II. IACUP OPERATIONS
A. Occupational Safety & Health Procedures
3. Hazardous Materials Guidance
RISK ASSESSMENT
The primary factors to consider in risk assessment and selection of precautions fall into two broad categories: agent hazards and laboratory procedure hazards. In addition, the capability of the laboratory staff to control hazards must be considered. This capability will depend on the training, technical proficiency, and good habits of all members of the laboratory, and the operational integrity of containment equipment and facility safeguards.
Reference
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, Section II
BIOSAFETY LEVELS
The laboratory Biosafety Level for use of an agent is classified according to the degree of protection provided to personnel, the environment, and the community.
Biosafety Level 1 (BSL1 or BL1) - is suitable for work involving well-characterized agents not known to consistently cause disease in immunocompetent adult humans, and present minimal potential hazard to laboratory personnel and the environment.
BSL-1 laboratories are not necessarily separated from the general traffic patterns in the building. Work is typically conducted on open bench tops using standard microbiological practices. Special containment equipment or facility design is not required, but may be used as determined by appropriate risk assessment. Laboratory personnel must have specific training in the procedures conducted in the laboratory and must be supervised by a scientist with training in microbiology or a related science.
Biosafety Level 2 (BLS1 or BL1) - is suitable for work involving agents that pose moderate hazards to personnel and the environment.
BSL2 differs from BSL-1 in that:
1. laboratory personnel have specific training in handling pathogenic agents and are supervised by scientists competent in handling infectious agents and associated procedures;
2. access to the laboratory is restricted when work is being conducted; and
3. all procedures in which infectious aerosols or splashes may be created are conducted in BSCs or other physical containment equipment.
References
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, Section IV
Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, Section V
CHEMICAL AGENTS
Issues of concern are toxicity, personal protection requirements, and disposal of chemicals and animals. MSDS sheets must be available.
References
College of Charleston Chemical Hygiene Plan
National Toxicology Program, Data & Resources
CONTROLLED SUBSTANCES
Registration is required in order to purchase controlled substances. Contact Research Protections and Compliance for more information.
Reference
US DEA List of Controlled Substances and Exemptions
INFECTIOUS AGENTS (see also Recombinant/Synthetic Nucleic Acids or Select Agents)
The Risk Group of an agent is classified according to potential effects on humans and the environment. Only those agents that meet the criteria for Risk Groups 1 and 2 are described below as College of Charleston facilities are not available to provide containment for higher risk groups.
- Risk Group 1 - Agents that are not associated with disease in healthy adult humans.
- Risk Group 2 - Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available; agents of moderate potential hazard to personnel and the environment.
References
American Biological Safety Association - Risk Group Database
National Parks Service, Office of Public Health - Infectious Agents list and Information
SELECT AGENTS
The Federal Select Agent Program oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products.
References
HHS and USDA Select Agents and Toxins Registry List
HHS and USDA Select Agent and Toxins Exclusions
RECOMBINANT OR SYNTHETIC NUCLEIC ACIDS (R/SNA)
IACUC Protocols using r/sNA must register the research with Research Protections and Compliance, Office of Research and Grants Administration.
Reference
NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
Exemption
Protocols falling under exemption categories in the NIH Guidelines require only that the research be registered.
Section III-F of the NIH Guidelines outlines the categories of Exempt Experiments and Appendices A and C provide detailed information on exemptions.
References
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Section III-F
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Appendix A. Exemptions Under Section III-F-6--Sublists of Natural Exchangers
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Appendix C. Exemptions Under Section III-F-8
Transgenic Rodents
The following uses of Transgenic Rodents fall under an exemption, thereby requiring only registration:
- The purchase or transfer of transgenic rodents for experiments that require BL1 containment.
- The breeding of two different transgenic rodents or the breeding of a transgenic rodent and a non-transgenic rodent with the intent of creating a new strain of transgenic rodent that can be housed at BL1 containment will be exempt from the NIH Guidelines if: (1) both parental rodents can be housed under BL1 containment; and (2) neither parental transgenic rodent contains the following genetic modifications: (i) incorporation of more than one-half of the genome of an exogenous eukaryotic virus from a single family of viruses; or (ii) incorporation of a transgene that is under the control of a gammaretroviral long terminal repeat (LTR); and (3) the transgenic rodent that results from this breeding is not expected to contain more than one-half of an exogenous viral genome from a single family of viruses.
Guidelines Specific to Research with Animals
Excerpts from the NIH Guidelines:
M-I-B-1. When an animal covered by Appendix Q containing recombinant or synthetic nucleic acid molecules or a recombinant or synthetic nucleic acid molecule-derived organism is euthanized or dies, the carcass shall be disposed of to avoid its use as food for human beings or animals unless food use is specifically authorized by an appropriate Federal agency.
M-I-B-2. A permanent record shall be maintained of the experimental use and disposal of each animal or group of animals.
M-II-A-1-b-(1). All genetically engineered neonates shall be permanently marked within 72 hours after birth, if their size permits. If their size does not permit marking, their containers should be marked. In addition, transgenic animals should contain distinct and biochemically assayable DNA sequences that allow identification of transgenic animals from among non-transgenic animals.
Section III-D-4-c-(2). The purchase or transfer of transgenic rodents is exempt from the NIH Guidelines under Section III-F, Exempt Experiments (see Appendix C-VII, The Purchase or Transfer of Transgenic Rodents)
References
ZOONOSIS
Zoonoses are diseases that can be transmitted from animals (wild or domesticated) to humans. The OSHA Occupational Safety and Health Administration (OSHA) and American Biological Safety Association (ABSA) Alliance has prepared a useful chart listing zoonotic diseases, the pathogen involved, hosts, transmission, symptoms treatment and other information. For information about zoonoses specific to an animal protocol, contact the IACUC Consulting Veterinarian.
References
ABSA Zoonotic Diseases Fact Sheet
Prevention of Zoonotic Diseases - College of Charleston Animal Program Standard Operating Procedure
Approved: September 8, 2016
Revised: September 27, 2019