49 CFR 173.196
Infectious substances (etiologic agents).
(a) Authorized packagings and components are as follows:
(1) Inner packagings comprising:
(i) A watertight primary receptacle;
(ii) A watertight secondary packaging; and
(iii) When the primary receptacle contains liquids, an absorbent material must be placed between the primary receptacle and the secondary packaging. If multiple-primary receptacles are placed in a single secondary packaging they must be wrapped individually to ensure that contact between them is prevented. The absorbent material, such as cotton wool, must be sufficient to absorb the entire contents of all primary receptacles.
(2) An outer packaging must be of adequate strength for its capacity, mass and intended use.
(b) Each package for infectious substances must be capable of passing the tests specified in § 178.609 of this subchapter.
(c) Packages consigned as freight must be at least 100 mm (3.9 inches) in the smallest overall external dimensions.
(d) For all packages containing infectious substances, an itemized list of contents must be enclosed between the secondary packaging and the outer packaging.
(e) Although exceptional cases, such as whole organs, may require special packaging, the great majority of infectious substances can and must be packaged according to the following guidelines.
(1) Lypholized substances. Primary receptacles include flame-sealed glass ampoules or rubber-stopped glass vials fitted with metal seals.
(2) Liquid or solid substances—(i) Substances shipped at ambient temperatures or higher. Primary receptacles include those of glass, metal or plastic. Positive means of ensuring a leakproof seal, such as heat seal, skirted stopper or metal crimp seal must be provided. If screw caps are used, they must be reinforced with adhesive tape.
(ii) Substances shipped refrigerated or frozen (ice, pre-frozen packs, dry ice). Ice or dry ice must be placed outside the secondary packagings. Interior supports must be provided to secure the secondary packagings in the original position after the ice or dry ice has dissipated. If ice is used, the packaging must be leakproof. If dry ice is used, the outer packaging must permit the release of carbon dioxide gas.
(iii) Substances shipped in liquid nitrogen. Plastic primary receptacles capable of withstanding very low temperatures must be used. Secondary packaging must also withstand very low temperatures and in most cases will need to be fitted over individual primary receptacles. Requirements for shipment of liquid nitrogen must also be observed.
(f) Whatever the intended temperature of shipment, the primary receptacle or secondary packaging used for infectious substances must be capable of withstanding, without leakage, an internal pressure which produces a pressure differential of not less than 95 kPa (14 psig) and temperatures in the range of −40 °C to +55 °C (−40 °F to +131 °F).
(g) The requirements of this section supplement the requirements of the Department of Health and Human Services contained in 42 CFR part 72.
(h) Exceptions. The following substances are not subject to any requirements of this subchapter if the items as packaged do not contain any material otherwise subject to the requirements of this subchapter.
(1) Diagnostic specimens.
(2) Biological products.
[Amdt. 173-224, 55 FR 52634, Dec. 21, 1990, as amended by Amdt. 173-241, 59 FR 67511, Dec. 29, 1994; 64 FR 10778, Mar. 5, 1999; 66 FR 45379, Aug. 28, 2001]
Effective Date Note: At 67 FR 53140, Aug. 14, 2002, § 173.196 was revised, effective Oct. 1, 2002. At 67 FR 54967, Aug. 27, 2002, the effective date was corrected to Feb. 14, 2003. For the convenience of the user, the revised text is set forth as follows: § 173.196 Infectious substances. (a) Division 6.2 packaging. A Division 6.2 packaging must meet the test standards of § 178.609 of this subchapter and must be marked in conformance with § 178.503(f) of this subchapter. Division 6.2 packaging is a triple packaging consisting of the following components: (1) A watertight primary receptacle. (2) A watertight secondary packaging. If multiple fragile primary receptacles are placed in a single secondary packaging, they must be wrapped individually to prevent contact between them. (3) An outer packaging of adequate strength for its capacity, mass and intended use. The outer packaging must measure at least 100 mm (3.9 inches) at its smallest overall external dimension. (4) For a liquid infectious substance, an absorbent material placed between the primary receptacle and the secondary packaging. The absorbent material must be sufficient to absorb the entire contents of all primary receptacles. (5) An itemized list of contents enclosed between the secondary packaging and the outer packaging. (6) The primary receptacle or secondary packaging used for infectious substances must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi). (7) The primary receptacle or secondary packaging used for infectious substances must be capable of withstanding without leakage temperatures in the range of −40 °C to +55 °C (−40 °F to +131 °F). (b) Additional requirements for packaging infectious substances. Infectious substances must be packaged according to the following requirements depending on the physical state and other characteristics of the material: (1) Infectious lyophilized (freeze-dried) substances. Primary receptacles must be flame-sealed glass ampules or rubber-stopped glass vials fitted with metal seals. (2) Liquid or solid infectious substances— (i) Infectious substances shipped at ambient temperatures or higher. Authorized primary receptacles are those of glass, metal, or plastic. Positive means of ensuring a leakproof seal must be provided, such as heat seal, skirted stopper, or metal crimp seal. If screw caps are used, they must be secured by positive means, such as with adhesive tape. (ii) Infectious substances shipped refrigerated or frozen (ice, pre-frozen packs, dry ice). Ice or dry ice must be placed outside the secondary packagings or in an overpack with one or more complete packages marked in accordance with § 178.503 of this subchapter. Interior supports must be provided to secure the secondary packagings in the original position after the ice or dry ice has dissipated. If ice is used, the outside packaging must be leakproof. If dry ice is used, the outside packaging must permit the release of carbon dioxide gas and otherwise meet the provisions in § 173.217. The primary receptacle and the secondary packaging must maintain their integrity at the temperature of the refrigerant used as well as the temperatures and pressures of air transport to which they could be subjected if refrigeration were lost. (iii) Infectious substances shipped in liquid nitrogen. Primary receptacles capable of withstanding very low temperatures must be used. Secondary packaging must withstand very low temperatures and in most cases will need to be fitted over individual primary receptacles. The primary receptacle and the secondary packaging must maintain their integrity at the temperature of the liquid nitrogen as well as the temperatures and pressures of air transport to which they could be subjected if refrigeration were to be lost. Refrigerated liquid nitrogen packagings must be metal vacuum insulated vessels or flasks (also called “dry shippers”) vented to the atmosphere to prevent any increase in pressure within the packaging. The use of safety relief valves, check valves, frangible discs, or similar devices in the vent lines is prohibited. Fill and discharge openings must be protected against the entry of foreign materials that might cause an increase in the internal pressure. The package orientation markings specified in § 172.312(a) of this subchapter must be marked on the packaging. The packaging must be designed to prevent the release of any refrigerated liquid nitrogen irrespective of the packaging orientation. (c) Live animals may not be used to transport infectious substances unless such substances cannot be sent by any other means. An animal containing or contaminated with an infectious substance must be transported under terms and conditions approved by the Associate Administrator for Hazardous Materials Safety. (d) Body parts, organs or whole bodies meeting the definition of Division 6.2 material must be packaged as follows: (1) In Division 6.2 packaging, as specified in paragraphs (a) and (b) of this section; or (2) In packaging meeting the requirements of § 173.197.