NEIC
EPA-330/9-81-003-R
NEIC PROCEDURES MANUAL FOR THE EVIDENCE AUDIT
OF ENFORCEMENT INVESTIGATIONS
BY CONTRACTOR EVIDENCE AUDIT TEAMS
April 1984
National Enforcement Investigations Center, Denver
U.S. Environmental Protection Agency
Office of Enforcement
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT AND COMPLIANCE MONITORING
EPA-330/9-81-003-R
NEIC PROCEDURES MANUAL FOR THE EVIDENCE AUDIT
OF ENFORCEMENT INVESTIGATIONS
BY CONTRACTOR EVIDENCE AUDIT TEAMS
April 1984
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
Denver, Colorado
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CONTENTS
CHAPTER I
CHAPTER II
CHAPTER III
CHAPTER IV
CHAPTER V
CHAPTER VI
CHAPTER VII
INTRODUCTION
CASE PREPARATION ASSISTANCE
THE EVIDENCE AUDIT FUNCTION
AUDIT PLANNING
FIELD INVESTIGATIONS AUDIT
LABORATORY OPERATIONS AUDIT
DOCUMENT CONTROL AUDIT
APPENDICES
A FIELD INVESTIGATIONS AUDIT CHECKLIST
B LABORATORY OPERATIONS AUDIT CHECKLIST
C DOCUMENT CONTROL AUDIT CHECKLIST
D SAMPLE NARRATIVE EVIDENCE AUDIT REPORT
E EVIDENCE AUDIT STATEMENT
FIGURES
1 DOCUMENT INVENTORY PRINTOUT
2 GENERATOR BY WASTE TYPE PRINTOUT
3 WASTE TYPE BY GENERATOR PRINTOUT
4 ANALYTICAL SUMMARY BY SAMPLING SITE
5 ANALYTICAL SUMMARY BY COMPOUND
6 COST SUMMARY PRINTOUT
7 SAMPLE PROFILE
8 SAMPLE TAG
9 CHAIN-OF-CUSTODY RECORD
10 ORGANIC TRAFFIC REPORT (VIAR)
11 INORGANIC TRAFFIC REPORT (VIAR)
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CHAPTER I
INTRODUCTION
The Environmental Protection Agency (EPA), through its Office of
Enforcement and Compliance Monitoring (OECM), Offices of Regional Counsel,
National Enforcement Investigations Center, Regional Environmental Services
Divisions, and contractors, executes a program of enforcement of environ-
mental statutes and regulations. The statutes upon which this program is
based include: The Federal Water Pollution Control Act (FWPCA), as amended
the Clean Water Act (CWA) of 1977; the Clean Air Act (CAA), as amended; the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended;
the Resource Conservation and Recovery Act of 1976 (RCRA); the Comprehensive
Environmental Response Compensation and Liability Act of 1980 (CERCLA); the
Safe Drinking Water Act (SDWA), as amended; and the Toxic Substances Control
Act (TSCA). Implementing regulations have been, and continue to be, prom-
ulgated according to timetables established by law, a variety of court deci-
sions and consent decrees, and administratively established schedules.
The Agency deploys in-house and contractor technical teams to conduct
evidence-gathering investigations and inspections and other enforcement-
related technical evaluations in support of the enforcement program. These
teams include engineers, scientists, technicians and attorneys, functioning
as individual investigators or groups, in offices, laboratories and field
sites. In addition, the Agency performs an oversight and/or shared oper-
ating role where enforcement programs have been fully or partially dele-
gated to State agencies.
Technical data, operating and process information, production data,
and related information produced or obtained in the course of enforcement
inspections, investigations, and evaluations are potential evidence. As
such, they must be (a) reliable, (b) gathered with constitutional safe-
guards and (c) maintained with integrity. The potential evidence may take
any of several forms including a field notebook, film, computer tape, a
sample tag, a degradable sample, etc. Typically, a case preparation
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1-2
investigation may generate large volumes of file material, samples, data
tabulations, and reports. Security and accountability (i.e., chain-of-
custody) must be maintained even while the evidence is in shipment.
Cases developed by EPA, pursuant to the environmental statutes for
referral to the Department of Justice, must be based upon rigorously docu-
mented evidence and supporting data in order to minimize delay in filing,
facilitate discovery proceedings, present a convincing case to the attor-
neys engaged in pre-trial negotiations, and finally, prevail in the
courtroom.
Current document handling procedures are not standardized and the types
and volume of documents relating to a case are often overwhelming to the
case attorney. It is increasingly seen that a single hazardous waste case
may involve 100,000 or more documents. The attorneys are confronted with
difficult tasks of assembling and organizing all documents, preparing wit-
ness lists, and extracting information necessary to prepare interrogatories
and conduct depositions. Documents delivered to the attorneys are often
poorly organized, not inventoried and come from numerous Agency and exter-
nal sources (i.e., Regional and Headquarters divisions and branches, Depart-
ment of Justice, State offices and contractors). Records obtained from the
opposition are often so voluminous or disorganized that it is difficult for
the case attorney to effectively review them. Lack of sufficient assembly
and organization of this material becomes obvious to the opposition at the
time of discovery, during settlement and negotiation discussions or at trial.
The consequences are to unknowingly expose case strategy, to inadvertently
release privileged or confidential material, or to be unaware of documents
that strengthen or weaken the case. The Agency position is vulnerable if
the litigation team does not have confidence in the integrity of the sup-
porting documentation. The case file must be complete and organized for
rapid and efficient access.
The National Enforcement Investigations Center has for many years
imposed internal evidence auditing procedures on case files developed in
the course of investigations conducted by the NEIC staff. These audits
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assist case attorneys in their preparations for pre-trial and trial phases
of Agency litigation efforts. The evidence audit system is designed to:
(1) establish an overall case document control system, (2) provide quick
and complete access to records, and (3) ensure admissibility of the evi-
dence. The system is flexible to accommodate the increase of material as
the case progresses and is adaptable to changes in case strategy.
With the advent of hazardous waste programs and the conduct of a major
portion of the Agency's hazardous waste site investigations by contractors,
NEIC was tasked to make evidence audits available to Regional and Head-
quarters staffs for case file development.
The Contractor Evidence Audit Team (CEAT) is available to Regional
Counsel Offices and State enforcement programs to perform evidence audits
and to assist EPA, State, or contractor staffs in establishing chain-of-
custody and document control systems. Points of contact between EPA and
the CEAT, for administrative matters, will be EPA's Contracting Officer and
the contractor's Project Manager. For operational assignments, direction
and delivery of completed work, contacts will be EPA's Project Officer or
Deputy Project Officer and the CEAT Leader.
This manual is intended to provide operational guidance to the CEAT;
the Project Officer, Deputy Project Officer and their technical staffs;
users of the service; and other agencies having related needs.
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II-l
CHAPTER II
CASE PREPARATION ASSISTANCE
The CEAT provides a service to EPA Regional and Headquarters legal and
program offices for assistance in management of case file systems. The
service supports EPA efforts in managing large volumes of documents gener-
ated in-house or obtained from State, local or industrial sources. The
work effort includes document sorting, organizing, numbering, inventorying,
reviewing and developing computer databases for information storage and
retrieval. The CEAT also provides a service to track the history and chain-
of-custody for samples collected as evidence.
Support for cases involving large numbers of documents is labor and
resource intensive. The Project Officer maintains strict control of the
project phases to ensure that objectives specified in the work plan are
completed in a timely and efficient manner. All work assigned to the CEAT
must be addressed in the work plan. Phases of case preparation assistance
are:
Request for Assistance
Project Planning/Development
Work Assignment
Work Plan
Work Product
Project Completion
Work hours and costs incurred will be tracked on a project-by-project
basis for use in cost recovery actions.
REQUEST FOR ASSISTANCE
Each project begins with a request for assistance directed to the NEIC
Project Officer. A verbal contact must be followed by a written request.
The Project Officer or Deputy must verify that the request is within the
scope of work of the CEAT contract. A written response to each request
will be provided and will identify NEIC and CEAT contacts to coordinate the
work. A project file will be initiated at this point and all documents
pertaining to the work will be included in that file. A CEAT project number
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II-2
will be issued for each case for document and cost accounting and, if the
request involves NEIC support, an NEIC project number may be assigned.
Case preparation assistance may require a rapid response and quick turn-
around on the work product. CEAT services can be initiated within a few
days if an emergency situation exists.
Requests for case preparation assistance are received from:
Administrator
Deputy Administrator
Assistant Administrators
Senior Enforcement Counsel ) with the knowledge and
Inspector General ) concurrence of the
Headquarters Office Directors ) Assistant Administrator
Headquarters Division Directors ) for Enforcement and
Department of Justice, Headquarters) Compliance Monitoring
Regional Administrators
Deputy Regional Administrators
Regional Counsels
Regional Division Directors ) with the knowledge and
U.S. Attorney's Offices ) concurrence of the
State and Local Program Directors ) Regional Counsel
PROJECT PLANNING/DEVELOPMENT
A meeting or conference call will be held with the principal parties
involved (NEIC, CEAT and requester). The following will be established:
Project title and location
Enforcement objectives and regulations involved
Name, phone number, and address of Regional or Headquarters
contact
Nature of work and specific objectives required
Time constraints and legal deadlines to be met
Justification for priority treatment
Location of all document sources and contacts
Volume of records to be managed
Assessment of physical condition of records and degree of
organization already accomplished
Location(s) of work to be performed
Requirement for computer services
Amount of participation by requester
Confidentiality requirements
Work product required
A record of this meeting or call will be prepared and placed in the
file.
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WORK ASSIGNMENT
The Project Officer or Deputy will issue a written work assignment to
CEAT leader including contacts, objectives, schedules and reporting require-
ments. A verbal assignment may be made in quick response situations and
will be followed in writing.
WORK PLAN
The CEAT task leader will prepare a draft work plan for the project.
The draft plan will be submitted to NEIC for approval and to the requester
for comment. Once acceptable to all participants, it will serve as the
basis for completing the work. A final plan will be prepared, a copy placed
in the file and work initiated.
Any deviation from the work plan by the CEAT or directed by the
requester must be approved by the NEIC Project Officer.
WORK PRODUCT
The work product will be determined for each case and may be a written
report or a memorandum stating that each objective has been completed.
Written communication between the CEAT and the requesting office must be
routed through the NEIC Project Officer or Deputy.
PROJECT COMPLETION
The CEAT leader will notify the NEIC Project Officer that each objec-
tive for the assignment has been completed. A memo transmitting any report-
ing requirements or computer printouts will be prepared by NEIC and sent to
the requester. Additional work required by the requester will be treated
as a new assignment.
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Case preparation assistance services are designed to ensure complete-
ness and integrity of the supporting documentation. This process is
intended to organize, inventory and summarize documents prior to referral
to the Department of Justice. EPA cases vary dramatically in volume and
type of records generated. Smaller and less complex cases present fewer
document management problems; however, all cases require the use of well-
organized Agency and discovered documents. Case preparation assistance
services conducted by the CEAT include: (1) case file organization, (2)
development of evidentiary computer databases, (3) preparation of sample
profiles and (4) other evidentiary support activities.
CASE FILE ORGANIZATION
Proper management of documentary evidence is a critical element in
enforcement case preparation. The CEAT provides assistance to ensure that
all case-related documents are gathered, organized and inventoried for use
by the litigation team and for production during Discovery. The document
gathering phase requires identification of all parties participating in the
investigation. The case attorney must instruct each division, branch or
contract group to produce their files. The CEAT assembles the records and
inventories each group's files. In order to facilitate document retrieval,
the CEAT extracts bibliographic information from each record and enters it
into a computer database. The database typically contains (1) the name of
the author, (2) author's organization, (3) document date, (4) addressee,
(5) document type, (6) document title and (7) number of pages. Other infor-
mation is recorded at the request of the case attorney. The database can
be searched on these categories for document retrieval. Document numbers
are stamped to serve as a file locator and to ensure file completeness and
accountability. The CEAT can also perform key wording for documents con-
sidered critical to case development.
An example of a document inventory printout is shown in Figure 1.
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II-5
Figure 1
DOCUMENT INVENTORY
DOCUMENT TYPE: Letter # PAGES: 3 DOCUMENT #: 12000 *
TITLE/DESCRIPTION:
TO:
Information for May *
Generator/Transporter
Meeting
FROM: *
SIGNED ?: Yes
WITHHELD REASON
Not Resp.
PRODUCED
PROGAM FILE CODE: 1
PROGRAM FILE
DOCUMENT TYPE: Memo
Signature, if
different from
author: *
*
» PAGES: 2 DOCUMENT #: 12004 *
Record #: 1
TITLE/DESCRIPTION: Contractor work
on Document
Inventory Assist.
TO:
FROM:
SIGNED ?: No
PROGRAM FILE CODE: 2
ENFORCEMENT FILE
WITHHELD
PRODUCED
REASON
RECORD #: 2
DOCUMENT TYPE: Report
# PAGES: 47
DOCUMENT #: 11006
TITLE/DESCRIPTION: Pesticide Cones.
TO:
FROM:
FOIA WITHHELD
WITHHELD REASON
Att Wk Prod
PRODUCED
PROGRAM FILE CODE: 3
OFF REG CSL
SIGNED ?: Yes
Signature, if
different from
author:
RECORD #: 3
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II-6
EVIDENTIARY DATABASES
The case development process may require summaries of technical
information. The CEAT provides a wide variety of computerized databases
for this purpose. Information summaries can be tailored to meet the needs
of specific cases. Examples of evidentiary databases include (1) waste
transactions at hazardous waste sites, (2) summaries of analytical data and
(3) summaries of costs for cost recovery actions.
Waste Transactions Databases
Many hazardous waste facilities have operated over a period of years
and have been involved in thousands of transactions with hundreds of waste
transporters and generators. Billing invoices, shipping manifests, account
ledgers, and other documents not only establish the "paper trail" leading
to hazardous waste generators, but also provide information needed to eval-
uate the degree of hazard presented by the waste facility. This informa-
tion may prove necessary to enforcement personnel in finding potential
responsible parties and in formulating an adequate remedial plan. EPA must
be able to identify what wastes were shipped by the generator, the quanti-
ties of wastes shipped, which of those wastes are "hazardous", and how those
wastes were treated, stored and/or disposed. CEAT services provide review
and summary of waste information and development of computer systems to
list the findings. Examples of database printouts are shown in Figures 2
and 3.
Summary reports from the database can be prepared by sorting and list-
ing data. Some of the important applications of information stored within
the database are:
A list of generators disposing of wastes at a waste facility
A list of generators based on the quantity of wastes disposed
of by them at the waste facility
A list of generators based on the types of wastes disposed of
by them at the facility
The frequency of facility use by a generator
The total quantities and types of waste present at the site
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Figure 2
GENERATOR BY WASTE TYPE
Generator
(Total Gallons)
World Chemical
(16,537 gallons)
Chemsafe Recycling
(10,591 Gallons)
Waste
Type
Waste
sulfuric
acid
HCL acid
Soda ash
Copper sulfate
Electroplate
sludge
Ammonium
hydroxide
Waste
sulfuric
acid
HCL acid
Sodium cyanide
Waste filter
cake
Waste oil
Vol ume
(Gallons)
1,310
8,230
221
1,565
3,666
1,545
428
2,412
394
2,296
5,061
% of Total
Volume
7.9%
49.8%
1.3%
9.5%
22.2%
9.3%
4.0%
22.8%
3.7%
21.7%
47.8%
Ledger/
Manifest
34/2347
48/3886
50/7713
5/3983
85/5574
63/8435
70/3181
45/1924
5/939
76/6070
78/6949
34/9982
32/7416
20/2880
83/992
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II-8
Figure 3
WASTE TYPE BY GENERATOR
Waste Type
(Total Gallons)
Waste sulfuric acid
(46,251 gallons)
Generator
H&L Plastics
Twins Solvent
Morrison Mfg.
Co.
American
Pharmaceutical
Sturbridge
Steel Co.
Auto-Glass,
Inc.
Volume
(Gallons)
1,946
4,281
5,864
4,487
13,160
16,513
% of Total
Volume
4.2%
9.3%
12.7%
9.7%
28.5%
35.6%
Ledger/Manifest
Numbers
62/3152
87/4908
84/8933
79/1886
77/8160
77/6457
33/2310
25/9579
28/7294
83/8818
68/1403
3/8297
32/7997
43/9659
17/8923
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For example, knowing which generators disposed of the largest quantities of
hazardous wastes found migrating offsite via groundwater or contaminated
leachate may aid in the assessment of civil or criminal penalties. Respon-
sibility for the disposal of specific chemical constituents can be traced
to the particular generator.
Analytical Summaries
CEAT services are provided to summarize and list analytical data on
computerized systems. Analyses from samples collected during enforcement
investigations can be arrayed in a variety of ways. Examples include lists
of:
All compounds detected at a given sample location
Frequency of occurrence of a particular compound at all sample
locations
Results of various sampling episodes over time
Ranking of compounds by concentration or occurrence
Compounds analyzed for but not detected
Quality control and quality assurance information can also be added to
the database. Precision, accuracy, detection limit and codes indicating
acceptability of data are common data quality indicators.
Examples of printouts of analytical summaries are shown in Figures 4
and 5.
Cost Databases
The CEAT work provides for development of databases to list cost infor-
mation for cost recovery actions. The CEAT reviews cost documents and
extracts data for entry into the computer. Printouts are prepared listing
the case name, the organization incurring costs, a breakdown of itemized
costs, amounts paid and name of payor.
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Figure 4
ANALYTICAL SUMMARY BY SAMPLING SITE
Site (10)
SMO Sample #
Lab
Case #
Sampling Date 09/14/83
Lab #
Well (10) OW - 1 Site Well
Agency USEPA/FIT
Analysis Date 10/08/83
Priority Pollutants - Organic Compounds
Acids
2,4,6-Trichlorophenol
P-Chloro-nrcresol
2-Chlorophenol
2,4-Dichlorophenol
2,4-Dimethyl phenol
2-Nitrophenol
4-Nitrophenol
2,4-Dinitrophenol
4,6-Dinitro-o-cresol
Pentachlorophenol
Phenol
Base/Neutrals
Acenaphthene
Benzidine
1,2,4-Trichlorobenzene
Hexachlorobenzene
Hexachloroethane
Bis(2-chloroethyl)ether
2-Chloronaphthalene
1,2-Dichlorobenzene ;
3-Dichlorobenzene
4-Dichlorobenzene
3'-Dichlorobenzidine
4-Dinitrotoluene
2,6-Dinitrotoluene
1,2-Diphenylhydrazine
Fluoranthene
4-Chlorophenyl phenyl ether
PPB DQ Base/Neutrals
100 UV 4-Bromophenyl phenyl ether
100 UV Bis(2-chloroisopropyl)ether
100 KV Bis(2-chloroethoxy)methane
100 UV Hexachlorobutadiene
100 UV Hexachlorocyclopentadiene
200 KI Isophorone
500 KI Naphthalene
500 UI Nitrobenzene
200 UV
100 UV n-nitrosodiphenylamine
590 V N-nitrosodipropylamine
Bi s(2-ethylhexyl)phthalate
Benzyl butyl phthalate
PPB DQ Di-n-butyl phthalate
Di-n-octyl phthalate
100 UV Diethyl phthalate
100 UV Dimethyl phthalate
100 KV Benzo(a)anthracene
100 UV Benzo(a)pyrene
100 UV Benzo(b)fluoranthene
100 UV Benzo(k)fluoranthene
100 UV Chrysene
1,400 UV Acenaphthylene
100 KV Anthracene
600 V Benzo(ghi)perylene
100 UV Fluorene
200 UV Phenanthrene
200 UV Dibenzo(a,h)anthracene
200 UV Indeno(l,2,3-cd)pyrene
100 UV Pyrene
100 UV
flon-Priority Pollutants Organic Compounds
Benzoic Acid
2-Methylphenol
4-Methylphenol
2,4,5-trichlorophenol
Am" 1 ine
Benzyl alcohol
1,400 I
50 UV
50 KV
1,000 UV
50 UV
200 UV
4-Chloroaniline
Dibenzofuran
2-Methylnaphthal ene
2-Nitroaniline
3-Nitroaniline
4-nitroaniline
PPB DQ
100 UV
200 UV
200 UV
100 UV
100 UV
3,000 V
100 KV
100 UV
100 UV
100 UV
100 UV
100 UV
100 UV
100 UV
100 UV
110 V
100 UV
200 UV
200 UV
200 UV
200 UV
100 UV
100 UV
200 UV
100 UV
100 UV
200 UV
200 UV
100 UV
500 UV
100 UV
200 UV
1,000 UV
1,000 UV
1,000
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11-11
Figure 5
SAMPLING DATA FROM 09/13/83 to 09/14/83
Parameter: P-Chloro-m-cresol
Sample Source Concentration (PPB) DQ
ow -
ow -
ow -
IW -
IW -
IW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
MW -
1 site well
2 site well
4 site well
1 interceptor well
2 interceptor well
3 interceptor well
IB monitor well
2B monitor well
3B monitor well
4B monitor we! 1
4B(D) monitor well duplicate sample
58 monitor well
6B monitor well
7B monitor well
7B(D) monitor well duplicate sample
8B monitor well
9B monitor well
10B monitor well
11B monitor well
12B monitor wel 1
13B monitor well
13B(D) monitor well duplicate sample
14B monitor wel 1
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
100
10
10
10
10
10
10
10
uv
UL
uv
UL
UL
UL
UV
UL
UV
UV
UL
UV
UV
UV
UV
UV
UL
UL
UL
UL
UV
UV
UL
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11-12
An example of a cost summary printout is provided in Figure 6.
SAMPLE PROFILES
Sample profiles are a graphic representation of sample history from
the time of collection through analysis and reporting. The profile tracks
the chain-of-custody, identifies names and dates of possession, lists docu-
ments verifying possession and presents analytical tasks performed.
The sample profile is intended to support the admissibility of evidence
and to identify potential weaknesses in the chain-of-custody or integrity
of samples. The CEAT works with the case attorney to review documents or
obtain other records which could rehabilitate the evidence. The profile
can also be used to produce a potential witness list for all people handling
the sample. An example of a sample profile is shown in Figure 7.
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PROJECT:
PAYOR: US E.P.A.
Amount Requested:
Date:
Amount Paid:
Amount Withheld:
Date:
Cost Type:
COST
Current
125274.99
04/30/87
125274.99
.00
00/00/00
Contracts
Figure 6
SUMMARY PRINTOUT
PAYMENT #: 2 CONTRACT #
PAYEE:
Comments D.C. #
286
0
Work period:
4-3 through 4-30-82
Work Performed: Site preparation,
waste loading,
disposal & monitoring
Cost Categories Current Comments D.C. #
Personnel: 32727.54
Equipment: 27402.50
Transport: 12080.00
Mat. & Prod.: 12723.15
Disposal: 40341.80
Miscellaneous: .00
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Figure 7
Evidence Profile
11-14
(s:w) CASE •:
NAME OF LABORATORY:
SAMPLE •'«:
Chaln-of-Custody Record
SAMPLESCOLLECTEB
OH:
BY:
Chaln-of-Custody Record
SAMPLES RELINQUISHED ON:
BY:
Chain-of-Custody Record
SAMPLES RECEIVED
ON:
BY:
Chain-of-Custody Record
SAMPLES RELINQUISHED TO:
. FEDERAL EXPRESS
OH:
BY:
Federal Express Air
Chain-of-Custody Record
FOR:
BY:
ON:
SAMPLES RECEIVED
SAMPLES STORED
Acid:
B/M:
Pest:
SAMPLE EXTRACTIONS
BY:
BY:
BY:
BY:
BY:
Splkes/STDS added
BY:
BY:
SMO Extraction Chronicle
Extraction Logbook Page(s)
Dally Extraction Record Paged)
YOLATILES (VOA)
PREPARATION
Extraction Chronicle
VOA GC/MS Worksheet
ACID FRACTION
GC/MS ANALYSIS
Acids GC/HS Worksheet!
GC/MS Logbook Pjge(s)
•Organic; Analysis
Data Sheets
BASE/NEUTRAL FRACTI
GC/HS ANALYSIS
OH:
BY:
B/H GC/ils Worksheets
GC/MS Logbook Page(s)
*0rganics Analysis
Data Sheets
PESTICIDES FRACTION>
GC ANALYSIS
ON:
BY:
v
Pesticides GC Worksheets
•Organic* Analysis
Data Sheets
'VOIATILES (VOA)
FRACTION GC/MS ANALYSIS |
ON: >
BY: '
VOA GC/HS Worksheets
GC/MS Logbook Page(s)
•Organlcs Analysis
Data Sheets
Results Tabulation Form
VOA fraction does not
require extraction
Samples may be stored for a varying
period after completion of analysis
based upon sanple type and contract
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CHAPTER III
THE EVIDENCE AUDIT FUNCTION
The work of the CEAT is to investigate adherence to procedures for
chain-of-custody, document control and security of evidence by enforcement
investigators and laboratories. The audits performed usually consist of
collecting raw data pertaining to field investigations and laboratory activ-
ities, recording the data and observations on checklists, preparing a sum-
mary report, and testifying in support of the authenticity of evidence
presented by the contract personnel. EPA employees may analyze the data
supplied and may spot check the performance of the team.
Requests for audits must be directed to the NEIC Project Officer.
Verbal contacts must be followed up in writing. The Project Officer or
Deputy verifies that the request is within the scope of work of the CEAT
contract. A written response to the requestor will state the NEIC and CEAT
contacts who will coordinate the work. A project file shall be initiated
and all documents pertaining to the project shall be included in that file.
A CEAT project number shall be assigned and, if NEIC support is required,
an NEIC project number may be assigned.
Requests will be accepted from:
Administrator
Deputy Administrator
Assistant Administrators
Senior Enforcement Counsel ) with the knowledge and
Inspector General ) concurrence of the
Headquarters Office Directors ) Assistant Administrator
Headquarters Division Directors ) for Enforcement and
Department of Justice, Headquarters) Compliance Monitoring
Regional Administrators
Deputy Regional Administrators
Regional Counsels
Regional Division Directors ) with the knowledge and
U.S. Attorney's Offices ) concurrence of the
State and Local Program Directors ) Regional Counsel
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Evidence Audit assignments will be issued, in written form, by the
Project Officer or Deputy except in urgent situations requiring immediate
response by the contractor. Any oral assignment will be followed by written
confirmation at the earliest practicable time.
Assignments will normally be made in terms of:
Field investigations audit
Laboratory operations audit
Document control audit
Combinations of the above
Field investigation audits and laboratory operations audits are to be
conducted according to the checklists and criteria provided in Appendices A
through E and include document control audit procedures. A document con-
trol audit is a "desk top" audit of field notebooks, chain-of-custody rec-
ords, and other documents located in the EPA Regional Office, Contractor's
field offices, or appropriate State agency offices.
Checklists will be submitted to the Project Officer within ten (10)
working days following completion of the audit. The checklist submission
will be accompanied by a narrative report which will summarize findings,
provide observations not covered by the checklists, identify all audit docu-
ments, and contain a statement of opinion by a Certified Public Accountant
(CPA) member of the CEAT. A sample narrative report is included as Appen-
dix D.
Audit teams will be tailored to meet the needs of the EPA enforcement
programs and priorities. A field investigations audit may require the serv-
ices of an engineer or technician while a laboratory operations audit
requires a chemist or person familiar with laboratory procedures. Teams of
two or three persons may be formed to conduct more complex audits.
The composition of audit teams will be determined by the Project Offi-
cer or the Deputy Project Officer (DPO) in consultation with the CEAT leader.
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III-3
The contract requirement for a CPA was included to ensure that the CEAT
embodies a credible internal quality control mechanism. EPA does not expect
that each auditor be a CPA, nor that each team include a CPA; however, the
CPA is expected to exercise internal controls and participatory oversight
such that he or she can certify to EPA that the work of the CEAT meets EPA
requirements. Each set of checklists and the summary report will include
an opinion to that effect by the CPA(s) [Appendix E].
At the conclusion of each audit, the audit plan, checklists, logbooks,
summary report and CPA statement, together with any related data or docu-
ments, will be submitted to the Project Officer. After review by the Proj-
ect Officer, copies will be provided to the Regional Counsel for inclusion
in the case files. Any material for which a claim of confidentiality has
been made will be transferred to the appropriate Document Control Officer.
All audit material is evidence and CEAT members are subject to call as
witnesses. They must comply with discovery requests, warrants, subpoenas,
or court orders for any case which they audit.
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IV-1
CHAPTER IV
AUDIT PLANNING
The Project Officer will maintain continuing liaison with Regional and
Headquarters enforcement officials to identify investigations most likely
to proceed to litigation and will prioritize those cases for auditing.
When possible, the audits will be scheduled to minimize travel time and
expenses. The Project Officer will confer frequently with the CEAT leader
to establish schedules and review progress.
As audits are scheduled, the Project Officer will arrange for the CEAT
to receive a copy of the plan of investigation. The project plan details
the project's scope, logistics and schedules. Items addressed in the proj-
ect plan include:
1. Objectives
2. Background information
3. Survey methods, including sampling locations, schedules and
procedures, analytical requirements, quality control program, etc.
4. Process data to be collected
5. Personnel and equipment requirements
6. Safety program and equipment
7. Chain-of-custody and document control procedures
With the exception noted below, an Audit Plan shall be developed by
the CEAT leader in coordination with the project coordinator assigned to
the investigation that is to be audited. The Project Officer may, on occa-
sion, direct that an unannounced audit be performed. The CEAT leader must,
insofar as possible, cause the audit schedule to conform to the schedule of
the investigator(s) being audited. The evidence audit should not cause
inordinate delays or otherwise inhibit the execution of the investigation,
laboratory operation, etc.
The CEAT personnel must conform to the safety regime imposed by the
project coordinator (i.e., same safety clothing, equipment and procedures
are to be used). The audit plan should include the statement of clothing,
equipment and procedures to be employed.
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IV-2
The Audit Plan will be reviewed by the Project Officer or DPO and,
when approved, will become the authorization for the CEAT to proceed. Ver-
bal authorization may be given by the Project Officer or DPO if followed by
a written authorization.
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V-l
CHAPTER V
FIELD INVESTIGATIONS AUDIT
This activity is to provide evidence audits for handling physical and
documentary evidence obtained during field investigations, onsite inspec-
tions or remedial actions. The audit addresses the investigator's adher-
ence to established policies and procedures for evidence handling, require-
ments of a project plan, and/or specifications in a contract or consent
decree. In the absence of specified requirements for a project, the Con-
tract Evidence Audit Team (CEAT) shall conduct the audit in accordance with
NEIC policies and procedures for document control and chain-of-custody.
Work hours and costs incurred by the CEAT will be tracked on a project-
by-project basis for use in cost recovery actions.
Audit phases are:
Request (see Chapter II)
Work assignment
Work plan
Audit preparation
Onsite audit
Reporting
WORK ASSIGNMENT
The Project Officer or Deputy will issue a written work assignment for
each audit. A verbal assignment may be made in emergency situations but
will be followed in writing. The assignment will normally include:
Name(s), address(es) and phone number(s) of contact(s)
Project location(s)
Objectives of the audit
Audit standards or requirements
Schedules
Reporting requirements
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V-2
WORK PLAN
The CEAT task leader shall prepare a draft work plan for submission to
NEIC and the requestor. Once accepted by all participants, it will form
the basis for completing the work. Any deviation from the work plan must
be approved by the NEIC Project Officer.
AUDIT PREPARATION
The auditors will review project plans, standard operating procedures,
safety plans, or other documents supplied by the requestor for background
information. Travel will be planned and audit logbooks and checklists pre-
pared. Safety equipment will be taken as needed.
ONSITE AUDIT
A briefing is scheduled with the field team leader prior to site entry.
The auditors shall describe the audit process and then obtain updated infor-
mation on the field tasks. The CEAT member(s) assigned to a particular
audit will contact the project coordinator in the field and proceed with
the schedule for conducting the field investigation audit. The audit is
the evaluation of sample identification and control, chain-of-custody pro-
cedures, field documentation, security of evidence and sampling operations.
The evaluation is based on the project plan and directions given by the
CEAT leader and the Project Officer. Specifics regarding the audit in pro-
gress are contained in the Audit Plan.
The CEAT will maintain a record of all activities performed during the
field investigation audit including logbooks, work papers and checklists.
The checklists are included herein as Appendix A. The auditor must accu-
rately track the dates and times of audit activities and the document num-
bers that have been reviewed. Included in the record will be the project
codes, project location, identification of the investigators assigned to
the project and auditor's name. .The checklists must be completed in their
entirety and any other pertinent information should be recorded in the
"comments" section.
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V-3
Pre-audit communication between the CEAT and the project coordinator
is necessary to determine if any special safety considerations or entry
problems exist. The CEAT member(s) arriving at the field investigation
site should follow entry procedures identical to those of the investigation
team. If possible, the auditor should enter the site with the team. The
CEAT should give the project coordinator ample time to arrange for their
entry. If the auditor arrives at the investigation site unannounced, the
facility should be entered in the following manner:
1. The plant premises should be entered through the main gate or
through the entrance designated by the source, if in response to an inspec-
tion notification letter.
2. The CEAT member should introduce himself/herself in a dignified,
courteous manner to a responsible plant official and briefly describe the
purpose of the visit. Identification credentials should always be shown.
A responsible plant official may be the owner, operator, officer, the plant
environmental engineer or agent-in-charge of the facility.
3. If a guard is present at the entrance, the CEAT member should
present credentials and request that the guard call his/her superior on the
phone. When the name is known, the member may request that the guard call
the responsible official directly.
4. If the Company provides a blank sign-in sheet, log, or visitors
register, it is acceptable to sign it. CEAT members must adhere to the
directives of the CEAT leader regarding signing a release of liability
(waiver) when entering a facility under the authority of Federal law.
5. If entry is refused, the CEAT member should not contest the issue
with the facility representative, but should immediately do the following:
a. Obtain name and title of the individual denying entry and
record the date and time.
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V-4
b. State that he/she is a member of a technical investigative
team under contract to EPA, ask if he/she heard and understood the reason
for the visit, record the answer and any reasons given for denial of entry.
c. Leave the premises and notify the appropriate CEAT leader
who, in turn, must notify the Project Officer or DPO.
Sample Control
The evidence audit addresses handling of samples from time of collec-
tion through analysis until final disposition. A sample is physical evi-
dence collected from a facility or from the environment. Evidence control
is an essential part of all enforcement investigations. A sample must be
identified as to the location, date, time and name of person collecting it.
A sample tag [Figure 8] is used for this purpose. All samples are also
listed in a Chain-of-Custody Record [Figure 9].
Contractor Field Investigation Teams conducting investigations for the
Hazardous Waste Site program use two additional forms for samples shipped
to contractor laboratories. They are Organic Traffic Report [Figure 10]
and Inorganic Traffic Report [Figure 11].
Data from onsite measurements are recorded directly into a field log-
book or Field Data Record (FDR).
Sample Tag
Samples are removed from the sample location and transferred to a lab-
oratory or other location for analysis. Before removal, however, a sample
is often separated into portions depending on the analysis to be performed.
Each portion is preserved in accordance with prescribed procedures and the
sample is identified with a sample tag. The information recorded on the
sample tag includes:
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Figure 8
SAMPLE TAR
V-5
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
Building 53, Box 25227, Denver Federal Center
Denver, Colorado 80225
SEPA
Project Code
Z
3?
CD
CD
Lab Sample No.
Station No.
Month/Day/Year
Station Location
30
1
OJ
CO
Bacteriology
3
&
-------
: i' u i c :•
C!:.A!N-OF-CUSTODV RECORD
ENVIRONMENTAL PROTECTION AGENCY
Office of Enforcement
CHAIN OF CUSTODY RECORD
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER
Building 53, Box 25227, Denver Federal Cenur
Denver, Colorado80225
PROJ. NO. PROJECT NAME
SAMPLERS: /Signature!
STA. NO.
DATE
TIME
STATION LOCATION
NO.
OF
CON-
TAINERS
REMARKS
Relinquished by: ISigntturtl
Date/Time
Received by: ISigntturtl
Relinquished by: ISigntturtl
Date /Time
Received by: (Signttunl
Relinquished by: /Signature!
Date /Time
Received by: (Signtture)
Relinquished by: ISigntturtl
Date/Time
Received by: /Signature!
Relinquished by: (Signature)
Date / Time
Received for Laboratory by:
/Signature!
Date /Time
Distribution: Original Accompanies Shipment; Copy to Coordinator Field Files
Remarks
N 1100
-------
U.S. ENVIRONMENTAL PROTECTION AGENCY HWI Sample Management Office
r'O BoxSiS Alex^n--in_: Virrr:-r22?13-7Co 55"-24=:• ITS 557-24?:
ORGANICS TRAFFIC REPORT
Sample Number
R 4576
T) Case Number:
Sample Site Name/Code:
SAMPLE CONCENTRATION
(Check One)
Low Concentration
Medium Concentration
SAMPLE MATRIX
(Check One)
Water
Soil/Sediment
©Ship To:
Attn:
Transfer
Ship To:
0 Regional Office:.
Sampling Personnel:
(Name)
(Phone)
Sampling Date:
CD For each sample collected specify ntu
of containers used and mark volume le
on each bottle.
Number of
Containers
Water
(Extractable)
(Begin)
(End)
Water
(VGA)
Shipping Information
Name of Carrier
Date Shipped:
Airbill Number:
Soil/Sediment
Water
(Ext/VOA)
Other
Sample Description
Surface Water
Ground Water
Leachate
Mixed Media
Solids
Other (specify)
<•) Special Handling Instruct*
Approx
Total V<
R4576
R4576
R4576
R4576
R4576
R4576
R4576
R4576
R4576
R4576
• Water
(Extractable)
• Water
(Extractable)
• Water
(Extractable)
• Water
(Extractable)
• Water
(VOA)
• Water
(VOA)
• Soil/Sediment
(Ext& VOA)
• Soil/Sediment
(Ext& VOA)
Water
(Ext& VOA)
• Water
(Ext & VOA)
ons:
(e.g., safety precautions, hazardous nature)
SMOCOPY
Finure 10
-------
U.S. ENVIRONMENTAL PROTECTION AGENCY HWI Sample Management Office
~ ~ n.-vQ!= I'.-.-.- — :- • wi":.:'--l_.'7".3 55?.9^cr .r-rc c>,7 :.-.-:-
INORGANICS TRAFFIC REPORT
Sample Number
1C 4101
I
I
7) Case Number:.
Sample Site Name/Code:
Sampling Office: _
Sampling Personnel:
(Name)
(Phone)
Sampling Date:
(Begin)
(End)
Sample Description:
(Check One)
Surface Water
Ground Water
Leachate
Mixed Media
, Solids
Other
(specify)
MATCHES ORGANIC SAMPLE NO.
(I) SAMPLE CONCENTRATION
(Check One)
Low Concentration
Medium Concentration
0 SAMPLE MATRIX
(Check One)
Water
Soil/Sediment
(T) Shipping Information:
Name Of Carrier:
Date Shipped:
Airbill Number:
Mark Volume Level
On Sample Bottle
Check Analysis required
Task 1 & 2
Task 3 Ammonia
Sulfide
Cyanide
SMOCOPY
(4) Ship To:
Attn:
Transfer
Ship To:
MC4101 -Taskl&2
MC 4101 -Taskl&2
MC4101 -TaskS
MC 4101 -TaskS
MC4101 -TaskS
MC 4101 -TaskS
MC4101 -TaskS
Figure 11
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V-9
Project Code - An assigned number
Station Number - A two-digit number assigned by the Project
Leader and listed in the project plan
Date - A six-digit number indicating the year,
month and day of collection
Time - A four-digit number indicating the time of
collection - for example: 0954
Station Location - The sampling station description, as specified
in the project plan
Samplers - Each sampler's name is listed
Tag Number - A unique serial number is stamped on each
tag
Remarks - The samplers record pertinent observations
The sample tag contains an appropriate place for designating the sam-
ple as a grab or composite and identifying the type of sample collected for
analysis. The sample tags are securely attached to each sample.
After collection, separation, identification and preservation, the
sample is maintained under chain-of-custody procedures discussed later. If
the composite or grab sample is to be split, it is aliquoted into similar
sample containers. Identical information is recorded on the tag of each
split. This identifies the split sample for the appropriate government
agency, facility, laboratory or company. In a similar fashion, all tags on
blank or duplicate samples are marked "Blank" or "Duplicate", respectively,
unless otherwise directed.
The CEAT will examine a selected number of sample tags for complete-
ness and accuracy. The team member will determine if the station number
and location are identified; the date and time collected are indicated; the
type of sample and analysis are specified; the preservative, if used, is
identified; and the sampler(s) signature(s) appear on the tag. The auditor
will also determine if the station location accurately identifies where the
sample was taken and if the sampling methods used were as specified in the
project plan or directed by the project coordinator.
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V-10
Chain-of-Custody Record
Possession of samples collected during enforcement investigations must
be traceable from the time collected until introduced as evidence in legal
proceedings. Chain-of-Custody Records are used for this purpose.
A sample is in your custody if the following criteria are met:
1. It is in your possession, or
2. It is in your view, after being in your possession, or
3. It was in your possession and then locked up to prevent tamper-
ing, or
4. It was in your possession and then transferred to a designated
secure area.
Custody Procedures
1. In collecting samples for evidence, only that number which pro-
vides a good representation of the media being sampled are to be collected.
To the extent possible, the quantity and types of samples and sample loca-
tions are determined prior to the actual field work. As few people as pos-
sible should handle samples.
2. The team member actually accomplishing the sampling is personally
responsible for the care and custody of the samples collected until they
are transferred or dispatched properly.
3. Sample tags must be completed for each sample, using waterproof
ink unless prohibited by weather conditions. For example, a logbook nota-
tion would explain that a pencil was used to fill out the sample tag because
a ballpoint pen would not function in freezing weather.
4. The project coordinator must review all field activities to deter-
mine whether proper custody procedures were followed during the field work
and decide if additional samples are required.
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V-ll
To maintain and document sample possession, chain-of-custody procedures
are followed.
Transfer of Custody and Shipment
1. Samples are accompanied by a Chain-of-Custody Record [Figure 9].
When transferring the possession of samples, the individuals relinquishing
and receiving will sign, date and note the time on the record. This record
documents sample custody transfer from the sampler, often through another
person, to the analyst.
2. Properly packaged samples are dispatched to the appropriate labor-
atory for analysis, with a separate custody record accompanying each ship-
ment. Shipping containers will be locked or secured with evidence tape for
shipment to the laboratory. The method of shipment, courier name(s), and
other pertinent information is entered in the "Remarks" section.
3. Whenever samples are split with a source or government agency, a
separate Chain-of-Custody Record or Sample Receipt is prepared for those
samples and marked to indicate with whom the samples are being split. The
sample tag serial numbers from all splits are recorded on the custody
record. The person relinquishing the samples to the facility or agency
should request the signature of a representative acknowledging receipt of
the samples. If a representative is unavailable or refuses to sign, this
is noted in the "received by" space. When appropriate, as in the case where
the representative is unavailable, the custody record should contain a
statement that the samples were delivered to the designated location and
the date and time noted.
4. All shipments will be accompanied by the Chain-of-Custody Record
identifying its contents. The original record will accompany the shipment,
and a copy will be retained by the project coordinator.
5. If sent by mail, the package will be registered with return
receipt requested. Freight bills, post office receipts and bills of lading
will be retained as part of the permanent documentation.
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V-12
The CEAT will select a predetermined number of Chain-of-Custody Records
to be audited in the field. The records must be reviewed to determine if
the station number and description corresponds to the sample tag, if the
date and time correspond, if the parameters to be analyzed have been prop-
erly identified, and if all custody transfers have been documented and the
date and time of transfer recorded.
The audit team will also determine if samples are kept in custody at
all times and are handled to prevent tampering. Sampling equipment should
also be checked for security and to detect tampering.
VIAR Traffic Forms
The firm VIAR and Company of Alexandria, Virginia, has been awarded a
contract by EPA to manage the shipment of samples from hazardous waste site
investigations and to allocate workloads to participating contractor labor-
atories. The Organic and Inorganic Traffic Reports [Figures 10 and 11] are
to be executed by Field Investigation Teams and are subject to audit as are
the previously discussed documents. This portion of the audit is to ensure
that the information recorded on the forms is correct and that it coincides
with the information on the sample tags and on the Chain-of-Custody Record.
Field Dcoumentation
Observation and measurements during field investigations must be docu-
mented in bound logbooks or Field Data Records. These records are intended
to provide sufficient data and observations lo enable participants to recon-
struct events that occurred during the project and to refresh the memory of
the investigators if called upon to give testimony during legal proceedings.
Logbooks: Project logbooks will be reviewed by the CEAT during the
field investigation audit to see that each is signed and all entries are
dated. Logbook entries must be legible, written in ink and contain accurate
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V-13
and inclusive documentation of an individual's project activities. Because
the logbook forms the basis for reports written later, it must contain only
facts and observations. Language should be objective, factual and free of
personal feelings or other terminology which might prove inappropriate.
All pertinent information should be recorded in these logbooks from the
time each individual is assigned to the project until the project is com-
pleted. Entries made by individuals other than the person to whom the log-
book was assigned must be dated and signed by the individual making the
entry.
Field Data Records: Where appropriate, Field Data Records (in the
form of individual sheets or bound logbooks) are maintained for each survey
sampling station or location. In-situ measurements and field observations
are recorded in the FDRs with all pertinent information necessary to explain
and reconstruct sampling operations. Each page of a Field Data Record is
dated and signed by all individuals making entries on that page. The coor-
dinator and the field team on duty are responsible for ensuring that FDRs
are present during all monitoring activities and are stored safely to avoid
possible tampering.
The CEAT will review Field Data Records in the same manner as the
logbooks.
Photographs: Photographs may be taken for evidentiary purposes and
must also be controlled. The CEAT will review field logbooks to determine
if the photographs are properly documented. When movies, slides or photo-
graphs are taken which visually show sampling sites or provide other docu-
mentation, they are numbered to correspond to the logbook entries. The
name of the photographer, date, time, site location and site description
are entered sequentially in the logbook as photos are taken. Chain-of-
custody procedures depend upon the type of film and the processing it
requires.
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V-14
Corrections to Documentation: As previously noted, unless prohibited
by weather conditions, all original data recorded in logbooks, FDRs, sample
tags, custody records and other data sheet entries are written with water-
proof ink. None of the documents listed above are to be destroyed or thrown
away, even if they are illegible or contain inaccuracies which require a
replacement document.
If an error is made on a document, the individual may make corrections
simply by drawing a line through the error and entering the correct infor-
mation. The erroneous information should not be obliterated.
Sampling Operations
The CEAT will review sampling operations to determine if they are per-
formed as stated in the project plan or as directed by the project coordi-
nator. The proper number of samples should be collected at the assigned,
locations. The CEAT will check to determine that the samples are in pre-
scribed containers and are preserved in accordance with standard operating
procedures. The CEAT will determine if the required field measurements and
quality assurance checks are performed and documented as directed.
A closing briefing shall be held with the field team leader to verbally
review CEAT observations. Written comments shall not be provided at this
time. Unresolved problems will be discussed with the NEIC Project Officer
and then with the requestor.
Reporting
A written audit report is submitted to NEIC within ten (10) working
days of the completion of the audit. The report shall include copies of
checklists and contain a statement signed by the CEAT CPA. Reports shall
be transmitted by the NEIC Project Officer or Deputy to the requestor.
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VI-1
CHAPTER VI
LABORATORY OPERATIONS AUDIT
The CEAT performs audits as requested at laboratories supporting
enforcement investigations. Evidence audits may be conducted for EPA,
State or contractor laboratories. The audit assignment will be made by the
Project Officer. The audit addresses sample control, laboratory documenta-
tion procedures, security of evidence and document control. The evaluation
will be based on project plans, laboratory standard operating procedures or
contract requirements.
Work hours and costs incurred by the CEAT will be tracked on a project-
by-project basis for use in cost recovery actions.
SAMPLE CONTROL
The CEAT will verify the following laboratory custody procedures:
1. A designated sample custodian accepts custody of the shipped sam-
ples and verifies that the information on the sample tags matches that on
the Chain-of-Custody Records. Pertinent information as to shipment, pick-
up, courier, etc. is entered in the "Remarks" section. The custodian then
enters the sample tag data into a bound logbook. The samples are then
stored in a secure area. The auditor will determine if the laboratory fol-
lows protocols established by EPA for sample storage and preservation.
2. The custodian distributes samples to the appropriate analysts.
The names of individuals who receive samples are recorded in internal labor-
atory records. Laboratory personnel are responsible for the care and cus-
tody of samples from the time they are received until they are exhausted or
returned to the custodian.
3. When sample analysis and necessary quality assurance checks have
been completed, the unused portion of the sample must be disposed of pro-
perly and according to a schedule established by the project coordinator,
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VI-2
project officer or case attorney. All identifying tags, data sheets and
laboratory records shall be retained as part of the permanent documentation.
LABORATORY DOCUMENTATION
All sample data, laboratory observations and calculations are recorded
in logbooks or on bench sheets. All documentation is accountable once proj-
ect information is recorded. Each document shows the project code, dates,
name(s) of analyst(s) and other pertinent information concerning the iden-
tification of the sample or laboratory results. Instrument printouts,
graphs and other documents are labeled in a similar manner. All other docu-
mentation concerning the project such as correspondence, report notes,
methods, documents, references, sample inventories, checkout logs, etc.
becomes part of the permanent record.
Logbooks need to contain information sufficient to recall and describe
succinctly each step of the analysis performed because it may be necessary
for the analyst to testify in subsequent enforcement proceedings. Moreover,
sufficient detail is necessary to enable others to reconstruct the pro-
cedures followed, should the original analyst be unavailable for testimony.
Any irregularities observed during the analytical process need to be noted.
If, in the technical judgment of the analyst, it is necessary to deviate
from a particular analytical method, the deviation shall be justified and
the rationale shall be fully documented.
The auditor will review selected examples from each document type to
determine if they are being handled in an approved manner. Recording shall
be done in ink and all corrections to documentation shall be done in the
manner previously described.
EVIDENCE SECURITY
The CEAT will review laboratory procedures to verify that samples are
in custody or secured from tampering during receipt, storage and analysis.
Tracking forms, bench sheets or logbooks are used to trace sample posses-
sion and document names of personnel handling samples.
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VI-3
DOCUMENT CONTROL
The CEAT reviews laboratory procedures for assembly and organization
of all documents pertaining to a particular case. Laboratory procedures
must ensure that all case-related documents are filed at the conclusion of
analysis. These records include but are not limited to:
Chain-of-Custody Records
sample tags
Traffic report forms
Sample log-in records
Sample tracking forms
Analyst logbook pages
Instrument printouts
Instrument logbook pages
Correspondence
QA/QC records
Bench records
Final report
The CEAT audits completed laboratory files and records for samples in
progress to determine adherence to laboratory procedures. Observations of
the auditor(s) are recorded in logbooks or on checklists [Appendix B].
REPORTING
The CEAT prepares a report within ten (10) days of the audit. The
report and checklists are submitted to the project officer for review and
then transmitted to the case attorney or program manager requesting the
audit.
CEAT ROLE IN LABORATORY AUDITS FOR THE NATIONAL CONTRACT LABORATORY PROGRAM
The CEAT is assigned by the NEIC Project Officer to conduct quarterly
onsite evidence audits in support of the National Contract Laboratory Pro-
gram (CLP). This program is managed by the Office of Emergency and Remedial
Response Support Services Branch and was created to provide analytical sup-
port for hazardous waste site investigations.
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VI-4
The work effort is to provide the CLP Program Manager with observa-
tions of contract laboratory evidence handling procedures. Requirements
are established for sample receipt, log-in, storage, tracking, data record-
ing, data reporting and document filing. These requirements are stated in
the contract as "Specifications for Chain-of-Custody and Document Control
Procedures". The CEAT reports any deviations from these policies and pro-
cedures to the NEIC Project Officer who notifies the CLP Program Manager
that corrections or improvements are needed.
The CEAT auditors form a team with representatives from the EPA Envi-
ronmental Monitoring Systems Laboratory - Las Vegas (EMSL-LV) to conduct
the onsite inspections. EMSL-LV has a support role to the CLP for monitor-
ing contract laboratory quality assurance requirements. They also provide
guidance for correction of laboratory technical problems. Close communica-
tion between NEIC, EMSL-LV, and the CEAT is necessary to coordinate these
audits.
Audit phases consist of:
Laboratory notification
Work assignment
Audit preparation
Onsite inspection
Reporting
Followup
Laboratory Notification
EMSL-LV has the responsibility to prepare a quarterly audit schedule
and notify the laboratories. NEIC and CEAT are advised as the inspections
are confirmed. Each laboratory director is informed of the date of audit,
names of the team members and topics covered. Copies of the notification
letter are provided to NEIC.
Work Assignment
The NEIC Project Officer or Deputy assigns, in writing, the audits to
be performed. The work assignments specify the laboratory location and
date.
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VI-5
Audit Preparation
The CEAT leader makes individual assignments for the audit team.
Auditors review files for previous inspection results and prepare notes for
items requiring followup action. Logbooks and checklists are prepared.
Contacts are made with the EMSL-LV team to confirm audit dates and
logistics. Travel arrangements are finalized.
Onsite Inspection
CEAT and EMSL-LV representatives meet prior to visiting the laboratory
to discuss any special problems to be addressed and for an update on any
changes since the last audit.
EMSL-LV designates a team leader who introduces the auditors and begins
a pre-inspection briefing with the laboratory director. CEAT members parti-
cipate in this briefing to identify evidence audit activities to be
addressed.
Following the briefing, a tour of the laboratory facility is made and
CEAT auditors make notes and fill out checklists. The procedures require
the auditor(s) to observe and record how the laboratory handles sample
receipt, log-in, storage, sample tracking, data recording, data reporting
and document filing. Specific laboratory documents are reviewed to assure
proper identification and recordkeeping practices are followed.
An exit briefing is held to present findings and make recommendations
to the laboratory director.
Reporting
An evidence audit report is submitted by the CEAT to the NEIC Project
Officer within ten (10) working days of the audit. Reports contain a state-
ment [Appendix E] signed by the CEAT CPA.
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VI-6
Followup
Deficiencies reported for an audit are addressed in the next quarterly
audit. If improvements have not been made, CEAT notifies the NEIC Project
Officer who, in turn, informs the CLP Manager.
The CEAT also supports the National Contract Laboratory Program (CLP)
by providing evidence audits of completed laboratory case files. The audit
is a review of records to determine if established policies and procedures
for document control and custody have been followed. In coordination with
the CLP Program Manager and the Sample Management Office (SMO), NEIC has
established a system for routing contract laboratory case files to the CEAT
for audit and then to Regional offices. Audit phases are:
Work assignment
Receipt of records
Evidence audit
Transmittal of records
Reporting
Work Assignment
This work effort is a continuing activity assigned by the Project
Officer. Individual case file assignments are not made unless there is a
priority request from a Regional office.
Receipt of Records
Contract laboratories submit completed case files to the CEAT on a
routine basis. Transfer of records is accomplished at the same time as
sample disposal (approximately 60 days after analysis). The records are
inventoried and numbered prior to shipment. The CEAT inspects and logs in
all shipments.
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VI-7
Evidence Audit
Evidence audits are conducted on all records received. Audit standards
are based on laboratory contract requirements and established EPA procedures
for evidence handling. A two-level audit system is in effect. All files
are checked for completeness and selected cases include development of sam-
ple profiles. Sample profiles are graphic representations of sample his-
tory from time of collection through analysis and reporting of data. The
large volume of records generated by contract laboratories requires that
the CEAT audit a percentage of the total. Selection of cases is on a random
basis; however, the NEIC accepts requests from Regional offices for audits
of priority cases.
Transmittal of Records
The CEAT transfers case files within 10 days to Regional offices upon
completion of the audit. Regional contacts for the documents are identified
by the Sample Management Office. Sample profiles and cover letters accom-
pany the transfer. Audit findings requiring clarification or special atten-
tion by the Region will be transmitted by NEIC.
Reporting
The CEAT provides a monthly summary of cases audited and copies of
transmittal cover letters to the Project Officer.
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VII-1
CHAPTER VII
DOCUMENT CONTROL AUDIT
A document control audit is conducted once field and laboratory records
have been completed, assembled, organized and stored. The audit consists
of a review of the case file to ensure completeness and consistency.
Work hours and costs incurred by the CEAT will be tracked on a project-
by-project basis for use in cost recovery actions.
Audit phases are:
Request (see Chapter II)
Work assignment
Work plan
Audit preparation
Document audit
Reporting
WORK ASSIGNMENT
The Project Officer or Deputy will issue a written work assignment for
each document audit. A verbal assignment may be made in emergency situa-
tions but will be followed in writing. The assignment will normally include:
Names(s), address(es) and phone number(s) of contact(s)
Project location(s)
Objectives of the audit
Audit standards or requirements
Schedules
Reporting requirements
WORK PLAN
The CEAT task leader shall prepare a draft work plan for submission to
NEIC and the requestor. Once accepted by all participants, it will form
the basis for completing the work. Any deviation from the work plan must
be approved by the NEIC Project Officer.
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VII-2
AUDIT PREPARATION
The auditors will review the work plan and prepare audit logbooks and
checklists [Appendix C]. Travel arrangements will be made as necessary.
Schedules will be worked out with the offices responsible for maintaining
the files.
DOCUMENT AUDIT
The CEAT will review the assembled file and record observations regard-
ing (1) file organization and format, (2) document accountability and (3)
separation and control of confidential business information. Investigation
teams and laboratories must establish orderly filing and inventory systems.
Following is a description of case file preparation procedures followed by
NEIC. This system serves as guidance for conducting document control audits
by the CEAT.
File Organization and Format
The file is assembled in the following order:
a. Project plan
b. Project logbooks
c. Field data records
d. Sample identification documents
e. Chain-of-Custody Records
f. Analytical logbooks, lab data, calculations, bench sheets,
graphs, etc.
g. Correspondence
1. Interoffice
2. EPA
3. Industry
4. Record of confidential material
h. Report notes, calculations, etc.
i. Reference literature
j. Sample (on hand) inventory
k. Check-out logs
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VII-3
1. Litigation documents
m. Miscellaneous - photos, maps, drawings, etc.
n. Final report
No confidential material is included in this file. Draft reports are
disposed of and only the final report appears in the file. Confidential
material must be maintained in a separate file under custody of a Document
Control Officer. Confidential material is checked out from the DCO on a
need-to-know basis.
A central element of the document control audit, to be performed by
the CEAT, will be a determination that filing systems ensure document
accountability and file security.
Document Accountability
To provide accountability, each document features a unique serialized
number which is assigned when the file is assembled. This number consists
of a three-digit project code, the Branch initials, and a three-digit docu-
ment number. For example, the first item in the Chemistry Branch file for
project 123 would have the number 123-CB-001.
The inventory list consists of the serialized document number and a
brief description of the item. Examples are:
123-CB-001 5/15/76 Memo from Mary Smith to John Doe
re Toxicity and Health Effects Data
123-CB-002 Computer Printouts, Blank #2, Air GC/MS, 2 pages
123-CB-003 6/1/76 Handwritten notes of John Doe, 3 pages
The document control audit specifically consists of checking each docu-
ment submitted for accountability. A written explanation is prepared for
any documents unaccounted for. Documents are reviewed to ensure that they
all appear on an inventory and that all documents listed on the inventory
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VII-4
are accounted for. The auditor will check the documents for the proper
numbering system. Documents are examined to determine that all necessary
signatures, dates and project codes are included.
Control of Confidential Business Information
The CEAT examines any documents marked "confidential" and determines
if they are handled and stored in the proper manner. Any information
received with a request of confidentiality is handled as "confidential".
When confidential material is received, it is marked as such and placed in
a locked filing cabinet or safe. Only authorized personnel are allowed
access to the file.
Reproduction should be kept to an absolute minimum. If it is essen-
tial that a copy be made, the person who maintains control of the file will
make the copy. No confidential information may be entered into a computer
or data handling system without proper safeguards. Requests for access to
confidential information by any member of the public or a State, local, or
Federal agency shall be handled according to the procedures contained in
the Freedom of Information Act regulations (40 CFR 2). All requests for
enforcement records are directed to the case attorney.
Toxic Substances Control Act Confidential Business Information
In 1976 Congress enacted PL 94-469, the Toxic Substances Control Act
(TSCA). This Act gives the U.S. Environmental Protection Agency a mandate
to protect public health and the environment from unreasonable chemical
risks.
Several product categories which fall under the jurisdiction of other
Federal laws have been exempted from this law. These categories are: pes-
ticides, tobacco, nuclear material, food, food additives, drugs, cosmetics,
and firearms and ammunition.
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VII-5
During the course of an evidence audit, the CEAT may encounter docu-
ments which a company has declared confidential under the Toxic Substances
Control Act. If such claim has been made, the project coordinator should
advise the CEAT during the pre-audit discussions. CEAT members are not
cleared for TSCA CBI and will not work with this material.
A Company may claim confidentiality for any or all information col-
lected by EPA during an inspection if it meets all of the following
criteria:
1. The Company has taken measures to protect the confidentiality of
the information, and it intends to continue to take such measures.
2. The information is not, and has not been, reasonably obtainable
without the Company's consent by other persons (other than government bod-
ies) by use of legitimate means (other than discovery based on a showing of
special need in a judicial or quasi-judicial proceeding).
3. The information is not publicly available elsewhere.
4. Disclosure of the information would cause substantial harm to the
Company's competitive position.
Once confidentiality has been claimed, there are stringent procedures
that must be followed. Each person who will have access to TSCA Confiden-
tial Business Information must have special clearance. Procedures for ob-
taining clearance and how to handle the information received are outlined
in the TSCA Confidential Business Information Security Manual.
Some examples of the requirements for handling TSCA Confidential Busi-
ness Information are listed below.
You are responsible for the control and security of all TSCA Confiden-
tial Business Information you receive. Specifically, you shall:
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VII-6
1. Discuss TSCA Confidential Business Information only with
authorized persons
2. Safeguard the information when actually in use by:
a. Keeping it under constant surveillance and being in a posi-
tion to exercise direct physical control over it
b. Covering it, turning it face down, placing it in approved
storage containers, or otherwise protecting it when unauthorized persons
are present
c. Returning it to approved storage containers when not in use
and at close of business
3. Not reproduce TSCA Confidential Business Information documents.
Copies must be obtained through a Document Control Officer (DCO)
4. Not destroy TSCA Confidential Business Information documents ex-
cept upon approval by and under the supervision of a DCO
5. Not discuss TSCA Confidential Business Information over the
telephone
The penalties for violating the required procedures are severe. A
"violation" is the failure to comply with any provision in the TSCA Con-
fidential Business Information Security Manual, whether or not such failure
leads to actual unauthorized disclosure of. TSCA Confidential Business
Information.
Violators of the procedures outlined in the manual may be removed from
the authorized access list and be subject to disciplinary action with pen-
alties up to and including dismissal.
Willful unauthorized disclosure of TSCA Confidential Business Infor-
mation may subject the discloser to a fine of not more than $5,000 or
imprisonment for not more than one (1) year or both.
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VII-7
The foregoing is a brief summary of the requirements imposed for hand-
ling TSCA Confidential Business Information. It is essential that personnel
be familiar with these requirements. TSCA confidential files are subject
to inspections by personnel from the EPA Security and Inspection Division,
as well as personnel from the Office of the Inspector General, to ascertain
that all procedures are being followed.
Personnel should not accept or assume custody of material or data
declared "TSCA Confidential" unless (a) the matter has been thoroughly dis-
cussed with the Document Control Officer, (b) the recipient(s) have been
cleared for "TSCA Confidential" by the EPA Regional Administrator, and (c)
approved procedures for handling the data have been implemented.
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APPENDIX A
FIELD INVESTIGATIONS AUDIT CHECKLIST
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FIELD CHECKLIST
Briefing with Project Coordinator
SIGNATURE OF AUDITOR
PROJECT COORDINATOR _
PROJECT LOCATION
TYPE OF INVESTIGATION
(authority, agency)
DATE OF AUDIT
PROJECT NO.
Yes No N/A
1. Was a project plan prepared?
are addressed in the plan?
If yes, what items
Yes No N/A
2. Were additional instructions given to project par-
ticipants (i.e., changes in project plan)? If yes,
describe these changes.
Yes No N/A
3. Is there a written list of sampling locations and
descriptions? If yes, describe where documents are.
Yes No N/A
4. Is there a map
is the map?
of sampling locations? If yes, where
Yes No N/A
5. Do the investigators follow a system of accountable
documents? If yes, what documents are accountable?
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Yes No N/A 6. Is there a list of accountable field documents
checked out to the project coordinator? If yes,
who checked them out and where is this documented?
Yes No N/A 7. Is the transfer of field documents (sample tags,
chain-of-custody records, logbooks, etc.) from the
project coordinator to the field participants docu-
mented? If yes, where is the transfer documented?
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