Department of Transportation Regulations

Overview

Department of Transportation (DOT) regulations assign the responsibility to the shipper (e.g., hospital) for properly packaging hazardous materials that are being transported offsite (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 ).

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 and infectious substances. For information on packaging and shipping other hazardous materials, consult the applicable sections of HERC and the DOT regulations found under Title 49.

The information presented in this section is specific to federal DOT regulations. Individual states may have somewhat different or additional rules. Check with your state agencies.

Definitions

Packaging and transportation regulations vary, depending on the type of material. The following are important definitions with regard to regulated medical waste and infectious substances.

The term regulated medical waste, is defined differently by many state and federal agencies. Under DOT rules, regulated medical waste (RMW) is a waste or reusable material suspected or known to contain an infectious substance, and is generated in the diagnosis, treatment, immunization, or biomedical research of humans or animals.

An infectious substance is referred to in DOT regulations as a Division 6.2 material and is defined as a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion) that can cause disease in humans or animals.

An infectious substance must be assigned the identification number UN 2814, UN 2900, or UN 3373, as appropriate:

• Category A: An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. A Category A infectious substance must be assigned (based on the known medical history or symptoms of the source patient or animal, endemic local conditions, or professional judgment concerning the individual circumstances of the source human or animal ) one of two identification numbers:

• UN 2814 -- infectious substance affecting humans, or humans and animals, or

• UN 2900 -- infectious substance which cause disease only in animals.

• Category B: An infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes. A Category B infectious substance must be described as Biological substance, Category B and assigned identification number UN 3373.

Regulated Medical Waste Packaging

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(c), 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.

(a) General provisions. Non-bulk packagings, Large Packagings, and non-specification bulk outer packagings used for the transportation of regulated medical waste or clinical waste or (bio) medical waste must be rigid containers meeting the provisions of subpart B of this part.

(b) Non-bulk packagings. Except as provided in 173.134(c) of this subpart, non-bulk packagings for regulated medical waste or clinical waste or (bio) medical waste must be UN standard packagings conforming to the requirements of Part 178 of this subchapter at the Packing Group II performance level. A non-bulk packaging used as a sharps container 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. Sharps containers must be securely closed to prevent leaks or punctures in conformance with the instructions provided by the packaging manufacturer in accordance with 178.2(c) of this subchapter.

(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 (c) 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(e) 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) 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.

(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) 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 nonbulk 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 concentrated stock cultures of infectious substances containing Category A 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 concentrated stock cultures of infectious substances containing Category B infectious substances; 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.

(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 178.810 (drop test) 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.

(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 concentrated stock cultures of infectious substances containing Category B infectious substances, unabsorbed liquids, and sharps may be transported in a BOP only if separated and secured as required in paragraph (d)(3)(v) of this section.

(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.

(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.

(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.

(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 or clinical waste or (bio) medical waste transported in a Large Packaging, Cart, or BOP must be packaged in a rigid inner packaging conforming to the provisions of subpart B of this part. conforming to the provisions of subpart B of this part. 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 must be securely closed to prevent leaks or punctures in conformance with instructions provided by the packaging manufacturer. Each sharps container exceeding 76 L (20 gallons) in volume must be capable of passing the performance tests in Part 178, subpart M, of this subchapter at the Packing Group II performance level. A sharps container may be reused only if it conforms to the following criteria:

(i) The sharps container is specifically approved and certified by the U.S. Food and Drug Administration as a medical device for reuse.

(ii) The sharps container must be permanently marked for reuse.

(iii) The sharps container must be disinfected prior to reuse by any means effective for the infectious substance the container previously contained.

(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. [67 FR 53140, Aug. 14, 2002, as amended at 68 FR 57632, Oct. 6, 2003; 68 FR 75744, Dec. 31, 2003; 71 FR 32261, June 2, 2006; 71 FR 78632, Dec. 29, 2006]

Category B Infectious Substances Packaging.

(a) Category B infectious substances. Except as provided in this paragraph (a), Category B infectious substances are excepted from all other requirements of this subchapter when offered for transportation or transported in accordance with this section. Category B infectious substances offered for transportation or transported under the provisions of this section are subject to the incident reporting requirements in 171.15 and 171.16 of this subchapter and to the requirements in 175.75(b) of this subchapter concerning cargo location. Except as provided in paragraph (a)(9) of this section, a Category B infectious substance meeting the definition of a hazard class other than Division 6.2 must be offered for transportation or transported in accordance with applicable requirements of this subchapter.

(1) A Category B infectious substance must be packaged in a triple packaging consisting of a primary receptacle, a secondary packaging, and a rigid outer packaging.

(2) Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents into the secondary packaging.

(3) Secondary packagings must be secured in rigid outer packagings with suitable cushioning material such that any leakage of the contents will not impair the protective properties of the cushioning material or the outer packaging.

(4) The completed package must be designed, constructed, maintained, filled, its contents limited, and closed so that under conditions normally encountered in transportation, including removal from a pallet or overpack for subsequent handling, there will be no release of hazardous material into the environment. Package effectiveness must not be substantially reduced for minimum and maximum temperatures, changes in humidity and pressure, and shocks, loadings and vibrations normally encountered during transportation. The packaging must be capable of successfully passing the drop tests in 178.609(d) and (h) of this subchapter at a drop height of at least 1.2 meters (3.9 feet). Following the drop tests, there must be no leakage from the primary receptacle, which must remain protected by absorbent material, when required, in the secondary packaging. At least one surface of the outer packaging must have a minimum dimension of 100 mm by 100 mm (3.9 inches).

(5) The following mark must be displayed on the outer packaging on a background of contrasting color. The width of the line must be at least 2 mm (0.08 inches) and the letters and numbers must be at least 6 mm (0.24 inches) high. The size of the mark must be such that no side of the diamond is less than 50 mm (1.97 inches) in length. The proper shipping name Biological substances, Category B must be marked on the outer packaging adjacent to the diamond-shaped mark in letters that are at least 6 mm (0.24 inches) high.

Category A Infectious Substances Packaging

(a) Category A infectious substances packaging. A packaging for a Division 6.2 material that is a Category A infectious substance must meet the test standards of 178.609 of this subchapter and must be marked in conformance with 178.503(f) of this subchapter. A packaging for a Category A infectious substance 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 either wrapped individually or separated to prevent contact between them.

(3) A rigid outer packaging of adequate strength for its capacity, mass and intended use. The outer packaging must measure not less than 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 ^oC to +55 ^oC (-40 ^oF to +131 ^oF).

(b) Additional requirements for packaging Category A infectious substances. Category A infectious substances must be packaged according to the following requirements, depending on the physical state and other characteristics of the material.

(1) Infectious substances shipped at ambient temperatures or higher. Primary receptacles must be made 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, paraffin sealing tape, or manufactured locking closure. Lyophilized substances may also be transported in primary receptacles that are flame-sealed with glass ampoules or rubber-stoppered glass vials fitted with metal seals.

(2) Infectious substances shipped refrigerated or frozen (ice, pre-frozen packs, dry ice). Ice, dry ice, or other refrigerant must be placed around 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 outer packaging or overpack must be leakproof. If dry ice is used, the outer packaging or overpack 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 transport by aircraft to which they could be subjected if refrigeration were lost.

(3) Infectious substances shipped in liquid nitrogen. 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 transport by aircraft to which they could be subjected if refrigeration were lost. Refrigerated liquid nitrogen packagings must be metal vacuum insulated vessels or flasks 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.

Training

49 CFR 172.704

A hazmat employer must train all hazmat employees in general awareness training, function-specific regulatory training, and safety training. For example, healthcare professionals need training to properly use any packaging authorized for the transportation of infectious substances.

Security

49 CFR 172.800, 49 CFR 172.802 and 49 CFR 172.804

DOT requires anyone that transports select agents and toxins regulated by 9 CFR 121 to develop and implement security plans under 49 CFR 172. DOT has developed a security template that can be used to identify points in the transportation process where security procedures should be enhanced.

Reporting and Recordkeeping

49 CFR 171.51, 49 CFR 172.201, and 49 CFR 177.817

For all hazardous materials other than hazardous waste, the shipping paper copy must be retained by the shipper for 2 years after the material is accepted by the initial carrier. Except for hazardous waste, carriers must retain a copy of the shipping paper for at least 1 year after accepting the hazardous material.

More Resources

Transporting Infectious Substances Safely (PHH50-0079-0706). U.S. Department of Transportation. An explanation of the new requirements for transporting infectious substances.

Overview DOT Changes Oct. 1, 2006. Stericycle. Overview of DOT rule changes affecting medical waste.