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This section addresses procedures for the safe handling of select carcinogens, suspect carcinogens, investigational drugs (INDs), and hazardous drugs (HDs). Table 12.11.1 lists these agents and their primary hazards, but it is not an exhaustive list. To use an agent not listed in the table in an animal study, you must inform EH&S of the agent to be used and include appropriate handling procedures in your IACUC application or modification to determine the appropriate handling procedures. Select carcinogens require the completion of a Carcinogen Memorandum of Understanding and Agreement (CMUA). See Section 4 for a description of the CMUA and Section 2.1 of this chapter for a definition of an authorized CMUA holder.
A select carcinogen is a chemical classified as:
In addition to carcinogens identified by the IARC, NTP, and WISHA, the table includes select carcinogens that meet the following criteria:
A chemical is classified as a select carcinogen if it is listed under IARC Group 2A, "probably carcinogenic to humans," or under 2B, "possibly carcinogenic to humans," or under the category "reasonably anticipated to be a carcinogen" by NTP, and causes a statistically significant tumor incidence in experimental animals under the following criteria:
Suspect Carcinogens are defined as those agents listed as IARC Group 2A, "probably carcinogenic to humans," or 2B, "possibly carcinogenic to humans," or under the NTP category "reasonably anticipated to be a carcinogen."
Hazardous drugs include those drugs as defined by the Federal Food, Drug, and Cosmetic Act that are not handled in a solid final form (capsules, tablets, pills) suitable for direct administration, and have one or more of the characteristics considered hazardous by WISHA.
According to WISHA's Hazard Communication Standard, agents with one or more of the following characteristics are considered hazardous:
Note: Both human and animal data are used for this determination.
An investigational drug or test agent is an agent used in research and not regulated as a drug by the Federal Food, Drug, and Cosmetic Act. These agents generally have limited standard toxicological information available. These agents must be handled with care until studies show otherwise.
At the Fred Hutch , the chemical is considered hazardous until data proves otherwise.
The four handling procedures listed in Table 12.11.1. are explained after the table.
Use this Table 12.11.1 to identify:
Table 12.11.1 is a summary of suspect and select carcinogens classified using the standard occupational health and toxicological references below. The table also includes INDs and HDs either identified by EH&S or used at Fred Hutch. References used to classify these substances are:
This table is not exhaustive. If you are using an agent not listed in Table 12.11.1 for research involving the use of animals, notify EH&S to discuss the handling procedures required. Be sure to include the safe handling procedures in the IACUC application or modification. Other toxicology information is provided as needed and as available.
Column two clarifies which agents require the PI or supervisor to submit a Chemical Carcinogen Memorandum of Understanding and Agreement (CMUA).
Column three lists the safe handling procedures required when using the agent. The fourth column lists the principle hazard of the agent as follows:
The letter I is used to identify those agents that are considered investigational agents or agents with insufficient toxicological information available to determine the hazard potential. These agents have the highest-level handling requirements to protect the health of employees handling these agents and the technicians caring for the animals in the study.
The last column identifies those agents listed by WISHA that require notification of use to Labor and Industries, medical surveillance for users, exposure monitoring as well as the completion of the CMUA.
Refer to Table 12.11.1 for a list of agents and their primary hazards, but it is not an exhaustive list.
This procedure should be followed for suspect carcinogens. When using large quantities of suspect carcinogens, EH&S recommends the use of Procedure 12.11.2 instead.
Employees handling the substance must know the health and physical hazards, routes of exposure, and how to use appropriate protective equipment.
Review and follow all steps in Procedure 12.11.1. In addition:
Animal studies involving the use of select carcinogens, hazardous drugs HDs, or INDs must comply with the following procedures. Agents identified as select carcinogens also require the completion of a CMUA by the PI or supervisor prior to use. See Table 12.11.1 for a list of agents that require the completion of a CMUA. Frequent (more than one time per month) use of a carcinogen may require medical monitoring.
The lab will handle the agents mentioned above in accordance with standard good lab practices and the following procedures:
The PI or a knowledgeable appointee must train workers who handle the drug or chemical to understand the physical properties of the substance, and must give workers the results of experimental studies that show any effects on health and any human data that may be available. If toxicological information is limited, then toxicological data from similar compounds should be reviewed. Employees handling the drug or chemical must be informed of the possible routes of exposure (e.g., inhalation, skin absorption, injection) and proper use of personal protective equipment and engineering controls. A summary of this information and the material solubility must be supplied to Animal Health Resource (AHR) technicians caring for the animals.
The following procedures must be followed for agent preparation:
Steps 1-5 listed in Section 12.11.2 should be followed during agent administration. A chemical fume hood or exhausted BSC is required during administration only if the agent is volatile or aerosolization is likely.
When the material is given via injection or gavage, syringes and IV sets with Luer-lock fittings should be used whenever possible. Priming can be performed into a sterile, alcohol-dampened gauze sponge. Do not prime sets or syringes into the sink or any open receptacle.
All animals must be housed in micro-isolator cages.
If the hazardous drug or chemical carcinogen must be administered in the diet, a closed caging system must be used. Mix all diets containing the material in closed containers inside a chemical fume hood or Class II, Type B2 biological safety cabinet (i.e., vented cabinet).
Animal handlers must wear gloves to prevent skin contact when performing work (changing bedding, handling animals etc.) with animals used in studies. The use of non-latex gloves is also recommended. Remove gloves and wash hands and arms thoroughly when work is complete. No other special precautions are generally needed to handle the animals, bedding, or cages.
Excreta from animals should be considered contaminated up to 48 hours following drug administration.
Dogs: Animal handlers must wear rubber boots and aprons while cleaning cages. When cleaning the cages avoid creating an aerosol. This can be done by rinsing water down the cage room wall or backsplash to dilute the excreta prior to spraying the area directly to clean the cages.
Small rodents: When cleaning rodent cages, wet the bedding to minimize dust and dispose of it with other bedding. Cages should be cleaned and disinfected as usual.
Under WAC 296-62-073 Carcinogens, work involving any amount of the following carcinogens must comply with the requirements below.
In addition, the following six carcinogens each have a specific set of regulations governing their use under 296-62-07329 through 296-62-07447. Air monitoring is required to document exposures for these chemicals. EH&S must be contacted prior to using the following chemicals:
The PI or supervisor authorizes a specific worker or workers to perform procedures using the carcinogen. Unauthorized workers are not permitted to perform such work.
All work with the carcinogens above will be performed in accordance with this section and the following requirements:
All containers must be labeled Carcinogen. Volatile carcinogenic agents must be stored with Group 2: Volatile Poisons inside a secondary tray or container (i.e., it must be double-contained) of sufficient capacity to contain all of the material should the primary container leak or break. Label the container with a warning of the material's carcinogenic potential. See Section 9, Proper Chemical Storage.
Excess study solution and materials grossly contaminated with the study material must be labeled and packaged by the researcher for pickup and disposal by EH&S.
Contaminated bedding must be removed in a manner that controls the generation of dust. This can involve wetting the bedding or using a High Efficiency Particulate Air (HEPA) filtered dump station.
If the material is water soluble, animal cages can be washed as usual and re-used in future studies. However, if the material is not water-soluble, AHR and the researcher should determine if the current wash method is sufficient to decontaminate cages.
Animal carcasses used in these studies can be disposed of as standard regulated medical waste.
Overt contamination of gloves or gowns, or direct skin or eye contact should be treated as follows:
Spills within the chemical fume hood or other containment should be cleaned immediately by lab staff responsible for handling carcinogens. Follow the procedures below:
Spills greater than 200 ml or a spill of a volitile carcinogen that occur outside a glovebox or chemical fume hood should be cleaned up by EH&S if lab is not prepared with adequate PPE to respond safely. In the event of a spill: