UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT
PROCEDURES MANUAL FOR THE EVIDENCE AUDIT
OF HAZARDOUS WASTE SITE INVESTIGATIONS
BY CONTRACTOR EVIDENCE AUDIT TEAMS
April 1980
NATIONAL ENFORCEMENT INVESTIGATIONS CENTER - Denver
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TABLE OF CONTENTS
CHAPTER I
CHAPTER II
CHAPTER III
CHAPTER IV
CHAPTER V
CHAPTER VI
CHAPTER VII
INTRODUCTION
THE EVIDENCE AUDIT FUNCTION
AUDIT PLANNING
FIELD INVESTIGATIONS AUDIT
LABORATORY OPERATIONS AUDIT
QUALITY ASSURANCE
DOCUMENT CONTROL AUDIT
APPENDIX A
APPENDIX B
APPENDIX C
APPENDIX D
APPENDIX E
FIELD INVESTIGATIONS AUDIT CHECKLIST
LABORATORY OPERATIONS AUDIT CHECKLIST
DOCUMENT CONTROL AUDIT CHECKLIST
SAMPLE NARRATIVE EVIDENCE AUDIT REPORT
EVIDENCE AUDIT STATEMENT
FIGURE 1
FIGURE 2
FIGURE 3
FIGURE 4
SAMPLE TAG
CHAIN OF CUSTODY RECORD
ORGANIC TRAFFIC REPORT (VIAR)
INORGANIC TRAFFIC REPORT (VIAR)
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1-1
CHAPTER I
INTRODUCTION
The Resource Conservation and Recovery Act of 1976 (42 USC 6901)
authorizes and requires the Administrator of the Environmental Protection
Agency, and the State environmental agencies to establish and operate
programs to manage and control hazardous wastes. The EPA Administrator has
established a program for the evaluation of hazardous waste sites by con-
tractor teams. Level of effort contracts for Field Investigations Technical
Assistance Teams (FIT) and fixed fee contracts for laboratory analyses of
liquid, gaseous and solids samples from hazardous waste site (HWS) investi-
gations implement Federal cleanup responsibilities. An additional con-
tractor team staffs the high-hazard laboratory at the National Enforcement
Investigations Center (NEIC) at Denver, Colorado.
It is expected that substantial numbers of the HWS investigations that
are performed by the FITs will suDport litigation under the enforcement
provisions of the Act. Accordingly, all information, data, samoles and
documents generated by the FITs must be treated as evidence.
The Agency employs evidence audit teams to evaluate chain-of-custody,
document control and evidence security procedures used by EPA employees.
Adherence to established procedures is a key element of EPA1s approach to
case development, and ensures that evidence produced during enforcement
investigations is viable and will withstand the rigors of scrutiny in and
by the courts. The magnitude of the investigative effort that is to be
mounted by the field investigations contract is such that a Contractor
Evidence Audit Team (CEAT) is necessary. The CEAT will function in a
manner similar to that of the EPA audit teams, except that the laboratory
analytical quality control audit function will be performed by EPA employees
of the Environmental Monitoring and SupDort Laboratory at Las Vegas, Nevada.
This manual is intended to provide ooerational guidance to the CEAT.
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1-2
CEAT members will be assigned to perform audits of field operations,
laboratory operations, and document control, or any combination thereof.
Points of contact between EPA and the CEAT, for administrative matters,
will be between the contractor's Project Manager and EPA1s Contracting
Officer; contacts will be between the CEAT Team Leader and EPA's Project
Officer for operational assignments, direction, and delivery of completed
work.
In order to gain a workinq understanding of the work to be performed,
it is necessary that CEAT members thoroughly understand this manual, and
the manual entitled "Procedures for Evaluations of Uncontrolled Hazardous
Waste Disposal Sites by Contractors." Additional material relevent to the
evidence audit function may be found in "NEIC Policies and Procedures
Manual." These documents are available from the EPA National Enforcement
Investigations Center, Bldg 53, Box 25227, Denver Federal Center, Denver,
CO 80225.
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CHAPTER II
THE EVIDENCE AUDIT FUNCTION
The work of the CEAT is primarily directed toward sampling of the
field investigations and laboratory contractors' adherence to EPA proce-
dures for chain-of-custody, document control and security of evidence. The
audits to be performed will usually consist of the collection of raw data
pertaining to the field investigations and laboratory contractors activi-
ties on behalf of EPA; recording the data and observations on checklists;
preparation of a summary report, and testifying in support of the authen-
ticity of evidence presented by the contractor personnel. EPA employees
may analyze the data supplied and may spot check the performance of the
team.
Work 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 confir-
mation at the earliest practicable time.
Assignments will normally be made in terms of:
A. Field Investigations Audit,
B. Laboratory Operations Audit, and/or
C. Document Control Audit.
Field Investigations Audits and Laboratory Operations Audits are to be con-
ducted according to the checklists and criteria provided in Appendices A,
B, and C, and include Document Control Audit procedures. A Document Con-
trol Audit is a "desk top" audit of field notebooks, chain-of-custody
records and other accountable documents conducted in the EPA Regional
Office or the field office of the national contractor, once the documents
have been called in.
Checklists will be submitted to the Project Officer within ten (10)
working days following completion of the audit. The checklist submission
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will be accompanied by a narrative report, which will summarize findings,
provide observations not covered by the checklists, identify all audit
documents, and a statement of opinion by a Certified Public Accountant (CPA)
member of the CEAT. A sample narrative report is included as Appendix D.
Audit teams will be tailored to meet the needs of the EPA enforcement
programs and priorities. A field investigations audit may require the ser-
vices of an engineer or technician while a laboratory operations audit will
require a chemist or person familiar with laboratory procedures. Teams of
two or three persons may be formed to conduct the more complex audits.
The composition of audit teams will be determined by the Project
Officer or the Deputy Project Officer (DPO) in consultation with the CEAT
leader. 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(s) is expected to exercise internal controls and participatory
oversight such that the CPA(s) 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). (See Appendix E.)
At the conclusion of each audit, the audit plan, the checklists, loq
books, summary report, and CPA statement, together with any related data or
documents, will be submitted to the Project Officer. After review by the
Project Officer, copies will be provided to the Regional Deputy Project
Officer 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 and they must comply with discovery requests
for any case they audited.
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CHAPTER III
AUDIT PLANNING
The Project Officer will maintain continuing liaison with the Regional
Deputy Project Officers (DPO) to identify the field 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 from the DPO. The project
plan details the project's scope, logistics, and schedules. Items addressed
in the project plan are:
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
The Project Officer will obtain a list of accountable field documents
issued to the FIT Leader. The accountable documents that will be used by
the FIT include logbooks, field data records, sample tags, and chain-of-
custody records. These documents will be labeled with a project code
number and a unique serial number prior to issuance. All accountable field
documents are assigned to the project coordinator. The coordinator distri-
butes them to appropriate project personnel and documents the transfer in a
logbook. The CEAT will check the list of accountable field documents to see
that the proper forms are used during the field investigation, and that
entries in and on forms and log books are made in accordance with EPA
prescribed procedures. The list of accountable documents will also be used
during the document control audit.
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With the exception noted below, the Audit Plan is developed by the
CEAT Leader in coordination with the FIT Leader assigned to the investiga-
tion that is to be audited. (The Project Officer may, on occasion, 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 FIT
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 reqime imposed by the FIT
Leader, 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.
The audit plan will be reviewed by the Project Officer or DPO, and
when aporoved, and attached to the work order, will become the authoriza-
tion for the CEAT to proceed. Verbal authorization, followed up with a writ-
ten authorization, may be given by the Project Officer or DPO.
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CHAPTER IV
FIELD INVESTIGATIONS AUDIT
The CEAT member(s) assigned to a particular audit will contact the FIT
Leader 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 procedures, field documentation, security of
evidence and sampling operations. The evaluation is based on the TAT project
plan, the manual "Procedures for Evaluations of Uncontrolled Hazardous
Waste Disposal Sites by Contractors," and directions given by the CEAT
Leader and by the Project Officer. Specifics regarding the audit in progress
are contained in the audit plan.
The CEAT will maintain a log of all activities performed during the
field investigation audit. The log will consist of work papers and checklists.
The checklists are included herein as Appendices A-C. The auditor must
accurately track the dates and time of audit activities and the document
numbers that have been reviewed. Included in the log will be the project
codes, the project location, the FIT assigned to the project, and the
auditor's name. The checklists must be completed in entirety and any other
pertinent information should be recorded in the "comments" section.
Pre-audit communication between the CEAT and the FIT Leader 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 FIT. If possible, the auditor
should enter the site with the FIT. The CEAT should give the FIT Leader
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 resDonse to an inspection
notification letter.
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IV-2
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 or agent
in charge for the facility, including the plant environmental engineer.
3. If a guard is present at the entrance, the CEAT member should
present credentials and suggest that the quard call his/her superior on the
phone. The member may request that the guard call the responsible official
directly when the name is known.
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 the 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;
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,
whom in turn, must notify the Project Officer or DPO.
SAMPLE CONTROL
A sample is physical evidence collected from a facility or from the
environment. Evidence control is an essential part of all enforcement
investigations. A sample must be properly identified. Sample identifi-
cation documents must be carefully prepared in order that (a) identification
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and chain-of-custody can be maintained, and (b) that sample disposition can
be controlled. The sample identification documents that will initially* be
employed by the FITs are:
Data from on-site measurements are recorded directly into the field
logbook or Field Data Records (FDR). Examples of on-site measurements are
pH, temperature, conductivity, radiological measurements, etc.
Sample Tags
All necessary serialized sample tags are distributed to field investi-
gators by the FIT Leader (or designated participant) and the serial numbers
are recorded in the FIT Leader's logbook. Individuals are accountable for
each tag assigned to them. A tag is considered in their possession until
it has been filled out, attached to a sample, and transferred to another
individual with the corresponding Chain-of-Custody Record. At no time are
any sample tags to be discarded and if any tags are lost, voided, or dam-
aged, the facts are noted in the appropriate FDR or logbook immediately
upon discovery and the FIT Leader is notified. The FIT Leader must, in
turn, inform the DPO of the facts related to the lost, voided, or damaged
tags. At the completion of the field investigation activities, all unused
sample tags are returned to the FIT Leader who checks them against the list
of assigned tag serial numbers. Tags attached to those samples which are
split with the source or another government agency shall be accounted for
by recording the serialized tag numbers.
Samples are removed from the sample location and transferred to a
laboratory 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 pro-
cedures and the sample is identified with a sample tag. The information
recorded on the sample tag includes:
* Torms may be consolidated in the future.
1. Sample Tags
2. Chain-Of-Custody Record
3. Organic Traffic Report (VIAR)
4. Inorganic Traffic Report (VIAR)
Figure 1
Figure 2
Figure 3
Figure 4
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Project Code
Station Number
- An assigned number
- A two-digit number assigned by the FIT Leader
Date
and listed in the project plan
- A six-digit number indicating the year, month,
Time
and day of collection
- A four-digit number indicating the military
Station Location
time of collection - for example: 0954
- The sampling station description as specified
Samplers
Tag Number
Remarks
in the project plan
- Each sampler is identified
- A unique serial number is stamped on each tag
- The samplers record pertinent observations
The sample tag contains an appropriate place for designating the sample
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 will be marked "Blank" or "Duplicate" respectively.
The CEAT will examine a selected number of sample tags for completeness
and accuracy. The team member will determine if the station number and lo-
cation has been identified, the date and time collected are indicated, the
type of sample and analysis are specified, the preservative, if used, is
identified, and the samplers' signatures appear on the tag. The tag numbers
will be checked to ensure that they are the ones issued to the Droject.
The auditor will also determine if the station location accurately identifies
where the sample was actually taken and if the sampling methods used were
as directed by the project coordinator.
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SAMPLE TAG
Project Code
Station flo.|
Month/Day/Year
Time
Designate:
Comp. Grab
©
Station Locatio
n 1
Samplers 1
Signat
ures
I
Tag Ho. Lab Sample No
M-OOOl
Remarks:
Bacteriology
Mutagenicity
Pesticides
Volatile Organics
Priority Pollutants
Orqanics GC/MS
Oil and Grease
Cyanide
Metals
Mercury
Phenoli cs
COD, TOC, Nutrients
CO CO
o o
—• o
CL
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(/¦>( 2
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ANALYSES
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(obverse)
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
(Appropriate Address)
[reverse)
FIGURE 1
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IV-6
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. Serialized chain-of-custody records are assigned and accounted
for in a manner similar to that used for sample tags.
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 tampering, 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 provides
a good representation of the media being sampled are to be collected. To
the extent possible, the quantity and types of samples and sample locations
are determined prior to the actual field work. As few people as possible 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 water proof ink
unless prohibited by weather conditions. For example, a logbook notation 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 FIT Leader must review all field activities to determine whether
proper custody procedures were followed during the field work, and decide if
additional samples are required.
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To maintain and document sample possession, chain-of-custody proce-
dures are followed.
Transfer of Custody and Shipment
1. Samples are accompanied by a chain-of-custody record (Fig. 2).
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
laboratory for analysis, with a separate custody record accompanying each
shipment. 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" box.
3. Whenever samples are split with a source or government agency, a
separate chain-of-custody record 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 of the appropriate party, 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 note the date and time.
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 FIT Leader.
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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ENVIRONMENTAL protection agency
Office of Enforcement
CHAIN OF CUSTODY RECORD
(Appropriate Address)
PfOJ NO
Project Name
NO
OF
CON-
TAINERS
RE,iARKS
SAI iPLERS fS'tpaiurej
ST A NO
OATE
Ttf'E
a>
o
3
cc
«J5
STATION LOCATION
flolinquished by tSi
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IV-9
The CEAT will select a predetermined number of the 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 appropriately identified; 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 locked up to prevent tampering. Sampling equipment
should also be checked for security and to detect tampering.
VIAR Traffic Forms
The firm VIAR & Co., of Alexandria, VA, has been awarded a contract,
by EPA, to manage the shipment of samples from HWS investigations and to
allocate workloads to the participating contractor laboratories. The
Organic and Inorganic Traffic Reports (Figures 3&4) are to be executed by
the FIT and are subject to audit as are the previously discussed documents.
The essence of this aspect of the audit is that the information recorded
upon the forms is correct and that it coincides with the information on the
sample tags and on the Chain-of-Custody Record. Deficiencies noted must be
recorded in the audit log, and must be reported to the DPO at first opportu-
nity.
FIELD DOCUMENTATION
Observation and measurements during field investigations must be docu-
mented in accountable logbooks or field data records. These records are
intended to provide sufficient data and observations to enable participants
to reconstruct events that occurred during the project, and to refresh the
memory of the FIT members if called upon to give testimony during legal
proceedings.
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U.S. ENVIRONMENTAL PROTECTION AGENCY - H'VI Sample Management Office
P.O. Box SI 8, Alexandria, VA 22313 - 703/6S3-0SS.5
ORGANICS TRAFFIC REPORT
IV-10
Sample Number
CASE NUMBER:
SAMPLE SITE NAME:
SAMPLE TYPE: (Check One)
RUN OFF
WELL
RECEIVING WATER
LEACHATE
SHIP TO:
ATTN:
EFFLUENT
OTHER
(specify)
REGIONAL OFFICE:
Mark Volume Level on Sample Bottle
Date
Sampled
ANALYSIS LAB:
Rec'd by:
Date/Time Rec'd:
Sample Condition on Receipt
Sampling Personnel:
EXTRACTABLE
(Phone)
EXTRACTABLE
sampling Date:
(Begin) (End)
EXTRACTABLE
EXTRACTABLE
VOA UNPRESERVED
> HIPPING INFORMATION
Name of Shipper:
VOA UNPRESERVED
(Duplicate)
Date Shipped:
Airbill Number:
DESCRIPTION OF SAMPLE LOCATION:
.SPECIAL HANDLING INSTRUCTIONS:
(e.g., safety precautions, hazardous nature)
FIGURE 3
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iv-n
p /ft Ti
w
*1 PP/&
Sample Number
(7) Case Number.
Sample Site Name /Code:
(7) Sample Type: (Check One)
Run OH
Well Water
Receiving Water
Leachate
Effluent
Other
(specify)
(T) Ship To.
Attn:
(7) Regional Office. _
Sampling Personnel
(Name)
(Phone)
Sampling Dale
(Begin)
(End)
Shipping Information:
Name Of Shipper
Date Shipped .
Airbill Number
(T) Description of Sample Location
MATCHES ORGAhiCS SAMPLl NO .
(T^Mark Volume Level On Sample Bottle
^—' Date Sampled
Task 1
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IV-12
Logbooks
Project logbooks will be reviewed by the CEAT during the field investi-
gation audit to see that each is signed and all entries are dated. It
should also have a document control number on the inside cover.
Logbook entries must be legible, written in ink, and contain accurate
and inclusive documentation of an individual's project activities. Because
the logbook forms the basis for the later written reports, it must contain
only facts and observations. Language should be objective, factual and
free of personal feelings or other terminology which might prove inappropriate.
Entries made by individuals other than the person to whom the logbook was
assigned are dated and signed by the individual making the entry.
The logbook of the FIT Leader will document the transfer of logbooks
to the individuals who have been designated to perform specific tasks on
the survey. All pertinent information should be recorded in these logbooks
from the time each individual is assigned to the project until the project
is completed.
Field Data Records
Where appropriate, serialized Field Data Records (in the form of indi-
vidual sheets or bound logbooks) are maintained for each survey sampling
station or location and the project code and station number are usually re-
corded on each page. The FIT Leader also numbers the FDR covers with the
appropriate project code and station number. All in-situ measurements and
field observations are recorded in the FDR's 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 coordinator and the field team on duty are responsible for
insuring that FDR's are present during all monitoring activities and are
stored safely to avoid possible tampering. Any lost, damaged or voided
FDR's are reported to the project coordinator.
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IV-13
The CEAT will review field data records in the same manner as the log-
books.
Photographs
Photographs may be taken for evidentiary purposes and these must also
-\
be controlled. The CEAT will review the logbooks to determine if the photo-
graphs are properly documented. When movies, slides or photographs are taken
which visually show sampling sites or provide other documentation, they are
numbered to correspond to the logbook entries. The name of the photographer,
date, time, site locations 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.
Corrections To Documentation
As previously noted, unless prohibited by weather conditions, all
original data recorded in logbooks, FDR's, sample tags, custody records and
other data sheet entries are written with waterproof ink. None of the
accountable serialized 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 an accountable document assigned to one individual,
that individual may make corrections simply by crossing a line through the
error and entering the correct information. The erroneous information
should not be obliterated. Any subsequent error discovered on an accountable
document should be corrected by the person who made the entry. All subsequent
corrections must be initialed and dated.
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 FIT Leader. The
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IV-14
proper number of samples should be collected at the assigned locations. The
CEAT should check to determine that the samples are in proper containers
and are properly preserved.
The CEAT will determine if the required field measurements and quality
assurance checks are being performed and documented as directed.
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V-l
CHAPTER V
LABORATORY OPERATIONS AUDIT
The CEAT will perform audits of laboratory activities in the contractor
laboratories that are supporting the HWS investigations. The assignment will
be made by the Project Officer. The audit will address sample control, labora-
tory documentation, security of evidence and quality assurance. The evaluation
will be based on the project plan, directions from the Laboratory Contract
Project Officer, and instructions provided the laboratory personnel by the
laboratory director.
The auditor's worksheets used for the field investigation audit will be
continued so that all project audit information will be recorded in one set
of records. Checklists for laboratory activities (Appendix B) will be filled out.
The auditor will record the project number, the laboratory contractor, the
laboratory location, the date, and the auditor's signature.
SAMPLE CONTROL
The CEAT will determine the number of samples that were collected during
the field investigation and verify that all have arrived at the laboratory. Each
sample will have an identification tag and be recorded on a chain-of-custody
record. The auditor will examine tags and chain-of-custody records to see that
descriptions, dates, and times match. All transfers of custody of samples
should be documented and the auditor will review a predetermined representative
number and trace custody from time of collection to the laboratory. The auditor
will determine from laboratory documentation if the samples were received under
custody.
The following laboratory custody procedures will be followed:
Laboratory Custody Procedures
1. A designated sample custodian accepts custody of the shipped
samples and verifies that the information on the sample tags matches that
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V-2
on the chain-of-custody records. Pertinent information as to shipment, pickup,
courier, etc., is entered in the "Remarks" box. The custodian then enters the
sample tag data into a bound logbook which is arranged by project code and
station number. The samples are then stored in a secure area. The auditor
will determine if the laboratory follows protocols established by EPA for sam-
ple storage and preservation.
2. The custodian distributes samples to the appropriate analysts. The
names of individuals who receive samples are recorded in internal laboratory
records. Laboratory personnel are responsible for the care and custody 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 properly.
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 will be re-
corded in logbooks or on serialized bench sheets. All documentation will be
accountable once project information is recorded on it. Each document will
show the project code, dates, name(s) of analyst(s) and other pertinent infor-
mation concerning the identification of the sample or laboratory results.
Instrument printouts, graphs, and other documents will be labeled in a similar
manner. All other documentation concerning the project such as correspondence,
report notes, methods, documents, references, sample inventories, checkout
logs, etc., will become part of the permanent record and will be serially num-
bered and inventoried.
The logbook needs 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,
-------
V-3
sufficient detail is necessary to enable others to reconstruct the procedures
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 particu-
lar 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.
/
Before a final laboratory report is sent out, the laboratory will assemble
and cross-check information on corresponding sample tags, custody records,
bench sheets, analyst logbooks, and samole entry logbooks to ensure that
data pertaining to each particular sample is consistent throughout the record.
A statement that all project evidentiary data has been accounted for, and an
explanation of any deviations from established procedures should be included in
the laboratory project file.
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VI-1
CHAPTER VI
QUALITY ASSURANCE
The contract laboratories must follow specified quality assurance pro-
cedures to assure that high-quality data are produced. The Environmental
Monitoring and Support Laboratory-Las Vegas (EMSL-LV) will review the procedures
and the laboratory documentation to determine if these operations have been
performed. The audit activities of the CEAT must be closely coordinated with
the QA activities of EMSL-LV. Where possible Laboratory Audits and QA evalua-
tions should be coordinated by the Project Officer or Deputy.
Methods used by contractor laboratories should be specified and a quality
assurance program detailed. All quality assurance data and observations shall
be recorded in logbooks or on bench sheets. The quality assurance program
consists of quality control and quality assurance documentation.
Ouality control is the documentation and evaluation of methods, personnel
training, and routine performance checks integral to each measurement Drocess.
Examples of routine checks are instrument maintenance and calibration, and
blank, duplicate, and spiked sample determinations.
Quality assurance documents the independent checks performed to verify that
the quality control system is effective and adequate. An example is use of
laboratory reference standards. Quality assurance also consists of accuracy and
precision of data. Accuracy is the degree of agreement between a measured value
and the true value. It is difficult to determine accuracy of a measurement on
an environmental sample because the true value is unknown. Therefore, the
accuracy of an individual measurement procedure is usually determined by analyz-
ing a standard reference material, or by spiking a sample with a known quantity
of material and re-analyzing.
Precision is the degree of agreement between repeated measurements using
the same method or technique.
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VI - 2
The primary responsibility for the proper performance of a measurement
including QC checks lies with the analyst making the measurement. The analyst
evaluates the QC results as soon as possible after the measurement is per-
formed. When QC results are determined to be outside accepted limits, the
measurement process is stopped, problems are corrected and documented, and
then the measurement is continued.
The quality assurance program data is to be summarized by EMSL-LV and
made a part of the permanent project file.
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VII-1
CHAPTER VII
DOCUMENT CONTROL AUDIT
Once the field and laboratory operations have been completed, the
individual files assembled from these groups should be sent to the Deputy
Project Officer at the EPA Regional office. The CEAT will review the
assembled file in the regional EPA office and make an evaluation based on
file organization and format, accountability of documents based on the
document numbering system and inventory, and separation and control of any
confidential information or confidential business information claimed under
the Toxic Substances Control Act.
The FITs and laboratories must establish orderly filing and inventory
systems. The following describes the filing and document control system
used by the NEIC in preparing project files. This system will serve as a
basis for comparison with other systems.
File 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 Cards,
Graphs, etc.
G. Correspondence
1. Inter-office
2. EPA
3. Industry
4. Record of Confidential Material
-------
VI1-2
H. Report notes, Calculations, etc.
I. Reference Literature
J. Sample (on hand) Inventory
K. Check-out Logs
L. Litigation Documents
M. Miscellaneous - photos, maps, drawings, etc.
N. Final Report
No confidential material should be included in this file. Cover draft
reports should be disposed of and only the final report should appear in
the file. Confidential material must be maintained in a separate file
under custody of the Document Control Officer in the EPA Regional Office.
Confidential material may be 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 the FIT and contract laboratory
filing systems ensure document accountability and file security.
Document Numbering System and Inventory Procedure
To provide accountability to the appropriate individuals, 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 two-digit document number. For example, the first item in
the Chemistry Branch file for project 123 would have the number 123-CB-01.
The inventory list consists of the serialized document number and a
brief description of the item. Examples are:
123-CB-01 5/15/76 Memo from Mary Smith to John Doe
re Toxicity and Health Effects Data
123-CB-02 Computer Printouts, Blank #2, Air GC/MS, 20 pages
123-CB-03 6/1/76 Handwritten notes of John Doe, 3 pages
-------
VII-3
Two copies of the inventory list accompany the files. One copy is put in
the evidentiary file and one copy is maintained by the Deputy Project Officer in
the Regional office. The file is now accountable and any documents removed from
it must be checked out through the person maintaining the file.
The document control audit specifically consists of checking each document
submitted for accountability. All documents used for the field investigation
should be checked against the list of field documents issued to the project
coordinator. Any documents missing or unaccounted for must be explained in
writing. Documents other than those issued should be reviewed to ensure that
they all appear on an inventory and that all documents listed on the inventory
are accounted for. The auditor should check the documents for the Droper num-
bering system.
The documents shall also be examined to see that all necessary items such
as signatures, dates, and project code are included.
Confidential Information
The CEAT will examine any documents that are marked "confidential" and
determine 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 shall be marked as such and
placed in a locked filing cabinet or safe. Only personnel authorized by the
Regional Administrator, Enforcement Division Director or Deputy Project Officer
shall be allowed access to the file.
Reproduction should be kept to an absolute minimum. If it is essential
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.
-------
VI1-4
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 such requests shall be referred to the responsible Regional
organizational unit.
TOXIC SUBSTANCES CONTROL ACT CONFIDENTIAL BUSINESS INFORMATION
During the course of an evidence audit the CEAT may be confronted with
documents 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.
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:
pesticides, tobacco, nuclear material, food, food additives, drugs, cosme-
tics, and firearms and ammunition.
A company may claim confidentiality for any or all information collected
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
bodies) 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.
-------
V11 - 5
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
obtaining clearance and how to handle the information received are outlined
in the TSCA Confidential Business Information Security Manual and the TSCA
Confidential Business Information Security Briefing Booklet.
Some examples of the requirements for handling of TSCA Confidential Infor-
mation are listed below.
You are responsible for the control and security of all TSCA Confiden-
tial Business Information you receive. Specifically you shall:
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 position
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
except upon approval by and under the supervision of a DCO.
5. Not discuss TSCA Confidential Business Information over the
telephone.
-------
VII-C
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 act 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
penalties up to and including dismissal.
Willfu11 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 year or both.
The foregoing is a brief summary of the requirements imposed for hand-
ling of TSCA Confidential Business Information. It is essential that
contractor personnel be familiar with these requirements. TSCA Confiden-
tial 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.
Contractor personnel should not accept nor assume custody of material
or data declared "TSCA Confidential" unless (a) the matter has been thor-
oughly discussed with the Deputy Project 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
-------
A-
EVIDENCE AUDIT CHECKLIST
Field Investigations Audit
Froject ".so. Date_
Project Location Signature_
TAT Tea?i
1) '.^5 a project coordinator been appointed?
Comments
No 2) Was a project plan prepared?
Coimrcents
Yes No 3) Was a briefing held for project participants9
Corjnents
Yes Y.o i) Were additional mstrucLions given to project
participants7
Corpireiits
-------
Is there a written list of sampling locations
a;..
Comments
Is there a list of accountable field documents
cb.eck.ed out to the project coordinator?
Continents
Is the transrer or field documents from the
coordinator to field participants documented
in a logbook?
Comments
Are samples collected as stated in the project
plan or as directed by the cordinator7
Comments
Are samples collected m the type of containers
specified in the project plan or as directed
by the coordinator?
Comments
-------
Ace samples preserved as specified in the project:
ptin or as directed by the coordinator?
Con—ion ts
Are the number, frequency, and type of samples
collected as specified in the project plan
or as directed by the coordinator?
Comnents
Are tne number, frequency, and type of measure-
ments and observations taken as specified in the
project plan or as directed by trie cooruir.ator?
Comments
Arc samples identified with sample tags9
Comments
Are blank and duplicate samples properly ident-
ified?
Comments
Am '..ample ti.i", seri.il numbers for samples split
'Jj Hi otlu1 r or^.mi^aL j ons recorded in a logbook
-------
or on a chain-or-custody record?
Co^Terts
Are samples listed on a chain-of-custody record9
Comments
Is chain-of-custody documented and maintained?
Comsncs
Are quality assurance checks performed as
directed?
Comments
Are photographs documented in logbooks as re-
quired7
Comments
Have any .iccountable documents been ]ost?
Comments
-------
Have any accountable documents been voided7
Comments
Have any accountable documents been disposed o
Ccnments
-------
APPENDIX B
LABORATORY OPERATIONS AUDIT CHECKLIST
-------
EVIDENCE AUDIT CHECKLIST
Laboratory Operations
Project No.
Project Location
Contractor Laboratory
Date
Signature
Yes Mo 1) Is a project plan available to laboratory
personnel or have ir.siruccioni> been given
by the coordinator or supervisor?
Comments
Yes No 2) Were all samples collected during the field
investigation received by the laboratory?
CoTrmentb
Yes No 3) Arc sample tags on all containers?
Comments
-------
Are bamules received by laboratory accompanied
by a chdin-oi-custoay record?
Comments
Can custody of samples be traced from the time
of collection to receipt by the laboratory''
Comments
Were the samples received under custody?
Comments
Was the shipping container properly secured?
Comments
Is a laboratory custodian designated?
Comments
Were sample tags and chain-of-cu^tody records
checked to see that information matches''
Comments
-------
Wore samples logged in to the laboratory
record?
Comments
Are samples stored in a secure area?
Comments
Are sanoles stored in a way to maintain pre-
servation ?
Commencs
Arc sample holding time limitations satisfied7
Comments
Do laboratory records demonstrate personnel
transferring and receiving samples in the
lab?
Comments
Once analysis ls completed, arc sample ta;;s re-
moved and incorporated into the permanent
record'
Cori.iients
-------
Are analytical methods documented and
available to ana]ysts7
Comments
Are quality assurance procedures documented
ana available to analysts?
Comments
Are quality assurance procedures recorded as
required7
ComiT-en Cb
-------
APPENDIX C
DOCUMENT CONTROL AUDIT CHECKLIST
-------
EVIDFNCE AUDTT DOCUMENT CHErKF.tST
project No.
"rojccL Location Date
i AT Tea.i Signature
DOCI' 'CVL
'J DC
)ocLiu one
l o.
Is
the document
signed
15
the oocuncnL
date d
Arc
record i rigs
i n i nk
Are errors
proper 1y
corrected
Are al]
blanks
conv.ileLed
Remarks
1
1
1
I
o
|
-------
Document Control Audit
C-2
7_,'T|';n'V(3]2 \n!)T'p C'""C£tjTST
Project No.
Project Location_
Fi?.p Location
Date
Signature
; es
i;o
1) Have -_'he i.icij-.'i^aai filet* beer, assembled (field
investigation, laboratory)?
Conmants
Yes No 2) Is there an inventory for each file?
Coments
Yes No 3) Is there a lif,t of accountable field documents'
Comments
Yes No 4) Are all accountable fieJd documents present or
accounted for? (fi.ll out additional checklist)
Connie nts
-------
Is there a document numbering system?
Coirjiient';
Has each document been assigned a document control
number?
Comments
Are all documents listed on the inventory acc-
ounted for?
Corrnents
Are there any documents in the file which are
not on the inventory?
Comnents
Is the file stored in a secure area?
Comments
Are there any additional project docu'p.enL-. uh u h
have beon dncJaicd confidpnt La] 7
-------
Yes No 11) Are there conf~jLdcntia] documents stored in a
secure area scparote fron the other project
docu-.enLs?
Cj'ii?snts
C-4
Yes No 12) Is access to the confidential files restricted?
Co-jpents
Yes I.'o 13) Have the conficenc^aJ docjrrerLs been nartcud or
stih/ioad "Confidential"?
Connents
Yes No _ 14) Is t'he confidential information inventoried?
Co-^ents
Yes rio 15) Is the confidential information numbered for
doci'nient control7
Comments
Yen No ]6) have any documents been cl.n.tned conf Ldenl i el
Co - '.'n'cs
-------
lv_ 11 L
rs
ent
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
43
49
50
i.v/jii mLL'JU I i I n 'jL 1. UU'„Ui'!tji I Li I C'j i\L i.
ition
)e Date
ied Signature
Returned
Comments
Document
Nn.
Returned
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
91
95
96
97
98
99
100
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APPENDIX D
SAMPLE NARRATIVE EVIDENCE AUDIT REPORT
-------
D-l
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF ENFORCEMENT
NATIONAL FIELD INVESTIGATIONS CENTER-DENVER
BUILDING 53, BOX 25227, DENVER FEDERAL CENTER
DENVER, COLORADO 80225
C.G. Wills, Chief, Enforcement Specialists Office date October 4, 1979
fi.om Robert Laidlaw, Evidence Audit Unit
subject Project Review, ABM-Wade Disposal Site, Philadelphia, PA (616)
Attached for your review is the draft evidence audit report for project 616,
ABM-WADE Disposal Site, Philadelphia, PA.
-------
EVIDENCE AUDIT REPORT
ABM-WADE DISPOSAL SITE, P H T.T ADELPHIA,
OCTOBER 4, 19-79
PA. EROJECT 616
An evidence audit was conducted on project documents for project
616 during September, 1979. All accountable documents charged to the
project are accounted for. Project documents generated within the
individual branches are complete as listed on each branch inventory.
These documents have been reviewed and are in accordance with NEIC
policies and procedures. Field and laboratory operations were not
The following accountable documents were issued to the project
coordinator on February 5, 19 79
In addition, six custody locks and two keys were issued on the same
Custody tag numbers 2805 through 2826 are attached to sample
containers that are located in the chemistry regulated laboratory.
These tags are accounted for as follows:
2805-Sta 01 3/14/79
-------
D-3
2
2816-Sta
10
3/14/79
@
0955
2817-Sta
11
3/14/79
@
1000
2818-Sta
12
3/14/79
@
1005
2819-Sta
13
3/] i/79
@
1030
2820-Sta
22
3/14/79
@
1035
2821-Sta
20
3/14/79
@
1040
2822-Sta
14
3/14/79
@
1045
2823-Sta
21
3/14/79
@
1048
2824-Sta
16
3/14/79
@
1051
2825-Sta
15
3/14/79
@
1054
2826-Sta
17
3/14/79
@
1100
Once the samples and containers have been disposed of, the tags
will be removed and placed in the evidentiary file. Accountable
documents that were charged to the project but which were not used,
had the project number removed or were disposed of and are not included
in the project evidentiary file. These unused documents are listed
below.
logbook 616-02
logbook 616-03
logbook 616-04
logbook 616-05
logbook 616-06
custody tags 2835 through 2854
custody records 0477 through 0485
In addition, all custody locks and keys were returned.
The ABM-WADE Disposal Site file consists of the following individual
inventoried branch files:
Central file
Field Operations Branch file
Process Control Branch file
Technical Services Branch file
Chemistry Branch file
Each of these files were evaluated to determine if the documentation
contained any significant deviations from accepted NEIC policies and
procedures. In my opinion, there were no significant deviations in the
documentation that would co^pro-ni^e the evidence for this project.
-------
The review of the Central File demonstrated that all documents
were inventoried and numbered with the project number and serialized
document number. All of the documents listed on the inventory are
present in the file. There was one document, (616-CF-15), that pertains
to project 618, this was removed and placed in the project file for 618.
The Central File did not contain an official written request for
work to be performed. However, the request for work is discussed in a
memo from Mr. Benson to the Director, NEIC, on January 26, 1979 (616-CF-16)
and further discussed in a memo from the Deputy Assistant Director, Operations
on February 2, 1979 (616-CF-12). These memos did detail the objectives
of the project and related these objectives to an enforcement action
under section 7003 (RCRA).
The Field Operations Branch file demonstrated that all documents
are accounted for and are inventoried. All of the documents are
properly identified and numbered with the exception of the photographs.
The photographs are described on the back of the prints and in the logbook,
but arc not individually numbered.
The Process Control Branch file contains properly identified and
organized documents. These documents were handled in a manner consistent
with NEIC policies and procedures. All documents listed on the inventory
arc accounted for.
The Technical Services Branch tile ib inventoried and all documents
on the inventory arc accounted for. The documents are not individually
labeled with the project nurher or a seriali ;ed document number.
-------
D-5
The Chemistry Branch file contains properly identified and
organized documents. The documents listed on the inventory are all
accounted for and are labeled with the project number and a serialized
document number. All of the documentation appears to be handled
consistent with NEIC policies and procedures. The branch file contained
references to methods used for metals analysis. Samples were analyzed
by ICP-AES. There is no standard method available for analysis of
metals from sediment or solid waste samples. Quality assurance work
uas used to demonstrate the acceptability of this method. It would have
been desirable to have described in detail the procedure and the accompanying
quality assurance work.
These files are secured in the evidentiary file located in Building 53.
-------
APPENDIX E
EVIDENCE AUDIT STATEMENT
-------
E-l
Date
TO: , Project Officer
EPA National Enforcement Investigations Center
Bldq 53, Sox 25227, Denver Federal Center
Denver, Colorado 80225
SUBJECT: Evidence Audit Statement, Project No.
My ooinion, based upon my review of the documentation generated by
the Field Investigation/Laboratory Operations/Document Control activities
for Project Number , is that the Chain-of-Custody and
Evidence Security requirements meet or exceed those specified by EPA's
"NEIC Policies and Proedures Manual" (EPA 330/9-78-001). Exceptions to
this statement are noted below.
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