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Policy on Approval for the Use of Hazardous Materials in Animal Activities

Institutional Animal Care & Use Committee

| Approval Date:

October 2, 2023 12:00 am

This policy enacts those provisions of the following federal and state requirements pertaining to the use of hazardous materials in research, teaching, and testing activities that involve vertebrate animals.

Applicability

This policy is applicable to all vertebrate animal activities conducted under the auspices of the University of Michigan (U-M), and applies to all campus locations under the purview of the U-M IACUC.

Glossary Definitions

Hazardous Materials

Hazardous Materials are those materials that constitute a hazard to humans or the environment. The Policy on Approval for the Use of Hazardous Materials in Animal Activities applies to the specific hazardous materials listed below when used in conjunction with vertebrate animals:

  • Biological agents requiring handling conditions above Biosafety Level 1 (BSL-1).
  • Biological agents requiring animals to be housed in conditions above Animal Biosafety Level 1 (ABSL-1).
  • Biological specimens (e.g., saliva, blood, and urine) collected from humans or non-human primates.
  • Biological toxins (e.g., Botulinum toxin including cosmetic BOTOX).
  • Activities involving non-exempt recombinant or synthetic nucleic acid molecules technology (rDNA techniques).
  • HHS and USDA Select Agents and Toxins, as defined in Federal Regulations 7 CFR 331, 9 CFR 121, and 42 CFR 73. The current list is available at https://www.selectagents.gov/SelectAgentsandToxinsList.html.
  • Activities involving any radiation producing equipment or materials including ionizing, non-ionizing, x-rays, and lasers.
  • Chemicals designated by the National Institute of Occupational Safety and Health (NIOSH) as hazardous drugs, carcinogens, reproductive hazards, nanoparticles, or toxic chemicals, as well as materials that may have serious impact on the environment during release or disposal that are used in conjunction with animals.

Policy

Activities involving hazardous materials used in conjunction with vertebrate animals must be done in accordance with the approval of the relevant University oversight committees, where applicable, and in accordance with Environment, Health & Safety (EHS)-defined engineering control practices, using the appropriate Personal Protective Equipment (PPE), and following all applicable safety SOPs and policies.

  1. Biohazards: Before the IACUC approves the use of biohazards in animals, approval by the Institutional Biosafety Committee (IBC) is necessary. Animal users provide the required information needed to conduct the risk assessment (e.g., nature of hazard and route of administration) through a submission to the IBC. The review and approval process of the IBC includes EHS staff who specialize in biosafety and who identify appropriate control measures for the work.
  2. Radioisotopes: Before the IACUC approves the use of radioisotopes in animals, approval by the Radiation Policy Committee (RPC) is necessary. Animal users provide the required information needed to conduct the risk assessment (e.g., nature of hazard, dose, and route of administration) through a submission to the RPC. The review and approval process of the RPC includes EHS staff who specialize in radiation safety and who identify appropriate control measures for the work.
  3. Chemical hazards: Before the IACUC approves the use in animals of chemicals designated by the National Institute of Occupational Safety and Health (NIOSH) as hazardous drugs, carcinogens, reproductive hazards, nanoparticles, toxic chemicals, or materials that may have serious impact(s) on the environment during release or disposal, EHS provides a review and identifies appropriate control measures. These hazards and information needed to conduct the risk assessment (e.g., nature of hazard, dose, and route of administration) are provided to the IACUC and EHS directly in the animal care and use protocol.
  4. X-rays and Lasers: Before the IACUC approves the use of X-rays or class 3B or 4 lasers in animals, EHS approves the individual unit being used by the laboratory. EHS works as the liaison to register all radiation-generating machines with the State of Michigan prior to operating the machines. The EHS Radiation Safety Service (RSS) helps ensure compliance with the State of Michigan ionizing radiation rules. EHS RSS also ensures that the campus use of Class 3B or Class 4 lasers complies with regulations, ANSI Standards, and maintains the Laser Safety Program.

Compliance

The IACUC has been delegated authority by EHS to enforce the provisions of this policy and, if necessary, suspend research or implement sanctions if policy infractions should occur. The delegation includes but is not limited to:

  1. Monitoring activities covered by this policy;
  2. Enforcing the implementation of the defined requirements; and
  3. Implementing sanctions and/or suspensions.

SPECIES: Cats / Chickens/Avian / Cows / Dogs / Ferrets / Fish, Amphibians, and Reptiles / Guinea Pigs / Hamsters / Mice / Other Rodents / Primates / Rabbits / Rats / Sheep / Swine

TOPICS: Health and Safety

Questions?

For questions, additional detail, or to request changes to this policy, please contact the Office of the Assistant Vice President for Research – Director of the Animal Care & Use Office at [email protected] or (734) 763-8028.