Guidance on the Use of Infectious Waste Treatment and Radiation Facilities Outside of Registered Space In general all material contaminated with biological select agents and toxins (BSAT) including animal samples and concentrated vials of material should be decontaminated prior to leaving the select agent registered containment area. There are situations when this cannot occur based on the location of autoclaves, digesters, renderers, and radiation treatment sites which are located in separate rooms, buildings or locations outside of registered select agent space. This guidance document provides the minimum risk mitigation measures needed to ensure appropriate security and decontamination of BSATs while these separate locations are being utilized. The Federal Select Agent Program may request documentation on these procedures. Solid Waste Treatment Separate infectious waste treatment areas such as autoclave rooms, digester or renderer rooms and incinerator facilities do not need to be listed in an entity registration as long as these areas are not used for the storage of unprocessed select agent and toxin contaminated materials. If the waste treatment facility is not in containment the entity should ensure the following practices are in place.
Some entities will provide the decontaminated waste to a medical waste vendor who will take the waste to an incinerator and some entities will place the decontaminated waste in the normal waste stream. Whatever process is used by the entity, the entity is expected to have procedures in place to mitigate the risk to public, animal or plant health, or environmental exposure should a failure of the decontamination process be detected after the materials has been released. Entities should be mindful that high use equipment or older equipment may require more frequent maintenance. While biological indicators to test decontamination systems are not specified in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) it is reasonable to expect the entity to verify by some means that the decontaminations system is operating within specifications and is able to effectively decontaminate infectious waste. Liquid Waste Treatment Liquid waste that is not decontaminated in the solid waste treatment stream may be decontaminated by several means. Contaminated liquid waste may be decontaminated by holding in a container, or sink with chemical disinfectant. An Effluent Decontamination System (EDS) may also be utilized if large amounts of liquid waste such as liquid from showers and from animal holding facilities are generated. In general, the EDS, holding tank, cook tank or pass through systems, do not normally require registration, however registration may be required in special circumstances. The entity should confirm the need to register especially if large animal waste is processed. If the entity has an EDS, the entity should confirm the following:
Radiation Facilities Entities that use radiation facilities (irradiators) which are not within the level 3 or 4 containment areas are not required to include the facility on their registration however the following conditions should exist if the facility is used for radiation of select agents.
|
||
Home | Resources | About Us | Forms | Helpful Information | Operations | Select Agents & Toxins | FAQ's | ||