Downloaded from https://www.everyspec.com c. The IMCOM safety office will coordinate with aviation units as per local agreements. Commanders will coordinate the support requirement upon receiving the request for support. Chapter 20 Biological Safety 20–1. Introduction a. This chapter establishes DA safety policies and procedures for the use, handling, transportation, transfer, storage, and disposal of infectious agents and toxins (IAT) rated at BSL–2 and above used in microbiological activities in permanent or temporary clinical laboratories, biomedical and biological research settings, microbiology teaching laboratories, and veterinary reference laboratories.
These policies and procedures apply to all U.S. Army activities and facilities in which IAT are used, produced, stored, handled, transported, transferred, or disposed—to include the ARNG and the USAR, and to contractors and consultants conducting microbiological and biomedical activities for the Army. Policy and procedures for contractors required to possess or use Army- or DOD-provided IAT are covered in paragraph 20–15 of this regulation. b. Army Headquarters employing mobile laboratories will develop specific procedures for the mobile laboratories’ biosafety program and documentation.
At a minimum, the program will include risk assessment, engineering controls (safety, health, and environmental), SOPs, hazard analyses, training (user and maintenance), and inspection, testing, validation, and maintenance requirements. Army Headquarters will submit mobile laboratories’ biosafety policies to the ODASAF for review by the DABSHC. c. DA Pam 385–69 contains minimum technical safety and occupational health requirements for developing man- agement and control processes for biological operations involving IAT. Its implementation is mandatory. d.
Best practices and lessons learned collected from both Government and industry that serve as examples of how others have met challenges, introduced innovation, and advanced the science of biological safety are available from the DABSHC. Contact the ODASAF for additional information. 20–2. General a. The transport, storage, handling, use, and disposal of IAT will occur in a manner that will not adversely affect the safety and health of employees, military personnel, visitors, the surrounding community, or the environment. The overarching principle for safety in biological activities is to minimize the potential exposure of personnel and the environment to IAT.
Biological activities will be conducted using facilities, equipment, and procedures commensurate to the level of risk of the activity or the BSL. The minimum number of appropriately qualified and trained personnel will be engaged in the activity for the shortest period of time and with the minimum amount of material—consistent with program objectives and safe operations. b. All testing of protective equipment or detection devices employing IAT will be conducted in appropriate BSL laboratories, chambers, or other facilities. All testing will be conducted using the least hazardous IAT consistent with mission objectives. c.
Field testing (open air) is restricted to the use of IAT simulants, unless the Secretary of Defense determines that testing is necessary for national security in accordance with 50 USC 1512. 20–3. Biological safety programs a. Each Army Headquarters, major subordinate command, and agency conducting biological activities will include a biological safety section in their written Safety and Occupational Health Program prescribing responsibilities and procedures for implementing this chapter and DA Pam 385–69.
When another military department, command, or agency conducting biological activity is a tenant on an installation, that organization shall coordinate its biological safety program with the senior commander. b. The installation, institute, or activity’s Safety and Occupational Health Program will include a biological occupa- tional health element meeting the requirements of DA Pam 385–69. 20–4. Mishap risk management a.
The risks associated with biological activities will be assessed and documented and controls established (person- nel training and qualification, procedures, containment equipment, and facility design) to contain IAT and to protect workers, support personnel, the environment, and laboratory products. DA Pam 385–30 can be used as a guide for mishap risk management. b. A risk assessment will be completed and documented for every operation involving IAT. The principal investiga- tor or immediate supervisor (whoever has the best understanding of the activities and risks) is responsible for conducting the risk assessment.
This shall be done in close coordination with the safety and occupational health and other SMEs (for example, environmental, emergency response, security, facilities, and maintenance) and/or the facility safety committee to ensure compliance with established guidelines and regulations. The risk assessment will identify 77 AR 385–10 • 23 August 2007/RAR 4 October 2011