What does 49 CFR 173.197 (Regulated medical waste) require?
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As Ask X3, your fleet-compliance assistant, here is what 49 CFR 173.197 requires for transporting regulated medical waste, clinical waste, or (bio) medical waste:
* General Rule: Non-bulk packagings, Large Packagings, and non-specification bulk outer packagings must be rigid containers that meet specific standards (49 CFR 173.197).
* Non-Bulk Packagings: Must be UN standard packagings at the Packing Group II performance level. Sharps containers must be puncture-resistant and securely closed to prevent leaks or punctures following the manufacturer's instructions.
* Large Packagings: Must meet specific construction, testing, and marking requirements, including passing a vibration test and periodic design requalification. Authorized types are metal (50A, 50B, 50N) or rigid plastic (50H). Liquid waste must use rigid inner packagings and include enough absorbent material to absorb the entire liquid volume in a release. Sharps containers in Large Packagings must be puncture-resistant, capable of retaining liquids, and tested/certified as intermediate bulk containers for liquids.
* Non-Specification Bulk Outer Packagings (Wheeled Carts and BOPs):
* Inner packagings must be properly contained, and carts/BOPs must have smooth, non-porous interior surfaces without cracks or defects.
* Except as allowed, carts and BOPs must be used exclusively for medical waste and disinfected before reuse.
* Certain materials (like untreated Category A stock cultures, and most Class 7 or Division 6.1 toxic wastes) are prohibited. Other items (like chemotherapeutic waste, Category B stock cultures, unabsorbed liquids, and sharps) are only allowed if packed in rigid non-bulk packagings (or properly separated and secured in a BOP).
* Wheeled Carts: Must be a solid, one-piece body (max volume 437 gallons) made of metal, rigid plastic, or fiberglass with a leak-preventing lid, capable of passing a drop test at Packing Group II, with inner packagings restrained to prevent breakage.
* Bulk Outer Packagings (BOPs): Must be metal or fiberglass, hold between 123.6 and 1,590 cubic feet, have fully welded or seamless bottom and side joints with a weatherproof top, and be leakproof to hold at least 79.2 gallons with closures open. Different packaging types inside a BOP must be separated by rigid barriers to prevent damage from shifting loads.
* Inner Packagings (for Large Packagings, Carts, and BOPs): Must be marked or tagged with the offeror's name and location (city and state), unless the entire shipment originates from and goes to a single location. Plastic film bags for solids (max 46 gallons) must pass specific ASTM tear and impact resistance tests and can hold waste containing absorbed liquid if enough absorbent is present to retain all liquid.
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