Search Fred Hutch Extranet

2.1 Biological Substances

Biological substances include any materials that contain or are reasonably expected to contain a microorganism (such as bacteria, viruses, rickettsiae, parasites, or fungi) or other agents (such as prions) that can cause disease in humans or animals, but transported in a form such that exposure will generally not cause permanent disability or life-threatening or fatal disease in healthy humans or animals. Such materials are referred to as "Biological Substances, Category B".

Most research specimens shipped from the Fred Hutchinson Cancer Research Center fit within this definition of Biological Substances, Category B, including blood samples, blood components, tissue samples, body fluids, and cultures of some RG-2 agents. Such substances must be shipped according to current EH&S Fred Hutch guidelines.

Note that some substances may be classified as "Category A Infectious Substances", subject to more stringent training and packing requirements, while other substances pose lower risks and are therefore exempt from hazardous materials shipping regulations. Before shipping a material according to the guidelines for Category B substances, refer to Sections 2.2 and 2.3 for more information on these other types of biological substances.

2.2 DOT-Exempt Biological Substances

Some biological materials pose lower risks of causing harm during transport and are therefore exempt from the hazardous materials transportation regulations. Exempt materials include:

  1. A material that does not contain a microorganism capable of causing disease in healthy humans or animals, or a material that is unlikely to cause disease in humans or animals;
  2. Non-infectious biological materials from humans, animals, or plants. Examples include non-infectious cells, tissue cultures, blood or plasma from individuals not suspected of having an infectious disease, DNA, RNA, or other non-infectious genetic elements;
  3. A material containing microorganisms that are non-pathogenic to humans or animals;
  4. A material containing pathogens that have been neutralized or inactivated such that they no longer pose a health risk;
  5. A material with a low probability of containing a microorganism capable of causing disease in healthy humans or animals, or where the concentration of microorganisms is at a level naturally occurring in the environment so it cannot cause disease when exposure occurs. Examples include environmental samples, such as water or a sample of dust or mold;
  6. A biological product (a virus, therapeutic serum, toxin, antitoxin, vaccine, blood component, etc. applicable to the prevention, treatment, or cure of a disease or condition of humans or animals) that is subject to Federal approval, permit, review, or licensing, such as those required by FDA or USDA;
  7. Blood collected for the purpose of transfusion or preparation of blood products;
  8. Blood products, plasma, plasma derivatives, blood components, tissues or organs for transplant, and human cells, tissues, and cellular and tissue-based products regulated under authority of the Public Health Service Act and/or the Food, Drug, and Cosmetic Act.
  9. Dried blood spots or specimens for fecal occult blood detection placed on absorbent filter paper or other material;
  10. Patient samples (other than those containing Category A Infectious Substances described in 2.3) being transported for research, diagnosis, investigational activities, or disease treatment or prevention, when transported in a motor vehicle used exclusively to transport such materials;
  11. A human or animal sample being transported for routine testing not related to the diagnosis of an infectious disease. Examples include samples sent for drug/alcohol testing, cholesterol testing, blood glucose level testing, prostate specific antibody testing, testing to monitor kidney or liver function, or pregnancy testing, or for tests for diagnosis of non-infectious diseases, such as cancer biopsies, and for which there is a low probability the sample is infectious.

The following packing requirements apply to exempt specimens described in 10 and 11 above:

  1. The package must be marked, "Exempt human specimen" or "Exempt animal specimen" as appropriate;
  2. The packaging must consist of a leak-proof primary receptacle (vial), a leak-proof secondary receptacle (such as a ziplock bag), and an outer packaging of adequate strength for its capacity, mass, and intended use, and with at least one surface having minimum dimensions of 4 inches by 4 inches;
  3. For liquids, absorbent material in sufficient quantity to absorb entire contents must be placed between the primary receptacle(s) and the secondary packaging;
  4. When multiple fragile primary receptacles are placed in a single package, they must be individually wrapped or separated to prevent contact between them;
  5. The secondary container must be labeled with the biohazard symbol; and
  6. Your name and phone number as well as the recipient's name and phone number must be written on the outside of the package.

2.3 Category A Infectious Substances

Category A Infectious Substances include any materials that contain or are reasonably expected to contain a microorganism (such as bacteria, viruses, rickettsiae, parasites, or fungi) or other agents (such as prions) in a form capable of causing permanent disability or life-threatening or fatal disease in healthy humans or animals when exposure occurs. Classification of a material as Category A must be based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal.

Category A Infectious Substances are seldom shipped at Fred Hutch. For reference, some examples of Category A substances include Ebola virus, Hantaan virus, Lassa virus, Monkeypox virus, and cultures of the following: HIV, HBV, highly pathogenic avian influenza virus, Polio virus, and West Nile virus. Note these are only a selected few examples of Category A substances. EH&S should be consulted for assistance in classifying Infectious Substances.

Shipping Category A Infectious Substances off-site requires special packing supplies and training. Contact EH&S for assistance.

2.4 Importing Biological Material

An investigator planning to import biological material into the United States is responsible for obtaining the necessary permits from either the United States Department of Agriculture (USDA) or the Centers for Disease Control and Prevention (CDC). An approved EMUA (Memorandum of Understanding and Agreement) is required for the importation of etiologic agents and vectors. See Chapter V, Section 2, Memorandum of Understanding and Agreement: Etiologic Agents and/or Recombinant DNA Experiments (EMUA). A copy of the approved permit must be supplied to EH&S for attachment to the investigator's corresponding EMUA.

2.4.1 CDC Permit

Packages containing etiologic agents or vectors, unsterilized specimens of human and animal tissues containing an infectious agent and originating in foreign locations, must have an importation permit issued by the United States Public Health Service (USPHS). Importation permits are issued only to the importer, who must be located in the United States. Fred Hutch does not have a blanket permit; therefore permits must be individually attained for each import situation. The importation permit, with the proper packaging and labeling, will expedite the clearance of a package of infectious materials through the USPHS Division of Quarantine and release by U.S. Customs. Contact EH&S for assistance with importation permits.

Completed application forms may be returned by mail to the CDC Etiologic Agent Import Permit Program, or faxed to 404. 498.2275. If you are unsure whether you need a permit, complete the application and they will determine whether a permit is required. Only investigators of faculty standing with an approved EMUA or consent of the Biosafety Officer have authority to sign CDC Importation forms.

The importer is legally responsible for assuring that the foreign personnel package, label, and ship the infectious materials according to hazardous materials shipping regulations. Shipping labels containing the universal biohazard symbol, the address of the importer, the permit number, and the expiration date are also issued to the importer with the permit. The importer must send the labels and one or more copies of the permit to the shipper. The permit and labels inform the U.S. Customs Service and U.S. Division of Quarantine personnel of the package contents.

2.4.2 APHIS Permit

USDA Animal and Plant Health Inspection Service (APHIS) permits are required for infectious agents of livestock and biological materials containing animal material. Cell lines and animal-derived media are also considered restricted materials.

2.4.3 USDI Permit

United States Department of Interior (USDI)/U.S. Fish and Wildlife Service Bureau permits are required for import of certain live animals and materials of animal origin.

2.5 Exporting Biological Material

The export of biological material may require a CITES permit and/or a license from the Department of Commerce. A CITES permit is issued by the USDI's U.S. Fish and Wildlife Service Bureau and is designed to protect endangered and threatened species throughout the world. Contact EH&S for assistance with exportation permits.

2.6 Chemicals

The U.S. Department of Transportation regulates transport of most chemicals as hazardous material. Transport requirements vary depending on type and quantity of material and the manner of transportation. The table below lists various categories of hazardous materials and examples of corresponding chemicals. If preparing a chemical for transportation, please call EH&S for assistance. EH&S can determine what training is necessary and if any exceptions apply.

2.6.1 Examples of Hazardous Characteristics

Hazardous Characteristic

Examples

Flammable Ethanol, Methanol, Xylene, Acetone, Paraformaldehyde
Corrosive Hydrochloric Acid, Sulfuric Acid, Sodium Hydroxide, Potassium Hydroxide
Toxic Phenol, Chloroform
Oxidizing Oxygen, Silver Nitrate, Silver Nitrite
Organic Peroxide Methyl Ethyl Keytone Peroxide, Benzoyl Peroxide
Miscellaneous Dry Ice, Formalin

2.7 Dry Ice (Carbon Dioxide, Solid)

The DOT regulates the transportation of dry ice; therefore you must be trained and certified to transport or ship the material. Training for shipping dry ice is available on the EH&S website; this training must be completed prior to shipping with dry ice. Please refer to the online training page of the EH&S website for the training course and exam or call EH&S for assistance.

2.8 Radioactive Materials

Radioactive material that is taken out of Fred Hutch buildings and transported on public roads to another location must be shipped according to U.S. Department of Transportation (DOT) regulations. Failure to meet the DOT regulations can result in fines of up to $50,000 per violation. Contact EH&S prior to any shipment of radioactive materials off campus to ensure compliance with DOT and other regulations and license requirements.

When radioactive materials are shipped to another facility, Fred Hutch must first obtain a copy of that facility's radioactive materials license. In addition, the material must be packaged appropriately, with the correct markings and labeling on the outside of the package.

Refer to Section 3.7 for requirements applicable to on-site transport of radioactive materials.

2.9 Liquid Nitrogen

Liquid nitrogen is regulated as a hazardous material for transport, except when a dry shipper is used. A dry shipper is a specially designed Dewar flask that absorbs the liquid nitrogen in a porous material so that it cannot spill. When using a dry shipper, be sure to follow the manufacturer's instructions and completely remove any remaining liquid nitrogen after the unit has been charged.

A dry shipper used to transport biological substances or infectious substances via aircraft should be certified by the manufacturer to meet all other air transport requirements applicable to those materials.

When liquid nitrogen is transported in a Dewar flask, or a tank other than a dry shipper, it is regulated as a hazardous material and training and certification are required. Contact EH&S for more information or refer to the EH&S website.