4090.13,20 Page 1 of 4 FSH 4090.13 - GOOD LABORATORY PRACTICES HANDBOOK WO AMENDMENT 4090.13-93-1 EFFECTIVE 11/10/93 CHAPTER 20 - PERSONNEL 20.3 - Policy. Ensure that personnel are qualified to conduct studies in compliance with Good Laboratory Practices and document employee qualifications in up-to-date, detailed records of training, experience, and education (sec. 21). 20.4 - Responsibility. 20.41 - Line Officers. It is the responsibility of line officers to instruct members of their staffs to report health or medical conditions that may affect the study to the Study Director. 21 - STAFFING. (Sec. 01, ex. 01; 40 CFR 160.29). 21.1 - Qualifications. All individuals involved in a study, including supervisors, Study Directors, technicians, field personnel, and quality assurance staff, must have adequate training, education, and experience, or a combination thereof, to properly carry out their assigned responsibilities. Individuals involved in pesticide studies should also be trained in hazardous material recognition and should be able to read, understand, and implement the safety procedures listed on the Material Safety Data Sheet. All training should be documented in the individual's training record (sec. 22 and FSM 6141). 21.2 - Number of Personnel. Ensure that the station or laboratory is staffed with a sufficient number of trained personnel to conduct each study according to the protocols. 21.3 - Precautions to Avoid Cross-Contamination. 21.31 - Attire. Dress appropriately for the duties performed. Change clothing as frequently as necessary to: 1. Ensure personal safety (FSH 6709.11, sec. 8-1). 2. Prevent test systems or test, control, and reference substances from being contaminated with microbiological, radiological, or chemical agents. 21.32 - Health. Take all health and personal sanitation precautions necessary to prevent contamination of test systems or test, control, and reference substances. (This is usually a concern only in vertebrate studies.) Exclude individuals with an illness or medical condition that could jeopardize the quality or integrity of a study from direct contact with the test systems or test, control, and reference substances. 22 - TRAINING RECORDS AND POSITION DESCRIPTIONS. Each field personnel office must keep accurate, current job descriptions and records of the training, education, and experience of all supervisory and technical staff involved in Good Laboratory Practice (GLP) studies. These records may be kept separate from other personnel records, such as salary and health benefits records, to make them more readily accessible to U.S. Environmental Protection Agency inspectors when requested. Anyone working with GLP studies should maintain a current Factor IV (FSM 6151.3 and FSH 6109.15, ch. 30) or equivalent standardized training form that is updated annually and lists: 1. Education. Include degree(s) held, institution(s), and dates attended. 2. Experience. Include position(s) held and dates of employment; post-graduate training (external and in-house); promotions; special awards and honors; instrumentation capabilities; and studies performed with the accompanying area of responsibility. A sample format for identifying training accomplishments (education and experience) of GLP staff employees is shown in exhibit 01. 22 - Exhibit 01 Sample Format for Recording Training TRAINING RECORD FOR GOOD LABORATORY PRACTICES STAFF Name: Jessie A. Micales Date: 4/10/93 EDUCATION Degrees: (Institutions and Dates) Ph.D., Virginia Polytechnic Institute and State University, Blacksburg, VA Major: Plant Pathology. June 1985. B.S., Delaware Valley College of Science and Agriculture, Doylestown, PA Major: Agronomy (summa cum laude). May 1979. EXPERIENCE Positions Held, Dates of Employment: 7/89 - present: Research Plant Pathologist, GS-13, Forest Products Laboratory, Madison, WI 9/85 - 7/89: Research Plant Pathologist, GS-12, Forest Products Laboratory, Madison, WI 6/84 - 9/85: Research Associate, Cornell University (stationed at USDA-ARS Foreign Disease and Weed Science Research Unit, Frederick, MD) 6/79 - 6/84: Research Assistant, Virginia Polytechnic Institute and State University, Blacksburg, VA Post-graduate Training Courses: (External training, In-house training) Date: August 3-4, 1992 Subject: Grammar, Writing, and Editing Workshop Location: Careertrack Seminar, Madison, WI Date: June 29-30, 1992 Subject: Training for Directive Authors Location: Information Systems Staff, Washington, DC Date: February 2-3, 1992 22 - Exhibit 01--Continued Subject: Introduction to Good Laboratory Practices and Auditing Location: International Center for Health and Environmental Education: Alexandria, VA Date: December 7-8, 1991 Subject: Writing Standard Operating Procedures for Regulatory Compliance Location: International Center for Health and Environmental Education: Alexandria, VA Promotions, Special Awards, Honors: USDA Certificate of Merit, July, 1992 Instrumentation Capabilities: HPLC; FPLC; scanning electron microscopes; ultracentrifuge; personal computers (IBM) - graphics, statistical, word processing, and data base software; spectrophotometers; other standard laboratory equipment. Studies Performed and Areas of Responsibility: CLTH 21402 - Chlorothalonil: field dissipation study. Study Director. CLTH 21709 - Chlorothalonil: efficacy for sapstain control on lumber. Study Director.