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Oklahoma State University
University Research Compliance

A unit in the Division of the Vice President for Research

Biosafety - Biosafety Definitions

Biosafety Definitions

Biohazardous Agents

  1. Infectious/pathogenic agents classified in Risk Groups 2, 3, and 4: bacterial, fungal, parasitic, viral, rickettsial, or chlamydial agents as defined by the National Institutes of Health (NIH) or,
  2. Other microorganisms that have the potential for causing disease in healthy individuals, animals, and/or plants, or
  3. Biological toxins including metabolites of living organisms and materials rendered toxic by the metabolic activities of microorganisms (living or dead), or
  4. Any biological agent or toxin listed on the Select Biological Agent list by the Centers for Disease Control and/or the USDA Animal Plant Health Inspection Service (APHIS).

Recombinant or Synthetic Nucleic Acid Molecules

  1. Molecules that are a) constructed by joining nucleic acid molecules and b) that can replicate in a living cell (i.e., recombinant nucleic acids);
  2. Nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules (i.e., synthetic nucleic acids), or
  3. Molecules that results from the replication of those described in (i) or (ii) above.

Gene Therapy

Delivery of exogenous genetic material (DNA or RNA) to somatic cells for the purpose of modifying those cells.

Alternate Responsible Official (ARO)

The University official named by the Responsible Official to act on behalf of the University regarding regulations governing the possession, receipt or transfer of regulated biological agents and toxins within the parameters outlined in the following Codes of Federal Regulations: Title 42 CFR, Part 73, Title 9 CFR, Part 121, and Title 7 CFR, Part 331. OSU's Alternate Responsible Officials are the Assistant Vice President for Research Compliance and the Biological Safety Officer.

Biological Safety Officer (BSO)

The university official charged with providing biosafety oversight in laboratories where biological research, teaching and testing is conducted.

Biologically Derived Toxin

Biologically-derived Toxins include all naturally occurring molecules produced by animals, plants, microorganisms or other biological agents that have a median lethal dose (LD50) value of less than 50 mg/kg (as determined for rats). This includes the synthetic or recombinant production of naturally occurring biologically-derived toxins. Examples are bacterial exotoxin, some plant lectins such as ricin, and certain mycotoxins (aflatoxins, sterigmatocystin, luteoxkyrin, rugulosin, patulin, etc.) (George Mason University, 2007).

Biosafety in Microbiological and Biomedical Laboratories (BMBL)

The Public Health Service (PHS) publication which describes the combinations of standard and special microbiological practices, safety equipment, and facilities constituting Biosafety Levels 1-4, which are recommended for work with a variety of infectious agents in various laboratory settings.

Biosecurity

Protection of high-consequence microbial agents and toxins, or critical relevant information, against theft or diversion by those who intend to pursue intentional misuse.

Environmental Health and Safety (EHS)

The Oklahoma State University unit of environmental health and safety.

Infectious Agents

Organisms in Risk Group 2 or above that include a broad spectrum of organisms able to cause human, animal, or plant disease.

Institutional Biosafety Committee (IBC)

The federally mandated committee required at institutions that receive funding from the NIH for research involving recombinant DNA molecules.

NIH Guidelines

The National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Office of University Research Compliance (URC)

The administrative office responsible for ensuring compliance with external regulations and OSU policies governing research and teaching activities using biohazardous materials. This office is part of the Division of Research and Technology Transfer, and acts as the administrative arm for the Institutional Biosafety Committee.

Research

Any investigative activity engaged in by OSU personnel using University facilities or resources, regardless of funding source.

Research Protocol

The application prepared by the principal investigator as the first step to receive approval to conduct research or teaching activities with biohazardous materials.

Responsible Official

The Oklahoma State University official designated to act on behalf of the University's select biological agent program. The OSU President has given this authority to the Vice President for Research. This Vice President is the signatory authority for the University on funded research and contracts.

Security

Policies, procedures, or devices intended to prevent unauthorized entry to laboratory areas and prevent unauthorized removal of dangerous biologic agents from the laboratory.

Select Agent

Specifically regulated pathogens and toxins as defined in Title 42, CFR, Part 73, Title 9 CFR 121, and Title 7 CFR 331. These agents have the potential to pose harm to human health, animal health, and/or plant health (or to animal or plant products).

Select Agent Program

The Centers for Disease Control (CDC) and the United States Department of Agriculture Animal and Plant Health Inspection Service (USDA/APHIS) programs for monitoring acquisition, transport, security, safety, inventory, and personnel conducting research or teaching with select agents and their toxins based on the potential of these agents and toxins to harm humans and/or other animals, or plants or animal and plant products. The regulations for the select agent program are codified in Title 42 CFR Part 73, Title 9 CFR, Part 121, and Title 7 CFR Part 331. The President of Oklahoma State University authorized the Vice President for Research as the Responsible Official for ensuring Oklahoma State University's compliance with this program.

Storage

Retention of biological materials by University employees or on University property, including materials kept in open laboratory space, incubators, refrigerators, or freezers.

Teaching

Teaching activities include classroom demonstrations, laboratory exercises and research projects that are required for completion of a course at the undergraduate, graduate, or professional level.

USA PATRIOT Act

A law signed by President George W. Bush on October 26, 2001, that places restrictions on persons who possess select agents and toxins and provides criminal penalties for possession of such agents that cannot be justified for peaceful purposes.