Institutional Animal Care and Use Committee Policy Title: Chemical and Drug Hazards PURPOSE To describe the procedures for all individuals involved in the dosing, handling, disposal and housing of animals dosed with hazardous drugs or chemicals at The University of Kansas Medical Center. SCOPE Drugs and chemicals that are toxic, known or suspected carcinogens, reproductive hazards, teratogens, mutagens and antineoplastic agents may be used in animal protocols. All chemicals being used must be documented in an Institutional Animal Care and Use Committee (IACUC) approved Animal Care and Use Protocol (ACUP). Failure to document all hazards may result in suspension of research privileges. As all chemicals and drugs do not pose the same risk to human health, each ACUP or Risk Assessment document shall be reviewed for the determination of risk level on a case-by-case basis. Therefore, increased containment and/or more stringent procedures may be required to be implemented that are not described within this SOP. The term may is used through-out this document and is not intended to be synonymous to the terms mandatory, shall, requirement or must, but rather as an alternative, added precaution or possibility for requirement. Finally, different animal species may be treated differently as each species may pose specific challenges. Due to the prevailing nature of this type of research involving rodents this SOP will concentrate on hazardous research involving mice and rats. RESPONSIBILTIES Principal Investigator (PI) A. Submit a thoroughly completed ACUP or Risk Assessment document that includes: a) A list of all hazardous drugs or chemicals b) All known human hazards at the dosage levels to be administered c) Effective PPE that reduce or eliminate exposure d) Additional measures to be taken in order to mitigate occupational exposure B. For Medium and High Containment Areas, post the Section H portion of the IACUC approved protocol and available Material Safety Data Sheets (MSDS) within the LAR designated area 72 hours prior to animal dosing. Additionally, the PI is to place Chemical Hazard cage cards on all cages at the time of dosing.
Low Containment Areas do NOT require Chemical Hazard Cage Cards or MSDS posting. Special Note: PI s are NOT to remove cage cards, only LAR staff are permitted to do so. C. Train research staff in good laboratory practices as well as hazards specific to the PI s research environment and ensure personnel donning N-95 masks have been trained and fit-tested. PI s must ensure that personnel donning PAPR s are properly trained. D. The PI is strongly encouraged to play an active role in determining the risk level by providing all vital information to assist the EHS department in providing an accurate assessment to prevent research hindering and/or occupational exposure. Environment, Health & Safety A. Utilize multiple entities, individuals and/or departments to determine the risk level regarding each hazard. Multiple factors will play a fundamental role (e.g. hazard half-life, toxicity level, dosage level, pharmacokinetics EPA regulated chemicals or other regulations). B. Inform IACUC administration, LAR management and the PI of proper safety measures to be implemented for Medium and High Risk Level agents. NOTE: Low Level Risk agents do not require notification. LAR Facility Management A. Communicate to LAR staff information related to hazardous chemicals and drugs from the IACUC. Additionally, notify IACUC regarding breaches of procedures or practices. B. Ensure that LAR staff complies with all safety measures implemented, including training on proper use of personal protective equipment and safety equipment. Ensure personnel donning N-95 masks have been trained and fit-tested. Management Staff must unsure that personnel donning PAPR s are properly trained. Comment [RCL1]: I think I would rephrase this as it reads to me like the PAPR s need to be trained rather than the employee. I would change it to have a period after fit tested and start a new sentence that says something along the lines of PI s must ensure that personnel donning PAPR s are properly trained. Comment [RCL2]: See comment above IACUC Committee A. Assist in upholding decisions made by the EHS office in regards to hazard level. STANDARD PRACTICES The below procedures represent general standard practices for animal housing, animal handling, hazard communication, final animal disposition, contaminated bedding/water/feed and any additional safety measures to be taken for each risk level regarding animals dosed with hazardous chemicals or drugs. Regarding any housing scenario, all PI s must consult with LAR management prior to ordering/creating animals for all logistics regarding specific housing rooms and cage locations within each room as well as equipment availability (e.g. biological safety cabinets BSC).
Low Risk Hazards A. Low risk animals will be considered and handled as no-risk due to the extremely low chemical hazard. NOTE: it must be understood that the no-risk status only applies if the chemical is being used appropriately and at the approved doing/prepared levels denoted within the IACUC protocol. B. Examples of Low Risk Hazards In general, the following hazards can be categorized as Low Risk. NOTE: it must be understood each project is taken on a case-by-case basis and particular factors may play role in re-categorization to a higher risk. a. Tomoxifen b. Ethanol c. Advertin d. BPA-bisphenol e. Taurine f. Omeprazole Medium Risk Hazards A. Animal Housing Animals will be housed in the Medium Risk Containment area designated for chemical and drug animal housing. Ventilated housing cage systems or disposable caging shall be implemented. The LAR will be responsible for cage changing. Animals may be placed back into general holding areas as determined on a case-by-case basis. Two criteria must be met in order to successfully return animals to any general holding area: 1. The desire to return animals to the general holding area after a period of time must be denoted in the approved IACUC Animal Protocol Section H thoroughly describing the reason and appropriate data for assurance of no personnel occupational exposure threat from a chemical for drug stand-point. 2. LAR approval must be granted prior to animal transfer. B. Animal Handing Increased PPE practices may be implemented (N-95 mask, PAPR unit, double nitrile gloves, disposable gowns, bouffant cap, shoe covers, safety eyewear). Outer gloves shall be changed when transitioning to animals dosed with a different agent or a different PI. Animal manipulations shall be performed in either a Cage Changing Station or BSC. C. Hazard Communication
The PI is required to post the Section H portion of the IACUC approved protocol within the LAR designated area 72 hours prior to animal dosing. Additionally, the PI is to place Chemical Hazard cage cards on all cages at the time of dosing. D. Final Animal Disposition Standard carcass disposal practices may be implemented. E. Contaminated Bedding, Water & Feed Contaminated bedding, unused water and feed will be considered contaminated 3 days post dosing and until after the first cage change unless specified otherwise. Contaminated bedding, unused water and feed shall be dumped by the LAR and collected as biohazard waste. NOTE: Autoclaving contaminated waste in not recommended unless there is an associated biohazard. F. Additional Safety Measures PPE shall be removed prior to exiting the animal room as biohazard waste. Hands shall be washed after glove removal. G. Examples of Medium Risk Hazards In general, the following hazards can be categorized as Medium Risk. NOTE: it must be understood each project is taken on a case-by-case basis and particular factors may play role in re-categorization to a lower or higher risk. a. Streptozotocin b. Tributyltin Chloride High Risk Hazards A. Animal Housing Animals will be housed in the High Risk Containment area designated for chemical and drug animal housing. Ventilated housing cage systems or disposable caging shall be implemented. The LAR will be responsible for cage changing. Animals may be placed back into general holding areas as determined on a case-by-case basis. Two criteria must be met in order to successfully return animals to any general holding area: 1. The desire to return animals to the general holding area after a period of time must be denoted in the approved IACUC Animal Protocol Section H thoroughly describing the reason and appropriate data for assurance of no personnel occupational exposure threat from a chemical for drug stand-point. 2. LAR approval must be granted prior to animal transfer. B. Animal Handing Increased PPE practices shall be required (N-95 mask, double nitrile gloves, disposable gowns, bouffant cap, shoe covers, safety eyewear). Additional PPE requirements may be implemented (carbon and/or HEPA filtered respirator system devices - PAPR). Outer gloves shall be changed when transitioning to animals dosed with a different agent or a different PI. Animal manipulations shall be performed in a Class II, Type B2 BSC. C. Hazard Communication
The PI is required to post the Section H portion of the IACUC approved protocol within the LAR designated area 72 hours prior to animal dosing. Additionally, the PI is to place Chemical Hazard cage cards on all cages at the time of dosing. D. Final Animal Disposition Standard carcass disposal practices can be implemented. If the hazard is EPA regulated, the PI shall contact the EHS department for animal carcass disposal. E. Contaminated Bedding, Water & Feed Contaminated bedding, unused water and feed shall be dumped by the LAR and collected as biohazard waste. All bedding will be considered contaminated for the life of the study while housed in the chemical hazard room. Unused feed and water treated with EPA regulated hazards may need to be collected by the LAR and be submitted for chemical waste pick-up through EHS. NOTE: Autoclaving contaminated waste in not recommended unless there is an associated biohazard. F. Additional Safety Measures PPE shall be removed prior to exiting the animal room as biohazard waste. Hands shall be washed after glove removal. G. Examples of High Risk Hazards In general, the following hazards can be categorized as High Risk. NOTE: it must be understood each project is taken on a case-by-case basis and particular factors may play role in re-categorization to a lower risk. a. Carbon tetrachloride b. Experimental drugs in which the PI cannot offer data to support it as being a lower risk. Biological/Chemical Combined Risk Hazards There may be projects that require the use of med-high risk chemical hazards and biological hazards that may be potentially harmful to research animals. These scenarios will require animals to be housed in a specific Bio/Chem Containment area. The practices that will be implemented will be the same as for High Risk Hazards. Before any animals are ordered the PI must contact LAR management in order to make arrangements for animal housing space. An example of a study that would be considered a Bio/Chem hazard would involve carbon tetrachloride and MPV (Mouse Parvo Virus). AT-RISK INDIVIDUALS There are some individuals that may be at higher risk of illness, injury or death due to either pre-existing health conditions or future health dispositions. Examples may include: pregnant women, women at child bearing age, women who plan to be pregnant and any immunocompromised individual. Personnel who fall into one of these categories may be at a higher risk of occupational exposures that may cause serious harm to health, fetuses, reproductive systems or in extreme circumstances, exposure may potentially be lethal. Hazards that have the potential to pose these risks will require special personnel considerations.
Considerations may include: the donning of additional PPE, restriction from working in such areas, job duty reassignment or additional safety measures. Any individual that feels they fall into an At-Risk status should immediately notify both their supervisor and the KU Occupational Health Clinic to ensure measures are taken to mitigate any occupation exposure. POTENTIAL EXPOSURES KUMC is dedicated to fostering a safe environment. As with any animal bite or scratch, individuals bitten or scratched by animals exposed to hazardous chemicals are expected to notify their supervisor immediately. The employees who have been potentially exposed to chemical hazardous agents will seek medical attention by visiting the Occupational Health Clinic in G110 Delp between 7am to 4:30pm Monday through Friday. If the potential exposure occurs after hours then the individual will go to the KU Hospital Emergency Room (followed by a visit to the Occupational Health Clinic on the next business day). Additionally, the Environment, Health & Safety Office must be notified of the incident. Comment [RCL3]: According to their website, their hours are 7 am to 4:30 pm. Approved/Renewed by IACUC: 2-17-15 2013-10-15