- 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,
- Other microorganisms that have the potential for causing disease in healthy individuals,
animals, and/or plants, or
- Biological toxins including metabolites of living organisms and materials rendered
toxic by the metabolic activities of microorganisms (living or dead), or
- 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
- Molecules that are a) constructed by joining nucleic acid molecules and b) that can
replicate in a living cell (i.e., recombinant nucleic acids);
- 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
- Molecules that results from the replication of those described in (i) or (ii) above.
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
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.
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.
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.
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.
Any investigative activity engaged in by OSU personnel using University facilities
or resources, regardless of funding source.
The application prepared by the principal investigator as the first step to receive
approval to conduct research or teaching activities with biohazardous materials.
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.
Policies, procedures, or devices intended to prevent unauthorized entry to laboratory
areas and prevent unauthorized removal of dangerous biologic agents from the laboratory.
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.
Retention of biological materials by University employees or on University property,
including materials kept in open laboratory space, incubators, refrigerators, or freezers.
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.