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.

• Solid select agent waste is transported to and placed in the decontamination unit by a person who has access approval to BSAT following security risk assessment (approved SRA). Please refer to http://www.selectagents.gov/risk.html for SRA information.
• Waste is transported in covered containers that are decontaminated before removing from containment and the inside of the container decontaminated before removing from the waste treatment area.
• Waste is transported using personal protective equipment determined appropriate by a risk assessment.
• Waste should not be transported through a public area but if this is the case because the entity has no other option there is a description in the incident response plan on how the entity would deal with a spillage in the public area.
• The decontamination unit is started as soon as the material is placed in the unit and it is confirmed by the person with the approved SRA that the decontamination cycle begins. It is not necessary for the entity to require the person with the approved SRA to remain in the area during the entire decontamination cycle but only to be reasonably assured that the cycle has begun.
• The person with the approved SRA confirms that the decontamination cycle, using system settings expected to render the contaminated material non-infectious or non-toxic, has been completed according to system specifications.
• The decontamination unit is on a regular maintenance schedule.
• There is a means of verifying that all parameters of the decontamination cycle have been attained (e.g., recording tape, biological indicators, probes, etc.).
• Records are maintained of decontamination that includes material decontaminated, date of decontamination, cycle description and any verification documentation. These records should be maintained for three years.
• There is documentation to verify the process used is capable of completely decontaminating the material to be processed.

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:

• The pipe leading from the containment area to the EDS is sealed and checked at least annually for leaks. A double walled pipe is preferred.
• There are procedures and structures in place to contain more liquid than the EDS system would process should there be a spill of the liquid from the EDS.
• Procedures are in place for the cleanup of a spill from the EDS.
• There is documentation that the decontamination cycle is adequate for the material to be processed.
• There are records of routine maintenance of the EDS.
• In cases where there are high levels of contamination or high matrix content such as in infected animal holding areas there should be procedures for waste treatment prior to leaving containment.
• There are records that EDS operation staff have been trained on how to respond to leaks and spills.

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.

• An SRA approved individual transports the select agent material to the radiation room, places the material into the radiation unit, ensures that the unit is operating and confirms at the end of the cycle that the radiation cycle has been completed without interruption.
• The material container is decontaminated before leaving containment and the material is transported in an enclosed transfer containment device.
• There are the means to control access to the radiation room at least during the time the select agent material is in the room.