Biological Toxins- Biological toxins encompass a vast range of peptides, small molecules, and macromolecular proteins that cause disease by interfering with biological processes. Biological toxins reside between traditional definitions of biological and chemical agents. They are produced by living organisms, are unable to replicate, and do not result in communicable diseases. (Biosafety in Microbiological and Biomedical Laboratories- 6^th edition)

Dual Use Research of Concern- Life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be misapplied to do harm with no, or only minor, modification to pose a significant threat with potentials consequences to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. (USG Policy for Oversight of DURC and PEPP)

Genetically Modified Organisms- an organism whose genome has been engineered, by using recombinant DNA technology and reproductive cloning, in the laboratory in order to favor the expression of desired physiological traits or the generation of desired biological products.

Gene Drive Modified Organisms- Organisms where gene drives have been utilized to enhance a genetic element’s ability to pass from parent organism to offspring, circumventing traditional rules of inheritance and greatly increasing the odds that an altered gene spreads throughout a population.

Hazardous Drug- NIOSH defines a hazardous drug as a drug that is:

1. Approved for use in humans by the FDA-CDER, and
2. Not otherwise regulated by the U.S. Nuclear Regulatory Commission; and
3. Either:
   1. ​Is accompanied by prescribing information in the "package insert" that specifies special handling information to protect workers handling the drug; or
   2. Is identified as a carcinogenic hazard, developmental hazard, reproductive hazard, genotoxic hazard, or other health hazard by exhibiting one or more of the following toxicity criteria in humans, animal models, or in vitro systems:
      • ​Carcinogenicity;
      • Developmental toxicity (including teratogenicity);
      • Reproductive toxicity;
      • Genotoxicity;
      • Organ toxicity at low doses; or
      • Structure and toxicity profile that mimics existing drugs determined hazardous by exhibiting any one of the previous five toxicity types;

unless the drug also exhibits a molecular property that may limit the potential for adverse health effects in healthcare workers from exposure to the drug.  

Highly Toxic- (1) The term “highly toxic” means any substance which falls within any of the following categories: (a) Produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, at a single dose of fifty milligrams or less per kilogram of body weight, when orally administered; or (b) produces death within fourteen days in half or more than half of a group of ten or more laboratory white rats each weighing between two hundred and three hundred grams, when inhaled continuously for a period of one hour or less at an atmospheric concentration of two hundred parts per million by volume or less of gas or vapor or two milligrams per liter by volume or less of mist or dust, provided such concentration is likely to be encountered by man when the substance is used in any reasonably foreseeable manner; or (c) produces death within fourteen days in half or more than half of a group of ten or more rabbits tested in a dosage of two hundred milligrams or less per kilogram of body weight, when administered by continuous contact with the bare skin for twenty-four hours or less. (https://www.law.cornell.edu/definitions/uscode.php?width=840&height=800&iframe=true&def_id=15-USC-933950842-2127699563&term_occur=999&term_src=title:15:chapter:30:section:1261#:~:text=(1)%20The%20term%20%E2%80%9Chighly,of%20fifty%20milligrams%20or%20less)

LD₅₀- dose that is lethal to 50% of the test animals.

Nanomaterials- particles or engineered materials that have at least one dimension between 1-1000 nanometers. Nanomaterials can be spheres, rods, tubes, and other geometric shapes. The small particles may be bound to surfaces or substrates, put into solution or suspension, attached to a polymer, or handled as a dry powder.

Select Agents/Toxins- Biological agents and toxins that have been determined to have the potential to pose a severe threat to both human and animal health, to plant health, or to animal and plant products. Refer to https://www.selectagents.gov/sat/list.htm for the current list of Select Agents and Toxins.