Lancaster Laboratoriesoff )WPC)RATF f>

Woodward-Clyde Consultants pEASTERN REGION

5I2O BUTLER PIKEPLYMOUTH MEETING

PENNSYLVANIA 19462

SUPPLEMENT TOQUALITY ASSURANCE PROJECT PLANRI/FS WORK PLANDU PONT - NEWPORT SITENEWPORT, DELAWARESEPTEMBER 7, 1989

VOLUME III

1989QUALIFICATION MANUAL

2425 New Holland Pike, Lancaster, PA 17601 - 5994(717) 656 - 2301

TABLE OF CONTENTS1989 EDITION-

JANUARY PRINTING

I. INTRODUCTION

Description of Company 1-1Company History 1-1Geographical Area Served 1-2Ownership 1-2Board of Directors 1-2Consultants 1-2

II. ORGANIZATIONAL STRUCTURE

Technical Divisions II-1Support Services II-4

III. PHYSICAL FACILITIES & INSTRUMENTATION

Buildings III-lInstrumentation HI-2Computer Equipment III-7Vehicle Fleet III-8

IV. QUALITY ASSURANCE PROGRAM

Objectives IV-1QA Standard Operating Procedures IV-2Accountability IV-6Quality Control IV-8

V. TECHNICAL OPERATIONS

Standard Testing:Work Flow Routing V-2Reporting of Results V-2Client Access System V-3Billing V-3

Specialized Testing:Work Flow Routing 'V-4Reporting V-4Billing V-4

Contract Research & Development:Reporting V-6Billing V-6

VI. TECHNICAL DIVISIONS

Environmental Sciences DivisionOrganic Analysis Group VI-1Pesticides and PCBs Group VI-2Inorganic Analysis Group VI-3Gas Chromatography/Mass Spectroscopy Group VI-4Water Quality Group VI-5

Health Sciences DivisionFood Chemistry Group VI-7Food Microbiology Group VI-8Bioassays Group VI-11Pharmaceutical Group VI-12Industrial Hygiene Group VI-13

Second and Third 'Shifts VI-15

VII. SUPPORT SERVICES

Finance/Data Processing VII-1Human Resources VII-1Physical Services VII-1Sample Administration/Transportation VII-2Marketing VII-2Technical Service Specialists VII-3Data Package Group VII-3

VIII. ACCREDITATION, CERTIFICATIONS & REGISTRATIONS

Company Memberships VIII-2Staff Memberships VIII-3

APPENDIX A - Standard Terms and Conditions

APPENDIX B - Analysis Summary Sheet

APPENDIX C - Resumes of Key Personnel

IINTRODUCTION

This manual provides a detailed picture of Lancaster Laboratories, Inc. withspecial emphasis on our personnel, physical facilities, instrumentation and qualit-,assurance programs. It allows the reader to appraise our ability to provide thosetechnical services which we offer. The best way for a prospective client to judgeour capabilities is by a personal visit. However, if limitations of time and

geographical distance preclude such a visit, we hope this manual will prove anadequate substitute.

A. DESCRIPTION OF COMPANY

Lancaster Laboratories, Inc. is an independent company offering high qualitytechnical services in the chemical and biological sciences with personal attentionto client needs. These services include chemical analyses, microbiological

testing, contract research and development, and consulting. The firm is aprivately held corporation and is not a subsidiary of another company. It is,therefore, an independent, technical service company and does not manufacture or

distribute goods. Its "product" is accurate and timely technical information. Asa for-profit, taxpaying organization, its continued existence depends on thequality of the services it offers and the efficiency with which it delivers them.

B. COMPANY HISTORY

The firm was founded in 1961 by Dr. Earl H. Hess (its current president) inresponse to a perceived need for high quality technical services by theagricultural and industrial community in Southeastern Pennsylvania. Initial staffconsisted of Dr. Hess, one technician, and Mrs. Hess as a part-time secretary andbookkeeper. The organization reached its present size of over 280 persons throughcontinual growth, which has required eight expansions of the physical plant. In1985, the technical departments were split into two divisions, EnvironmentalSciences and Health Sciences. '

HR30SU8

1-2

C. GEOGRAPHICAL AREA SERVED

Our clientele ranges over the entire conterminous United States and beyond,into South and Central America, and Europe. Although the majority of our clients

are in the Middle Atlantic states, the advent of overnight deliveries allows us tooffer prompt service to the entire country. Our clients include privateindividuals, private business enterprises of all sizes, trade associations,universities and colleges, and federal, state, and local government organizations.

D. OWNERSHIP

The company is incorporated under the laws of the Commonwealth of Pennsylvaniaand is operated as a closed corporation. Earl H. Hess, founder, is the largest

stockholder; all .other stock is held by family members and key employees.

Lancaster Laboratories holds equi.y in two joint ventures with the ERM Group.One is Mountain States Analytical in Salt Lake City, UT, in which the partners areERM, Inc. and ERM-Rocky Mountain. The other is Gulf States Analytical in Houston.TX, in which the partner is ERM-Southwest.

1. Board of Directors

The Board of Directors of the corporation consists of the following members:

Earl H. Hess, Ph.D., PresidentFred R. Albright, Ph.D., Senior Vice PresidentKenneth E. Hess, B.S., Vice President, TreasurerCarol D. Miller, M.B.A., Vice President, SecretaryJ. Wilson Hershey, Ph.D., Vice PresidentGlenn M. Cahilly, Ph.D., Vice PresidentChristoph J. Grundraann, Ph.D., Board Member Emeritus

2. Consultants

The following are consultants retained by the corporation:

Christoph J. Grundmann, Ph.D.James D. Glasse, D.D.

IIORGANIZATIONAL STRUCTURE

The organizational structure of the company is shown on the organization chartsI - - _ - -

on pages II-6 - II-9. There are two technical divisions and one support servicedivision.

Although many additional employees, including technicians and laboratoryassistants, work in our laboratory, the following is a list of all technical ar.dsupport service personnel with whom clients are likely to have contact. Resumes of

key technical personnel can be found in the Appendix.

A. TECHNICAL DIVISIONS

1. Health Sciences Division

Fred R. Albright, Ph.D., 'Director

a. Food Chemistry Group

David V. Schumacher, B.S., Senior Chemist 7Gloria A. Gates, B.S., Chemist IISandy Bailey, B.S., Chemist INoreen Curristen, B.S., Chemist IWanda Graham, B.A., Chemist IVictoria Pillion, B.S., Chemist ITammy L. Showers, B.S., Chemist IRichard Hartz, Associate ChemistGordon Beitzel, B.S. Systems Associate

b. Food Microbiology Group

Martha M. Klenk, B.S., Group Leader IIValerie J. St.Clair, B.S., Microbiologist IVLisa E. Miller, B.S., Microbiologist I, Coordinator

c. Bioassay Group

Mark W. Kaiser, Group Leader IIC. Robert Graham, B.S., Senior MicrobiologistEarl R. Custer, B.S., Microbiologist IIIAnne L. Jacobson, B.S., Microbiologist I, CoordinatorMike Yunginger, B.S., Microbiologist I

II-2

d. Industrial Hygiene Group

Jack T. Follweiler, B.S., Group Leader IPatrick C. Weidinger, B.S., Industrial Hygienst II, CoordinatorGordon A. Lodde, B.S., Industrial Hygienist IRuth Hagen, B.S., Associate Industrial Hygienist,

Coordinator Laboratory ServicesMary McGee, B.S., Associate Industrial HygienistScott Sharp, B.S., Associate Industrial HygienistPaul Swarm, B.S., Associate Industrial Hygienist

e. Pharmaceuticals Group

Joe Friel, B.S., Senior ChemistJohn Kenna, B.S., Chemist I

Environmental Sciences Division

J. Wilson Hershey, Ph.D., DirectorRichard M. Burke, M.S. Assistant to the Division Director

a. Org-nic Analysis Group

Richard C. Entz, B.A., Group Leader IIDelwyn K. Schumacher, B.S., Chemist IV, CoordinatorDennis Urban, M.S., Chemist III, CoordinatorJudy Colello, Associate ChemistMary Lou Eckels, B.A., Associate ChemistSue Kreider, Associate ChemistSandy Patton, B.S. Associate ChemistJeff Schlegelmilch, B.S., Associate ChemistLivonia W. Smith, B.S., Associate ChemistChris Sweigart, B.S., Associate ChemistMelissa Yanchuck, B.S., Associate Chemist

b. Pesticide/PCB Group

Charles J. Neslund, B.S., Group Leader IJenifer E. Hess, B.S., Chemist II, CoordinatorNancy Saunders, B.S., Chemist ITamra L. Sprout, B.S., Chemist IGreg Beard, B.S., Associate ChemistGregory France, B.S., Associate ChemistCharlene Hinish, B.S., Associate ChemistSeth Kensinger, B.S., Associate Chemist

c. Water Quality Group

Elizabeth A. White, Group Leader IIBob Heisey, B.S., Chemist IJohn A. Layman, Associate ChemistMark A. Clark, B.S., Associate Chemist AR305I5I

d. Inorganic Analysis Group

Lee A. Seats, B.S., ManagerBetsy S. Menefee, B.S., Chemi-sf II, CoordinatorDebora K. Gifford, B.S., Chemist II, CoordinatorEric W. Cuba, B.S., Chemist I'Beatrice M. Joseph, B.S., Chemist I '•.Max Snavely, B.S., Chemist IKelly Banazewski, B.S. Associate ChemistDavid Hawk, B.S., Associate ChemistMichael Hintenach, B.S., Associate ChemistJim Kushubar, Associate ChemistDonna R. Sackett, Associate ChemistSusan Shorter, B.S., Associate ChemistCindy Smith, B.S., Associate ChemistRobert Stauffer, B.S., Integration Systems Specialist II

e. Instrumental 1C, TOC

Ramona Wendt, B.S., Chemist II, CoordinatorTerry Schuck, B.S., Chemist IMary Dormer, B'.S., Associate ChemistRobin Mock, B.S., Associate ChemistNancy Wagner, B.S., Associate ChemistDavid Wright, B.S., Associate Chemist

f. GC/MS Group

Nelson H. Risser, B.A., ManagerTim Oostdyk, B.A., Group Leader II, GC/MS VolatilesRichard S. Rodgers, B.S., Group Leader II, GC/MS ExtractablesJohn Snyder, M.S., Chemist IVBryan Winship, B.S., Chemist IVChristine Brennian, B.S., Chemist IIJohn Morton, M.S., Chemist IIRosemary Yovic, B.S., Chemist IIMichelle Droney, B.A., Chemist IRobin Eaton, M.S., Chemist ILes Erb, Chemist ICheryl Matias, B.S., Chemist IKaren Barney, B.S., Associate ChemistSusan Croyle, B.S., Associate ChemistJanet Culbertson, B.S., Associate ChemistDave Hoppman, Associate ChemistChristine Kelly, B.S., Associate ChemistRobert Mellinger, B.S., Associate ChemistRichard Reed, Associate ChemistTina Thoman, B.S., Associate ChemistLynn Wallace, B.S., Associate ChemistKevin Witman, B.S., Associate Chemist

68305152

II-4

B. SUPPORT SERVICES

Glenn M. Cahilly, Ph.D., Director

1. Corporate Services

Earl H. Hess, Ph.D., President, CEOAnne V. Osborn, M.A., Assistant to the PresidentGerry Hershey, Administrative AssistantLaima Reidenbach, Executive Secretary

I 5

M O

"> ^ti ta

tl Z*rfeI 'i_ uo eU lu

i

itV) «

4i

(fl —(rt 1

= CV

1 *O I_l 1bx e

I

*. I

e i1 '> .

(c< 4

l»!

Ic

«1I

3iJ

S

§Su.;

arf

^

SrfA

A

C

. u I

X O Kl— "X t)

i I JUl U!

O

UII1.

a 6 >

£ tl M... a. o—, 0 —

* fe fu. </> Z

.• «

u.- 1 1 :ti «• » -1 1 1- i. J5ae u vi >•

vi ti• u

«T >. 5in wz £ "

C

C II tl

S '1 i

tiuu

u u .5

S S £S « ••"w *"• £ S5 S 1

4 U

X (A4>• oc

M!Q U Oa »o ti t>t- u uu > a

S « ,

! « ,- - i

«tl

M —«

1

ss sS i £u 5 S

f «i 1 5e a. </>z • (- ti*: g

i > X* .2 rL. C IIu. VI Z

tlU

tl

V) B 'U

". I— tl

1 1a u —ti ~tilac x X

g

I !

'aL. U

U s

11V," >. '

•g t I— i L.)tf tl U

(0 b. OX 0 u.

2T :

! 1 iS 6(9 u.

-

b.

•- tl >.

^ a. S||§x u a

1/1

u •" p*

i I x= 110 b•s 1 1s s S 1

RR305I56

II-3

IO M

ij != iu £i f3 ^

_ I

gtl)'>

• O•= fe «f<- IIi! £* i» 5

X *£ CA

2 ? -5 1 2

' s I1 > UJ

• ** *tl U" fc i

fe*rfi)* i:!

u 5 1 ————

! 4 \-o SU *rf *

52 fe.- S 8« * ...

i|tc * oz x u

t> —** ••X

5L. to*

* --e « SS " *•8 a. uw 5 ti= S Suj <j a

vjM

1-S— 1- •*

Charles

He<

Gr<X4> Lead)

Pesticides

<a• IA

i = tUJ U —-u"O -J U

^ Hu S o»— 1. 1_•e ca o

VI

» 8u¥ '-^ b. IfTs 5 </>S 1 -II ••O -i u

^ 1^u o u— L. S•e (J >-

<

5=15 H -i!*Ill» u 3

VI« M• t>.*- i1:5f | i"82^ -j1 |S£Ji 2 SK 0 O

88305157

! 8

-

i- o cJ 8- -5•5 S 5- L. Oor *- u

1+t

J 1!OB — M

U t) •- <± i < .— ti <* « •15 If— u i•e u vi •

uCA3 91• c E ••

VI •- — ••« ^ if> <•• i £ ««• J g 1II — Ck (Z <l> (

" o. eC u T3 "i ; i i

z

5'•* •e T•" i.

oi 11- 0

VJ--DU<!9

ij

*

S3

1

L

_

C/l *•*• (A

* 51 *

Thomas Wo

Account trx

o• ttf JX I "lU t| 9•s I "§ S bZ _l «

*

2 y 5> 5fl U ZO O L

•)If

ir

;»

Jii

£• ^ '«) a o • iL, 3 ^

^ « S :

!l! ICD V) (J |

M iS t i

X

S .i !b. U*- V) I«• 1

c ~ a '*5 *- & iti < « I c 'u c 5 5(0 01 ••- O • —a — 13 i- «a L. •» —.0 e o > >u S 5 c -

i§

. g 3VI — >oo c ouen ui tien — — u<o c COB IE 0 —V « It VI

1 f 1 £— Q. b. — •u F p (0 iX V) U Z

Gterm Cahilly. Ph.D.

Vice President/Director

Support

Services

Div

isio

n

* K «jC L. 4V fak*- o. cg g;si t > l €

Gerald Clipper

Plant Engineer

Manager

Physical S

ervices

Carol D.

Miller, N.B.A.

Vice President/

Director Hunan Resources

David Hooley, Ph.D.

Group Leader

1

Computer Services

Barry Gehnum

Coordinator

1General

Maintenance

Margaret S

toltzfus

Coordinator

IIHuman Resources

Lorraine Heagy

Group Leader

1Of

fice Support S

ervices

RR305I58

Ill

PHYSICAL FACILITIES AND INSTRUMENTATION

A. BUILDINGS

The physical facility is located on a four-acre lot on Pennsylvania Route 23(2425 New Holland Pike) about five miles northeast of the City of Lancaster, PA.In addition to a major building complex, there are three auxiliary buildingshousing a general maintenance shop, auto maintenance and storage areas; two solventstorage sheds located at some distance from the other buildings; and waste storagefacilities.

The main building complex has a total area of 68,000 square feet includinglaboratories, offices, refrigerated and room-temperature sample storage, library,data processing center, employees' lunch room, conference rooms and garage area.The facility has undergone eight expansions to accomodate our growing staff. Inaddition to the main facility, our Industrial Hygiene Group occupies 3,000 squarefeet in a nearby industrial park. The air-handling system for the main laboratoryis specially designed to protect sensitive instruments from harmful vapors and toensure that samples are not contaminated. In addition, sample preparations andinstrumental analyses are performed in separate rooms. The building is protectedby a sophisticated fire alarm system. All outside doors, except the main entranceare kept locked at all times to prevent unauthorized entry. Employees are issuedcards which allow them to enter the building, and the main entrance is monitored byan attendant who registers visitors during normal business hours. During weekendsand second and third shift operations, all doors are locked and a security guard ison duty to prevent unauthorized entry into the laboratory and accept packages.

*8305!59

B. INSTRUMENTATION

"LLI Group" indicates the technical group withmajor responsibility for the instrument.

No. ofInstrument Units. Manufacturer/Model No. LLI Group

Gas Chromatography:

Gas Chromatograph/ 2 Finnigan OWA 1020 with GC/MSMass Spectrometers (GC/MS) 1050 software upgrade(With: electron impactor chemical ionization,32 MB disk drive, capillaryor packed column, oscilloscopetuning, purge and trapconcentrators, 9-tracktape drive)

Gas Chromatograph/ 1 Finnigan INCOS 50 GC/MSMass Spectrometer (GC/MS)Electron impact ionizationwith purge and trap concentrator

GC/MSD* 8 Hewlett-Packard 5970B GC/MS(With: RTE6-VM operatingsystem on HP-1000 computer,9-track magnetic tape drive,132 MB disk drive, and 2 withpurge and trap)

Gas Chromatograph*"1" 11 Varian 3700 Organic Analysis(4 have capillary Pesticides/PCBsGC capability) Food Chemistry

Gas Chromatograph** 2 Varian 6000 Organic Analysis(1 has capillary Pesticides/PCBsGC capability)

Gas Chromatograph*"*" 8 Hewlett-Packard 5890 Organic Analysis(2 have capillary GC/MSGC capability) Pesticides/PCBs

Gas Chromatograph"'' 6 Tracer 540 Organic Analysis

Gas Chromatograph*"*' 1 Shimadzu ISA Pharmaceuticals

Auxiliary Equipment for Gas Chroma re-graphs:

Purge and Trap 3 Tekmar LSC-2 Organic AnalysisConcentrator

Purge and Trap 6 Tekmar 4000Concentrator(one with autosampler)

flR805i60

Instrument Units Manufacturer/Model No. LLI Croup

Headspace Sampler 1 Hewlett-Packard 19395A GC/MS

Thermal Desorber for 1 Tekmar 5010 Organic AnalysisTenax Tubes

Detectors available for GC: Electron Capture, Flame Ionization, Photoionization. HallElectrolytic Conductivity, Nitrogen/Phosphorus, Thermal Conductivity, and FlamePhotometric

All of the chromatographs are attached to electronic integration systems. The largestsystem employed is an HP1000 computer with LAS software.

High Performance Liquid Chromatography:

High Performance 8 Shimadzu LC-6A Food ChemistryLiquid Chromatograph*"1" Pesticides/PCBs

Pharmaceuticals

High Performance 1 Varian 5010 PharmaceuticalsLiquid Chromatograph*+

Auxiliary Equipment for High Performance Liquid Chromatography:

Post Column 1 Kratos PCR 520 Pesticides/PCBsDerivatization Unit SF-980, SF-400

Detectors availably for HPLC: Refractive Index, Ultraviolet, and Fluorescence

Atomic Absorption/Emission Spectrophotometry:

Inductively Coupled 1 Thermo Jarrell-Ash Inorganic AnalysisArgon Plasma ICAP 61Spectrometer*"1"

Inductively Coupled 1 Thermo Jarrell-Ash 1100 Inorganic AnalysisArgon PlasmaSpectrometer*"*"

Atomic Absorption 1 Perkin-Elmer 5000 Inorganic AnalysisSpectrophotometer*

Atomic Absorption 1 Varian SpectrAAlO Inorganic AnalysisSpectrophotometer

Atomic Absorption 1 Varian SpectrAA40 Inorganic AnalysisSpectrophotometer"1"

Atomic Absorption 1 Varian SpectrAA400 Zeeman Inorganic AnalysisSpectrophotometer"1"

Atomic Absorption 1 Shimadzu AA-670 ft R ,jO>S dhWnlstrySpectrophotometer*

HI-4

No. ofInstrument Units. Manufacturer/Model No. LLI Group

Mercury Analyzer 1 Spectro Products Hg4 Inorganic Analysi

Graphite Furnace* 2 Varian GTA-96 Inorganic Analysis

Molecular Absorption/Emission Spectrophotometry:

Fourier Transform Infrared 1 Perkin-Elmer 1610 Organic AnalysisSpectrophotometer Water Quality

Scanning UV/Visible 1 Bausch & Lomb Water QualitySpectrophotometer Spectronic 2000

Scanning UV/Visible 1 Perkin-Elmer Lambda 3B PharmaceuticalsSpectrophotometer

Visible 3 Turner Instruments 330 Water QualitySpectrophotometer Food Chemistry

Bioassays

Nephelometer 1 Monitek 21 Water Quality

Fluorometer 1 Turner Instruments 110 Food Chemistry

Spectrofluorophotometer*"*" 1 Shimadzu RF540 Food Chemistry

Microscopes:

Petrographic 2 Olympus BH-2 Industrial HygieneMicroscope with PhaseContrast, PolarizedLight andPhotomicrographicCapability

Polarizing and Phase 1 American Optical 120 Industrial HygieneContrast Microscope

Stereo Microscope 2 American Optical 570 Food Microbiology

Stereo Microscope 1 American Optical 2071 Food Microbiologywith FluorescentAntibody Attachment

Stereo Microscope 1 American Optical Spencer Industrial Hygiene

Miscellaneous Instrumentation:

Ion Chromatograph*"*" 1 Dionex 2010 Water Quality

Total Organic Carbon 2 O.I. Corp. 700 Water QualityAnalyzer*

AR3G5162

No. of .Instrument Units Manufacturer/Model No. LLI Group

Total Organic '2 Mitsubishi TOX-10 Water QualityHalogen Analyzer

Autoanalyzer* 2 Technicon AA-2 Water Quality

Autoanalyzer*"1" 3 Scientific Instrument Food Cherr.istrvAP-100, AS-140,AC-100, AF-100

Viscosimeter 1 Brookfield LVT Organic Analysis

Refractometer 1 Bausch & Lomb Pharmaceuticals

Closed Cup Flashpoint 1 Fisher Scientific TA6 Water QualityApparatus, Pensky-Martin

Bomb Calorimeter 1 Parr 1241 Water Quality

Flow Proportional 5 ISCO 1580 Water QualityComposite WaterSampler

Flow Proportional - 1 ISCO 1680 Water QualityComposite WaterSampler

Antibiotic Zone 2 Fisher Scientific 126 BioassaysReader

Freeze Dryer . 1 Virtis B3 Bioassays

Wellcutter for Antibiotic • 1 Purdue BioassaysAssay

Fibertec E with Bath 1 Tecator 1023, 1024 Food Chemistry

Fibertec 1 Tecator TC-1020 Food Chemistry

Soxtec 1 Tecator 1043 Food Chemistry

Gene-Trak Detection System 1 Gene-Trak Food Microbiology

Zero Headspace Extractor 5 Associated Design 3740 Water Quality

Zero Headspace Extractor 1 Millipore SD1 Water Quality

Oxygen and Combustible 1 Bacharach Sniffer 202 Industrial HygieneGas Meter

Sound Level Meter 1 DuPont SCM-1 ' '. Industrial Hygier.e

Hot Wire Anemometer 1 Datametrics 800VTP-2 Ind

III-6

No. ofInstrument Units Manufacturer/Model No. LLI Group

Velometer 1 Alnor Series 6000 Industrial Hy

Oxygen Analyzer 1 Biomarine Industrial Hygier.e

Personal Sampling Pump 6 Bendix BDX44 Industrial Hygier.e

Personal Sampling Pump 5 SKC 224-175D Industrial Hygiene

Personal Sampling Pump 10 SKC 224-PCXR3 Industrial Hygier.e

Personal Sampling Pump 2 Bendix BDX74 Industrial Hygiene

High Volume Air 20 Micro Trap, Inc. Industrial HygieneSampling Pump Micro-max I

Fibrous Aerosol Monitor 1 GCA FAM-1 Industrial Hygiene

Dissolution System 1 Van-Kel 600 Pharmaceuticals(6 spindle)

Dissolution System 3 Hanson QC72RB Pharmaceuticals(6 spindle)

Disintegration Apparatus 1 Van-Kel 1113 Pharmaceuticals

Hardness Test Apparatus 1 Vector 2E Pharmaceuticals

Friabilator/Counter 1 Van-Kel 10809 Pharmaceuticals

Laser Barcode Scanner 1 Intermec 12-MI620A SampleAdministration

* Indicates autosampler capability

**" Indicates peripheral data handling equipment

The previous list shows our major instrumentation or instruments which demonstratespecific capabilities. In addition, we have numerous minor instruments (e.g., pH metersand analytical balances), and support equipment (e.g., ovens, centrifuges, incubators,autoclaves, muffle furnaces, etc.). We also have walk-in refrigerators for samplestorage and a reverse osmosis, deionized water system, which is U.V. sterilized andcontinuously circulating to all laboratories. A 20 KW electric generator is availableon a standby basis to supply electrical power to selected areas of the laboratory incase of a power outage. To reduce spikes and spurious line voltage changes toinstruments which can affect results or damage electronic equipment, "conditioned power"is fed to all sensitive instruments (e.g., GCs, HPLCs, GC/MSs). In aj|dlt!lg>in-allessential computer hardware is on "uninterruptable power", a battery syi ira wHiottyprovides continuous conditioned power in the event of a short power outage.

C. COMPUTER EQUIPMENT

Our laboratories make extensive use of computers for both businessapplications, technical operations (e.g., our sample management svsiero), and QAprogram (see section on Quality Assurance). The following is a list of the majorcomponents of our computer system.

WANG VS 7310 Super Mini Computer System0 16 MB Ram0 >100 connected terminals0 1.36B On Line Disk0 6250 Bit/Inch Tape Drive

° 8 Printers including 26 page/minute Laser

WANG VS 65 Super Mini Computer System0 2 MB Ram0 400 MB of Disk

WANGNET Broadband Local Area Network

MITEL SX 1002 Voice/Data PBX° 65 Data ports in use

35 IBM Compatible PC (XT clones)

30 WANG 240 PC (AT clones)

10 KVA 3 Phase Uninterrupted Power System0 Dedicated to Computer Systems only

flR305!65

HI-8

D. VEHICLE FLEET

Sample pick-up service is offered to all clients within reasonable drivingdistance of our laboratories. We currently offer this service to clients inLancaster County, York County, Philadelphia, Reading, Allentown/Bethlehem/Easton

areas; New Castle County, DE; and Camden and Burlington Counties, NJ, from ourLancaster location. We maintain a fleet of sedans, station wagons, vans, andtrucks for sample pick-up service, field operations in industrial hygiene atclients' plants and other locations, wastewater sampling, and general use by ourprofessional staff. Most of these vehicles are equipped for communication betweenmobile personnel and home base. Our drivers are trained in proper sample handling

and custody procedures, so that sample integrity is maintained during transport.

A830SI66

IV

QUALITY ASSURANCE PROGRAM

The major function of an independent laboratory in today's society is togenerate technical information. In our case, the information consists of theresults of chemical analyses and microbiological' tests, along with whateverauxiliary information is necessary for proper interpretation, and research reports.

The uses to which this information is put by our clients are many and varied.It may be used to demonstrate compliance with a government regulation; to evaluatea raw material for a manufacturer or food processor; to demonstrate value or.quality of a finished product,-as in nutritional analyses; to establish the basisfor a patent; or to decide a legal dispute. This information has a high andintrinsic value over and above the cost of providing it to a client. Since thisinformation is important to our clients, it is necessary to produce it under aprogram which will assure that it has the necessary "quality," i.e., that it has adegree of accuracy commensurate with its intended use. This section of the manualwill describe the Quality Assurance Program under which we operate. Detailsrelating to specific types of technical operations will be found in the sectionsdealing with the various technical groups.

A. OBJECTIVES OF THE QUALITY ASSURANCE PROGRAM

The objectives of our Quality Assurance Program, as directed by CorporateManagement are:

° To establish quality control procedures which will ensure that datagenerated in the laboratory are within acceptable limits of precision andaccuracy.

° To establish procedures to document that these quality control measuresare, in fact, being carried out.

0 To establish procedures to ensure the "accountability" of the data, i.e.,that the results reported do apply to the sample as submitted. »nQfm I

IV-2

° To establish procedures to ensure that any result reported to a client istraceable to:

The date the analysis was run

The analyst who performed the test

The raw data generated during the performance of the test

The condition of any instrument or equipment at the time ic was usedin the test

The status of the quality control system at the time of the test

° To establish procedures which minimize the possibility of loss, damage ortampering with the data.

The adainistration of our Quality Assurance Program is the responsibility ofthe Quality Assurance Director in cooperation with the Division Directors and GroupLeaders. The Quality Assurance Director reports directly to the President, thusensuring that corrective-actions-can be taken immediately for any qualityproblems. The Quality Assurance Director does not have any direct supervisoryresponsibility for the generation of technical data to avoid any "conflict ofinterest" which could interfere with the Quality Assurance Program.

The formal structure of our Quality Assurance Program is described in a set ofStandard Operating Procedures (SOPs). Copies of these SOPs are given to each GroupLeader and they are available to all laboratory personnel. The following is a listof our current Quality Assurance (QA) SOPs, with a brief description of each.

QA-101 Sample Collection - In order for meaningful analytical data to beproduced, the samples must be representative of the system from which theyare drawn. Our samplers are trained and use written sampling procedures.Sample containers ar« chosen according to the analyses to be performed andare labelled to fully identify each sample. Where necessary, chemicalpreservatives and temperature adjusted storage during transport to thelaboratory are employed.

QA-102 Sample Log-in - To ensure accountability of results, each sample isassigned a unique sample identification number as soon as possible afterits receipt at the laboratory. Information corresponding to sampleidentity is logged with this sample number. $R30^ I fi R

IV-3

QA-103 Sample Storage and Disposal • Because sample integrity can be compromisedby improper storage, samples are maintained in various locations toprevent deterioration. Locations are assigned in refrigerators, freezersand at room temperature to assure that the chemical, physical andbiological properties of samples do not change prior to analysis. Sample

locations are tracked by computer to prevent loss. After results arereported to clients, samples may be held for a period of time in caseadditional testing is required. Samples are then disposed of or returnedto the client.

QA-104 Chain-of-Custody Documentation - Samples being tested for litigation orregulatory purposes may require locked storage and documentation of thelaboratory personnel who used the sample as well as the times during which.the sample was .removed..from .locked .storage. Chain-of-custodydocumentation minimizes the possibility of tampering with the samples, andis available upon request.

QA-105 Analytical Methods Manual - The method manuals, which are comprised ofclear, complete written instructions for performing each standard test,are the basis for our analytical testing program. In addition to theactual procedure, each method includes safety and quality controlinformation. Every standard method is assigned a unique identificationnumber to ensure traceability. Copies of the methods are readilyavailable to analysts in the lab.

QA-106 Validation and Authorization of Analytical Methods - Although our routinetesting procedures are based on official or standard methods wheneverpossible, laboratory personnel must verify that acceptable precision andaccuracy are obtainable before management will approve the use of anymethod. Validation studies may include the use of standard referencematerials, fortified samples or replicate analyses.

QA-107 Analytical Methods for Non-standard Analyses - Frequently, clients requestanalyses which are not regularly performed in our laboratory although wehave the technical capabilities to do so. In these instances, methods maybe supplied by the client, dictated by regulations, de f Q er Jmj y ;?scientific literature or developed in the laboratory. In any case,

IV-4

special procedures must be followed to ensure that the method used isthoroughly documented. In addition, records of validation or qualitycontrol samples performed are maintained.

QA-108 Subcontracting - For the convenience of our clients, some analyses whichwe do not perform may be subcontracted to other laboratories. These

laboratories must submit evidence of their qualifications to us. Whereverpossible, laboratories certified by appropriate agencies will be used.

Results produced by subcontracted laboratories will always be designatedas such on our laboratory reports.

QA-109 Laboratory Notebooks - All data which are manually acquired in thelaboratory are entered into bound notebooks. Distribution of notebooks topersonnel is controlled, with a master file kept of the recipient of thenotebook, date issued, date returned and place of storage of completednotebooks. Personnel are instructed in the proper method of data entry.

All entries are made in ink, dated and signed. Blank pages or substantial

portions of pages are cancelled out. Periodic review and signing ofnotebooks by supervisors is also required.

QA-110 Reagents - Chemical and reagent quality will have a significant impact onour analytical results. Procedures for receiving, preparing, documentingand storing reagents have been set forth to ensure that only supplies ofadequate quality are used in our testing. Each analytical method containsspecifications for the required materials.

QA-111 Instrument and Equipment Calibration - All instruments and other equipmentare calibrated on a regular basis in accordance with written procedures,with frequency of calibration dependent on the type of instrument and itsfrequency of use. Acceptable limits of accuracy are also described in theprocedures.

QA-112 Instrument and Equipment Maintenance - All maintenance work done oninstruments and equipment is recorded in bound notebooks, with separatenotebooks kept for each instrument. Routine, preventive maintenance is

performed according to written procedures. "H-aUO I 70

IV-5

QA-113 Data Entry and Verification - In order to minimize errors, data reduction

and transcription is computerized wherever possible. Analysts responsiblefor the generation of data also have the responsibility to log their rawresults into the computer for reporting to clients. Results are thenreviewed by a supervisor or the supervisor's designee before reporting toclients.

QA-114 Data Storage and Security - The data generated in our laboratories is avaluable commodity, purchased by our clients. In order to providetraceability, data are stored in an orderly fashion under controlled accessso that loss, deterioration, or tampering is prevented. Copies of reportsand all supporting raw data will be maintained for ten years.

QA-115 .Quality Control.Records - The term "quality control" is used to denotethose laboratory procedures whose purpose is to ensure that the analytical

system is in control within established limits of accuracy and precision.Quality control procedures for each analysis are documented in the writtenmethod. Results of quality control analyses are subjected to statisticalevaluation to detect trends and outliers. Documentation of quality controlsamples includes the actual results obtained and graphs of the data withestablished acceptance limits.

QA-116 Investigation and Corrective Action - One of the most effective means formaintaining the production of high quality data is to respond immediatelyto indications of suspicious data or equipment malfunctions. Wheneverresults from quality control samples fall outside of established limits,the cause of this irregularity is investigated and corrected as soon aspossible. Documentation of these activities is then used to prevent futureoccurrences of the problem.

QA-117 Personnel Training Records - Supervisors are required to maintain personneltraining records of all personnel under their supervision. Trainingrecords for technicians indicate the date on which they were considered tobe proficient in various laboratory techniques or in various analyticalmethods. Training records for professionals indicate special tcainiy§ oreducation received over and above their educational qualirications.

IV-6

QA-118 Quality Assurance Audits - To ensure that laboratory personnel are adheringto the procedures set forth in our Quality Assurance Operations Manual,periodic checks of each group are made by the Quality Assurance

Department. These audits may entail observation as procedures are carriedout or a review of records to demonstrate traceability and compliance withall documented record keeping procedures. Reports of the findings of theseaudits are made to management.

QA-119 Proficiency Samples - The choice and frequency of quality control samplesare specified in the analytical method and are often based upon therecommendations of regulatory agencies such as EPA. In addition, samples

are obtained from various organizations that conduct collaborative studiesor provide reference materials. Control samples are also submitted blindto analysts so that they-may .be analyzed without any bias which may be

introduced by known quality control samples.

QA-120 Documentation of Programming for the Sample Management System - The sample

management system is used to perform calculations which convert raw data tothe final result reported to our clients. Thus the computer code is partof the chain of documentation relating to each sample and must be recorded.

B. ACCOUNTABILITY OF RESULTS

The term "accountability" as applied to testing results refers to theprocedures taken to assure that the data reported do refer to the samplesubmitted. In other words, that there has been no sample mix-up and the sample hasbeen properly handled in its transit through the laboratory to minimize changes inchemical composition or bacteriological quality.

At Lancaster Laboratories, Inc., we rely on our computerized Sample ManagementSystem to track and control movement of samples from the time of receipt untildisposal. The system works as follows:

IV-7 :

Samples are received at the laboratory in one of three ways: by personaldelivery, by mail or common carrier, or by sample pick-up by laboratory personnelAll samples are received by personnel of the Sample Administration Group, who areresponsible for sample log-in and tracking. The first step, after a sample isreceived, is its placement in our Sample Management Program. All samples arelogged into the computer along with pertinent information, e.g., the client's name,account number, client designation or description, and analyses or other testsrequested. The computer assigns a unique number to the sample and requestsinformation regarding necessary storage conditions, e.g., refrigeration, freezing.etc. The computer then assigns a storage location number which designates wherethe sample will be kept until analysis is begun and prints a label which isimmediately attached to the sample container. The computer also assigns a storagetime or disposal date which varies according to the nature of the sample or withspecific instructions from the client.

The data base, which is thus automatically generated, is used in many ways.For example, each Group Leader receives a daily printout, which lists all samplesand analyses waiting to be run in his/her laboratory. This is of inestimable valuein planning and organizing the workload. The date of sample collection is alsoavailable through the computer to ensure that holding times are met, whereapplicable.

When a sample is to be analyzed, it is retrieved from the designated storagespace by the analyst or by a member of the Sample Administration Group if storage

is in a controlled-access area. During analysis, raw data is recorded in ink inbound notebooks and then entered into the computer against sample number andanalytical method number. The computer performs many of the calculations to avoida common source of error. When all analyses are completed and have been verifiedby a supervisor or designate, the computer generates a report. The client receivesa copy of the face of the report containing the results of the analysis pluscomments entered by the Group Leader or the analyst where necessary. The back ofthe laboratory copy of the report contains the raw data plus the names of theanalysts who obtained it. This copy is retained in our archives.

ftR305I73

IV-8

The following page is a copy of a simulated report. Note that opposite eachreported result is a code number, which identifies the analytical method used. Inaddition, to avoid ambiguity in interpreting results, the reverse side of theclient's copy of the report contains an explanation of all symbols and units usedin reporting data. The report also contains the name of the Group Leader whoreviewed the final report.

In the case of samples which are likely to be involved in litigation or a legaldispute, more stringent sample handling procedures are available upon request.Strict "chain of custody" procedures are followed. The delivery of the sample isdocumented, the sample is kept under locked storage and photographs or videotapesmay be used to document the condition of the sample or visual aspects of the test.After analysis, samples will be returned to the client or disposed of at hiswritten request.

C. QUALITY CONTROL

1. Analysis of Blank, Spiked, Duplicate, Reference and Control SamplesEach specific analytical method includes the particular quality controlrequirements performed to ensure that the data produced is of knownquality. In addition to the necessary calibration standards, thesequality control checks may consist of one or several different types ofchecks. Blanks, spikes, duplicates, reference materials and controlsamples are employed, as appropriate for the analysis. The generalcriteria for the use of each of these types is outlined below.

Blanks are analyzed with aost types of analyses to prevent reporting offalse positives caused by factors in the laboratory systea. Blanks areprepared and analyzed using the same reagents and equipment as the samplesin the batch the blank represents. Acceptance criteria for blanks isbased on a multiple of the laboratory detection limit.

Spiked samples are samples fortified with a known amount of target analyteand subjected to the entire analytical procedure. The recovery of themethod is calculated and indicates the appropriateness of tflle*me*h«itfer4,the matrix. Many of the gas chromatographic analyses in the EnvironmentalDivision employ the special category of quality control samples known as

ANALYSIS REPORTi : > • • • • • •

.ancasterLaboratories ™»™25 New Holland Pike, Lancaster, PA 17601-5994 (717)656-2301

WLK1586 D 1 4

LLI Sample No. WW 1335799

cmith Engineering, Inc. Date Reported 12/16/88000 Any Street Date Submitted 12/ 8/88

^ancaster, PA 17601-5994 Discard Date 1/16/89

ater Sample from Monitoring Well #5Collected on 12/8/88 at 1547 by MLH

RESULT LIMIT OFA»AT,YSIS AS RECEIVED QUANTITATION LAB CODET jtl Coliform < 2.2 /100ml 2.2 030301500itrite Nitrogen < 0.05 mg/1 0.05 021900800

..itrate Nitrogen 11. mg/1 0.5 022000700Ammonia Nitrogen 4.1 mg/1 0.1 022202600rtho-Phosphate as P 2.1 mg/1 0.25 022601100otal Organic Carbon 8.5 mg/1 0.5 027302500

The Total Organic Carbon (TOG) result reported above was determined bymeasuring total carbon by a persulfate digestion/infrared detectionmethod on an acidified sample which has been purged of inorganiccarbon using nitrogen. It represents "non-purgeable TOG".

'esticides/PCB's attached 017819500ead 0.25 mg/1 0.05 025501200.richloroethene 12. ug/1 1. 041800500

1 V.OPY TO : John Smith

Respectfully SubmittedLancaster Laboratories, Inc.

00649 10.00 2700 Reviewed and Approved by:

Elizabeth A. WhiteGroup Leader, Water Quality

l"hf ican Association for_at / Accreditation

aL Biological & EnvironmentalResting.

18305!75

vtemt American Council ofndep ent Laboratories, Inc.

See Reverse Side For ExplanationOf Symbols And Abbreviations AndOur Standard Terms And Conditions

- '-. -, •*•-•£"•- -icr-«B£-i?t:*

reporting, technical data.

1. < means j'less than". The number following the sign is the smallest amount which can be detectedusPrig this specific test. ~ ~~ - r

2. > rfieTins "greater than".

3. £LJ2. means ""none detected".BMPL means "Below Minimum Detection Level"

4. TNTC means "Too Numerous To Count". ',

5. MPN means "Most Probable Number". Used in reporting certain bacteriological results which arecalculated from a statistical formula related to the bacterial count observed in a series of dilutionsof the sample. ' . ' . ! " - ' '• '•

6. JU means "International Units". Used in Reporting results on certain Vitamin assays.

7. CP Units means "cobalt-chloroplatinate units". Used in reporting color of aqueous solutions.

8. umhos/cm means "micromhos/cm". Used in reporting srpecific*c6nductance of solutions.

9. jTry means "nephelometric turbidity units".

10. fib > 5 um/ml means "fibers greater than 5 microns in length, per ml".11. C and_F represent degrees of temperature and refer to Celsius and Fahrenheit respectively.

12. _Cal means (diet) calories.

13. Jb_. means pound(s). - -- t„-„. •„ ! ; i

14. meg means milliequivalents, a chemical term meaning 1/1000 of the equivalent weight of a sub- *•.stance or element. - & - ' - - - • 9 -

15. kg means "kilogram(s)"-One kilogranjis 1000grams.- • -j means "gram(s)". The unit of weight used in the metric system. One gram equals about 1/30thof an ounce.mg means "milligram(s)"; One milligram is 1/1000 of a gram.ijg means "microgram(sV'. One-millionth of a gram.

16. I means "liter(s)". The unit of volume used in "the metric system.~rt\\ means "miililiter(s)". One milliliter is 1/1000 df a liter._ul means "microliter(s)". One microliter is 1/1000 of a milliliter or one-millionth of a liter.

17. m3 means "cubic meter(s)". Usually used as a volume unit in air analyses. '.

18. ppm means "parts per million". One ppm is equivalent to one milligram per kilogram (mg/kg), orone gram per million grams. For aqueous liquids ppm is usually taken to be equivalent to milligramsper liter (mg/l), because one liter of water has a weight very close to a kilogram. For gases orvapors, one ppm is equivalent to one microliter of gas per liter of gas.

19. ppb means "parts per billion". One ppb is 1/1000 of a ppm and is equivalent to one microgramper, kilogram (ug/kg). For aqueous liquids ppb is usually taken to be equivalent to micrograms perliterjug/l).

20. %_rrSans percent or part per hundred. This is usually followed by the designation "by weight"meaning grams per hundred grams. If followed by the designation "by volume" it refers to volumeper unit volume, e.g., millilitersfqerjhundredmilliliters.

r ~- -. -'*:- --* "" * Iv. * * *

-= -- ~° * -t — 11 'Clients should be aware that a most important step in a chemical or microbiological analysis is

the collection of the sample. Unless the sample analyzed is truly representative of the bulk of materialinvolved, the test results will be meaningless.. If you have questions regarding the proper techniques ofcollecting samples, please contact us. We cannot be held responsible for sample integrity, however,unless sampling has been performed by a member of our staff. !&&•••*>• fl C IftR$|£3 f

* * * * * *

WARRANTY AND LIMITATION OF LIABILITY — In accepting analytical work, we warrant the accu-racy of test results for the sample as submitted. We disclaim any other warranties, express or implied,including a Warranty of Fitness for Particular Purpose and Warranty of Merchantability. We accept nolegal responsibility for the purpose for which the client uses the test results. No purchase order orother order for work shall be accepted by the company with any conditions that' vary from our Stand-ard Terms and Conditions. If Lancaster Laboratories performs;-work requested by the client, conditionsat variance to our Standard Terms and Conditions are not part of the contract.

matrix spike duplicates. This is the analysis of a pair of fortifiedsamples from the same source. The use of matrix spike duplicates yieldsprecision information as well as recovery. The acceptance criteria forpercent recovery on spiked samples is based on EPA or other agencyrecoanendation or past information generated in our laboratory.

Duplicate sample analysis is the analysis of the same sample twice inorder to determine the precision of the analysis. The relative percentdifference (RPD) between the two determinations is calculated and comparedto values prescribed by EPA or determined by statistical analysis of pastinformation generated in our laboratories.

Reference materials are samples which contain a known amount of targetanalyte. These are routinely analyzed to ensure accuracy of theanalytical procedure. The reference materials may be from NBS or EPA, orthey may be prepared in our own laboratories. Accuracy informationdetermined from reference materials is valuable because variables specificto sample matrix are eliminated. The acceptance criteria for this type ofquality control is either dictated by the agency from whom the material isobtained or by statistical analysis of past information generated in ourlaboratories.

Control samples are similar to reference materials except that the truevalue of the target analyte is not known with specific degrees ofconfidence. Acceptance criteria is developed by applying statisticaltechniques to repetitive determinations.

In addition, many of our chromatographic analyses employ surrogate andinternal standards to evaluate analytical efficiency. The acceptancecriteria for the recovery of these compounds is the same as that listedabove for spiked samples.

The results of all quality control samples are entered into the computerin the same way as the results of client samples. The computer isprogrammed to compare the individual values with the acce^tangfi limits and

O-|A t'Ji i 1 / /inform the analyst if the results of the quality controItHsr? Ire in or

HR8Q5I77

•IV-10

out of specification. If the results are not within the acceptancecriteria, corrective action suitable to the situation must be taken. Thismay include, but is not limited to, checking calculations, examining other.QC analyzed with the same batch of samples, qualifying results with acomment stating the observed deviation, and reanalysis of the* samples inthe batch. Daily reports of QC outliers are generated by the computerizedsystem to keep management informed. The cause and solution to theproblems is documented to prevent recurrence. In addition, computerizedreports on the results for all QC analyses including mean and standarddeviation are generated monthly. These are used by the QA Department tocheck for trends which may indicate method bias. Control charts areplotted via computer and may be accessed at any time by all analysts.

These programs have been found to be invaluable in monitoring ouranalytical procedures and detecting situations where the system wastending to lose control before it became serious enough to affect theintegrity of the sample results.

2. Blind SamplesFor many of the more common analyses performed in our laboratories, theQuality Assurance Director periodically submits blind samples to thelaboratory using a pseudo- client name. These blind samples are similarto control samples, and results are reported directly to the QualityAssurance Director, who evaluates the data. Summaries of the data areprepared periodically and reported to the Group Leaders and DivisionDirectors. The value of the blind sample system lies in the fact that theanalysts are unaware of the fact that they are analyzing a quality controlsample, thereby avoiding unconscious bias in performing the analysis.

3. Proficiency Saaple TestingProficiency samples and check samples are samples submitted to thelaboratory by an outside organization. The concentration of certainanalytes is known to the outside organization but not to the laboratory.The laboratory is required to analyze the samples for the indicatedsanalytes. <**

The proficiency sample testing programs are part of an accreditationprocess, and results of samples must be within limits defined asacceptable by the submitting organization, or the laboratory may lose it

accreditation. In the case of check sample programs, participation isvoluntary and results are used to compare the laboratory's competence toother participating laboratories. The following is a list of proficienc

testing and check sample programs in which Lancaster Laboratories, Inc.participates.

Organization Sample Type Analyces

U.S. Environmental Potable water Metals, organics ,Protection Agency THMs , nitrate and

fluoride, VOCs

U.S. Environmental Uastewater Various pollutantsProtection Agency

U.S. Environmental Bulk building AsbestosProtection Agency materials

American Industrial Filters and Metals, organics andHygiene Association charcoal tubes asbestos fibers

U.S. Department Adipose tissue Pesticides and PCBsof Agriculture

U.S. Department Meat (split Moisture, protein,of Agriculture samples) fat and salt

PA Department Dairy products Bacterialof Agriculture contamination

American Association Animal feeds Moisture, protein, fat,of Feed Control fiber, ash, phosphorus,Operations calcium and various

additives (nutritionaland veterinary drugs)

American Oil Vegetable oils Fatty acid profileChemists Society

New York Department Non-potable water Various organic andof Health inorganic pollutants

American Association of Cereal Vitamins., jniansls «*ierbCereal Chemists proximatfe.P *W«ierbH.ological

contamination

05179

TECHNICAL OPERATIONS

OPERATIONAL PROCEDURES

1. Standard TestingThis category of work includes microbiological tests and chemical analyses

using well-established methods, or methods which have been validated forthe matrix being analyzed. Whenever possible, "official" or "standard"methods are used. "Official" methods are those required for compliance togovernment regulations, e.g., the methods mandated by the EnvironmentalProtection Agency (EPA) for drinking water, wastewater, or solid waste or

methods developed by the National Institute of Occupational Safety andHealth (NIOSH) for industrial hygiene work. "Standard" methods are thoseestablished by standard-setting organizations, e.g., the American Society

for Testing and Materials (ASTM), the Association of Official AnalyticalChemists (AOAC), the American Oil Chemists Society (AOCS), or the UnitedStates Pharmacopeia (USP). These methods have been subjected to rigorous

validation studies and interlaboratory collaborative testing, and areconsidered very reliable. Analysis summary sheets which list basicprinciples and method references for each standard test are available upon

request. An example is given in Appendix B.

Occasionally a client will request that we test samples by a methodfurnished by the client, which is neither official nor standard. We willcoaply vith the client's request with the provision that we cannotguarantee accuracy or reproducibility of results unless a validation studyis authorized. In other cases, we develop our own in-house methods ofanalysis. In these cases, a validation study is always required before amethod is authorized for use in standard testing. We have a formaldocumented procedure by which permission is granted to our .laboratorypersonnel to use a new or modified method in this type of testing. Suchpermission may only be granted by the Division Director ftiiUiUQLilStyAssurance Director.

V-2

a. Work-Flow Routing

The computerized "Sample Management System", described in Section IVB, has many benefits for our clients. Accuracy is improved since manyof the calculations are done by the computer, eliminatingtranscription of data from one piece of paper to another. Inaddition, traceability of results is assured since each resultindicates by code the analyst who entered the raw data and the method

used. The Sample Management System has built-in levels of security toprevent unauthorized changes of data or verification status. OurGroup Leaders receive a daily printout of the status of all samples intheir lab, including a printout of those with priority status or thosewhich have exceeded a preset turnaround time. This is an importantaid to efficient work scheduling. In addition, a request forinformation on a client's samples can be immediately answered byinstant referral to a computer terminal near the Group Leader's desk.

b. Reporting of ResultsWhen all analyses are completed, the results are reviewed and approvedby the Group Leader. A copy of the report is mailed to the client.Each day's reports are reviewed by at least one member of CorporateManagement before they are mailed.

We recognize that one of the most important aspects of the services weoffer is "turnaround time," i.e., the time which elapses between thereceipt of a sample at the laboratory and the report of the finalresults. This is one reason we operate on a three-shift,around-the-clock basis. Our normal turnaround time is about 7-14days, but it can vary considerably depending on the workload in thevarious groups analyzing the sample and the nature of the analysis.

If faster turnaround time is required, clients should discuss theirneeds with the Group Leader(s) responsible for the work. Every effortwill be made to expedite reporting results, but we may require asurcharge to cover our incurred expenses in doing so.

One way of shortening turnaround time is, personal delivery of sanplesto the laboratory or pick-up of samples by our personnel. Another

method is to request that results be reported by telephone or Fax,Such requests will always be honored and will be confirmedsubsequently by mailed reports. The fastest means of getting hardcopy results for routine samples will be via our Client Access System.

c. Client Access System

Clients who have need of fast turnaround time and who submit sampleson a regular basis should investigate our computerized Client AccessSystem. Under this system, a client can access our computer system by

telephone and receive a printout in his/her own office or laboratoryof all analytical results on samples which are completed and

verified. The equipment required at the client's location is ateleprinter (or a computer terminal which can simulate a teleprinter)and an inexpensive telephone modem. For security purposes, such

clients are given access codes which limit access to their samplesonly. The codes are easily changed in case of a potential breach ofsecurity (e.g., loss of client key personnel).

Clients interested in our Client Access System should contact KennethE. Hess, our Director of Data Processing. There is no charge for thisservice.

d. BillingStandard analyses are billed on a per sample, per analysis fee basis,as described in our Fee Schedule, a copy of which is available uponrequest. Discounts are available, as described in the Fee Schedule.A copy of our Standard Terms and Conditions may be found in Appendix A.

2. Specialized TestingThis type of work includes analyses for which standard methods are notavailable, or are available for substrates other than the samplesbeing considered. This type of work is only attempted if we areconvinced on the basis of our best professional judgeme_n£ that_our_facilities and expertise are sufficient to assure a

of success.

a. Work-Flow RoutingThese analyses are generally brought to the attention of the DivisionDirector by either the client or the Group Leader first approached.The Division Director, in consultation with the Group Leader, willmake the decision whether or not to attempt the analyses. If thedecision is made to proceed, the work flow will follow the general

outline given under Standard Testing.

In cases involving litigation or the possibility of future litigation,special precautions are taken in sample handling and analysis, asdescribed in Section IV-B.

b. ReportingResults are reported in a. manner similar to that described underStandard Testing. If the methods used are markedly different fromthose used in standard tests, a letter report disclosing the methodsis prepared. Any difficulties and/or special techniques orprecautions are also reported, as well as any interpretive informationwhich may be necessary to understand the results.

c. BillingBilling for specialized testing is on a per sample, per analysis feebasis, in accordance with our best estimate of the cost of doing thetests. This fee may be subject to later revision, either upward ordownward, as we gain experience with the test method. The client willbe informed of the fee or any fee revision prior to our beginning work.

Any method development or evaluation work which the client has agreedto finance is billed according to time records describing the level ofeffort of actual persons working on the project. Time charges arecalculated based on the time spent on the project, multiplied by theworker's hourly rate, multiplied by a factor which covers overheadcosts and profit. We reserve the right to determine the level oftechnical expertise required to solve a particular problem.

V-5

3. Contract Research and DevelopmentContract research and development has been an on-going activity atLancaster Laboratories, Inc. since its inception in 1961. We haveperformed this service for many manufacturing companies, both large andsmall, for engineering firms, for government agencies, and for trade andindustrial associations. Typical examples include: product formulationand evaluation for patent and marketing purposes; analytical methoddevelopment; waste and by-product utilization studies; waste treatmentstudies; competitive product evaluation and "deformulation"; shelf lifeand other stability studies; identification of unknown materials;"off-taste" and "off-odor" identification; and many other investigationsin the fields of chemistry and microbiology.

Such projects usually begin with a client conference with one or more ofour Division Directors or Group Leaders at no obligation to the client.The objectives of the project and possible technical approaches toachieving the objectives are discussed and, if possible, a rough estimateof the cost is given. After this meeting, assuming the client agrees,further discussions with technical staff are undertaken to refine theconcept of the proper technical approach. A brief literature survey maybe made to clarify technical questions and the feasibility of performing•the work in view of staff expertise, instrumental and equipmentcapabilities, and workload is evaluated. The client usually is notcharged for this phase of the investigation unless a more extensiveliterature search is necessary, which the client is asked to authorize.

At this point, assuming mutual agreement with the client, we prepare adetailed project proposal, including a cost estimate. This is done bybreaking down the work into a series of tasks and estimating the number ofwork hours and level of technical expertise (professional, technician,secretarial, etc.) needed for each task. From this we can estimate thecost of labor plus overhead to complete the project. Other relatedincidental expenses (e.g., the cost of special chemicals, travel costs, ifnecessary, and the like) are added to labor costs to arrive at a final

project estimate. AR305tS5

V-6

The project cost quotation may contain a contingency factor, whichrepresents our uncertainty in evaluating costs, or may be presented on a"not to exceed" basis, depending on the client's wishes. We require a

written authorization from the client to proceed with the project prior toour beginning work.

Clients should realize that because of the exploratory nature of the work,it is frequently very difficult to arrive at highly accurate projectcosts. It is also impossible to guarantee success, i.e., results whichare as expected beforehand by the client. (If this were possible, therewould be no need to do the work.) We can guarantee that we will put forthour best technical effort in pursuing the work as agreed.

a. ReportingContract research and development projects will be reported to clientsin the form of written reports. Reports are generated at theconclusion of the project or at intervals over the course of theproject depending on the client's specifications. Reports include adescription of the methods and materials used, experimental results,discussion of results and conclusions based on the results.

b. BillingContract research and development projects are billed at theconclusion of the project if completed within one month or on amonthly basis if not. When a client authorizes a project, a projectnumber is assigned to that project, and employee time is loggedagainst that number on a daily basis for all work done on theproject. Project costs are calculated by multiplying the employee'stime by his/her hourly rate and adding a factor to account foroverhead and profit. Extraordinary costs not normally included asoverhead are billed directly to the project as they are accrued. Themonthly or final invoice sent to the client contains a list ofitemized costs.

.UR305I86

VI

TECHNICAL DIVISIONS

Technical personnel and equipment are organized into two major divisions: the

Health Sciences Division, and the Environmental Sciences Division, which reflectboth the type of client served and the nature of the work done. The two Divisionsare further divided into Groups on the basis of the same criteria.

This section will describe these various groups with emphasis on specialexpertise available in the Group, and the quality assurance programs specific tothat Group. For a discussion of our overall Quality Assurance Program, see thesection of this manual titled "Quality Assurance."

For the names of key personnel in each Group see the section on TechnicalDivisions under Organizational Structure, and for instrumentation available to eachGroup, see the last column of the list of major instruments in the section titled"Physical Facilities and Instrumentation."

ENVIRONMENTAL SCIENCES DIVISION

A. ORGANIC ANALYSIS GROUP

The analysis of trace volatile organic compounds is the forte of this group.Using gas chromatographs (GCs) with purge and trap concentrators, environmentalsamples are analyzed for contaminants at concentrations as small as the parts perbillion (ppb) and even the parts per trillion (ppt) levels. In addition,capability is also available for identification and quantification of macroquantities of organics using infrared spectrophotometry.

Special expertise is available in the following areas:

0 Analysis of potable water for trihalomethanes and volatile organiccompounds for compliance with the Safe Drinking WaterH^tQQIS 187

° Analysis of groundwater, wastewater and solids for organic pollutants.

VI-2

° Identification of solvents in unknown industrial wastes by capillary GC.

° Chemical characterization by a variety of techniques, e.g., infraredspectroscopy.

Quality Assurance

1. Instrument Calibration

0 Gas Chromatographs: Multiple levels of standard solutions are used tocalibrate instruments each time a run is initiated. Instrumentresponse is checked periodically to prevent detector drift. Whereapplicable, surrogate standards are used in samples. Quality controlsamples obtained from US EPA are analyzed periodically.

° Purge and Trap Concentrators: Standard solutions are prepared andchecked each time a batch of samples is analyzed, and surrogatestandards are run with each sample.

° Infrared Spectrophotometer: A standard film of polystyrene is used tocalibrate the instrument periodically. Such calibration is donequarterly or when there is reason to believe instrument response mayhave deteriorated.

° UV/visible Spectrophotometer: Calibration is checked bimonthly withsolutions of known absorbances and wavelength characteristics.

2. StandardsFor analysts of volatile organic compounds by purge and trap GC, purgeablegases (e.g., chloromethane ,• bromomethane, vinyl chloride andchloromethane) are used in 200 ppm solution (obtainable from chemicalsupply houses). Furgeable halocarbons, which are purchased neat anddiluted as needed, are used for calibration and standardization. Purifiedsamples of benzene, toluene, chlorobenzene and ethyl benzene are used toprepare standard solutions for the analysis of purgeable aromaticcompounds.

3. Quality ControlEach batch of 20 samples analyzed by Purge and Trap techniques includes ablank, a matrix spike duplicate pair and a calibration check sample.

B. PESTICIDES AND PCBs GROUP

This group is responsible for the analysis of pesticides, PCBs and similarcompounds. Using gas Chromatography, a wide variety of samples including water,

AR305188

VI-3

soil, and foods are checked for trace residues. Automatic sample injectors, avariety of GC detectors, electronic integrators, and microprocessor instrumentcontrol make the efficient analysis of many samples possible. HPLC analysis forcarbamate pesticides is also available.

Special expertise includes:0 Analysis of potable water for pesticides and herbicides required for

compliance with the Safe Drinking Water Act.

° Pesticide residue analyses on agricultural products, foods, animal feeds,soils and water.

0 Polychlorinated Biphenyl (PCB) content of environmental samples,transformer oils and other industrial fluids.

Quality Assurance1. Instrument Calibration

Gas Chromatograph standardization is accomplished as described under theOrganic Analysis Group.

2. StandardsPurified pesticides and herbicides obtained from the EnvironmentalProtection Agency or chemical supply houses which guarantee purity are

used for preparing standard solutions for analysis of these compounds.

3. Quality ControlA blank and spike is analyzed with each batch of samples analyzed forPesticides/PCBs. Where required by the methodology a pair of matrix spikeduplicates is analyzed with each batch. Surrogate standards are added,where applicable.

C. INORGANIC ANALYSIS GROUP

This Group has major responsibility for analysis for inorganic elements andcompounds. Analysis for trace concentrations of inorganics by atomic absorptionspectrophotometry (AAS) and inductively coupled plasma spectroscopy (ICAP) arespecialties of this Group. Flame, furnace, hydride generation and cold vaportechniques are employed as appropriate to sample and analyte.

W305189

VI-u

Special expertise is available in this Group for:

° Analysis of sludge, leachates, soils and water for inorganic contaminants.

° Analysis of potable water for compliance with EPA regulations for traceinorganic elements.

Quality Assurance1. Instrument Calibration

The AA spectrometers are calibrated with each use by analyzing 3 to 5levels of standard solutions. The curve generated is periodically checkedthroughout the run. The ICAPs are calibrated according to the procedureprescribed by the EPA's Contract Laboratory Program (CLP).

2. StandardsTrace elements standards which have been checked against National Bureauof Standards (NBS) Standard Reference Materials (SRH) are purchased fromchemical supply houses for calibration of instruments. We maintainstandards for each element for which we analyze. In addition, quality

control samples obtained from USEPA are analyzed periodically.

3. Quality ControlEach batch of 20 samples includes a blank, a laboratory control, a spikeand a duplicate.

D. GAS CHROMATOGRAPHY/MASS SPECTROSCOPY GROUP

The combination of gas Chromatography and a mass spectrometer detector is apowerful tool for analysis of complex mixtures of organic compounds. In principle,it is possible not only to separate these compounds by Chromatography, but toobtain definitive confirmation of identity by the mass spectrometer. The techniqueis widely used in analysis of groundwater, wastewater and soils for industrialpollutants, and in special problems where the identity of trace contaminants mustbe determined.

AR30SI90

Special expertise is available for:

0 Priority pollutant analysis in waters and soils.

0 Identification of "off-flavor" or "off-odor" by dynamic headspace analysis.

0 Identification of unknown organic constituents.

Quality Assurance

1. Instrument CalibrationCalibration standards are run each shift (twice/day). The instrumenttuning is checked daily against EPA specifications and adjusted ifnecessary. Calibration and tuning is performed according to EPA method624 or 625 or CLP protocol, depending upon the analysis requested.

2. StandardsFor GC/MS analysis of the volatile, acid extractable and base/neutralcompounds in the EPA list of priority pollutants, pure liquids or standardmixes received from chemical supply houses are used to prepare standardsolutions. EPA quality control samples are analyzed periodically as anindependent check on the accuracy of our standards.

3. Quality Control

A blank and a pair of matrix spike duplicates are analyzed with each batchof 20 samples. Surrogate and internal standards are added to each sampleor extract.

E. WATER QUALITY GROUP

This Group is responsible for analysis of potable water and wastewater forthose contaminants not amenable to the instrumental techniques described in theprevious Groups. Examples would be: cyanide, phenols, phosphates, ammonia,turbidity, etc.

Analysis of wastes for hazardous components is also a responsibility of thisGroup with Resource Conservation and Recovery Act (RCRA) compliance andPennsylvania Department of Environmental Resources (PA DER) Module #1 specialties.

R8305I9I

VI-6

Major instrumentation for these analyses includes total organic carbon (TOC)analyzers, total organic halogen (TOX) analyzers, an ion Chromatograph, Techniconautomatic analyzers, and a full complement of field sampling equipment.

Special expertise is available in this Group for:0 Wastewater Sampling and Flow Measurement: Equipment and personnel are

available for field sampling of wastewater effluents, using either flowproportional or time proportional compositing techniques.

0 Groundwater Test Well Sampling and Monitoring: Battery-powered fieldpumps or Kammerer samplers are available.

0 Toxicity Characteristic Leaching Procedure (TCLP) and EP ToxicityTesting: Equipment and expertise are available for the EPA-mandatedleaching and toxicity testing for hazardous waste.

0 Wastewater Treatment Studies: Jar tests, activated sludge, dissolved airflotation, and sludge digestion tests can be run.

° Biochemical Oxygen Demand (BOD): BOD analyses are a specialty of thisGroup.

° Trace Cation and Anion Analyses: Ion Chromatography is used for analysisof a variety of ions, both inorganic and organic.

Quality Assurance

1. Instrument Calibration

° Total Organic Carbon (TOC) Analyzer: A calibration standard and fivecalibration check standards are run with each use of the instrument.An additional calibration check is run following every tenth sample.

0 Total Organic Halogen (TOX) Analyzer: A calibration standard andabsorption efficiency sample are run with each batch of samples,followed by three calibration check samples. Also, a calibrationcheck sample is run after every ten samples.

° Technicon Automatic Analyzers: Five different levels of standardsolutions are run with each group of samples. A calibration checkstandard is run after every ten samples.

0 Ion Chromatograph: Standard solutions are run at five differentconcentrations with each batch of samples. A calibration checkstandard is run after every ten samples.

° Conductivity Meter: Cell constant is checked at each use withstandard KCl solution.

° Dissolved Oxygen Meter: The instrument is checked with fiaeh useagainst the Winkler iodometric titration procedure foroxygen.

AR305I92

VI-7

0 BOD Incubators: The temperature is checked and recorded twice dailyThe thermometer,used is calibrated against a standard thermometertraceable to NBS.

0 Flowmeters for Wastewater Monitoring: These instruments arecalibrated immediately before use.

2. Standards

Chemically pure standards are purchased from supply houses for use ascalibration standards. Standard solutions with components typical ofthose found in wastewater, supplied by the EPA, are analyzed periodicallyfor a wide variety of analytes, and results are compared to certifiedvalues.

3. Quality Control

Due to the wide variety of tests performed by this group it is difficultto describe here the QC performed for each one. Generally, each batch of20 includes a blank, a spike, a duplicate, and a reference material.

HEALTH SCIENCES DIVISION

A. FOOD CHEMISTRY GROUP

This Group is responsible for chemical analyses of foods, animal feeds, andagricultural products, except for certain trace organic analyses which may beperformed by the Organic Analysis Group in the Environmental Division. In additionto standard tests, e.g., proximate analyses, special expertise is available in:

° Nutritional analysis, including sampling, labeling and consultation onregulatory requirements.

0 Vitaain analyses, including vitamins A, Bl (thiamine), C, D and E. Forother vitamin analyses requiring bioassay methods, please refer to theinformation listed under Bioassay Group.

0 Sugar analyses by High Performance Liquid Chromatography (HPLC) on foodsand beverages, including screens for dextrose, fructose, maltose, lactose,and sucrose.

0 Atomic absorption analysis for inorganic constituents i*ftpSdg 3nfeeds.

VI-8

0 Fatty acid profile analysis by gas Chromatography (GC). This technique isuseful for identifying the sources of animal and vegetable fats.

0 Analysis of laboratory animal feeds. Feeds used for laboratory animals innutritional and toxicity testing must be carefully characterized fornutritional content and possible contamination.

Quality Assurance

1. Instrument Calibration

0 HPLC: Standard solutions are run with each batch of samples, or afterevery four samples if there are more than four samples in a batch, andinstrument response is monitored.

° GC: Standards are run with each batch of samples and after every fivesamples if there are more than five samples in the batch, andinstrument response is monitored.

0 pH Meters: These instruments are calibrated with standard buffersolutions (pH 4.0, 7.0, 11.0) each day used.

0 AA: Trace elements standards which are traceable to NBS are purchasedfrom chemical supply houses for calibration.

° Analytical Balances: Calibration is checked daily with variousweights, and a complete overhaul and calibration is performed annuallyby a certified service company.

° Visible Spectrophotometer: A set of standard solutions is used formonthly calibration of absorbance and wavelength readings.

0 Fluorometer: A standard solution is run with each batch of samples,and instrument response is checked.

2. Standards:A complete inventory of high purity samples is kept for all analyses forwhich standards are available. These are used for instrument and methodcalibration. In addition, control samples of dry cereal, pasta, andchocolate are used for Quality Control (QC) charting for our mostfrequently performed analyses (proximate analyses, vitamins, sugars,metals, and cholesterol).

1. FOOD MICROBIOLOGY GROUP

This Group is responsible for all microbiological testing of food, animal feedsand industrial products. In addition to standard tests, e.g., plate counts andbacteriological identification, special expertise is available as followsj|j ^ Q 5 f 9 If

VI-9° Extraneous Matter: Identification and quantitative estimation of the

contamination of various foods and agricultural products by unwantedmaterial, e.g, rodent hairs, insect fragments, synthetic fibers and othermaterials.

0 Analysis for selected pathogens such as Salmonella and Listeria.

° Sanitary Inspection: Our staff is experienced in inspection of foodprocessing plants, equipment, and warehouses for sources ofmicrobiological, rodent and insect contamination, and can makerecommendations for elimination of insanitary practices.

° Microbiological analysis of cosmetic and pharmaceutical products accordingto U.S. Pharmacopia methods.

Quality Assurance

1. Instrument and Equipment Calibration

° A-0 Microscope: Field diameter calibration is conducted every twoyears in conjunction with Milk Sanitation Certification by thePennsylvania Department of Agriculture.

0 Incubators, Refrigerators and Water Baths: Temperatures are read andrecorded twice daily. Thermometers are immersed in liquid.

° Autoclaves: A maximum registering thermometer is used daily.Autoclave tape and Diacks are used to indicate maximum temperatures ineach run, and time and temperature are recorded continuously for eachrun.

° pH Meters: pH meters are calibrated each day used, with commercialbuffer solutions.

0 Thermometers (glass): Glass thermometers are checked annually againsta standard thermometer traceable to the NBS.

° Thermometers (dial type): These thermometers are checked semiannuallyagainst a standard thermometer traceable to the NBS.

° Oven (for dry heat sterilization): A thermometer record is keptshowing date, time and temperature of each cycle; test strips are runwith each cycle.

0 UV Sterilizer: This equipment is checked quarterly by the spreadplate irradiation procedure.

0 Automatic Pipettor: This is calibrated each day it is used.

0 Analytical Balance: Accuracy is checked daily with various weights.

2. StandardsAll chemicals and nutrients used in microbiological testing/mr*reurghgsedfrom supply houses which guarantee specifications to be equal or better

HR3Q5I95

VI-10

than required by the Food and Drug Administration (FDA), United StatesPublic Health Service (USPHS), etc. Stains used are "biological grade,"i.e., certified by the Biological Stain Commission.

Standard cultures of microorganisms are obtained from the American TypeCulture Collection (ATCC), government agencies, medical schools orindustry.

3. ProceduresMicrobiological testing is less amenable to statistical techniques of QCthan is analytical chemistry. Many microbiological tests are qualitative,involving identification of microorganisms; while in other tests,meaningful standards are not available and substrates are perishable. Forthese reasons, microbiological QC must rely on strict control ofmaterials, test parameters, e.g., time and temperature, and individualanalyst technique and training. The following are illustrative of QCprocedures used in our laboratory.

0 Sterility checks are run on each batch of dilution water.

° Sterility and pH checks are run on each batch of broth used.

0 Airborne microbial density measurements are performed daily.

0 Spikes and duplicates are run regularly.

0 Records are kept of media batch sterilizations showing lot number,date, sterilization time and temperature, and initial and final pH.

° A dilution water toxicity test is run every six months.

0 Media are dated when received and opened, and discarded if caked.

0 Laboratory pure water is checked annually for bactericidal propertiesand for heavy metal contamination.

° Laboratory pure water is checked monthly for pH, chlorine residual,standard plate count, and low level ammonia. Conductance of the wateris continually monitored, and recorded twice daily.

° All new plastic caps for dilution bottles or agar bottles are boiledthree times in deionized water, and the final water wash is checkedfor inhibitory substances prior to use.

° Records are maintained of bacteriological suitability of detergentsand procedures for their use.

AR30SI96

VI-11 ' -

0 Coliform media in tubes is discarded after one week if not used.

° Each canister of sterilized pipets is spot checked for pH.

° Bacteria spikes are initiated regularly for E. coli, Pseudoir.onas, andStaphylococcus tests. All reagents and/or media used are recorded aswell as corresponding preparation dates, expiration dates, and controlnumbers, as applicable.

° A toxicity test is performed for each lot number of Brilliant GreenDye.

0 Positive and negative controls are initiated for the following: eachgroup of FA slides, phosphatase tests, Staphylococcus coagulasereactions, and antibiotic tests.

C. BIOASSAYS GROUP

This Group has responsibility for bioassay testing, which is based uponmicroorganism growth and/or inhibition. This type of analysis is frequently usedto determine pharmaceutical concentrations in animal feeds and vitamins in foodproducts. Responsibility for the testing of potable water for coliform bacteria, asymptom of contamination by human or animal waste, also lies with this group.Special expertise is available in:

° Evaluation of antifungal, bacteriostatic and bactericidal products usingstandard methods (e.g., ASTM methods).

0 Zone of inhibition techniques used to determine pharmaceutical content inanimal feeds.

° Biological assay for vitamins including pantothenic acid, folic acid,niacin, choline, and vitamins B6 and B12.

Quality Assurance1. Instrument and Equipment Calibration

Instrument and equipment calibration procedures are generally the same asdescribed for the Food Microbiology Group, to the extent that theequipment is available in this Group.

The Spectrophotometer used in the vitamin assay is calibrated monthly forabsorbance and wavelength accuracy.

/IR3G5197

VI-12

2. StandardsPurchase and specification of standards are generally the same as in the

Food Microbiology Group. The vitamin solutions used to standardize theSpectrophotometer are prepared from material obtained from USP.

3. ProceduresTo the extent that they are applicable, QA procedures for this Group arethe same as for the Food Microbiology Group. However, the followingprocedures are specific to the testing of potable water for coliformbacteria:° Lot numbers of membrane filters and date of receipt are documented.

° At least ten sheen or borderline sheen colonies are verified on LaurelSulfate Tryptose (LST) Broth and 21 Brilliant Green Bile Broth (BGBB)when ten or more colonies are found, and the final counts are adjustedaccordingly.

° Start and finish membrane filter control tests (rinse water, mediumand supplies) are performed on each filtration series.

° Most Probable Number (MPN) analyses are carried to completion on allEPA-related samples.

° At least one heavy growth-no gas MPN sample is carried throughcompletion each quarter.

0 Duplicate counting is done monthly by each analyst certified for watertesting.

° Duplicate analyses are performed on 102 of incoming water samples,choosing samples most likely to give positive results. Duplicates arerun by the same analyst.

° Positive and negative organism controls are run monthly.

° A sterility check is performed on each lot of sample containersprepared for microbiological water tests.

D. PHARMACEUTICAL GROUP

This Group is responsible for analysis of finished pharmaceutical products fordosage strength, dissolution rate, disintegration rate, hardness, and otherphysical properties specified in the United States Pharmacopeia (USP). Inaddition, the Group provides analytical support for bioavailability studies of newPharmaceuticals and bioequivalence studies of approved pharmaceuticals in

SR3Q5I98

dosage forms. Raw material testing using methods specified in the USP, Food

Chemicals Codex and other compendiums is also provided by this group.

Quality Assurance

1. Instrument Calibration

0 HPLC: Standard solutions are run after every four injections andinstrument response is monitored. The relative standard deviation ofthe standards is calculated for each set of injections.

° pH Meter: These instruments are calibrated with standard buffersolutions (pH 4.0, 7.0, 11.0) each day used.

° Analytical Balances: Calibration is checked daily with variousweights, and a complete overhaul and calibration is performed annuallyby a certified service company.

0 UV Spectrophotometer: A set of standard solutions is used for monthlycalibration of absorbance and wavelength readings as recommended bythe manufacturer.

0 Dissolution Bath: Calibration is performed twice a year usingprednisone tablets as specified in USP/NF XXI, Physical Test <711>Dissolution, and as recommended by the manufacturer.

0 Disintegration Bath and Apparatus: This equipment is set up asspecified in the USP/NF XXI, Physical Test <701> Disintegration, andas recommended by the manufacturer.

° Hardness Tester: Calibration is performed once a year by a certifiedservice company.

2. StandardsUSP Reference Standards or working reference standards which have beenassayed against a USP Reference Standard are available.

E. INDUSTRIAL HYGIENE GROUP

The responsibility of this Group is the evaluation of health hazards resultingfrom indoor air pollution in workplaces, homes and schools. Much of the work ofthis Group is conducted on-site at client facilities, supplemented by laboratoryanalysis of samples collected and evaluation of health hazard potential. Ourlaboratory is certified by the American Industrial Hygiene Association, and a

Certified Industrial Hygienist is on staff. SB 30 5 ! 99

VI-14 .

Special expertise which is available includes:

° On-site personal or area air sampling for identification and quantitationof airborne contaminants. This may be done for evaluation forOccupational Safety and Health Administration (OSHA) compliance, forindustrial hygiene purposes, or for industrial process control. NIOSHprotocol is used in collection of air samples, where applicable.

0 Air sampling for analysis for asbestos fibers in schools, office buildingsand elsewhere. Instantaneous airborne fiber concentrations can bedetermined using a Fibrous Aerosol Monitor (FAM).

° Monitoring of building contractors' adherence to specifications inasbestos removal projects.

° Identification and quantitation of asbestos in bulk materials, e.g.,building materials and insulation.

0 Surveys and inspections of buildings for compliance with Asbestos HazardEmergency Response Act (AHERA).

° Use of battery-powered, portable personal monitoring pumps with collectiondevices to evaluate full, 8-hour workday exposure of employees tohazardous materials.

° Measurement of noise levels and noise exposure hazards.

° Evaluation of fume hoods and other protective ventilation devices by meansof a hot-wire anemometer.

° Evaluation of indoor air for hazardous substances, e.g., carbon monoxide,carbon dioxide, formaldehyde, and exterminator-generated pesticides.

Quality Assurance

1. Instrument Calibration

0 Area Ambient Air Samplers: These devices are calibrated before andafter use by flowmetering devices, e.g., rotameter, limited orifice,etc.

° Personal Air Samplers: These are calibrated by soapfilm flowmeterbefore and after sampling.

° Dry Gas Test Meter: This device is calibrated by an orifice meter.

2. Standards

° Standards are provided by the EPA for evaluating personnel and methodsfor the quantitation of asbestos in bulk materials.

AR3052QQ0 Samples from the NIOSH Proficiency Analytical Testing (PAT) program v ware used to determine proficiency in counting asbestos fibers forairborne asbestos analysis.

Other analyses of samples collected by this Group are carried out by theInorganic and Organic Analysis Groups and are subject to the QA programs in those

Groups.

SECOND AND THIRD SHIFTS

Our second shift operates from approximately 4:30 p.m. to 1:00 a.m., Monday

through Friday, while our third shift works from 10:00 p.m. to 7:00 a.m., Sundaythrough Thursday. In addition, some groups require technical staff on Saturday andSunday to maintain the operations. The operating hours of personnel on various

shifts overlap to ensure good communications and continuity of operations.

Personnel of these two shifts at our Lancaster location are responsible for avariety of duties. In addition to performing certain standard analytical testsregularly, they are responsible for sample preparation steps such as sampledigestion for trace element analyses. This shortens the time for turnaround on

multiple, repetitive analyses, thus improving our efficiency. They are alsoresponsible for glassware cleaning, glassware and instrument set-up for the day

shift personnel, autoclaving, media preparation and certain building maintenanceservices. Clients with emergency problems occurring in off-hours can beaccommodated with certain services, e.g., sample receipt or early alerting of Group

Leaders to the need for RUSH analyses.

&R30520I

AR305202

VII

SUPPORT SERVICES

The following describes some of the Groups of personnel which supply support to ourTechnical Divisions and whose operations are frequently vital to the efficient andreliable provision of the services we offer.

A. FINANCE/DATA PROCESSING

This Group is responsible for all financial transactions of the company and theestablishment and maintenance of all data processing programs.

All financial transactions, including accounting, billing, accounts receivable,accounts payable, purchasing and payroll, are monitored and recorded by personnel ofthis Group.

Data processing includes, in addition to our computerized accounting system, allcomputerized aspects of our technical operations, e.g., our computerized SampleManagement System, computer aspects of our QA program, and our Client Access System.Continued research and development into new and improved hardware and software areongoing activities of this Group.

B. HUMAN RESOURCES

Human resource management includes coordination of all hiring, employee orientation.safety, monitoring the employee evaluation program, and other personnel managementfunctions. Secretarial services are also coordinated by this Group. Because of thetechnical nature of our business, a well-trained staff is critical to the production ofquality data. Human Resources has oversight of the employee training program whichincludes on-site training in basic subjects and training courses offered by outsideorganizations.

C. PHYSICAL SERVICES ftR3052iMajor functions of this Group include buildings and grounds maintenance. This

Group also has certain responsibilities which impact directly on the quality andreliability of our technical services:

i I

HR305206

VIII

ACCREDITATIONS, CERTIFICATIONS, REGISTRATIONS, AND CONTRACTS

Accreditation of a laboratory has been defined as "the verification by acompetent, disinterested third party that a laboratory possesses the capability toprovide accurate test data and that it can be relied upon in its day-to-dayoperations to maintain high standards of performance."* The terms "certification,""registration" and others have been used in the past, and are currently being usedby some organizations, as synonyms for accreditation, but in recent years a

consensus has been reached to restrict the term accreditation to laboratories andother organizations and to reserve certification to individuals, e.g., CertifiedIndustrial Hygienist, or Certified Public Accountant, or to products which conformto certain standards or specifications.

Accreditation is thus the one generally accepted method by which a laboratorysuch as ours can demonstrate its capability of generating acceptable, professional

*

quality test results in those areas in which it claims competence. To this end, wehave actively sought accreditation by organizations offering it in those areasrelevant to our technical expertise.

Although organizations offering accreditation differ somewhat in the details oftheir programs, they generally evaluate laboratories in four basic areas:personnel (education, training and experience), physical facilities,instrumentation/equipment, and quality assurance programs. The evaluation isperformed by one or more of the following procedures: periodic on-site inspectionof the laboratory by assessors experienced in technical operations and management,periodic testing of proficiency evaluation samples, and periodic updating of thelaboratory's file to reflect changes in personnel, equipment or services offered.

The following lists the accreditations, registrations, and contracts currentlyheld by Lancaster Laboratories, Inc.:

° American Association for Laboratory Accreditation (A2LA): A2LA is a privatesector, non-profit organization whose sole mission is accrediting laboratoriesin twelve fields of testing. Lancaster Laboratories, Inc. is accredited in theenvironmental field of testing. HR305207

* From paper presented to the Annual Meeting of the Texas Council of EngineeringLaboratories, by Earl H. Hess, Ph.D. (January 28, 1984).

v : l i - /;

° American Industrial Hvgiene Association (AIHA): AIHA accreditslaboratories for their ability to analyze collection media used in airpollution sampling for a broad variety of industrial workplacecontaminants.

0 EPA Contract Laboratory Program (CLP): This program is not truly anaccreditation program, although many people consider it a de factoaccreditation. In order to receive an EPA contract to perform laboratorywork in support of Superfund investigations, a laboratory mustsuccessfully bid on a contract, obtain acceptable results on performancesamples, and pass an on-site inspection by EPA officials. LancasterLaboratories currently has an active Routine Analytical Services contractfor Organics analysis and also performs Special Analytical Services (SAS)for the EPA-CLP.

° Food and Drug Administration (FDA): Because of our work forpharmaceutical companies, we are a registered FDA laboratory required toadhere to the Good Laboratory Practice (GLP) and Good ManufacturingPractice (GMP) regulations and subject to periodic, unannounced audits.This registration does not imply FDA approval.

0 State Water Authorities: We are accredited in the following states, by theappropriate authorities, for the analysis of drinking water and, whereapplicable, for wastewater analyses: Pennsylvania, Maryland, Virginia, NewJersey, West Virginia, Utah, and New York (non-potable water only).

0 U.S. Department of Agriculture (U5DA): We are certified by USDA for meattesting and are on the USDA list of recognized laboratories forchlorinated hydrocarbon pesticide and PCB residue analysis.

0 U.S. Public Health Service (USPHS): The Food Microbiology Group is anApproved Dairy Laboratory, subject to evaluation by USPHS through thePennsylvania Department of Agriculture.

A. COMPANY MEMBERSHIPS

The following lists those business and technical organizations in whichLancaster Laboratories, Inc. holds membership:

0 American Association for Laboratory Accreditation° American Council of Independent Laboratories0 American Industrial Hygiene Association° American Management Association° American Water Works Association0 Association of Official Analytical Chemists0 Better Business Bureau of Eastern Pennsylvania° Chambers of Commerce:

United States Chamber of CommercePennsylvania Chamber of CommercePennsylvania Small Business Advocacy Council (PASBAC)

Lancaster (PA) Chamber of Commerce and Industry° National Federation of Independent Businesses° Pennsylvania Manufacturing Confectioners Association (Associate Member)° Society for the Advancement of Management

B. STAFF MEMBERSHIPS

The following organizations are those in which one or more members of our staffhold individual memberships:

° American Association for the Advancement of Science° American Association of Candy Technologists° American Association of Cereal Chemists0 American Chemical Society0 American Industrial Hygiene Association0 American Oil Chemists Society° American Society for Microbiology° American Society for Testing and Materials° American Society for Training and Development° American Society of Mass Spectrometry° American Society of Personnel Administration° Association of Official Analytical Chemists° Association of Wall and Ceiling Industrialists0 Coblentz Society° Delaware Valley Chromatography Forum0 Institute of Food Technologists° International Association of Business Communicators° International Society of Wang Users° National Asbestos Council° New York Academy of Science° Pennsylvania Dairy Laboratory Directors Association° Society for Applied Spectroscopy0 Society of Quality Assurance0 Water Pollution Control Federation

AR305209

APPENDIX A

Standard Terms and Conditions

210

Standard Teras and Conditions

Confidentiality ... Strict confidentiality is maintained in all of our dealingswith clients. Confidentiality agreements, therefore, are signed willingly. It isassumed, of course, that the client will respect all such relationships of trustand will not use Lancaster Laboratories, Inc.'s name and/or data in any mannerwhich might cause harm to the company's reputation and/or business. Under nocircumstances is the name of Lancaster Laboratories, Inc. (LLI) to be published --either alone or in association with that of any other party -- without its approvalin writing. In any instance where information is subpoenaed by and must bereleased to a regulatory or legal body, the client is promptly notified.

Credit Terms ... Payment in advance is required for all clients except those whosecredit has been established with our company. For clients with LLI-approvedcredit, terms are net 30 days, after which time a 1-1/2Z per month service chargeis added to all unpaid balances.

Billing ... All fees are charged or billed directly to the client. The billing ofa third party will not be accepted without a statement, signed by the third party,which acknowledges and accepts payment responsibility. (NOTE: We will not beresponsible for the re-collection of samples whose holding times have been exceededdue to late requests for third party billing.)

Fee Discounts ... Fees listed in our fee schedule are based upon single samples.Economy-of-scale discounts are available and are determined by the number ofsamples and the nature and spectrum of the requested analyses. Quotations areprovided free of charge.

Minimum Billing ... Minimum fee for service is $10.

Rush Analyses ... A surcharge is added to the list fee if rapid reporting isrequested; that is, if work must be begun immediately upon receipt of the sample.The surcharge will be 50-100Z of the list fee, depending upon the analysis to beperformed. Rush analysis service is offered contingent upon prearrangement withour Technical Services Department. However, any sample delivered after regularbusiness hours (5 p.m.) will not be entered into our rush analyses handling systemuntil the next business day.

Sample Pickup Service & Charges ... LLI provides sample pickup service throughout awide geographic region, with new service areas added regularly. Our drivers aretrained in all procedures necessary to maintain sample integrity during shipment,as well as in security and chain-of-custody requirements. A base charge of $7is made for each stop that is on a regularly scheduled route. If more than10-minutes is required to make the stop, the additional time is charged at $16/hour(in 10-minute intervals). Nonrecurring or nonscheduled pickups are chargedaccording to geographic zone. For information concerning pickup services and/orcharges, please contact our transportation coordinator at extension 260.

Holding Times ... We cannot be responsible for holding times that are exceeded forsamples delivered on weekends or after 5 p.m. on weekdays if delivery is madewithout prior notification and approval.

Sample Containers/Sample Collection ... We will provide and ship the aptgrCsample containers to clients at no charge. Clients requesting overnight?cdelivery of sample containers will be invoiced for the associated charges. LLI haspersonnel available for the on-site collection of samples, or who can explain

AR3Q52! i

Standard Terms and Conditions-2-

sample collection procedures and techniques "to clients. (Call our TechnicalServices Department for further information.) It is the responsibility of theclient to ensure proper sampling and to bear the cost of delivering samples to thelaboratory under proper storage/preservation conditions. We cannot be heldresponsible for sample integrity unless the sampling has been performed by a memberof our staff.

Sample Submission Requirements . . . All samples submitted must be accompanied by aletterhead (including a purchase order number) or purchase order which clearlyenumerates the analyses required. For the sake of accuracy and processingefficiency, please include the following:

1. full names of analyses and, if listed herein, catalog numbers.(Please call our Technical Services Department if you need assistanceor have questions in this regard.);

2. sample type, source, time and date of collection;

3. estimated concentration levels (if known);

4. the date the results are needed;

5. the current billing address.

NOTE: For the protection of our laboratory personnel, samples which might presenthealth hazards, such as those containing high levels of toxic materials, must beclearly marked and identified.

Unlisted Analyses ... We are continually adding to our analytical capabilities inresponse to new state and federal regulatory requirements and/or clients' needs.Please call if the analysis you need is not listed in our schedule of fees andservices.

Hazardous Wastes . .. Unused portions of samples found or suspected to be hazardousaccording to state or federal guidelines are returned to the client upon completionof the analytical work. This includes samples known or suspected to containhazardous materials as defined by state or federal regulatory agencies. The costof returning the sample may be invoiced to the client. The sample and portionsthereof remain the property of the client at all times.

Retention of Samples ... After the analytical results have been reported, samplesare retained in our storage facilities according to the following schedule. Priorarrangements smst be made if samples are to be held for periods longer than thoseindicated.

Sample Type Retention Time

Wastewater & Sludge 7 days

Foods, perishable 7 days

All other samples 30 days &R3Q52 ! 2

Water tested for potability is discarded immediately after theanalysis.

Standard Terms and Conditions-3-

Samples ... Any sample submitted with multiple phases (e.g. water/oil)-.11 have each phase processed, analyzed and billed as a distinct entity unlessinstructions accompanying the sample specify otherwise.

Environmental Quality Assurance Samples ... All analyses are performed usingstandard QA/QC protocols (i.e. the inclusion of blanks, standards, controls andspiked samples in every batch). Additional QC samples which might be requested,and which we consider "project-specific," are billed at the applicable unit pricefor the test(s). Such additional charges will apply to project specific QA/QCsamples for batches with fewer than twenty samples, and to field and trip QA/QCsamples. Quotations for work requiring project specific QA/QC sample analysesshould be requested in advance.

Reports ... Reports may not by reproduced, except in full, without prior writtenapproval by LLI.

Special Reports ... Additional charges may be necessary for customized reportswhich differ significantly from the LLI format. Additional charges will apply forspecific QA/QC report formats, such as NJDEP Tier I or EPA CLP reports. Please askfor a quotation, NOTE: No reports or copies thereof will be sent to anyone otherthan the client unless the client formally requests us to do otherwise in writing.

Litigation ... All costs associated with compliance to any subpoena for documents,for testimony in a court of law, or for any other purpose relating to workperformed by LLI, shall be paid by the client. Such costs shall include, but arenot limited to, hourly charge for persons involved, travel and accommodations,mileage, attorney's preparation of testifier, and all other expenses deemedreasonable and associated with said litigation.

Warranty and Limits of Liability ... In accepting analytical work, we warrant theaccuracy of test results for the sample as submitted. We disclaim any otherwarranties, expressed or implied, including a Warranty of Fitness for ParticularPurpose and Warranty of Merchantability. We accept no legal responsibility for thepurposes for which the client uses the test results. No purchase order or otherorder for work shall be accepted by the company which includes any conditions thatvary from the above described Standard Terms and Conditions. If LancasterLaboratories, Inc. performs work requested by a client, conditions at variancewith the above described Standard Terms and Conditions are not part of theclient-LLI relationship and/or contract.

Equal Opportunity/Affirmative Action Notice ... Lancaster Laboratories, Inc. is anequal opportunity/affirmative action employer and complies with all the regulationsof executive order 11246 and the regulations promulgated thereunder.

SB3052I3

APPENDIX B

Example of Analysis Summary Sheet(Available Upon Request for all Standard Analyses)

A83Q52IU

ANALYSIS SUMMARY SHEET

Name: Detection Limit: Analysis:Total Solids 250 ml - 5 mg/1 #203

Needed for Calculation: N/A

Analysis Name:

Type of Sample: Waters

Sample Size: 250 ml

Container Type: Plastic or Glass

Preservative: None

Group Doing Test: Chem 2

Holding Time: 7 days

Special Instructions:

Scope:

Applicable to potable surface, well, and saline waters, domestic and industrialwastewaters, and sludges and solids.

Basic Principles:

A well-mixed sample is evaporated in a weighed beaker and dried to constant weightin an oven at 103 - 105°C. The increase in weight is the total solids.

vReference:

EPA Methods for Chemical Analysis of Water and Wastes, EPA 600/4-79-020, p. 106.3.

Other Related Reference(s):

Standard Methods for the Examination of Water and Wastewater, 15th Ed., 1980, p. 92,#209A.

A83Q52I5

APPENDIX C

Resumes of Key Personnel

IH3052I6

CORPORATE SENIOR MANAGEMENT

Earl H. Hess, Ph.D., President and Founder

Education:

B.S. Chemistry (cum laude) Franklin and Marshall College t.1952)Ph.D. Organic and Biochemistry, University of Illinois (1955)

Post Doctoral Experience:

Chemistry Faculty, Franklin and Marshall College (1955 - 1957)Research and Development Division, General Cigar Company (1957 - 1961)Established Lancaster Laboratories, Inc. (1961)

Publications:

Various U.S. and foreign patents, scientific papers in basic and appliedresearch (bibliography furnished on request).

Biographical Listings:

American Men and Women of ScienceMen of AchievementWho's Who in the EastWho's Who in Frontier Science and TechnologyWho's Who in Technology Today

Awards. Citations and Honorary Societies:

Honorary Societies - Phi Beta Kappa, Phi Lambda Upsilon, Sigma XiAmerican Council of Independent Laboratories, Inc.,

Special Service Award (1979)Roger W. Truesdail Award for Outstanding Service to IndependentLaboratories (1983)

Distinguished Pennsylvanian (1982) (William Penn Committee)Business Leader of the Year (1988) Pennsylvania Chamber of Business andIndustryFranklin & Marshall Alumni Citation (1988)

Professional, Trade. Civic, Memberships, and Offices:

American Council of Independent Laboratories (ACIL)President (1985 - 1986)

Lancaster Chamber of Commerce and Industry, Chairman of the Board (1935)Pennsylvania Chamber of Commerce. Board of DirectorsU.S. Chamber of Commerce, Board of Directors; Chairman, EnvironmentalCommittee and of Legislative Policy Committee of the Small Business CouncilChairman, Pennsylvania Delegation to 1986 White House Conference on SmallBusinessIssues Commissioner, Pennsylvania Governor's Conference on Small Business(1988)Pennsylvania Small Business Advisory Council (1988)American Association for Laboratory Accreditation (A2LA). JKBifiLftfitt - _ ,Accreditation Council . - l

UR8052I7

C-2

American Society for Testing and Materials (ASTM)Committee on Laboratory Evaluation E-36

American Chemical Society (ACS)American Public Health Association (APHA)American Association for the Advancement of Science (AAAS)New York Academy of SciencesBethany Theological Seminary, Oakbrook, IL, Board of Directors,

Chairman Business and Finance CommitteeBusiness Executives for National Security (BENS)Commonwealth Foundation, Board of DirectorsMeridian Bank, Susquehanna Valley Divisional Board

Other Affiliations:

Mountain States Analytical, Inc., PresidentStandard Laboratories, Inc., Advisory Board

Fred R. Albright. Ph.D.. Senior Vice President/Director, Health Sciences Division

Education:

B.S. Chemistry, Muhlenberg College (1966)Ph.D. Biochemistry, University of Illinois (1970)

Continuing Education:

Johns Hopkins University School of Medicine, Department of PhysiologicalChemistry Postdoctoral Study (1970 - 1972)PA State University Continuing Education: An Environmental Checklist:

Preventing Legal Liability (1987)

Professional Experience:

Sun Oil Company Research and Development Laboratories in Marcus Hook, PA,Summer Research Employee (1965)

Rohm and Haas Chemical Company, Research and Development Laboratories,Summer Research Employee (1966)

With Lancaster Laboratories, Inc. since 1972Senior Vice President/Director of Health Sciences Division (1987)

Publications;

Fourteen scientific papers in areas of enzyme biochemistry and lipidmetabolism, and in agricultural/environmental analytical chemistry; one patent.

Biographical Listings:

American Men and Women of ScienceWho's Who in the East HR3Q52!

C-3

Awards and Citations:

American Cancer Society, Postdoctoral Fellowship (1971 - 1972}Damon Runyon Memorial Fund for Cancer Research, Postdoctoral Fellowship(1970 - 1971)NSF Small Business Innovation Research Grant (1979 - 1980)Oraicron Delta KappaWho's Vho in American Colleges and UniversitiesPhila. Section IFT Award - Food Technologist Most Deserving of Recognition1985

Memberships and Appointments:

American Association of Cereal ChemistsAmerican Council of Independent Laboratories (ACIL)American Oil Chemists SocietyDelaware Valley Chromatography ForumInstitute of Food Technologists - Chairperson,

Philadelphia Section (1983 - 1984);Councilor (1984 - 1987)

Lancaster Chamber of Commerce and Industry, Chairperson, Government AffairsSteering Committee

U.S. Chamber of Commerce, Food and Agriculture Committee (1987 - )Phi Lambda UpsilonDelegate to 1980 White House Conference on Small BusinessUnitarian Church of Lancaster - President, Board of Trustees (1982 • 1983)Millersville University Board of AdvisorsBoard of Directors, Planned Parenthood of Lancaster CountyAmerican Association of Cereal ChemistsPennsylvania Manufacturing Confestioners' Association (PMCA)

Research Committee (1986 - )Chairman, Perm State Research Project

Glenn M. Cahilly, Ph.D., Vice President/Director Support Services

Education:

B.S., Rutgers University (1958)M.S., Virginia Polytechnic Institute (1961)Ph.D., Biochemistry & Nutrition, Virginia Polytechnic Institute (1964)

Continuing Education:

Cornell University, Bioengineering Protein Separating Techniques (1969)Technicon Corp., Autoanalyzer Techniques (1970)Xerox Corp., Professional Selling Skills (1978)R. B. Harris Corp., Marketing Management (1978)

Professional Experience: fti305219MDS Health Group Ltd., Vice President (1977 - 1982)Biozyme Medical Laboratories, Inc., President (1969 - 1977)W. R. Grace & Co., Manager, Biochemistry Research Department (1966 • 1969)

C-4

Worthington Biochemistry Corp.. Technical Director (1964 - L966)Vineland Training School, Research Biochemist (1963 - 1964)Inter-departmental Committee on Nutrition for National Defense - U.S.Department H. E. W. , Analytical Biochemist (1961)With Lancaster Laboratories, Inc. since 1988

Vice President/Director Support Services

Publications:

Various scientific papers covering topics in nutrition, biochemistry andclinical medicine. One U.S. patent.

Honorary Societies:

Sigma XiPhi Lambda UpsilonPhi Sigma

Memberships:

American Chemical SocietyAmerican Management AssociationOlean (NY) Chamber of CommerceNY Academy of ScienceAmerican Institute of ChemistsAgricultural Research InstituteAnimal Nutritional Research CouncilAmerican Clinical Laboratory AssociationPA Chapter of AMT and ASMTVirginia Tech and Rutgers Alumni AssociationsPennsylvania Institute of ChemistsAllegany County (NY) Cooperative ExtensionNew York State Christmas Tree Growers' Association

J. Wilson Hershey, Ph.D., Vice President/Director, Environmental Sciences Division

Education:

B.A. Cheaistry, Millersville State College (1972)M.S. Chemistry, Villanova University (1983)Ph.D. Analytic*! Chemistry, Villanova University (1985)

Continuing Education:

Attended numerous technical meetings and seminars primarily in the field ofinstrumental analysis, including short courses in gas Chromatography and atomicspectroscopy.Currently enrolled in MBA program at Villanova University.

Professional Experience:

With Lancaster Laboratories, Inc. since 1972Vice President/Director of Environmental Sciences Division (1987)

C-5

Publications:

Five scientific publications in analytical chemistry

Awards and Citations:

Outstanding Senior Chemistry Major Award - Millersville State College

Memberships and Appointments:

American Chemical Society ;Delaware Valley Chromatography Forum

Kenneth E. Hess, B.S., Vice President/Director of Finance and Data Processing

Education:

B.S. Chemistry, Juniata College (1975)

Continuing Education:

Various courses in accounting and computers

Professional Experience:

With Lancaster Laboratories, Inc. since 1975Vice President/Director of Finance and Data Processing (1987)

Carol D. Miller, M.B.A., Vice President/Director of Human Resources

Education:

B.S. Applied Mathematics/Economics, Ursinus College (1982)M.B.A. Administrative Management, Saint Joseph's University (1987)

Continuing Education:

Franklin and Marshall College, Interviewing and Selection Techniques (1983)Franklin and Marshall College, Personnel Management (1983)Managing Human Performance (1984)

Professional Experience:

With Lancaster Laboratories, Inc. since 1981 "ftVice President/Director of Human Resources (1987)

C-6

Memberships and Appointments:

Leadership Lancaster, 1984 GraduateAmerican Society of Personnel AdministratorsAmerican Society for Training & Development (1985)Junior Achievement, Board of Directors (1985 - 1986)Multiple Sclerosis Society, Board of Directors (1985 - 1988)

C-7

KEY PERSONNEL

Sandra R. Bailey, B.S., Chemist I, Food ChemistryHealth Sciences Division

Education:

B.S. Chemistry (cum laude), University of Delaware (1987)

Continuing Education:

Scientific Instruments Auto Analyzer Training Course (1987)

Professional Experience:

With Lancaster Laboratories, Inc. since 1987

Nancy J. Bornholm, B.S., Technical Service Specialist IIEnvironmental Sciences Division

Education:

B.S. Chemistry, (magna cum laude) Muhlenberg College (1981)

Continuing Education:

Basic Serology, Federal Bureau of Investigation (FBI) Academy (1983)Introduction to Hairs and Fibers, FBI Academy (1983)Forensic Chemists Seminar, Drug Enforcement Administration (1984)Survey of Glass, FBI Academy (1984)Instrumental Analysis of Paints and Polymers, FBI Academy (1984)ACS Short Course, Analytical Chemistry of Contaminants in Surface andGroundwater (1986)

Professional Experience:

University of Connecticut Health Center, Laboratory Technician (1977 - 19801Institute for Cancer Research, Research Technician (1981)Baltimore City Crime Laboratory, Mobile Crime Unit Trainee (1981 - 1982)Maryland State Police Crime Laboratory, Forensic Chemist III (1982 - 1985)With Lancaster Laboratories, Inc. since 1985

Technical Service Specialist II (1988)

Christine K. Brennian, B.S., Chemist II, GC/MS Volatile*Environmental Sciences Division

Education: ft8305223B.S. Chemistry, West Virginia University (1982)

C-8

Continuing Education:

Basic Programming, West Virginia University (1983)Dionex Ion Chromatography Seminar (1984 - 1985)ACS Short Course, Analytical Chemistry of Contaminants in Surface andGroundwacer (1986)

Professional Experience:

West Virginia University Medical Center, Electron Microscopy Technologist,(1982 - 1984)With Lancaster Laboratories, Inc. since 1984

Chemist II (1988)

Richard M. Burke, M.S.. Assistant Division DirectorEnvironmental Sciences Division

Education:

B.S. Chemistry, Lemoyne College (1969)M.S. Chemistry, State University of New York - College of Environmental Scienceand Forestry (1978)

Professional Experience:

Donohue & Associates, Laboratory Project Manager (1978 - 1979)Camp Dresser & McKee, Inc., Laboratory Services Manager (1979 - 1981)Kemron Environmental Sciences, Field Services Manager (1981)IT Corp.. Laboratory Manager (1982 - 1987)IT Corp., Regional Lab Director (1987 - 1988)With Lancaster Laboratories, Inc. since 1988

Publications:

Arsenic in the Marine Environment (1978)

Memberships and Appointments:

American Chemical SocietyAmerican Society of Testing and MaterialsWater Pollution Control Federation

Eric V. Cuba, B.S., Chemist I, InorganicsEmrironaental Sciences Dirision

Education:

B.S. Chemistry, King's College (1985)

Professional Experience:

With Lancaster Laboratories, Inc. since 1986Chemist I (1988)

C-9

Noreen Curristin, B.S., Chemist I, Food ChemistryHealth Sciences Division

Education:

B.S. Chemistry and Biochemistry, University College Galway, Ireland (1986;Higher Diploma in Applied Science, Analytical Chemistry and Biochemistsry,University College Glaway, Ireland (1987)

Continuing Education:

Technical Seminar, HPLC and Dissolution Assays in the Pharmaceutical Field(1987) in University of DublinChrornpak LC Basic Course (1988)

Professional Experience:

Elan Pharm. Co., Westmeath, Ireland, Analytical Chemist (1987)With Lancaster Laboratories, Inc. since 1988

Memberships:

Royal Society of Chemists (London)

Earl R. Custer, B.S., Microbiologist IIIHealth Sciences Division

Education:

B.S. Biology, University of Pittsburgh (1969)

Professional Experience:

With Lancaster Laboratories, Inc. since 1973Microbiologist III (1985)

Michele M. Droney, B.A., Chemist I, GC/MS VolatilesEnvironmental Sciences Division

Education:

B.A. Chemistry, East Stroudsburg University (1987)

Professional Experience:

With Lancaster Laboratories, Inc. since 1987Chemist I (1988)

Awards. Citations, and Honorary Societies:

American Institute of Chemists Award (1987)

Memberships and Appointments: .noftET

American Chemical Society

C-10

Robin Young Eaton, M.S., Chemist I, GC/MS VolatilesEnvironmental Sciences Division

Education:

M.S. Chemistry, Virginia Commonwealth University (1983)B.S. Chemistry, Longwood College, (1980)

Professional Experience:

Instructor for the Pennsylvania State University at the York Campus and theCapital College locations teaching General Chemistry and Organic Chemistrycourses (1984 - 1988)With Lancaster Laboratories, Inc. since 1988

Presentations and Publications:

Two scientific presentations on Catalysis at American Chemical Societymeetings, and one scientific presentation on Catalysis at the Eighth NorthAmerican Catalysis MeetingThree scientific papers in the area of Catalysis for Synthesis Gas Conversion

Memberships:

American Chemical SocietyAmerican Association for the Advancement of Science

Richard C. Entz, B.A., Group Leader II, Organic AnalysisEnvironmental Sciences Division

Education:

B.A. Chemistry, Wabash College (1972)

Professional Experience:

Teaching Assistant, Kansas State University (1972 - 1974)U.S. Department of Agriculture, Research Assistant (1974 - 1977)U.S. Food and Drug Administration, Division of Chemical Technology, Chemist(1977 - 1984)With Lancaster Laboratories, Inc. since 1984

Group Leader (198S)

Publications;

Four publications in areas of environmental analytical chemistry and volatileorganic compounds.

Awards and Citations:

Undergraduate Chemistry Award, Wabash College (1972)Phillips Petroleum Research Award (1976)

£8305226

C-ll

Memberships and Appointments:

American Chemical Society

Les Erb. B.A., B.S., Chemist I, GC/MSEnvironmental Sciences Division

Education:

B.A. Biology, Eastern Mennonite College (1982)B.S. Business Administration, Easter Mennonite College (1982)

Continuing Education:

ACS Introduction to Mass Spectrometry (1987)

Professional Experience:

With Lancaster Laboratories, Inc. since 1985Chemist I (1988)

Jack T. Follweiler, B.S., Group Leader II, Industrial HygieneHealth Sciences Division

Education:

B.S. Analytical Chemistry, Juniata College (1982)

Continuing Education:

Industrial Hygiene Refresher Course (1985)"Asbestos in Buildings • A Symposium" (1985)U.S. EPA Course: "Asbestos Hazards, Evaluation and Abatement" (1986)McCrone Research Institute: "Advanced Asbestos Identification" (1986)U.S. EPA: "Symposium on Indoor Air" (1986)U.S. EPA Course: "AHERA Building Inspector" (1987)

Professional Experience:

ICI Americas, Inc., Analytical Chemist/Industrial Hygienist (1982 - 1985)With Lancaster Laboratories, Inc. since 1985

Group Leader (1987)

Memberships and Appointments:

Lancaster County Industrial Safety Council (LCISC)Central Pennsylvania Section - American Industrial Hygiene Association(CPS-AIHA), Co-Director, Professional Development (1987 & 1988)EPA Technical Consultant for air sampling and analytical methodologies(EPA Region III) HR305227

C-12

Joseph V. Friel, B.S., Senior Chemist, Pharmaceutical*Health Sciences Division

Education:

B.S. Chemistry, PMC, Widener University (1964)20 credits, chemistry - State University of New York (1966 - 1971)

Professional Experience:

Ayerst Laboratories, ascending positions in all phases of quality controllaboratory testing (1964 - 1982)Ayerst Laboratories, Manager, Estrogen Labs (1982 - 1986)Scott Paper Company, Chemical Services Technician (1986 - 1987)With Lancaster Laboratories, Inc. since 1987

Gloria A. Gates, B.S. , Chemist II/Coordinator, Food ChemistryHealth Sciences Division

Education:

B.S. Chemistry, Bloomsburg State College (1983)

Continuing Education:

ACS Short Course - Maintaining and Troubleshooting Chromatographic SystemsWorkshop (1986)Chrompack - Wide Bore GC Course (1988)

Professional Experience:

Berkley Products, Analyst (1983)Warner-Lambert, Farke Davis, Associate Chemist (1984 - 1985)With Lancaster Laboratories, Inc. since 1985

Chemist II (1987)

Debora K. Gifford, B.S., Chemist II/Coordinator, Inorganic AnalysisEnvironmental Sciences Division

Education:

B.S. Health and Physical Education, Ursinus College (1977)

Continuing Education;

General, Organic and Analytical Chemistry Courses, Muhlenberg College(1979 - 1981)Calculus Course, Villanova University (1983)Physics I and II, Ursinus College (1985)

flR305228

C-13

Professional Experience:

Eastern PA Health Care Foundation, Special Projects Coordinator (1978 - 1931BCM Lab, Technical Supervisor (instrumentation) (1981 - 1985)With Lancaster Laboratories, Inc. since 1985

Chemist II, Coordinator (1988)

C. Robert Graham. B.S., Senior MicrobiologistHealth Sciences Division

Education:

B.S. Dairy Science, Pennsylvania State University (1963)

Professional Experience:

With Lancaster Laboratories, Inc. since 1965Senior Microbiologist (1985)

Publications :

Effect of Supercritical Fluid Extraction on Microorganisms (1987)

Memberships and Appointments:

Pennsylvania Dairy Laboratory Directors AssociationApproved Dairy Inspector, Pennsylvania Department of AgricultureAmerican Association of Candy Technologists (Philadelphia Section, Board ofDirectors)Pennsylvania Manufacturing Confectioners AssociationAssociate Referee of AOAC for Extraneous Filth in Cocoa Press Cake and CocoaPowder

Wanda M. Graham, B.A., Chemist I, Food ChemistryHealth Sciences Division

Education:

B.A. Chemistry (summa cum laude), Messiah College

Continuing Education:

Society for Applied Spectroscopy - "Successful Atomic SpectrometricDeterminations" (1987)AOAC Seminar on Trace Analysis (1988)

Professional Experience:

Lancaster Laboratories, Inc. Summer of 1985 (training)With Lancaster Laboratories, Inc. since 1986

Chemist I (1988)

C-14

Randall H. Guthrie, B.S., Marketing ManagerHealth Sciences Division

Education:

B.S. Biology, Cannon University (1977)

Continuing Education:

West Chester State University, Inorganic Preparation (1979)lenter for Professional Advancement (1978 - 1982)

Preparing NDA's and IND'sPharmaceutical Quality Assurance and ControlGood Manufacturing PracticesHigh Performance Liquid ChromatographyHigh Purity Process WaterThin Layer Chromatography

Juran Quality Improvement Program (1983)Philip Crosby Associates, Quality Management and Instructor College (1987)Perm State University, Personal Selling (1988)

Professional Experience:

Johnson Matthey Inc., Manager, Quality Assurance (1977 • 1987)With Lancaster Laboratories, Inc. since 1987

Marketing Manager (1988)

Memberships and Appointments:

American Chemical SocietyAmerican Society for Quality ControlParenteral Drug AssociationAmerican Association of Pharmaceutical Scientists

Robert G. Heisey, Jr., B.A., Chemist I, Vater QualityEnvironmental Sciences Division

Education:

B.A. Chemisty, Millersville State College (1972)

Professional Experience:

RCA Corp., Engineering Technician (1972 - 1987)With Lancaster Laboratories, Inc. since 1988

Jenifer E. Hess. B.S., Chemist II/Coordinator, Organic AnalysisEnvironmental Sciences Division

Education:

B.S. Chemistry, University of Delaware (1984)

ftf?3Q5230

C-15

Professional Experience:

J. M. Huber Corporation, Research Chemist (1984 - 1985)With Lancaster Laboratories, Inc. since 1985

Chemist II (1987)

Memberships:

Chromatography Forum of Delaware ValleyI

H. Louise Hess. B.S., Director, Quality Assurance

Education:

B.S. Chemistry (cum laude), Lebanon Valley College (1978)

Continuing Education:

Several short courses in atomic absorption and gas ChromatographyQuality Assurance of Chemical Measurements, ACS (1985)Quality Assurance in Microbiology, AOAC (1985)Villanova University graduate work in analytical chemistry (1986)

Professional Experience:

With Lancaster Laboratories, Inc. since 1978Director, Quality Assurance (1985)

Publications:

Two scientific papers on basic research in physical chemistry

Memberships and Appointments:

Society of Quality Assurance

David J. Hooley. Ph.D., Group Leader I, Computer Services

Education:

B.A. Chemistry, Eastern Mennonite College (1973)Ph.D. Chamistry, Virginia Polytechnic Institute (1981)

Continuing Education:

Effective Management of Chemical Analysis Laboratories (1984)Masscomp MC5500 Hardware Maintenance (1986)Attended numerous conferences on analytical chemistry, scientific computing ar.dlaboratory information management.

flR30523i

C-16

Professional Experience:

WVPT-TV, Harrisonburg, VA, Operating Engineer (1972 - 1974)Virginia Polytechnic Institute, Research Assistant (1974 - 1981)Standard Oil Research & Development (1981 - 1987)With Lancaster Laboratories, Inc. since 1987

Publications and Presentations:

Five scientific publications on computer applications in analytical chemistryIntegrating LIMS and Business at Lancaster Laboratories, Inc.: ContinuingDevelopment given at 102nd AOAC Annual Meeting

Memberships:

American Chemical SocietyPhi Lambda UpsilonForth Interest Group

Anneliese Hutchison, B.S. , Technical Service Specialist IEnvironmental Sciences Division

Education:

B.S. Molecular and Cell Biology, Pennsylvania State University (1986)

Professional Experience:

With Lancaster Laboratories, Inc. since 1986Technical Service Specialist I (1988)

Anne (Jeannie) Jacobson, B.S., Microbiologist I/Coordinator, BioassaysHealth Sciences Division

Education:

B.S. Biology, Lambuth College (1986)

Continuing Education;

Limulus Amebocyte Lysate Testing Workshop (1988)

Professional Experience:

With Lancaster Laboratories, Inc. since 1986Microbiologist I (1987)

Russell R. Johnson, B.A., Marketing Specialist IIEnvironmental Sciences Division

RR305232B.A. English, Franklin and Marshall College (1973)

C-17

Continuing Education:

Dun & Bradstreet Seminars "Improving Customer Relations" and "Analyzing andImproving Direct Mail" (1985)

Professional Experience:

Prudential Insurance Company, District Representative (1973 • 1974)SCA Services, Greater Lancaster Division, Operations Manager (1974 • 1980)SCA Services, Mid-Atlantic Region, Regional Sales Manager (1980 - 1982)RCA Service Company, Branch Sales Manager (1982 - 1984)With Lancaster Laboratories. Inc. since 1985

Marketing Specialist II (1988)

Beatrice M. Joseph. B.S., Chemist I, Inorganic AnalysisEnvironmental Sciences Division

Education:

B.S. Chemistry, College of Pharmacy and Chemistry, Iraq (1953)

Continuing Education:

Atomic Absorption Spectrometry

Professional Experience:

St. Joseph's Hospital, Research Institute, Laboratory Technician (1969 - 1976)With Lancaster Laboratories, Inc. since 1976

Chemist I (1977)

Mark W. Kaiser, Group Leader II, BioassaysHealth Sciences Division

Education:

Elizabethtown College, Biology 120 credits (1983)

Professional Experience:

With Lancaster Laboratories, Inc. since 1.983Group Leader (1985)

Memberships and Appointments:

Parenteral Drug Association, Microbiological Subcommittee

John K. Kenna, B.S., Chemist II, PharaaceuticalsHealth Sciences Division

Education:

B.S. Chemistry, St. Joseph's University (1984) Mft305233

C-18

Professional Experience:

Wyeth Labs, Quality Assurance Analyst IV (1978 - 1987)With Lancaster Laboratories, Inc. since 1987

Chemist II (1988)

Memberships:

Chromatography Forum of Delaware Valley

Martha M. Klenk, B.S., Group Leader II, Feed MicrobiologyHealth Sciences Division

Education:

B.S. Business Administration (Management), Millersville University (1985)Biology, 36 credits, Millersville University (1983)

Continuing Education:

Rapid Methods and Automation in Microbiology, Kansas State University (1986)Immunology, Lebanon Valley College (1986)

Professional Experience:

Hershey Chocolate Company, Microbiology Technician (1985 • 1986)With Lancaster Laboratories, Inc. 1978 - 1984, 1986 - Present

Group Leader (1986)

Memberships:

Society for the Advancement of Management (SAM)International Association of Milk, Food, and Environmental Sanitarians (IAMFES)

Gordon (Tony) Lodde, B.S., Industrial Hygienist I, Industrial HygieneHealth Sciences Division

Education:

B.S. Occupational Safety and Hygiene Management, Millersville StateUniversity (1987)

Continuing Education;

School of Aerospace Medicine, USAFEnvironmental Protection (1981)Industrial Radiation Hazards (1982)Industrial Hygiene Measurements (1984)Asbestos Hazard Evaluation and Abatement Workshop (1987)Asbestos Abatement for Inspectors (1988)Radon Testing and Mitigation Specialist (1988)

C-19

Professional Experience:

U.S. Air Force, Industrial Hygiene Technician (1979 - 1984)Analytics Laboratories, Asbestos Abatement Monitor (1984 - 1986)With Lancaster Laboratories, Inc. since 1987

Memberships and Appointments:

Central Pennsylvania Chapter of the AIHA

Kathleen M. Loeven, B.S.. Data Package Specialist, Quality Assurance

Education:

B.S. Biology, West Virginia Wesleyan College (1969)

Continuing Education:

Environmental Analytical Quality, Hewlett Packard (1988)

Professional Experience:

Microbiological Associates, Biological Laboratory Technician (1969 - 1970)Schuyler Laboratories, Laboratory Technician (1970 • 1971)Victor F. Weaver, Inc., Labeling-Specifications Supervisor/Liason with USDA(1985 - 1988)With Lancaster Laboratories, Inc. since 1988

Cheryl Matias, B.S., Chemist I, GC/MS EztraccablesEnvironmental Sciences Division

Education:

B.S. Chemistry, Youngstown State University (1982)

Continuing Education:

George Washington University, Forensic Science: Graduate Level (1983 - 1984)University of Virginia, Instrumental Analysis: Graduate Level (1984)Northern Virginia Community College, Data Processing - FORTRAN, COBOL (1984 -1985)

Professional Experience:

Federal Bureau of Investigation, Washington D.C., Chemist (1982 • 1987)With Lancaster Laboratories, Inc. since 1988

Betsy S. Menefee, B.S., Chemist II/Coordinator, Inorganic Analysis,Second Shift LeaderEnvironmental Sciences Division AH 30 52 35

Education:

B.S. Chemistry. Salem College (Winston-Salem, NC) (1958)

C-20

Professional Experience:

Duke University, Research Assistant (1958 - 1959)With Lancaster Laboratories, Inc. since 1979

Chemist II (1987)

Publications:

Two scientific publications in analytical chemistry

Richard F. Miller, B.A., Public Relations Coordinator,Group Leader II, Sample Administration/Transportation

Education:

B.A. Journalism, Pennsylvania State University (1982)

Professional Experience:

Video Mill, Inc., President (1982 - 1985)With Lancaster Laboratories, Inc. since 1985

Group Leader II (1987)

John F. Morton, M.S., Chemist II, GC/MS VolatilesEnvironmental Sciences Division

Education:

B.S. Biochemistry, California Polytechnic State University (1974)M.S. Chemistry, University of Delaware (1977)

Continuing Education:

Introduction to Data Processing and Algorithm Design in BASIC coursework,Gwynedd-Mercy College (1983)The LC Short Course, Waters Associates (1983)The Series 1020/OWA Operator Course, Finnigan MAT Institute (1985)USEPA Symposium on Waste Testing and Quality Assurance, Washington D.C. (1988)

Professional Experience:

BCM. Inc., Analytical Chemist (1978 - 1980)Envirosafe Services, Inc., Q.C. Supervisor (1980 - 1981)Copper Range Company, Chief Chemist (1982)Q.C. Inc., Analytical Chemist (1983 - 1988)With Lancaster Laboratories, Inc. since 1988

Publications:

Preparaton for Steroid Esters of Hydroxypropyl Cellulose, J. Polymer Sci, (1979)Timed-Released Depot for Anticancer Agents II, Acta Pharm. Suec. (1978)

C-21

Memberships:

American Chemical Society

Charles J. Neslund. B.S., Group Leader I, Pesticides and PCBsEnvironmental Sciences Division

Education:

B.S. Chemistry, University of Pittsburgh (1982)Organic Chemistry (1983)

Professional Experience:

Magee Women's Hospital, Pittsburgh, Laboratory Technician (1981 - 1984)With Lancaster Laboratories, Inc. since 1984

Group Leader (1987)

Memberships:

Chromatography Forum of Delaware Valley

Kiaberly A. Oliver, B.S., Quality Assurance Specialist I

Education:

B.S. Biology, Pennsylvania State University (1983)

Continuing Education:

Center for Professional Advancement, Good Laboratory Practices (1988)

Professional Experience:

Biospherics, Inc., Laboratory Technician (1983 - 1984)Eastern Laboratory Service Associates, Laboratory Technician (1984 - 1985)With Lancaster Laboratories, Inc. since 1985

Quality Assurance Specialist I (1988)

Timothy S. Ooitdyk, B.A., Croup Leader II, GC/MS VolatilesEnvironmental Sciences Division

Education:

B.A. Chemistry (cum laude), Franklin and Marshall College (1985)

Continuing Education: a———— ———— ftfICP Seminar (1985)

C-22

Professional Experience:

Nabisco Brands Technology Center, Technician (Summer 1983)With Lancaster Laboratories, Inc. since 1985

Graup Leader (1987)

Publications:

One scientific publication in analytical chemistry

Awards and Citations:

Phi Beta Kappa, Franklin and Marshall College

Victoria A. Pillion, B.S., Chemist I, Food ChemistryHealth Sciences Division

Education:

B.S. Chemistry, Alvernia College (1983)

Continuing Education:

HPLC Course, The Chromatography Forum of Delaware Valley (1986)Basic HPLC Course, Chrompack Inc. (1987)

Professional Experience:

Warner Lambert Co., Lititz, PA, Associate Analyst (1984 - 1987)Royer Pharmaceutical Corp., Fort Washington, PA, Analytical Control Chemist(1987)AMP Inc., Harrisburg. PA, Chemist II (1988)With Lancaster Laboratories, Inc. since 1988

Nelson H. Rlssar. B.A., Manager. GC/MSEnvironmental Sciences Division

Education:

B.A. Chemistry, Shippensburg State College (1977)

Continuing Education;

Chromatography Forum of Delaware Valley, Capillary GC (1981)Dionex Ion Chromatography (1983)Finnigan MAT 1020/OWA Operation (1983)Finnigan MAT 1020/OWA Maintenance (1983)Finnigan MAT Mass Spectra Interpretation and GC/MS (1984) _Finnigan MAT OWA/1050 Software (1986) «n305238Hewlett Packard 5988/5966/5970 RTE Operator's Training Course (1987)

C-23

Professional Experience:

Frederick Cancer Center, Frederick MD, Analytical Chemist (19"7 - 1979)With Lancaster Laboratories, Inc. since 1979

Manager, GC/MS (1987), Project Manager, U.S. EPA Contract LaboratoryProgram

Publications:

Four scientific papers on chemical analysis of carcinogens

Memberships and Appointments:

Chromatography Forum of Delaware ValleyAmerican Society for Mass Spectrometry

Richard S. Rodgers, B.S., Group Leader II, GC/MS ExtractablesEnvironmental Sciences Division

Education:

B.S. Chemistry, Millersville University (1975) '.

Continuing Education:

Perkin-Elmer Atomic Absorption Workshop (1977)5985 Gas Chromatograph/Mass Spectrometer Users (1980)Analytical Methods for Priority Pollutants (1981)Symposium on Advances in Analytical Methods for Monitoring Organic Chemicals inthe Environment - Water and Hazardous Wastes (1984)GC/MS System Manager Training Course • User 1 (1986)Interpretation of Mass Spectra - Short Course (1987)

Professional Experience:

Millersville State College, Department of ChemistryLaboratory Assistant (1971 - 1972)Chemistry Technician (1972 - 1975)

Ichthyological Associates, Inc., Analytical Chemist (1975 - 1977)Radiation Management Corporation

GC/MS Operator, Manager (1978 - 1985)With Lancaster Laboratories, Inc. since 1985

Group Leader (1987)

Memberships and Appointments:

Chromatography Forum of Delaware ValleyAmerican Chemical SocietyAmerican Society for Mass Spectrometry

C-24

Nancy Saunders, B.S., Chemist I, Pesticides and PCBsEnvironmental Sciences Division

Education:

B.S. Chemistry, Syracuse University (1985)

Professional Experience:

Cayuga County Laboratory, Auburn, NY, Senior Technician (1967 - 1985)With Lancaster Laboratories, Inc. since 1986

Chemist I (1988)

Memberships and Appointments:

Chromatography Forum of Delaware Valley

Terry Schuck, B.S., Chemist I, Instrumental Water QualityEnvironmental Sciences Division

Education:

B.S. Environmental Resource Management, Pennsylvania State University (1984)

Continuing Education:

The Institute for Environmental Education, Groundwater Monitoring Seminar (1986)

Professional Experience:

With Lancaster Laboratories, Inc. since 1984Associate Chemist (1987)

David V. Schumacher, B.S., Senior Chemist, Food ChemistryHealth Sciences Division

Education:

B.S. Biochemistry (cum laude), Pennsylvania State University (1972)

Continuing Education;

Immunochemical Techniques for Chemists • American Chemical Society (1988)

Professional Experience:

With Lancaster Laboratories. Inc. since 1972Senior Chemist (1985)

PM. , flPublications:

Four scientific publications in agricultural/environmental analytical chemistry

C-25

Memberships and Appointments:

Institute of Food TechnologistsChromatography Forum of Delaware ValleyAssociation of Official Analytical Chemists

Delwyn K. Schumacher, B.S., Chemist IV/Coordinttor, Organic AnalysisEnvironmental Sciences Division

Education:

B.S. Chemistry, Pennsylvania State University (1977)

Continuing Education:

Rubber Technology, American Chemical Society (1979)Capillary Chromatography, West Chester State University (1980)

Professional Experience:

Pennsylvania Departzent of Environmental Resources, Laboratory Technician (1977)Armstrong World Industries, Inc., Chemist (1977 - 1979)With Lancaster Laboratories, Inc. since 1979

Chemist IV (1987)

Publications:

Cosigned 2 records of invention involving assembly line furniture finishing forArmstrong World Industries (1977)Cosigned patent application for a polymerizing silicone masonry treatment forprotection against weathering for Lancaster Laboratories' client (1984)

Lee A. Seats. B.S., Manager, Inorganic AnalysisEnvironmental Sciences Division

Education:

B.S. Chemistry, Millersville University (1979)M.B.A. courses begun, St. Joseph's University (1987)

Continuing Education:

Three-day training course on Inductively Coupled Plasma Spectroscopy,Instrumentation Laboratories (1983)

Professional Experience:

With Lancaster Laboratories, Inc. since 1979Manager (1987)

C-26

Richard A. Shober. B.S.. Group Leader I, Technical ServicesEnvironmental Sciences Division

Education:

B.S. Chemistry, Muhlenberg College (1984)

Continuing Education:

Inductively Coupled Plasma Spectroscopy, Allied Analytical (1985)ACS Short Course, Analytical Chemistry of Contaminants in Surface andGroundwater (1986)

Professional Experience:

With Lancaster Laboratories, Inc. since 1984Group Leader (1987)

Publications:

Poster paper at Pittsburgh Conference on Development of In-House Software ForUse With ICP (1986)

Tammy L. Showers, B.S., Chemist I, Food ChemistryHealth Sciences Division

Education:

B.S. Biology, Albright College (1980)

Continuing Education:

Graduate Courses in Anatomy at Temple University (1981)Basic HPLC Course, Chromatography Forum of Delaware Valley (1985)Maintaining and Troubleshooting Chromatographic Systems - ACS Short Course(1986)Advanced HPLC Course by Chrompack, Inc. (1988)

Professional Experience;

With Lancaster Laboratories, Inc. since 1984Chemist I (1986)

Max E. Snavely, B.S., Chemist I, Inorganic AnalysisEnvironmental Sciences Division

Education:

B.S., Chemistry, Lebanon Valley College (1977) ftR^fl^?! O

Professional Experience:

Sterling Drug, Inc., Quality Control Chemist (1977 - 1980)Andrew S. McCreach & Sons. Inc., Analytical Chemist (1980 - 1987)With Lancaster Laboratories, Inc. since 1987

C-27

John L. Snyder, M.S., Chemist IV, GC/MS ExtractablesEnvironmental Sciences Division

Education:

B.A. Chemistry, Messiah College (1975)Lancaster Theological Seminary (1979 - 1980)M.S. Chemistry, Villanova University (1985); Currently doing research for Ph.D.

Professional Experience:

Teacher, Zimbabwe & Zambia (1975 - 1978)National Hydron (1978 - 1979)Charles Snyder (1981 - 1982)With Lancaster Laboratories, Inc. since 1982

Chemist IV (1987)

Publications:

Co-author, Emission Spectroscopy Review Article (1986)Analytical Chemistry Paper, TOX as an Analytical Tool, EPA Solid WasteSymposium (1987)Co-author, Emission Spectroscopy & Review Article, Analytical Chemistry (1988)

Memberships and Appointments:

American Chemical Society

Tamra Sprout, B.S., Chemist I, Pesticides and PCBsEnvironmental Sciences Division

Education:

B.S. Chemistry (cum laude), Millersville University (1985)

Continuing Education:

Masters Chemistry Program, Villanova University

Professional Experience:

With Lancaster Laboratories, Inc. since 1985Chemist I (1987)

Memberships and Appointments:

Chromatography Forum of Delaware Valley

Valerie J. St. Clair. B.S.. Microbiologist IV, Food Microbiolog^.83052^3Health Sciences Division

Education:

B.S. Biology, James Madison University (1977)

C-28

Continuing Education:

MIF/IAICM Listeria Workshop (1986)AMI Listeria Workshop (1987)Rapid Methods and Automation in Microbiology Workshop (1987)ASM Salmonella spp. and Campylobacter lyuni Workshop (1988)Seafood Surveillance Program HACCP Workshop for Breaded Fish and SpecialityProducts (1988)Pennsylvania State University graduate work in food microbiology (1988)

Professional Experience:

With Lancaster Laboratories, Inc. since 1977Microbiologist IV (1987)

Memberships and Appointments:

American Society for MicrobiologyPennsylvania Manufacturing Confectioners' Association

Robert Stauffer. B.S.. Integration Systems Specialist IIEnvironmental Sciences Division

Education:

B.S., Microbiology, Pennsylvania State University (1979)B.S., Computer Science, Millersville University (1986)

Continuing Education:

Hewlett-Packard HP1000 System Manager Training (1988)Hewlett-Packard HP1000 Laboratory Automation System Programming Training (1988)

Professional Experience:

Frederick Cancer Research Center, Microbiology Research Technician (1979 - 1981)Victor F. Weaver, Inc., Quality Assurance Inspector (1982 - 1984)Victor F. Weaver, Inc., Computer Programmer/Operator (1984 - 1987)With Lancaster Laboratories, Inc. since 1988

Memberships and Appointments:

INTEREX - International Association of Hewlett-Packard Computer Users

Jill A. Trishman, B.S., Technical Service SpecialistHealth Sciences Division

Education:

B.S. Biology. Dickinson College (1979)

C-29

Professional Experience:

With Lancaster Laboratories, Inc. since 1984Technical Service Specialist (1986)

Dennis J. Urban, M.S., Chemist III, Coordinator, Organic AnalysisEnvironmental Sciences Division

Education:

M.S. Chemistry, St. Joseph's College (1976)B.A. Chemistry, Millersville State University (1972)

Continuing Education:

Seminars for various methods of instrumental analysis in the areas of gasChromatography, high performance liquid Chromatography and infrared spectromet:

Professional Experience:

RCA, Associate Engineering Technician (1972 - 1977)Wyeth Laboratories (Marietta, PA), Control Analyst (1977 - 1979)Wyeth Laboratories (West Chester, PA), Chemist II (1979 v- 1980)RCA, Senior Engineering Technician (1980 - 1982)

Member, Technical Staff (1982 - 1987)With Lancaster Laboratories, Inc. since 1987

Memberships and Appointments:

American Chemical SocietySociety of Applied SpectroscopyChromatography Forum of Delaware Valley

Barbara J. Weaver, CIH, Specialist III, Marketing/Technical ServiceHealth Sciences Division

Education:

B.S. Chemistry, Elizabethtown College (1971)

Certifications:

American Board of Industrial Hygiene - certified in comprehensive practice ofindustrial hygiene, cert. #2719

Continuing Education:

Elizabethtown College, Business Law (1979)NIOSH course #553 "Industrial Hygiene Sampling, DecisionMaking, Monitoring and Record Keeping, Sampling Strategies"g||93fThomas Jefferson University: "Workshop in Industrial ToxicoTogy^ ir9SO)' -Villanova University, Graduate work, Special Topics Environmental/AnalyticalChemistry (1981)

C-30

Northeastern Association of Microscopy (NEAM):"Analytical and Quantitative Microscopy" (1981)

"Comprehensive Industrial Hygiene Review" - Cincinnati (1983)"Asbestos - The Workplace. Buildings and Schools:

Risk Assessment Management" Johns Hopkins School of Hygiene and PublicHealth (April 1984)

One Day "Workshop on Asbestos Job Surveillance and Air Monitoring"Marshall Marcus, CIH for School District of Philadelphia (June 1984)

West Chester, Graduate work, Environmental Health (1985)

Professional Experience:

Warner Lambert, Inc., Quality Control Chemist (1971 - 1973)Hershey Medical Center, Junior Research Technician (1973 • 1974)Elizabethtown College, Laboratory Instructor (1977 - 1978)With Lancaster Laboratories, Inc. since 1978

Marketing/Technical Service Specialist III (1987)

Publications:

Albright, F.R., et al., "Fluorescent Dye Binding Technique for the Detection ofChrysotile Asbestos," Microscope (1983)

Biographical Listings:

Under Barbara J. Felty:Who's Who in the East. 19th edition (1983 - 1984)

Memberhips:

American Industrial Hygiene Association, Central Pennsylvania Section -Treasurer (1981 - 1984), President-Elect (1985 - 1986), President (1986 - 1987)Chemical Health and Safety Section, American Chemical SocietyLancaster County Industrial Safety Council (Director 1988 - 1989)National Asbestos Council

Patrick C. Weidinger, B.S., Industrial Hygienist II, Field Operations Coordinator,Industrial Hygiene, Health Sciences Division

Education:

B.S. Occupational Safety and Hygiene Management, Millersville University (1986)

Continuing Education:

Asbestos-Hazard Evaluation and Abatement, Drexel University (1987)Course recognized by the EFA

Asbestos Abatement for Inspectors, Tufts University (1987)Course recognized by the EFA

Asbestos Abatement Conference for Management Planners, TempleCourse recognized by the EPA

Assessing Bioaerosols in Indoor Environments, University of Michigan (1988)

flR3052i*6

C-31

Professional Experience:

High Industries, Inc., Safety and Health Intern (1986)With Lancaster Laboratories, Inc. since 1986

Industrial Hygienist II, Field Operations Coordinator (1988)

Awards, and Citations:

Scholarship presented by Central PA Chapter of the American Society EngineersOccupational Safety and Hygiene Management

Memberships and Appointments:

American Industrial Hygiene Association (AIHA)American Society of Safety Engineers (ASSE)

David J. Weiser, B.S., Coordinator I, Data PackageEnvironmental Sciences Division

Education:

B.S. Education, Biology, Millersville University (1987)

Professional Experience:

With Lancaster Laboratories, Inc. since 1988

Ramona Wendt, B.S., Chemist II/Coordinator, Vater QualityEnvironment*! Sciences Division

Education:

B.S. Chemistry, Grove City College (1984)

Continuing Education:

Basic Ion Chromatography, Dionex (1988)

Professional Experience:

With Lancaster Laboratories, Inc. since 1979Chemist II Coordinator (1988)

Elizabeth A. White, Group Leader II, Vater QualityEnvironmental Sciences Division

Education: ^ ,* „ A « »——— A83052«*7Associate Degree, York Junior College, Chemistry Major (1946 - 1948)

C-32

Professional Experience:

York Junior College, Laboratory Assistant (1948 - 1950) Full-time (1950 -1951)Nina Dye Works, Laboratory Technician (1951 - 1953)With Lancaster Laboratories, Inc. 1965 - 1967 and 1975 - Present

Group Leader (1984)

Bryan F. Vinship, B.S., Chemist IV, ResearchEnvironmental Sciences Division

Education:

B.S. Analytical Chemistry, Juniata College (1981)

Continuing Education:

"Liquid Chromatography Short Course".Chromatography Forum of Delaware Valley(1982)Hewlett Packard 3350 Operator Training Course (1986)Shimadzu HPLC and C-R3A Repairs Course (1986)

Professional Experience:

Department of Energy, Shale Research Project Assistant (1978 - 1980)Juniata College, Laboratory Assistant (1980 - 1981)With Lancaster Laboratories, Inc. since 1981

Chemist IV (1988)

Publications:

Poster paper at Fall AOAC Meeting concerning analysis of pharmaceuticals incough lozenges (1984)

Memberships and Appointments:

Association of Official Analytical ChemistsChromatography Forum of Delaware Valley

Rosemary Yovic, M.S., Chemist II, GC/MS EztractablesEnvironmental Sciences Division

Education:

B.S. Chemistry, Lock Haven State College (1983)M.S. Chemistry, Drexel University (1987)

Professional Experience:

Hospital of the University of Pennsylvania, Professional Medical(Certification in American Society of Clinical Pathology, ChemistrySpecialization) (1983 - 1985)

With Lancaster Laboratories, Inc. since 1986Chemist II (1988), BNA Coordinator

L

C-33

Awards and Citations:

Highest Achievement in Organic Chemistry Award for scholastic year (1981)

Michael E. Yunginger, B.S., Microbiologist I, BioassaysHealth Sciences Division

Education:

B.S. Biology, Millersville University (1985)

Professional Experience:

With Lancaster Laboratories, Inc. since 1986Microbiologist I (1988)