US Environmental Protection Agency Office of Pesticide Programs Office of Pesticide Programs Microbiology Laboratory Environmental Science Center, Ft. Meade, MD Standard Operating Procedure for Records and Archives (SOPs) SOP Number: ADM-03-04 Date Revised: 11-02-11 ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 1 of 13 EPA/OPP MICROBIOLOGY LABORATORY ESC, Ft. Meade, MD Standard Operating Procedure for Records and Archives SOP Number: ADM-03-04 Date Revised: 11-02-11 Initiated By: Date: / / Print Name: Technical Review: Date: / / Print Name: Technical Staff QC Review: Date: / / Print Name: QA Officer Approved By: Date: / / Print Name: Effective Date: / / Controlled Copy No.: Withdrawn By: Date: / / ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 2 of 13 TABLE OF CONTENTS Contents Page Number 1.0 SCOPE AND APPLICATION 3 2.0 DEFINITIONS 3 3.0 HEALTH AND SAFETY 4 4.0 CAUTIONS 4 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 4 10.0 PROCEDURE AND ANALYSIS 4 11.0 DATA ANALYSIS/CALCULATIONS 8 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT 8 13.0 QUALITY CONTROL 9 14.0 NONCONFORMANCE AND CORRECTIVE ACTION 9 15.0 REFERENCES 9 16.0 FORMS AND DATA SHEETS 10 ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 3 of 13 1.0 SCOPE AND APPLICATION: 1.1 The purpose of this procedure is to provide guidance for the labeling and archiving of records generated by the Office of Pesticide Programs/Biological and Economic Analysis Division/Microbiology Laboratory Branch (OPP/BEAD/MLB) located at the Environmental Science Center, Fort Meade, Maryland. 1.2 This procedure applies to all records generated by the laboratory staff and the quality assurance unit. 2.0 DEFINITIONS: 2.1 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 ref. 15.1). 2.2 Electronic Versions of the Record Copy: Electronic versions of the record copy of laboratory test reports are created with office automation applications. Electronic versions may be deleted when the paper record copy is generated. The retention of the electronic version of the record copy shall not exceed the retention of the paper copy. 2.3 Records Schedule or Series: EPA's official policy for records and information retention and disposal which provides mandatory instructions for what to do with records no longer needed for current agency business (see ref. 15.1). 2.4 File Closure: When a record is no longer actively in use, it may be closed, designating the record as inactive. To close a file, record the closing date on the file itself. Files are typically closed at the end of a calendar year unless otherwise specified in MLB's File Structure (see ref. 15.10). 2.4.1 File closure marks the beginning of the record retention schedule (e.g., the amount of time closed/inactive records must be retained before they may be destroyed; see ref. 15.10, Disposition Instructions). The laboratory may store closed records on-site in room D217 or transfer ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 4 of 13 them to an off-site storage facility (see section 12.0) until such time as the documents may be destroyed. 2.5 NARA: National Archives and Records Administration 3.0 HEALTH AND SAFETY: Not applicable 4.0 CAUTIONS: 4.1 Confidential business information (CBI) is not filed in room D217. CBI is retained by the individual in a secure location, following OPP standard procedures. 5.0 INTERFERENCES: None 6.0 PERSONNEL QUALIFICATIONS: 6.1 Personnel are required to be knowledgeable of the procedures in this SOP. Documentation of training and familiarization with this SOP can be found in the training file for each employee. 7.0 SPECIAL APPARATUS AND MATERIALS: 7.1 3" or 5" accordion folders 7.2 Fiberboard Box Special, Purpose (Records Retiring); purchase through GSA 8.0 INSTRUMENT OR METHOD CALIBRATION: Not applicable 9.0 SAMPLE HANDLING AND STORAGE: 9.1 Each analyst is responsible for filing raw data sheets, transmittal memos or report folders associated with specific tests or analyses in the appropriate binder or file cabinet in D217. 10.0 PROCEDURE AND ANALYSIS: 10.1 Laboratory Test Reports and Supporting Documentation - EPA Records Schedule No. 337 10.1.1 Laboratory test reports and supporting documentation for the laboratory shall be maintained following EPA Records Schedule No. ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 5 of 13 337, Laboratory Test Reports and Supporting Documentation. Laboratory test reports include product performance, Antimicrobial Testing Program (ATP) test reports, Virology Program reports, Biofilm Program reports, Homeland Security Program reports, all supporting documentation for the aforementioned reports (e.g., quality and control records, chain of custody documents, study protocols, etc.), and other test reports produced by MLB (ref. 15.2). 10.1.2 Laboratory Test Reports and Supporting Documentation records may be destroyed 10 years after file closure. Close inactive records at the end of the calendar year (see section 2.4). 10.2 Test Method Evaluation Records - EPA Records Schedule No. 339 10.2.1 Records related to the review, evaluation, collaboration, modification and validation of test methods used for analysis of environmental samples and pesticides products shall be maintained under EPA Records Schedule No. 339, Test Method Evaluation Records. Method reports include method evaluation, collaboration and validation reports associated with research and development, as well as all essential laboratory raw data and original test method data submitted by companies or collaborating agencies (ref. 15.3). 10.2.2 Test method evaluation records may be destroyed 25 years after file closure. Close inactive records at the end of the fiscal year. 10.3 Program Management Files (including internal and external audits) - EPA Records Schedule No. 006 10.3.1 Records relating to the on-going management of programs and routine projects within programs, including internal and external audits, shall be maintained following EPA Records Schedule No. 006, Program Management Files. Records may include correspondence, memoranda, staff meeting records, meeting minutes, routine office procedures, reports relating to general policy, oversight reviews (e.g., internal and external audit reports), interagency activity, and project control files showing assignments, progress, and completion of projects (Ref. 15.4). 10.3.2 Program management files may be destroyed five years after file closure. Close inactive records at the end of the calendar year. ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 6 of 13 10.4 Quality Assurance Project Plans (QAPPs) and Quality Management Plans (QMPs) - EPA Records Schedule No. 185 10.4.1 QAPPs and QMPs shall be maintained following EPA Records Schedule No. 185, Collections of Quality Assurance Project Plans. QAPPs describe procedures used to plan, implement, and assess environmental measurement activities to ensure that measurements of the appropriate type and quality are made to support decisions. QMPs document the quality system of the organization conducting environmental and laboratory data collection activities (Ref. 15.5). This schedule includes contractor QAPPs and QMPs. 10.4.2 QAPPs and QMPs may be destroyed 10 years after file closure. Close inactive records at approval, or at last amendment or last review. 10.5 Training Material - EPA Records Schedule No. 200 10.5.1 Records used by Agency personnel in planning, preparing, writing, arranging, and conducting training programs for EPA and non-EPA employees, including state and other federal agency on non-federal personnel shall be maintained following EPA Records Schedule No. 200, Training Material. Records consist of working files generated during development phase of training, workgroup meeting notes, correspondence, memoranda, training participation surveys and rosters, instructional materials, manuals, and other training aides (Ref 15.6). 10.5.2 Training provided by MLB is considered to be "routine training" rather than EPA "mission-related" (ref. 15.6). Routine training material records may be destroyed 5 years after file closure. Close inactive records after course or material is superseded. 10.6 Standard Operating Procedures - EPA Records Schedule No. 007 10.6.1 Records that document EPA's policy decisions and program operational procedures shall be maintained following EPA Records Schedule No. 007, Directives and Policy Guidance Documents. Records consist of official policy decisions, delegations of authority, operating guidance, procedures manuals (e.g., standard operating procedures), technical resource documents, regulatory interpretation and implementation, and mandates for action (Ref. 15.7). ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 7 of 13 10.6.2 Records published or released to the public (e.g., Copy 0 of SOP placed on Agency's website) are to be transferred to the National Archives in five-year blocks, 20 years after file closure. Close inactive records upon issuance or publication or when superseded. 10.6.3 Unpublished records or those not released to the public may be destroyed 10 years after file closure. Close inactive records upon decision to not publish or issue. 10.7 Routine Procurement Files - EPA Records Schedule No. 036 10.7.1 Routine procurement files for MLB shall be maintained following EPA Records Schedule No. 036, Routine Procurement Files. Routine procurement files contain Agency procurement and supply records documenting the acquisition of goods and non-personal services by the MLB (see ref. 15.8). Documents include copies of purchase documents (e.g., purchase requests, shipping airbills, travel authorizations, training authorizations, contracts credit cards and bank card slips), direct deposits forms for vendors, specifications, bids, schedules of delivery, initiating requisitions, receipt, inspection, and payment. Related background material, such as computer printouts, funding obligations reports, etc., are also covered by this series. 10.7.2 Transactions exceeding $3,000.00: Destroy records 6 years and 3 months after file closure. Close inactive records upon completion. 10.7.3 Transactions at or below $3,000.00: Destroy records 3 years after file closure. Close inactive records upon completion. 10.7.4 Records containing confidential business information, such as purchase card logs and procurement requests, must be shredded to protect confidentiality. 10.8 Contract Management Records - EPA Records Schedule No. 202 10.8.1 Routine contract management records for MLB shall be maintained following EPA Records Schedule No. 202, Contract Management Records (Ref. 15.9). Contract records include all correspondence and related records pertaining to the award administration, receipt, inspection and payment of any and all contacts to which EPA is a party and which are maintained and used by the Agency or Contracting Officer for contract documentation and for performance ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 8 of 13 and financial monitoring and oversight activities. Also includes reviews and audits conducted by the Financial Analysis and Rate Negotiation Service Center (FARSC). 10.8.2 Contract-level Contracting Officer's Representative (COR): Destroy records 6 years and 3 months after final payment for the overall contract. Close inactive records upon filing of final invoice or completion or termination of the task order or work assignment. 10.8.3 Records containing personal or confidential business information must be shredded to protect confidentiality. 10.8.4 Contracts that are being audited, protested, or are in any other kind of legal action cannot be destroyed until the case is closed. 11.0 DATA ANALYSIS/CALCULATIONS: None 12.0 DATA MANAGEMENT/RECORDS MANAGEMENT: 12.1 Inactive records archived in D217 must be labeled with the following, according to NARA guidelines: EPA Records Schedule or Series number, Function number, and NARA disposition number. For closed or inactive records, the closing date must be clearly written on the file. Additional information may be found in 15.10 and on the US EPA National Records Management Program EPA Series Website (see ref 15.1). 12.1.1 EPA Records Schedule or Series #: Function #: NARA Disposition #: 12.2 All records shall be retained according to the Agency's records schedules and to the policies of the Agency's National Records Management Program. 12.3 Records shall be retained on-site for a minimum period of three years. After the three year period and at the discretion of the Branch Chief, records may be labeled as in section 12.1 and shipped to the appropriate Federal Records Center (FRC) for off-site storage. 12.3.1 Records shipped off-site for storage must be removed from binders and placed in an accordion folder. The accordion folder is labeled with the EPA Records Schedule or Series number, Function number and NARA disposition number. The closing date for each record must also ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 9 of 13 be clearly identified, either written on the accordion folder or on an itemized list of documents to be contained within the box (section 7.2). Any box sent off-site must be entirely filled with only one EPA records schedule or series number to be accepted by the FRC. 12.3.2 Consult the US EPA National Records Management Program EPA Series Website (see ref 15.1) for guidance on how to send records to the FRC (e.g., paperwork to complete, etc.). 13.0 QUALITY CONTROL: 13.1 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. 13.2 Records associated with all EPA Records Schedule or Series numbers identified in Section 10.0 will be archived in notebooks or file folders and kept in secured file cabinets in D217. Only authorized personnel have access to the secured files. 14.0 NONCONFORMANCE AND CORRECTIVE ACTION: 14.1 Any instances of non-compliance with this SOP will be corrected upon discovery. 15.0 REFERENCES: 15.1 US EPA National Records Management Program Website (www. ep a. gov/record s/p ol i cy/s chedul e/numb er). 15.2 US EPA Records Schedule, EPA Series No. 337, Laboratory Test Reports. 15.3 US. EPA Records Schedule, EPA Series No. 339, Test Method Evaluation Records. 15.4 US EPA Records Schedule, EPA Series No. 006, Program Management Files. 15.5 US EPA Records Schedule, EPA Series No. 185, Collections of Quality Assurance Project Plans (QAPPs). 15.6 US EPA Records Schedule, EPA Series No. 200, Training Material. 15.7 US EPA Records Schedule, EPA Series No. 007, Directives and Policy Guidance Documents. ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 10 of 13 15.8 US EPA Records Schedule, EPA Series No. 036, Routine Procurement Files. 15.9 US EPA Records Schedule, EPA Series No. 202, Contract Management Records. 15.10 Microbiology Laboratory Branch's File Structure. Attached. 16.0 FORMS AND DATA SHEETS: None Attachment #1: MLB File Structure ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 11 of 13 ATTACHMENT #1: MICROBIOLOGY LABORATORY BRANCH'S FILE STRUCTURE Schedule # Function # Disposition Item Description/Type of Record: File Contents 337 108-025-06-01 LABORATORY TEST REPORTS & SUPPORTING DOCS. NARA Disposition # Nl-412-07-50/8 a Disposition Instructions: Close inactive records at end of year. Destroy 10 years after file closure. 339 108-025-06-01 TEST METHOD EVALUATION RECORDS NARA Disposition # Nl-412-07-43 a Disposition Instructions: Close inactive records at end of fiscal year. Destroy 25 years after file closure. i)06 301-093 PROGRAM MANAGEMENT FILES NARA Disposition # N1-412-06-6/2 b Disposition Instructions: Close inactive records at end of calendar year. Destroy 5 years after file closure. 185 304-104-06 QUALITY ASSURANCE PROJECT PLANS (QAPPs) NARA Disposition # Nl-412-07-1/7 a Disposition Instructions: Approved or Accepted QAPPs. Close inactive records at approval, or at last amendment or review. Destroy 10 years after file closure. NARA Disposition # Nl-412-07-1/7 b Disposition Instructions: Approved or Accepted QMPs. Close inactive records when suspended or after completion of the last ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 12 of 13 review conducted under the plan, whichever is later. Destroy 10 years after file closure. 200 305-109-02-04 TRAINING MATERIAL NARA Disposition # Nl-412-06-11 a Disposition Instructions: Routine Training Materials. Includes training course plans and materials used for personnel and management training unrelated to the environmental missions of the Agency. Close inactive records after course or material is superseded. Destroy 5 years after file closure. 007 306-111 DIRECTIVES AND POLICY GUIDANCE DOCUMENTS NARA Disposition # N1-412-06-7 a(l) Disposition Instructions: Published or Released to the Public. Close inactive records upon issuance or publication or when superseded. Transfer to the National Archives in 5 year blocks, 20 years after file closure. NARA Disposition # N1-412-06-7 b Disposition Instructions: Unpublished or Not Released to the Public. Close inactive records upon decision to not publish or issue. Destroy 10 years after file closure. i)36 405 ROUTINE PROCUREMENT FILES NARA Disposition # GRS 3/3 a(l)(a) Disposition Instructions: Includes transactions and related papers that EXCEED the simplified acauisition threshold and all construction contracts EXCEEDING $3000. ------- SOP No. ADM-03-04 Date Revised 11-02-11 Page 13 of 13 Close inactive records upon completion. Destroy 6 years, 3 months after file closure. NARA Disposition # GRS 3/3 a(l)(b) Disposition Instructions: Includes transactions and related oaoers that AT OR BELOW the simplified acquisition threshold and all construction contracts AT OR BELOW $3000. Close inactive records upon completion. Destroy 3 years after file closure. 202 405 CONTRACT MANAGEMENT RECORDS NARA Disposition # N1-412-06-6/5 b Disposition Instructions: Includes all correspondence and related records pertaining to contracts to which EPA is a party. Records containing sensitive information must be shredded. Contracts that are being audited, protested, or are in any other kind of legal action cannot be destroyed until the case is closed. For the Contract-level Contracting Officer's Representative (COR). Close inactive records upon payment for the overall contract. Destroy 6 years, 3 months after file closure. ------- |