TITLE 49 - TRANSPORTATION

SUBTITLE B - OTHER REGULATIONS RELATING TO TRANSPORTATION

CHAPTER I - PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION

SUBCHAPTER C - HAZARDOUS MATERIALS REGULATIONS

PART 173 - SHIPPERS - GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS

subpart e - NON - BULK PACKAGING FOR HAZARDOUS MATERIALS OTHER THAN CLASS 1 AND CLASS 7

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.

[67 FR 53140, Aug. 14, 2002]