US Environmental Protection Agency
Office of Pesticide Programs

Office of Pesticide Programs

Microbiology Laboratory

Environmental Science Center, Ft. Meade, MD

Standard Operating Procedure for
Chain of Custody Procedures for
Antimicrobial Samples

SOP Number: COC-01-07

Date Revised: 05-27-15

SOP No. COC-01-07
Date Revised 05-27-15
Page 1 of 9

SOP Number



Chain of Custody Procedures for Antimicrobial Samples


This SOP describes procedures used by the Microbiology Laboratory
Branch for the login, tracking, and disposal of antimicrobial product


This SOP applies to only those product samples requiring chain of
custody (COC) documentation.

Approval Date

SOP Developer:

Print Name:

SOP Reviewer

Print Name:

Quality Assurance Unit

Print Name:

Branch Chief

Print Name:

Safety, Health, and
Management Office

Print Name:

Date SOP issued:

Controlled copy

Date SOP withdrawn:

SOP No. COC-01-07
Date Revised 05-27-15
Page 2 of 9

Contents	Page Number













































SOP No. COC-01-07
Date Revised 05-27-15
Page 3 of 9

1. Definitions

1.	Chain of Custody (COC): Formal documentation showing the full process
of receipt, transfer, handling, disposition, and disposal of specific
antimicrobial samples.

2.	Product sample Custodian: Product sample custodians are authorized
through training to open shipping containers containing samples
(including official samples and samples from sources other than official
[inspector] collection, see 10.6), inspect a sample, place and remove
samples from the sample storage area, record chain-of-custody
information, prepare product dilutions, and return samples to the storage

3.	Date of sample disposal = Date that the sample is removed from chain of
custody and declared as waste.

2. Health and

Follow procedures specified in SOP MB-01, Laboratory Biosafety. The Study
Director and/or lead analyst should consult the Material Safety Data Sheet for
specific hazards associated with products.

3. Personnel
and Training

The COC sample custodians are MLB scientists, who are qualified by training
to be sample custodians, and are listed on the COC Sample Custodian Form
(see Section 14, Form 8). Each custodian must be trained on current COC
procedures and documentation must be maintained and updated regularly.

4. Instrument


5. Sample

Handling and


6. Quality Control

1.	Timely, accurate, and legible sample information recorded in ink is
required on all chain-of-custody documentation.

2.	For quality control purposes, the required information is documented on
the appropriate forms.

7. Interferences

1.	Insufficient chain-of-custody documentation, illegible entries by the
inspectors, or incorrect entries of sample identity by the inspectors may
interfere with completion of the sample login process.

2.	Illegible, missing, or incorrect entries that may interfere with the
completion of the sample login process are addressed by contacting the
inspector for clarification. Deficiencies must be documented. A written
explanation by the inspector may be required.

3.	Samples which arrive in poor condition (e.g., leaking) will not be accepted
for analysis. The sample is disposed of following the specified procedures

SOP No. COC-01-07
Date Revised 05-27-15
Page 4 of 9

and the sender notified. For officially-collected samples, the inspector and
the Office of Enforcement and Compliance Assurance (OECA) are
notified to send replacement samples.

4. COC seals may become detached over time due to dehydration and must
be checked periodically to inspect their integrity.

8. Non-

Management of non-conforming data/information will be specified in the
study protocol; procedures will be consistent with SOP ADM-07, Non-
Conformance Reports.

9. Data


1.	Data will be archived consistent with SOP ADM-03, Records and

2.	For a current list of sample custodians for the laboratory, see Section 14.
After each addition to or deletion from the list, an updated electronic copy
of the list is be filed in the shared directory with the other forms
associated with this SOP.

10. Cautions

1.	Condition of the primary shipping container, the product sample, and the
chain-of-custody seal must be noted on the appropriate form.

2.	Samples should be logged in and transferred to the storage facility as soon
as possible by an official OPP Microbiology Laboratory sample custodian.

3.	Sample custodians are responsible for signing out samples for testing and
returning the samples to the storage area following procedures outlined in
this SOP.

11. Special

Apparatus and

Rooms B204 and D204 at EPA's Environmental Science Center have been
designated as the secured storage sites for product samples. Flammable
samples are stored in the locked flammable storage cabinet in room B204. All
other samples are stored in room D204. The temperature and relative
humidity of sample storage rooms are monitored by the computer-based
Environmental Monitoring and Alarm System (see SOP QC-05, Monitoring
Environmental Parameters.)

12. Procedure and

12.1 Sample

Receipt and

a.	Product samples should be shipped to the Microbiology Laboratory
to the attention of Michele Cottrill, US EPA, Environmental Science
Center (ESC), 701 Mapes Road, Ft. Meade, MD 20755-5350 or her

b.	When applicable (e.g., voluntary product submission for ATP
testing), MLB will submit form COC-01-07 F7 to the
registrant/manufacturer to document the efficacy test conditions; this

SOP No. COC-01-07
Date Revised 05-27-15
Page 5 of 9

form should be retained in the COC folder for the product.

c.	Upon delivery of the sample and receipt by ESC loading dock
personnel, the sample is delivered to MLB; however, only an MLB
sample custodian may open the box, inspect contents, and initiate
chain of custody forms.

d.	Loading dock personnel are required to date and initial the Shipping
and Receiving Record for Disinfectant Products (see Section 14).

e.	Upon receipt, inspect each shipping container for external structural
damage, tampering, and evidence of leaks or spills. Any sign of
damage, tampering, or leaks or spills must be documented on the
Shipping and Receiving Record for Disinfectant Products (see
Section 14) and any chain-of-custody forms provided by the

f.	Take photographs of the shipping container, label, and contents as
necessary to further document their condition.

g.	Open the shipping container to inspect the contents for leakage or

h.	Review the chain-of-custody documentation sent by the inspector,
and if necessary apply signature and date of receipt.

i.	Review all paperwork sent by the inspector to identify any pertinent
information such as lot number (see 12.2, a, xi), sample expiration
date, storage conditions, etc.

j. Initiate a History of Official Sample Form (EPA Form 3540-17 - see
Section 14) if not included with sample.

k. For product samples from sources other than official inspector
collection (e.g., products purchased from the marketplace which
require COC documentation), initiate chain of custody
documentation beginning with the Shipping and Receiving Record
for Disinfectant Products and the History of Official Sample Form.
Fill out the appropriate sections of the form.

1. Place the sample container in a plastic bag, and seal. Fill out the
official seal and affix to the plastic bag.

m. Sample collection and chain-of-custody information is maintained in
the Disinfectant Product Field Chain-of-Custody Documentation
from Inspector notebook. Deficiencies in paperwork accompanying
the shipment (i.e. lack of field chain-of-custody papers) are

SOP No. COC-01-07
Date Revised 05-27-15
Page 6 of 9


n. Complete the Comprehensive Sample Log form (see Section 14).

This log is stored in a notebook in room D217. Place the sample in
the designated sample storage area. All samples must be in
secondary containment.

o. Prior to testing, initiate a Laboratory Chain-of-Custody Form (see
Section 14) and a Chain-of Custody Seal Log (see Section 14).

p. Fill out the Laboratory Chain-of-Custody Form whenever a product
sample is removed from storage and the seal broken (also see SOP
MB-22: Disinfectant Product Preparation and Sampling, section 12).
Place broken chain-of-custody seals in the Chain-of-Custody Seal
Log (see Section 14). A new chain-of-custody seal is established on
the sample as per the directions in the Pesticides Inspection Manual
(see Section 15).

q. Inspect product samples under COC quarterly to determine the
integrity of the COC seals, to inspect the sample containers for
leakage, and assess samples for further retention. Replace any COC
seal if it becomes compromised (e.g., torn or lack of adhesiveness) -
archive the original COC seal in the seal log. Document the date of
inspection, location of samples, the name of the person inspecting the
samples, and findings/action items on the inspection log (see Section

12.2 Filling out the
History of
Sample Form

a. Complete one form per product sample number. Follow the guidance
for data entry for the specified fields listed below; fields #l-#4 are

i.	#5. DATE RECEIVED: Enter the date the shipment was
received by the laboratory. This date is the same as the date
entered on the Shipping and Receiving Record for
Disinfectant Products.

ii.	#6. RECEIVED BY: The signature of the MLB personnel
responsible for receiving the shipment from the loading dock
personnel is required; date of signature is also required. The
individual who receives the sample may not necessarily be a
sample custodian; however, a sample custodian is responsible
for completing the History of Official Sample Form. Transfer
of the sample from the MLB receiver to an MLB sample
custodian must be documented.

SOP No. COC-01-07
Date Revised 05-27-15
Page 7 of 9

iii.	#7. RECEIVED FROM: Record the name of the ESC
loading dock personnel and the person who actually shipped
the package to the ESC (inspector, administrative assistant).

iv.	#8. SENT VIA: Enter the name of the shipping company and
type of delivery.

v.	#9. SAMPLE CONDITION: Record as Good or Poor; if
Poor, describe the condition in detail in #15 REMARKS.

vi.	#10. CONDITION OF SEALS: Record as Good, Poor, or No
Seals (products from sources other than official collection); if
Poor, describe the condition in detail in #15 REMARKS.

vii.	#11. SEALED BY: Enter the name which appears on the
seals (the name should also appear on inspector's chain-of-
custody paperwork).

viii.	#12. DATE SEALED: Enter the date taken from the seals.
The seal date must be the date of collection specified on the
inspector's chain-of-custody paperwork. If a sample was
sealed on a date other than the date of collection, contact
OECA for guidance.

ix.	#13. PIECES RECEIVED: Enter the number of seals and the
number and type of product containers per seal.

x.	#14. PLACE STORED: Enter the official sample storage
room (B204 flammable cabinet for flammable samples or
D204 for all others).

xi.	#15. REMARKS: Record notable items such as damaged
samples, labeling clarification, special sample storage
requirements, name of the sample custodian completing the
History of Official Sample Form (if different from the
individual in #6), and lot number.

For official samples, record lot number on the History of
Official Sample Form only if the inspector has recorded a lot
number on his paperwork. Do not assume that codes
imprinted on containers are lot numbers. If the inspector
failed to record a lot number on his paperwork, the sample lot
number is considered to be unknown. The inspector may be
contacted for verification. For samples received from sources
other than official inspector collection, the lot number may be

	extrapolated from the labeling, paperwork accompanying the

SOP No. COC-01-07
Date Revised 05-27-15
Page 8 of 9

sample, sticker affixed to bottle, etc. as long as the number
recorded is clearly a lot number.

12.3 Sample

a.	Consult with MLB management prior to sample disposal to ensure
that all testing and client needs have been met. Process and dispose
of samples that have expired, are leaking, or are no longer required to
be maintained, according to the ESC's waste disposal practices.

b.	For products to be disposed, remove the COC seal from the product,
initial and date in the appropriate box, and place the seal in the
Chain-of-Custody Seal Log.

c.	Complete the "Product Disposal Information" section on the
Laboratory Chain-of-Custody Form. Make an entry on the form to
indicate that the sample was removed from storage room as in
Section 12.1, k but note in the "Purpose of Removal" block that the
sample was removed for disposal.

d.	Note the date of disposal on the Comprehensive Sample Log.

e.	If the sample is in a plastic bag, remove the sample and discard the
bag, if not compromised.

f.	Once the COC paperwork is completed and the seal removed, place
the sample in secondary containment, declare it as "waste", and
contact the ESC Safety, Health and Environmental Management
(SHEM) manager (x52681) or facility waste contractor (x52857) to
request and arrange for a waste pick up and disposal.

13. Data Analysis/


14. Forms and Data

Forms are stored separately from the SOP under the following file names:

1.	Shipping and Receiving Record

for Disinfectant Product Samples Form COC-01-07_Fl.doc

2.	History of Official Sample Form

(EPA Form 3540-17) COC-01-07_F2.doc

3.	Laboratory Chain-of-Custody Form COC-01-07_F3.doc

4.	Chain-of-Custody Seal Log COC-01-07_F4.doc

5.	Comprehensive Sample Log COC-01-07_F5.doc

6.	Sample Inspection Log COC-01-07_F6.docx

SOP No. COC-01-07
Date Revised 05-27-15
Page 9 of 9

7.	Efficacy Test Conditions Form COC-01-07 F7.docx

8.	Sample Custodians for the Laboratory COC-01-07_F8.docx

15. References

1. Pesticides Inspection Manual (Chanter 9) 2002. Link: Pesticide Inspection