4090.13,T of C Page 1 of 11 FSH 4090.13 - GOOD LABORATORY PRACTICES HANDBOOK Contents ZERO CODE CHAPTER 10 COMPLIANCE WITH GOOD LABORATORY PRACTICES 20 PERSONNEL 30 FACILITIES 40 EQUIPMENT 50 FACILITY OPERATION 60 PROTOCOL AND CONDUCT OF A STUDY 70 RECORDS, REPORTS, AND ARCHIVING 80 QUALITY ASSURANCE UNIT 90 INSPECTIONS AND AUDITS ZERO CODE Contents 01 AUTHORITY 03 POLICY 04 RESPONSIBILITY 04.1 Deputy Chiefs for Research, State and Private Forestry, and the National Forest System 04.2 Regional Foresters, Station Directors, Area Director, Director of the Forest Products Laboratory, and Institute Director 04.3 Line Officers 04.4 National and Local Quality Assurance Unit Managers 04.5 Study Directors 05 DEFINITIONS 06 REFERENCES 06.1 Good Laboratory Practices 06.2 Manuals 06.3 Briefings 06.4 Quality Assurance 06.5 Pesticide Assessment Guidelines CHAPTER 10 - COMPLIANCE WITH GOOD LABORATORY PRACTICES Contents 11 APPLICABILITY OF GOOD LABORATORY PRACTICES 11.1 Types of Studies Requiring Good Laboratory Practices 11.2 Types of Studies Not Requiring Good Laboratory Practices 11.21 Studies Not Submitted to the Environmental Protection Agency 11.22 Development of New Pesticides and Testing Procedures 11.23 Efficacy Tests 11.3 Types of Studies That Allow More Relaxed Good Laboratory Practices 12 ASPECTS OF COMPLIANCE 12.1 Applicability 12.2 Statement of Compliance 12.3 Inspections 12.4 Effects of Noncompliance CHAPTER 20 - PERSONNEL Contents 20.3 Policy 20.4 Responsibility 20.41 Line Officers 21 STAFFING 21.1 Qualifications 21.2 Number of Personnel 21.3 Precautions To Avoid Cross-Contamination 21.31 Attire 21.32 Health 22 TRAINING RECORDS AND POSITION DESCRIPTIONS CHAPTER 30 - FACILITIES Contents 30.3 Policy 31 TEST SYSTEM CARE FACILITIES 31.1 Separation of Species 31.2 Biohazard Facilities 31.3 Collection and Disposal of Contaminated or Hazardous Materials 31.4 Regulation of The Environment 32 TEST SYSTEM SUPPLY FACILITIES 32.1 Storage Areas 32.2 Facilities for Plant Growth 33 FACILITIES FOR HANDLING TEST, CONTROL, AND REFERENCE SUBSTANCES 34 LABORATORY FACILITIES 35 ARCHIVING FACILITIES CHAPTER 40 - EQUIPMENT Contents 40.3 Policy 41 EQUIPMENT DESIGN 42 CALIBRATION AND MAINTENANCE 42.1 General Considerations 42.2 Standard Operating Procedures 42.3 Documentation CHAPTER 50 - FACILITY OPERATION Contents 50.3 Policy 51 MASTER SCHEDULE 51.04 Responsibility 51.1 Contents 51.2 Updates 52 STANDARD OPERATING PROCEDURES FOR OVERALL OPERATIONS 52.1 Format 52.2 Topics 52.3 Changes and Deviations 53 REAGENTS AND SOLUTIONS 54 TEST SYSTEM CARE 54.1 Standard Operating Procedures for Test System Care 54.2 Prevention and Treatment of Incidental Disease 54.3 Identification 54.4 Separation of Species 54.5 Detection of Contaminants 54.6 Pest Control 54.7 Acclimatization 55 TEST, CONTROL, AND REFERENCE SUBSTANCES 55.1 Characterization 55.11 General Considerations 55.12 Solubility and Stability 55.13 Storage Containers 55.14 Retention of Reserve Samples 55.2 Handling 55.21 Chain of Custody 55.22 Documentation 55.23 Standard Operating Procedures 55.3 Mixing with Carriers 55.31 Analyses 55.32 Labeling 55.33 Vehicles CHAPTER 60 - PROTOCOL AND CONDUCT OF A STUDY Contents 61 PROTOCOLS 61.1 Description 61.2 Contents 61.3 Amendments 61.4 Deviations 61.5 Review and Approval 62 CONDUCTING STUDIES 62.1 Accordance with Protocol 62.2 Labeling Specimens 62.3 Collecting Raw Data 62.31 Manual Data Collection 62.32 Automated Data Collection CHAPTER 70 - RECORDS, REPORTS, AND ARCHIVING Contents 70.4 Responsibility 70.41 Line Officers 70.42 Study Director 71 REPORTING STUDY RESULTS 71.1 Format and Content of the Final Report 71.2 Approval 71.3 Amendments 71.4 Retention 72 ARCHIVING 72.1 Materials to be Maintained 72.2 Facilities 72.3 Archiving Methods 72.31 In-house Archives 72.32 Contract Archives 72.4 Archiving Subcontracted Material 73 RETENTION OF SPECIMENS AND RECORDS 73.1 Duration 73.11 Fragile Specimens 73.12 All Other Materials 73.2 Elimination of Requirement 73.3 Transfer of Archives CHAPTER 80 - QUALITY ASSURANCE UNIT Contents 80.1 Authority 80.4 Responsibility 80.41 Deputy Chief for Research 80.42 National Quality Assurance Unit Manager 80.43 Line Officers 80.44 Local Quality Assurance Unit Manager 81 PERSONNEL 81.1 National Quality Assurance Unit 81.2 Local Quality Assurance Unit CHAPTER 90 - INSPECTIONS AND AUDITS Contents 90.1 Authority 90.3 Policy 90.4 Responsibility 90.41 Deputy Chiefs for Research, State and Private Forestry, and the National Forest System 90.42 National Quality Assurance Unit Manager 90.43 Regional Foresters, Station Directors, Area Director, Director of the Forest Products Laboratory, and Institute Director 90.44 Local Quality Assurance Unit Manager 91 QUALITY ASSURANCE UNIT INSPECTIONS 91.1 National Quality Assurance Unit Inspections 91.2 Local Quality Assurance Unit Inspections 91.3 Inspection Records 92 FOREST SERVICE REVIEWS 92.1 Management and Activity Reviews 92.2 Supervisory Reviews 93 U.S. ENVIRONMENTAL PROTECTION AGENCY INSPECTIONS 93.03 Policy 93.1 Refusal of Inspection 93.2 Types of U.S. Environmental Protection Agency Inspections 93.3 Inspection Process 93.31 Notification 93.32 Preparation 93.33 Opening Conference 93.34 Facility Inspection 93.35 Study (Data) Audit 93.36 Closing Conference 93.37 Post-inspection Activities 93.38 Routes of Appeal