Containment Levels for Chemical Administration in Animals

Boston University
Boston Medical Center

Containment levels for chemical administration in animals

Prepared by:
Environmental Health and Safety

7/3/17

704 Commonwealth Avenue
Boston, Massachusetts 02215
(617) 353-4094

85 E. Newton Street, M-470
Boston, Massachusetts 02118
(617) 638-8830

1. Purpose and Scope

1.1. The purpose of this program is to provide a designation of containment levels that outlines the requisite administrative controls, engineering controls and personal protective equipment necessary to protect researchers, BUASC staff, and the environment from potential exposures involving animals that have been treated with and exposed to potentially hazardous chemicals that are housed or handled in BUASC spaces.

2. References

2.1. Regulations

2.1.1. 29 CFR 1910 Subpart G Occupational Health and Environmental Control
2.1.2. 29 CFR 1910 Subpart H Hazardous Materials
2.1.3. 29 CFR 1910 Subpart I Personal Protective Equipment
2.1.4. 29 CFR 1910 Subpart Z Toxic and Hazardous Substances
2.1.5. 29 CFR 1910.1450 – OSHA Laboratory Safety Standard
2.1.6. 29 CFR 1910.1200 – OSHA Hazard Communication Standard
2.1.7. 40 CFR 261 Identification and Listing of Hazardous Waste
2.1.8. Boston Fire Prevention Code

2.2. BU Policies

2.2.1. Boston University Chemical Hygiene Plan
2.2.2. Boston University Guidelines – Transporting Laboratory Materials Outside of the Laboratory
2.2.3. Boston University Chemical Inventory Program
2.2.4. Boston University Quarterly Research Safety Inspections Program
2.2.5. Boston University Door Placard Program
2.2.6. Boston University High Hazard Chemical Program

2.3. Supplementary Documents

2.3.1. Guide for the Care and Use of Laboratory Animals, 8th edition
2.3.2. Biosafety in Microbiological and Biomedical Laboratories, 5th edition 2.3.2 IARC Group 1, 2A and 2B Lists – International Agency for Research on Cancer lists for known, probable and possible carcinogens
2.3.3 National Toxicology Program list of carcinogens
2.3.4 National Library of Medicine TOXNET online database

3. Definitions

3.1. BUASC – Boston University Animal Science Center, the animal facilities located on the Medical Campus and Charles River Campus, respectively.

3.2. BUASC space – A housing room, procedure room, or other support spaces directly managed by BUASC administration.

3.3. Chemical Containment Level (CCL) – A containment level designated by Environmental Health and Safety (EHSEnvironmental Health & Safety) that outlines the requisite administrative controls, engineering controls and personal protective equipment to protect personnel from animals that have been treated with potentially hazardous chemicals that are being housed or handled in BUASC spaces.

3.4. IACUCInstitutional Animal Care and Use Committee IACUC oversee... – Institutional Animal Care and Use Committee

3.5. Potentially Hazardous Chemical – for the purpose of this document a potentially hazardous chemical is a substance when administered to an animal, can be hazardous to humans or the environment based on how it is metabolized and excreted in the species to which it was administered.

3.6. Satellite Housing Labs – a separate space outside BUASC used to house animals based on IACUC approval.

4. Roles & Responsibilities

4.1. IACUC

4.1.1. Notify EHS Research Safety when protocols for treating animals with potentially hazardous chemicals have been submitted

4.2. BUASC Staff

4.2.1. Ensure that appropriate facilities, equipment and PPE are available for the assigned chemical containment level in BUASC spaces

4.2.2. Ensure that researchers are following the appropriate procedures defined in the chemical containment level in BUASC spaces. Notify the principal investigator and Environmental Health and Safety if non-compliance is noted.

4.2.3. Ensure that BUASC staff are appropriately trained and are following appropriate cage change procedures, that appropriate cages and bedding are used and appropriate waste containers are available as required by chemical containment level

4.2.4. Supply cage cards and signage available to the researchers to identify rooms and animals involved in procedures using chemicals as dictated by the chemical containment level.

4.2.5. Ensure the appropriate signage was posted on the door to the room by the researcher when animals are being or have been treated with a chemical, as required by the chemical containment level.

4.3. BUASC Trainer

4.3.1. To provide BUASC specific training to all researchers and PI’s working in BUASC

4.4. EHS Research Safety

4.4.1. Assist in the determination of the CCL based on the individual risk of each project’s chemicals, doses, animal metabolism and other factors and communicate the requirements for that level to the PIPrincipal Investigator View Boston University's policy on... and BUASC in a timely manner

4.4.2. Update requirements outlined in the chemical containment levels as needed

4.4.3. Provide assistance to BUASC and PIs in training staff and researchers as requested

4.4.4. Coordinate review of IACUC protocols within EHS as needed

4.5. EHS Environmental Management

4.5.1. Make waste determination of bedding, carcasses, cage wash effluent, etc.

4.6. Principal Investigators

4.6.1. Assign a preliminary CCL upon submission of an IACUC protocol.

4.6.2. Provide information to allow EHS Research Safety Staff to perform an appropriate risk assessment for the chemical exposure in animals

4.6.3. Ensure that research staff are appropriately trained

4.6.4. Ensure that research staff follows the procedures prescribed by the chemical containment level for the project as specified by EHS.

4.6.5. Notify Research Occupational Health of any suspected exposure to a potentially hazardous chemical

4.7. Research staff

4.7.1. Follow the procedures prescribed by the chemical containment level for the project as specified by EHS. Notify Environmental Health and Safety and BUASC staff if the procedures require modification.

4.7.2. Notify Research Occupational Health of any suspected exposure to a potentially hazardous chemical

4.7.3. Obtain and post the appropriate signage on the door to the room when animals are being or have been treated with a chemical, as required by the chemical containment level.

4.7.4. Use the appropriate cage card to identify animals that are involved in a project using chemicals, as required by the chemical containment level.

4.8. Laboratory Safety Committee

4.8.1. Ensure that all work at Boston University and Boston Medical Center is completed per the requirements outlined in the Chemical Hygiene Plan.

4.8.2. Provide enforcement actions against laboratories that are not in compliance with this procedure.

4.9. Research Occupational Health Program (ROHP)

4.9.1. Review research-related exposure to potentially hazardous chemicals.

5. Special Requirements

5.1. Training

5.1.1. All researchers performing research with animals must attend BUASC’s New Researcher Orientation and Environmental Health and Safety’s Laboratory Safety Training.

5.1.2. Researchers must also be trained on the requirements set forth by the assigned CCL.

• For all CCL’s, the principal investigator must assure that the researchers are informed of the hazards associated with the chemical being used.
• For CCL 2, BUASC will communicate the requirements beyond the standard BUASC requirements for non-chemical work to the researcher.
• For CCL 3 and 4, the Principal Investigator, with assistance from EHS and in collaboration with BUASC, will ensure that the researchers are trained in the protocol-specific requirements.

6. Applicable Locations

6.1. Chemical Containment Levels (CCL) are designated for animal manipulations, housing, and associated support functions in BUASC spaces and satellite housing labs.

6.2. These CCL are applicable for BUASC laboratory manipulations of these chemicals. Instead, the requirements in the Chemical Hygiene Plan, High Hazard Chemical Program, and other relevant programs apply to laboratories outside of BUASC.

7. Procedures and Instructions

7.1. General Information

The CCL’s have been designated CCL1-4 ascending from the least hazardous to the most hazardous. The following outlines the definition and general practices for each level. A detailed description for each level can be found in the chart found in Appendix A and examples of hazardous substances for each level can be found in Appendix B

7.1.1. CCL 1
Suitable for work involving the use of chemicals which can cause minimal potential harm to BUASC and laboratory personnel and the environment.

• No additional measure beyond approved Animal Biosafety level of work

7.1.2 CCL 2
Suitable for work involving the use of chemicals which can pose a moderate risk to BUASC and laboratory personnel and the environment from an animal exposed to a hazardous substance.

• Additional Measures
  • Double gloves are required for handling animals
  • Secondary containment must be used for transportation of animals
  • Use of microisolator or ventilated cages and low dust bedding.
  • MSDS sheets must be available in the Chemical binder of the housing rooms
  • Light Blue cage card and door sign

7.1.3 CCL 3
Suitable for working involving the use of chemical which can pose a serious risk to BUASC and laboratory personnel and the environment after an animal has been exposed to a hazardous substance.

• Additional Measures
  • Double gloves and use of Biosafety Cabinet or Fume Hood are required for handling animals
  • Double gloves and N95 required for work outside of Biosafety Cabinet or Fume Hood
  • Secondary containment must be used for transportation of animals
  • Use of microisolator or ventilated cages and low dust bedding
  • MSDS sheets and a Chemical Information Sheet (if necessary) must be available in the Chemical binder of the housing rooms
  • Fluorescent Green cage card and door sign.

7.1.4 CCL 4
Suitable for work involving the use of chemical which can pose a life-threatening risk to the BUASC and laboratory personnel and environment before, during and/or after the animal is exposed to hazardous substance.

• Additional Measures
  • Requirements for CCL 4 will be reviewed on a case by case basis by EHS
  • SOP required
  • Hot Pink cage card and door sign

7.2. Additional Procedure for CCL Use in Aquatic Environments

This procedure is mandatory for introducing chemically treated animals into non-treated animal populations.

7.2.1. Animals treated with hazardous agents must be maintained in clean/non-treated water for 72 hours to allow the animal to metabolize or excrete the hazardous agent.

7.2.2. Following the 72 hour post administration time period the animal must undergo three washes by serial transfer to clean water.

7.2.3. After the third wash the animal can then be introduced to the non-treated population

• Additional Measures:
  • Tank water containing hazardous agents will be disposed of as hazardous waste
  • Housing must have secondary containment

7.3. Procedure for the Assignment of CCL

7.3.1. A principal investigator applying for IACUC approval of a project involving chemicals in animals will identify an initial CCL.

7.3.2. IACUC will assign protocols to EHS for review through INSPIR system

7.3.3. As part of the review of the specific protocol, EHS will perform a risk-based review of the project and consult with PI and BUASC regarding any additional protocol specifics.

• When the review is complete EHS will communicate with the PI, IACUC, BUASC and others as needed with regard to the assignment of the CCL for the protocol.
• Due to the nature of metabolism, EHS may also allow animals to be housed at a lower CCL after the chemical has been fully metabolized and no future administrations will occur. Examples of these scenarios are listed in Appendix B.

7.3.4. If necessary, EHS will provide the Principal Investigator with a Chemical Information Sheet per Boston University’s High Hazard Chemical Program if High Hazard Chemicals have been identified in the protocol review.

• Additionally, if High Hazard Chemicals are involved in the protocol, the PI in consultation with EHS will create protocol-specific standard operating procedure (SOP) using the SOP template found in the University’s High Hazard Chemical Program.

7.3.5. EHS and/or PI will provide CCL specific training to the research staff for that may include the following: PPE, waste handling, signage, emergency response procedures, and deactivation methods.

7.3.6. EHS and/or PI will consult with Research Occupational Health for any medical services (post-exposure antidotes, medical evaluations, etc.).

7.3.7. BUASC will provide the appropriate room, cages, bedding and other husbandry supplies for the researcher to begin work.

8. Forms

8.1. Appendix A: Chemical Containment Levels for chemical administration in animals

8.2. Appendix B: Chemical Containment Level examples

8.3. Boston University High Hazard Chemical SOP Template (provided by EHS if designated as necessary).

9. Records Management

9.1. EHS will keep records of the protocols reviewed and their assigned chemical containment levels.

9.2. BUASC will keep a record of protocols with chemicals and their assigned chemical containment levels.

10. SOP Revision History

Appendix A: Chemical Containment Levels

*Note LASC req. = Current BUASC requirements

Appendix B: Chemical Containment Levels Examples

*Bleomycin was listed on the AAALAC hazardous chemicals list. The level would depend on the route of administration (i.e. intratracheal vs IP).