4090.13-93-1 Transmittal Page 1 of 3 FOREST SERVICE HANDBOOK WASHINGTON FSH 4090.13 - GOOD LABORATORY PRACTICES HANDBOOK Amendment No. 4090.13-93-1 Effective November 10, 1993 POSTING NOTICE. Amendments are numbered consecutively by Handbook number and calendar year. Post document in numerical order of chapters (1109.12, sec. 4.32, ex. 01). Remove entire national text of the Handbook and replace with this amendment. DO NOT REMOVE SUPPLEMENTS OR INTERIM DIRECTIVES. Retain this transmittal as the first page of this document. New Document Names New Pages 4090.13, Contents 2 4090.13,0 Code Contents 1 4090.13,0 Code 28 4090.13,10 Contents 1 4090.13,10 3 4090.13,20 Contents 1 4090.13,20 4 4090.13,30 Contents 1 4090.13,30 2 4090.13,40 Contents 1 4090.13,40 4 4090.13,50 Contents 1 4090.13,50 25 4090.13,60 Contents 1 4090.13,60 25 4090.13,70 Contents 1 4090.13,70 8 4090.13,80 Contents 1 4090.13,80 4 4090.13,90 Contents 1 4090.13,90 16 Digest: This Handbook provides direction on the principles and requirements of Good Laboratory Practice (GLPs) for Forest Service management and technical personnel. Any study that is performed with the intention of submitting the data to the U.S. Environmental Protection Agency or the U.S. Food and Drug Administration in support of a research or marketing permit must follow GLP standards. 01 - 06.5 - Sets forth Authority (sec. 01), Policy (sec. 03), Responsibility (sec. 04), Definitions (sec. 05), and References (sec. 06) in the zero code chapter for the new Handbook on Good Laboratory Practices. 11 - 12.4 - Establishes a new chapter that provides direction on the applicability of Good Laboratory Practices (GLPs) (sec. 11) and aspects of compliance (sec. 12). 20.3 - 22 - Establishes a new chapter that provides direction on staffing requirements and training for personnel conducting, or involved with, Good Laboratory Practices. 30.3 - 35 - Establishes a new chapter that provides policy and direction to determine requirements for test system care facilities (sec. 31); test system supply facilities (sec. 32); facilities for handling test, control, and reference substances (sec. 33); laboratory facilities (sec. 34); and archiving facilities (sec. 35) where Good Laboratory Practices are conducted or stored. 40.3 - 42.3 - Establishes a new chapter that provides direction on equipment requirements including equipment design (sec. 41) and calibration and maintenance (sec. 42) for studies complying with Good Laboratory Practices. 50.3 - 55.33 - Establishes a new chapter that provides direction on facility operations required for Good Laboratory Practices, including preparation of master schedule (sec. 51); standard operating procedures (sec. 52); reagents and solutions (sec. 53); test system care (sec. 54); and characterization, handling, and mixing with carriers of test, control, and reference substances (sec. 55). 61 - 62.32 - Establishes a new chapter that provides direction on the preparation of protocols and collection of raw data for Good Laboratory Practices. 70.4 - 73.3 - Establishes a new chapter, Records, Reports, and Archiving that provides direction on reporting study results (sec. 71), archiving (sec. 72). 80.1 - 81.2 - Establishes a new chapter that provides direction on the requirements and duties of local and national Quality Assurance Units in support of Good Laboratory Practices. 90.1 - 93.38 - Establishes a new chapter that provides direction on inspections conducted by local and national Quality Assurance Units (sec. 91 and 92) and the U.S. Environmental Protection Agency (sec. 93) in conjunction with Good Laboratory Practices. This Handbook is now available electronically in the National Information Center in the same format as the paper copy. Henceforth, amendments to this Handbook will be issued to Forest Service units electronically on a document basis. DAVID G. UNGER Acting Chief