Look for updated information at PracticeGreenhealth.org

Department of Transportation Regulations

Please note that this page refers to federal DOT requirements. State and local regulations may differ.

Overview

Department of Transportation (DOT) regulations assign the responsibility to the shipper (e.g., hospital) for properly packaging hazardous materials that are being transported off site (see shipper’s responsibility in 49 CFR 173.22. It is also the responsibility of the shipper that each employee involved with packaging is properly trained (see 49 CFR 173.1).

Healthcare facilities may ship various types of hazardous materials, including chemicals, compressed gases, etc. The information in this section is limited to packaging of regulated medical waste. For information on packaging and shipping other hazardous materials, consult the DOT regulations found under Tile 49.

Definitions

The term regulated medical waste, is defined differently by many state and federal agencies. Under DOT rules, regulated medical waste means “a waste or reusable material known to contain or suspected of containing an infectious substance in Risk Group 2 or 3 and generated in the diagnosis, treatment, or immunization of human beings or animals; research on the diagnosis, treatment or immunization of human beings or animals; or the production or testing of biological products.” (see 49 CFR 173.134(a))

Risk group means a ranking of a micro-organism’s ability to cause injury through disease. A risk group is defined by criteria developed by the World Health Organization (WHO) based on the severity of the disease caused by the organism, the mode and relative ease of transmission, the degree of risk to both an individual and a community, and the reversibility of the disease through the availability of known and effective preventative agents and treatment. The criteria for each risk group according to the level of risk are shown in the following table.

Risk Group Pathogen Risk to Individuals Rick to the Community
4 A pathogen that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly, and for which effective treatments and preventive measures are not usually available. High High
3 A pathogen that usually causes serious human or animal disease but does not ordinarily spread from one infected individual to another, and for which effective treatments and preventive measures are available High Low
2 A pathogen that can cause human or animal disease but is unlikely to be a serious hazard, and, while capable of causing serious infection on exposure, for which there are effective treatments and preventive measures available and the risk of spread of infection is limited. Moderate Low
1 A micro-organism that is unlikely to cause human or animal disease. A material containing only such micro-organisms is not subject to the requirements of this subchapter None or very low None or very low

An infectious substance is also referred to in DOT regulations as a Division 6.2 material. This designation is based on the classification scheme found in 49 CFR 173.2.

Materials meeting the definition of a regulated medical waste must be offered for transportation and transported in conformance with the regulations for RMW (49 CFR 173.197). However, a material that previously contained an infectious substance that has been treated by steam sterilization, chemical disinfection, or other appropriate method, so it no longer meets the definition of an infectious substance is exempt from the DOT rules. However, state or local regulations may apply to the packaging and shipping of this material. Use the H2E RMW state resource locator for more information.

Regulations

Although RMW is by definition an infectious substance, it does not fall under the packaging requirements for infectious substances (49 CFR 173.196) because of an exception found in 49 CFR 173.134 (see 173.134©, exceptions for regulated medical waste). Therefore, the applicable DOT regulations for packaging regulated medical waste are limited to 49 CFR 173.197, which have been reformatted below for easier reading.

Title 49: Transportation

Part 173 – Shippers – General Requirements For Shipments And Packagings

Subpart E – Non-bulk Packaging for Hazardous Materials Other Than Class 1 and Class 7

173.197 Regulated medical waste [67 FR 53140, Aug. 14, 2002, as amended at 68 FR 57632, Oct. 6, 2003; 68 FR 75744, Dec. 31, 2003].

  • (a) General provisions. Non-bulk packagings, large packagings, and bulk outer packagings used for the transportation of regulated medical waste must be rigid containers meeting the provisions of subpart B of this part.
  • (b) Non-bulk packagings. Except as otherwise provided in 173.134 of this subpart, non-bulk packagings for regulated medical waste must be DOT specification packagings conforming to the requirements of Part 178 of this subchapter at the Packing Group II performance level. A non-bulk packaging must be puncture-resistant for sharps and sharps with residual fluid as demonstrated by conducting the performance tests in Part 178, Subpart M, of this subchapter on packagings containing materials representative of the sharps and fluids (such as sterile sharps) intended to be transported in the packagings.

  • (c) Large Packagings. Large Packagings constructed, tested, and marked in accordance with the requirements of the UN Recommendations (IBR, see 171.7 of this subchapter) and conforming to other requirements of this paragraph© may be used for the transportation of regulated medical waste, provided the waste is contained in inner packagings conforming to the requirements of paragraph (e) of this section. Each Large Packaging design must be capable of meeting the vibration test specified in 178.819 of this subchapter. Each Large Packaging is subject to the periodic design requalification requirements for IBCs in 178.801 of this subchapter, and to the proof of compliance requirements of 178.801(j) and record retention requirements of ¤178.801(l) of this subchapter. Inner packagings used for liquids must be rigid.
    1. (1) Authorized packagings. Only the following Large Packagings are authorized for the transportation of liquid or solid regulated medical waste:
      • (i) Metal: 50A, 50B, or 50N.
      • (ii) Rigid plastic: 50H.
  1. (2) Additional requirements. Each Large Packaging used to transport liquid regulated medical waste must contain absorbent material in sufficient quantity and appropriate location to absorb the entire amount of liquid present in the event of an unintentional release of contents. Each Large Packaging design intended for the transportation of sharps containers must be puncture resistant and capable of retaining liquids. The design must also be tested and certified as meeting the performance tests specified for intermediate bulk containers intended for the transportation of liquids in subpart O of part 178 of this subchapter.
    • (d) Non-specification bulk packaging. A wheeled cart (Cart) or bulk outer packaging (BOP) is authorized as an outer packaging for the transportation of regulated medical waste in accordance with the provisions of this paragraph (d).
      1. (1) General requirements. The following requirements apply to the transportation of regulated medical waste in Carts or BOPs:
        • (i) Regulated medical waste in each Cart or BOP must be contained in non-bulk inner packagings conforming to paragraph (e) of this section.
        • (ii) Each Cart or BOP must have smooth, non-porous interior surfaces free of cracks, crevices, and other defects that could damage plastic film inner packagings or impede disinfection operations.
        • (iii) Except as otherwise provided in this paragraph (d), each Cart or BOP must be used exclusively for the transportation of regulated medical waste. Prior to reuse, each Cart or BOP must be disinfected by any means effective for neutralizing the infectious substance the packaging previously contained.
        • (iv) Untreated cultures and stocks of infectious substances containing Risk Group 4 materials may not be transported in a Cart or BOP.
        • (v) Division 6.1 toxic waste or Class 7 radioactive waste, with the exception of chemotherapeutic waste, may not be transported in a Cart or BOP.
        • (vi) Division 6.1 or Class 7 chemotherapeutic waste; untreated stocks and cultures of infectious substances containing Risk Group 2 or 3 pathogenic organisms; unabsorbed liquids; and sharps containers may be transported in a Cart or BOP only if packaged in rigid non-bulk packagings conforming to paragraph (a) of this section.
          1. (2)Wheeled cart (Cart). A Cart is authorized as an outer packaging for the transportation of regulated medical waste if it conforms to the following requirements:
            • (i) Each Cart must consist of a solid, one-piece body with a nominal volume not exceeding 1,655 L (437 gallons).
            • (ii) Each Cart must be constructed of metal, rigid plastic, or fiberglass fitted with a lid to prevent leakage during transport.
            • (iii) Each Cart must be capable of meeting the requirements of 178.603 (drop test), as specified for solids at the Packing Group II performance level.
            • (iv) Inner packagings must be placed into a Cart and restrained in such a manner as to minimize the risk of breakage.
              1. (3) Bulk outer packaging (BOP). A BOP is authorized as an outer packaging for regulated medical waste if it conforms to the following requirements:
                • (i) Each BOP must be constructed of metal or fiberglass and have a capacity of at least 3.5 cubic meters (123.6 cubic feet) and not more than 45 cubic meters (1,590 cubic feet).
                • (ii) Each BOP must have bottom and side joints of fully welded or seamless construction and a rigid, weatherproof top to prevent the intrusion of water (e.g., rain or snow).
                • (iii) Each opening in a BOP must be fitted with a closure to prevent the intrusion of water or the release of any liquid during all loading, unloading, and transportation operations.
                • (iv) In the upright position, each BOP must be leakproof and able to contain a liquid quantity of at least 300 liters (79.2 gallons) with closures open.
                • (v) Inner packagings must be placed in a BOP in such a manner as to minimize the risk of breakage. Rigid inner packagings may not be placed in the same BOP with plastic film bag inner packagings unless separated from each other by rigid barriers or dividers to prevent damage to the packagings caused by load shifting during normal conditions of transportation.
                • (vi) Division 6.1 or Class 7 chemotherapeutic waste, untreated cultures and stocks of infectious substances containing Risk Group 2 or 3 pathogenic organisms, unabsorbed liquids, and sharps may be transported in a BOP only if separated and secured as provided by paragraph (d)(3)(v) of this section
  1. (e) Inner packagings authorized for Large Packagings, Carts, and BOPs. After September 30, 2003, inner packagings must be durably marked or tagged with the name and location (city and state) of the offeror, except when the entire contents of the Large Packaging, Cart, or BOP originates at a single location and is delivered to a single location.
    • (1) Solids. A plastic film bag is authorized as an inner packaging for solid regulated medical waste transported in a Cart, Large Packaging, or BOP. Waste material containing absorbed liquid may be packaged as a solid in a plastic film bag if the bag contains sufficient absorbent material to absorb and retain all liquid during transportation.
      1. (i) The film bag may not exceed a volume of 175 L (46 gallons). The film bag must be marked and certified by its manufacturer as having passed the tests prescribed for tear resistance in ASTM D 1922, “Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method” (IBR, ¤171.7 of this subchapter) and for impact resistance in ASTM D 1709, “Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method” (IBR, ¤171.7 of this subchapter). The film bag must meet an impact resistance of 165 grams and a tearing resistance of 480 grams in both the parallel and perpendicular planes with respect to the length of the bag.
      2. (ii) The plastic film bag must be closed with a minimum of entrapped air to prevent leakage in transportation. The bag must be capable of being held in an inverted position with the closed end at the bottom for a period of 5 minutes without leakage.
      3. (iii) When used as an inner packaging for Carts or BOPs, a plastic film bag may not weigh more than 10 kg (22 lbs.) when filled.
  • (2) Liquids. Liquid regulated medical waste transported in a Large Packaging, Cart, or BOP must be packaged in a rigid inner packaging conforming to the requirements of paragraph (a) of this section. Liquid materials are not authorized for transportation in inner packagings having a capacity greater than 19 L (5 gallons).
  • (3) Sharps. Sharps transported in a Large Packaging, Cart, or BOP must be packaged in a puncture-resistant inner packaging (sharps container). Each sharps container exceeding 76 L (20 gallons) in volume must be capable of passing the performance tests in ¤178.601 of this subchapter at the Packing Group II performance level. A sharps container may be reused only if it conforms to the following criteria:
    1. (i) The sharps container is specifically approved and certified by the U.S. Food and Drug Administration as a medical device for reuse.
    2. (ii) The sharps container must be permanently marked for reuse.
    3. (iii) The sharps container must be disinfected prior to reuse by any means effective for the infectious substance the container previously contained.
    4. (iv) The sharps container must have a capacity greater than 7.57 L (2 gallons) and not greater than 151.42 L (40 gallons) in volume.

[training requirements]

More Resources

How to Transport Infectious Substances. U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration.
H2E HERC