US Environmental Protection Agency
Office of Pesticide Programs

Office of Pesticide Programs

Microbiology Laboratory

Environmental Science Center, Ft. Meade, MD

Standard Operating Procedure for
Disinfectant Sample Login and Tracking

SOP Number: COC-01-06

Date Revised: 06-18-12


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 1 of 17

EPA/OPP MICROBIOLOGY LABORATORY
ESC, Ft. Meade, MD

Standard Operating Procedure
for

Disinfectant Sample Login, Tracking, and Disposal
SOP Number: COC-01-06
Date Revised: 06-18-12

Initiated By:

	Date: / /

Print Name:

Technical Review:

QA Review:

Approved By:

Date:

/ /

Print Name:

Technical Staff

Date: / /

Print Name:

QA Officer

Date: / /

Print Name:

Branch Chief

Date: / /

Print Name:

Safety, Health, and Environmental Management Office

Effective Date:
Controlled Copy No.:
Withdrawn By:

/ /

Date: / /


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 2 of 17

TABLE OF CONTENTS

Contents
Page Number

1.0 SCOPE AND APPLICATION	3

2.0 DEFINITIONS	3

3.0 HEALTH AND SAFETY	3

4.0 CAUTIONS	3

5.0 INTERFERENCES	4

6.0 PERSONNEL QUALIFICATIONS	4

7.0 SPECIAL APPARATUS AND MATERIALS	4

8.0 INSTRUMENT OR METHOD CALIBRATION	4

9.0 SAMPLE HANDLING AND STORAGE	5

10.0 PROCEDURE AM) ANALYSIS	5

11.0 DATA ANALYSIS/CALCULATIONS	9

12.0 DATA MANAGEMENT/RECORDS MANAGEMENT	9

13.0 QUALITY CONTROL	9

14.0 NONCONFORMANCE AND CORRECTIVE ACTION	9

15.0 REFERENCES	9

16.0 FORMS AM) DATA SHEETS	9


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 3 of 17

1.0 SCOPE AND APPLICATION:

1.1 This protocol describes procedures used by the Microbiology Laboratory Branch
for the login, tracking, and disposal of disinfectant samples. Documenting the
receipt, storage, handling, use, and disposal of product samples is essential.
Various chain-of-custody forms are used to document the movement of all
product samples from sample collection through disposal.

2.0 DEFINITIONS:

2.1	Sample Custodian = Sample custodians are authorized 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 area.

2.2	PPE = Personal Protective Equipment

2.3	Date of sample disposal (Forms 16.3 and 16.5) = Date that the sample is removed
from chain of custody and declared as waste.

2.4	Declare a sample as waste (section 10.15.5) = Place sample in secondary
containment and clearly label the secondary containment bin as "waste". See
section 10.15.5 for additional information.

3.0 HEALTH AND SAFETY:

3.1	Follow precautions for storage and handling as stipulated by the product
manufacturer.

3.2	Flammable samples are stored in locked flammable storage cabinets (room
B204).

3.3	Wear appropriate PPE (lab coat, gloves, and safety glasses) while handling
samples. Refer to Chapter 3 of the Chemical Hygiene Plan for additional
information on PPE.

4.0 CAUTIONS:


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 4 of 17

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

4.2	Samples should be logged in and transferred to the storage facility as soon as
possible by an official OPP Microbiology Laboratory sample custodian. Sample
custodians are responsible for signing out samples for testing and returning the
samples to the storage area following procedures outlined in this SOP.

5.0 INTERFERENCES:

5.1	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. 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 are documented. A
written explanation by the inspector may be required.

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

6.0 PERSONNEL QUALIFICATIONS:

6.1	Sample custodians for the laboratory have been identified in Section 16.7 below.
Personnel may not be designated as sample custodians unless they have received
training on this SOP. Training is conducted and documented as per SOP ADM-
04, Training. Refresher training is provided as needed.

6.2	Documentation of training and familiarization with this SOP can be found in the
training file for each sample custodian.

7.0 SPECIAL APPARATUS AND MATERIALS:

7.1 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.)


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 5 of 17

8.0 INSTRUMENT OR METHOD CALIBRATION: Not applicable
9.0 SAMPLE HANDLING AND STORAGE:

9.1	Product samples are handled and maintained for testing per the conditions
outlined below in the "Procedure and Analysis" section.

9.2	All samples must be in secondary containment.

9.3	Wear appropriate PPE while handling samples (see section 3.3).
10.0 PROCEDURE AND ANALYSIS:

10.1	Product samples are shipped to the Microbiology Laboratory to the attention of
Michele Cottrill, USEPA, Environmental Science Center (ESC), 701 Mapes
Road, Ft. Meade, MD 20755-5350.

10.2	Upon arrival at the ESC loading dock, loading dock personnel receive the sample
and deliver it to the recipient. In the absence of the recipient, the package may be
signed for by another staff member. However, only a sample custodian may
open the box and initiate chain of custody forms. Loading dock personnel are
required to date and initial the Shipping and Receiving Record for Disinfectant
Products (see 16.1) in the appropriate block.

10.3	For a current list of sample custodians for the laboratory, see section 16.7. 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.

10.4	Each shipping container is inspected by a sample custodian for external structural
damage, tampering, and evidence of leaks or spills. Any sign of damage,
tampering, or leaks or spills is documented on the Shipping and Receiving
Record for Disinfectant Products (see 16.1) and any chain-of-custody forms
provided by the inspector. See section 5.2. A photograph is taken of the
shipping container.

10.5	The shipping container is opened and the contents are inspected. The plastic bag
and the chain-of-custody seals, if the product was received under seal, are closely
inspected for damage or signs of tampering. Individual samples are inspected for
leakage or damage by a sample custodian. The sample custodian will review the
chain-of-custody documentation sent by the inspector, and if necessary apply
signature and date of receipt. The sample custodian will review all paperwork


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 6 of 17

sent by the inspector to identify any pertinent information such as lot number (see
10.7.11), sample expiration date, storage conditions, etc. Then, the sample
custodian will initiate a History of Official Sample Form (EPA Form 3540-17)
(see 16.2). A photograph is taken of the product sample.

10.6	For product samples which arrive from sources other than official inspector
collection (for example, products purchased from the internet, direct shipment
from the registrant, etc.), initiate chain of custody documentation beginning with
the Shipping and Receiving Record for Disinfectant Products (section 10.2)
through the History of Official Sample Form (section 10.7). Fill out the
appropriate sections of the form. Take a photograph of the shipping container
prior to opening. Take a photograph of the product sample after inspection.

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

10.7	Correct and complete entry of information on the History of Official Sample
Form is an essential component to the chain-of-custody documentation. One
form is used per unique product sample number. The sample custodian who
received the shipment may request another sample custodian to complete the
History of Official Sample Form, as long as the sample custodian completing the
Form performs the actual inspection of the shipping container and sample. For
clarification purposes, follow the guidance for data entry for the specified fields
listed below; fields #l-#4 are self-explanatory:

10.7.1	#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.

10.7.2	#6. RECEIVED BY: The signature of the sample custodian responsible
for receiving the shipment from the loading dock personnel is required;
date of signature is also required. The sample custodian signing as the
sample receiver may not necessarily be the individual who completes the
History of Official Sample Form.

10.7.3	#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).

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

10.7.5

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


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 7 of 17

10.7.6	#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.

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

10.7.8	#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.

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

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

10.7.11	#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. (Note: 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. For samples received from sources
other than official inspector collection, the lot number may be
extrapolated from the labeling, paperwork accompanying the sample,
sticker affixed to bottle, etc. as long as the number recorded is clearly a
lot number.).

10.8	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 documented.

10.9	Complete the Comprehensive Sample Log form (see 16.5). 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.


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 8 of 17

10.10	Prior to testing, a sample custodian initiates a Laboratory Chain-of-Custody Form
(see 16.3) and a Chain-of Custody Seal Log (see 16.4) for each product sample
received.

10.11	The Laboratory Chain-of-Custody Form is filled out whenever a product sample
is removed from storage.

10.12	The product label is photocopied or photographed directly from a product
container; a copy is filed in the Disinfectant Product Field Chain-of-Custody
Documentation from Inspector notebook. In addition, sample numbers found on
the product containers are photocopied; copies are filed in the Disinfectant
Product Field Chain-of-Custody Documentation from Inspector notebook.

10.13	Broken chain-of-custody seals are retained on a Chain-of-Custody Seal Log (see
16.4). A new chain-of-custody seal is established on the sample as per the
directions in the Pesticides Inspection Manual (see ref. 15.1).

10.14	The entire inventory of disinfectant samples is evaluated at the end of each
quarter 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 16.6).

10.15	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.

10.15.1	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.

10.15.2	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 10.11, but note in
the "Purpose of Removal" block that the sample was removed for
disposal.

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


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 9 of 17

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

10.15.5	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.

11.0 DATA ANALYSIS/CALCULATIONS: None

12.0 DATA MANAGEMENT/RECORDS MANAGEMENT:

12.1 Data are recorded promptly, legibly, and in indelible ink on all forms.

Completed forms are archived in notebooks kept in secured file cabinets in room
D217. Only authorized personnel have access to the secured files. Archived data
is subject to OPP's official retention schedule contained in SOP ADM-03,
Records and Archives.

13.0 QUALITY CONTROL:

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

13.2	For quality control purposes, the required information is documented on the
appropriate forms (see 16.0).

14.0 NONCONFORMANCE AND CORRECTIVE ACTION:

14.1	Any deviation from the protocol is documented.

14.2	Entry errors or entry omissions are corrected immediately upon discovery.

15.0 REFERENCES:

15.1 Pesticides Inspection Manual (Chapter 9) 2002. See

http://www.epa.gov/oecaerth/resources/publications/monitoring/fifra/manuals/fifr
amanual.pdf.

16.0 FORMS AND DATA SHEETS:

16.1 Shipping and Receiving Record for Disinfectant Product Samples Form


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 10 of 17

16.2	History of Official Sample Form (EPA Form 3540-17)

16.3	Laboratory Chain-of-Custody Form

16.4	Chain-of-Custody Seal Log

16.5	Comprehensive Sample Log

16.6	Sample Inspection Log

16.7	Sample Custodians for the Laboratory


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 11 of 17

16.1 Shipping and Receiving Record for Disinfectant Product Samples Form
OPP Microbiology Laboratory

Shipping and Receiving Record for Disinfectant Product Samples

Loading Dock Personnel (Date/Initials):

Loading Dock Personnel (Date/Initials):

Shipping Container # of
Date and Lime Received:

Shipping Container # of
Date and Lime Received:

Received Bv:

Received Bv:

Received Lrom:

Received Lrom:

Lvpe of Delivery:

Lvpe of Delivery:

Lracking Number (if available):

Lracking Number (if available):





Sample Custodian (Date/Initials):

Sample Custodian (Date/Initials):

Condition of Primary Shipping Container:
Product Name(s):

Condition of Primary Shipping Container:
Product Name(s):





EPA Reg. No.(s):

EPA Reg. No.(s):





Sample Numbers:

Sample Numbers:














-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 12 of 17

16.2 History of Official Sample Form (EPA Form 3540-17)

PAGE 1 OF

UNITED STATES

1. SAMPLE NO.

2, REGISTRATION NO.

ENVIRONMENTAL PROTECTION AGENCY





OEPA HISTORY OF OFFICIAL SAMPLE -





3. PRODUCT

LABORATORY



4. LABORATORY

5.	DATE RECEIVED

6.	RECEIVED BY

7. RECEIVED FROM

8, SENT VIA

9.	SAMPLE CONDITION

10.	CONDITION OF SEALS

11, SEALED BY

13 PieCES RECEIVED

14, PLACE STORED

IS. REMARKS

EPA FORM 3540-17 (01-01)


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 13 of 17

16.3 Laboratory Chain-of-Custody Form
OPP Microbiology Laboratory

Laboratory Chain of Custody Form

Product Information: Product Disposal Information:
EPA Rcs>. #: Date of Disposal:

Product Name: Sample Custodian Initials:
Sample #: Amount Disposed:
Lot #: Reason for Disposal:

Date Received:

Date/Time Removed

Sample
Custodian
Initials

Removed
From

Purpose of Removal

Amount Used
(mL)

Returned
To

Sample
Custodian
Initials

Date/Time Returned


















































































































































-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 14 of 17

16.4 Chain-of-Custody Seal Log
OPP Microbiology Laboratory

Chain-of-Custody Seal Log

Product Information:

Product EPA Reg. #: Product Name:
Sample #:

Date Product Received: / /

Date/Initials

Apply Seals Below (1 seal per row)














-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 15 of 17

16.5 Comprehensive Sample Log
OPP Microbiology Laboratory

Comprehensive Log for Samples Received or Purchased by Laboratory

Calendar Year:

Date
Received

Sample
Custodian
Initials

* Name of Product

Number of
Containers

EPA Reg. No.

Control or Sample #

Storage
location

**Program

Date
Disposed/
Initials





















































































































































































* Add the Suffix P for Purchased Items

** ATP=Antimicrobial Testing Program, B=Biofilm, HS=Homeland Security, VTP=Virucidal Testing Program


-------
SOP No. COC-01-06
Date Revised 06-18-12
Page 16 of 17

16.6 Sample Inspection Log
OPP Microbiology Laboratory

Sample Inspection Log

Date of
Inspection

Location

Initials of Person
Inspecting Samples

Findings/Action Items










































-------
16.7 Sample Custodians for the Laboratory
OPP Microbiology Laboratory

1.	Michele Cottrill

2.	Jason Duncan

3.	Jafrul Hasan

4.	Knoxley Japal

5.	Rebecca Pines

6.	Luisa Samalot-Freire

7.	Stephen Tomasino

8.	Kiran Verma

9.	Michele Wingfield

SOP No. COC-01-06
Date Revised 06-18-12
Page 17 of 17


-------