32 C.F.R. § 627.19 Large-scale operations.
Title 32 - National Defense
(a) Large-scale. In addition to the requirements stated in §627.13, the following applies to research or production activities involving viable etiologic agents in quantities greater than 10 liters: (1) All large-scale operations will be conducted in facilities described in §627.47. (2) Cultures will be handled in a closed system. (3) Sample collection, the addition of materials, and the transfer of culture fluids shall be done in a manner which minimizes the release of aerosols or contamination of exposed surfaces. (4) A closed system or other primary containment equipment that has contained viable organisms shall not be opened for maintenance or other purposes unless it has been sterilized. (5) SOPs will include a section describing and requiring a validation of the process equipment's proper function. (6) Scientists, technicians, equipment workers, and support personnel with access to the large-scale production area during its operation will be included in the medical surveillance program. (b) BL–2—LS. In addition to the requirements stated in §§627.19(a) and 627.14, the following procedures will be employed for BL–2—LS: (1) Rotating seals and other mechanical devices directly associated with the closed system used for the propagation and growth of viable organisms shall be designed to prevent leakage or shall be fully enclosed in ventilated housings that are exhausted through filters which have efficiencies equivalent to HEPA filters or through other equivalent treatment devices. (2) A closed system used for the propagation and growth of viable organisms and other primary containment equipment used to contain operations involving viable organisms shall include monitoring or sensing devices that monitor the integrity of containment during operations. (3) Systems used to propagate and grow viable organisms shall be permanently identified. This identification shall be used in all records reflecting testing, operation, and maintenance and in all documentation relating to the use of this equipment. (c) BL–3—LS. In addition to the requirements stated in §§627.19(a) and 617.14, the following procedures apply: (1) Personnel entry into the controlled area shall be through the entry area specified in §627.47(c)(1). (2) Persons entering the controlled area shall exchange or cover their personal clothing with work garments such as jumpsuits, long sleeved laboratory coats, pants and shirts, head cover, and shoes or shoe covers. On exit from the controlled area, the work clothing may be stored in a locker separate from that used for personal clothing, or discarded for laundering. Clothing shall be decontaminated before laundering. (3) Entry into the controlled area during periods when work is in progress shall be restricted to those persons required to meet program support needs. (4) Prior to entry, all persons shall be informed of the operating practices, emergency procedures, and the nature of the work conducted. (5) The universal biohazard sign shall be posted on entry doors to the controlled area and all internal doors. The sign posted on the entry doors to the controlled area shall include a statement of agents in use and personnel authorized to enter. (6) Equipment and materials required for the management of accidents involving viable organisms shall be available in the controlled area. (d) BL–4—LS. Guidelines for these operations are not established. If these are needed, they must be established by the United States Army Surgeon General or the NIH on an individual basis.
Title 32: National Defense
PART 627—THE BIOLOGICAL DEFENSE SAFETY PROGRAM, TECHNICAL SAFETY REQUIREMENTS (DA PAMPHLET 385–69)
Subpart C—Operational Requirements
§ 627.19 Large-scale operations.
