Downloaded from https://www.everyspec.com uses licensed and unlicensed vaccines to protect at-risk Soldiers and Army civilian employees. The U.S. Army Medical Research and Materiel Command manages the Special Immunization Program. b. Immunization with a licensed vaccine, or a statement of declination from the individual, may be required as a prerequisite for working with certain biological agents. c. Unlicensed vaccines are given under investigational new drug (IND) protocols.
Due to the investigational, unlicensed status and the limited availability of vaccines given under IND protocols, immunization with an IND vaccine is strictly voluntary and is limited to those individuals to whom the risk of their use has been fully analyzed and justified. Vaccines given under IND protocols are only to be used to provide an additional level of protection. They are not to be used in lieu of safe laboratory practices, agent containment, or PPE. 20–9. Training and information All personnel who work directly with or who otherwise have a potential for occupational exposure to IAT will receive training in accordance with chapter 10 of this regulation and DA Pam 385–69. 20–10.
Inspections Government biological activities will be inspected in accordance with the requirements of DA Pam 385–69. Contract biological activities will be inspected in accordance with DA Pam 385–69 for each contract requiring the use of Army- or DOD-provided IAT. 20–11. Maintenance controls A continuing maintenance process will be implemented for equipment and facilities. The maintenance process at a minimum will address— a. Identifying critical equipment and utility system components. b. Inspecting, testing, certifying, maintaining, and documenting critical equipment and utility system operating components. c.
Investigating, reporting, and correcting equipment and utility system problems, failures, and user errors. d. Ensuring maintenance personnel possess the necessary knowledge, skills, and qualifications to inspect, test, certify, and maintain critical equipment and utility systems. e. Responding to equipment and utility system failures or disruptions. 20–12. Transportation of etiologic agents a. When transporting IAT, the agent will be prepared and/or certified for shipment by personnel who have successfully completed the 40–hour Transport of Biomedical Material Course offered by the U.S.
Army Public Health Command or other DOD or Army-approved HAZMAT shipper certification course and appointed in writing by the activity or unit CDR or designated representative stating the scope of authority and expiration date. b. Packaging, labeling, and shipping will be in accordance with applicable Federal, State, and local laws and regulations, to include DA Pam 385–69 and the following: (1) 7 CFR Part 331 (biological select agents and toxins (BSAT) only). (2) 9 CFR Parts 92, 94, 95, 96, 121, 122, and 130 (BSAT only). (3) 15 CFR Parts 730–774. (4) 42 CFR Parts 70 and 71 (5) 42 CFR 73 (BSAT only). (6) 49 CFR, Vol 2, Chapter I.
(7) International Air Transport Association Dangerous Goods Regulations. (8) International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air. (9) DTR 4500.9–R. (10) AR 50–1 (BSAT only) and Interim Guidance for the Shipment BSAT within the Army (BSAT only). (11) AFMAN 24-204(I)/TM 38-250/NAVSUP PUB 505/MCO P4030.19/DLAI 4145.3. c. Transportation of IAT on installations will be in accordance with the DTR, Part II, Chapter 204, Paragraph C, Regulatory Requirements. 20–13. Disposal controls All cultures, stocks, and other potentially infectious materials are decontaminated before disposal using an effective method.
Depending on where the decontamination will be performed, the following methods should be used prior to transport: a. Materials to be decontaminated outside of the immediate laboratory must be placed in a durable leakproof container, maintained in the laboratory or designated storage area until it is transported. b. Materials to be removed from the facility for decontamination must be packed in accordance with applicable 79 AR 385–10 • 23 August 2007/RAR 4 October 2011