US Environmental Protection Agency
Office of Pesticide Programs
Office of Pesticide Programs
Microbiology Laboratory
Environmental Science Center, Ft. Meade, MD
Standard Operating Procedure for
Maintaining, Tracking and Archiving of
Records
SOP Number: ADM-03-07
Date Revised: 03-07-18

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SOP No. ADM-03-07
Date Revised 03-07-18
Page 1 of 9
SOP Number
ADM-03-07
Title
SOP for Maintaining, Tracking and Archiving of Records
Scope
This SOP provides guidance for maintaining, tracking, labeling and
archiving of records generated by the Microbiology Laboratory
Branch.
Application
This procedure applies to all records generated by the laboratory
staff and the quality assurance unit.


Approval Date
SOP Developer:

Print Name:
SOP Reviewer

Print Name:
Quality Assurance Unit

Print Name:
Branch Chief

Print Name:


Date SOP issued:

Controlled copy
number:

Date SOP withdrawn:


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SOP No. ADM-03-07
Date Revised 03-07-18
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TABLE OF CONTENTS
Contents	Page Number
1.
DEFINITIONS
3
2.
HEALTH AND SAFETY
3
3.
PERSONNEL QUALIFICATIONS AND TRAINING
3
4.
INSTRUMENT CALIBRATION
3
5.
SAMPLE HANDLING AND STORAGE
3
6.
QUALITY CONTROL
3
7.
INTERFERENCES
3
8. NON-CONFORMING DATA
3
9.
DATA MANAGEMENT
4
10.
CAUTIONS
4
11.
SPECIAL APPARATUS AND MATERIALS
4
12.
PROCEDURE AND ANALYSIS
4
13.
DATA ANALYSIS/CALCULATIONS
7
14.
FORMS AND DATA SHEETS
7
15.
REFERENCES
7

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SOP No. ADM-03-07
Date Revised 03-07-18
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1. Definitions
1.	Record: All books, papers, maps, photographs, machine readable
materials, or other documentary materials, regardless of physical form or
characteristics, made or received by an Agency of the United States
Government under Federal law or in connection with the transaction of
public business and preserved or appropriate for preservation by that
Agency or its legitimate successor as evidence of the organization,
functions, policies, decisions, procedures, operations, or other activities of
the Government or because of the informational value in them (see section
15.1).
2.	Electronic Versions of the Record Copy: Electronic versions of records
may be created with office automation applications.
3.	Records Schedule or Series: EPA's official schedule for retention and
disposal of Agency records. MLB records fall in the following record
series; 1004 (procurement and contracts), 1016 (proficiency testing and
GLP related files), 1023 (policy and guidance documents), and 1035
(efficacy test reports, research reports, QA related documents, lab
notebooks, quality control records etc.). Refer to attachment 1.
4.	File Closure: When a record is no longer actively in use, it may be closed,
designating the record as inactive. File closure marks the beginning of the
record retention schedule.
5.	NARA: National Archives and Records Administration.
2. Health and
Safety
Not applicable.
3. Personnel
Qualifications
and Training
1. Refer to SOP ADM-04, OPP Microbiology Laboratory Training.
4. Instrument
Calibration
Not applicable.
5. Sample
Handling and
Storage
Not Applicable
6. Quality Control
1. The records management practices of the Microbiology Laboratory
Branch conform to the Agency's records schedules and to the policies of
the Agency's National Records Management Program.
7. Interferences
None.
8. Non-
conforming
1. Any instances of non-compliance with this SOP will be corrected upon
discovery.

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SOP No. ADM-03-07
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Data

9. Data
Management
1.	Product efficacy test reports and research studies are catalogued
according to the numbering system in the Master Schedule. Records are
filed consecutively following the Master Schedule.
2.	The MLB Master List (MLB share file - Master List - document
control) is used to track other relevant lab documents (standard
operating procedures, equipment manuals, quality records, records (e.g.
QMP, QAPP and QAARWP), procurement records, contract records and
external documents (e.g. AO AC and ASTM standard methods). The
Master List specifies the location of documents.
10. Cautions
1. Confidential or sensitive information is maintained by the recipient in a
secure location consistent with the Agency's requirements. CBI is not
filed in the common file areas (D217 and D219).
11. Special
Apparatus and
Materials
1.	3" or 5" accordion folders
2.	Fiberboard Box Special, Purpose (Records Retiring); purchase through
GSA
12. Procedure and
Analysis
1. Staff and management all have record keeping responsibilities. The
procedures outlined below are organized by type of record.
12.1
Studies Tracked on
the Lab Master
Schedule
a.	Research Reports: Consolidate all test sheets and supporting
documentation for a study in a study binder. Once the study memo
summarizing the data is finalized, the Branch Chief (BC) will note
the date on the master schedule. The analyst will return the
complete binder including the final study memo to the QAU. The
QAU will file the binder in D217 according to the "R" number.
Maintain these files for 20 years after file closure.
b.	For Product Efficacy Reports and Proficiency Test Exercises, once
the memo is finalized (refer to ADM-01), the BC will note the date
on the master schedule. The analyst will file the blue book copy
including the Biological Report of Analysis and supporting test
sheets, in D217 by the registration number assigned to the product.
Maintain these files for 10 years after file closure.
c.	Three years after retiring the fiscal year master schedule, the
documents will be boxed, labeled and stored in an alternate secure
location (for example, D219) or sent to the Federal Record Center in
order to free space in D217 (limited) for new and active files.
d.	If records are maintained on site, they may be destroyed at the point
in time consistent with the record retention schedule.

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SOP No. ADM-03-07
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e. Place a pocket folder indicating the number/name of the record as a
place holder for the record when removing records from D217 or
satellite storage.
12.2
Documents
Tracked on the
Master List
a.	Standard Operating Procedures, QMP, QAPP, QAARWP,
procurement records, contract records, and external references (e.g.
AO AC and ASTM standard methods) are tracked on the master list.
b.	SOPs are updated on a three-year cycle or more frequently as
necessary to keep the documents current. The QAU is responsible
for maintaining SOP related updates. Refer to ADM-02 for the
procedure for tracking and maintaining copies of the SOPs.
c.	The official '0' version of an SOP is filed in D217 by SOP number
for one review cycle. After the cycle is complete, the '0' versions
may be boxed, labeled and stored in an alternate location (D219) by
SOP number.
d.	The laboratory's Quality Management Plan and annual report
(QAARWP) are reviewed on an annual basis. The Master List is
updated as necessary to reflect the most recent version. These
documents are provided to the Office of Pesticide Programs Director
of Quality Assurance to compile into an overarching office wide
document. The documents are for one review cycle.
e.	Quality Assurance Project Plans are project specific. The Master List
is updated as necessary to reflect the most recent version. QAPPs are
closed upon completion of the project.
f.	Upon receipt of a new piece of equipment, place a sticker with the
current date (month/year) and update the master list. Place the
manual in the bottom drawer of the file cabinet outside D206 or keep
the manual with the piece of equipment. Manuals may be discarded
when the equipment is no longer actively in use.
g.	Publications and copies of standard methods are tracked in the master
list and maintained as long as they are useful to the laboratory.
h.	Documents developed by the laboratory in this category are subject
to a 10 years retention schedule after file closure.
12.3
Quality Control
Records
a.	Quality control documents such as calibration certificates, equipment
logs, microorganism transfer logs, etc. are maintained in binders by
activity.
b.	Once a binder is full or three years have elapsed (whichever comes
first), archive the records in D217 by activity (e.g. autoclave QC
logs). If space is constrained, box and move to a satellite storage

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area in the facility,
c. Maintain these files for 10 years after file closure.
12.4
Routine
Procurement Files
a.	Routine procurement files consist of routine acquisitions and contract
management records for program related procurements (e.g. Montana
State University) maintained by contracting officers (COs) and
contracting officer's representatives (CORs), including
correspondence and other documents related to the award,
administration, receipt, inspection, payment, review, and audit of
contracts.
b.	Routine procurement files documenting the acquisition of goods and
non-personal services (e.g., printing services) maintained by the
procurement organization, including purchase documents such as
purchase requisitions, credit card and bank card slips, direct deposit
forms for vendors, specifications, bids, schedules of delivery,
initiating requisitions, records of receipt, inspection, and payment.
c.	Records for routine procurements - requests for procuring items,
approval from the divisional budget officer, orders, and receipts are
filed in the Agency's Payment Net (PNET) system. PNET
constitutes the Agency's official record keeping system for these
transactions. It is not necessary or desirable to maintain paper copies
of these records once filed and approved in PNET.
d.	Actions initiated through EAS are electronically stored and EAS
constitutes the official repository for these documents (e.g.
documents for purchases above the purchase card limit, with terms
and conditions etc.) EAS records are maintained for six years.
e.	Contract records maintained by the on-site COR include the contract,
task orders written against the contract, invoices, final deliverables,
requests to exercise a contract option, and files closing out the
contract. These files are maintained by the COR. Contract records
are maintained for six years after the contract is complete or
terminated.
12.5
Policy and
Guidance
Documents
a.	Guidance documents and supporting documentation are maintained
in the D217 archives. If records are uploaded to regulations.gov as
part of a public docket file, the lab copies do not need to be
maintained. The retention of records on regulations.gov are under
control and management of the docket staff and ds are subject to the
public docket retention schedule.
b.	Documents leading to decisions supporting testing guidance and

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SOP No. ADM-03-07
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guidelines are indexed and maintained for 20 years.
12.6
Retirement of
Records
a.	If space permits, all records will be maintained at the Environmental
Science Center for the length of their retention schedule. If file and
storage space is constrained, the files will be boxed and sent to the
Federal Record Center (FRC).
b.	The US EPA National Records Management Program EPA Series
Website (see ref 15.1) provides guidance on how to send records to
the FRC (e.g., paperwork to complete, etc.). The laboratory will seek
assistance from an Agency records management specialist to
complete the steps necessary to ship the records to the FRC.
13. Data Analysis/
Calculations
1. None.
14. Forms and Data
Sheets
1.	Attachment 1: Microbiology Laboratory Branch's File Structure.
2.	Microbiology Laboratory Branch: Master list of Documents kept on the
shared drive.
15. References
1.	List of EPA schedules in final status: US EPA National Records
Management Program Website:
https://www.epa.gov/records/list-epa-records-schedules-final-status
2.	EPA Records schedules in final status:
https://www.epa.gov/sites/production/files/2017-
07/documents/20170707_epa_records_schedules_in_final_status.pdf
3.	US. EPA Records Schedule, EPA Series No. 1035, Test Method
Evaluation Records.
4.	US EPA Records Schedule, EPA Series No. 1016, Controls and Oversight
5.	US EPA Records Schedule, EPA Series No. 1004, Acquisitions and
contracts.
6.	US EPA Records Schedule, EPA Series No. 1023; Regulatory
Development and Implementation, and Dockets.

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SOP No. ADM-03-07
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ATTACHMENT #1: MICROBIOLOGY LABORATORY BRANCH'S RETENTION SCHEDULE
Schedule #
Function #
NARA Disposal authority
Description/Disposition
1035
108
Environmental
Management
Item c. Routine
environmental programs
and project records
DAA-0412-2013-0021-
0003
Product efficacy test reports (ATP) and supporting documentation.
Items related to the receipt and tests made on pesticide samples and supporting
documentation, including raw data, media reagent preparation records, quality
and control records, chain of custody, test results, sterilization and calibration
records, temperature and air sampling records, inspection records, standard
operating procedures and other reports and assessments.
Collections of lab standard operating procedures (SOPs) used to assure quality
of analytical procedures used by EPA laboratories to assess environmental
measurement activities or document the quality system of the organization
conducting the environmental collection activities.
Collection of approved or accepted quality assurance project plans (QAPPs)
and quality management plans (QMP) that describe procedures to assess
environmental measurement activities or document the quality system of the
organization conducting the environmental data collection activities.
Quality control records such as equipment calibration, monitoring water,
detergent residue, EMAS etc.
Record retention is 10 years after file closure.


Item b. Long term
environmental program
and project records
DAA-0412-2013-0021-
0002
Scientific research project files related to basic, exploratory research for
projects conducted by EPA personnel in the Office of Chemical Safety and
Pollution Prevention (OCSPP) that provide demonstration or proof of concept
projects including collaborative and method validation studies.
Research studies records may be destroyed 20 years after file closure.

1023
306
Regulatory Development
and Implementation; and
Dockets
General dockets and non-substantive rulemaking records. Background material for
the establishment of public dockets for guidance materials for testing. Materials

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SOP No. ADM-03-07
Date Revised 03-07-18
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posted to regulations.gov for the purposes of a public comment period are


Items a thru d
maintained by the docket staff following the docket record retention schedules.


DAA-0412-2013-0010-
Destroy 20 years after file closure.


0001 thru 0004


1004
405
Acquisition and Contracts
Routine procurement files relating to orders for supplies and materials. Contract



related records for contracts that have been completed or terminated.


Items b and d




Destroy 6 years after file closure.


DAA-0412-2013-0014-



0002



DAA-0412-2013-0014-



0004


1016
301
Itemb. Long term
Records related to Good Laboratory Practice (GLP) and audit report files for audits


controls and oversight
of laboratories involved in performing studies and analyses of environmental


records
programs, including inspector worksheets, supporting documentation,



correspondence and related records.


DAA-0412-2013-0015-
Destroy 20 years after file closure.


0002


Item c. Routine control
Laboratory performance evaluation studies and proficiency testing (PT) records.


and oversight records
Destroy 10 years after file closure.


DAA-0412-2013-00015-



0003



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