Ask X3What does 49 CFR 173.196 (Category A infectious substances) require?
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According to 49 CFR 173.196, packaging for a Category A infectious substance (Division 6.2 material) must meet specific test standards (§ 178.609) and be marked according to § 178.503(f).
You must use a triple packaging system consisting of:
1. A leakproof primary receptacle: Must be made of glass, metal, or plastic (for ambient or higher shipments) and include a positive means to ensure a leakproof seal (such as a heat seal, skirted stopper, metal crimp seal, or a secured screw cap). It must withstand an internal pressure differential of at least 95 kPa (14 psi) and temperatures from −40 °C to +55 °C (−40 °F to +131 °F) without leaking.
2. A leakproof secondary packaging: If you put multiple fragile primary receptacles in a single secondary packaging, you must wrap them individually or separate them to prevent contact. It must also withstand the 95 kPa pressure differential and temperature range without leaking.
3. A rigid outer packaging: Must be of adequate strength for its capacity, mass, and intended use (using approved drums, boxes, or jerricans) and measure at least 100 mm (3.9 inches) at its smallest external dimension.
4. Absorbent material: For liquid infectious substances, place enough absorbent material between the primary receptacle and secondary packaging to absorb the entire contents of all primary receptacles.
5. An itemized list of contents: Enclosed between the secondary packaging and the outer packaging.
Additional requirements based on shipping temperature and physical state:
* Refrigerated or frozen (ice, pre-frozen packs, dry ice): Place the refrigerant around the secondary packagings or in an overpack, and use interior supports to secure the secondary packagings after the refrigerant dissipates. If using ice, the outer packaging or overpack must be leakproof. If using dry ice, it must allow carbon dioxide gas to release and meet § 173.217. Materials must maintain integrity at the refrigerant's temperature.
* Liquid nitrogen: Use metal vacuum insulated vessels or flasks vented to the atmosphere (no safety relief valves, check valves, or frangible discs in vent lines). Fill and discharge openings must be protected against foreign materials, package orientation markings (§ 172.312(a)) must be applied, and the packaging must prevent the release of refrigerated liquid nitrogen regardless of orientation.
Other restrictions:
* Live animals: Cannot be used to transport infectious substances unless no other means exists, and requires approval from the Associate Administrator for Hazardous Materials Safety.
* Body parts, organs, or whole bodies: Must be packaged either in the standard Category A triple packaging or in packaging meeting § 173.197.