation of Arlington, Virginia.

George S. Jenkins, Chairman, Consultation Networks, too, Washington, D.C

Harold J. Johnson, Jr., President, CCB Corporation, Baltimore, Maryland.

Gilbert V. Levin, Ph.D., Chairman of the Board, President, Biospherics Incorporated, Beltsvttle, Maryland.

M. Karen Levin. Vice President. Communications, and Director,Informatlon Services Division, BiosphericsIncorporated, Beltvttle, Maryland. • : -

Donald M. Mosiman, Esq., Attorney and partner, Heron, Burchette, Ruckert, and Rothwell, Washington.D . C . ' . . . - . . - . - . - ; - . - ' . :

Corporate Officers

Gilbert V. Levin, Ph.D., Chairman of the Board and President -Robert G. Edwards, Ph.D., Vice President for Science Services.

Margaret E. Orayson, Chief Financial Officer.

M. Karen Levin, Vice President, Communications, and Director, Information Services Division.

Mary Jo Szoraoy, Vice President, Operations.

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SENIOR CORPORATE SCIENTIFIC STAFF

LEVIN, GILBERT V., PH.D., P.E, ENVIRONMENTAL ENGINEERING, FOUNDER. PRESIDENTAND CHAIRMAN OF THE BOARD OF DmECTQRS. 41 YEARS EXPERIENCE.

Dr. Levin provides overall direction to the Company. He is responsible for developing financial andprogrammatic plans, and supervising the conduct of research and development programs with emphasis oninnovative processes and products. Dr. Levin lists among his achievements the invention of the PhoStripmethod to remove phosphorus and nitrogen from wastewater; microbial radloresplrometry, rapid microbialidentification methods; and the use of the left-handed sugars, Lev-O-Cal, as low-calorie sweeteners. Inaddition, he was responsible Cor designing an experiment to detect life on Mars for the NASA VlldngMission; was co-experimenter on the NASA* Mariner 9 Mars Orbtter, and was principal investigator inprojects concerning planetary quarantine, saline water conversion, biological wastewater treatment,'measurement of microbial biomass by firefly bfoluminescent assay for ATP, and automated measurementof primary productivity. Prior to 1967 he was Director of the Life Systems Division of a Virginia-basedlaboratory. He also served in the Public Health Departments of Maryland, California, and the District ofColumbia.

EDWARDS, ROBERT O., PH.D., ORGANIC CHEMISTRY/BIOCHEMISTOY, VICE PRESIDENT FORSCIENCE SERVICES. 20 YEARS LABORATORY EXPERIENCE (9 YEARS ORGANIC CHEMISTRYRESEARCH, 11 YEARS ENVIRONMENTAL CHEMISTRY).

Dr. Edwards has overseen the dally administration of independent testing laboratories. Including BiosphericsLaboratory Division, for the past eleven yean. He has participated In a variety of analytical projectsrequiring his organic and biochemistry background. During his previous career at a Baltimore laboratorythat specialized In both environmental and petroleum analysis, Dr. Edwards oversaw the operation of tworegional branch laboratories, and the staffing of two other laboratories for the VS. Army; he was promotedfrom Laboratory Director to President and Chief Operating Officer. In addition. Dr. Edwards introducedcomputerized information and data evaluation systems developed In-house, and a variety of advancedautomatic analytical Instrumentation. While a post-doctoral Research Fellow and Research Associate at theUniversity of Pennsylvania School of Medicine, he participated in metabolic studies connected with cancervirus research.

ZEHNER, LEE R PH.D., ORGANIC CHEMISTRY, prRECTQR. BIOTECH PROGRAMS. 16 YEARSEXPERIENCE.

Dr. Zehner directs the corporate R&D program aimed at developing low-caloric bulk sweeteners as theirproduction processes, and at expanding use of the Pbosirip method to remove phosphorus and nitrogenfrom wastewater. He has been a Senior Research Chemist, Process Development Group Leader, andOrganic Research Manager for major chemical manufacturing companies. Dr. Zebner holds over 20 US.Patents which include the use of D-tagatose as a low-caloric bulk sweetener, the preparation and productionof catalysts, and the preparation of commerdaUy useful esters.

MCTIOUE, JAMES F., PRD., EPIDEMIOLOGY, fRTNCTPAL INVESTIGATOR. INFORMATIONSERVICES DIVISION. 23 YEARS EXPERIENCE.

Dr. Mdlgue served as the principal epidemiologist and scientific advisor on AIDS to the U.S. SurgeonGeneral. He was also the US. Public Health Service (PHS) scientific liaison with State and local health

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departments for the control of AIDS. He worked with the Food and Drug Administration in thedevelopment of the AIDS blood screening procedure and alternative HIV testing sites. While serving asan epidemiologist with the Centers for Disease Control, be designed and managed the Initial studies ofpestidde monitoring In human subjects and was the deputy director of the Perriae Primate ResearchLaboratory.

BEADLE, JAMES R., PH.DM ORGANIC CHEMISTRY, SENIOR RESEARCH ASSOCIATE. BIOTECHPROGRAMS. 9 YEARS EXPERIENCE.

Dr. Beadle develops proprietary chemical processes for production of new carbohydrates. He serves asgroup leader for the Lev-O-Cal research team. He Is skilled in creative synthetic organic chemistry. In hisprevious career in the chemical Industry he headed a research group developing new methods for specialtyproducts.

TABLE OF CONTENTS• • ' *PAGE

L PROFESSIONAL ANALYTICAL AND FIELD SERVICES 1

A. Environmental Analytical Services , 1

B. Agricultural Chemical Services 1

C Ground Water Investigations -• 2

D. Environmental Audits/Assessment Services 2

IL FACILITIES, EQUIPMENT, AND INSTRUMENTATION 3

I A. Facilities : 3

B. Equipment and Instrumentation 5

IIL REPRESENTATIVE PROJECTS AND EXPERIENCE 10

: A. Environmental Analysis • 10

B. Agricultural Chemistry 13' • C Ground WaterStudles 17

D. Environmental Audits/Assessments 17

IV. PERSONNEL . . 20i . '•._<••. i:' '

. V. CERTIFICATIONS AND ACCREDITATIONS 24

VL QA/QC OVERVIEW 25

I. PROFESSIONAL ANALYTICAL AND HELD SERVICES

ANALYTICAL SERVICES ;) • = • ! . ' iV.*ii:

o Full service capability In organic and Inorganic chemistry and microbiology for analysis ofsoil, sludge, sediment, wastewater, drinking water, ground water, air, hazardous waste, andother sample matrices.

o Full experience with specific analytical and data reporting requirements for RCRA,CERCLA, New Jersey ECRA, dean Water Act, Safe Drinking Water Act.

o Bulk characterizations of drummed wastes, sludge, and formulations. Bulk analysis for. ; - , . . : • . ' asbestos. ; _ *.- -+1 • r-' ' • . - • ? ' • ' .

o Analysis of industrial hygiene samples and sampling media by NIOSH methods.

o Method development and method validation services for unusual methods, specializedrequirements, or modifications of established methods for specific situations.

AGRICULTURAL CHEMICAL SERVICES

Laboratory Analysis

o Pesticide residue determinations: magnitude of the residue In crops and processedcommodities, In food and feed, and In animal tissues; dissipation In soils; diet of testanimals; market basket surveys. Analysis of large volumes of samples In support of productregistratlon/reregistratlon with EPA under FIFRA; Good Laboratory Practices implementedsince 1981. . ,

o Method development, method validation and Independent Laboratory Confirmation foranalysis of pesticide residues In crops, animal tissues, soil and water.

Management and Coordination of Studies .,r ,

O Soil dissipation : ,, ;,5^, , . . . .-; - ,„ - ^ [^ I. . .. ,

0 Field dissipation . . ,

o Rotational crops

o Crop residues

o Applicator exposure to sprays and dusts

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Technical Writlnt

o Pesticide analytical data for product registration:

environmental fateresidue chemistryexposure (subdivisions K and H)spray drift evaluation

o Pre-submission review and assessment of pesticide data and study reports.

o Formatting of reports to meet EPA submission requirements.

o Development of standardized field and feed and analytical protocols, and final reports forpesticide studies.

o Data validation and quality assurance of environmental studies.

. o Technical editing.

o Proposal preparation.

GROUND WATER INVESTIGATIONS

o Ground water vulnerability assessments.

o Design and conduct of ground water monitoring studies.

o Soil, water and sofl-gas sampling.

o Field analysis for volatile compounds.

o Pesticide Root Zone Model (PRZM) simulations for pesticide leachate potential

o Expert testimony and scientific assistance la litigation.

o Technical review of various aspects of proposed standards and legislation.

o Interactions with regulatory agencies.

ENVIRONMENTAL AITDITS/ASSESSMENTS

o Environmental audits for real estate transactions.

o Risk assessments for environmental contaminants.

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FACILITIES, EQUIPMENT, AND INSTRUMENTATION

FACILITIES

Biospherics Incorporated occupies a 100,000 square foot, custom facility built in 1987 and locatedin Beltsville. Maryland near metropolitan Washington, D.C with access to three major airports. TheLaboratory Division covers approximately 15,000 square feet It Is designed and fully equipped as a state-of-the-art environmental analysts laboratory. Floor plans are provided.

Key areas include:

Shtppint and Receivint

"Dils area is served by both a secure entrance door and a loading dock, and is adjacent to thesample logging room.

Sample Logging/Storage Facilities

A separate and secure room is maintained for sample logging and is equipped with a computerizedsample management system and separate storage areas. Locked sample storage facilities are located in ornear the logging room and include cabinets, refrigerators (including separate refrigerators for volatile*analysis samples), a 240 square foot walk-in cold room (4*Qand a 1000 square foot walk-In freezer (-20*C).The walk-in cold room and freezer have continuous temperature recorders with an alarm monitored by anoff-site security firm, Biospherics personnel can be alerted on an around-the-clock basis whenevertemperatures exceed control limits.

Wet Chemistry Complex • (

Two laboratories (one for sample extraction for organic analysis and one for inorganic wetchemistry) are located in the center of the facility and are supported by a separate glassware preparationroom, and a sample preparation room for residue analysis. These laboratories are equipped with eight fumehoods, six sinks, and 144 linear feet of bench space.

Metals Analysis Preparation

The metals analysis preparation room contains 42 linear feet of bench space, two sinks, and one8-foot fume hood. The room Is equipped wilt gas, air, and vacuum lines.

Instrumentation Rooms

The laboratory area Is bounded by six custom-designed Instrumentation rooms.

1 The high pressure liquid chromatography (HPLC) laboratory is equipped with acomputerized data acquisition system.

2 The volatile organic compound (VOC) analysis laboratory has its own separate ventilationsystem, maintained under positive pressure to prevent Intrusion of laboratory solvents.The room contains all purge-and-trap sample concentrators and autosamplers used for both. gas chromatography (GQ and gas chromatography/masi spectrometry (GC/MS) systems.The GCs used for VOC analysis are equipped with a number of different detectors, andare also In this room, linked to a central data acquisition system.

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GC/MS'j lo the next room are connected to their sample concentrators by short heatedtransfer lines passing through the wall

3 OOMS instruments are arranged In sets, each containing a volatile organic* analysisinstrument, a semi-volatile organic analysis Instrument, and a data system, to providecomplete redundancy In the event of failure of any Individual component "Die room hasa separate air-conditioning unit to handle the large output of heat from thisinstrumentation, and is fire-protected with a halon system.

4 OC instruments for both environmental analysis and pesticide residue studies are locatedIn the GC Laboratory. All are equipped with automatic samplers. Those .utilized forresidue work generally require a wider variety of detectors.

5 The room for metals analysis contains atomic absorption (AA) spectrophotometers equippedfor graphite furnace, flame, and cold vapor analyses, in addition to an inductively coupledplasma (ICP) emission spectrometer. Tne instruments are fully automated and computer-controlled. .

6 Miscellaneous instrumentation 'room contains an Ion chromatograph (1C), Technlconautoanalyzer, total organic halogen (TOX) and total organic carbon (TOC) analyzers, andinfrared (IR) and ultraviolet/visible light (UV/VIS) spectrophotometers.

Microbiology Laboratory

IMS Is equipped for analysis of water .and other media for bacteria, yeasts, mold, and fungi.

Archive Room

All records retained by the laboratory for work performed In compliance with Good LaboratoryPractices under FIFRA are kept in this room, which has strictly limited access and is protected by a halonfire prevention system. ' ••'• f--''* r

Environmental Services Division '-''' i(

Industrial hygiene facilities are located adjacent to those of the Laboratory Division and comprisea 5,000 square foot space bousing field industrial hygiene services, along with two laboratories and acalibration room. One laboratory for asbestos analyses (bulk and fiber) Is equipped with 10 opticalmicroscopes and a High Efficiency Paniculate Air Filter (HEPA) sample preparation area. An electronmicroscopy laboratory and an associated preparation laboratory house a transmission electron microscope(TEM) and preparative equipment The calibration room b maintained for field equipment preparationand calibration. ""•::*-•'-

- Research and Development Laboratoriesr L

Another 5,000 square feet of the laboratories are dedicated to research and development programs.They are equipped with isolation rooms, walk-In hoods, synthesis areas, and a metabolism laboratory.

Support Faculties - ' *-[ \ ; -;/;;;; : - ' " '

Support facilities In the remainder of the building Include a word processing section, conferencerooms, warehouse and storage area, a telecommunications center, a computer center, and administrationareas.

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Building security Is administered by a outside security company. All entrances to the building arelocated and alarmed. Programmed electronic key-cards control access 24 hours a day. Additionally, videocameras are Installed at the key-card controlled entrances. If an alarm sounds, an off-site private securitystation contact designated Blospherics employees and the police.

Fire protection consists of an automatic sprinkler system la all rooms except the GQMS Lab andthe Archive Room, which are equipped with automatic-discharge halon systems. Additionally, there are fireextinguishers throughout the building and emergency showers and fire blankets In the laboratory.

The water purification system employs a reverse osmosis (RO) unit, an activated carbon bed, adeionlzing (DI) resin bed and a UV sterilization unit The laboratory clean water service to the organiclaboratory is additionally passed through a charcoal filter after the RO/DI treatment

EQUIPMENT ANP INSTRUMENTATION

A listing of the principal equipment and instrumentation in Biospherics* analytical laboratoriesappears below. It includes four GOMS's, twelve GCs, four HPLCs, three AA's, one ICP, and a TEM.This apparent redundancy of instrumentation Is essential for handling large volumes of samples and fastturnaround requirements.

Laboratory Instrumentation . . .

Gas Cnromotograph* (GCs)

12 units, Hewlett-Packard 5880 (4) and 5890 (8) .

o Fully automated with 7672A and 7673A autosampters

o . Multiple general and specific detectors:

Electrolytic conductivity (Hall)Electron Capture.Flame lonizatloaFlame Photometric .Nitrogen/PhosphorusPhotolonlzationThermal Conductivity

o AH units microprocessor- or computer- (IBM PC-AT/Maximi software)controlled

o , Capillary and packed column capabilities

o Purge and trap concentrator systems withautosamplen: 3 units (Tekmar LSC-2/ALS) for volatile organic analysisbyGC

Gu Cbromatogr»ph/Mass Spectrometers

4 units, Hewlett-Packard 5985 (1) and 5890/5970 (3)

o Hewlett-Packard RTE Data System with 3 diskdrives, 2 HP 2934A printers

o Hewlett-Packard RTE-A Data System withWinchester-like disk drive and 2 HP 12235ARuggedwriter printers ,.,/...

o 9-irack tape units (2) and floppy-disk dcliverables capability

o NBS Welly Libraryt . .-•-.;-> f•'"•' - - ' 'o CI/EI dual source, 10-1000 amu on HP 5985 , .

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o Purge and trap concentrator systems with autosamplers (2 units, TekmarLSC-2/ALS and LSC-200CVALS 2016); automated heated purge and trapcapability

High Pressure Liquid Chromatographs (HPLC) ..

o 9 pumps (Waters, Oilson, EJdex) . • :.

o 1 pump and solvent conditioner for up to quaternary gradient (Hewlett-Packard 1050 system)

( j o Autosampters (3 Waters, 1 Hewlett-Packard)

o Multiple wavelength UV/VTS (4), fluorescence (2) and diode array (1)detectors ..-.. [

o • • Column-switching capabilities .

o Post-column derivailzation capability

o Column ovens

o Medium-pressure liquid chromatograph (MPLC) with fraction collector

o Manual Injecton (2)

o Computer-automated and controlled (Maxima chromatography data system,NEC APCIV computer and Hewlett-Packard ChemSution)

Inductively-Coupled Aifoa PUsnu EmUfloa Spectrometer (ICP)

• ' • • ' • Perkto-Elmcr 6500 XR /" r -':

o Computer-controlled

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o Fully automated, computer-controlled

o High resolution optics *

Atomic Absorption Spectrophotometers (AA's)

2 units, Pcrkln-EImer 5000 and 3030

o Graphite furnaces

o Fully automated, computer or microprocessor-controlled

1 unit, Perkin-Elmer 370

o Flame and cold vapor capabilities

Total Organic Halogen Analyzer (TOX)

1 unit, Xertex Dohrman

Total Organic Carbon Analyzer (TOQ i1 unit, Xertex Dohrman, wttn Horiba PIR-2000 detector

Technlcon Autoanalyzer n

b Dual channel

o Cartridges for ammonia, chloride, nitrate, nitrite, orthophosphate, sulfate

Ion Chromatograph (1C) ,

1 unit, anlon, Dlonex 2000

o Fully automated

o Microprocessor-controlled

Infrared Spectropbotometer (IR)

1 unit, Perldn-EImer 1420

o Ratio-recording

o Data station-controlled; dual disk driveUltraviolet/Visible Spectrophoioneters (UV/VIS)

2 units, Milton Roy Spcctronlc 1201 and 301

Miscellaneous ...

Electronic Analytical Balances ripH Meters/Specific Ion Electrode MetersCentrifuges „ ^IncubatorsUltrasonic Disrupters .. ' -. • -Rotary EvaporatorsN-EvapsShakersBlenders, Tissuemteers and Food ProcessorsFurnaces and Ovens

- - . - - : , ?-ir ».•.•• '• •Field Equipment

1 unit Sentex "Sccntograph" field-portable gas Chromatograph with electron capture andargon lonlzatlon detectors and Toshiba 1200 computer control

1 unit Photovac TIP II total kmizable particle detector for soil-gas studies, with 2 gas-sampling probes and Heath Plunger Bar

1 unit JMC Zero Contamination foil sampling tube

1 unit 2-lncfa JMC Professional Bucket Auger with extensions

1 unit Oeopump 2 AC/DC peristaltic well pump

1 unit Orundfos Pump SP27,10 HP

2 units Solinst Electronic water level Indicators

1 unit KV Macho system electric hammer and drill adapter

Bailers (teflon, stainless steel); portable pH, temperature and specific conductance meters;air-sampling pumps

Computer EquipTqentj Laboratory DMslofl

9 units IBM PC work stations, models AT and PS12-60,6 of which are networked

1 unit IBM PS&-80 dedicated Hie server

1 copy Radian Corporation Sample & Analysis Management (SAM) software for laboratoryinformation management and report generation

2 units HP Laser Jet n printers

3 units NEC P3 NLQ Plnwriter printers

1 unit HP TUnk Jet printer

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1 unit HP 7475A 6-pen plotter

1 unit Epson FX-85 dot-matrix printer

2 units. T1100 Plus and T1200H Toshiba lap-top computers

Software: Lotus Symphony 2.0. dBase IV, Work Perfect 5.0, Harvard Graphics, HarvardTotal Project Manager.

Computer Equipment: Corporate

WANO VS 5600 word and data processing system with multiple work stations and printers,and communications software

IBM System 36

Environmental Services Division Laboratory Equipment

Transmission Electron Microscope (TEM)

1 unit Hitachi Model 600 AB

o Energy Dispersive X-ray Analyzer with Deltadass kevex

o Evaporative Coater

o Plasma asher

o Sputter coatcr

Polarized Light Microscopes

6 units Olympus

Phase-Contrast Microscopes

10 units Olympus, Zelss, Nikon

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IIL REPRESENTATIVE PROJECTS AND EXPI -IENCE

Biospherics has be n performing laboratory testing since It was founded In 1967. In the interveningyean it has been Involved a wide variety of analytical chemistry projects, irom wastewater monitoringto the Viking mission to Mars. With the advent of Federal and State legislation aimed at protecting allaspects of the environment • air, soil, surface water, ground water, vegetation, wild life, the food chain, thework place - Biospherics has been la the forefront in providing the laboratory and industrial hygiene supportservices necessary to enable our clients to comply with the law.

With the exception of government contracts, our clients' names are kept confidential. In therepresentative project summaries that follow, only the general types of commercial clients are Identified.

ENVIRONMENTAL ANALYSIS

U.S. Environmental Protection Arencv/EMSL 1981 - 1986. 1983 • Present

Biospherics has been a quality assurance reference laboratory for the EPA/EMSL Quality AssuranceBranch for the past 6 years. Tht Laboratory Division has provided analytical validation services for themethods found In "Methods for Chemical Analysis of Water and Wastes,* EPA-600/4-79-020, as well as othernew methods under evaluation.

From 1981 to 1986 Biospherics received yearly contracts to evaluate and validate methodequivalency, precision, and accuracy for organic* Inorganic, and microbiological water quality parameters ina variety of Industrial effluents and drinking water supplies. Samples were collected from NPDES-pennittedprocesses and water supplies and analyzed to evaluate methodology. Task assignments Included generatingprecision, accuracy, and equivalency statements for over 20 contaminants in effluents and surface water. •-During one 12-month period, the laboratory performed 15,000 analyses for EMSL, investigating the ( japplicability and equivalency of newly approved methods for trace metals, cyanides, and phenolic* in V»xindustrial effluents.

U.S. Air Force Occupational-and Environmental Health Laboratory fOEHLV Brooks AFB 1981 - Present

Biospherics* laboratory analyzes hundreds of samples every month for a combination of volatileorganic*, EP toridty, IgniublUty, waste characterization, trace metals, asbestos, organic vapors, PCB's,pesticides, and many other organic and inorganic parameters. Analyses are performed on many matricesincluding air, solids, liquids, water, wastewater, oils, bulk materials, commercial products, and biological*.EPA-approved OC and GC fS methods are used routinely. A 15-worUng day turnaround time b requiredin most cases, with the ability to be able to report results la as little as 24-to-48 hours when necessary.

A major project successfully handled for OEHL by Biospherics has been the quality monitoring ofdrinking water at USAF bases in Western Europe and Central America. Biospherics has prepared samplebottles and outward-bound and return shipping containers, arranged shipment of kits to bases, andcoordinated their return under proper temperature controls and la sufficient time to enable fully validanalyses to be performed within the 14-day holding time.

/> ."' '"

OEHLfeubcontractor to Environmeptal Engineering Company 1986 • 1991

This project Is designed to (a) evaluate U.S. Air Force sites for environmental contamination, (b)determine the nature of the hazard and evaluate risks to the environment, public, and 'US. Air Forcepersonnel, (c) assess feasibility for remedial action and develop plans, (d) support remedial actions, and (e)support US. Air Force environmental programs In general Biospherics provides full analytical laboratorysupport; sampling/field support for bottle preparation, shipping, preservation, and chaln-of-custody;consultation for health and safety plan and QA/QC plan development; and other environmental sciencessupport as required. , - L

OEHLfeubcontractof to Environmental Engineering Company 1989 • 1994

Biospherics is a member of the team which b contracted to provide industrial hygiene,environmental, engineering and analytical services to OEHUBrooks Air Force Base for 5 years. Theemphasis of the contract Is on ambient air monitoring and analysis; however, soil and water samples willalso be analyzed by Biospherics for organic, Inorganics, pesticides, biological, radiological*, and PCB's.Biospherics will also be performing all TEM analyses of asbestos.• " " . - , - - .. ,,'- .•,;;.'•*:*; Li,'1':""1; ' • ' "' " , ';.... . .-< - • - ' .Montgomery County. Maryland. Department of Environmental Protection 1987 - 1989

. Hundreds of analyses are performed monthly for landfill, ground water, drinking water, surfacewater, effluent, and other environmental programs. Analyses are performed for a wide variety of organicand inorganic parameters including priority pollutants, trace metals, minerals, and nutrients. Samplingsupport Is provided with bottle preparation and preservation services. Drinking water, ground water, andsurface water samples are analyzed for volatile organic by OC and OC/MS methods. A 5-day to 3-weekturnaround Is required.

Maryland Environmental Services (MES>. Department of Natural Resources 1988 * 1990

The purpose of this contract is to provide the Maryland Environmental Services Operations andMaintenance Division with analytical and back-up services to MES laboratories for organic and inorganicconstituents in water, wastewater, sludge, and soil simples. The analytical results from these samples willbe used to support investigations and facilities for which MES b responsible, including drinking watertreatment plants, wastewater treatment plants, ground water monitoring sites and sludge disposal facilities.A 7-day to 3-week turnaround time b required.

1 " ; ' " . " ' - • > •Maryland Department of Transportation 1987 • 1989 • • \- '

- • - ' - . ' '" '"' *••••*•>"''''<:' '' ' " , , , , ' ' ' -' '

Under contract to the State Highway Administration, Biospherics provides sampling and analyticalsupport as needed. Samples of sott, ground water, surface water, effluent and well water were routinelyanalyzed tor organic and Inorganic parameters. Including priority pollutants, trace metals, minerals andnutrients. . '.' . "

Malor Computer Manufacturer 1985 - 1988. *1 fif\'..',Jr

Biospherics analyzed over 200 samples monthly for a ground water monitoring program, forhexavalem chromium, fluoride, and volatile organic*. In addition, special projects were performed foranalysis of water samples by OC/MS methods for priority pollutants and water quality parameters.

11

.r ,, T ARl*OQ27l_>, Y,V~ '- •••-••* '.;

Major Environmental Enptneerint Firms

Much of Biospherics environmental work consists of providing analytical and Industrial hygiene v Jservices to environmental and architectural engineering firms. Dozens of batches of soil and water samples "xarrive at the laboratory In preserved containers and coolers supplied by Biospherics, on a dairy basb, Theyare analyzed for a wide variety of organic and inorganic parameters, pesticides and/or PCB's. A numberof different reporting requirements must be satisfied la accordance with the laws of the State from whichthe samples come, or with regulations under which the sampling may be performed.

U.S. Kaw. David Tavlor Naval Ship Research and Development Center 1979 - 1985

Biospherics provided engineering and analytical services for the US. Navy Shipboard Pollution 'Abatement Program. The laboratory analyzed materials, Including chemical formulations, to be used on-board ship. Determination of bulk constituents, as well as outgassed and condensed products, was•performed to assess the presence and impact of potentially hazardous components.

NSRDC also contracted with Biospherics to conduct surveys of various airborne contaminants. Airsamples were collected on board ship during normal transatlantic operations for fuel oil, nitrogen oxides,sulfur dioxide, trace metals, paniculate* and polynuclear aromatics and others. Samples were analyzed bothon site and In the laboratory. Different collection and analysis methods were used for fuel oil, nitrogenoxides, and sulfur dioxide for the purpose of method evaluation. The final report included statistical•analyses of the methods, recommendations of methods, and overall assessment of potential health hazards.

. Thousands of analyses for ofl in water were performed la support of the Navy evaluation ofoU/water separators and monitors. Required turnaround time of results was from 24 hours to four weeks.

National Institutes of Health 1982 - 1984

The National Institutes of Health required oa-demand analytical services for Its occupational andenvironmental programs. Analytical tasks Included: analysis of 230 multi-layered solvent wastes for organicsolvent composition, toxic metals, flash point, and 20 other chemical and physical characteristics; analysisof 50 solid waste samples for EP-tcnddty, corrosrvity, IgnftabUiry, and reactivity, on-going analysis of friableinsulation materials for asbestos; analysis of air-sampling media for organic vapors, trace metals, andasbestos; and quality control analysis of reagent water, personal protection devices and laboratory chemicals.

Major Archltecture/Enpfneeriny Company 1987

For a major survey and analysis project, Biospherics analyzed 17,000 bulk asbestos sample* fromD.C government buildings la a 5-month period. A 48-hour turnaround time was required for all samples.Up to 350 samples were analyzed per day.

General Services Administration 1988 - Present

The laboratory and ESD work jointly to provide GSA with comprehensive Industrial hygiene surveyand analytical services. Biospherics has performed a wide variety of sampling surveys for environmentalhealth hazards including asbestos, pesticides, PCBX formaldehyde and other chemicals throughout theNational Capital Region. The laboratory hat analyzed thousands of drinking water samples for water qualityparameters, including lead.

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.' District of Columbia. Environmental Control Ptvlsfon 1988 - 1989 '

Biospherics prepared and analyzed a large number of fresh and frozen white fish samples for(j chlordane, PCB's, heavy metals, and priority pollutants.

Department of Justice 1988

A comprehensive environmental health assessment was conducted In response to medicalabnormalities experienced by females working in one building. The study Included feet-finding interviewsand meetings, walk-through examinations of the premises, ventilation and air-quality surveys, watersampling and analyses for lead, nalogenated hydrocarbons, and aromatlcs.

AGRICULTURAL CHEMISTRY ;£ ,: '

International Pesticide Manufacturer 1987 * 1988 • • "Specialized HPLC Analysis

The contract was for the analysis of crop samples generated from Magnitude of Residue tests onpeanuts, including peanut vines, hay, hulls and autmeat, for the registration of a herbicide. All aspects ofthe work were conducted under EPA's FIFRA Good Laboratory Practices. All methods required twodimensional HPLC : :,:

Two wavelengths were monitored using ultraviolet absorbance detection. Only one wavelength wasused for quantitation; the ratio of the wavelengths was calculated as a confirmatory technique. One of theBiospherics Investigators presented (as an Invited speaker) a description of this method at the Twenty-seventh Annual Eastern Analytical Symposium in New York City during 1988.

Mafor Pesticide Manufacturer 1988 * PresentSoil Analysis/Terrestrial Dissipation Study

Hie contract was for the analysis of son samples generated by a Terrestrial Dissipation Study, forthe registration of an insecticide. All aspects of the study were conducted under the EPA's FIFRA GoodLaboratory Practices. Considerable efforts were made to modify extensively a method which had beendesigned to analyze the parent only, to allow the quantitation of a major metabolite, and to separate soilInterferences. - -" . - ;- ••, /^Criv?' • "•'' ' • "•" -

Samples were extracted, cleaned up, concentrated, and analyzed on two separate OC systems (FPD-P and NPD). Data was collected from two sites at various time intervals, resulting in approximately 1,000data points.

MaTor Chemical Manufacturers 1989 - 1990 rResidue Studies

Multi-Residue Method Testing T ^

The object of this testing b to determine the behavior of pesticides and their metabolites throughthe standard Pesticide Analytical Methods for foods, which PDA uses to screen samples for multipleproducts at one time. Standard solutions are tested In order to observe what response can be expectedusing different types of columns and detectors. Recoveries are evaluates inroujh clean-up columns and the

13

entire method is tested with fortified foods. A total of 16 products are being tested for one client, 4 foranother.

Ma lor Chemical Manufacturer 1986 - PresentSpecialized HPLC Analysis

This contract Is for the analysis of crop samples generated from Magnitude of the Residue tests onpeas, lentils, soybeans, canola and canola processing fractions, as well as son residue samples, for theregistration of a herbicide. All aspects of the work wen conducted under EPA's FIFRA Good LaboratoryPractices. All methods required two dimensional HPLC, preceded by medium pressure liquidchromatography (MPLQ for fractionation. Separate fractions were analyzed (under separate conditions)for the parent and the add metabolite.

The anarytes were measured by fluorescence detection In the soil matrices and ultraviolet absorbancein the. plant matrices. A minor metabolite was analyzed In the peas and lentils by a similar method, usingelectrochemical detection.

Malor Pestldde Manufacturer 1987Animal, Tissue Residue Study

Ooat and chicken tissues. Including goat milk and chicken eggs, and the animals' feed, were analyzedfor levels of a pesticide and its metabolite. The in-life ponton of the study was subcontracted andsupervised by Biospherics.

The analytical method, which detivatized the parent of the metabolite, quantified the total residueby OC/MS with concurrent confirmation of its identity. The method provided was first slightly modifiedto adapt It from crop samples to animal tissues. Complete method validation and storage stability studieswere also conducted.

Malor Pestldde Manufacturer 1987 « 1989Water, Soil and Sediment' AnalysisRun-Off and Pond Dissipation Study

The studies on this insecticide were conducted to determine its environmental fate In areas doseto bodies of water. They were used for registration with EPA. The method provided by the client wasmodified for the various matrices. After extraction and clean-up specific to each matrix, parent andmetabolites were analyzed by OQF1D or COM3.

Government Agency 1989 - 1991Soil Analysis

Terrestrial Dissipation Study

Soils are analyzed for residues of two herbicides. The studies are conducted to ascertain theenvironmental fate of these long-lasting herbicides in soils under different climatic conditions. A total ofabout 3,000 samples will be analyzed. Very tot turn-around times are necessary to determine the depthof analysis at the next sampling event

After extraction, concentration and clean-up, the samples are analyzed by HPLC and diode-array

14

\ z

UV detection; optimal wave-length monitored for each herbicide Is determined by UV detection. Separationof interferences is achieved either under isocratic conditions or under a programmed gradient of threesolvents.

Maior Chemical Manufacturer 1989Crop Analyses

Independent Method Validation v • .:Magnitude of the Residue Study;, ." .

An analytical .method for the determination of residues of a fungicide In fruits is validatedindependently In three crops, under minimum communications, to satisfy the requirements of PR 8S-5.After validation, about 150 fruit samples are analyzed to determine the Magnitude of the Residue.

After extraction and concentration, the samples are cleaned up by liquid phase extraction, followedby florisil clean-up, concentration and analysis by OC/ECD. .

Foreign Pesticide Manufacturer 1988 - PresentCrops Analysis ~ ,,*;- .^ ••*,_. . : •

Magnitude of the Residue Studies . : :'

An analytical method, which had been developed for another Insecticide of the same class, wassupplied. It was modified to provide consistent recoveries of the parent and one metabolite on OC with:flame photometric detection, and for another metabolite on HPLC with UV detection.

A storage stability study was conducted on selected commodities, representing the Raw AgriculturalCommodities of the more than 1,200 samples analyzed.

International Pesticide Manufacturer 1989Soil Analysis


Soil samples are analyzed to determine the environmental late of a fungicide. From a total ofabout 500 samples, a portion is analyzed with a very short turn-around time to help determine the depthof sampling for the second year of sampling.

After extraction and concentration, the samples are cleaned by solid phase extraction, furtherconcentrated and analyzed by GQNPD. -• ,-: - •

Mafor_Pesttdde Manufacturer 1986 .1989Crops Analysts ' \ "

Magnitude of the Residue Study > ; . - ; - . '

Many different crops were analyzed for the residues of a pesticide and its metabolite. The studieswere conducted in pan to satisfy the Magnitude of the Residue requirements for registration, in pah asa market basket survey to define exposure, v .

' . After extraction, the parent was hydroryzed to the metabolite and distilled. Apajtysjs was done feyeither of two methods: (I) exposure with a reagent for color development and narjsls fcy

15

spectrophotometer, (2) derivatizatlon, and analysis and confirmation by OC/MS.

Mator Chemical Manufacturer 1989 - 1991Soli Analysis


Soil samples from a long-term terrestrial dissipation study are analyzed to determine theenvironmental late of a long-lasting fungidde In the soil environment

After extraction, concentration and clean-up through a florisll column, the sample is furtherconcentrated and analyzed by OC/NPD.

Pesticide Manufacturers' Consortium 1988 • 1989' Soil, Sediment and Water Analysis

Terrestrial Field Dissipation StudyAquatic Field Dissipation Study

Samples included soil and irrigation water samples from a Terrestrial Study, sediment and watersamples from an Aquatic Study. Analytical schemes were developed to assure that all aspects of theenvironmental rate of the copper-containing pesticide could be evaluated, and included the followinganalyses: sulfate, alkalinity, total organic carbon, dissolved organic carbon, total caldum, total magnesium,total copper (furnace), dissolved copper (furnace), extractable Iron, -extractable copper, extractablemanganese, total copper (flame), TSS cupric Ion, TSS total copper and TSS dissolved copper.

All methods were validated for the matrices to be analyzed, and blind QC samples were includedIn the analyses in addition to the recovery samples.

•M*"Malor Pestldde Manufacturer 1988 - 1989

'Water AnalysesAquatic Toxlcity Study .

Water samples collected by the contractor conducting In-life aquatic toxicology testing were analyzedfor total concentration of a fungldde.

The method supplied was first modified from a crop matrix to a water matrix, and validated;sample* were analyzed by CC with a Flame Photometric Detector for concentration of the parent only.dose coordination with the in-life contractor was necessary to accommodate the short holding times of thesamples.

Malor Pesticide Manufacturer 198S - 1989Management and Coordination of Studies-Field Dissipation

Twelve Terrestrial Dissipation Studies are monitored for respect of protocols and adherence toGood Laboratory Practices In the field studies. Protocols have been reviewed and changes suggested to thesponsor, field cooperators have been visited and then* understanding of the protocols checked; fieldprocedures have been inspected. All aspects of sample handling and shipment are supervised, and^allsample transfers are verified. Including receipt by the analytical laboratories. RainfolfaTnpnTto'retf Itly,and the field cooperators are contacted when they need a reminder to apply supplemental irrigation.

16 J

ARU00276

This monitoring and coordination of studies relieves the manufacturer of the day-to-day, detailedreview of each study. Monthly reports summarize activities and problems encountered in the studies, whichallow the manufacturer to take action if necessary.

ftfafor Chemical Manufacturer 1987 - 1989 {' . . - . TDevise Standardized Protocols and final Reports lor Pestldde Studies

Documents were designed to minimize time and labor needed to generate specific protocols andreports and to assure the client of compliance with EPA data reporting requirements. Standardized In-lifereports and data checklists were also designed for several studies Including field dissipation and residues oncrops, processed foods/feeds, poultry, and livestock.

Agrichemfcal Manufacturers 1987 - 1989Summary Reports o f Pesticide Studies ' : * ' " . . "

Under contract to several alchemical manufacturers, Biospherics wrote a number of summaryreports on pestfdde studies. He reports synthesized field and analytical data for submission by themanufacturers to the EPA. The reports were required to support registration of a variety of pesticides.Types of studies reported Included residues In crops and poultry tissues and eggs, and dissipation In soils.

GROUND WATER AND ENVIRONMENTAL CONTAMINATION ASSESSMENT

United States Department of Agriculture (USDA> 1988 -1991 .Pre-dosiire Site Investigation: Soli and Waster Analyses

The Yakima Agricultural Research Laboratory (YARL) was Investigated under the ResourceConservation and Recovery Act (RCRA) and the Comprehensive Environmental Response, Compensationand Liability Act (CERCLA) because diluted pesticide solution had been discharged Into a drain systemover a 20 year period. • '

Four monitoring wells were Installed, sampled and analyzed monthly for four months and quarterlythereafter. Analysis of well water, soil and sludge samples include 25 Inorganic, microbial, and physicalparameters, 25 pesticides and related compounds, and benzene, toluene, and xylene. Background soilssamples were collected from areas outside the Influence of the drain-field.

Contract Laboratory Program (CLP) quality control measures are being followed for analyses. AnInternal quality control program was used for analytical methods not covered by CLP. Analyses of sampleswere made under multiple methods for pesticide* and other organic, metals and radioactivity. Over 1,000determinations have been made. • " '•••. ; '*•' <

The Information obtained was used to generate a CERCLA Hazard Ranking Scheme score belowthe cutoff value for inclusion In the CERCLA National Priority List (NPL).

A Pestfdde Manufacturer 1987 • 1988•Florida Citrus Ground Water Study

Biospherics and a pesticide manufacturer conducted a study to determine the Impact of a newnemaiodde on the subsurface environment of a bedded dims grove hi Florida. The. specific objective of

17

the study was to determine the background level la ground water, the pattern of movement throughoutthe subsurface after application, and the extent to which it moved to and persisted in ground water.

A 2-acrc test plot, (wont case environment of sandy soil and three foot depth to ground water),was selected and monitoring equipment was Installed. A 65-day sampling schedule followed. Analysis wasdone by ICP and OC methodologies. The study showed that the pesticide moved rapidly to ground waterbut dissipated very rapidly.

Major Pestldde Manufacturer 1988 • PresentSmall Scale Prospective Ground Water Study . '

Biospherics designed a pesticide ground water study In the Arkansas River valley of Kansas.Biospherics staff has conducted field work and to also managing an on-sfte contractor. The purpose of theproject was to apply an experimental pesticide and potassium bromide tracer and track their subsurfacemovement and fate. Technical aspects of the project include protocol development, selecting a suitable site(U. hydrogeologlcally vulnerable), characterizing the root, vadose and saturated zones, and compiling,interpreting and reporting analytical and field data. Ground water monitoring wells, soil pore watersamplers and tenslometers were installed for sample collection, water table elevations, vadose moisturemovement, and aquifer testing.

Office of Technical Assessment fOTAVCongreM of the United State* 1988 - 1989Pesticides and Nitrates In Ground Water

Biospherics researched and authored an overview report for OTA oa agrichemlcals In ground water.Topics included: the state of knowledge, extent and occurrence of agrichemicals In ground water; healthimplications of the concentrations found; non-point sources vs. point sources; limited database of specialcropping systems; regulatory authorities and reactions to pesticide contamination incidents; current andpotential Impacts of the regulatory patchwork quilt

ENVIRONMENTAL AUDITS/ASSESSMENTS

Commercial Developer 19S8-1989Ground Water Risk Assessment for Pesticide* at Proposed Golf Course Site

A golf course has been proposed for construction at a site in Michigan. The golf course is to beconstructed In an area with a shallow water table adjacent to a river. Pesticides would be applied to thegolf course for weed, fungus, and Insect control The State has asked whether pesticides applied to thegolf course could leach to ground water and migrate to the river in environmentally harmful concentrations.

Soil data regarding texture! class, organic carbon content, etc were reviewed as were constructionguidelines for soils under proposed greens, tees, and fairway*. Test borings Indicated the depth to groundwater. Stream flow data were collected. Topographic maps and hydrogeology reports were reviewed. Alist of 13 proposed pesticides was compiled for evaluation. Mobility, persistence, and toxldty data wereobtained for the 13 pesticides.

. A screening level, conservative risk assessment targeted three pesticides for detailed simulationmodeling using the Pesticide Root Zone Model (PZRM> It was concluded that pesticides more mobile,persistent, and toxic than dlcambra should not be used.

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AM00278

Various Rcat Estate Developers. Washington D.C Area • OngoingLevel I Environmental Audits of Strip Shopping Centers and Office Buildings

' Aerial photographs dating back to 1948 (as available) are examined for signs of potentiallyhazardous activity. Use/occupancy and&r deed records are searched. A visual hazard Inspection isconducted to look for signs of Improper chemical use, storage, or disposal Samples of ceiling and floortile, doors, insulation, etc, arc collected and analyzed for asbestos content Soil gas studies are conductedas needed around underground storage tanks (USTs) and dry cleaners. USTs can be tested or removed.Soil and ground water can be sampled and analyzed In Level I or Level n audits as needed. Regionalhydrogeology is summarized to note the potential for ground water vulnerability. The presence of PCB'sand urea-formaldehyde foam are noted. Appropriate guidance and recommendations are provided.

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IV. PERSONNEL

The backgrounds of the Biospherics' professional staff provide a unique opportunity for clientsrequiring specialized and/or general scientific services. The diversified experience of the scientists andengineers include; chemistry,' industrial hygiene, soU and environmental sciences, microscopy, geology,hydrogeology, engineering, and public health. Biospherics1 laboratories are supported by a full complementof technicians, aides, quality assurance specialists, and clerical staff.

Biospherics' science services are segmented according to specialization. The Laboratory Divisionhouses an inorganics group, organic group, pesticide residue group, and ground water group. The followingpersonnel profiles illustrate Blospberics* comprehensive expertise in all aspects of management, analysis, andtechnical support • • ^r^,:;

LABORATORY DIVISION MANAGEMENT

DANTSKER, EDWARD, D.V.M., MA,* CHEMISTRY, DIRECTOR. LABORATORY SERVICESDIVISION. 29 YEARS EXPERIENCE (10 YEARS ENVIRONMENTAL CHEMISTRY).

Dr. Dantsker, In addition to having a Master** degree in Chemistry, received a Doctorate'In VeterinaryMedicine in 1959. As the Director of the laboratory he b responsible for assigning projects to Its SOmember staff, and for Its efficient operation. Prior to coming to Biospherics, Dr. Dantsker specialized intrace metals and wet chemistry analyses according to Contract Laboratory Program protocol for anotherenvironmental laboratory. While Director of t trace metals and wet chemistry lab, he helped computerizesample log-in and reporting and developed SOP1 for trace metals analysis, wet chemistry, and sample receipt

•,, and storage. Earlier in his chemistry career he participated in the discovery and analysis of predous metalsi J in sewage sludge and Incinerator ashes. He is proficient In the operation of ICP, furnace and flame AA,V_x and Autoanalyzer Instrumentation. :{jr ! •;

OUDNASON, H. MARKUSt B.S, CHEMISTRY. fAANAOER. LABORATORY SERVICES. 14 YEARSEXPERIENCE. .-..,-*rrv,vr -

. , . , . - • . - • - . . - . - . • ••:.••;••* t-.t > . : . - . : . " < " ' • • ~ 'Mr. pudnason has been with Blospberics since 1979 and has been the laboratory manager for the past two

t years. He is responsible for managing major government and industry contracts for environmental,occupational health, and pesticide residue analysis. -He Is the primary technical liaison between thelaboratory and contractors, for the past 5 years he has been actively Involved in contracts with the AirForce, Navy, EPA, and GSA- Mr. Oudnason specializes In trace analysis of organic and inorganiccompounds in environmental and biological matrices, and method development. He is skilled using a varietyof instrumentation Including: OC, OC/MS, AA. ICP, HPLC, Autoanalyzer, 1C, wet chemistry, UV-VTS, IR,and both phase contrast and polarized light microscopes.

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AR<tOQ28l

QUALITY ASSURANCE UNIT

- - • ' . - - ' ' - ' • - ' 'RYAN, KEITH B.SH MICROBIOLOGY, QUALITY ASSURANCE MANAGER. 14 YEARSEXPERIENCE (5 YEARS QA/QC EXPERIENCE).

Mr. Ryan manages the Quality Assurance Unit. His primary responsibility Is the development.Implementation and management of the laboratory's QA/QC program (which incorporates inspections,analytical monitoring with blind reference samples and control charts, technical report and data review, andfield service audits). He specializes In reviewing residue data management systems for major pesticidechemical manufacturers for compliance with Good Laboratory Practice (OLP) guidelines. In addition, Mr.Ryan writes SOP's and oversees licensing, AIHA accreditation, State certification, and performance underPAT programs. In 1988 Mr. Ryan particpated In the Pesticide Regulation/Technical Conference,Washington, D.C

BILYEU, JILL V., B.S,, CHEMISTRY, OA/OC COORDINATOR. 5 YEARS EXPERIENCE

Ms. Bltyeu is responsible for reviewing environmental chemistry tab data for contract adherence to approvedmethods, and assists In the setup and review of control charts. She also reviews lab performance evaluationstudies and audits the equipment and Instrument calibration program. Prior to coming to Biospherics, Ms.Bilyeu was a Project Leader at a Virginia laboratory and is experienced in analysis by HPLC and OC

GROUND WATER PROGRAM CROUP

COHEN, STUART, PRD., CHEMISTRY, GROUND WATER PROGRAM MANAGER. 14 YEARSEXPERIENCE.

Dr. Cohen manages Biospherics' Ground Water Program. He to responsible for program design andimplementation. His efforts have Included study design, vulnerability assessments, placement of monitoringwells, laboratory analysis, identification of mobile and persistent chemicals, and ground water modelling.Formerly with the EPA, Dr. Cohen was a key scientist for studies Involving pesticides In ground water,and participated in the regulatory action process on all pesticides In ground water. Dr. Cohca li alsoexperienced in sampling and analysis of air, son, sludge, and ground water. He Is currently supervising aSupcrfund cleanup assessment at Yaklma, Washington for the United States Department of Agriculture.

GOWLAND, PATRICIA A* CP.S&. MS* AGRONOMY AND SOIL SCIENCE, PROJECT LEADER.11 YEARS EXPERIENCE.

Ms. Gowland b a certified professional soil scientist and is OSHA-certified for Level A hazardous wastework. For environmental audits she performs field work, interprets results and writes reports. Her dutiesInclude the installation of suction ryrimeters and soil gas probes, sampling of soil gas, soil and water,hydrogeologic testing, and modeling using PRZM. She has hands-on experience using a variety of hardwareand software and is an experienced programmer. Prior to Joining Biospherics, Ms. Gowland wrote QA plansand spedal reports for the EPA. In addition, she has taught soil analysis at several universities.

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ARt*00282

SENITA. JOSEPH A., B.S., GEOLOGY, PROJECT LEADER. 5 YEARS EXPERIENCE

Mr- Senlta performs field work for ground water studies, and assists In the preparation of study reports.He has 40 hours of OSHA training and b.certified for Level B for hazardous waste work. Hisresponsibilities Including installing and sampling ground water monitoring wells, suction (yslmeters and soilgas probes. He conducts field hydrogeology tests and reduces field data for report preparation. He Isexperienced using the Pesticide Root Zone Model (PRZM) to simulate fete of pesticides in unsaturatedzones, prepares environmental audits of real estate and coordinates underground storage lank (UST) testingand removal In addition, Mr. Senita interfaces with clients and assists with interpretation of results.

SECTION LEADERS

TRIMMER. CLARA T, MS* FOOD SCIENCE, INORGANIC CHEMISTRY SECTION LEADER. 12YEARS EXPERIENCE

Ms. Trimmer is experienced in a wide variety of inorganic analyses. She oversees the inorganic section foranalysis of soil, water, wastewater, wastes, air, ash, oil, coal and other matrices. Ms. Trimmer specializesin physical, chemical, and microbiological analyses of environmental and industrial samples. She ensuresadherence to analytical protocols for contractual requirements. Ms. Trimmer is skilled using GC, flame andfurnace AA, and ICP instrumentation. • t , "

LABARE, ALICIA M, BA, CHEMISTO.Y. f STgCTDE RESIDUE SECTION LEADER. 5 YEARSEXPERIENCE.

Ms. LaBare specializes In management of pesticide residue projects. She is also experienced In OC/MSanalysis of water and soils for volatile* and seml-votatiles using EPA methods 8240, 624, 625, 524.2 and8270, and analysis by GC of water, soil and air samples for pesticides and herbicides using EPA methods8080, S150,60S, 615, and of oil and wipe samples for PCS'*.

• *. 1 - • -;,.'. | ' . . . . ; , ... . ' , ; . *

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PAREKH, USHA M,, B.S., MICROBIOLbdY/CHEMKTmY, OROANICS ANALYSIS SECTIONLEADER. 12 YEARS EXPERIENCE

Ms. Parekh supervises and coordinates analysts In the Organic* Analysis laboratory. She is responsible forevaluating and verifying analytical data. She crass references protocols and methods including CLP, ECRA,EPA, and NIOSH methods. She b experienced In performing methods all EPA OC methods for organicpollutants.

SUPERVISORS/PROJECT LEADERS

CHAPMAN, PETER R, B.S., ENVIRONMENTAL SCIENCE, METAL ANALYSIS SUPERVISOR.INORGANIC CHEMISTRY. 5 YEARS EXPERIENCE .

Mr. Chapman specializes In trace metal analysis using EPA, NIOSH, OSHA, and CLP methodologies. Hisexperience includes: large-scale water testing for lead for various government agencies: fnilwls of wai£r

22

ARl*00283

and soU for contracts under EPA CLP, air cassette testing, and analysis of ground water.

MCDANIEL, HARLESS A* B&, CHEMISTRY. OC S SUPERVISOR. 8 YEARS EXPERIENCE

Mr. McDaniel is responsible for the daily organization of the OC/MS laboratory. He specializes la volatile*and semi-volatiles analysis by GOMS in accordance with EPA methods 624, 625, 8240, and 8270. Inaddition, Mr. McDaniel Is experienced in GC analysis with packed or capillary columns and Hall, BCD,FID, and PID detectors.

TROY, ANNETTE L, BA, CHEMISTRY/BIOLOGY, PESTICIDE RESIDUE PROJECT LEADER. 5YEARS EXPERIENCE

Ms. Troy conducts pesticide and veterinary drug residue analyses for a variety of matrices. She develops,modifies, and validates methods using GC and HPLC

GOLDEN, PAUL E, B.S., CHEMISTOY, PROJECT LEADERyHPLC LABORATORY SUPERVISOR.6 YEARS EXPERIENCE *Mr. Golden fat responsible for the technical and administrative aspects of assigning projects requiring HPLCanalyses. He maintains the HPLC instruments, prepares equipment for post-column derivatization andcolumn switching and trains analysts In correct methodologies for analysis and equipment troubleshooting.Mr. Golden is thoroughly familiar with GL? procedures, and also GOMS analysis.

BRUNK. WAYNE J., PROJECT LBADER XTTtACTTON LABORATORY SUPERVISOR. 11 YEARSEXPERIENCE

Mr. Brunk Is responsible for the administration of assigned pesticide residue projects. He performs methodvalidation and sample analysis using GQ GQFID, GC/FPD and GOMS according to GLP requirements.His administrative duties include the dairy monitoring of projects, property organizing and presenting datato clients and controlling production costs. la addition, Mr. Brunk supervises the training of new chemists,and extractionists.

23

ARU0028U

• vsaas-Vjss-

ii .1 4 ARlf00285

V. CERTIFICATIONS AND ACCREDITATIONS

A compilation of the following current laboratory certifications and accreditations Is Included In thisdocument

________ TYPE________m EXPIRATION DATE

State of Maryland Certification June 30,1990

State of New York DOH Certification April 1,1990* ••. .

Commonwealth of Pennsylvania Approval Indefinite

State of Delaware Certification ' Contingent upon Maryland

Commonwealth of Virginia Certification June 30,1990

State of New Jersey Certification June 30,1990 • awaiting new certificate

A1HA Accreditation Indefinite I .

Memberships

Johns Hopkins Health Associates *American Chemical Society (ACS)American Industrial Hygiene Association (AIHA) .American Public Health Association (APHA)American Society for Testing and Materials (ASTM)Association of Official Analytical Chemists (AOAC)National Water Well AssociationNational Asbestos CouncilEngineering Society of Baltimore

24

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ARU00290

MAY \ 1 !9<J9

COMMONWEALTH OF PENNSYLVANIADEPARTMENT OF ENVIRONMENTAL RESOURCESMay 6, 1989

,, ^ . Certified Mall / P 899 339 797Biospherics, Inc. I.D. f68-377, MD017Dear Laboratory Directors : : . '-. :: - Res Water Supply Study 022

A Water Supply Study 023Recently, a set of chemical Perfornance Evaluation samples were sent to you ,for analysis through EPA's Quality Assurance program. The results of your ,..analyses, the true values, and acceptance Units are provided on the attacheddata report. Based on this report, your current status In the LaboratoryCertification Program in Pennsylvania Is as shown belows

Category of Analysis Certification Statue

____M____;_____ "Certified" or Current Statue Maintained

. . • The approval to report data under the Safe Drinking/ . Water Act remains unchanged.

I.H/P.TTHM.VOC.VC.V3.04 Classified as "AdmtnUtratlve Approval*

Inforoatlon on Approved aethoda, data reportinginitructlent, and a laboratory identification number,If applicable* vlll be forwarded shortly.

._ - .-..,:•-. *?(» , &; f _ - • ' . ' -

Claaeified ae >ifot Certified"

No drinking vater analyst• data vlll be accepted bythe Departnent or its Deslgnee in the category Hateduntil satisfactory Performance Evaluation resultshave been achieved. . ' .Intention toClaasifT as "Hot Certified"

You nay appeal this.actIon by following Appendix A of• the Procedures for the Approval and Certification of

- Drinking Water Laboratories within 15 days of your' r receipt of this letter. ;

I-Inorganlcs, TO-Metale, W-Hltrate/FlUorlde, S/C-Sodlum/Corroslvity. .0-Organlcs, H/P-Herblcldes/Pestlcldes,'TTHM-Trlhalomethanes, .VOC-Volatile Organic ChemlcalsfCroup 1), VC«Vinyl Chlorlde(6roup 2),US-Unregulated Organic Chemlcals(6roup 3). U4-Unregulated Chemlcals(Group 4)

Other Comments i : • . ' '-.' "'''...-.'J $*'"*• - ^ '-iw.*-"- " • . • . - • ' - f

If you have any questions on-your laboratory's status, contact Mrs. Tradeat (717) 787*4669. •

fV'** . -,.., , . > : ? . t o • - . • " • - - - - • . • - - " .Laboratory Certification / :.. - , ; *Division of Technical Services j( '•"Bureau of Laboratories,'.," \-,-^ '-'^'^J--.-~ "' \;'.-'!:'- " ''--'"•

' • - ' - - • • ^ ,

'fl'Rl»002.9l

DELAWARE HEALTHAND SOCIAL SERVICESDIVISION of PUBLIC HEALTH

Phone! (302) 736-4731

December 20, 1988

Biospheries Inc.12061 Indian Creek CourtBeltsville, Maryland 20765

ATTENTION: Eileen Berry-HeinzDear Madam:

On the basis of the documentation provided to us concerningthe report of site inspection and the analysis of performancesamples, analytical results submitted to the Delaware Division ofPublic Health are acceptable for reciprocity enforcement purposesunder the Safe Drinking Hater Act for the following parameters:

Total Coliform, (MPN,MF) Endrin, Lindane, Methoxychlor,Toxaphene, 2,4-D, 2,4,5-TP (Silvex), Arsenic, Barium,cadmium, Chromium., Lead, Mercury, Silver, Selenium, &Fluoride. . . .

This approval is effective until June 30, 1989, and iscontingent upon successful analysis of annual performanceevaluation samples and maintenance of qualified staffing. Any.changes in staffing, physical facilities, or major equipmentchanges must be* reported to this office*

By copy of this letter we are informing the state ofMaryland, Department of Health and Mental Hygiene LaboratoriesAdministration of our action, and requesting that theyimmediately inform us of any change in certification status ofyour laboratory, as our continued certification is dependent uponcontinued satisfactory evaluation by the State of Pennsylvania.

If you have any questions, do not hesitate to contact ouroffice.Very truly yours ^ ^^^ Very truly yours,

Richard Hovell, III \ Mahadeo P. Verma, Ph.D.Program Howell \Director of LaboratoriesOffice of Sanitary Engineering Division of Public HealthRBH/avcc: Dr. Verma ,

BUIUONO • 8O2 Save* LAKC PLAZA • Oov am. n A t A n • TKLCPHONC:I3O21736-47O1t , „ „ . - , • - " • • ' '

2 9 1989

, .. COMMONWEALTH o/VIRGINIADEPARTMENT OF GENERAL SERVICES

DIVISION OF ; f ,-: •<•••:. '*•''.' 1 NORTH I4TH STREETCONSOLIDATED LABORATORY SERVICES ,; ..*- v? ,,, RICHMOND. VIRGINIA23219 3691

,- • " i " , " • - " i • - - •' -

June 23, 1989

Kiss Frsncss Dillon , -Biospherica, Incorporated -12051 Indian Creek CourtBtltsville, MD 20705

Dear Miss Dillon:

Based on the data submitted and the annual fee received, the Counonvealthof Virginia grants reciprocal certification to Biospherics, Incorporated lo*csted in Rockville, Maryland.

RECIPROCAL CERTIFICATION FOR THE ANALYSIS OF WATER

CERTIFIED - MICROBIOLOGY

Total Colifora - KF sad MPN Procedures

" 'CERTIFIED * INORGANIC CHEMICALS

Arsenic, Barium, Cadmium, Chromium, Copper, Lead, Mercury, Selenium, Silver,Nitrate, Nitrite, Fluoride, Sodium,-Corroeivity, Calcium, Alkalinity, pH,

T. Dissolved Solida

CERTIFIED - ORGANIC CHEMICALS

Endrin, Lindane, Methoxycblor, Toxaphene, 2,4-D, 2,4,5-TP (8ilvex)v Broooforsi,Bromodichloromethene, Chloroform, Chlorodibromomethane

CONDITIOKAL APPROVAL - VOLATILE ORGANIC CHEMICALS

Benzene, Carbon Tetrachloride, 1,4-Dichlorobentene, l,2-Dlchloroethincv1,1-Dichloroethylcne, l,l,l*Tricbloroethane, Trichloroethylene, Vinyl Chloride

Tour Laboratory I.D. Number la 00033.

Effective July 1989 through June 1990*

DIVISION OF ADMINISTRATIVE SERVICES «OlVlSlC " •'" • * ., «««WTDIVISION OF PUftCMASES 4 SUPPl* • DIVISION Of CONSOtlOATED LAB f RlSK MANAGEMENT

BRU00293

Miss Francis DillonPage 2June 23, 1989

Your Laboratory I.D. Number is to be used when reporting compliance datato the Virginia Health Department. This reciprocal certification is contin-gent on continued approval by the Stats of Maryland. You shall keep uaadviaed of any changes in your status.

Sincerely,

A. V. Tisdemann, Jr., Ph.D.Virginia Laboratory OfficerSafe Drinking Water Program

AWTtAVTuj

cci Mr. Alien Banner, VSBDDr. J. Medaen Joseph, DHHH, Stats of Maryland

Stare o* NEW JE«SEVOF ENVIRONMENTAL

0**ICE OF CUALITY ASSURANNUAL CERTIFIED FA*A«ET*» LIST co»

INCORPORATED (60t»«?) IS C«»TTBTED *5 •e*e n1 TH«BELOW UVTtL JU^« 10 i^*««

WATER

NIT94TS, AUTO CD

CMLO^IDE* HG OM A<;

coLO^t FL«TINU*« COBALTABS/LAS MSTMVLSNS BLUEPH, GLASS ELSCTMOOE

952 TOT DISS SOLIDS, TOT

455 SOCIU^t *L«*§

4*6 SULFATEt GIIAVTN OK TUAVID

491 BAff ATOMIC ABSOft^TION

402 AGt ATOMIC ABSORPTION

403 CUt ATOMIC ABSOMTtON

FEf ATOMIC ABSORPTION

Ol/

. . ... AR(»00296--' •";' '• v'-Trr

DRINKING WATS* LflBO*ATO*v

( J

40* IN, ATOMIC ABSORPTION412 MGfWANUAL COLD VA»0*

AS, GRAPHITE FURNACEBA, G'APMITe FURNAC*

CP, G

417 C», G

41^ P9f C*4?HITE eURN*CE

420 SEt G»ASMITs FU»NACE

• «2i «Gt GRAPHITE FURNACE422 CU, G^AFHtTE 'URNACE

423 F£t GRAPHITE FURNACE

424 *Nt GRAPHITE FURNAC5

454 NAt ATOMIC ABSORPTION

GAS CHRO-ATOGRAPMV441 ORGANOCHLOFINE

SNDPINLINDAN6- •^ETHOXYCMLORTOXA»M£NE

442 ' CHLOROPM5NOXV ACID HERB2»4-D

443 TftlHALOMETHANESCHLOROFORMBROMOFOft*BRONODICHLORO«£THANfOIBftOMOCHLORO«£THANE

POLLUTION LABORATORY CERTIFICATION

LIMITED CHEMISTRY

TOTAL '

2

-U • •..,.. , • flRl*00297

WATER POLLUTION LABQRAT.IPYLIMITED CHEMISTRY03722 CYANIDE* A«EN TQ

ATOMIC ABSORPTION

C1002 ARSENIC (AA)

01012 MPVLLIUM (AA)

0102? C«OMIUM (AA)

01032 CHROMIUM VI (AA)

01034 CADMIUM (AA)

01042 COPPER (AA)

01051 LEAD (AA)

01054 THALLTU* (AA)

C106T NICKEL (*A) • •

01077 SILVER (AA)

01042 ZINC (AA) J

01047 ANTIMONY (AA)01147 SELENIUM (AA)71400 MERCUPY (AA)

GAS CHRQtATOGIUPHV04032 PENTACHLOROPHENOL44007 PESTICIDES

39130 AtDftINi 340 DIELDRIN39360 ODD393(3 DDE

PAGE 3 LAW 6-T441oi/ir ^

ARU00298

t

WATER »OLLUTI3N LABORATO»v CERT:»ICA»I3-j

GAS CMRpMATOG»A»HY

44007 PESTICIDES3437QDDT34410 HEPTACHLOR343SO CHLORDANE

01/IC/S4

AR(t00299

AMERICANINDUSTRIALHYGIENEASSOCIATION

, inc.Industrial 'tfgfena fa&oralory

tamChas fulfilled AlH A crlttrii forIndustrial Hygiant laboratory Accreditation.This accreditation shall b* •ffietiva untiltht — lit- day at M»y. I9»9 ___,lubjtet to continued compiianct witnAlHA accreditation crittna. •

PfMItftfllAmtriCA* IndufltriAl Mygitftt

CdmffllllM

»I»J April I.Out

AR(f00300v

. .

I

"•".*:-. ' ' • ' • • " . • '•'••• •'• .-'• i ' (t - • * - . - " - ' . • ' • ' . • • • - • •• .vi/rif'-.Y.;* ;;'-!??-'••" ; •' •:-i-"--:'-':-';' "'....'•' ' : |; ; ' ::•.";" '.-f;.- -'" .' ['' ' ' v -'

VL QA/QC OVERVIEW

The accuracy and reliability of laboratory analyses in regulatory or health related testing b ofparamount importance. Through its extensive Quality Assurance/Quality Control (QA/QQ program,Biospherics has built a repui ,t;on for producing timely, accurate and defensible results. The LaboratoryDivision Is committed to periorm all laboratory projects in. compliance with Federal and State QualityControl guidelines. The QA/QC program is defined In the laboratory's QA Plan (a 140-page document)and Standard Operating Procedure manual Each technician, analyst, supervisor, and manager is responsiblefor following the QA/QC Program and Insuring that it is implemented for all laboratory projects.

A Quality Assurance Unit oversees Implementation of the program In the laboratory. The QAUnit ensures that facilities, equipment, personnel, methods, records, and controls are In compliance withapplicable regulatory guidelines. Each laboratory project is monitored through the application of a QA/QCprogram which includes the following elements:

o Centralized project fileso Written standard operating procedureso Rigorous chain-of-custody procedureso QC of data by analysis of blanks, reference samples, spiked samples, duplicates, and

surrogate spikeso Documentation of non-conformance events and corrective action takeno . Periodic inspections of projects In progresso Frequent equipment calibration and maintenance Inspectionso Archiving of project records under controlled accesso Data review and validation

Hie Table of Contents from the QA Plan Is Included on the following pages. o

25

Afi 1*00302

Section No.: Cover PageRevision No.: 002

Date: August 1989Page: ! of t

BIOSPHERICS* INCORPORATEDQuality Assurance Plan

This is a proprietary document Intended totely for rt>e use of Biospherics Incorporated. Itshall be made available to Biospheric*' clients and certification agencies M tc used forreview purposes only. The Information shall not be duplicated, wed. or disclosed inwhole or to part lor any «her purpose.

BIOBPHERIC8* INCORPORATEDTechnologist for Envlnnmtnt and Hnllh

Section Mo.: Table of ContentsRevision No.: 002

Oat* i August 1989Page: 1 of 2

Quality Assurance PlanTable of Contents

1.0 Laboratory Quality Assurance Plan Identification

2.0 Introduction

3.0 Quality Assurance Policy Statement

4.0 Quality Assurance Management

4.1 Introduction4.2 Assignment of Responsibilities4.3 Communications4.4 Document Control4.5 QA Program Assessment

5.0 Personnel Qualifications

6.0 Facilities. Equipment, and Services ' - •

6.1 Laboratory Facilities6.2 Equipment6.3 Instrument Maintenance6.4 Material Procurement and Control — Standard* Reagents, and

Solvents

7.0 Data Generation

7.1 Quality Assurance Project Plans7.2 standard Operating Procedures7.3 Sample Chaln-of-Custody7.4 Sample Management7.5 calibration7.6 Determination of Detection and Quantltation Limits

8.0 Data Processing

8.1 Collection8.2 Validation8*3 Storage8.4 Transfer8.5 Data Reduction

9.0 . Data Quality Assessment

9.1 Definition of Terms9.2 Routine Quality Control Procedures9.3 Quality Control Charts

2UBQAU t ARU0030U.

Section No.; Table of ContentsRevision No.: 002

Date: August 1989. ' Page: 2 of 2

i. ] 10.0 Corrective Action

10.1 Nonconformance Event Corrective Action and Documentation• 10.2 Internal Audits10.3 External Audits10.4 Audit of Subcontractors i

11.0 implementation Requirements and Schedule :

12.0 References . ' •

Appendix List

A. Personnel ResumesB. SOP IndexC. Sample Containers, Preservatives, and Holding TimesD. Quality Control Sample Acceptance Criteria

2 LABQAU

: ^ flRU00305

Section No.: Cover PageRevision No.: 002

BIOSPHERICS* INCORPORATEDQuality Assurance Plan

,, CONFIDENTIALTW» to • proprietary document Intended solely for the oat of Biospherict Incorporated, llshall bt made avaJUMe IB Btospheria* client! and certification agencies to be used forreview purpotat only. Tha information shatt not bt duplicated, used, or disclosed inwhole or la part for any other purpose.

BIOBPHERICB* INCORPORATEtfor EivJronmtitt *n* " -/r

flRt*00306

. . , ; Revision Ko.i 002Dates October 1989Pag*i 1 of 2

Quality Assurance Plan' Table of Content!

1.0 Laboratory Quality Assurance Plan Identification . :

2.0 Introduction ,.'-2*••.?-.5 I • - • - •:.-..•••.', f,

3.0 Quality Assurance Policy Statement

4.0 Quality Assurance Management . ' .

4.1 Introduction . _ -4.2 Assignment of Responsibilities4.3 Communications ••-, %Mv. ,/.,;;; L v ^ • ;4.4 Document Control; . /; .-••. - . • .4.5 QA Program Assessment

5.0 Personnel Qualifications

6.0 Facilities, Equipment* and Services

6.1 Laboratory Facilities . •6*2 Equipment6.3 Instrument Maintenance6.4 Material Procurement and Control—6tandard. Reagents* and

, Solvents

7.0 • Data Generation

7.1 Quality Assurance Project Plans7.2 Standard Operating Procedures7.3 Sample Chain-of•Custody7.4 Sample Management7.5 Calibration7.6 Determination of Detection and Quantitation Limits

S.O Data Processing

1.1 Collection1.2 Validation ,-8.3 Storage6*4 Transfer8.5 Data Reduction.

9.0 Data Quality Assessment

9.1 Definition of Terns9.2 Routine Quality Control Procedures9.3 Quality Control Charts

2 LXBQXU

ARI*00307

no*; UUADate i October 1989Page t 2 of 2

10.0 Corrective Action

10.1 Voncenformanco Event Corrective Action and Documentation10.2 Internal Audits10.3 External Audits10.4 Audit of Subcontractors

11.0 Implementation Requirements and Schedule

12.0 References

Appendix List

A. Personnel ResumesB. SOP IndexC. Sample Containers* Preservatives* and Holding TimesD. Quality Control Sample Acceptance Criteria

2 LABQAU

ARU00308

Kevision Mo.I 002Datei October 1989Pegei 1 of 2

1.0 LABORATORY QUALITT ASSURANCE PLUT IDENTIFICATION

Document Titlei Laboratory Quality Assurance PlanBiospherics Incorporated•\. •'

•- ,, ••-..,„„ (n, •#" ''•• ~' ' '- ' -

Document Control Humbert .

Organisation Title Addresst Biospherics Incorporated12051 Indian Creek CourtBeltsville, MD 20705

"-. Responsible Officials .fi.'Markus GudnasonTelephonei (301) 369-3900

Titles Manager* Laboratory Operations

Quality Assurance Officeri Mr. Keith RyanTelephoneI (301) 369-3900; . » „.•»"'•• I1 . . - - •' • ' ,'.,'•

. . .; Plan.Coverages Laboratory Division EnvironmentalLaboratory* vhich includest

H / Client Services/Marketing^-^ • . Sample Control

Sample Extraction and Preparation LaboratoryInorganics Analysis Laboratory

• '• Organies Analysis LaboratoryOlassvare Hashing and Laboratory SuppliesData ReviewReport Preparation and ReviewQuality Assurance .

2 LABQAU

1 - ; mOQ3Q9

Revision Ho.t 002Datei October 1989Pagei 2 of 2

Concurrences! ,

(1) Name Keith Ryaa •Title Manaaec* Quality A*puranca

Signature ttsltf /Cj'ML*~ —— I Dates /#//>/ M

B. Markus Gudnasoa

Signature S" ' * ' *7~tr~ *~" ____• Data)l

(3) Name Edward DeatskerTitle Director* Laboratory Division

Dat.,

2 LABQJUI

;-.-:-. flRl*003IQ

Revision Mo.: 002Datet October 1989Paget 1 of 1

2.0 INTRODUCTION .

Biospherics is committeds|o perform all laboratory analyses in fullcompliance with State and Federal Quality Control (QC) guidelines. TheQuality Assurance/Quality Control (QA/QC) program. is defined in theLaboratory's QA Plan and Standard Operating Procedure Manual. A separateQuality Assurance Unit oversees implementation of the program in thelaboratory. The QA .unit ensures that facilities* equipment, personnel,methods* records* and controls are In conformance with Biospherics' StandardOperating Procedures (SOPs) as well as with-applicable EPA Quality Controlguidelines. , . . . , t , cI ..:.., . . . - " • • ; :

. • - . . . - • j -•, ^- -I ; • :. ' ' ' • . • - . -1 ' , •„ ' • ' • . - t *•. r .' ~ • " Jl' • ' •'-

Each laboratory project is monitored through application of a QA/QCprogram which includes the following elementss

• Centralised Project files.• Written SOPs.* Rigorous chain of custody procedures.. . . , « < • •• QC of data by analysis of reference samples* spiked samples*

duplicates and surrogate spikes.e Documentation of noacpnfornaace events and corrective action taken.'« Periodic inspections of projects in progress.* Frequent equipment calibration and maintenance inspections.i'1-', * Archiving of project records under controlled access.

2 LABQAU

i? J C flRfc00311

Revision Ho.: 002Date: October 1989Pagei 1 of 1

3.0 QUALITT ASSURANCE POLICT STATEMENT

Biospborics Incorporated it firmly committed to produce analyticalresults which are accurate* precise* comparable* representative* andcomplete. To reach this goal* the laboratory has adopted the QualityAssurance/Quality Control program defined in this document. The QA Plan issupplemented by a manual of Standard Operating Procedures. The QA/QCProgram should be implemented for all Environmental Laboratory projects.

Each technician* analyst* supervisor* and manager is responsible forfollowing the QA/QC Program as it applies to his or her job function. Thiiresponsibility must be carried out with diligence and consistency.

The QA Plaa has beea prepared by "the Quality Assurance Manager.iRevisions will be made in the future as necessary.

ApprovalsKeith Ryan II ' DateManager* Quality Assurance•

B. tterkua Oudaasoa DateManager* Laboratory Operations

2 LABQAU

ARU003I2

Revision Ko.t 002Datei October 1989Pagei 1 of 2

4.0 QUALITX ASSURANCE MANAGEMENT

4.1 INTRODUCTION ji "~ ;

t Jklh "L

An organisational chart which depicts the QA Management structureI * -*•

at Biospherics Is provided[on the following page. As shown, theQuality Assurance Unit is independent of the data generating andmanaging groups. 1 . ' '

2 LABQAU .

• ARI*003I3

Revision No.i 002Datei October 1989Paget 2 of 2

2 LABQAU

Revision No.: 002Datei October 1989Pagei 1 of 3

4.2 ASSIGNMENT OF RESPONSIBILITIES '

Quality Aaatirai^^^ Manac/ei* ' ' ' '••'"* • ' ' . ' . • * " - . - ' '

The Quality Assurance Manager has overall responsibility for the' 'development end administration of the quality assurance program. This

effort is supported by three QA. Coordinators* a Sample ControlSupervisor end five ?Sample Coordinators. An analytical qualitycontrol program is conductedtto ensure the production of valid data.The QA Manager supervises Implementation of the analytical QC programand interacts with the project staff in determining corrective actionprocedures. ' •" •" '-"••"•' "";i i::';::"::i - • - - - • -

• • ' • : . . - "- tf$(: \ - • " .. . - •

Additional functions performed by the QA Manager includes

e Preparing written documents defining QA/QC procedures.e Review and approval of standard operating procedures.

( j . * Maintaining copies of 411 current procedures.•'. Scheduling end performance of quality audits.• Traiaiag employees In QA/QC techniques.• Overseeing inter-laboratory testing programs.• Maintaining current knowledge of approved methods end other

regulatory requirements. ' • •• Serving as a liaison to EPA end ether regulatory agencies.e Reviewing aon-confor»ance reports and corrective action

" responses to assure that operations have been appropriatelycorrected. "•*'•"••' *" ;i - . • )f;-:. ,:, !.' •-• - .

e Continually assessing the QA program.' '" V " * ' ' • " - ^ " f L \ :• V'"^;-V^J !f |.,',-.,,, • • •• * .-•= ', ' .-. .. .,

The QA Officer has the authority to' halt operations if the work hasnot been performed according to appropriate procedures*

2 LABQAU

AR<t003!5

Keviaion MO.t U04Datet October 1989Pagei 2 of 3

Quality Xs«Mranr» TTnit Staff

The QX Staff has the responsibility and authority to monitor anyphase of laboratory operations. Its functions include the followingi

• Preparing and submitting blind QC check samples to the lab andevaluating lab performance*

* Checking outcome of QC samples oa a routine basis to assurethat control Unite are being met and internal SOPs forcontrol chart analysis are followed.

• Performing inspections of lab operations and records to assesscompliance with SOPs and contract requirements.

• Preparing reports of lab inspections or data review forlaboratory management and the QA Manager.

• Immediately notifying QA Manager of noa-coaformaace eventswhich have not beea resolved*

•> Assisting in writing of SOPa* .* Performing dutiea of QA Manager in Manager's absence.* -Reviewing and approving performance evaluation sample results

prior to submission to regulatory agencies.

t.laboratory Mufiitoemeat

The lab aaaagaMBt has responsibility for directing thelaboratory operational groups to follow the QA/QC program. Thisresponsibility ia met through the following itepei

e Recruiting* hiring* and training suitably qualified personnel.

* Allocating sufficient staff* time* materials* and equipment toaccomplish required tasks.

2 LABQAH

ARt*003l6

•« •••»««* 41 M • *

Datei October 1989Paget 3 of 3

• Integrating QC. steasures into the job descriptions oflaboratory personnel ao that each employee is responsible forthe quality of the work he/she produces*

• Effectively responding to corrective action, requirementsidentified by QA.

* . , . - • *:*•? <• ',;.: '• . -- -• ,„

* Assignment of SOP writing. . .

• Review and approval of SOPs*

The laboratory supervisors play a key role In the implementationof the Quality Assurance/Quality Control program. The supervisor isresponsible for the quality of data generated by his/her group. Alloperations performed in bis/her section must comply with internalStandard Operating Procedures and individual contract requirements.The Supervisors must train analytical personnel* prepare er updateSOPs for each operation, and instruct analysts to perform QC checks.The Supervisor assures that all QC criteria for each data set havebeen met before releasing results for reporting. Additionally* thesupervisor documents nonconformance events and corrective action takenla the central project files.

The analysts art responsible for following the appropriatemethods* documenting their activities and results concisely* andimplementing the QC checks which are defined in Blospherles* SOPs.The analyst* are expected to produce data of Measurable quality and,therefore* emst evaluate outcome of QC samples as part of theanalysis. Aa the first line of control* the analyst stay identifyquality problems and initiate a nonconformance report.

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4.3 COMMUNICATIONS

The statue of the laboratory Quality Assurance program isevaluated and documented monthly by a report from the QA Manager. Thereport is Issued to the Division Director and the Company President.

The monthly report summarises analytical problems* correctiveaction recommended and taken* preventive action recommended and taken,status of proficiency testing programs and lab certifications andother related information.

Audits* inspections* and data reviews performed by the QA Unitare documented ia reports to the supervisors and management* Findingsand recommendations are reported by QA./The supervisor responds* onthe report* with corrective actioa and/or preventive action taken.The audit report* with supervisor comments, is circulated tomanagement for review*

QA verifies that the corrective actioa and preventive actioa was V—/appropriate and has been implemented. The report is then filed by QA.

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Revision Ho.i U02Datei October 1989Pagei 1 of 1

4.4 DOCUMENT CONTROL

QA reports for specific projects, systems audits and otherInspections are filed in locked cabinets separate from other study

• • •• * ' ' • ' - '"•*'••' \ r , .?• -" - ;records. The Individual reports contain the initials of all personnelwho have reviewed that report.' " ' ; -c'.': r,1! t,;* • • • - : :' '•

U.V . " " • - . : • -'' • ' '"••-Original signed Standard Operating Procedures are kept by the QAUnit. A historical file Is maintained, Mhen an SOP is revised* theold version is stamped "OBSOLETE" and dated. Each SOP is narked withan effective date.- The QA unit maintain! a distribution list for theSOPs. See below. Updates are distributed to each manual by QAstaff* Obsolete SOPs are removed from each manual at that time.

SOP SectionsBook ombar '"" Ltieatiott - ..— > • ' * in the Manual

1 Lab Administration all2 V.P* Science Services all

i / 3 QA Manager all^-^ x 4 QA Staff Office all

5 Inorganics Office all6 . . Inorganics Office . all7 • Orgaalcs Office all8 • ' Organies Office . all9 Met Chemistry Lab • - all10 Archives ' * all11 • Xaorgaalcs Instrument Room12 Metals Analysis13 Metali -Preparation '14 ' OCIS OC/MS16 GC VO A17 HPLC18 Micro tab19 Sample Control20 Glassware Mashing

*s**s**s**5**s*,s**s**5*

*7*10*12*18*19*7*10*12*18*19,7,10,12,11,19*7*10*12*17,7,10,12,17*7*10*12*17*7*10*12*17,7,10,12,14

*8*10*1'2*15*7*12

See Section 8.3 for further Information on data storage.•The SOP Index is available in Appendix B to this QA Plan.

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4.5 QA PROGRAM ASSESSMENT

The QA program is evaluated by the QA Manager oa a monthly basisand reported. See section 4*3 above. Additionally* an annual statusreport of QA activities and progress will be issued to the VicePresident for Science Services and the Company President. This reportwill include such information ass

* Statue of or changes to the QA Plan.• Statue of QA Project Plans* as appropriate.• Measures of Data Quality (current control charts).• Significant problems* accomplishments* and recommendations.• Results of performance audits.e Results of Systems Audits.• Statue of QA requirements for contracts.e Summary of QA training.* Recommendations for staff and instrumentation. .

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5.0 PERSONNEL QUALIFICATIONS

Biospherics' management recognises the need for appropriateeducation, training, and experience to ensure that its personnel canperform their assigned : tasks 'and successfully follow their chosen

•• * ' -career paths. The benefits of supplying this training* education* andexperience are not only for the individual employee. The organisationbenefits also* since it profIts by the stability of the work force andinternal promotion of Its employees. • Training will also result inconsistency of logic between 'analysts and supervisor*. Finally, thebenefits are to clients who can have confidence In the precise andaccurate performance of the requested analyses.

.. - ., • Therefore* ell job grades require certain minimum levels ofeducation and experience 'Which are defined by Corporate Personnel

, Policy. In-house training programs augment these basic education andexperience levels by supplying additional Information about technical

, subjects* safety* corporate policy* quality awareness* and supervisory( and managerial techniques.' Tuition reimbursement Is provided forthose Individuals who would like to take relevant undergraduate or

,. graduate courses either la or outside of a degree program.*' , •»,<!*.::•.• .••'! "- - •• J - . , ' - " •

. •• *

la-bouse technical training is conducted by the supervisor of. each area or his/her qualified appointed alternate. Training la

* initiated by the analyst thoroughly studying the written assayprocedure* followed by a discussion of the SOP for that assay with the- . , * > , .

- V trainer vbo will Subsequently give a demonstration of the assay. Thetrainee then performs the Is say en. a series of blind QC samples totest his/her »astery of the procedure, the trainee's results as wellas bis/her techniques are'-appraised by the trainer. Successfulresults and appropriate techniques are the basis for the qualificationof an analyst.in that particular assay. Failure to attain appropriateresults or skill levels necessitates further coaching and traiaina.tfntil an analyst is qualified* be or she siay aot periorm Kbat asscay ensamples submitted by clients*

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A training and experience record and job description ismaintained la the Quality Assurance archives for each lab employee.

After initial training* an employee's performance Is monitored byhis/her supervisor for compliance with quality* production* and safetygoals. This appraisal is completed Informally on a daily basis asassignments are scheduled and completed and as quality control chartsare updated. The supervisor is also available for consultation duringthe work day* A more formal appraisal of each employee's performanceoccurs at project checkpoints and a written performance review isconducted annually.

Corporate and safety orientation classes are presented by thePersonnel Department and the Safety Committee during the early stages

' • of employment. To augment the training classes* informal technicalpresentations are delivered for staff by the Section Leaders*supervisors* and managers periodically*

To provide information on project-specific requirements* projectplanning and review meetings are conducted at the Initiation and atlogical checkpoints for all major projects. At these meetings* theproject manager* quality assurance representative, managerial andsupervisory staff define and review the project requirements and planfor and appraise laboratory performance* (Project requirements aredefined formally In Quality Assurance Project Plans (QlPPs) whenspecified by the contract.) These meetings provide training about thescope) of work* the schedule* and the'quality assurance requirements.A time) for questions and answers la provided to ensure completeunderstanding of the requirements* Corrective and preventatlve actionplans are reviewed to insure that nonconformances are minlmisad oreliminated.

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Reviiion No.i 002Datet October 1989Pagei 3 of 3

Supervisors* section leaders* and managers also attend la-housetraining sessions to Improve their supervisory and managerial skills.Topics included la these sessions include the essentials ofcommunications* motivating subordinates* giving orders end

" ' !• "" i - ' CT ft "'

instructions* coaching* assessing employee performance and goal-; i S ,'J =•- * * i 'f 1" ',. ''

setting* project management* scheduling* and budgeting.

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6.0 FACILITIES* EQUIPMENT, AND SERVICES

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Biospherics Incorporated* a District of Columbia corporation* wasfounded la 1987 to provide services and products in environmentalengineering* public health* and biotechnology. The company hasdeveloped Into a diversified scientific and technological firm with anestablished position la the Nation's environmental and health fields.It provides a broad range of environmental health and informationservices to private industry as well as Federal* State* and localgovernment agencies. The business Is structured around threeoperating divisions and a corporate product development groups theLaboratory Division* the Environmental . Services Division, theInformation Services Division* and the Biotech Programs group.

The Laboratory Division provides complete analytical testing andfield Investigation services for the Identification* measurement* andcontrol of pollutants in the environment* as well as full laboratory . jsupport services for the registration of pesticides. TheEnvironmental Services Division (ESD) provides industrial hygieneconsultation and analytical services to identify* evaluate* monitorand eliminate hasards la the work place. ESD specialises inIndoor-air quality studies* PCB monitoring and removal* and nasardousmaterlal/hasardoua waste identification and monitoring. TheInformation Services Division (ISD) operates federally andcommercially funded free telephone Information services on healthcare* pharmaceutlcals* and other government programs for the public.The Biotech Programs group represents the Rtt> arm of the Company andIs primarily dedicated to the development of proprietary products andprocesses.

flRl*0032U

tiu* 1Datei October 1989

i of s

8.1 LABORATORY FACILITIES -'- 1 : " i '

In late 1987* Blospberies Incorporated occupied a 100*000 squarefoot* custom-built facility located in fcranendale Technology Park*Beltsvllle* Maryland between Baltimore* , Maryland and Washington,D.C.. The Laboratory Division occupies approximately 20*000 square

& . '

feet*. It Is designed and fully equipped as a state-of-the-artanalytical chemistry and microbiology laboratory. Floor plans areprovided en the following pages. Key areas includes

tfofe Chamistrv Comdex

Two laboratories (one for Sample extraction for organic analysisand one • for inorganic wet chemistry) are located central to the

• -f . • - t •: & jifacility and are supported by a glassware preparation room* and asample preparation room for pesticide residue, analysis. Theselaboratories are equipped with eight fume .hoods* six sinks* and 144linear feet of beach space. . '

The laboratory area is bounded by six specially designedinstrument rooms as followss <1) B7LC* (2) CC/VOC, (3) GC/MS* (4) CC,

,. . ,; i. vp^wmfei.^ '','.• •

(S) QV/VIS/IR/TOC/TOX* and (C) AA/ICP. All rooms are speciallydesigned \ with (1) Isolated ventilation systems to preventcross-contamination* (2) dedicated electrical circuitry* (3) hood and

' - • • ' . . • ; , ; I I •• Tlocal exhaust ventilation 'where needed, and (4) remote specialty gasdistribution systems* Analyses of volatile compounds are separated

i - '* I-- " - . " . '

from operations which ase Solvents*

. A microbiology laboratory for bacteriological* fungal* and other' i * S'j . » ; 1 1

microorganism testing is maintained and equipped with Incubators.

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Revision No.t 002Datei October 1989Pagei 2 of 5

mij3

Is

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fiRU00327

bection Ho.i 0.4Revision No.i 002

Datei October 1989Pagei 1 of 6

8.2 EQUIPMENT* INSTRUMENTATION jA listing of the principal equipment and Instrumentation la

Biospherics' analytical laboratories appears below. It includes fourgas chromatograph/mass spectrometers* twelve gas chromatogr&phs* fourhigh pressure liquid chromatographs* three atomic absorptionspectrophotometers* one inductively-coupled plasma emissionspectrometer* and a transmission electron microscope. This apparentredundancy of instrumentation Is essential for handling large volumesof samples and fast turnaround requirements.

Laboratory Instrumentation

GAS CHRGftOXOGRAPHS (CC's)s

12 units* Hewlett-Packard 5880 (4) and 5890 (8)Fully automated with 7872A and 7673A autosamplers.Multiple general and specific detectorsi

Electrolytic Conductivity (Ball)Electron CaptureFlame lonisatloaNitrogen/PhosphorusPhotoionisatioaThermal Conductivity

All units microprocessor or computer (IBM PC-AI/Maxlma software)controlled

Capillary and packed column capabilities.

Purge and trap concentrator systems with autosamplers s 3 units(Tskmar LSC-2/ALS) for volatile organic analysis by GC.

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Research—And Development Laboratories

Another 5,000 square feet of the laboratories are dedicated to.research and development programs. They are equipped with isolationrooms* walk-in hoods* synthesis areas* and a metabolism laboratory.

1 " f • us' -=- " . ' • • ' ' • - •

Support FaellAtJaa

Support facilities in the remainder of the building include (1)word processing section* (2) conference rooms* (3) warehouse andstorage areas* (4) telecommunications center* (S).computer center and(8) administration areas.

,_ •"- * " ' ' . _ ^ . ..* ti £' •••i •'!'

Building security Is administered by Security Incorporated. All.f'!",. -. . - - . '

entrances to the building are locked and alarmed. Programmedelectronic key-cards control access 24 hours a day. Additionally*video cameras are installed at the key-card controlled entrances. Ifan alarm sounds* personnel at the Security Incorporated stationcontact designated Biospherics employees and'the police.. . . •

Fire protection consists of an automatic sprinkler system in all4.IT..X', . .'- - ' ..-.. . • *

rooms except .the GC/MS tab And the Archive Room* which are equippedwith automatic discharge halon systems. •Additionally* there are fireextinguishers throughout tike building and emergency showers and fireblankets in the lab. • i . •. ,• * ' -.._,..-• * *

The water purification System is supplied by Hydro Service Inc.of Rockville* Maryland. The system employs a reverse osmosis . (RO)unit* an activated carbon bed* a deioaising (DI) resin bed and a W

* . ,--*. ?.,„;.u... * - •••-••'•.sterilisation unit* The laboratory clean water service to the organiclaboratory is additionally pasted through a charcoal filter after theRO/DI treatment. . .

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INOOCnVlXX-COOPLKD ARGON PLASMA EMISSION SPECTROMETER (ICP)s

Perkla-Elmer 6500 XB.• Computer-controlled.• Fully automated* computer-controlled.• High resolution optics.<

ATOMIC ABSORPTION SPECTROPHOTOMETERS <AA's)s

(i) 2 units* Jerkin-Elmer 5000 and 3030• Graphite furnaces (2).• Fully automated* computer or microprocessor-controlled.

. (11) 1 unit* Parkin-Elmer 370• * . Flame and cold vapor capabilities

TOTAL ORGANIC HALOGEN ANALYZER (TOZ)l

' ^ J1 unit* Xertex Dohrman. *

TOTAL ORGANIC CARBON JUOZIZEB (TOC)l

1 unit* Xertex Dohrman* with Borlba FIR-2000 detector.

I1CH11COSJ JUJZtUBALXEKB ZZt

1 unite Dual channel.e Cartridges for ammonia* chloride* nitrate* nitrite*

orthophosphate* suifate.

101 CHKOiaZOGRAPB (1C) I

1 unit* anlon* Dlones 2000.• Fully automatede Microprocessor-controlled.

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Revision No.t 002Datei October 1989Paget 2 of 6

4 units* Hewlett-Packard 5985 (1) and 5890/5970 (3)e Hewlett-Packard RTE Data System with 3 disk drives* 2 HP 2934A

printers. ' .• Hewlett-Packard RTE-A Data System with Winchester-like disk drive

and 2 HP 12238A Ruggedwrlter printers.• 9-track tape units (2) and floppy-disk dellverables capability.• , NBS Welly Library ^s_i,u ': f .: K ;• CI/EI dual source* 10-1000 emu on HP 5985• Purge and trap concentrator systems with autosamplers (2 units,

• . Takmar LSC-2/ALS • end LSC-2000/ALS 2016); automated heatedpurge and trap capability.

HIGH PRESSURE LIQUID CHRCMATOCRAPHS .(HPLC) I . ./ : « • ?| ._£,, *„. i. . , . •, -• ,

• 9 pumps (Maters* Ollson* Eldsx).*. 1 pump and solvent conditioner for up to quaternary gradient. (Hewlett-Packard 1050 system).• Autosamplers (3 Waters* 1 Hewlett-Packard).* Multiple wavelength UV/VIS (4)* .fluorescence (2)* and diode array

(1) detectors. '•• Column-switching capabilities. '* Post-column derivatlsation capability; •' .• Column ovens. • v...,.,, ^;f:.;i, „...•- > . - * - _.• Medium - pressure liquid Chromatograph (MPLC) with fraction

collector*e Manual injectors (2). . • ;e Computer-automated and controlled (Maxima chromatography data: - . system* NEC APC 17 computer and Hewlett-Packard ChemStatloa).

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Revision No.* 002Datet October 1989Pages 5 of 6

e . EV Macho system electric hammer and drill adapter.e Bailers (teflon* stainless steel); portable pH, temperature and

specific conductance me tarsi air-sampling pumps.

LABORATORY DIVISIONS

» IBM PC work stations (9 units)* models AT and PS/2-60, 8 of whichare networked.

• IBM PS/2-BO dedicated file server.* Radian Corporation Sample & Analysis Management (SAM) software

for laboratory Information management and report generation.e HP LaserJet II printers (2 units)• NEC P3 HLQ Pinwriter printers (3 units). .• Printronlx 6240 line printer (1 unit)• HP Think Jet printer (I unit)• HP 7475A 6-pem plotter (1 unit) j• Epson FZ-85 dot-matrix printer (1 unit)• Softwarei

Lotus Symphony 3.0dBase IVWord Perfect 5.0 '*Harvard GraphicsHarvard Total Project Manager

• Toshiba lap-toy computers (2 units* T1100 Plus and T1200H)

CORPOtAZK EQUIPMENT

* WAN9 VS 5600 word and daVa processing system with multiple workstations and printers* and communications software.

• IBM System 36

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Ravision No.i 002Date i October 1989Page i 4 of 6

INFRARED SPECTBOPHOTOKER (IR)s

1 unit* Perkin-Elaer 1420• Ratio recording - * ' ""

• - - . 1 ?- ™ *> *•", .; • ' * . ' • * . '

• Data station-controlled, dual disk drive

ULTRAVIOLET/VISIBLE SPECntOPBOIOHlilkS (UV/VIS)|

2 units* Milton Roy Spectronic 1201 and 301

MISCELLANEODSl "^ -"- '- »E

Electronic Analytical BalancespH Meters/Specific Ion Electrode MetersCentrifugesIncubatorsUltrasonic Disrupters ,Rotary EvaporatorsN-EvapsShakers "* ' ' " . " , " "

• r . . Bltnd*r§' flsiuemiiers and Food ProcessorsFurnaces and Ovens . ,^ t

FIELD EQUIPMENT

1 ' • « . . - ' • ' . , : • - - • ir . if"[' - - • • • _ •' • . - . -• Sentex "Sceatograph* field-portable gas cbromatograph with electron^ f ..et*tBM •**. *r*OB /onlsation detectors and Toshiba 1200

computer control.* Kwtovac TIP XI total loniiable particle detector for soil gas

studies, with 2 gas-saapllng probes and Heath Plunger Bar.• JMC Zero Contamination soil sampling tube.

• • 2-inch JMC Professional Bucket Auger with extensions.• Ceopump 2 AC/DC peristaltic well pump."o*. Grundfos Pump BF27, 1/3 KT.• . Sollnst Electronic water level indicators (2 u4t$)

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Revision No.t 002Data i October 1989Paget 1 of 2

6.3 INSTRUMENT MAINTENANCE

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Each instrument has a written Standard Operating procedure* whichdescribes the methods for routine inspection* cleaning* maintenance,testing* calibration* and/or standardisation. Materials and standards•required to perform these operations are specified. Frequency ofthese types of checks varies* depending upon the type of instrumentand its usage. The SOP defines a realistic and effective schedule forthe activities described above.

*The persons responsible for performing calibration, maintenance,

and cleaning are those operations parsons using the equipment, unlessotherwise designated by the Section Manager. Biospherics also usesmanufacturers* service contracts for preventive maintenance and repairof selected equipment.

Written records are maintained to document all inspection,maintenance* testing* calibration* and/or standardisation procedures.The records include date (month* day* and year)* description of , jactivity and actual findings* the name of the person performing theoperation* and a statement as to whether the maintenance operationswere routine and -followed SOPs. This information Is kept in a logbookspecific for each instrument. Logbooks are stored in close proximityto each instrument.

• '

In the event of equipment failure or malfunction* analyses laprocess are stopped or transferred to another instrument. Trouble-shooting activities recommended In the . operation manual for thatinstrument are performed* and* if necessary* repairs made by themanufacturer's service department. .The equipment is clearlyidentified as out of service and Is not used until required repairshave been made.

Nonroutine repairs 'performed as a result of equipment, malfunctionare documented in the logbook to show the nature of the 'aerect* ~now *

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Datet October 1989Pagei 6 of 6

Services Division Laboratory

.TRANSMISSION ELECTRON MICROSCOPE (TEM)i... - 1 .- • - .. 4, „ ,- .

Hitachi Model 600 AB „„, t

• Energy Dispersive X-ray,Analyser with Delta Class Kevex• Evaporative Coater ^ s . •'•-..• ft Plasma asher ... ,^ ...J. - . . ^ --. ^--.-^ .- .- <• .-• Sputter coater

POLARIZED LIGHT MICROSCOPES '<6 units)I

Olympus ' . '. ^ pv,-,

PSASE-COaTTRAST lOCXOSCOPES (10 units) t

• ,- • - • ,: • ..- ^\ S^ f," ' ' . - - . .Olympus* Esiss* Nikon .,

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Revision No.i 002Datai October 1989Pagei 1 of 2

6.4 MATERIAL PROCUREMENT AND CONTROL—STANDARD, REAGENTS, AND SOLVENTS

Each chemical purchased for laboratory use is ordered byspecifying the grade required for the intended use. Pereons who placethe orders are not permitted to make any substitutions withoutauthorisation from the Section Manager. This restriction is intendedto avoid inadvertent purchase of materials of substandard quality.The grades typically used at Biospherics include the following!

• Technical - used for cleaning or non-quantitativepurposes.

• Purified - used for some qualitative analytical workwhere purity is not critical and specificcontamination'is noted to be absent.

* ACS Reagent - used for analytical work.• Spectrograde - used in IB* AA* and UV applications.• Pesticide - used for pesticide determinations and other

Grade GC applications. i• Primary - used for preparatloa of standards* x -—'

Standard calibration, quality control* andstandardisation.

* *

Standards for organic compounds are typically obtained asconcentrated solutions from EPA (when available) or a commercialsource. Metals standards are obtained from commercial sources as1*000 ppai certified solutions. Standard materials for inorganicparameters are typically primary standard grade* when available* oranalytical grade. Calibration standards and reference materials usedfor spiking are obtained from different sources.

, * «All reagents* acids* solvents* standards* and other chemicals are

dated upon receipt and when opened. -If no expiration date is providedby the manufacturer* Blosphsrlcs chemists assign a suitable expirationdate. Chemicals are purchased la quantities which will-ha .consumed: &aless than three years. .

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Section No. i 6.3Reviiioa No.i 002


and when the defect was discovered* and any remedial action taken inresponse to the defect.

Quality Assurance • monitors the equipment maintenance andcalibration program through inspections of instruments and logbooksevery month. Deviations from established SOPs are communicated to the

, . • . «- V •'

Section Leaders* who are responsible for taking required correctiveaction. The reports are filed in the laboratory archives.

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Revision No.i 002Patei October 1989Paget 1 of 2

7.0 DATA GENERATION

7.1 QUALITY ASSURANCE PROJECT PLANS

Contracts for selected projects la the laboratory requiredevelopment of and adherence to a Quality Assurance Project Plan(QAPP). The USEPA document entitled "Interim Guidelines andSpecifications for Preparing Quality Assurance Project Plans," QAMS005/80, is used as general Instruction for writing the QAPP. Specificrequirements of the sponsoring agency are incorporated. Each QAPPcontains the following information!

• Title page, with approval signatures and dates.* Table of contents.• Project organisation and responsibilities.• QA objectives for measurement data in terms of precision,

accuracy* completeness* comparability and representativeness.• Sampling procedures. . je Sample custody.• Calibration procedures and references.• Analytical procedures.•e Data analyses, validation* and reporting.• Internal QC checks.• Performance and systems audits.e Preventive maintenance procedures and schedules.e Speelfio procedures to be used to assess data precisloa*

accuracy* comparability and representativeness of specificmeasurement parametsrs Involved* on a routine basis.

e Corrective action.e QA Reports to management.

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Solvents are stored la, a separate* locked solvent storage room,: , Is vented to the outside of the building. Individual bottles of^^y . solvents are kept in the "flammable" cabinets under the laboratory

f .hoods. Acids are leapt in a safety cabinet for corrosives and la"corrosives" cabinata under tume hoods. Dry chemicals are held on

.-'* -i

designated shelves at ambient lab temperature. Organic compoundstandards are stored la several small freesers* which are dedicated to

, standards only. Standards for inorganic compound analysis are held inroom-temperature cabinets, '"

To control quality of "purchased chemicals* the oldest supply isused before a new bottle la opened ("first In, first out"). Analysts

• are responsible for'checking ippearance' of the chemical prior to useto assure that the physical s'tate of the material is correct. Purityand stability of reagents are monitored by performing blank,,,, . . , * jdeterminations and 0C samples along with analytical batches.Additionally* each manufacturer's lot of solvent is checked forpotential contaminants by prescreening the solvent through the

i appropriate method. ' The results of the solvent purity check arecompiled in a separate logbook and are indexed by solvent name*manufacturer* and lot number. The solvents which have passed thepurity screening are listed en a bulletin board outside the extractionlab door, tf a lot has not been accepted based en this presereenlngcheck* it is not released from the solvent storage room.

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aeciion fto.t / .2Jtevision No.t 002


7.2 STANDARD OPERATING PROCEDURES ^ j

Biospherics utilises standard operating procedures (SOPt) todefine the exact routines to be followed In each department. Thereare SOPs covering all facets of the organisation* from sample receiptand analytical methods through data archiving. A copy of the SOPIndex is provided la* Appendix B. The entire SOP manual Is availablefor client review at Biospherics.

The SOP manual consists of over 10ft individual SOPs. Each SOPdocument Is approved separately and Identified by means of effectivedate and approval signatures. An SOP may be Initiated by any staffmember. The document. is submitted to the QA Unit* which* la turn*circulates a copy of the draft document to the laboratory managementfor comment. The draft SOP and management comments are returned tothe SOP initiator for final revision. The revised SOP Is thencirculated by the QA Unit for approval. Each SOP must be signed bythe initiator and supervisor of that operation. Additionally* the QA , >Manager, Lab Manager* and Division Director (or Assistant Director)review and approve SOPs.

Each laboratory and office area has a copy of the SOPs applicableto operations performed la that area. For example* the Sample ControlRoom has a manual containing SOPs concerning the facility* samplecontrol operation* . computer systems maintenance* and safety. The SOPmanuals in the office areas contain a complete set of all SOPs for theDivision.

*

The QA Unit plays a major rolo in the establishment of the SOPs.Members of the .QA Unit write many of the SOPs or assist others lapreparation of SOPs. The QA Unit centralises the circulation andapproval process. All SOPs are reviewed and approved by the QAManager, finally* the QA Unit inserts updates of SOPs to all of themanuals and maintains the historical file of outdated

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No.t 7.2No., 002

octet1 of

m"DAto

. . - r-' Biospherics utilises standard operating procedures (SOPs' " . • daflns the exact routines to be followed IB each department._^* -• - - - « ,"-" . ' *

. a r e SOPs covering all facets of the organisation* from sample r.• and analytical'methods through data archiving. A copy of the

' , : r index Is provided in'Appendix B. The entire SOP manual Is aval;^ . : for client revitv at Biospherics.- ;'v " ( .. , .: , : /t *:!*•.'.. V"."" - -

The SOP manual consists of over 100 individual SOPs. Eachdocument is approved separately and identified by means of effecdate and approval signatures. An SOP may be initiated by any stmember. The document .is submitted to the QA Unit* which* la tutcirculates a copy of the draft document to the laboratory managenfor comment. The draft SOP and Management comments are returnedthe SOP initiator for final revision. The revised SOP is thencirculated by the QA Unit for approval. Each SOP must be signed

( the initiatorfaal supervisor of that operation. Additionally* the\ ,- ^ Manager, Lab Manager* and Division Director (or Assistant Dire etc

review and approve SOPs* . . .

Each laboratory and office area has a copy of the SOPs applicai, .L_t a^,,., *• • -. .

to operations performed in that area, for example* the Sample CoatsRoom has a manual containing SOPs concerning the facility, sample'•;.'• • •• ; ' • i. *-t, * ni?...' •-*•*•• .

_ " r , * . . control operation* .computer systems maintenance, and safety. The Stmanuals In the of floe areas contain a complete sst of all SOPs for VDivision. .

* ' > * .i • . !

_- ' The QA Unit plays a major role in the establishment of the SOPs.: Members of the ,OA Unit write many of the SOPs or assist others in

preparation of SOPs* The QA Unit centralises the circulation andapproval process* All SOPs are reviewed and approved by the QAManager. Finally* the QA Unit i***rfc« »**••*• ** COPS to all of themanuals and maintains the historic™ «*•-or.-outdated SOPs.

* -

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Revision Mo.i 002Date I October 1989Paget 1 of S

7.3 SAMPLE CHAIN-Or-CUSTODT

All Incoming samples are delivered to the Sample Control Officefor inspection* log-in* and storsgs. Sample Control is staffed withfull-time Sample Coordinators. Immediately upon receipt* the sampleset is unpacked and checked versus any accompanying client paperwork.If a field chaia-of*custody sheet Is received with the samples, it iithe responsibility of the Sample Coordinator to sign for laboratorycustody. (Biospherics provides a Chain of Custody Record with samplecontainers. See copy on the next page.)

The Sample Control inspection of the samples include thefollowing checkss

• Custody seal status. , ,e sample container integrity.e Holding temperature at time of receipt.* Type of container (plastic or glass).e pn of sample If chemical preservation is required.e Volume of sample.• Sample Identity.

The procedures for inspection and log-in of samples are providedla SOP NO. S.3. EPA requirements concerning sample preservation andholding time are Incorporated into SOP 1.4. See Appendix C for atabulation of the sample preservation procedures from EPA Manual sw84ft.

2 LABQAU

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2 LABQXtJ

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2 LABQAU

section no*i '•-»Revision Mo.t 002

Datei October 1989Pages 5 of S

The results of the incoming sample inspection are documented on vJthe a page Project Tracking Form. See copy on the following pages.The Project Tracking Perm Is the basis of the sample management systemwhich is deserlbsd in detail la Sectioa 7.4.

Samples are assigned .a unique* sequential number during thelog-in process. Biospherics uses Radian Corporations' Sample andAnalysis Management (SAM) software and a network of IBM personalcomputers. Computer-generated labels which list the Biosphericssample number* client Identification, tests to be performed* storagelocation* and proposed disposal date are attached to each container.

The samples are stored ia locked sample storage areas by SampleControl. Distribution of samples to the*.laboratory and correspondingreturn of samples Is documented via signatures oa a system-generatedchaln-of custody form. The Sample Control Staff is responsible forthe documentation. • •

Samples are kept for at least 60 days from the time the samplesare 'received. After 60 days the samples are disposed of unlessotherwise specified by the client. Disposal of all samples must berecorded on the Sample Control chain-of-custody record.

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flRl*003l»6

Revision Ho.t 002Date I October 1989Page I 1 of 6

7.4 SAMPLE MUTAOEMEHT

• Biospherics us«s three techniques as part of its complete samplemanagement program— >SAM data base printouts of assignments and workbacklog* ce&trallsed project filing and posted work schedule boardsfor each laboratory group. Each function will be described in detailbelow.

*

In section 7.3 of the QA Plan* the Project Tracking Form wasdiscussed as the location where results of the incoming sampleinspection are recorded* After this step* the Project Tracking Formand a copy of the field paperwork or client paperwork which arrivedwith samples is sent, to the Client Services Department. Client

... -. , ,- (| ..-,. " ; ' .. ~ -

Services compares the information submitted with that in its own filesto assure that the sample Set agrees with work arranged via previous

,;- "L 'iHfc""-1'1 * • .

communication. Client Cervices then records the test codes requiredfor each sample and assigns a Sectioa Leader to coordinate the project

: -. . ' •• - •• -•, -:-t .j, •-;•;!! ft .'. . • • •as Project Manager. .Special instructions to the lab regarding report*u* 6*to* sample preparation* QC requirements or special handlingrequired are also recorded by Client Services. The Project Tracking

. • - ,'- r ' , . • . . * ."./;•.:•''- ,"f. ' - - , " - " " " >

Form is returned to Sample Control for computer log-in of the sample

., • • vt ..• - ,. -Sample Control eaters, the client information, sample. - • . . • • " " f^fT ^ : ' " • * • . • * . .

identification aad test codes liato the SAM data base. Each set of. • • • . . , • -, 1 n • • • • ft J { I ' ? . - ' . - ' • • • ' . ( 'samples which are received from a client at the same time are assignedto a Work Order* the Work Order can accommodate up to 42 fractions.therefore* if a single set arriving at one time contains over 42fractions* more than one Work Order say need to be assigned. WorkOrder numbers consist of a saven-digit number as follovst

. -> i-T^^.^-T-i iff 3* fl;+'P =H --- ' ^ " 'T " ~" V - V •

19 01 001 ^" ? ' , ,Where 89 signifies the year - 1969 . t . ,

01 signifies the month • January001 signifies 'the first Work Order asftligned; ifiUtbat

.- • month "r" ' ' " " ' •

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Section Ho.! /.4Revision Mo.t 002

Datet October 1989Pages 2 of 6

Individual samples are labeled with the work order number with aauffix code of two digits and one alphabetical character. In thesuffix* the number indicates a sample identification and thealphabetical figure denotes a sample fraction such as an unpreservedaliquot.

Example88 01 001 - Ola

OlbOle

88 01 001 - 02a (different sample)

After log-In on SAM* hard copy printouts are generated from thedata base. Sample Control keeps a. printout of the Work Order*Chaia-of-Cuetody form and a copy of the Project Tracking Form. Seeattached pages for an example of the SAM printouts.

Sample Control Initiates the Project File by placing the ProjectTracking Form* original client paperwork* and corresponding SXMprintouts of Work Orders'and Work Sheets into a file folder labeled byWork Order number. See attached page for example of a Work Sheetprintout. The file is forwarded to the sppropriate Section Leader.

The Section Leader or his/her delegate assigns work to theappropriate department supervisor* Work required by the oppositesection (organic or inorganic) is assigned to the other Section Leaderwho* in turn delegates the assignment to department supervisors inhis/her section*

Assignments are issued via the Work Sheet printout. SAM has beenprogrammed to create a separate work sheet for each department. TheWork Sheet contains essential information such as sampleidentification* test required* due date to comply with EPA holdingtime and date results are due to the client. The Section Leaderplaces the Project File in the active central file/W tSon 'I gisallows all supervisors and analysts to accsss this file for additionalinformation at any time.

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Revision Ho.l 002Datet October 1989Page t 3 of 6

2 LABQAU

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Revision Mo.t 002Datet October 1989Pagei 5 of 6

Revision Ho.i 002Datei October 1989Pag*t 6 of 0

The department supervisors accept assignments (via Work Sheets) , jfrom the Section Leaders. Each assignment is entered by parameter onthe work schedule boards. These boards provide at a glance a summaryof the volume of samples in the laboratory for each teat/ the specificdue dates, holding time, rsviev datss, rsport mailing dates* etc. Theschedule boards serve as a planning tool for supervisors and analysts,and are monitored informally by QA, and Management.

tech supervisor is responsible for assigning analytical batchesfor processing. The supervisor prepares a listing of samples to beanalysed, the name of the tests to be performed, and the analysissequence to be followed—including quality control samples and anyspecial instructions. The actual documentation used to prepare thebatch assignments may vary according to the type of test performed.The batch assignment documentation must be. retained with the study'data.

All study data are either filed In the central project file or \ jthe data location is referenced in that file. As each test iscompleted* the SAM data base Is updated to elose out the test. Eachday, a printout is obtained froa SAM which lists, by test, all samples

* 'received but not yet analysed. These reports are used by departmentsupervisors to coordinate work assignments.

Reports of analytical.' results are'tabulated and placed in thecentral project file* All correspondence* verbal or written, internalor external* is documented in the central file. The Section Leadermonitors the) progress of each project and reviews the final report.All reports are issued by the Lab Manager. A copy is placed in thecentral project file. The Project Tracking form is used to documentdates of reporting and invoicing. Once a project is reported, it isremoved from the work schedule boards and changed to closed status onSAM.

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ARU00352

Revision No.t 002Datet October 1989Pagei 1 of 3

7.5 CALXBRATXO* XV

The calibration protocols are specified in the IPX AnalyticalMethod, or* when appropriate*; the manufacturer'« operating

. instructions are followed. Routine procedures are highlighted belowt

OC/MS 1) The instrument Is tuned using the compoundappropriated for the analyses to be

, performed. Decafluorotriphenylphosphine. .. . (CrTPP) is used for the semi-volatile

. . compound analysis. Bromofluorobeasen* (BFB)• . .. is ,used for the volatile compounds.

Acceptance criteria for the mass spectra arespecified in the appropriate EPA Methods.

, : . - the tuning procedure is performed once every.. 12 hours. The tuning is performed prior to

. any other instrument operation at the. beginning of the shift.

N .X , T • . • 2) A 6-point calibration is performed using all• - . • ' . . ., -compounds specified in the method. Compounds

, . designated as System Performance Check. , * ' ; Compounds (SPCC) and Calibration Check

• .' Compounds (CCC) must meet the criteria. , oefinad in the method.

3) Zf steps 1 and 2 swat method criteria,- . - . . • . .--. . . . . . . . ssmples Bay be analysed. After 12 hours, the

. .. •. . , .; . instrument's tune must be checked and a daily- ' .calibration check performed. The response

, . . ., _ factors of the daily calibration check. . ,. . components may not exceed 25 or 30 percent, .. .. , • . „ difference, depending en the method, from the

' s initial B-point calibration.

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•vision Ho.i 002Datei October 1989Pagei 2 of 3

GC 1) A five-point calibration curve is initiallyrun. The standards must cover thequantltation range of the method. Therefore,a low-level standard is run at thequaatitation limit. Linear regression mustyield a correlation coefficient of 0.997 orbetter for all compounds detected in the

' samples.2) A mid-level standard is run as a calibration

check after every tea samples and again atthe end of the run. The response must bewithin 25 percent of the initial calibrationstandard.

AA (rURHXOt) The following procedures are performed, on a daily basis i1) The instrument is initially calibratsd with

two high standards and a blank. Acalibration curve, consisting of 4 levels ,

' (depending on the method) and a blank, is ^"^run. This procedure* vsrlf ies the linearityof the calibration. A correlationcoefficient of 0.997 or greater is required.

2) Calibration verifications, consisting of ablank and a mid-level standard, are .run afterevery tenth sample. Response of themid-level standard. must be within *10 percent.

AA (7LAMB) 1) The procedures for calibration of flame„ - - , . . . . f

analyses are Identical to those for furnacecalibration* with the followingmodification. The Initial calibration isperformed using one mid-level standard and anauto isro function. The calibration curveand continuing calibration verification areperformed as described above.

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Revision Ho.! 002Datei October 1989Paget 3 of 3

The following procedure* are performed on a daily basisiICP 1) The instrument is calibrated on a blank and

.„ -4, ' , f f • j,,

•/ ' ' : • ' :"*one standard. \: -, 2) ! A calibration verification standard and

calibration blank are run prior to samples': - , * f, -: * =-* , _ - , „ = ; -

and again after every ten samples. Resultsof tht blank must be less than the detectionlimit and ths calibration verificationstandard mutt be within ±10 percent.i

SPCCTROPEOTOMETRXC 1) A 5-point curve plus a blank is analysedAUTOARALYZ2R in triplicate. The lowest standard is

XOK CHROMATOCRAPH equivalent to the detection limit. Samples'may be quaatltated within the range of the

" ^standard curve, the correlation coefficient--"" - ugt be equal to 0.997 or better. The

' ' ''calibration curve is prepared quarterly orwhenever new reagents are used.

2) On a daily basis* a high and low standard arerun as calibration cheeks. The results mustbe within elO percent of the original curve

' ~or the entire calibration curve mutt be

3) Calibration verification standards are: - ' • • • -. Inserted after every 10 samples. The check

standard must agree within «10 percent of the" initial calibration check. Xf this criterion' is not achieved the system Is evaluated esout of control. The cause must beinvestigated and all samples since ths lastacceptable calibration verification standardmust be repeated.

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^ - • flRl»00355


7.6 DETXRMXKATXOK OP DETECTION XHD QUAHTXTATXOV LIMITS

Two types of detection limits are routinely determined atBiospherics»the Instrument Detection Limit and the Method DetectionLimit. An instrument Detection Limit (XDL) is defined as the smallestsignal above background noise which is reliably detected. A MethodDetection Limit (KDL) is ths minimum concentration that can bemeasured with 99 percent confidence that the aaalyte is greater thanaero. The MDL's are determined from analysis of spiked blank watersand soils.

Instrument Detection Limits are measured primarily for metalsanalysed by atomic absorption spectrophotometer (AAS) and inductivelycoupled plasma (ICP). The XDL should be determined when new equipmentis acquired* after major instrument repairs** and when required byspecific contracts. For example* CLP contracts require quarterlydetermination of detection limits. The XDL is obtained by thefollowing procedurei V^X

1) A standard is prepared at 3-5 times the level of the estimateddetection limit.

2) On 3 non-consecutive days* 7 consecutive measurements of thestandard are obtained* The standard is treated as a sample,with rinses or blanks run between each replicate.

3) The average of the daily standard deviation is multiplied bythre« to obtain the XDL*

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Datei October 1989P«g«i 2 of 2

Method Detection Limits should be measured for all new testsemployed at Biospherics. Both water and soil matrices should betested. The procedure is defined in 40 Cnt Part 136, Appendix B

BogiaUr October 26* 1984. The procedure is outlinedbelowi - ' ' • _ , ' .

,.*..„ ••» f • . - - - " .; - ' >T * i. • ' ' •- - '•1) An estimate of the detection limit is made.

i<. -'-- ,. «:..Sv ; ' ' . ' ' • • ;- ' ' :2) A minimum of seven replicates of blank water or soil are

•piked at a level 1 to 5 times the estimated detection limit.When eppropriate* spike compounds are added.

; ... » ' * ft1*: -"

3) The spiked samples are processed through every stsp of theanalytical method. .

'; •" ' " ^t ' , ' • , , ' ! ' '

4) The standard deviation for the seven samples is multiplied by- - C^v-ir . 'A , • ' '••

3.143 (students t value at 99\ confidence at BT-1 degrees of. . - t ', . • £& 2 ' . 1|j • : '' -

freedom) to obtain the MDL*-. • ' .*• ' ".•- • &M: *• - - - • -

- ' . •- .- •,,**>:. • : ' •- --- -The Practical Qoaatitation Limit (PQL) is ths lowest level that

can be reliably achieved within specified limits of precision andaccuracy during 'routine laboratory operating conditions. IPX's SH-846Manual provides PQL's for typical matrices— groundwater, soils, and

»-*•?.';-•-wastes. Quaatitation limits are also specified as contract-requireddetection limits. The laboratory supervisor sets the Practical

nlf*1 ' •" ' .Quantltatioa Limit based en knowledge of instrument's response and

.**••: '&?.•:."" •'day-to-day precision, the fuaatitation limit must exceed thelaboratory MDL. The MDL Study verifies the capability of thelaboratory to detect the compounds at the guantitation limit.Additionally* one of the calibration standards in each run is

* i ' H * !! ' -performed at the quantitation limit. . . -

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ARU00357


S.O DATA PROCESSING

S.I COLLECTION

Accuracy and completeness of data records are essential inmaintaining the quality of laboratory results. General procedures fordata recording are defined in SOP No. 10.3 and No. 10.3.1. Ink isused for all entries. All entries are signed and dated. Correctionsare made with a single line through the error* initials, and date.

Data records are maintained for all transfers and processing ofeach sample from the time the sample is received until the results arereported and the sample is disposed of. The records kept for receipt,log-in, and sample custody have been discussed in Sections 7.3 and7.4. Preparation of standard solutions is. documented in boundnotebooks. Bach stock material and solution Is assigned a numberwhich is referenced in the preparation log. Prepared solution numbersare recorded on the analysis data sheets* The standard solution *preparation log contains entries regarding the eonrce material whichincludeai

e Compound name.» Purity.e Manufacturer and lot number.* Concentration* if in solution form.

' • Solvent* when appropriate*** Date consumed or disposed of*

The solution preparation is documented by the following informations

• Compound Identification*e Source material (by number)*• Assigned solution number*e Date prepared.• Quantity weighed out or measured by volume.e Final volume after preparation.

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no.t «.uRevision Mo.i 002


* Solvent used.• Final concentration.• Expiration date .• Date disposed of. /

Data for inorganic (nbnmetal) compound analyses, are recorded inbound notebooks assigned to each test. The required information foreach analysis includes but is not limited to i the analyticalprocedure; any procedure 'changes required! Biospherics' internalsample number* raw analytical data* standard solutions usedipreparation of reagents "when appropriate i signature and date. If aninstrument printout is obtained for the analyses, the printouts are

-• ^ f * * --, \ "i '• • • :' s • . .- •signed, dated and retained, the printout Is inserted in the notebookif sise permits. Otherwise" ihe printout is filed in a separate filewith a cross reference recorded in -the lab .notebook and on theprintout.

for metals analysis* a digestion log is maintained in a separatenotebook. The digestion is documented by record of Biospherics*internal number* sample volume* elements* method, spike true value,date and initials. Digital printouts of results are obtained forgraphite furnace and ICP analyses. Flame* method analyses have a stripchart printout.

Final calculation of results for ICP are recorded directly en theICP printout* For furnace and flame work* a separate calculation pageIs prepared to reference analysis date, instrument identification/Biospherics sample number* initial result* dilution or concentrationperformed* final results* true valve of QC or spiked samples* percentrecovery obtained* and comments* Bach data set is paginated and filedin the metals data notebook.

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flRU00359

Revision wo.iDates October 1989Pagei 3 of 3

Data for organics compound extraction techniques are recorded oncustom designed* preprinted Sample Horkup Sheets. All detailsregarding the extraction are recorded on this form. The data includethe following entries) extraction method; sample matrix; extractiondate; surrogate spiking solution number and concentration; matrixspiking solution numbers and concentration; Biespherics sampleidentification number; sample amount; quantity of surrogate and matrixspike added; final extract volume; extract storage location andsignature of chemist. One copy of the Sample Horkup Sheet is kept inan extraction log book. A second copy of the sheet travels with theextracts to the analysis laboratory. Bard copy printouts of GCchromatograms and GC/MS mass spectra are generated. All instrumentprintouts and compound identifications are checked manually and theinstrument printouts are filed with the Sample Horkup Sheets la thecentral project tile.

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ARU00360

««viaion Mo.IDatei October 1989Pagei 1 of 3

S.2 VALIDATION - . - . / •:::;: * , * * . - • • -• . • - ' • :. S J'.i'^ .!

• • Data validation is the process whereby data are accepted orrejected based on a sat of criteria. The validation procedure isdescribed below.

. • ,., ,. . • . • •ir '.'••»- --. ' • - *r' *'''•• ' • ' ' - • 'All data receive a 100\ review by either the supervisor or a

second analyst of equal or higher experience and responsibility. Thisreview validates that the following requirements have beenappropriately meti'

• Calibration met or exceeded a correlation coefficient of. - -, . ? , J --", ** ;i, V T'!: „ r •••0.997. Standards in the calibration curve covered theexpected concentration ranges of the samples including thedetection limit. All sample results fell within the range ofthe standard curve* Initial and continuing calibrationverification checks met the acceptance criteria defined in themethod SOP*

. , • , -• ' , • - * • ? ; .fts*;,'•••'• • " •-L j " • Method blanks were processed with each analytical batch andN^X , . . ... , ? - . • . > ' , . " ' . ft :iV r- -, ' '

were free of contamination.• Results of duplicate samples and matrix spike duplicates were

within'the precision control limits. See Appendix D for' control limits.e Matrix spike recovery vas within acceptable control limits.

See Appendix D for control limits.e Laboratory control samples. were analysed according to

frequency specified in the SOP and the results obtained werewithin control limits. See Appendix & for control limits.

e For organic compound analyses* surrogate spike recovery waswithin control limits. See Appendix 0 for control limits.

• For CC analysis* the compounds identified fall within thedaily retention time window. '(The dally retention time windowis defined as the absolute retention time of a mid-levelstandard * 3 standard deviations. The standard deviation isobtained from an initial check of 3 injections of-standard*- iwithin a 72-hour period.)

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Revision NO.I 002Datei October 1989Paget 2 of 3

• Compounds Identified by GC/KS have been manually rechecked by J,comparison with the data system library. Retention time andratloe of fragmentation are verified. There are two datasystems* each supporting 2 GC/KS. The NBS library of massspectra is ussd on one system. The other data system librsrywas generated in house by injection of standards.

• Calculations have been accurately performed.• Data for the analyses provide a complete audit trail. Data

notebooks and data sheets correctly reference the analyticalmethod* the standard solutions used* internal Biosphericsnumbers* original data values* sample results in correctunits* calculation formula for all conversions, signature ofthe analyst* and date. Instrument printouts must identify theperson responsible for the data generation and the date of therun.

• *

The supervisor or other data reviewer signs the data sheet todocument approval. Zf the complete revle* was performed by someone , Aother than the supervisor* a less detailed second check la performedby the supervisor. The supervisor checks a minimum of 10% of thedata. No data may be reported without supervisor approval evidenced< > - • - ' .by signature* on the data page.

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Revision Ko.i 002Datei October 1989Pag*i 3 of 3

A tabulation of results is prepared by the supervisor or analystand submitted to the supervisor with the data. The tabulation ischecked by the supervisor during the data review. After approval, thetabulation is transcribed into the report format by assigned reportwriters. The report and complete project file go to the SectionLeader for final check. . The Section Leader's review covers thefollowing pointsi •

e Transcriptions are checked for accuracy and use of appropriateunits. P ,;. , , .

• QC data are reviewed to assure that internal specification andcontract requirements have been met.

• Nonconformance reports*, if any, are reviewed for completion ofcorrective action and impact upon results. Informationcontained in the monconformaace report may need to be includedin the narrative report to the client.

• Results make sense compared to historical information about\_j the site and results for other parameters tested at the same

time.

After the Section leader reviews and approves the report, it issubmitted to the Laboratory Operations Manager for final approval andissuance. A copy of the signed report is retained in the project filefor archiving.

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Revision Ho.i 002Datei October 1989Pagei 1 of 1

9.3 STORAGE

Data notebooks* instrument printouts, sample chaia-of-custodylogs* files* and contracts are retained for a period of 5 years. Ifcontract requirements deviate from this procedure, the contract-specified holding time is followed.

Equipment ussge and calibration logs which are not study*specificare kept for a minimum of 10 years. Original SOPs, current andoutdated, are permanently archived.

All laboratory records are archived by ths QA Department ialocked storage rooms. The QA Manager controls accsss to these rooms.Records are submitted to the archives in archive boxes. Each box Isnumbered. A cross index of documents by subject is maintained forexpedient retrieval of information.

2 LABQAU

Revision No.t 002 /Datet October 1989Paget 1 of 1

8.4 TRXNSFER

Transcription is a potential source of error. Therefore, alltranscriptions are checked by a second person.

Two types of transcriptions are most commons

1) Transcription of a value from a chromatogram orinstrument printout to a data sheet for furthercalculation of a result. This transfer is checked bythe data reviewer prior to release of results.

2) Transcription in the report preparation and typingstage. The Section Leader checks this step or assignsthis task to "someone other than the preparer of the

,. - -, report. . --.;+?•.?# --: -. - - •- ,

2 LABQAU

1 00365

Revision No*t 002Datei October 1989Paget 1 Of 2

3.5 DATA REDUCTION

Data reduction includes all processes which change either theform of expression or quantity of data values. The size ordimensionality of the data set is reduced.

To validate all reduction operations* all calculations ormanipulations of data are recorded in the data. A description of theformula used is provided.

Bioapherics uses standalone computers and automatedmicroprocessor-controlled equipment and instrumentation to reduce rawdata to final form, such ass

• HP 1000 computer with additional disk drive and HP RTR-X Datasystem for GC/KS.

e IBM PC with Maxima data acquisition software oa HP 5890 andTracer GC's.

• Level 4 integration on HP. 5880 and Tracer CC*s completelyprogrammable for instrument control and data manipulation.

e Integration systems with calibration curve calculationcapabilities on all other GC and HPLC equipment.

Calculation of results is performed by these systems based onstandard curve responses and is printed with each sample responseand/or summarised in tabular fora at the end of each analysie set.

Hhea data calculations using linear regression are performed withcalculators* the correlation coefficient* slope* and y-iatercept valueare recorded in the data.

The procedure for correct use of significant figures and foundingof numbers is*defined in SOP 10*3.1*

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ARU00366

Revision Mo.i 002Datei October 1989Pagei 2 of 2

The founding rules cited in the USEPA Handbook of AnalyticalQuality Control in Hater and Nastewater Laboratories ere followed forall manual rounding of numbers.

2 LABQAU


9.0 DATA QUALITY ASSESSMENT w9.1 DEFINITION OF TERMS .

Aecuracy

Accuracy is defined as ths degree of agreement of a measurement*X, with an accepted true value* T. Biospherics uses four types ofcheek samples for accuracy assessment—the lab control sample (orblank spike), the matrix spike, continuing calibration standards andmethod blanks. (A measure of "not detected" in a sample known to befree of the aaalyte (V12.* method blank) is a measure of accuracy.)

The formula used to calculate accuracy isi

Accuracy • Concentration measured x 1QO\

Concentration spiked

For matrix spikes, the' formula must correct for background ^-^concentration found in the unspiked fractioai

Accuracy » Concentration aftar ipllcitia •• BaetarouaJ eopeeptratioa vinn%.

Concentration spiked

•Precision

Precision is a measure of the mutual agreement among individual' measurements of the same property* usually under prescribed similarconditions* Analysis precision is assessed through comparison ofduplicate samples or duplicate matrix spike samples. The term isexpressed as relative percent difference (RPD).

KP9 • | MS «. MSP | « 100\ for matrix spike samples0.5 (MS * KSD)

RPD • [ *eB 1 - Beo a | _ x 100% for duplicate samples -^s0.5 (Rep 1 * Bep 2)

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; - • • - . . . • • ' . flR«*0036«

Revision Ho,i 002Datet October 1989Pagei 2 of 3

Completeness is a measure of the amount of valid data obtainedfrom a measurement system compared to the amount expected undercorrect normal conditions. To maximise completeness of laboratoryanalysis, it is essential to have a sufficient quantity of each sampleto provide for original and repeat analyses should the original'analysis fail to meet acceptance criteria.

Biospherics' objective for completeness is 100\. However, datasets which do not meet this abjective are not subject to rejection.To do so would be unreasonable because all valid data are usable.

expresses the degree to which data accurately and preciselyrepresent an environmental or process 'condition.

Field sampling operations have a major impact on datarepresentativeness. Factors including site selection, sampling tools,equipment cleaning procedures* sample preservation, and many othersmust be considered. ' Similarly* laboratory operations could impactrepresentativeness if there were day*to-day fluctuations inmethodology. • Samples should be well -mixed prior to takingsubsamples. Liquid samples ere shaken vigorously prior to aliquotiagand soils are stirred well with a spatula. Accuracy and precisionresults of the daily quality control samples provide a measure ofrepresentativeness*

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K»viaioa MO.iDatet October 1989Pagei 3 of 3

Comparability expresses the confidence with which one data setcan be compared with another* This quality indicator Is enhanced bythe following controls used at Biosphsrics.

e Standardised EPA approved methodology for sample preservation,holding, and analysis.

• Consistent reporting units for each parameter in similarmatrices.

• EPA- or NBS-tracsable standards when available.• Frequent analysis of USEPA QC samples. .• Participation in iaterlaboratory performance evaluation

studies.• Frequent performance and system audits*

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ARU00370

Revision No.i 002Datei October 1989Paget 1 of 3

9.2 ROUTINE QUALITY CONTROL PROCEDURES

Data quality in the organic chemistry laboratory is evaluatedthrough performance of ths following; QC measures! method blanks,„ < , . « * ,surrogate spikes, matrix "spikes and matrix spike duplicates, labcontrol samples, calibration check standards, and second columnconfirmation of compounds quaatltated by GC (except those analysed byMethods 601 and 602) i

The acceptance criteria for the QC measures is defined in themethods of EPA CH-846V Method blanks may not exceed the detection

•• • limit. The detection limits are filed by the department supervisorand are' available to the analysts at all times. If the method blankvalues exceed the detection limit* all samples in the batch must bereanalysed. Zf there is insufficient sample to reanalyze, the resultsmust be flagged when reported. Surrogate spike recoveries are

!t " -- .ffii f e' .' '

(j evaluated using the USSPA Contract Laboratory Program (CLP)specifications. For the methods which are not covered by the CLP

. „, , .;, ... ."i If";. t;',. " -

• program, Biospherics uses a target range of 25-200 percent. Controlcharts for surrogate recovery have been set up. Once sufficient data

• > ... i- .-. V T "' """ -T -become available, coatrol limits will be calculated - as the meanpercent recovery * 3 Standard deviations. If surrogate recovery ismot within the established acceptance criteria* the .sample is

-, , . •• . -i s= ~s .. i' • ' • " *' ' ' '",reextractsd to evaluate 'potential matrix interferences. If matrix

, . . *rt'-!f -r Jl •:'»!:« - *-<•"

. interferences are confirmed by repeated poor surrogate spike recovery,the results are reported along with a statement that matrixInterferences were confirmed.

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»«ction wo.t v.2Revision Ho.i 002

Datei October 1989Pag*i 2 of 3

Unless otherwise specified by the contract, the QC samplefrequency is as follows i

Surrogate spike each sample* standard and blankMethod blank every batchMatrix spike 1/20 of each matrixspike duplicate 1/20 of each matrixLab control sample weekly for 601 and 602, monthly

otherwise

Bioapherics currently uses CLP and SH-846 acceptance criteriawhen evaluating matrix spike recovery and lab control samplerecovery. Results of these QC samples should be plotted oa controlcharts with internal control limits to be set during 1989.

Chemiefcr

The OC samples for Inorganic chemistry parameters consist of labcontrol samples* blanks, duplicate samples* and spiked samples. Thesesamples are analysed at a rate of one per tea determinations.

» * - v- -' .

The acceptance criteria for each control check is method-•speclflo. Percent recoveries for lab control samples are plotted oacontrol charts* The control limits art calculated as the mean psrcentrecovery e 3 standard deviations. If control limits have not basa setbased on historical data* a value within ±20% of the true value isconsidered within control*

•eagent blanks art analysed to detect reagent or systemcontamination* • Background levels la samples are considered in theevaluation of reagent blank' results. Xn all cases* the blank must beless than ths detection level or 50\ of the sample result. Typically,sample results are corrected for the reagent blank.

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Revision No.i 002Datei October 1989Pagei 3 of 3

Sample duplicates are used as an assessment of precision. Anacceptance criterion of «20 relative percent difference (RPD) or ±KDLis applied for water samples.

Spiked sample results indicate accuracy, which may be affected bymatrix interferences. The normal acceptance range is 70-130 percentrecovery of the spike amount when the matrix is water. If matrixinterference is evidant, corrective steps include dilution, cleanup,matrix modification or use of an alternative method.

Control charts are maintained for lab control sample percentrecovery, matrix spike recovery, and duplicate precision.

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flRt»00373

xeviiion MO.t UU2Datei October 1989Paget 1 of 2

9.3 QUALIT7 CONTROL CHARTS

• ' • • - • ' • • •frqeuraey

Accuracy control charts are prepared la order to plot values forlab control samples* surrogate splks* and matrix spike recoveries.Results from each matrix must be charted separately. Control limitsare statistically calculated from a minimum of 30 data points.Control limits are sst as the msan * 3 standard deviations. Warninglimits are at the mean * 2 standard deviations.

Results which excsed the warning limits but not the controllimits alert the analyst to a potential problem. Sample results areaccepted, but the procedures and standards are checked. If the labcontrol sample exceeds the control limit* the analyst must stop workoa the analysis. .The analyst* supervisor* and QA Coordinatorinvestigate potential causes of the problem. After the cause isdetermined and corrected* ssmples from the original set are rerunalong with duplicate spiked samples and a lab control sample. Control'limits are recalculated periodically. The frequency of this isdependent on the number of data points accumulated.

• •'

QC sample results are plotted oa a 'daily basis so that findingsmay be promptly evaluated. t The charts -are used to detect trendsbefore an out-of-control situation develops. Examples of situationsto monitor closely arei

e Four (4) or more consecutive points on one side of themidpoint of the chart* -

e Gradually increasing or decreasing response.e Cyclical patterns*e Broadened range of response.

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ARl»0037l*

•»» * *>«vision No.i 002


Control chart, for prtcmon ,r. plot, of th. r.lativ. p.rc.ntdlff.r.nc. (UD) b.tw..n pair. e« .„*!. «UpUcat.. or ..trl. .pik.duplic.t... B.i.tiv. p.r9«t ««.r«e. i. e.leul.t.d .s th. 100 x

. ,.ch-"• , -• f. -j ; j™ J • — — — —— —— vvfTH* ••**•£• MABUf

since precision is typically concentration-dependent, care must betaken to chart low-l.v.i wd^Wgh-level sample. ..parately.

The control level for precision is defined as the average RPD ,3.27.

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Revision No.t 002Datei October 1989Page I 1 of 3

10.0 CORRECTIVE ACTION . j

10.1 NONCONFORKANCE EVENT CORRECTIVE ACTION AND DOCUMENTATION

Documentation of analytical problems and corrective actioa takenis an essential part of the data record for each project.Xdeatlficatloa* implementation* and monitoring of the actions thatcould have prevented the analytical problem provide a method forimproving the quality of laboratory performance. A Nonconformancereport sheet has been designed to record problems* corrective actions.impact on analytical results* and suggested preventive actions for thefuture. A copy of this report sheet is Included oa the following page.

The Nonconformance Report must show complete backgroundinformation about the event* including!' date, and shift* analysis andphase; the client name; the sample identification number; and adescription of the event which occurred. The report must furtheriacludet the corrective action taken; indication of the status of the . jsystem; an assessment of impact oa analytical results; and suggestionsfor preventive actioa. •

* *

The Nonconformance Report is initiated by the person experiencing'or noticing the discrepancy and completed by his or her supervisor.For example* the initiator provides the description of the event andcorrective action taken; the supervisor adds the impact and preventiveaction.

Copies of the completed reports are) distributed to the ProjectManager* the Lab Manager* and the QA Manager. The Project Managerreviews the Nonconformance Report and then places a copy of the reportinto the Project Pile* Zf the event has caused any impact oa theanalytical results*' the Project Manager will meet with the QA Managerand then communicate with the client* either personally or throughClient Services.

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ARW0376


ENVIRONMENTAL LAB > NOH-CONFORMANCE REPORT

Distrlbutioat - ' Bav 2/S9

Section Leader •• Project manager * Project File (original)iQuality Assurance Manager otheri ______________________Lab Manager . - . : • -. . •; ,j ,E; ;* ? <'": ________ ' " "'__________Date of Occurrences ______-^__ Hork Order iTime of Occurrencei • FraetieniClient or Project Namei _^___.______ Analysis! „Phase of Analysis I ______.«——^^_^Description of Events v _ _ _ _ _ _ _ _ _ _ _ _ _

Possible Causes of Non-Conformancei

Most Probable Cause of Noa-Coaformaftces

Corrective Actioa Takens ___

I j ' Results of Corrective Actions

Other Action Required!

Is System back in control? • • If No* circulate this formimmediately without taking further action.

Impact oa Analytical Results i

Suggestion for Preventive Action for Futures

Reported Byi _____ Dates ____ Supervisors _____ Dates

Additional Actions

Initiated Bys _______________ Dateii

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The Lab Manager checks that corrective actioa has beeaappropriate* confirms analytical impact* and ensures theimplementation and monitoring of preventive action.

The QA Manager reviews the Noneoaformance Reports and files themfor follow-up actioa. Periodically the QA Manager meets with ProjectManagers and Laboratory management to evaluate corrective actioa andpreventive actioa effectiveness. All sffsctlve preventive actioa isdocumented for all appropriate laboratory aactions. Supervisors ofeach area are responsible for any SOP revision needed to reflect thesepreventive actions.

Initial preventive actioa plans which are evaluated as being'ineffective cause a team to be formed ta identify the root cause ofthe problem and the effective preventive actioa. This team is led bythe supervisor of the area where the initial aoncoaformance occurredend at least one member of the Quality Assurance Unit and managementparticipate. Progress of this team and monitoring of the .effectiveness of preventive actioa is documented by the team leader ^and logged and filed by the QA Manager.

ARI*00378

AttCtlOO *O.1 1U.2Revision Ho.i 002


10.2 INTERNAL AUDITS

Xmlifca

A performance audit is a planned independent check of theoperation of a measurement system to obtain a quantitative measure ofthe quality of the data generated. In practice* this involvesanalysis of standard reference samples or materials which arecertified as to their chemical composition or physical characteristics.

* . - ': *> f . ' * i- ' * ' '

The QA Unit prepares and submits performance evaluation (PE)samples to the laboratory on a semi-annual basis or more frequently.The fact that the samples are PE samples is not revealed to analystsor supervisors. These blind samples provide a check on all operationsperformed in the leb* including bottle preparation* sample holding*extraction* analysis* data validation* and reporting. The blind PEsamples are prepared from EPA reference materials. Findings reported

„ a If • < .. „ -y " ' -

i by the laboratory are compiled into a summary report by the assigned{ J ' - . , - , . , , . - * - . --. * - - • •— QA Coordinator and Issued to the QA Manager and Lab Operations

Manager. Unacceptable results require investigation by the LabManager* documentation of "corrective action by the Lab Manager* andfollow-up review by the QA Unit. ; •

The results of the blind PE samples and documentation ofcorrective actioa vill be filed by the QA Department in locksd storage.

Byetems Audits

Systems audits are on-site reviews of a laboratory's qualityassurance system and physical facilities for sampling* calibration*and measurement* Systems audits are performed by the QualityAssurance Unit semi-ennually. Additional systsms audits may be

"performed for sslected projects* this schedule is also euoBlenentad.by the numerous external audits performed by state cer educationagencies and clients*

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* '•»!'. 1- s .-.•-'• L* i-' ', .

Revision Ho.t 002Datei October 1989Pagei 2 of 2

During the systems audit* all areas that may impact quality areevaluated!

Personnel -Sufficient number and skill level?Equipment and facility -Adequate for activities performed?Methodology -Authorised by client?. Procedures

conform with published EPA Methods?Sample Chain of Custody -Complete?QC sample performance -QC charts in use?Adequacy of SOPs -Sufficient in detail to perform the

task?Corrective Action -Are actions taken documented and

sufficient?Data Processing - -Accurate? Retrievable?

Document File -Complete?

Findings of systems audits will be reported to the laboratory Jmanagement. If corrective action la required* the responsible Section ""Manager will prepare a written response* The QA Unit will conduct afollow-up audit a month after the original audit*

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ARl*00380

kevision Ho.t 002Datei October 1989Pagei 1 of 1

10.3 EXTERNAL AUDITS g .

Performance Audit*

Biospherics participates in the USEPA performance evaluationstudies for water supply and water pollution parameters and the NIOSHProficiency Analytical Testing (PAT) Program. Additionally*Biospherics analyses performance cheek samples to maintain statecertifications. Currently* Biospherics has certifications inMaryland* Virginia* Delaware* New Jersey* New Tork, and Pennsylvania.

1 . . '-, ,

Systems Xufllta , , , „_

- • - ; - . - . - - : • * f^S* t':;" •."The state certification programs listed above require on-site

inspections on an annual or bi-annual basis. The laboratory is alsoaccredited by the American Industrial Hygiene Association. Theaccreditation includes an inspection once every 3 years.

Biospherics welcomes all clients and potential clients to inspectour facilities and Quality Assurance Program. Mutually agreeablescheduling arrangements may be made by contacting the MarketingDepartment. ' ; '

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10.4 AUDITS OF SUBCONTRACTORS

Analysis performed by subcontractors should meet or exceed therequirements of Biospherics' QA/QC program. Potential organisationswill bo screened and suitable candidates identified by the MarketingDepartment. . •

The QA Unit'will evaluate the QA program of the subcontractorthrough review of the laboratory's written Quality Assurance Plan,typical SOPs* and latest USEPA performance evaluation sample results.If PE results are not available* Biospherics will submit blind PEsamples to the subcontractor. Successful completion is required. Anon-slte audit of the facility will be performed as necessary.

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....-• •; AJUO-0382

Revision No* t 002Datei October 1989Pagei 1 of 1

11.0 IMPLEMENTATION REQUIREMENTS AND SCHEDULE

The Quality Assurance Plea becomes effective oa the first dayafter approval by the management personnel listed in section 1.0. Anyquestions regarding implementation should be addressed to Fran Dillonor Mark Gudnasoa. ;- -

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; ,r-V' '-•• flfllf00383

Rtvislon Ho.i 002Datei October 1989Pages 1 of i

12.0 REFERENCES

REGULATIONS

40 CrR 136.3e Required containers* preservation techniques* andholding times

40 era 136 Quldelines establishing test procedures for theanalysis of pollutants under the Clean Hater Act

40 en 136 Methods for Organic Chemical Analysis ofAppendix A Municipal and Industrial Hastevater

40 era 136 Definition and procedures for the determinationAppendix B of the method detection limit

40 era 136 Inductively Coupled Plasma - Atomic EmissionAppendix C Spectrophotometer Method for Trace Element

Analysis of Hater and Hastes. Method 200.7

MANUALS

EPA 600/4-79-020 . Method for Chemical Analysis of Hater and Hastes(1983)

EPA 600/4-79-012 Quality Assurance Handbook for Analytical QualityControl in Hater and Hastewater Laboratories(1979)

* *

SM-846 Test Methods for Evaluating Solid Hastes* ThirdEdition (1986)

Standard Methods for. the Examination of Hater andHastes*/ 16** Editlda* American Public HealthAssociation.

QAMS 005/80 Interim Guidelines and Specifications forPreparing Quality Assurance Project Plans* USEPAOffice of Monitoring System and QualityAssurance* December 29* 1980

QAMS 004/60 Guidelines and Specifications for Preparing. Quality Assurance Program Plans* USEPA Office ofMonitoring System and Quality Assurance*September 20* 1980.

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ARU0038U

u.i App«nCUX ARevision No.i 002


APERSONNEL RESUMES

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Revision Mo.t 002Dates October 1989Pages 2 of 2

J List of Management and Supervisory Personnel for Environmental Lab . j(Resumes are attached)

Corporate

Robert Edwards* Ph.D. Vice President* Science Services

Laboratory Man adamant

Edward Daatsker Director* Laboratory Division

H* Markus Gudnasoa Manager* Laboratory Operations

Oranic

Ueha Parekh Supervisor* organic Extractions, and GCLaboratory • *

Harless MacDaniel Supervisor*. GC/MS Laboratory

Inoranic

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Clara Trimmer Supervisor* Inorganic Het Chemistry Lab

Peter Chapman . Supervisor* Metals Laboratory

QroupA Hater Program*.

Stuart Cohen Manager* Ground Hater Programs

Assurance

Keith Ryan Manager* Quality Assurance

ROBERT G. EDMARDS, Ph.D. .Vies President for Science Services

EDtTCXTlQH . . . . - , * * ' /..' • . M«I? fl ,'' • '- -- ' • • ; - - " '

Ph.D.* Organic Chemistry/Biochemistry/ University of Oxford* Oxford* England,1973. ' , . . - , - -

B.A.* M.A.* Chemistry* University of Oxford, Oxford* England, 1969, 1973.B.Sc.* Organic Chemistry* University of Oxford, Oxford, England, 1970.

- F '•• - - " '-EXPERIENCE . -. -_: ' ;-,^OC"i *? ••.' ~ "-" " - . _;' • ."] ^ ,.

1988 to Preseatl Vlee Pr es Jflept for Seleaee Services - Biospharics'Incorporated, Beltsvllle* MD, j

Overall corporate responsibility for administration of the LaboratoryDivision, Including marketing* budgeting and operations . Divisionspecialises la environmental analysis* pesticide registration studies andground water investigations* with a staff of up to 85. Divisionsuccessfully audited by EPA and various pesticide manufacturers forcompliance with Good Laboratory Practices, by Mitre Corporation for U.S. AirForce Installation and Restoration Program* and by various States forenvironmental certification. - • " -' '

Participation la Management Committee for a low-calorie sweetener program,ia long-term corporate planning* and in iatsrdivlsional projects. -

1986 to 1988t Vlee President. Geonex Corporation* St. Petersburg* Florida,Praaidept and Chief Operating Off leer. Hartal' Laboratory Services* (a Geonexsubsidiary)* Towsoa* Maryland. • : : . . : • , , •

1960 to 1986i Vlee Preel fflt/ iite General fjp««7ay- Martel LaboratoryServices. •= - - .-.- . ,*a J'.;" 1; • - ' " " . , " ? . •

1976 to 19801 t.»frrtrnt:Bry P r e f *»|fl hief Chefatst. Martel LaboratoryServices.• _ . • -Oversaw all day-to-day operations as well as marketing and sales* financeand general eoaiinlatration. Bad ultimate responsibility for the quality ofthe* analytical results. Provided the parent corporation with the monthlyfinancial and operational reports* and prepared the annual budget.

Laboratory specialised in analysis of both environmental samples and -petroleum products* including apectromotric oil analysis programs for boththe aircraft and automotive industries. Expanded the laboratory to IncludeGC* GC-MS* AA* ICP* TOQC, .and a computerised laboratory Information :management network tor both sample tracking and reporting* with softwaredeveloped in-house. Satellite laboratories were established ia both Texasand Illinois. Staffed petroleum analysis laboratories for the U.£ ,Army atFort Bragg* V.C.* and Hunter Army Airfield* Savannah* GX. - • .

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R<it)0367

ROBERT 0. EDMARDS* Ph.D.Pag. 2

1973 to 1978i Research Associate and Poiit-nofft0r»i »«M?rrh -,HM.University of Pennsylvania School of Medicine* Philadelphia* PA.

Conducted investigations of llpld biosynthesis and metabolism la normal andvirally transformed cells.

1972 to 1973i Laboratory Instructor. Biochemistry Department, University ofOxford, Oxford* England.

Taught experimental biochemistry to medical studsnts.

HPttOBS. XMXRPS. XHD PROFESSIONAL AFFILIATIONS

RESEXRCH STUDENTSHIP from Science Research Council of Great Britain* 1970 to1972.

COLLEGE PRIZE for Chemistry* 1968 *.... ~ ' ' . - •'

OXFORD UNIVERSITY PRIZE for excellence ia Practical Organic Chemistry* 1967.

MEMBERSHIPS I

American Chemical Society tAssociation of Official Analytical Chemists x_xAmerican Association for the Advancement of ScienceNational Ocean Industries Association

Member of Environmental Effects subcommittee* 1984*1986Engineering Society of Baltimore* 1980*1988 -

Member of Publications Committee* 1980-1986National Business Aircraft Association* 1983-1987

PUBLICATIONS . ' • . .

Edwards* N.O. and Blough* H.A. (1973) I llpld metabolism la RSV-trans formedcolls. Proceedings: of »Ji* Tt rfl International Popgress, for Virology.Madrid* Spain* September 1975* p.253.

Edwards* 1.0. and Bands* A.R. (1976) I "Metabolism of the phosphonlumanalogue of choline la * TP and ia yixfc and its detection in phosphollpidsby Up-NMR. »im»M«. Biophye. Aeta 431* 303-316*

Edwards* B.O. and Blough* H.A. (1976) i A new pathway for phosphollpldbiosynthesis la chick cells* Fed* Proa* 7* 1723.

Blough* H.A. and Edwards* R.fl. (1978) t Effect of viral gene expression oahost cell lipid metabolism. Ia "Biological and Molecular Modes, of GeneticExpression and their Control! Oxford International Symposiuk*t»lTO* *{Pil«Kent* ad.). Oriel Press* Stocksfleld* Northumberland* England* pp. 64-78.

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ARl*00388

ROBERT G. EDNARDS* Ph.D,Page 3 *. -.-

PUBLICATIONS fPflnMmt.fl)

'l rj1.".?.!*:*-!?"7''' '«• •«•« .f lectio, udbiosynthesis

-Blough* H.A. (1980)1 Biosynthesis of envelope

----•———- —r«j. " la *Cell Membranes and Viral Envelopes" (HA Band J.M. Tiffany* eds.). Academic Fress, London, TO. 557-614. *i .- , ; .; ;' '. "- :./'-: fi. */. • / . -- * - - . ' . - . •

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EDNARD DAHTSEE. .'-Director* Laboratory Division

EDUCATION

Doctor of Veterinary Medicine* Belaya Tserkov Agricultural Institute* USSR*1959.

M.S.* Chemistry* Tyraspol Pedagogical Institute* USSR* 1964.

EXPERIENCE . - • .

1989 to Present! Director, Laboratory Division. Biospherics Incorporated,Beltsvllle* HD. .

Directs the Laboratory, Division, which provides environmental* agricultural,and occupational analytical services* ground-water assessment services, andenvironmental fate studies. Responsible for financial and technicalperformance of the Division. Lesds a staff of 80 technical personnel In theperformance of over 85,000,000 in laboratory services annually. Managesprograms and contracts requiring environmental analytical services*pesticide residue analyses* and analytical method development/validation.

1982 to 1989 1 Director of Trace; Met>l« a fl yfft^Cheaiatrv^a^ftgttoriea* JTCEnvironmental Consultants* Inc.* Rockvllle* MD.

Supervised IS employees and established and developed a trace metalslaboratory. .Acted as project manager of EPA contracts and various SAScontracts. .Oversaw various RtD projects in the frame of Suporfund SAEincluding participation in development and establishment of SOW and protocolfor high haiardous materials.

Developed and implemented a Hydride Generation method for simultaneousanalysis of As* So* and fib by ICP with GFAA for better detection limits.Trained laboratory personnel* set quality control and assurance proceduresand maintained Instrumentation* Executed various environmental projectsincluding part of Washington, D.C* Blue Plains monitoring project.

Developed and enforced BOPs for Trace Metals analysis* Hat Chemistry* andsample receipt/storage*

Computerised sample login and report generation for metals analysis underEPA protocol using ICP as well as GFAA* Flame AA* Auto analyser.

1981 to 1982i Ph*»ieal gmylnaef. Transcircult* Inc.* Falls Church* VA.

Responsibilities Included monitoring and troubleshooting variouselectroplating processes* QA/QC overview* and supervision of the analyticallaboratory* * .

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EDWARD DANTSEXR .Page 2 . . ? . - , , • > :: '•-- j* *;.'.<'• -. :

1960 to 19811 Ch«-i«t. Tr»e« Mafcala Laboratory. Versar, Inc.* Springfield,VA.

. - . : " . ; , - ' :--- r < " I**"''**' ' ' ' " " ^ _ . - . . / . . 'Conducted sample preparation t and instrumental analysis under Super fundProgram. Utilised various instrumentation i Flame AA* GFXX, ICP.

Participated ia discovery and analysis of precious metals t (Au* Ag) In.sewage sludge incinerator ashes from several locations in USA.

'I960 to 1978 t Teacher of QrffBa^g *nd InQrgflffilc Chemistry. Kiev* USSR*

* . * • • " * . S -. -=V-. ';; iv..- " - '~ \ 'PRESEMTXTIQKS . ^. i ,:

Several presentations at the EPX meetings under Super fund ContractLaboratory. Program. .----:•-, ? ', ! ..•• " i -> « '-..•- "~^ _ j ' _... - ,. •' • ' • , -"?".'•' fl !t*-"'.':i r "ll; - ; • " ' :PXTENTS ,. . - - . : - •, -= ,v-: j; i.: .. • • . * ' • ' " ' , . . ' - ' '

US Patent for "Process and Apparatus for Removing of Adhesive Tape".

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_» < »_• *. ['. :• J

H. MXE-US GUDNASONManager* Analytical Services

EDUCATION

B.S.* Chemistry* George Mason University* Fairfax* VA* 1977,Special Courses la AA* GC* laboratory automstioa.

EXPERIENCE

1988 to Presentl Manager, Analytical Services. Laboratory Division,Biospherics Incorporated* Beltsvllle* MD.

Manages Analytical Services Branch performing over 200,000 analyses annuallyfor environmental and occupational health programs. Specializes la thetrace analysis of organic and inorganic compounds in environmental andbiological matrices* research and method development* as well as qualityassurance implementation. Skilled in multiple analytical techniquesIncluding GC* AA* ICP* HPLC* Autoanalyser* 1C* wet chemistry* UV-VIS, IB,etc. Manages major government and Industry contracts for environmentalanalytical services some of which includei

o . Pesticide residue analyses by GC* GC/KS, HPLC* Agricultural ChemicalManufacturers.

o Method Validation/Equivalency Programs* U.S. EPA* Cincinnati.

o Groondwater Volatile Orgaaio Analyses by CC and GC/MS* IBM.

o Occupational and Environmental Analytical Ssrvlces, U.S. Air Force.

o Laboratory Analytical Services* Montgomery County* Maryland.

o Analytical Chemistry Services* U.S.'Navy.

1979 to 19891 Section LeaJ*>f. Analytical Services* BiosphericsIncorporated* Beltsville* MD*

Section Leader for environmental and occupational analytical programs.Supervised and conducted analytical programs for orgaaie and inorganicparameters la multiple matrices. Responsibilities Included performingchemical analyses for commercial* industrial and governmental clients.Performed elemental analyses by AA and ICP techniques* wastecharacterisation by OC and IB* PCB's analyses by GC* PNA*s by HPLC* waterquality parameters' by multiple techniques* orgaaie vapors by gaschromatography* and bulk asbestos by PLM*

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ARW0392

H. MARCUS GUDNASON " • - -Page 2 -. .-.." ::;',;:•::: «:. •

Experience Included GC sample preparation and instrumental analysis of air,air sampling media* water* soils* sediments* biological tissues, foods,chemical formulations* 4\nd metal alloys. Participated ia the followingprojects!

o Analytical Services* Brooks Air Force Base* General ServicesAdministration, Social Security Administration* PEPCO and Navy.

o EPA Methods Validation Project for trace metals* cyanides and phenolic*in industrial effluents. /. -

o. EPA Chemical Analytical Services for quality assurance reference samples., -I I'- • • • .. •• . • ., .1 » -, •i •«••,.. I . . . . . .e Methods development for organo-tla compounds in paint products.

o Contaminant determinations for sewage overflow assessment programs.• • . • f '* • ; '5^ F ;• ; . . '•* " '"• ' _ .. ' .

o Hasard Response Team for Montgomery County; MD... .. . > , , . . . , . - • H> ..,,! „ * ; . „ , . , • ' ' T,

o Shipboard Pollution Abatement Program* Navy. - - •- '

1977 to 19791 Laboratory Specialist. George Mason University* Fairfax* VA.• « *• .', ' L,, : " '. ' - • '• -

Laboratory facilities and instrumentation were prepared for research,experimentation* and educational applications. Mas responsible for settingup and maintaining atomic absorption and Technicon autoanalyserinstrumentation.

1975 to 19761 Laboratory Technician. American Wood Preservers Bureau,Arlington* VA.

Prepared samples and instrumentation for analysis of wood and woodpreservatives by atomic absorption and wet chemistry. Performed wastewateranalyses in support of NPDES compliance programs.

MEMBEESHIM _ .

American Chemical SocietyAmerican Industrial Hygiene AssociationSoclsty for Applied IpectroseopyAmerican Society for Testing and Materials

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USHA M. PAREXBPROJECT LEADER/CHEMIST

EDUCATION .

B.B.* Microbiology/Chemistry* St. Xavisr's College* Bombay* India* 1976

1988 to present! ANALYTICAL ' CHEMIST/PROJECT LEXPEt. BiosphericsIncorporated* Beltsvllle* MD

Supervise junior chemists* evaluate and verify analytical data from GC.Coordinate GC analysis. Calibrate and perform routine maintenance oaInstruments. Check quality control protocol such as CLP* ECRA with EPA andNIOSH Methods such as EFA-601* 602* 608* 616* 814* 8080* 8150* 8140, etc.for priority pollutants* Order parts* rsagents and glassware. Recommendequipment purchase and replacement. Prepare and justify proposals fornecessary purchase of Instruments and expense. Perform troubleshooting* asnecessary to maintain quality control standards of the lab.

1986 to 19881 £H__1SX_IX« Department of Health and. Mental Hygiene, State ofMaryland* Baltimore* MD

Worked as Chemist in pesticide lab* Responsible for extraction* analysis,and reviewing data using EPA methods. Assist and supervise all aspects oflaboratory work to achieve best quality work.

1978 to 1986t CHEMIST- The Johns Ropklns Hospital* Baltimore* MD

Worked in all areas of Chemistry Lab analysing body fluids.• • *'

MEMBER SHIPt ' ' '.

Delaware Chromatography Group .Washington Chromatography Discussion Group '•

2 LABQAU

EARLESS A. mTDAHIEL, JR.. . . GC/MS Supervisor

EDUCATION , -

B.S.* Chemistry* Rhodes College* Memphis, Tennessee* 1982. , ,

EXPERIENCE . -,

1988 to Presenti CC/KS Supervisor, Biospherics Incorporated, Beltsvllle, MD,Ft _. ,- . r-

In charge of dally organisation and sample analysis for GC/MS Section.Specialised in HP GC/KS end RTE data systems for BHX and volatile organlcs.analysis by EPA protocol. '" " .

1984 to 1988i ChULiAtJU' Memphis Environmental Center (Velsicol ChemicalCorp.)* Memphis* TH. "

Responsible for GC/MS analyses of all BNA samples. Specialised in gaschromatoyraph/mass spectrometer analyses of environmental samples.Experienced ia the use and operation of Hewlett Packard's RTE data system.Experienced ia the use of EPA methods 624* 625* 8240* and 8270 for volatileorganics analysis by purge and trap and semi volatiles analysis. Hands onexperience with HP 5985 GC/KS, HP5996 GC/KS, HPS993 GC/MS* and HP5890-5970GC/MS. ' •',.'•" -Y-'"-' *

Also experienced ia GC analysis with packed or capillary columns.Familiar with multiple GC detectors including Hall* ECD, FID* and FID aswell as HP 5880A GC's and Varlan 1700 GC.

1981 to 19841 Technologist! fit. Judas Children's Research Hospital,Memphis* TH. - . i. . ••

Isolated and characterised viral proteins. Isolated and Identifiedlafluensa virus from the field."

BQMQBS '' "'- " * '""'''•: 'U" "' ' '

Hickmaa Scholarship Cor Academic Achievement

MEMBBBSHIPS

American Chemical SocietyMid-South Cbromatography Discussion Croup.

2 LABQAU

fiRJ*00395

PETER H. CHAPMANMetals Supervisor* Inorganic Chemistry ,

EDUCATION

B.S., Environmental Science* Eutstown University* Eutstovn, PA, 1984

EXPERIENCE

1988 to Present! Metals Supervisor. Inorganic Chemistry. BiosphericsIncorporated* Beltsville* MD.

1986 to 19881 Assistant Prefect Scientist. Roy P. He•ton. Inc., Llonville,PA

1984 to 1986$ Environmental gfr«-i«*i. Priaceton Testing Laboratory,Princeton* NJ

Complete knowledge of trace metal analysis of environmental samples.Extensive experience in the .following areast (a) atomic absorptionspectrescopy for the flame and graphite furnace areas (b) Inductivelycoupled plasma spectroscopy (e) cold vapor atomic absorption.

Familiar with most EPA, NIOSH* OSHA* and CLP methodology and requirements.This includes all digestion and preparation procedures for samples ofvarious types regarding metals analysis.

Speelfie projects have Included! ~

o Large scale lead In water testing for various governmental agencies,

o EPA-CLP analysis.of water and soil for actual EPA contracts.

o •. Personal air cassette testing for United States Air Porce.

o Groundwater survey analysis for Army Corp of Engineers.

o Hasardooa waste characterisation via EP-Toxicity.

2 LABQAU

CLARA T. TRDMERInorganics Supervisor

EDUCATION

M.S., Pood Sciences* Department of Materials Science and Engineering* ThePennsylvania State University* State College* 1985. :

B.S.*'Chemistry* College of Sciences* Uaiversltay Naclonal de Colombia,Bogota* 1977. , . . . . , , ~.,;"' ' ' • > - - ' '

1988 to Present! 'inorganic Lab Supervisor, Biospherics Incorporated,Beltsville* MD. , n( l :

Supervises basic physical* chemical and microbiological analyses iaenvironmental samples. Ensures analysts adhere to SPA and/or otherestablished methodologies end Internal alkalinity control requirements.Assigns personnel and develops schedules.

1986 to 19881 Laboratory Supervisor. Industrial Wastes/Laboratory ServicesDivision, rort Worth Water Department, fort Worth*' TX.

Supervised analytical activities of three person team performingenvironmental testing of industrial and domestic wastes. Provided technicalsupport and training* Specific methodologies included gas chromatographicanalyses and spectroscopic metal analyses; (flame and furnace atomicabsorption and ICP). Developed and implemented a laboratory QualityControl/Quality Assurancs program in compliance with Federal* State andlocal government regulations. .

Member of Technical Review Committee for implementation of InstallationRestoration Program at Carswell AFB, Ft. Worth.

- ! - ' * ,»- , *- <*' - - . ' ' ' •• \ - . ' , - • , • ,.-• . ' - -'_.., i:,,V'»h-3. i ,, .

1984 to ,19851 Stipervleor.. Coal Research and Quality Control -Program*lastituto de lavestigaciones Technologlcas, Bogota* Colombia.

Performed studies oa coal characterisation, coking* llqulflcatlon andwashabillty* Directed studies from initiation to final report. Designedexperimental runs* supervised data collection, analysed data and wrotereport findings. ' • - ••

Managed the efforts of S people .in the analytical lab and 3 people runningthe email scale pilot plants for coal carbonisation* coal baneficiatlon andcoal Unification, - - - - - - - -

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CLARA T. TRUMEHPage 2

1979 to 19821 Chiailfc* Coal Research and Quality Control Program, Institutedo lavestlgaciones Tecnologleas* Bogota* Colombia.

Performed research and wrote reports on coal character sat ion andutilisation. Involved on carbonisation projects* performed gaschromatographic analyses of carbonisation and Unification by products.Experienced using petrographlc microscope and optical microscopy ofprocessed coals. Performed a project of characterisation of coal ashesproduced by the 3 largest electric coal powered plants ia Colombia.Specialised la flame atomio absorption spectroscopy.

1977 to 19781 Chemist. Asesorlas Industrials y Agrleolas, Bogota* Colombia

Determined nutrient/irrigation requirements for exportable carnations.Developed a method of chemically controlling bud opening. The process wasalso used to cope with market fluctuations, *1976 to 19771 Chemist. Magel Ltd.* Bogota* Colombia.

Conducted a research project on production of edible gelatin from cowhides. Experimentally developed production parameters at a semi-pilot scaleand characterised formal products*

MEMBEBSHTPg

American Chemical Society

PUBLICATIONS ANP PRESENTATIONS• *

Torres* C. and Jimenes* M,* "Determination of Selenium la Soils and VegetalMaterial! Study of the Inhibition of its Absorption la Ray grass (Loliummultlflorum).** Presented at 5th Intl. Colloquium on Soils* Bogota*Colombia* August* 1977 (B.S. thesis* Ualversldad Naeional de Colombia).

Torres* C. "Characterisation of Colombian Coals." Presented at 1st Intl.Symposium oa Coal* Ixtapa* Mexico* Sept** 1961.

Torres* C. anbd Oliver* B** "Carbonlsaeion de Hullas Colombianas***Technologia* No* 130* 1981*

Torres* C.* "The Influence of Hydrogen Availability on Coal LiquefactionRetrogressive Reaction.1* M.8» Thesis* The Pennsylvania State University,Fuel Science Dept.* May* 198S.

Torres* C.* "Reacclones do Retrogradacloa en funcion del Envejeclmeato delCarbon", Tecaologla*~Ho. 1S3* 1985*

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flRl.00398

STUART E. COHEN* Ph.D. , " '-Manager* Ground Water and Environmental Programs

EDPCXTIQN

Ph.D.* Chemistry* George Washington University* 1984 (thesis work inphysical organic chemistry at the National Institutes of Health). B.A.,Chemistry, University of Maryland* Baltimore County* MD, 1975. Seven shortcourses and training sessions sponsored by the American Chemical Society,the National Cancer Institute* and EPA in chemical carclabgenesls* chemicalengineering, physical organic chemistry* environmental chemistry, and groundwater contamination. .stM; ^ :. .. ~ - . •- "' - • .-'•••-.

EXPERIENCE

1986 to Present. HaaflfllT* Ground Water and Environmental Programs,Blospberics Incorporated* Beltsville, MD.

' ,...• • ; - . - : . * , - ;.,•/? 5:51 v . -. : ' . . - - ; . - • ' , - v;Manages programs to evaluate ground water and environmental contamination bypesticides and hazardous wastes* Manages environmental programs for realestate transactions. Responsible for program design* implementation* andconduct. Programs vary from basic consultation to full-service effortsinvolving study design* vulnerability assessments, risk assessments*placement of monitoring wells* soil gas analysis* -modelling, etc. Sharesresponsibility with the Industrial Hygiene Division for conductingenvironmental audits. Suporfuad site project manager. .

1976 to 1986. Chemiat mnA tlrtmntl , t*ter Tf«m Le djtr.. Office Of Pesticidesand Toxic Substances* Environmental Protection Agency* Washington* DC.

Was one of EPA's key scientists for the development* implementation* andconduct of pesticides in ground water programs* Responsibilities andfunctions included! : Management of §1.4 million, budge ti cochair of nationalwell-water survey steering. committee* senior physical scientist on allpesticides la ground water regulatory actioasi direction of ground waterstudies by pesticide industry* main intorageacy and international contact oapesticides la ground water* syntheeised interdisciplinary risk assessmentsfor several chemicals over a 2-year period* conduct of EDB ground water riskassessment which led to emergency suspension actioa of .all soil uses in1983* expert witness Cor EPA In psCP Imminent aasard suspension bearing in19791 development of bloratlonal pesticides testing guidelines* assessmentof heptachlor in milk in Hawaii* quality control reviews* testing guidelinesand regulations for new chemicals under TSCAi and technical liaison withenforcement attorneys. ,\ ,*: • t- >- ^ . - . ; . . •- t , * . . • - , -C- • '

-*- • '•-". : ?'"',;> ':•-'-> ?-'- '•? ."r: & ^-\ - ,-*.-, „ ' /. ,.-- : ,-1980 to Present* fl_alt_H_r_tr in organic chemistry at the Laboratory ofChemistry* NIADDK* National Institutes of Health <HIH)< Bethesda* MD. (Oneyear full-time detail during 1981-1982* part-time since then).

197S to 1976. Researr^ Tjflftfitetmi at Jahns Hopkina University School ofMedicine* Department of Immunology* Baltimore* MD. Proataglandinsantibody radiolmmunoaasys (I135* H** C14)

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STUART 2* COHEN* Ph.D.Page 2

HONORS AND AWARDS

EPA Special Achievement Award (cash award) for work la ground watercontamination by pesticides* 1965.

EPA Bronse Medal for the sthylene dibromide ground water assessment, 1984.

James Buchanan Duke Honor Scholarship* 1972.

MEMBERSHIPS

American Chemical Society-Environmental Chemistry* Pesticide Chemistry, andOrgaaie Chemistry Divisions! Chemical Society of Washington* National WaterWell Association* Member* International Union of Pure and Applied Chemistry,Pesticide Commission (198S-1993)

JOTOKXL L BOOK PtTBLICXTTOirg .

Cohen* B. 2. and L. A* Cohen* "Linear Pree Energy Relationships in theHydrolysis of Substituted (Trifluoromethyl)lmldasoles*" manuscript iaprogress. .

J. J. Plgnatello and 8. 2. Cohen* "Environmental Pate of Btbylene Dibromidein Soil and Ground Water*" Invited'paper for Residue »«vi«va. manuscript iaprogress.

Lorber* M. V.* B* 2. Cohen* 8* Noren and 0* De Buchaaannet "An IntegratedApproach to Determining the Potential for Aldicarb to Leach to Ground Wateria the Continental United States*" manuscript in progress.

Jungclaus, 0. A* and 8* 2* Cohen* "Hydrolysis of Ethyleno Dibromide*"manuscript in review* >

Weaver* M.f.* 8.2* Cohen* and J.J. Plgnatello* "Environmental Chemistry ofEthyleno Dibromide** ia Proeee-flinae of th§ frffT3lCP *:itr*l Impaeta oa firotindHater » X Confer*ne-- National Water Well ASSOO.* 169-190* Dublin* Ohio,1988.

Aharoasoa* V.* 8* 2* Cohen* 1* Drescher* T. J* Glsh* 8. Gorbach* P. C.Xeamey* 8* Otto* T. t* Roberts* and J* W. Vonk* "Potential Contamination ofGround Water by Pesticides - Aa International Assessment*** Pure ana-fetOU* £1(10)* 1419-1446* 1987*

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ARdOOttOO

STUART E. COHEN, Ph.D.Page 3

JOTTBKXL t BOQr KniLtejLTTOMg

Cohen, S, E.* C, Eiden, and M* N. Lorber; "Monitoring Ground Water forPesticides in the USA*" In EV%Ifration of Pesticides in Ground Water.American Chemical Society Symposium Series 315* W. T. Garnet, R. C.Hoaeycutt* and H. N. Nigg* ed«* American Chemical Society* 170-196,Washington* DC* 1986. ' . . ; , - '

*', ''; '"T'T If.' •' ' . -

Cohen, 6. 2.* S. M. Cresgsr* I. f. Cartel, and C. G. Enfleld* "Potential forPesticide Contamination of Ground Water Rssulting from Agricultural Uses,"in Treatment and Piapoaal of Pesticide Wastes. American Chemical SocietySymposium Series 259* R. r. Krueger and J. N. Seiber* ed** 297-325*Washington, DC, 1984. „ . : - , . . .

, . . „ . - ' . ' . * - ' - = ' " " S ! ' • • ' ' , -

Enfleld, C. 6.* R* T. Carssl, 6, Z. Cohen, T. Pbaa* and D. M. Walters*"Approximating Pollutant Transport to Ground Water," Ground Water. _£(*),1982.

Eweig* G., S. I. Cohen, and P. S. Bets; "EPA Registration Requirements forBiochemical Pesticides* with Special Emphasis on,Pheromoaes" in insectSuppress ion yt»^ C.QBtr°}l*fl Rjil*iie .Ph*rtM*°a* SynEenq. Vol. i. ||* Berosa andA. F. Kydonieus* ed.* CRC Press* Boca Baton* PL* 1982.

Hague, ft.* J. ralco* S. *X* Cohen* TC. ftlordan* "Role of Transport and rateStudies la the Exposure* Assessment* and Screening of Toxic Chemicals*"laflypamftesff Exposure end w.a«afrJ.ftsaa«ia*>nt of To«|c Chemi.qals, (. Haque* ed,*Ann Arbor Science* MX* I960* . •

Cohen, S. E.* G. Eweig* M. Lav* D, Wright, W. t. Boatoyan* "Analytical ,Determination of N-altroso Compounds in Pesticides by the United StatesEnvironmental Protection Agency. A Preliminary Study" la EnvironmentalAspects of N-nitrosQ Compound*. I* A* Walker* M. Castegnaro* L. Grlciute, R,X. Lyle* eds.* International Agency for Research on Cancer (IARC), Lyon*franco* 1978. - ,-- -.*f^-•- : - " \-, ,

Adkinson* V. P.* T. Barren/ 8. tovell and 8. E. Cohen; "ProstaglandinProduction by Human Peripheral Blood Cells in Vitro*" J- Lab, ciinieal

» 1043*1083* 1977. ;

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ARlfOOlfOI

SXUAEX 2. COGEN, Ph.D.Page 4

gPX ft OTHEl PtTBLieXTIQWit

"Agricultural Chemical News*" (sole author) a scientific news column in thequarterly journal Ground Water Monitoring Beyley published by the NationalWater Well Association.

"Alachlor Special Review Technical Support Document*" September, 1986* and-Notice of Preliminary Determination to Cancel Registrations of AlachlorProducts Unless ths Terms and Conditions are Modified*" coauthor withseveral other EPA staff of both publications* Federal Register si '(195),36166-36172*10/8/86.

Task manager of the report "Ground Water Vulnerability Assessment la Supportof the Plrst Stage of the National Pesticide Survey"* a large effortInvolving Research Triangle last.* Roy P. Waston* Inc., and Woodward-ClydeConsultants* EPA Contract No* 68-01-6646* Washington* DC* February 14* 1986.

"DBCP Use On Certain Pineapple Plelds On Maul • Implications Por PotentialDrinking Water Contamination"; 8.2. Cohen, Exposure Assessment BranchT8-769C* Office of Pesticide Programs* EPA* Washington* DC 20460* March*1965. .

Task manager of a four aquifer* soil/ground water study of four pesticides,by Cal. Dept. Pd. * Xgr.i £volumes have been published.by Cal* Dept. Pd. A Agr.l Pesticide Movement ta Ground wateri three related . /

Conducted the ground-water contamination assessment for EDB* resulting iathe Sept. 1963* emergency suspension by EPA! work summarised In the EDBPosition Document 4 and the Federal Beo-Jete* (£____» 46228-46248* Oct. 11,1983).

"DBCP In Ground Water In The Southeast"* 8. 2. Cohen, Exposure AssessmentBranch T8-769C* Office of Pesticide Programs* EPA* Washington, D.C. 20460*August* 1981*

Project officer of work by 0* Carter* J. tlgon* and 0. Dlckerson <ClemsonU. )| BtuJy of PBCT Qrnntjfl Hateg C;flpffr'«<i*«*t lesifl f in Boil and Ground Waterin fiQafr* r*fflTlBfl- March* 1981.

Project officer of contract 1560/12-79-001* Hendry* D.8. and R. A. Xenley*Xtmospherla Reaction Products of Or—a«ia goBmatmda- June* 1979* EPA.

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STUART 2. COHXH, Ph.D.Page 5

t OTHER PPB iCATIQyS (Continued)

Co-author of environmental fater testing guidelines (pp. 16251-16280) in"Discussion of Premanufacture Testing Policy and Technical Issues* Requestfor Comment" (EPA)* rederal Register 44 (S3)* March 16* 1979.

Principal author of a proposed regulation that requires the chemicalIndustry to submit health and 'environmental test data on ne* chemicalsubstances under TSCA $5* $720.13 of "Prsmaaufacture NotificationRequirements and Rsvlew Procedures*" In Federal .Register 44 (7), January 10,

TESTIMONY

Testified on pesticides in ground water before the Senate Committee enEnvironment and Public ' Works (Seas. Burdick* Dursnberger* at. al.)(invited)* Washington* DC, June JO, 1988.

Testified on environmental risks and ground water assessment of pesticidesbefore the Vermont Environmental Board pursuant .to Vermont Act 250*Wllllston, Vermont* May 3* 1988.

r- Testified on EDB la ground water before the Superior Court of the State ofWashiagton* Mt. Veraon* Washington* October 6* 1987.

\ s Deposition given en EDB la ground water before the Superior Court of theState of Washington* RocJtville, MD, May 22* 1987,

Testified on pesticides in ground water before Senator Leahy's Committee OAAgriculture* Nutrition* and forestry (invited)* Washington, DC* April 29*1987. , v

• , - ». ', ? •; *." ,•;•:/ ;I;LI '* ',• «•••'• . - . • . . • ,

Testified on EDB Special Review before Congressman Synar's EnvironmentalSubcommittee of the House Committee en Oversight and Investigations*Washiagton* DC* September* 1983. . . - ;

• Testified on DBCP in ground water In the PirRA Imminent hasard suspensionhearing before Admiaistratlvs Law Judge Barwood; Washington* DC* August*

. .Appeared as a speaker or panel member in a total of 16 public hearings*press conferences* briefings of ;stste legislators* and public advisorycommittee meetings from 1976 to 1916 during tenure at EPA. •

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STUAKT 2. COHEN* Ph.D.Page 9 >

Cohea* 8.2. and J.A. Senlta* "Extent of Pesticide Plumes ia Ground Water Inthe U.S.*" The Third Chemical Congress of North America; American ChemicalSoclsty meeting abstracts AGRO III* Toronto* Ontario* 1988.

Lecturer for the Executive Enterprises Institute at their PesticideRegistration educational seminars* 1987 and 1988* Washington* DC.

Cohen* 8*2.* M.P. Weaver* and J.J. Plgaatsllo* "Environmental Chemistry ofEthylene Dibromide," National Water Well Assoe. Conference on AgriculturalImpacts oa Ground Water* Des Koines, Iowa* March* 1988.

Cohea* 8.2.* "Pesticides In Ground Water from Normal Use - A Focus Oa Turf,'*S8th International Calf gonrsa Conference and Show Proceedings. Golf CourseSuperintendents Association of America* Lawrence* Kansas, 1987.

Jungclaus* 0. A. and S. 2. Cohen* "Hydrolysis of Ethylene Dibromide*" 191stAm. Chem. Soe. National Meeting* [EHVR 6]* New York* NX* 1986.

Cohea* 8. 2.* "Pesticides la Ground Water*" Environmental and Water IssuesIn the Northeast - Training Seminar* sponsored by the Golf CourseSuperintendents Society of America* Cape Cod* MA* April 7* 1986.

Cohen* 8. 2.* "Monitoring Ground Water For Pesticides In Ths USA*" 169thAm. Chem. Soo. National Meeting* PEST 34* Miami Beach* FL, 1985. Similarpresentation also made to a European conference In W. Berlin at the expenseand under the sponsorship of the Federal Health Office of the FederalRepublic of Germany* 11/85*

Cohen, 8. 2.* "EDB Ground Water Contamination-- The EPA Assessment*" FifthAnnual Meeting Abstracts i Society of Environmental Toxicology and Chemistry,Arlington* 7A* November* 1984* . •

Cohen* 8* 2.* "EDB in the Subsurface Environment - Ground Water and SoilResults" 18Bt* annual meeting of the American Chemical Society (Committee onEnvironmental Improvement)* Philadelphia* PA* 1984.

Cohea* 8. 2.* B. M. Creeger* H. P* Carsel* and C* 0* Eafleld* "Potsatlal forGround Water Contamination by Pesticides Resulting from Agricultural Uses*"presented in different forms six times to .(D the 186th national meeting ofthe-American Chemical Society (September* 1983* PEST 89)* (2) the autumn1983 Regulatory Conference of the National Agricultural Chemicals Assoe.*

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STUART S. COHEN* Ph.D.Page 7

(Continued)

(3) the January, 1984 meeting of the Chemical Society of Washington, (4) theFirst Annual Citiitn's Conferenes en Ground Water Contamination (March,1984* Washington, DC)* (S) the Second National Pesticide Forum of theNational Coalition Against ths Misuse of Pesticides (March, 1984*Washington, DC)* and (6) a conference in the Senate Office Buildingorganised by the Environment fc Energy Study Institute (March* 198S).

Cohen* L. A.* S, 2. Cohtfn* and R. Eimoto* "Photochemical Perfluoroalkylatlonof Imldasoles," la the abstracts of the 10th International Symposium ofFluorine Chemistry* Vancouver* Canada/ August, 1982. . . • .

Cohen* 6. E.* "Monitoring for Ground Water Contamination by Pesticides*"before EPA's Scientific Advisory Panel (a peer-review group)* Arlington, vx,March* 1981. Several related presentations have been given to this groupSince, then.. "' . * . •- '-.»•',. I *• ' - • ' .. -

"DBCP Ground Water Contamination I. Environmental . Chemistry II. 'Environmental Monitoring*" Office of Pesticide Programs* EPA* Washington*DC* July 1980.

"Environmental Chemistry of Organic'Compounds*" University of Maryland \Baltimore County* Chemistry Department* November* 1979. * , , '-'-•'-

i j . ' ' - T. *"g-f' ft*! "I"" ' " , . ' ' " "

"Environmental Fate Chemistry! Transport and Persistence of OrganicPollutants la the Environment*" George Washiagton University ChemistryDepartment* January* 1979. : • '• • : " "

A summary of the above N-altroso paper presented to the International Agencyfor Research on Cancer* August* 1977* In Durham, NH. , .

2 tABQAU

KEITH RTXNManager* Quality Assurance . j

EDUCATION

B.S.* Microbiology* University of Florida* Galnesvllle* FL, 1971. Graduatecourses ia toxicology* blostatlstlcs* computer science* epidemiology*biochemistsry* and virology* NIB*

EXPERIEHCE

1989 to Present! Manaoeg. Quality Assurance. Biospherics Incorporated,Beltsville* MD.

Oversees the Quality Assurance Program for the Laboratory Division.Responsible for the development* implementation and management of thelaboratory's QA/QC program including inspections* analytical monitoring*data report and review* and. field audits. Specialises la reviewingpesticide residue studies for compliance with Good Laboratory Practice (CLP)staadarde. Write SOP's and oversees licensing, XIBA accreditation. Statecertifications* and performance under PAT programs.

•\. *

1985 to 19891 staff Scientist- Blosphsries Incorporated* Beltsville* MD.

Reviewed residue data management systems for major pesticide chemicalmanufacturers and produced standardised protocol and report formats tofulfill CLP and Pesticide'Assessment Guidelines requirements. Also analysesaoil* pleat* and animal residue data and writes final reports for submissionto the ETA.

Performed CLP audits of pesticide studies oa environmental fate and oa cropand soil residues. m .

Provided diverse technical writing services. Including a summary report oalaboratory automated data management* a manual for specialised analyticalprocedures* and a comprehensive manual of guidelines for conducting andreporting of residua studies* from field trial design through instrumentalanalysis.

Supervleed abstracting/coding of material safety data sheets (MSD8*s).Monitored work flow and performance of 9 MBDS abstractors and reviewers.

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KEITH BTANPage 2

1984 to 19851 Quality Assurance M»nno«r. Togerls Laboratories, Inc. TempleBills* MD.

Responsible for assuring the accuracy and reliability of all toxicologic andanalytical chemistry studies and for certifying their compliance withrelevant EPA and PDA GLP standards. laspeeted all aspects of each studytprotocol* actual conduct of study* data generated* and final report.Identified and documented deviations from protocol* practices with higherror potential, sources of bias* and incidental conditions that mightimpact upon study results. Verified congrulty and contiauity of primary

, data and edited final reports for completeness* clarity* and fidelity tostudy data. iAlso monitored overall operational parameters (water quality, calibration oflaboratory equipment, environmental conditions ia animal study area, etc.)maintained comprehensive* index archives of raw data* preserved tissues* andhlstologie blocks and slides from completed studies.

1976 to 19791 Deputy Project Manager- Tractor JitCO, Inc.* Rockvllle* MD.

Supervised technical personnel in the production of a microfiche file ofpesticide use literature and accompanying automated index for use by EPA.Audited toxleologie studies* performed German-to-Engllsh translations oftoxieologic journal articles* and conducted literature searches online and

I j manually.

PUBLICATIONS

"Alcohol and Blood-Sugar Disorder! An Overview** Alcohol- Health, andResearch World. Winter* 1984*

"Assessment of Need for Alcoholism treatment Services i PlanningProcedures*" Alcohol* Health* sad BaseareB World. Winter* 1985.

"Cost Effectiveness of Third-Party Coverage for Alcoholism Treatment i AReview of Three atnAJM.". Alcohol. Wealth. Md Seseareh World. Winter* 1985.i"A Systems Approach to Reducing Alcohol Problems at the Community Level*"Aleohnl. geeltfr. f»rfl ••search World. Fall* 1985.

MEMBERSHIPS .

SQX* APHA

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ARltOOltO?

Revision No.t 001Datet October 1909Pagei 1 of 9

uttma BSOP iran

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LABORATORY DIVISION*• BOP IffDHt

60P

1.0 INTRODUCTION

2.0' INSPECTIONS

2.1 GOVERNMENT AGENCY INSPECTION

2.2 CLIENT INSPECTION , < . .-. -, .

3.0 PERSONNEL QUALIFICATIONS AID TRAININO

3.1 CLP RESPONSIBILITIES OF FACILITY MANAGEMENT

3.1.1 PERSONNEL POLICIES CONCERNING 1UXESS

3.2 STUDY DIRECTORS

3.3 GENERAL OPERATING PROCEDURE FOR QA/QC UNIT

I ; 3.3.1 MASTER SCHEDULE SHEET •\s__x . . , . . :.-,• - -•*'.'•-"•• •• - •

3.3.2 QA PROTOCOL FILES. -....-.--,, : ,.,.,,. t - -.».*•• •* ''"' •'• -'• •3.3.3 -QX MONITORING OF PROTOCOL AND SOP DEVIATIONS

3.3.4 QA STUDY INSPECTION

3.3.5 QA REVIEW OF FINAL STUDY REPORTS* " _ "

3*3.t CLP COMPLIANCE BECORD STORAGE

3*3.7 RECORDS RETENTION

4.0 *-«»*• »TOBT IACZLX9•*.« B»«nrnn_r-irm__m . n u . . ! . ; ,

4.1 USE OF PESTICIDES IN THE FACILITY

4.2 SOFTWARE DEVELOPKENT ZESTING AND RELEASE

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ARifOQIt09

0Revision No.i 001


• 4.3 DISPOSAL OF LABORATORY WASTES , >

4.4 FACILITY SECURITY

4.5 RO/DI LABORATORY HATER SYSTEM

4.5.1 VALIDATION OF REAGENT WATER PURITY FOR INORGANICPARAMETERS

4.6 LEYBOLD-BERAEU8 VACUUM SYSTEM

4.7 COMPRESSED AIR SYSTEM

5.0 CENTRAL COMPLIANCE FOB MXINTKHXNCB AND CALIBRATION OF LABORATORYEQUIPMENT

S.I PI-5000, GRAPHITE FURNACE ATOMIC ABSORPTION SPSCTROPHOTOMETEE

5.1.1 PB 370A ATOMIC ABSORPTION SPECTROPSOTOMETER

5.1.2 PE 3030 ATOMIC ABSORPTION SPSCTROPHOTOMETEE

5.2 DRYING OVENS

5.3 INFRARED SPECTROPBOTOMETEB PB-727B ,

5.3.1 INFRARED SPECTROPBOTOMETER PB 1420

. 5.4 MILTON ROY SPECTRONIC 301 AND MILTON ROY SPBCTEOHIC 1201

S.S ANALYTICAL .TOP LOADING* ELECTRONIC* AND TRIPLE BEAM BALANCES!SARTORIUS* METTLEB* CABN* OHAUS .

5.0 HP-5880A, HP-7620* HP-5890, TRACOR 500

5.7 pi METER

9*7.1 pi METER ACCUMEX MODEL 815 MP

5.7.2 pB MEXEB - ORION SA 520

5.7.3 pB METER -ORION SA 720

. 5.9 GUIDELINES FOB 'TEN MAINTENXNCB AND USE OF MISCELLANEOUSMICROBIOLOGY EQUIPMENT , -

5.10 GUIDELINES FOR THE MAINTENANCE AND CALIBRATION OF LIQUIDSCINTILLATION COUNTERS (LSC) .

2 LABQAU

Datet October 1909Paget 4 of 9

S.J2 GUIDELINES FOR THE MXINTENXNCE AND CALIBRATION OF THE BZOLOGZCALMXTERIAL8 OH DI ZEE (BMO)

5.13 MATERS TRACOR BIGH PERFORMANCE LIQUID CHROMATOGRAPH '

5.14 TRACOR 560 GLC WITH ELECTRON CAPTURE* HZ63

5.16 GUZDELINES FOR THE MXXNtENANCE AND CALIBRATION OF THE VARZAN 1400FLAME ZONZ2ATZON DETECTOR (FID)

'I , •. ' -r'l:- ••• 'I' r *

5.16 DISSOLVED OXYGEN APPARATUS

5.19 MSA CARBON MONOXIDE INDICATOR - MODEL 70 , . ,

5.20 THERMOMETER CALIBRATION

5.21 SYBRON BARNSTEAD PM-70CB CONDUCTIVITY BRIDGE

5.21.1 BECKMAN RC-16C CONDUCTIVITY BRIDGE

B.22 DISTILLATION APPARATUS, . t.. ' •-' i *

5.22.1 BUCBI 320 Bj DISTILLATION UNIT - .

5.23 TOX ANALYZER

5.24 TURBIDITY METERi , . - ...•.'-...:- vv/:,;.. •, ,- -- 5.26 GC/MS MODEL 5985B

5.26.1 GC/MS SAMPLE CONTAMINATION CONTROL FOR VOUTILE SAMPLES

S.27 TECHNICON AUTO ANALYEER II " ' "

. S.28 DOHRMANN TOTAL ORGANIC CARBON ANALYZER ' '

5.29 CIONEX 20001 • ZON CBJOMATOCRAPH

S.30 MECHANICAL PIPETS * - .'3-?: * " ° :

5*31 KRJJOnCX EXTRACTION 8Y8TEM* MODEL 3003

5.32 PE 6500 XI INDUCTIVELY COUPLED ARGON PLASMA SYSTEM

5.33 MEDIUM PRESSURE LIQUID C&ROMOTOGRAPB

8.34 HHEXTON MICRO PROCESSOR BOTAIY EQUIPMENT

S.35 BOBARt FOOD PROCESSOR

5.36 T1SSUXMIZER- ' • " »

2 Z>ABQXU

Paget 5 of 9

6.0 TESTING FACILITIES OPERATION*

6.1 USE OF VOLUMETRIC GLASSWARE

6.3 PREPARATION OF ETHERAL -ALCOHOLZC SOLUTIONS OF DIAZOMETHXNE

6.4 COLUMN CHROMXTOGRXPHY

6.5 SOLZD PHASE EXTRXCTION <SFB) CXRTRZDGE SYSTEM USE

6.13 PESTICIDE RESIDUE METHOD TRIAL* VALZDATZON, DEVELOPMENT XNDTROUBLESHOOTING

7.0 REAGENTS AND SOLUTIONS

7.1 STANDARD PREPARATZON XND LOGGZNG

7.2 PZPET HXSHZNG - RESIDUE

7.3 GLXSSHARE HXSHINO - RESIDUE

7.4 GLXSSHXRE NXSHZNO - ANXLTTZCAL SECTION . .

7.5 CLEXNZNO OF SXMPLE PREPARATION EQUIPMENT

7.6 GLXSSHXRB HXSHIHG - RXDZOXCTIVE MXIERZXL

7.7 GLXSSHXRB DEXCTZVXTION THROUGH SILANIZATION

8.0 SAMPLE/TEST ARTICLB PROCEDURES

8.1 TEST AND CONTROL ARTICLE CHARACTERIZATION AND DISTRIBUTION

. 6.2 SAMPLE CONTROL OPERATIONS

8.2.1 SAMPLE LOGGINO * PROCESSING OP CASH XND CHICKS

8.2.2 SXMPLE LOGGINO - SPECIAL PROCEDURES

8.3 STORAGE ARIA TEMPERATURE MONZTORINO ' .

8.4 SXMFLB STORAG8 .

8.5 SOIL SXMPLE PERMIT REQUIREMENTS

8.6 SXMPLE COMPOSITZNO

2 LXBQXU

Revision No.t 001Datet October 1989Paget 6 of 9

9.0 PROTOCOL UQOZUMEHTS

10.0• •-.-- •"•', f,:. - . • • '- "...'"'

' 10.1 STUDY IMPLEMENTXTZON

10.2 ANXLYTICAL PROJECT ; IMPLEMENTATION - SCHKDULZNG* ASSZGNMEHT ANDREPORT GENERATION

. . .- " -- • ?],-•.? .,1 • ' ; . " " ' - -10.2.1 ENVZRONMENTAL LXB NONCONFORMXNCE REPORT

..-,--- - - •. * C'''v':.'r ' • •10.3 DATA RECORDING .

10.3.1 SIGNIFICANT FIGURES

10.3.2 DZLUTIONS

10.4 PESTZCZDE RESIDUE RECORD KEEPING • " '

11.0 PROJECT REPORTS - CLP STUDIES

12.0 GENERAL LABORATORY SAFETY REGULATIONS

12.1 SAFETY ORIENTATION OF LXBORXTORY EMPLOYEES- - - . "U:1'.::1 .

12.2 PROCEDURES TO BE USED BY EMPLOYEES IN THE EVENT OF AN EMERGENCYAT BZOSPHERZCS .

12.r FIRST AID '

12.4 EXTREME TOXZCZTZES 1

12.5 SAFETY BEGULAIIONS FOR THE USE OF RADIOACTIVE MATERIALS

12.5.1 BADIOACTZV8 KXTERIAt ACCOUNTABILITY PROCEDURES • • ;

12.6 SAFETY * BADIAZZON ACCIDENT PROCEDURES

12.7 SAFETY BEGULAIZON8 •MICROBIOLOGY LABORATORY( ' L . • -

, , 12.8 SXTETI MONITORING PROCEDURESr'- '" i'iff .1P""'° ':' • ' ' "

12.9 AIR QUALITY MONITORING * IN BOUSE

12.10 MEDICAL SCREENING OF PERSONNEL

2 LABQAU

ARltOOItO


13.0 PURCHASZNO

14.0 BACTERIOLOGICAL EXAMZKAXION OP HATER SAMPLES

14.1 QUXLITY CONTROL PEOGRXM FOR BXCTERZOLOGZCXL XNXLYSES OF HATERSAMPLES

14.2 COLLECTION OF HATER SAMPLES FOR BXCTERZOLOGZCXL XNALYSZS

14.3 METHODS FOR BACTERZOLOGZCAL XNALYSZS OF HATER SAMPLES

14.4 MAZNTENANCE OF EQUIPMENT USED FOR BACTERZOLOGZCAL ANALYSZS OFNXTER SXMPLES

15.0

15.1 SXM SYSTEM MAINTENANCE

15.2 COMPUTER MXZNTENXNCE

15.3 COMPUTES MAINTENANCE RECORDS . -

16.0 FIELD SAMPLING AND MEASUREMENT PROCEDURES FOB GROUND-HATERCOHTAMINXnO* INVESTICAIIOBT

16.1 GUIDELINES FOB PURGING MONITORING NELLS

16.2 GUIDELINES FOB SAMPLING MONITORING HELLS

16.3 (RESERVED)

16.4 GUIDELINES FOB SOIL SAMPLING

16.5 GUIDELINES FOR SOIL GXS'SAMPLING AND* ANALYSES

17.0 ORGANIC CHEMISTS* '

17*1 PUEGEABLS BALOCASBON8 BY GC

17*2 PURGEABU ASOMAXICS BY GC

17.3 CHLOROPHENOXY ACID HERBICIDES BY GC

.17.4 ORGANOCHLORINE PESTICIDES

17.5 PCB BY GC -

2 LXBQXU

,r ; .. ' - i" -I* -

Datei October 1989Pagej 8 of 9

17.6 NON-ROUTZNE CC ANALYSIS

17.7 VXLZDXTZON OF ORGANIC SOLVENT PURITY

17.8 EDB/DBCP - - ; l? ' ;: * ~~~

17.9 RESERVED ^ :

17.10 RESERVED

17.11 BIEX BY GC • • ; . . ? :

17.12 COLUMN TRACKZNG r,lv r

17.13 STANDARDS TRXCKZKO - '

17.14 ORGANIC VAPORS \ -

. 17.15 ZNITIXL DEMONSTRATION OF CXPABZLZTY - ORGXNIC METHODS

17.16 METHOD DETECTION LIMIT STUDIES - ORGXNIC METHODS

17.17 ONGOING QC CHECKS '•> ORGANIC COMPOUND .ANALYSES

17.10 CONTROL CHARTS - ORGANIC COMPOUND ANALYSES

17.19 RESERVED \ ! I r "\

17.20 ' VOA BY OC/MS j

18.0 INORGANIC LABORATORY PROCEDURES

10.01 MINIMUM QC UQUIREMENTS FOR INORGANIC NET CHEMISTRY AND METALS

18.02 GLOSSARY OF TWMINOUXnf ^

18.03 . DETERMINATION OF INSTRUMENT AND METHOD DETECTION LIMITS IN THEINORGANIC KNVZRONMKNIAL LABORATORY

18.1 ALKALINITY (TXItlMETBIC* pH4.S)

28.2 CONDUCTANCE] . ,,,.-— •

18.3 BARDNESS ^_ IT._,_.„., ?a r-..r: '•• : . - • ' • . • /'

18.4 HETBYLENE BLUE ACTIVE 1BUB6TXNCES

16.S NITROGEN* AMONIA (COLORZMETXIC* AUTOMATED PHENATE) , ^

18.6 NITROGEN* NITRATE-NITRITE (COLORZMETRIC AUTOMXTED CADMZUHREDUCTION) „ .', , ,;!; .

2 LABQXU

AR<fOO<ii5

KVVAI1OB MO.1 001

Datet October 1909Pag*l 9 of 9

18.7 NITROGEN* NITRITE (COLORIMETRZC AUTOMATED)- '

18.8 TOTAL JCJKLDXHL NITROGEN (TO)

18.9 OZL AND GRKXSE (GRAVZMETRZC* 6EPXRXTORY FUNNEL EXTRACTION)

18.10 OZL XND GREXSE (SPECTROPHOTOMETRIC* ZNFRXRED)

18.11 pH

18.12 TOTXL SOLIDS (TS)

13.13 TOTXL DISSOLVED SOLIDS (TD8)

18.14 TOTXL ORGXNZC HXLIDES (TOX)

18.15 TURBZDZTY

19.0 METALS LABORATORY PROCEDURES

19.1 HXTEB SXMPLE PREPARATION FOR METALS ANALYSIS BY CLPMETHODOLOGY.

19.2 PREPARATION AND DIGESTION OF HATER SAMPLES PRIOR TO XNXLYZZNGFOR DISSOLVED* TOTAL AND TOTAL RECOVERABLE METALS ACCORDING TO v JUSEPA METHODS FOB CHEMZCAL XNXLYSI8 OF KXTEB XND HXSTES*EPA-600/4-79-020

19.3 SOIL/SEDIMENT SAMPLE PREPARATION FOB METALS ANALYSIS BY CLPMETHODOLOGY - ACID DIGESTION PROCEDURE FOR ICP, FLAME AX XNDFURNACE 'AA ANALYSES

.19.4 PREPARATION AND DIGESTION OF SOIL SXMPLBS PRIOR TO ANALYZINGFOB METALS USIN0 FLAA* GFAA OR ICP USZNO USEPA SN-646METHODOLOGY •

19.8 FILTO ABD CASSETTE FILTER PREPARATION FOB METALS ANXLYSZS

19.8 KXTRXCTZON PROCEDURES FOB TOXZCITY

• 19.7 BEXAVALBNT CHROMIUM ANALYSIS

19.8 PREPARATION AND DIGESTION OP HXTEB SAMPLES PRIOR TO ANALYZINGFOB MEECURY BY COLD VAPOI TECHNIQUE

19.9 LEAD IB PAINT PREPARATION

19.10 STXHDXRD TRXCEXBILITY

19.11 GLXSSHXRE CtEANINO FOB METALS ABD INOROABIC CHEMISTRY

2 LXBQXV

ARI»OOI»I6

2 LXBQXU

1O. f


• : JtfPENDIX C f- -'SXMPLE1 CONTAINERS, PRESERVATIVES,

AND BOLDINO TIMES

*•-'<• * !r- ^ .*-'

NO.I Appendix CRevision Ho. t 002


TABLE *H6. BflgJIJBD OKXUNDB, nCSDGMnON TUtfigCD, m tttDQC IKS

PfMarvatlon tecim* toldli* tlav

Bseurtsl TettstCbllfona, fscsl snd toolfecil screpcocoocl Cool, 4'C, 0.08 MtsX I tours

Inorganic TfrsUl * * *» G Gaol, 4*C ' |4 days»G Goal, 4*C 14 days

Ool, 4*Ct LSI to fflQ 28 dsysCool, 4*C * * &8 tour

AcidityAlkalinity

Btodissicsl

Rlochsslcsl ocyfsn

(talcs! ogysn(WorldsOOortns, tocsl nslduslCblarQrvlds, tocal sndto chlotinecloiflifirids

IonEJsldshL and ocsjsnlA

HitalsiGrain* VZtfercurrfetsls, ocspc cftnalia VIendsstoaryMl erst*KtliSlS) IliUttSNicrltsOil sod

ODolt 4% OJ3MB Nit* 4 tours

tount G (tons nquirtd 28 dsyi0 Oool, 4*C 48 tours

. G Oaol, 4*CV LSI CO (03 28 dsys

. G How nquin 28 dsyst 6 Mont twjUnd Anslya lisaittiLilji.6 Cool, 4*C 48 toun »t 0 Oxd, 4*0. NsCB to 5*M2, U days

tfcna nqutnd - • 28 days• 0 ML to pW, LSI U BH3 « vnchs" Mart nqulnd * * Mtlyss

t G Gaol, 4% L& to p»3 28 days

24 toursZSdtyt6 amths

0 Qjol, 4*C a toun0 Gaol, 4*0. LSI ta (4*3 U dsysG 0901,4*0 * * 48 toun

Oaol, 4*C, LSI to pB3 28 days0 Oaol, 4*C, to 3r LSI t» 28 dsyt

FUtsr tsssfftifsty, ooal, 4*C 48 tounnd s«s> HM fvjfutad Aoslyv

d» Pis as sifis snd sten IB dark 8 toursIhnoU . OOftly Ottl, 4*C, LSI t* pBg 28 dsys-—•——(•IsssiNiU 0 QMl,4*C * * 48 tounIte phocus, local , 0 CDol, 4*C, LSI »H*3 28 dsys

flool, 4*C * 7d«yscotslPlltsrsUsftof UurahU (OB)

wlttllsStiles

OMl9**C 7 dsys0-Mtl. 4*0 7 daysGDol, 4*0 48 taunOn!, »*C 'dsys(tel.4'0 28 daysQ»l» **C 28 dsyv

TWO-31

Datet October 1909Page t 3 of 3

1MUIM6. «W» COfMW, f«D5Wn» tt

CtBS

, 0 tool, 4«C B dm6 tool, 4'C, add sloe sestets 7dm

plus sodlui totattds to ptt*

6 tool, 4'C U toun• G 'Nans neutrsd Analyst, C tool, 4'C 48 toun

Organic ftstsi~ hovashls iiaartcw C, Ulaa-Unsd tool, 4'C, O.OOB IMA .4

:lc C, Ta/lao-llnsd Oool, 4*C» OXOB *,*A» 14 dm^MHM H>"t *M M • • •

Acrolsla snrf «ctylonltrlU 0, Ta/lOB-Unerf ' Cbol, 4*C. OXDBt IU.O.. 14 dsys•van AJJusc pH to 4-3 *ij

Rsnols C, ftflfln*U0sd op Cbol, 4'C, 04UBC fc.1,0. 7 dsys well •ftnetlan.

C, feXlfln llisBl csy* Cool* 4'C. 0JOB seuijQ. 7 d*Mfhchslsuwun C, teflflD-Unsdesf tool, 4"C *** 7 days isxll

. • 40 dayt aftsr sanctionMltcosAlnss C, tsf Isn-Uasd cs» tool, 4'C, ston IA tfsn, «u dsys sftsr mttrmtla

Ids, serylonttrtU 0. Mlfln»liasl csj» Cbol, 4'C**'1 40 dsy« sftsr saiKtlan' C, Mlon-Uasd csp tot, 4X OJOB NULQ. 40 days sftsr «tncttan

- stoct In SjsffiiC. MlOB-ilasd O* Ocol, 4'C, OODB fc.t.0. 40 dm afcsr •ctrsctlan

•WdleimAA* L .A * ' A*A* H sl^ -• - *- m m w•np u ••••sl IMK BI SBKa aTV AD ••Sin•v f Pv p ^ v ^ F v rvanv B»» vsBBm

(vtloethsrs C, MlflB-Unsd csp Owl, 4'C, 0*OOB IM-OL 40 dm cftsr sanctionOxlorlnscsd Ivdracsctas 0, feflan-Ussd c+~ tool, 4*C iij 40 dm «ftsr sanctionTOC C.Trflflo-llfl* as> tool, 4'C, OJDB IhJLflL 40 diyt oftsr •araetlonIbcsl «l*tU h«la|SQS C. MlflB-UDSd cs» tool, 4'C, LBX to fcTG 7 dsys

Nstlctdes ftstst . * *VMtleldos C, MlSB-Uasd 001 tool, 4*C, pfl M 40 dm tftsr •ttsction

Alpns, fcsuttdiui >, 0 ________WCLCopliC 4

(F) sr CUss (G)

.WO -12Rsvlsioo

I9B6

iJl. - V.' !;,."l;

Datet October 1909Pagot I of 10

APPIHDIX DQUALITX COVTROZ. SAMPLRACCXFTAVCR CRITERIA

SKCTZOH 1 ORGAKIC PXRAMKXER8BECTIOI 2 IVORGAXIC PARAME7ZR8

2 LABQAU

Date I October 1909Paget 2 of 10

SECTXOH 1 ORGANIC PARAMETERS

6010 EALOGENATZD VOLATILE ORGAVZC8

. Surrogate Compound tfater \ Soil %

' Bromochlorometbano 80-120 80-120

Matrix Splice Compound

l*l-Dichlorootbsn* 60*140 „ 60-140Trichloroetbtne 60-140 60-140Bromofora 60-140 60-140

Citre 0 r^

Coofficioat of eorrelotlon £0.997

Pally C« lib ration Xqe^pt«pgf Criteria t

CCC • 80*120% ' . • :

* smst contain BO tsrgtt conpounds st or above the PQL- surrogats Bust be ia range eitsd above

2 LABQAU

* *Revision Ho.i 002


8020 AROMATIC VOLATILE OROAKZCS j

Surrogate Compound Hater % Soil X

o-chlorotoluene 80-120 80-120

Sike Comound

1* 4-Dicblorobonssno 60-140 60-140Chlorobenxe , . 60-140 . 60-140Toluene 60-140 60-140Bonsono 60-140 60-140

Acceptance;

Coefficient of corrolatlon j.0.997

Pally Calibra,t fta Aeeept nej Criteriat

CCC - 80-120\ '

* must contala no targst compounds at or above the POL* surrogato stust bo ia rango eitod above

2 LABQAU

„ > , flfli»00i»22

Initial Calibration Curve Accetance

Cosffieioat of correlation iO. 997

Mo. i 002Datei October 1909Paget 4 of 10

6080 ORGAMOCBLORZHE PESTICIDES AND PCBs

ffurrooate Compound • Hater \ Soil \

r 24-154 • 20-150

Katrlr SpAfce Compound

Liadano 56-123 46-127Raptachlor 40-131 . 35*130Aldria <' ••; . ; 40-120 ' . 34-132Dieldrin 52*126 31-134Eadria 56-121 42-1394*4**DDT 38-127 23-134

*ag*

* ao target eoopouads at or above the PQL- surrogate must be ia range cited above

2 LABQAU

ARliOOtt23

_ HO.i Appendix DRevision No.! 002


8150 CBLOROPBENOXt ACID BERBZCZDE8

purrograte f empoyn . Mate* \ Soil \

2,4-DB 20-180 20-180

Matrix Sike

2,4-D 25-175 40-1602*4*S-TP(Silves) 25-175 40-1602*4, 5-T 25-175 40-160

Initial Calibration JTurve Aeop 'mqe Priteriai

CPS \ RSD

Continulny Cal j.brat QiyAgceptppf* Criteria!

CCC \ D

- no targst compounds at or abovo the PQL- surrogato must bo ia rang* clttd abovo

LABQAU

, , flRl*OOU21*

Revision No.i 002Datet October 1909Pagst 6 of 10

504 EDB/DBCP DETERKZIAIIOH I* MATER

CompQunfl

ffo surrogates . -

Matrl* Spike Compound Hater \- - (? .Til**"' ''"'

EDB - "• f ' ' " * ' '

40-160

ZftVtAftA JfrHfrrjtiop Curvf Apefp^ance^ Cy^eripr

Coefficient of correlation 2,0.997.. . . • . - - - ' < - I • ' - I - ' 1

pally Calibration Aeeeptanee Criteria!

CCC \ D i25\ : ;

• ao target compounds at or above the PQL

Msvision No.t 002Datet October 1909Pagei 7 of 10

8240 GC/MS VOLAIZLBS.

Inlt

Fraction

VOAVOAVOA

Praetioa

VOAVOAVOAVOAVOA

i 1 C llbr t

Surrogate Compound

Toluene»d|4*Bromofluorobensene1* 2-Dichloroethaae-d4

MATRIX SPIltS RECOVERY

Matrix Spike Compound '

1* 1-DlchlorpetheneTrichloretheneCblorobenseneTolueneBensene . ,

ion Curve AccflDtanCO Crltl

Hater

88-11086-11576-114

LIMITS

Hater

61-14571-12075-13076-12576-127

trial

Low/Medium Soil

81-11774-12170-121

Soil/Sediment

59-17262*13760-13359-13966*142

RP calculated for each compoundSPCCs EP 0.300 (0.250 for broaofon)CCCs

Da 11'

MSD <30\

• *v Calibration Aef*fDf|nj*§ CrltliiJU.

(each. 12 hours)SPCC 10.300 (0.250 for broaofora)CCC \D <25\

* ** target compounds at or above the PQL• all sorrogstes must be ia range cited above

2 LABQAO


8270 GC/MS SEMZ VOLATILES

Practioa

BHABHA :

BHABHA'BHABNA

• . . '. 1

Practioa

1 BH, BH

BHBHBHBH *AcidAcid

; AcidAcidAcid

initial Calibi

Surrogate Compound.i--f..ij.--»»i"'"1 ""• •

Hitrobenitns-dj •; 2-riuorobipbenyl

p-Terphenyl-dj,4Phenol -de > =2-riuorophenol2 * 4 * 6-Tribronbphenol

" .'"JU'V • •MATRIX SPIKE RECOVERY

r . V1 V" " •»•'' ••'Matrix Spike Compound

l*2*4-TrichlcrobehseneAceaaphthene [:%'.: 4. > ; '•2*4*DiaitrotolneaePyrene ,,w, . —— -H-Hitrcso-Dl-n-Propylaninal*4*DichlorebenseaePentacblorophenol ; L :Phenol2-Chlorophenol4-Chloro-3-Metbylphenol4-Hltropbenol

ration Curve Aecevtance Crit,

Hater

35-11443-116 .33-14110-94 .21-10010-123

- tLIMITS

- ;Hater

39-9046-11624*9626*12741*11636*970*103

12-8927-12323-9710-80

*

ICiftt

Low/Medium Soil

23-12030*11518*13724*11325-12119-122

Soil/Sediment

38-10731-13726-8935-14241-12528-10417-10926-0025-10226-10311-114

RFi calculated for each compoundSPCCs Rf JLO.OSO i ;CCCS \RSD <30A :

"' .' fT '•£! IT"'" *""'" f •'

pa y Ca lihra,t p AcClPtaBr* criteriat

SPCC 10.050CCC V) <30V : :

Blank - no target compounds at or above the PQL; - one surrogate »ay be out of the acid fraction if >10\1 - one surrogate aay be out of the base/aeutral fraction if >10\

2 LABQAU

—OM

fa O

I"1'

*• •• •• *•

d o -S 3nz i « *e e3*S SU -4

oe

NH

S**1

S o o o p oSo q o oopopop popoopppoow w N CM M N ?5 N m ft S M rS <N M S S S S S« »H p< 4 rt 4 *4*4*4*4*^»4*^p^p4p4

3 2222222 22229259549 5333333 3333333333

a ' 9 2 9329' 299 o o o e o5i 5, »«. »o.«. A «.«, »B. m. uv m. m. »n

a*as ssas ass'•? * * * +1+1+1+1 +|4»|4>|+| +1+1+1 4

.** «*^€4. ff * + + ++ „i o P o o o o i i o P o i loeooo1 TiTi TiTiTiT,1 ' Til,?,1

iJ-*• Mj S **3,3, 53,3,3,2 ^ 3,3,9 '3,3,3,3,3

A5r • § ^7 b« B a

^ Au er erfa M . ^«

HI illil 1 Jiaias*. ,i3.g«°ii|gi -llSli

• v*j j y w j joci^mno^oK a ~ u

I 8 SJl -4 a.rt W <*l|sga ss§g|ss Srtrt-i4rtrtrtrtrt -

I, I | j

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?I- --28 T! 2*4 fa fa fa• ** +1

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; , . "*'*fci*KflbKi«*M.

+» W • • « «P.«P.>".»P.«n.«P.*P.lo.»P.?.ip.»0.in.S.io.S. §«

en vflC

- , ' -r • C ..**/£

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APPENDIX B

QUALITY ASSURANCE PROGRAM

OCTOBER 1988

Alliance Technologies Corporation213 Burlington Road

Bedford, Massachusetts 01730617/275-9000

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TABLE OF CONTENTS

Section Page

1 QUALITY ASSURANCE POLICY, ORGANIZATIONAND DOCUMENTATION

1.1 Quality Assurance Policy and Objectives B-31.2 Quality Assurance Organization B-41.3 QA Project Plans B-61.4 QA Manual B-6

2 ELEMENTS OF QUALITY ASSURANCE

2.1 Personnel Training for QA . • B-8Z2 Configuration Control B-82.3 Procurement Quality Control B-82.4 Document Control B-92.5 Equipment Maintenance and Calibration B- 1 02.6 Preliminary or Pretest Preparadon B- 1 12.7 Sample Collection and Handling B- 1 12.8 Sample Analysis B-122.9 Intralaboratory/Intcrlaboratory Testing B-122. 1 0 Data Reporting B- 1 32.11 Data Validation B-142.12 Statistical Analysis of Data B-152.13 Audit Procedures B-16Z14 Corrective Action Procedures B-17

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ALLIANCE TECHNOLOGIES CORPORATIONQUALITY ASSURANCE PROGRAM

1 QUALITY ASSURANCE POLICY, ORGANIZATION AND DOCUMENTA-TION , . . ' . . - . . . ; . , -./. :!;;/r: : • , v ----- - - >'

This Quality Assurance .(QA) Program Description sets forth Alliance TechnologiesCorporation program for quality assurance. It describes the QA policy and organization andsummarizes the approaches taken by Alliance to meet various QA specifications forenvironmentally-related work. This program statement has been extracted from the AllianceCorporate QA Manual. ,',>-, '•.-*-'<, f ;

Alliance Technologies Corporation was one of the first major government contractors toestablish a QA/QC Program related solely to environmental programs. In 1979, Alliance(formerly OCA Technology Division) prepared a QA Project Plan for the $5.1 million LoveCanal Study Program which Alliance managed for the U.S. EPA. The four-volume QAProject Plan described sampling procedures, analytical procedures, and subcontractor QAPlans. This was the first QA Project Plan in the U.S. to be prepared under EPA's QualityAssurance Management Staff guidelines (QAMS-005/80). In the years following, Alliancehas prepared and submitted to EPA over 150 QA Project Plans on a vast range ofenvironmentally-related subjects. vr ._ "V , , ,

1.1 QUALITY ASSURANCE POLICY AND OBJECTIVES

Management at Alliance Technologies Corporation is fully committed to an effective QualityAssurance/Quality Control (QA/QQ Program whose objective is the delivery of a qualityproduct That product may be a report resulting from the analysis of gathered data, samplingand analysis, computer -modeling or engineering assessments. The Quality AssuranceProgram works to provide complete, precise, accurate, representative data in a timelymanner. In all cases, the end use of the product and the existing budget constraints areconsidered in planning specific quality measures. The Alliance QA Director directs theoverall program with strong management support

At Alliance, quality assurance Is defined as the overall management system which operatesto ensure that the quality control systems are functioning well. Quality assurance includessuch activities r as .independent performance /audits, interiaboratory comparisons, systemaudits, periodic evaluation of quality control procedures and data, and a corrective actionsystem. "; " _'. _ " ; - - ? " ' ;.' ""'V,^- v-..:: .-. .. . .••:" • •; -. •"-" " -'-

• '\ •"• ' • -. , '-'" s- • ~C'. f. •••i-".j*fj*/1l: * i • f ' . , ' . ' . , ' ' • , "" • '-'

Quality control refers to the continuing routine checks on quality within each segment ofproject activity such as field measurements, sampling, analysis and data collection andhandling. The Alliance Technologies Corporate QA Manual details specififl &4l(tyjcbjig-(J}rocedures for these segments. The QC measures include periodic instrument calibrations,- • - • -

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routine equipment maintenance, calibration check samples, technical review of projectreports, and edit tests with error diagnostics. i j

1.2 QUALITY ASSURANCE ORGANIZATION

The Alliance Technologies Corporation Quality Assurance Program conforms with EPA andNIOSH recommendations and is supervised by the Alliance Director of Quality Assurancewho reports directly to the President. This gives the QA Director the necessary authorityand independence to find and correct any existing quality problems. The QA/QC organizationchart is depicted in Figure B-l.

The Alliance Technologies program includes a corporate QA/QC Committee, Division QC 'Committees, a QA Manual, specific QA Project Plans, personnel training, and audit andcorrective action procedures. The program is designed to provide both continuity andflexibility in ongoing QC activities in all divisions. Continuity, structure and direction areprovided by the QA/QC staff; their responsibilities are outlined in this section. The AllianceQA Manual is an important aid in achieving continuity. Flexibility is furnished by the QA/QCstaff and by QA Project Plans discussed in Section 1.3.

The Director of Quality Assurance is a member of the Alliance Senior Staff and is, therefore,independent of the operating divisions. The QA Director directs the QA Program, selectsprojects for audit and conducts audits of Alliances' and subcontractor work, chairs theQA/QC Committee, consults with the QC staff on ongoing QC activities, reviews andapproves QA Project Plans, reviews work plans and reports for QA requirements, and \_Jinitiates or follows up on corrective actions as necessary. Revisions to the QA Manual andspecialized training sessions are coordinated by the QA Director.

The Laboratory Services Coordinator reports directly to the QA Director and is independentof the technical divisions. The Laboratory Services Coordinator develops guidelines for theselection of chemical analysis subcontractors, works with Alliance technical staff to defineand procure chemical analysis services, assists in the preparation of QA Project Plans,coordinates the efforts of analytical subcontractors, assesses compliancewith data quality objectives, and evaluates the quality of subcontracted chemical analysiswork. • ' '•

The needs of large programs which incorporate technical work by several divisions may bebest met by assigning a Program QC Coordinator to the specific program. If the ProgramManager and QA Director agree it is appropriate, the Program Manager appoints a person ,thoroughly familiar with the technical goals of the program to work with the QA staff indeveloping and implementing appropriate QC measures. Program QC Coordinators report totheir Program Manager and QA Director; they provide a monthly written report of QCactivities to the Program Manager and the QA Director. The Program QC Coordinators aremembers of the QA/QC Committee and are responsible for maintaining awareness a>i»acu*tprojects and their QC needs* They coordinate technical review of project reports andmaintain awareness of document control requirements and procedures. Their QCresponsibilities are defined and agreed to by the Program Manager, and the QA Director.

ALLIANCETechnologies Corporation

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CHEMIST

•" .VICEPRESIDENT rCHIEF OPERATING OFFICER

PRINCIPAL CHEMIST

Joanna Hall

Responsbte tor strategic planning, ; . * (Bedford DMslon, Health anddlrKHon of other OAatafT. oversight of ' Erwlrcflmenlal Sciences Department)•to Affiance QA program, development/ ( . Re onsMe tor special expertise Inreview of SOPs, QA manual. QA program/ ' organic chemistry, preparation/reviewproject plans ofQAPPt

LABORATORY SERVICES' COORDINATOR

QUALITY ASSURANCESCIENTIST

Lome Comeford, Ph.0. H t*,,, n«»vi^«n m Stephanie Mark

Responsbte far system aucHls, technical ;•-•• * ftesponsbte for bboralory «enfces • Responsfcte*r technical report •report revJews.edlling of SOPi. . procurement, laboratory tutJls, . . reviews, lystemaudls, data qua%QArecorosadmlnlstraflon / analytical data quality assessment assessments, quaniycomio! for fie

•pedal axperdse hi Inorganic ohemtetn/, TES VI end TESX contractspreparattonAevtewofQAPP«

~ ^ Figure B1. Alliance Technologies Corporation Quality Assurance organization chart.

flfil*OOI»36

On certain occasions the QA/QC needs of large programs can best be met by identifying a"team" of subcontractors and integrating relevant aspects of each "team's QA Program intoAlliance's quality system under the supervision of Alliance's QA Director. The steps takento implement a QA program for subcontractors include: 1

• Informing each subcontractor of Alliance's quality system requirements andrequesting identification of a QA Coordinator.

• Communicating with each QA Coordinator to ensure understanding ofQA/QC requirements.

• Requiring each subcontractor to provide specific QC procedures and aconcise QA Program Plan summary.

The designated QA Coordinator for each subcontractor implements the QA/QC Program intheir organization. These QA Coordinators report directly to Alliance's QA Director onquality matters. Some of the QA/QC activities appropriate to subcontractor activities arelisted in the QA Manual, Sections 1.2,2.3 and 2.13.

1.3 QA PROJECT PLANS *

Alliance Technologies technical staff operates under the guidelines of the QA Program usingappropriate procedures provided in the QA Manual and in sampling and analysis methodmanuals. This ensures that even small projects have written QC procedures provided.

For larger projects or those with detailed QA/QC needs, a QA Project Plan outlining QArequirements and providing specific QC procedures is prepared. These plans utilizeprocedures from the Alliance QA Manual as appropriate, but they are specific to an individualproject A QA Project Plan may contain sampling and analysis equipment calibration andmaintenance procedures/or specify document control procedures for a questionnaire used inan engineering analysis activity.

The Plan content is designed to incorporate the appropriate QC procedures and to meet clientspecifications. Most QA Project Plans are prepared according to EPA's "Interim Guidelinesand Specifications for Preparing Quality Assurance Plans," QAMS-005/80, U.S.Environmental Protection Agency, Washington, D.C, 1980. The Division QC Coordinatorsand the QA Staff have copies of this guideline document available. These plans are subjectto review and approval by the QA Staff.

1.4 QA MANUAL

Alliance has developed a QA Manual which clearly states Alliance QA/QC procedures. Thefollowing QA Manual sections have been developed to cover the range of Alliance'sactivities.

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• General Principles outlines the overall quality program and policies and theelements of quality assurance as they apply generally to Alliance services.Specific QC procedures are contained in later sections of the QA Manual.

• Sampling and Field Measurements includes sections on pretest preparation,equipment maintenance and calibration, sample identification and chain ofcustody procedures, and Final Report requirements.

• Chemical Analysis outlines procedures for procurement of analytical services/data quality objectives, analytical data quality assessment, and fieldmeasurement procedures. Intralaboratory and interlaboratory testing, datarecording and audit procedures are described.

• Technical Data Handling includes QC procedures appropriate to datagathering, and manual and computerized data handling. Sections on projectfiles, engineering surveys and calculations, computer modeling and reportreview are included.

2 ELEMENTS OF QUALITY ASSURANCE

This section describes specific elements of the Alliance QA Program. These elements arecritical to meeting the Alliance goal of providing quality products and services. Fourteenelements of quality assurance have been included in the design of the Alliance QA/QC

'gram:

• Personnel Training : >:C1 f'

• Configuration Control r^^h ; '';• - • i . • •-". -T*H,;.i'': • ' , -' - • . ' • :

• Procurement Quality Control -

• Document Control J ' - .

• Equipment Maintenance and Calibration ' '

* Preliminary or Pretest Preparation

• Sample Collection and Handling• .. •• - - . : . • . - . . ... ,.-....- •wiiv,!l.nH • -. • • - ;

• Sample Analysis • '--1 •' J srfa k-*' .• •. -

• Intralaboratory and Interlaboratory testing ^

• Data Reporting

• Data Validation

B7 V ALLIANCEQ;i!,fli;flRI|OOI»38

• Statistical Analysis of Data

• Audit Procedures

• Corrective Action Procedures

The Alliance Corporate QA Manual, Sections 2, 3, and 4 contain more detailed discussions ofthe QA elements appropriate to each technical activity and includes specific QC procedures.

2.1 PERSONNEL TRAINING

The objectives of QA training are to make Alliance Technologies personnel aware of theimportance of quality assurance and to inform them of the overall .Program and their personalpart in it The significance of each person's job and performance is emphasized to fosterpersonal involvement in the Program.

Employees are trained in their job operations so they can apply QC procedures to a soundbase. Sampling and analysis programs involve complex technical procedures and precisefollowing of directions, so special attention is given to on-the-job training for newemployees, or to a staff member working with a procedure for the first time.

2 CONFIGURATION CONTROL

Configuration Control is the system used to record changes in equipment or the physicalarrangement of that equipment The responsible Division maintains a Site Log at each siteto record daily activities during a field measurement or sampling project. Changes inequipment or its arrangement onsite may have significant effects on field measurements orcollected samples. The Site Log records any significant events that occur and provides avaluable history for use in troubleshooting or explaining questionable results.

23 PROCUREMENT QUALITY CONTROL

In general, procurements fall into two classes-materials and services.

Materials ~

When applicable, Purchase Requisitions include quality requirements and theserequirements are incorporated in the Purchase Order. Appropriate materials are subjected toacceptance tests or incoming inspection; records of these tests are maintained.

The requisitioning division is responsible for evaluating the quality of purchased materialsand notifying the Purchasing Department of any deficiency. The Purchasing Departmentinitiates Vendor Corrective Action if necessary.

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Services • ,- . •• . • . '•• . ,.,v, fb:;;.: i - ' - • - '

In addition to the control over procured materials, a rigorous program of procured servicescontrol is maintained. Subcontractors employed by Alliance Technologies Corporation arerequired to conform to the Alliance quality program. For example, if a service laboratoryperforms some analytical work under contract to Alliance, that laboratory must describe itsQC procedures and submit documentation of the QC work performed. In addition, Allianceroutinely incorporates QC samples (blanks, -duplicates or audit samples) in the sample load.The results on these samples provide an Independent measure of the quality of thesubcontractor's work. ; v :: ::i: ^

2.4 DOCUMENT CONTROL

The varied activities of Alliance Technologies Corporation require many forms of documentcontrol to provide completeness and traceability, clear sample identification and chain-of-custody information, confidentiality, current technical and QC procedure descriptions, andretrieval of information. Documents generated Include computer programs, lab and field datasheets, technical drawings, official project memos and reports. Section 2, 3 and 4 of theAlliance QA Manual address document control procedures appropriate to each technicalwork area; general information is provided here. ' '

Standardized data forms .are designed to gather the complete set of data needed for aparticular technical activity. Telephone Conversation (Telecon) Reports, Survey

V Questionnaires, Instrument Calibration Sheets and Inspection Checklists are examples ofthe many types of data sheets used by Alliance Technologies staff members. Thestandardized forms also ensure the comparability of data gathered by different peopleworking on the same task. ..

Document control of data gathered from various sources is maintained by keeping a record orlog of all the data. The log includes the title and/or description of each item, its source and/orauthor and the date it was received. It Is useful to number each data item and provide akeyword or other very brief summary of the contents.; \ .- -

The documentation of sample identification and handling, and assignment of a responsibleperson are essential in many Alliance Technologies projects. Section 2.7 of this documentdiscusses chain-of-custody policies. QA Project Plans include the specific custody forms tobe used.

A confidentiality requirement may extend to the documents cited above as well as to-sitesurveys, process information and field measurement data. The Document Control Officerensures that Alliance Technologies makes every effort to provide and maintain confidentialityat all stages of data handling. . ^ i';^tei^ ; ' -

'.-•..,-• . -' ' --: •• r- .- N. •:i:-ten V ,• • l • ". r ..." • • '•Certain EPA programs require special handling of confidential informati i" ' Alliance,

ployees performing such work sign a confidentiality agreement form in accordance with*'ection 114C of the Clean Air Act as amended (2 USC 1857 et seq.). In addition, each

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employee then receives a security manual entitled, Manual for Treatment of ConfidentialBusiness Information which contains the policies and procedures followed by Alliance.

Other EPA Programs may require Alliance to obtain a security clearance to receiveconfidential business information specific to various other regulatory authorities. In the pastAlliance has received such clearances under the Toxic Substances Control Act (TSCA) (15USC 2601 et seq.) and the Resource Conservation and Recovery Act (RCRA) (42 USC 6901et seq.). When these clearances are required under specific programs the appropriatesecurity manual is submitted and Alliance employees then execute confidentialityagreements on a need to know basis. Specific security manuals prepared 'for theseregulatory authorities are available from the Alliance Document Control Officer.

The project manager is responsible for the control of all official project memos and reportsissued and for the completeness of the project file. The Contracts Administration officeretains a copy of all progress and final technical reports; those requiring confidential handlingare kept in combination-locked filing cabinets.

It is important that the most recent revision of a technical procedure can be identified and isavailable for use. Most of these procedures are contained in the QA Project Plans and inSections 2, 3 and 4 of the QA Manual. The Alliance Technologies Corporation system fordocumenting and updating these documents follows EPA and NIOSH recommendations. Thesystem uses a standardized heading format and provides for replacement of pages that maybe changed within the technical procedure descriptions. , ,

Some projects require the compilation of a document inventory containing all projectdocuments. EPA's National Enforcement Investigations Center (NEIC) has outlinedrequirements for this type of document control In two publications: "NEIC Policies andProcedures Manual" and "Enforcement Consideration for Evaluation of UncontrolledHazardous Waste Disposal Sites by Contractors. '

Alliance follows the rigorous NEIC requirements when appropriate. They include thedesignation of a Document Control Officer and the identification of accountable documents.Preserialized sample identification tags and chain-of-custody records are used and a uniqueproject code is used for all project documents.

23 EQUIPMENT MAINTENANCE AND CALIBRATION

Alliance Technologies Corporation follows an orderly program of positive actions to preventthe failure of equipment or instruments during use. This preventive maintenance and carefulcalibration help to ensure accurate measurements from field and laboratory instruments.

Sampling equipment must be properly calibrated and maintained. As standard practice, themonitoring team shall check and record dates of calibration or servicing. Bncau6e bot|icalibration and maintenance of the sampling instruments are subject to close scrutiny in-legalproceedings, written records are required. Emphasis is placed on these standard practicesas a means of ensuring the validity of the results. Calibration records, equipment servicing,

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and performance evaluations for all equipment used in a project are kept by a personassigned that responsibility by the Project Manager. *

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2.6 PRELIMINARY OR PRETEST PREPARATION. . ' • • : -.; L,;v:K-!.; ?.-*'-- -'• ' - ' ' ' • ' '' ;- '"

Advance planning is critical for field measurements, sampling and analytical work; it isimportant for other tasks as well. The Project Manager defines the necessary preparationswhich are outlined in the QA Project Plan. For engineering assessment and economicanalysis projects,. this might include documenting survey forms and equipment checklists,and specifying engineering calculations and modeling programs to be used.

For ambient and source monitoring projects, the proper selection of sampling sites isfundamental to providing monitoring data that is both high quality and representative. Duringthe pretest preparation, an onsite visit is normally conducted and the Pretest SiteDescription Form is used to ensure that all necessary administrative details for samplecollection, and technical information for monitoring system design are obtained.

2.7 SAMPLE COLLECTION AND HANDLING

Statistical Sampling Design

Alliance statisticians aid in designing experiments so that they are statistically sound. This, is particularly useful in determining the number of observations (samples) needed to achievea certain precision or confidence level In the results and can be applied to informationgathering as well as to samples collected for chemical analysis.

Sample Collection

Various Division staff members collect samples used for field measurements and most ofthose are submitted to subcontractor laboratories for analysis. The Sampling.and FieldMeasurements Section contains pretest planning and sample identification procedures, andequipment maintenance and calibration procedures. Separate methods manuals for ambientand source air monitoring and air, water, ioil and sediment sampling contain the fieldmeasurement and sample collection procedures, ^ ;; * •

, .' .. .'. ._'r • ""„... „• i .- : i:tt.:. *,-£ (£t.£'(-••:•*:,:••• • . :.,- /' ' •."''-' •'••'•• >••"•Container cleanliness, sample preservation and storage conditions are carefully controlled,and the importance of proper sample identification is stressed. Stick-on labels or sampletags arc used to ensure the clear and unique identification of each sample collected. ; , '

Sample collection for an economic or policy analysis project might involve using theappropriate survey form to actually gather the data which is the sample. Reasonablenesscriteria are built in to spot questionable data early and enable resampling if necessary. Insome cases, existing data must be collected from several sources to provide the samples, foranalysis. • *

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Chain-of-Custody

Chain-of-custody procedures are almost always related to samples which are collected for ^laboratory analysis. The purpose of these procedures is to document the identify of eachsample and its handling, from its first existence as a sample until all laboratory analysis hasbeen completed and, if appropriate, information derived from the sample has been introducedas evidence in litigation.

The chain-of-custody for field measurements is maintained by the ambient or source site logor the project field log book. Samples collected in the field are identified, labeled andrecorded in the field log or on a packing sheet Custody forms (the field log, packing sheet ora separate Custody Record Sheet) are used to identify the person responsible for the sampleat all times from collection to final measurement or analysis.

2.8 SAMPLE ANALYSIS

Alliance Technologies Corporation conducts a wide variety of programs requiring reliablechemical analyses. Subcontractor laboratories perform the bulk of these analyses. However,all Alliance divisions perform field measurements and certain other analyses. All divisionsstrive to include appropriate elements of quality assurance in their programs.

23 INTRALABORATORY/INTERLABORATORY TESTING

Alliance Technologies Corporation makes use of Intralaboratory testing to achieve the bestpossible performance for subcontractor laboratories and interlaboratory testing to comparethat performance with other laboratories.

Intralaboratory Testing

Intralaboratory testing is performed to demonstrate that the analytical system is in control,to identify any sources of error within the measurement method, and to establish theprecision and accuracy of the method.

Alliance subcontractor laboratories use Laboratory Control Standards (LCS) whose truevalues are known to the analysts to establish that the instrumentation to be used is incontrol Control charts (described in Section 2.12) are provided in the instrument log and,before analyzing samples, the analyst must analyze the appropriate LCS and ensure that theanalysis value falls within the control limits for that instrument If the LCS exceeds thecontrol limits, corrective action is taken; no samples are analyzed until analysis of an LCSshows the instrument is in control.

Method blanks are run with every analysis batch; they aid in demonstrating good control, orin investigating problems. Some of the potential error sources are the operator or analvst .the equipment, the calibration, and the operating conditions.

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Precision is determined on replicate samples; if these replicate samples are standardreference materials, accuracy can be determined simultaneously. Alliance Technologies'subcontractor laboratories routinely use EPA reference samples and National Bureau ofStandards Standard Reference Materials. -Laboratory QC personnel prepare spiked samplesand duplicates to supplement these external reference standards.

Results of these analyses are examined by; the Alliance Laboratory Services Coordinator.The results are used to identify and correct problems in analytical procedures or techniqueand to provide an evaluation of the data reported. :

Interlaboratory Testing <-•-• ' ;,; - i^rr; ; ; -

Interlaboratory tests are designed to compare the performance of several laboratories.Usually, identical sample sets are submitted to a relatively large number of laboratories to behandled as routine samples and analyzed by a standard procedure. A coordinating labreceives all the results and summarizes the data so that any participating laboratory canevaluate and improve its own performance. Alliance subcontractor laboratories participateregularly in EPA Ambient and Source Interiaboratory Tests, Water Supply PerformanceEvaluations and Water Pollution Performance Surveys; the NIOSH Proficiency AnalyticalTesting (PAT) Program; the Asbestos Bulk Sample Analysis QA-Program; and specializedaudit programs such as that for Level 1 Environmental Assessment analyses. The AllianceLaboratory Services Coordinator and the QA Director evaluate the results; if any results arenot within the control limits established by the coordinating laboratory, corrective action isinitiated at Alliance. '/2.10 DATA REPORTING ^( , i !

Procedures for recording and reviewing;data «t several levels are used at Alliance tominimize human and automated data handling errors. Most of Alliance Technologies originaldata recording results from sampling, field measurements or analytical activities. However,survey information must be tabulated and previously existing data are often recorded in adifferent format for easier handling. -•_• — - v tbli h ."

Checklists and a site log are provided at each .sampling or monitoring site to aid personnel inrecording necessary information. Acceptance limits are written in whenever applicable foruse in immediate and later validation of the data and the format is designed to collect data ina useful and complete manner. Field measurement crews maintain a field project log bookand use standardized forms for recording data- Data gathering questionnaires and tabulationforms are designed to be complete, appropriate, and to include checks on the reasonablenessof responses. Care in entering and transcribing responses is emphasized.

Many of the Held and analytical measurements made by Alliance staff members areautomatically recorded; e.g., continuous emission monitors are usually tied into the AllianceFluke 1720 computer system in the Held. Alliance Instrument checklists include-checks onthe operation of these data handlers and Internal validity checks are used tcr flag

ulting from electronic interferences.

B-.3 A ALLIANCErA. TbChnotootes Corporation'

Whenever possible, calculations are computerized for efficiency and to avoid human error.The data system mentioned above calculates results as programmed and provide hard copyin the desired format Programs which require sophisticated computations and integration oflarge numbers of results may be handled on mainframe data processing systems available innearby installations.

The field operator, analyst and data gatherer should be alert to the importance of the datathey are recording. As appropriate, acceptance limits are provided to help the operator spotquestionable data and control charts are used whenever possible to show if the procedure isin control. Field team leaders and survey task managers review each day's data promptly sothat, if necessary, additional samples or other corrective action can be taken. Subcontractorlaboratory QC personnel initiate control charts for instrument performance and specificanalytical methods, and the Laboratory Services Coordinator reviews routine and specializedQC sample results as they pertain to each project In all technical divisions, the ProjectManager and/or the Section Head reviews data promptly to ensure its reasonableness anddetermine if corrective action is needed.

2.11 DATA VALIDATION

Data validation is the process of filtering data and accepting or .rejecting it on the basis ofsound criteria. Alliance Technologies supervisory and QC personnel use validation methodsand criteria appropriate to the type of data and the purpose of the measurement Records ofall data are maintained even those judged to be "outlying" or spurious values (see Section2.12 on outliers). ,

Usually acceptance limits or control chart control limits are used as the rejection criteria.Acceptance sampling techniques are used if appropriate to determine how many data itemsneed to be checked to determine with a given probability that all data items are valid andshould be accepted. The QA Project Plan states the number of data items to be validated.the allowable number of errors and further action to be taken when an error is found.

The general criteria used to evaluate sampling and field measurements data are:

• Steady state operation of the process being sampled

• Use of approved test procedures

• Use of properly operating and calibrated equipment

* Use of reagents that have passed QC checks

• Leak checks conducted when appropriate

• Held data sheets and custody records completed

-u ALLIANCE

• Sample clearly identified Analytical data is validated using the followingi , general criteria: = t-""" . • :' . . •"-' *=w« t ' ' ""-' • • •_ ;

• Documentation of sample identity and handling, e.g., preservation, andrequired analyses - i -T;r ;

• Use of approved analytical procedures -

• Use of QC checked reagents j ^ i ; ;

• Use of known QC samples (LCS) to ensure analytical system was in control

• Analysis of required blanks, duplicates and blind QC samples completed

* Precision and accuracy achieved on replicate QC samples.

The experience of the field team and Laboratory Services Coordinator is relied on forjudgment; questionable results are noted and'investigated but not usually rejected. As notedIn Section 2.10, the field team leader and Laboratory Services Coordinator perform thisvalidation during the review of data reports. ^ • •

2.12 STATISTICAL ANALYSIS OF DATA

tj Statistical tools and techniques are used with discretion to aid in the analysis of collecteddata. The Project Manager defines the type and extent of statistical analysis to beperformed for each project ..,,.*.. „_. v. -

Least-squares linear regression is often used in analytical work to relate concentrationvalues to instrument readings. Summary statistics are used to simplify the presentation ofdata and are especially useful in evaluating quality control samples. The accuracy achievedon QC samples Is evaluated by comparing the mean of repeated measurements with theknown value of the reference material; .the precision achieved is shown by the standarddeviation and the coefficient of variation. : v . ;S:s 1 > i : •>

Frequently used statistical techniques are briefly described in this section. .

Identification and Treatment of Outliers

A data point which deviates markedly from others in its set of measurements 'may bereferred to as an outlier. The outlier may result from an error in the measurement system ortechnique or, it may be a valid value due to unique circumstances at the time of sampling,analysis, or data collection. The suspected outlier value is recorded and retained in the dataset while it is investigated. There is t great reluctance to reject an observation even ifconfirmed as an outlier.

'*-I59 OAF

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The field or laboratory notebook should indicate any unique circumstances which occurredduring sampling or analysis. It is useful to also perform statistical tests on suspected ^ joutliers. If the suspect value is statistically identified as an outlier, further investigation isinitiated. The operator, analyst, or data gatherer who worked with the sample is consultedfor his knowledge of the specific sample and his experience with similar samples. This maygive an experimental reason for the outlier and a decision can then be made as to whetherthe outlying value should be kept in the data set. Further statistical analyses are performedwith and without the outlier to determine its effect on the conclusions. In many cases, twodata sets will be reported, one including and one excluding the outlier.

In summary, every effort is made to include the outlying value in the reported data. If thevalue is rejected, it is identified as an outlier, reported with its data set and its omission isnoted.

Control Charts

The control chart displays data in a form which graphically compares the variability of allresults with the average or expected variability of small groups of data. The variability maybe due to random (indeterminate) or to assignable (determinate) causes. The control chatdistinguishes indeterminate from determinate variation in a process 'or method by its controllimits. If a value falls outside the control limits, it is considered out-of-control, almostcertainly due to a determinate cause which has been added to the indeterminate variations.The control chart signals the need to investigate, find the determinate cause and correct it

Alliance Technologies Corporation uses the Shcwhart type of chart with control limitsdefined by the client, or calculated on the basis of the mean ±2 or 3 times the standarddeviation of the statistic used. If QC sample measurements show an out-of-controlcondition, it can be expected that an effective indicator of the need for corrective action.

2.13 AUDIT PROCEDURES

The Alliance Technologies Corporation Quality Assurance Program includes bothperformance and system audits as independent checks of the quality of data obtained fromsampling, analysis, and data gathering activities. Every effort is made to have the auditassess the measurement process in normal operation. Either type of audit may show theneed for corrective action.

Performance Audits

The sampling, analysis and data handling segments of a project are checked in performanceaudits. The Division QC Coordinators ordinarily arrange the audits so they are unknown tothe project staff, or a different operator/analyst performs the audit operation to ensure theindependence of the quantitative results.

The auditing frequency is outlined in the QA Project Plan and is based on past experiencewith particular sampling and analysis procedures, client guidelines and project needs. An

B16 ALLIANCETechnotogfetCorporahon

audit rate ranging from 5 to 10 percent is commonly used and results are plotted on controlcharts to permit continuous, rapid evaluation of quality control effectiveness.

To audit an air pollution measurement system, a separate set of calibrated flowmetcrs maybe used to audit the sampling flow rate. Data handling is checked by using the original rawdata and performing all necessary calculations and entry of data. The audit results arerecorded and compared with routinely obtained data. ,

Performance audits on a data planning and analysis project may include randomly answeredsurvey forms and planned incorrect transcription of data. These should trigger the validationprocedures by entering unreasonable combinations of responses and also check on theverifying or error coding of keypunch entries.:. 9; f \ ••

System Audits ' . . • . •-r^^ff *J i-; ' ' - ' ' "

This qualitative review checks that the QC measures outlined in the QA Project Plan are inuse; it is a general overview of the whole quality system for that project. The QA Directorusually conducts a system audit onsite at the start of a monitoring program. A system auditfor an engineering assessment of a process or control system might be conducted onsite; anaudit or an emission inventory project for a large geographical region would not TheLaboratory Services Coordinator conducts system audits of subcontractor laboratories.

2.14 CORRECTIVE ACTION PROCEDURES

Perhaps the single most important pan of any quality assurance program is a well-defined,effective policy for correcting quality problems. Alliance Technologies maintains a closed-loop collective action system under the direction of the QA Director with full managementsupport While the entire Quality Assurance Program operates to prevent problems, it alsoserves to identify and correct those that may exist Usually these quality problems requireeither on-the-spot, immediate corrective action or long- term corrective action.

Immediate Corrective Action

Specific QC procedures and checklists are designed to help field technicians and analystsdetect the need for corrective action. Error diagnostics perform the same function incomputerized data handling. Often the person's experience will be most valuable in alertingthe operator to suspicious data or malfunctioning equipment.

If a corrective action can be taken at this point, as part of normal operating procedures, thecollection of poor quality data can be avoided. Instrument and equipment malfunctions aremost amenable to this type of action and Alliance QC procedures include troubleshootingguides and corrective action suggestions. The actions taken should be noted in field orlaboratory notebooks but no other formal documentation is required, unless furtherrcorrective •action is necessary. These on-the-spot corrective actions are an everyday'{>art'of Ihe

t QA/QC system.

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If the problem is not solved in this way, more formalized long-term corrective action may benecessary. The following subsection discusses the Alliance Technologies system foreffectively handling these long-tenn actions. '

Long-Term Corrective Action

The need for long-term corrective action may be identified by standard QC procedures,control charts, performance or system audits. Any quality problem which cannot be solvedby immediate corrective action falls into the long-term category. Alliance uses a system toensure that the condition is reported to a person responsible for correcting it who is part ofthe closed-loop action and follow-up plan. '

Documentation of the problem is important to the system. A Corrective Action RequestForm is filled out by the person finding the quality problem and submitted to the QA Directorimmediately. This form identifies the problem, possible causes and the person responsiblefor action on the problem. The responsible person may be an analyst, field team leader, orthe QA Director. If no person is identified as responsible for action, the QA Directorinvestigates the situation and determines who is responsible.

The Corrective Action Request Form includes a description of the corrective action plannedand the date it was taken, and space for follow- up. The QA Director checks to be sure thatthe initial action is appropriate and has been Implemented and, at appropriate later dates,checks again to see if the problem has been fully solved. The QA Director enters allCorrective Action Forms in the Corrective Action Log. This permanent record aids the QADirector in follow-up and makes any quality problems visible to management; the log mayalso prove valuable in listing a similar problem and its solution.

This system has proved quite effective in handling sequential types of corrective action sinceit brings the form to the QA Director's attention at a time appropriate to check on the nextstage of corrective action. The same form can follow a problem until it has been solved.

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mctaTRACE, Inc.

LABORATORY OOAL*TY ASSURANCE PLAN

September 1988

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Table of Contents

I Section Title

n Section 1 - Laboratory Organization and Personnel

' Section 2 - Personnel-Training

'] Section 3 - Sample Receipt, Storage andI Chain-of-Custody

-| Section 4 - Material Procurement and Control

Section 5 - Facilities and Equipment**i1 Section 6 - Equipment Maintenance

Section 7 - Analytical Procedures

Section 8 - calibration

Section 9 - Limits of Detection

Section 10 - Analysis of Quality Control Samplesand Documentation

'x_>Section 11 - Corrective Action

Section 12 -'Holding Times and Preservation

Section 13 - Approvals from Other Agencies

Seqtion 14 *- Document Control

Section 15 - Quality Assurance Reports to Management

Section 16 * Accuracy, Precision, and Completeness

Appendix A - Resumes of Key Laboratory Personnel

Appendix B - Personnel Training SOPs• Appendix C - Chain-of-Custody SOPs

Appendix D - Equipment Maintenance SOP

Appendix E - Tables of Contents From SOPs

Appendix. F. - SOPs For Calibration Procedures and Frequency

Appendix 6 - Limits of Detection - SOP and EPA Exhibits C ~-S

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Section 1. metaTRACE ORGANIZATION AND PERSONNEL

metaTRACE Organization

The overall organization of metaTRACE is shown in Figure l.MetaTRACE designed this management organization and itsmanagement systems based on the many years of experience ofthe principals in the commercial laboratory business. Webelieve it is the best system for efficiently managing theanalysis of large volumes of samples while, at the same time,maintaining high quality -and responsiveness to thespecialized needs of individual clients. The elements of theoverall metaTRACE management structure are described below.

1. Principal Responsible; Corporate officialDr* David C* Kennedy, as President and CEO of metaTRACE,provides top corporate oversight on technical and financialperformance and supports the Technical Director in securingthe necessary resources for successful project performance.

J £ -- ;

2. Technical Director „<.>-!! I - - iDr. Carol H* Byington serves as Technical Director* She hascomplete responsibility and accountability for achieving allproject requirements - technical, schedule, and financial*Dr. Byington, as Executive Vice President of metaTRACE, hasdirect control of all technical resources to accomplishproject objectives. - —— ,

' . : i :o Document Control/Sample! Control Manager . '

Ms* Barbara B. Gillam serves as Document Production andControl Manager. She manages the timeliness and quality ofall project deliverables. j

o Information Management sys terns Manager 'Mr* John A. Hayden is the {manager of the Information Systems !Department. He is responsible for the administrative controland operations related to computerised data processing forboth internal company use find output to customers* He isalso responsible for assessing current and future metaTRACEneeds involving computers, robotics, automation and relatedsoftware. ',"". , ., .. .. . ..._,„„ - j . _,— -,—- ----- - - — - - •-•--

3. Project Administration • -Mr. Kenneth Baughman, .-. ") ..j --; Vice President, isresponsible for all program management activities; Throughhis Program Managers and their Project Managers, 'the specificrequirements of Individual! projects and clients aretranslated into results. and deliverables. Under themetaTRACE matrix management system, Mr. Baughman and 'Mismanagement staff represent the client and advocate hisinterests in executing the projects through the LaboratoryOperations organization. The Quality Assurance Manager andthree Program Managers are under Mr. Baughman 's control.

Figure 1. metaTRACE Organization

*| D.C. Kennedy, Ph.D.1 President

1

— K.T. ArinkController

C.H. Byington* Ph'.D.Executive Vice President

Technical Director

B.B. Gil lainManager. Document

Control/Sample Control

J. HaydenInfo. Management Systems

R.K. RobesbnVice President

Operations Management

K.J. BaughmanVice-President

Project Administration

Organic AnalysesH. Borg

Inorganic AnalysesP. Hamburg

Sample PreparationJ. Collins

Radiological PreparationR. Patterson

QA/QCC. Scarpellino

Envi ronmental ProgramsR. Mannz

Radiological Programs-P. Kelly

DOD ProgramsM. Martin

Radiological AnalysesE. Holland

o Quality Assurance Manager,Mr. Christopher D. Scarpellino serves as the QualityAssurance Manager. A rigorous QA/QC program has beenimplemented at metaTRACE. Mr* Scarpellino manages andmonitors this program, directs the production of Laboratoryand Project QA Plans, and.administers the various Federal andState laboratory certification programs.

o Environmental Programs. Mr. Richard H. Mannz is theEnvironmental program Manager and is responsible for managingenvironmental projects for which chemical analyticalrequirements predominate.

,-.."• . . ,. ^ -, \ .,„„„., „. . - . - . . . . - ,. . . -,. -o Radiological Programs* Mr. Patrick Kelly is the

Radiological Program Manager and is responsible for managingprojects that have a large radiological analyticalrequirement.

o DOD Programs. Ms. Marleah M. Martin serves as theDepartment of Defense Program Manager and is responsible formanaging military projects and programs, including the U.S.Army Toxic and Hazardous Materials Agency (USATHAKA) ContractLaboratory Analytical Support Services (CLASS) Program.

4. Laboratory Operations ManagementMr. Ross K. Robeson, Vice President, is the LaboratoryOperations Manager. All laboratory production functions areunder his direct control and supervision. He is responsiblefor the timely production of quality analytical results.There are five key laboratory operational functions under hismanagement control, each managed by an experienced technicalsupervisor. These are:

* • • "•• .-"," -:' It t-rj1? '•.. - : - -•• : - • " . • • : , • _ to organic Analysis. Mr Harry M. Borg is the supervisor of

the Organic Analysis Department. He is responsible forscheduling and reviewing all analyses performed by GasChromatography (GC), GC/Hase Spectrometry, High-performanceLiquid Chromatography (HPLC), andIon Chromatography (1C).

ji-.f.f? ffv::;;. f •• •-. - ^ , - , - , . . - • . • i •-o Inorganic Analysis. ,Mr. Paul B. Hamburg is the

supervisor of the Inorganic Analysis Department. He isresponsible for scheduling ahd reviewing all AtomicAbsorption (AA) and Emission Spectroscopy and InductivelyCoupled .Argon Plasma (ICAP) Atomic Emission Spectrometry andmiscellaneous inorganic methods.

o -Sample Preparation/, Mr. John E. Coll ins is the .supervisor of 'the Sample-Preparation Department. He isresponsible for both inorganic and organic sample preparationfor low, medium and high-hazard samples, excluding .radiological preparations.

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1

o Radiological Preparation. Ms. Roxanne Patterson is thesupervisor of the Radiological Preparation Department. Sheis responsible for scheduling and reviewing the analyticalresults from all radiological sample preparation.

o Radiological Analysis* Ms. Elaine M. Holland is thesupervisor of the Radiological Analysis Department. She isresponsible for scheduling and reviewing the results ofalpha, beta and gamma counting and spectrometry.

Personnel

Resumes of key staff members are included as Appendix A.

Quality Assurance Responsibilities

Procedures for recording and reviewing data at several levelsare employed to minimize human'and automated data handlingerrors. •'• ' • - \'-[ ' ~. .''The flow diagram in Figure 2 defines the sequence of eventsduring a series of laboratory measurements, regardless of theanalytical technique employed. \ j

Laboratory Analyst

Data review and validation begins with the analyst performingthe analysis* The analyst is responsible for:

1.• Utilizing methodology without unauthorizedmodifications.

2. Meeting required QC criteria for any specified tuningand/or calibration requirements (go/no-go criteria).

3. Performing all sample analyses including methods blanks,check standards, replicates and spikes as specified bythe method or project QA Plan.

4. Verification and acceptable performance of samplespecific QC requirements (i.e., surrogate spikerecovery).• • •

5. Recording data in laboratory notebooks, data sheets, andsummary sheets (per Standard Operating Procedure f-G012).

6. A minimum of 10% of manual calculations should beindependently recalculated as an initial review.

7. Computer generated calculations should be reviewedinitially and spot checked to verify softwareperformance.* * ;

II flRUOOUSS

Figure 2. Internal metaTRACE Quality Review Flowchart

Project Administration/Client Initiation <(QA/QC Criteria)

" •-"" ' , , - • <'<"..:J4vO. ' - • - . - . . . . - - • ' • - ' - • •Operator inputs < ——————————— •-,

- -.*[..-. • ' ' ' I^ Laboratory Analyst

(Performs and/or reviews timing/ tuning/ baseline/calibration/ standards/ replicates/ spikes/

blanks and 'surrogates)

In ,ControJ?-;—no———reanalyze—•

lyes

Analyst's. . . . , Report; = ' - ' ' • - - . ! •

* l - • „"• * ", ''" i"' ' ..

Supervisor-^ ——————(Reviews reporh for completeness

QC compliance)' - ' ' • •

Report Complete no1——————-—no-—————and Compliant? •———————> Quality

•-!.;;( .'-J (problem) Assurance„ : (yes I Manager

I I A

Data Review/Validation<—————(Raw data review) t'.(Final data review)

Complete andf——————Compl ian t ?no

lyes

^Complete and yesCompliant? •————•

II noI

Information Systems—"1 I^ |i———————...—i

Laboratory Supervisor \ J1| The laboratory supervisor is responsible for the review and

validation of data generated by his/her laboratory componentsof the data include:

' 1. Verification of operational parameters such as GCconditions, etc. as required by the specific method

] * employed.. •| 2. Review of tuning and/or calibration data to verify

method specific acceptance criteria.-| 3. Review of method specific QC data such as surrogatej spike recoveries, duplicate precision, spike recoveries,

and QC control limits.4. Review of method specific identification criteria

'j " f> such as mass spectra or retention times.I 5. Hand calculations of manual and computer generated

calculations.|I Data Review/Validation Group

I The data review/validation group is independent of the1 operations portion of the laboratory and is responsible for:

1. Screening all data to ensure that the appropriate .QCprocedures and criteria wererused. •

t 2. Review of method specific identification criteriasuch as mass spectra or retention times..

i 3. Hand calculations of manual and computer generated| calculations.

4. Providing summary information to the QA Manager to-. obtain approval for the Information Systems group toi begin automated generation of the requisite report

forms.5. Review of the final data package to ensure its accuracy

1 and completeness prior to delivery to projecti administration and the client.

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section 2.,'-PERSONNEL TRAINING

The objectives of QA training are to make metaTRACE'spersonnel aware of the importance of quality assurance and toinform them of the overall QA Program and their personal partin it. The significance of each person's job and performanceis emphasized to foster personal involvement in the Program.

Employees are trained in their job operations so they canapply QC procedures to a sound base. Sampling and analysisprograms involve complex technical procedures and precisefollowing of directions, so special attention is given toon-the-job training for hew employees, or to a staff memberworking with a procedure for the first time. The employeefirst studies the written technical procedures, performs theoperations under the direct supervision of an experiencedstaff member and then, if appropriate, uses a standard orother QC sample to test his Biastery of the procedure. Theemployee is told the results of the QC checks to help improvehis performance, if necessary, and to develop a positiveattitude on his part. In most cases, excellent results arequickly obtained and the employee takes pride in knowing heis performing well. ' ^ - - ~• • - • . ' • • ;* at[ " '* • i J . '

The Standard Operating Procedures are an important tool inthis training, providing both an overview of policy and .specific procedures to be followed. The QA Manager works tohave all staff members follow these procedures. Currentprocedure write ups are used,to avoid word-of-mouth transferof incorrect technical instructions. metaTRACE's QA Managerprovides continuing information on quality assuranceactivities to all staff; technical seminars and trainingsessions are scheduled as appropriate.

The metaTRACE SOPs relating to personnel training .areincluded as Appendix B. j^,; . . *• r. . ' f r ". • .'•'" "'i-i-...1!' i.'.----••-• v •

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Section 3. SAMPLING, RECEIPT, STORAGE, AMD-, CHAIN-OF-COSTODYi

i The purpose of chain-of-custody procedures is to document the1 identity of the sample and its handling from its first> existence as a sample .until analysis and data reduction are

completed. Custody records trace a sample froa itsi collection through all transfers of custody until it is

transferred to the analytical laboratory. Internallaboratory records- then document the custody of the samplethrough its final disposition.

i " - - .Field sampling Operations

1 The metaTRACE QA Manager and/or Project Manager coordinatewith the field sampling crew to assure that standard methodsof collection are being implemented. This includes the

i appropriate sample containers, preparation and preservationof all samples along with any specific quality controlrequirements. - Chain-of-custody procedures related to sampleswhich are collected for laboratory analysis -will be initiatedby the field crew. Documents specifically prepared for suchpurposes will be used for recording pertinent informationabout the types and numbers of samples collected and shippedfor analysis. The purpose of these procedures is to documentthe identity of each sample and its handling, from its firstexistence as a sample until all laboratory analyses have beencompleted and, if appropriate, the information derived fromthe sample that has been introduced as evidence inlitigation. The SOPs maintained by metaTRACE, included inAppendix C, discuss this in greater detail.

Laboratory Operations

An overriding consideration for process evaluation data isthe ability to demonstrate that samples have been obtained 'from the locations stated and that they have reached thelaboratory without alteration. Evidence of collection,shipment, laboratory receipt and custody until disposal mustbe documented. Documentation is accomplished through achain-of-custody record that records each sample and theindividuals responsible for collection, shipment and receipt.A sample is considered in custody if it is in a person'sactual possession; in view after being in physicalpossession; locked so that no one can tamper with It afterhaving been in physical custody; and/or in a secured area,restricted to authorized personnel. Samples are packaged toprevent breakage or leakage, and labeled according to DOTregulations for transport by surface or air as labor$£j&£samples. Storage of samples by the laboratory will be under . iconditions specified for the analyses to be performed. All -srsamples submitted to the metaTRACE laboratory are brought tothe Sample Custodian who establishes or continues the

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RESPONSE MEASURES WORK PLAN VOLUME II

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