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346 Toxic Substances and Infectious Substances (Hazard Class 6)

346.1 Definitions

Hazard Class 6 consists of two divisions:

  1. Division 6.1 includes toxic substances, poisons, and irritating material. Examples of Division 6.1 materials (not all of which are mailable) include bromobenzyl cyanide, methyl bromide, motor fuel anti-knock mixtures, and tear gas.
  2. Division 6.2 includes infectious substances. Examples of Division 6.2 materials include infectious substances, biological products, regulated medical waste, sharps medical waste, used health care products, and forensic materials.
346.11 Division 6.1

The following terms are used in the standards for Division 6.1 materials:

  1. Toxic Substance is a poisonous material, other than a gas, that is known to be so toxic to humans as to cause death, injury, or harm to human health if swallowed, inhaled, or brought into contact with skin.
  2. Oral Toxicity refers to a liquid with a lethal dose (LD50) for acute oral toxicity of not more than 500 mg/kg or a solid with an LD50 for acute oral toxicity of not more than 200 mg/kg that, when administered by mouth, is likely to cause death within 14 days in half of the test animals.
  3. Dermal Toxicity refers to a material with an LD50 for acute dermal toxicity of not more than 1,000 mg/kg that, when administered by continuous contact with bare skin, is likely to cause death within 14 days in half of the test animals.
  4. Inhalation Toxicity applies to a dust or mist with a lethal concentration (LC50) for acute inhalation toxicity of not more than 10 mg/L, or a saturated vapor concentration in air at 68° F (20° C) of more than one-fifth of the LC50 for acute toxicity on inhalation of vapors and with an LC50 for acute inhalation toxicity of vapors of not more than 5,000 ml/m3 that, when administered by continuous inhalation for 1 hour, is likely to cause death within 14 days in half of the test animals.
  5. Irritating Material is any liquid or solid substance (such as tear gas) that gives off intense fumes and causes extreme but reversible localized irritant effects on the eyes, nose, and throat, temporarily impairing a person’s ability to function.
346.12 Division 6.2, Infectious Substances

The following terms are used in the standards for Division 6.2 materials:

  1. Infectious substance means a material known or reasonably expected to contain a pathogen. A pathogen is a microorganism that can cause disease in humans or animals. Examples of pathogens include bacteria, viruses, fungi, and other infectious agents. An infectious substance must be assigned to one of the following two packaging categories:
    1. Category A: An infectious substance transported in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure occurs. Category A infectious substances are nonmailable. A Category A infectious substance is assigned the identification number UN2814 or UN2900, 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.
    2. Category B: An infectious substance that does not meet the criteria for inclusion in Category A. A mailpiece known or suspected to contain a Category B infectious substance must bear the proper shipping name “Biological Substance, Category B” on the address side of the mailpiece and must be assigned to and marked with identification number UN3373 (as shown in Exhibit 346.12a2 7or, for regulated medical waste and sharps medical waste, identification number UN3291.

Exhibit 346.12a2

Mailpiece Symbol and Marking for Mailpieces Containing Biological Substance, Category B Substances

Exhibit 346.12a2, Mailpiece Symbol and Marking for Mailpieces Containing Bilogical Substance, Category B Substances

  1. Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product or arsphenamine or derivative of arsphenamine (or any other trivalent arsenic compound) intended to prevent, treat, or cure a disease or condition of humans or animals. A biological product includes a material subject to regulation under 42 U.S.C. 262 or 21 U.S.C. 151–159. Unless otherwise excepted, mark these mailpieces with identification number UN3373 (as shown in Exhibit 346.12a2) when they contain a biological product known or reasonably expected to contain a pathogen that meets the definition of a Category B infectious substance.
  2. Cultures are infectious substances that result from a process by which pathogens are intentionally propagated. This definition does not include a human or animal patient specimen as defined in 346.12e.
  3. Exempt human or animal specimen means a human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) transported for routine testing not related to the diagnosis of an infectious disease. Typically, exempt human specimens are specimens for which there is a low probability that the sample is infectious, such as specimens for drug or alcohol testing; cholesterol testing; blood glucose level testing; prostate-specific antigens (PSA) testing; testing to monitor heart, kidney, or liver function; pregnancy testing; and testing for diagnosis of noninfectious diseases such as cancer biopsies. Exempt human or animal specimens are not subject to regulation as hazardous materials but must be packaged according to 346.326.
  4. Patient specimen means material that is collected directly from humans or animals and transported for purposes such as diagnosis and research. Patient specimens include excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (such as transwabs, culture media, and blood culture bottles).
  5. Regulated medical waste, for USPS purposes, means a soft waste material (other than a sharp) derived from the medical treatment, diagnosis, immunization, or biomedical research of a human or animal. Soft medical waste includes items such as used rubber gloves, swabs, gauze, tongue depressors, and other similar material. Mark these mailpieces with identification number UN3291.
  6. Sharps medical waste, for USPS purposes, means a medical waste object that is capable of cutting or penetrating skin or packaging material and that is contaminated with a pathogen or may become contaminated with a pathogen derived from the medical treatment, diagnosis, immunization, or biomedical research of a human or animal. Sharps include used medical waste such as needles, syringes, scalpels, broken glass, culture slides, culture dishes, broken capillary tubes, broken rigid plastic, and exposed ends of dental wires. Mark these mailpieces with identification number UN3291.
  7. Toxin means a Division 6.1 material from a plant, animal, or bacterial source. A toxin containing an infectious substance or a toxin contained in an infectious substance must be classed as Division 6.2, described as an infectious substance, and assigned to UN2814, UN2900, or UN3373, as appropriate. A toxin known or suspected to contain a Category A infectious substance is nonmailable. A toxin known or suspected to contain a Category B infectious substance must be marked UN3373 and packaged under 346.321. Toxins from plant, animal, or bacterial sources that do not contain an infectious substance and are not contained in an infectious substance may be considered for classification as Division 6.1 toxic substances under 346.
  8. Used health care product means a medical, diagnostic, or research device or piece of equipment, or a personal care product used by consumers, medical professionals, or pharmaceutical providers, that does not meet the definition of a diagnostic specimen, biological product, regulated medical waste, or sharps waste, is contaminated with potentially infectious body fluids or materials, and is not decontaminated or disinfected to remove or mitigate the infectious hazard prior to transport.

346.2 Mailability

346.21 General
346.211 Division 6.1, Toxic Substances

The following conditions apply:

  1. International Mail. Division 6.1 toxic substances or poisons and irritating materials are prohibited.
  2. Domestic Mail via Air or Surface Transportation. A Division 6.1 toxic substance or poison that can qualify as a consumer commodity material or ORM-D (for surface only) is permitted when packaged under the applicable requirements in Appendix C (Packaging Instruction 6A). Certain other poisonous materials are permitted to be mailed only between authorized parties under specific conditions as specified in 346.231b.
346.212 Division 6.2, Infectious Substances
  1. International Mail. Category A infectious substances are nonmailable. A material that is classified as a Category B infectious substance and that meets the definition in 346.12a2 is permitted in international mail only when sent by First-Class Package International Service or the Priority Mail International Small Flat Rate Priced Boxes using Registered Mail service; when intended for medical or veterinary use, research, or laboratory certification related to the public health; and when materials are properly prepared for mailing. The mailer must receive written approval from the office of Mailing Standards. See chapter 6 and IMM 135 for specific requirements.
  2. Domestic Mail. Infectious substances are permitted only when they are intended for medical or veterinary use, research, or laboratory certification related to public health, and when properly prepared for mailing to withstand shocks, pressure changes, and other conditions incident to ordinary handling in transit. The following substances are mailable subject to the corresponding packaging requirements:
    1. Category B infectious substance via First-Class Mail, Priority Mail, or Priority Mail Express service.
    2. Sharps and other mailable regulated medical waste via First-Class Mail or Priority Mail service using merchandise return service.
    3. Used health care products via First-Class Mail, Priority Mail, or Priority Mail Express service.
    4. Forensic materials via First-Class Mail, Priority Mail, or Priority Mail Express service.
    5. Nonregulated materials via First-Class Mail, Priority Mail, Priority Mail Express, or Package Services.
    6. Exempt human or animal specimens via First-Class Mail, Priority Mail, Priority Mail Express, or Package Services.
346.22 Nonmailable Class 6 Materials

When hazardous materials that are nonmailable under 346.2 and DMM 601.10.17 are found in the mailstream, the procedures in POM 139.117 must be followed if the materials present an immediate threat to persons or property. The procedures in POM 139.118 are followed when there is no immediate threat to persons or property.

346.221 Division 6.1, Toxic Substances

The following Division 6.1 materials are nonmailable:

  1. Toxic Substances. Any toxic material having an LD50 for oral toxicity of 50 mg/kg or less is nonmailable, except when sent between authorized parties under the conditions permitted in 346.231b. Examples of nonmailable toxic materials include, but are not limited to, the following:
    1. Aniline oil (UN1547).
    2. Bromoacetone (UN1569).
    3. 3-Chloro-4-methylphenyl isocyanate (UN2236).
    4. Chloropicrin (UN1580).
    5. Cyanogen bromide (UN1889).
    6. Hexaethyl tetraphosphate, liquid or solid (UN1611).
    7. Hydrocyanic acid aqueous solutions (UN1613).
    8. Methyl bromide (UN1062).
    9. Methyl parathion, liquid (NA3018).
    10. Motor fuel antiknock mixtures (UN1649).
    11. Organic phosphate compound (NA1955).
    12. Parathion (NA2783).
    13. Phenylcarbylamine chloride (UN1672).
    14. Tetraethyl dithiopyrophosphate (UN1704).
    15. Tetraethyl lead, liquid (NA1649).
    16. Tetraethyl pyrophosphate, liquid (NA3018).
    17. Thiophosgene (UN2474).
  2. Irritating Materials. All irritating materials are nonmailable. Examples include the following:
    1. Bromobenzyl cyanide (UN1694).
    2. Chloroacetophenone (UN1697).
    3. Diphenylamine chloroarsine (UN1698).
    4. Diphenylchloroarsine (UN1699).
    5. Tear gas (UN1700, NA1693, and UN1693), except for those containing oleoresin capsicum.
346.222 Division 6.2, Infectious Substances

The following Division 6.2 materials are nonmailable:

  1. Blood collected for the purpose of blood transfusion known or suspected to contain a Category A infectious substance.
  2. A biological product, culture, stock, or other biological specimen known or suspected to contain a Category A infectious substance. Mailpieces that exceed 4 liters (1 gallon) for liquids or 4 kg.
    (8.8 pounds) for solids are nonmailable.
  3. A toxin known or suspected to contain a Category A infectious substance.
  4. Sharps medical waste and regulated medical waste that contain a Category A infectious substance.
  5. Used healthcare products that contain a Category A infectious substance.
346.23 Mailable Class 6 Materials

In addition to the mailable types of Division 6.1 and 6.2 materials cited in 346.21, the following materials are permitted to be mailed only within the conditions noted.

346.231 Division 6.1, Toxic Substances
  1. Consumer Commodity or ORM-D Materials. A Division 6.1 toxic substance that can qualify as a consumer commodity material or ORM-D material (for surface only) is mailable when all applicable conditions are met.
  2. Toxic Substances with LD50 Oral Toxicity of 50 mg/kg or Less. A Division 6.1 toxic substance having an LD50 for oral toxicity of greater than 5 mg/kg but less than or equal to 50 mg/kg is mailable only when sent between the following authorized parties and under the specified conditions:
    1. Toxic substances for scientific use (not outwardly or of their own force dangerous or injurious to life, health, or property) may be sent only between manufacturers, dealers, bona fide research or experimental scientific laboratories, and employees of federal, state, or local governments who have official use for such poisons and are designated by the agency head to receive or send such poisons.
    2. Poisonous drugs and medicines may be sent only from the manufacturer or dealer of the drugs and medicines to licensed physicians, surgeons, dentists, pharmacists, druggists, cosmetologists, barbers, and veterinarians (18 U.S.C. 1716). In limited circumstances, when the mailing is initiated by a drug manufacturer or the manufacturer’s registered agent, customers may return prescription drugs to the manufacturer or its registered agent as indicated in 453.36.
346.232 Other Nonregulated Toxic Materials

Liquids and solids such as pesticides, insecticides, and herbicides that are not regulated as hazardous materials under 49 CFR are mailable subject to Postal Service quantity restrictions that are based on the toxicity of the material.

  1. Liquids. Restrictions are as follows, subject to the general packaging requirements in DMM 601.1–8:
    1. A nonregulated toxic liquid having an LD50 of 50 to 500 mg/kg is permitted up to 16 fluid ounces per mailpiece.
    2. A nonregulated toxic liquid having an LD50 of 500 to 2,500 mg/kg is permitted up to 32 fluid ounces in a glass primary receptacle, or up to 1 gallon in a non-glass primary receptacle. Only one primary receptacle is permitted per mailpiece.
    3. A nonregulated toxic liquid having an LD50 of 2,500 to
      5,000 mg/kg is permitted up to 1 gallon in a glass primary receptacle, or up to 2 gallons in a non-glass primary receptacle. Only one primary receptacle is permitted per mailpiece.
    4. A nonregulated toxic liquid having an LD50 of greater than
      5,000 mg/kg is permitted with no quantity restriction.
    5. External markings specifying the contents and shipping papers are not required for nonregulated toxic liquids.
  2. Solids. Restrictions are as follows:
    1. A nonregulated toxic solid for which an LD50 rate equivalent to liquids can be established is mailable under the same quantity restrictions for Division 6.1 toxic substances specified in Packaging Instruction 6A in Appendix C and DMM 601.10.16.
    2. Packaging requirements for a nonregulated toxic solid are the same as those for Division 6.1 toxic substance (see Packaging Instruction 6A in Appendix C), except that up to 5 pounds may be contained in a single primary receptacle. Only one primary receptacle is permitted per mailpiece.
    3. External markings specifying the contents and shipping papers are not required for nonregulated toxic solids.
346.233 Division 6.2, Infectious Substances

Infectious substances, biological products, cultures and stocks, exempt human or animal specimens, patient specimens, regulated medical waste, sharps medical waste, toxins, and used health care products are permitted to be mailed within specific quantity limits and packaging conditions specified in 346.3 and DMM 601.10.17.

346.234 Nonregulated Materials

The following materials are not subject to regulation as Division 6.2 hazardous materials and are mailable when the packaging requirements specified in Packaging Instructions 6D in Appendix C and DMM 610.10.17.8 are met:

  1. A biological product, including an experimental or investigational product or component of a product, subject to federal approval, permit, review, or licensing requirements, such as those required by the Food and Drug Administration of the U.S. Department of Health and Human Services or the U.S. Department of Agriculture. A biological product known or suspected to contain a Category B infectious substance must be marked UN3373 (as shown in Exhibit 346.12a2) and packaged under 346.321. A biological product known or suspected to contain a Category A infectious substance is nonmailable.
  2. Blood collected for the purpose of blood transfusion or the preparation of blood products; blood products; plasma; plasma derivatives; blood components; tissues or organs intended for use in transplant operations; and human cell, tissue, and cellular and tissue-based products regulated under the Public Health Service Act (42 U.S.C.
    264-272) or the Food, Drug, and Cosmetic Act (21 U.S.C. 332 et seq.).
  3. Blood, blood plasma, and blood components collected for the purpose of blood transfusion or the preparation of blood products and sent for testing as part of the collection process, except when the person collecting the blood has reason to believe it contains a Category B infectious substance, in which case the test sample must be shipped as a Category B infectious substance. Materials known or suspected to contain a Category A infectious substance are nonmailable.
  4. Dried blood spots, collected by applying a drop of blood to absorbent material, or dried specimens for fecal occult blood detection. (These materials are not classified as exempt human or animal specimens.)
  5. Forensic material containing a biological material, such as tissue, body fluid, excreta, or secreta, not expected to contain a Category A or Category B infectious substance and transported on behalf of a federal, state, local, or Indian tribal government agency. A forensic material known or suspected to contain a Category B infectious substance must be shipped as a Category B infectious substance. A forensic material known or suspected to contain a Category A infectious substance is nonmailable.

346.3 Packaging, Marking, Labeling, and Documentation

346.31 Division 6.1, Toxic Substances

Mailable toxic substances must be prepared as follows:

  1. Consumer Commodity or ORM-D Materials. In all cases, the applicable requirements specified in 346.211 and 346.231 must be met. Packaging Instruction 6A in Appendix C must be followed.
  2. Toxic Substances with LD50 Oral Toxicity of 50 mg/kg or Less. The applicable requirements specified in 346.211 and 346.231 must be met. Packaging Instruction 6B in Appendix C must be followed. Each mailpiece must be plainly and durably marked on the address side with the proper shipping name and UN number of the material (unless exempted by DMM 601.12.11.6).
  3. For air transportation, parcels containing mailable Class 6 materials must bear the DOT square-on-point marking. The top and bottom portions of the square-on-point and the border forming the square-on-point must be black, and the center must be white or of a suitable contrasting background. The symbol “Y” must be black, located in the center of the square-on-point, and clearly visible. Mailpieces must also be marked with the proper shipping name “Consumer Commodity” and identification number “ID8000.” Each mailpiece must also bear an approved DOT Class 9 hazardous material warning label (see
    Exhibit 325c). A properly completed shipper’s declaration for dangerous goods prepared in triplicate must be affixed to the outside of the mailpiece.
  4. For surface transportation, parcels must be plainly and durably marked on the address side with “Surface Only” or “Surface Mail Only” and “ORM-D,” immediately following or below the proper shipping name (e.g., Consumer Commodity). Optionally, mailpieces may be marked with an approved DOT limited quantity square-on-point marking (see Exhibit 325b). The top and bottom portions of the square-on-point and the border forming the square-on-point must be black, and the center must be white or of a suitable contrasting background. Surface shipments containing qualifying ORM-D material bearing the square-on-point limited quantity marking are not required to be marked with the shipping name and identification number. Each mailpiece must bear a shipping paper.
  5. When the DOT square-on-point markings are used, markings must be durable, legible, and readily visible, and must be applied on at least one side or one end of the outer packaging. The border forming the square-on-point must be at least 2 mm in width, and the minimum dimension of each side must be 100 mm, unless the package size requires a reduced size marking of no less than 50 mm on each side.
346.32 Division 6.2, Infectious Substances

The proper packaging, marking, labeling, and documentation for mailable Division 6.2 materials are described in the following sections.

346.321 Category B Infectious Substances

Note: See Packaging Instructions 6C in Appendix C and DMM 601.10.17.4.

A material that is classified as a Category B infectious substance and that meets the definition in 346.12a2 must be triple-packaged, meeting the packaging requirements in 49 CFR 173.199, and sent with First-Class Mail, Priority Mail, or Priority Mail Express service. Each primary receptacle containing a liquid must be leakproof and surrounded by absorbent material sufficient to protect the primary receptacle and absorb the total amount of liquid should the primary receptacle leak or break. Each primary receptacle containing a solid must be siftproof. Secondary containers for liquids must be leakproof. Secondary containers for solids must be siftproof. The primary and secondary packaging must be enclosed in a rigid outer shipping container. A single primary receptacle must not contain more than 1 liter (34 ounces) of a liquid specimen or 4 kg (8.8 pounds) of a solid specimen. Two or more primary receptacles whose combined volume does not exceed 4 liters (1 gallon) for liquids or 4 kg (8.8 pounds) for solids may be enclosed in a single secondary container. In addition:

  1. The secondary container must be marked with the international biohazard symbol shown in Exhibit 346.321.
  2. The primary receptacle or secondary packaging 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) in the range of –40°F to 130°F (–40°C to 55°C).
  3. All mailpieces sent under 346.322 must be marked on the address side with the shipping name “Biological Substance, Category B” and “UN3373” (as shown in Exhibit 346.12a2) and as outlined in 49 CFR 173.199(a)(5). Regulated medical waste and sharps medical waste as defined in 346.12f and 346.12g must be marked UN3291. See 346.322.
  4. Orientation arrows are not required on these mailpieces but may be used.
  5. The outer packaging must show the name and telephone number of a person who is knowledgeable about the material shipped and has comprehensive emergency response and incident mitigation information, or of someone who has immediate access to the person with such knowledge and information.

Exhibit 346.321 

International Biohazard Symbol

Exhibit 346.321, International Biohazard Symbol

346.322 Sharps Waste and Other Mailable Regulated Medical Waste

Note: See Packaging Instructions 6D in Appendix C and DMM 601.10.17.6.5.

Regulated medical waste and sharps medical waste as defined in 346.12f and 346.12g and containing materials classified as Category B infectious substances must be marked UN3291 and are permitted for mailing only using merchandise return service (see DMM 507.10.0) with First-Class Mail or Priority Mail service, subject to the following requirements:

  1. Authorization. Each vendor of a complete regulated medical waste or sharps waste mailing container system (including all component parts required to safely mail such waste to a storage or disposal facility) must obtain authorization from the Postal Service prior to mailing. Before applying for authorization, each type of mailing container system must be tested and certified under the standards in 346.322d by an independent testing facility. The vendor in whose name the authorization is being sought must submit a written request to the manager of Product Classification at Postal Service Headquarters (see DMM 608.8.0 for address). The request for authorization must contain the following:
    1. An irrevocable $50,000 surety bond or letter of credit as proof of sufficient financial responsibility to cover disposal costs if the vendor ceases doing business before all its waste container systems are disposed of or to cover cleanup costs if spills occur while the containers are in Postal Service possession. The surety bond or letter of credit must be issued in the name of the vendor seeking the authorization and must name the Postal Service as the beneficiary or obligee. Vendors that market their containers to distributors are responsible for disposal and cleanup costs attributed to those containers. In addition, vendors must provide a list of distributors, including firm names, addresses, and telephone numbers, to the Postal Service on request.
    2. Address of the headquarters or general business office of the vendor seeking the authorization.
    3. Name, address, and phone number of each storage and disposal site.
    4. List of all types of mailing container systems to be covered by the request, a complete sample of each mailing container system, and proof of package testing certifications performed by the independent testing facility that subjected the packaging materials to the testing requirements in 346.322d.
    5. Copy of the proposed waste shipping paper to be used with each mailing container system.
    6. 24-hour toll-free telephone number for emergencies.
    7. List of the types of waste to be mailed for disposal in each mailing container system.
    8. Copy of the merchandise return service label to be used with each mailing container system and verification that the merchandise return service permit fee and accounting fee have been paid.
    9. Address of the Post Office or postage-due unit where the containers are delivered.
  2. Packaging. Regulated medical waste and sharps medical waste that also meet the definition of a Category A infectious substance are nonmailable, except for medical professional packages identified in 346.322b7, which may not weigh more than 35 pounds. A medical waste material treated by steam sterilization, chemical disinfections, or other appropriate method so that it no longer contains a Category A or Category B infectious substance must be packaged under 346.325. The packaging for regulated medical waste and sharps medical waste containing or suspected of containing a Category B infectious substance is subject to the following standards:
    1. Regulated medical waste and sharps medical waste meeting the definitions in 346.12f and 346.12g must be collected in a rigid, securely sealed, and leakproof primary receptacle. For sharps waste, the primary receptacle must also be puncture-resistant and may not have a maximum capacity that exceeds 3 gallons in volume. For regulated medical waste, the primary receptacle may not have a maximum capacity that exceeds 5 gallons in volume. Each primary receptacle may not contain more than 50 ml
      (1.66 ounces) of residual waste liquid. Each primary receptacle must display the international biohazard symbol shown in
      Exhibit 346.321. Package testing results must show that the contents did not penetrate through the primary container during package testing and that the primary container can maintain its integrity at temperatures as low as 0°F and as high as 120°F
      (–18°C to 49°C).
    2. The primary receptacle must be packaged within a watertight secondary container or containment system. The secondary container may consist of more than one component. If one of the components is a plastic bag, the bag must be at least 4 mil in thickness and must be used in conjunction with a fiberboard box. A plastic bag by itself does not meet the requirement for a secondary container. Several primary receptacles may be enclosed in a secondary container. The primary receptacle(s) must fit securely and snugly within the secondary container to prevent breakage during ordinary processing.
    3. The secondary container must be enclosed in a strong outer shipping container constructed of 200-pound grade corrugated fiberboard. The joints and flaps of the outer shipping container must be securely taped, glued, or stitched to maintain the integrity of the container. When tape or glue is used to secure an outer shipping container, the material must be water-resistant. Fiberboard boxes with interlock bottom flaps (i.e., easy-fold) are not permitted as outer shipping containers unless reinforced with water-resistant tape. The secondary container must fit securely and snugly within the outer shipping container to prevent breakage during ordinary processing.
    4. There must be enough material within the primary receptacle to absorb and retain three times the total liquid allowed within the primary receptacle (150 ml per primary receptacle) in case of leakage.
    5. Each mailpiece must not weigh more than 25 pounds. The container’s maximum allowable weight must be printed on the outside of the box and on the assembly and closure instructions included with each mailpiece. The mailpiece must be tested at the maximum allowable weight identified by the vendor.
    6. In each mailing container system, the authorized vendor must include a step-by-step instruction sheet that clearly details the proper sequence and method of container system assembly prior to mailing to prevent package failure during transport due to improper assembly. The instruction sheet must also include a customer service telephone number, or provide specific information on where such a telephone number is located elsewhere on the container system, for third-party end users to contact if they have assembly questions or find a component part is missing.
    7. Medical professional packages are intended for use by small medical offices, but they are not limited to use by medical offices only. One primary receptacle larger than 5 gallons in volume may be used for mailing pre-primary sharps receptacles (sharps receptacles normally used in doctors’ offices) and other regulated medical waste under the following conditions:
      1. The mailpiece must meet all the requirements in 346.32 except for the primary receptacle capacity limits of 346.322b1.
      2. Only rigid, securely closed, puncture- and leak-resistant pre-primary sharps receptacles that meet or exceed Occupational Safety and Health Administration (OSHA) standards as identified in 29 CFR 1910.1030 may be placed inside the primary receptacle. Each pre-primary sharps container may contain no more than 50 ml (1.66 ounces) of residual waste liquid. Several pre-primary sharps receptacles may be enclosed in the single primary receptacle.
      3. Multiple tie-closed plastic bags of regulated medical waste may be placed inside the single primary receptacle.
      4. The primary receptacle must be lined with a plastic bag at least 4 mil in thickness and must include sufficient absorbent material within the liner to absorb all residual liquid in the primary receptacle.
      5. The mailpiece must not weigh more than 35 pounds.
  3. Mailpiece Labeling, Marking, and Documentation. Regulated medical waste and sharps waste must meet the following requirements:
    1. Each primary receptacle and outer shipping container must bear a label, which cannot be detached intact, showing the following:
      1. The company name of the vendor to which the mailing authorization is issued.
      2. The USPS Authorization Number.
      3. The container ID number (or unique model number) signifying that the packaging material is certified and that the vendor obtained the authorization required by 346.322a.

      Place the label on the top or on a side of the container.

    2. The primary receptacle(s) and the outer shipping container must bear the international biohazard symbol in black with either a fluorescent orange or fluorescent red background as shown in Exhibit 346.321. The symbol on the outer shipping container must be at least 3 inches high and 4 inches wide.
    3. Each mailpiece must have a four-part waste shipping paper. The shipping paper must be affixed to the outside of the mailpiece in an envelope or similar carrier that can be easily opened and resealed to allow review of the document. The shipping paper must comply with all applicable requirements imposed by the laws of the state from which the container system is mailed. At a minimum, the information in Exhibit 346.322c3 must be on the shipping paper.
    4. The outer shipping container must bear a properly prepared merchandise return service label (see DMM 507.10.0). The merchandise return service permit must be held in the same name as that of the authorized medical waste vendor.
    5. The outer shipping container must be marked on two opposite side walls with the package orientation marking in 49 CFR 173.312 to identify the proper upright position of the mailpiece during handling.
    6. Mailpieces containing regulated medical waste or sharps waste must be marked on the address side with the correct UN number and proper shipping name (e.g., “Regulated Medical Waste, UN3291” or “Regulated Medical Waste-Sharps, UN3291”).
    7. Vendors must retrieve mailpieces held at processing facilities due to improper labeling, such as no return address, or due to improperly completed shipping papers.
    8. For medical professional packages, the additional marking “Medical Professional Packaging” must be clearly printed in lettering at least 2 inches high on the address side of the outer shipping container.

Exhibit 346.322c3

Shipping Paper for Regulated Medical Waste and Sharps Waste Containers

 

Section

Information Required

  1. Generator (Mailer)
  1. Name.
  2. Complete address (not a Post Office box).
  3. Telephone number.
  4. Description of contents of mailing container. “Regulated Medical Waste” or “Regulated Medical Waste-Sharps” is required as appropriate.
  5. Date container was mailed.
  6. State permit number of approved facility in which contents are to be disposed of.
  1. Destination Facility (Disposal Site)

Complete address (not a Post Office box).

  1. Generator’s (Mailer’s) Certification

The following certification statement must be printed on the shipping paper:

“I certify that this container has been approved for the mailing of [insert either
“regulated medical waste” or “sharps waste,” as appropriate], has been
prepared for mailing in accordance with the directions for that purpose, and
does not contain excess liquid or nonmailable material in violation of the
applicable Postal Service regulations. I AM AWARE THAT FULL
RESPONSIBILITY RESTS WITH THE GENERATOR (MAILER) FOR ANY
VIOLATION OF 18 U.S.C. 1716 WHICH MAY RESULT FROM PLACING
IMPROPERLY PACKAGED ITEMS IN THE MAIL. I also certify that the contents
of this consignment are fully and accurately described above by proper shipping
name and are classified, packed, marked, and labeled, and in proper condition
for carriage by air according to the national governmental regulations.”

This statement must be followed by printed or typewritten name of generator (mailer), signature of generator, and date signed.

  1. Destination Facility (Storage or Disposal Site)

The following certification statement of receipt, treatment, and disposal must be printed on the shipping paper:

“I certify that the contents of this container have been received, treated, and
disposed of in accordance with all local, state, and federal regulations.”

This statement must be followed by printed or typewritten name of an authorized recipient at destination facility, signature of authorized recipient, and date signed.

  1. Transporter Intermediate Handler Other Than the Postal Service (If Different From Destination Facility)
  1. Name.
  2. Complete address (not a Post Office box).
  3. Printed or typewritten name of transporter or intermediate handler.
  4. Signature of transporter or intermediate handler and date signed.
  1. Serialized Waste Shipping Papers

Each waste shipping paper or mail disposal service shipping record must be serialized using a unique numbering system for identification purposes.

  1. Comment Area

Each shipping paper must contain an area designated for entering comments or noting discrepancies.

  1. Completion and Distribution of Waste Shipping Paper

Each shipping paper must contain instructions for properly completing the four-part form. Copies of the form must be distributed as follows:

  1. One copy must be kept by generator (mailer).
  2. One copy must be kept by transporter or intermediate handler for 90 days.
  3. One copy must be kept by destination facility for 90 days.
  4. One copy must be mailed to generator by destination facility.
  1. Emergency Telephone Number

Each shipping paper must bear the following statement with appropriate information:

“IN CASE OF EMERGENCY, OR THE DISCOVERY OF DAMAGE OR LEAKAGE,
CALL 1–800-###-####.”

  1. Package Testing. Vendors must submit to the manager of Mailing Standards (see DMM 608.8.0 for address) package testing results from an independent testing facility for each package for which the vendor is requesting authorization. In addition, vendors must submit package testing results from an independent testing facility when the design of a container system changes or every 24 months, whichever occurs first. The test results must show that, if every mailpiece prepared for mailing were subject to the environmental and test conditions in 49 CFR and the additional test requirements in 346.322e, no contents would be released into the environment and the effectiveness of the packaging would not be significantly reduced. The Postal Service may require proof of accreditation or other documentation to support the credentials of an independent testing facility.
  2. Packages tested for approval as medical professional packages may not be tested using pre-primary containers that are currently or have previously been approved as Postal Service primary containers. In addition, test reports must identify by brand name the pre-primary containers that were used during testing.

  3. Testing Criteria. Each mailpiece must pass each of the tests described below:
    1. Leakproof Test. The test must be conducted on one primary receptacle with the lid in place, without the secondary and outer packaging. The test duration must be at least 5 minutes and must be conducted at 20 kPa (3 psi). The pass/fail criterion is as follows: no air leakage from anywhere other than the closure of the primary receptacle. Air leakage at the closure is not considered a failure if the primary receptacle passes the test for watertightness as determined by placing 50 ml of deionized water into the primary receptacle, securing the closure, and then turning the container on its side and observing for any evidence of leakage. Any evidence of water leaking from the primary receptacle is a failure.
    2. Stacking Test. One mailpiece must withstand the test in 49 CFR 178.606. The dynamic compression test must be conducted on the empty, unsealed mailpiece assembled for mailing, without the primary receptacle(s). The test mass is the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions. A compensation factor of 1.5 must be used to compute the test load, based on the vendor-identified weight. The pass/fail criteria are as follows: no buckling of the sidewalls sufficient to cause damage to the contents in the primary receptacle, and in no case does the deflection exceed 1 inch.
    3. Vibration Test. One mailpiece filled with sharps or other regulated medical waste must withstand the test in 49 CFR 178.608. The test mailpiece is filled with sharps or other regulated medical waste to the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions. The test sample is prepared as it would be for mailing. The pass/fail criterion is as follows: no rupture, cracking, or splitting of any primary receptacle.
    4. Wet Drop Test. Five mailpieces filled with sharps or other regulated medical waste must withstand the test in 49 CFR 178.609e. Each test mailpiece is filled with sharps or other regulated medical waste to the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions included with each mailpiece. Each mailpiece is prepared as it would be for mailing and subjected to a water spray as described in the test. A separate, untested mailpiece is used for each drop orientation: top, longest side, shortest side, and corner. The pass/fail criteria are as follows: no rupture, cracking, or splitting of any primary receptacle, and no contents may penetrate into or through the body or lid of any primary receptacle.
    5. Cold Drop Test. Five mailpieces filled with sharps or other regulated medical waste must withstand the test in
      49 CFR 178.609f. Each test mailpiece is filled with sharps or other regulated medical waste to the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions included with each mailpiece. Each mailpiece is prepared as it would be for mailing and chilled as described in the test. A separate, untested mailpiece is used for each drop orientation: top, longest side, shortest side, and corner. The pass/fail criteria are as follows: no rupture, cracking, or splitting of any primary receptacle, and no contents may penetrate into or through the body or lid of any primary receptacle.
    6. Impact Test. One mailpiece filled with sharps or other regulated medical waste must withstand the test in 49 CFR 178.609h. The test mailpiece is filled with sharps or other regulated medical waste to the vendor-identified maximum weight, not to exceed 25 pounds, as indicated on the outer shipping container and on the assembly and closing instructions included with each mailpiece. The mailpiece is prepared as it would be for mailing. The pass/fail criteria are as follows: no rupture, cracking, or splitting of any primary receptacle, and no contents may penetrate into or through the body or lid of any primary receptacle.
    7. Puncture-Resistant Test. Package testing results must show that, during all of the previous tests, the contents did not penetrate through the primary receptacle.
    8. Temperature Test. Package testing results must show that each primary receptacle maintained its integrity when exposed to temperatures as low as 0°F and as high as 120°F (–18°C to 49°C).
    9. Absorbency Test. Package testing results must show that the primary receptacle(s) contain enough absorbent material to absorb three times the total liquid allowed within the primary receptacle in case of leakage. Absorbency is determined by pouring 150 ml of deionized water into the primary receptacle(s), then turning the receptacle(s) upside down and observing for any evidence of free liquid not absorbed on contact. Any evidence of free liquid is a failure.
    10. Watertight Test. Package testing results must show that no leakage occurred when 50 ml of deionized water was placed into the secondary containment system and the entire system was turned upside down for 5 minutes.
  4. Suspension of Authorization. The Postal Service may suspend a vendor’s authorization based on information that a mailpiece no longer meets the standards for mailing sharps medical waste and regulated medical waste containers, or that the mailpiece poses an unreasonable safety risk to Postal Service employees or the public. The suspension can be made immediately, making the mailpiece nonmailable immediately. The vendor may contest a decision to suspend authorization by writing to the manager of Mailing Standards (see
    DMM 608.8.0 for address) within 7 days from the date of the letter of suspension. The appeal should provide evidence demonstrating why the decision should be reconsidered. Any order suspending authorization remains in effect during an appeal or other challenge. When a vendor is notified that its authorization to mail sharps or other regulated medical waste containers has been suspended, the vendor must immediately do the following:
    1. Recall all identified containers.
    2. Notify all customers that they cannot mail the identified containers.
    3. Suspend sales and distribution of all identified containers.
    4. Collect the identified containers from distributors, consumers, and the Postal Service without using the mail and in accordance with all federal and state regulations.
346.323 Used Health Care Products

Note: See Packaging Instructions 6E in Appendix C and DMM 601.10.17.6.

A used health care product known or reasonably suspected to contain a Category A material is nonmailable. A used health care product not suspected to contain an infectious material, or that is known or suspected to contain a Category B infectious substance and is being returned to the manufacturer or manufacturer’s designee is mailable with First-Class Mail, Priority Mail, or Priority Mail Express service subject to the following packaging requirements:

  1. Each used health care product must be drained of liquid to the extent possible and placed in a watertight primary receptacle designed and constructed to ensure that it remains intact under normal conditions of transport. For a used health care product capable of cutting or penetrating skin or packaging material, the primary receptacle must be capable of retaining the product without puncture of the packaging under normal conditions of transport. The primary receptacle must be marked with the international biohazard symbol shown in
    Exhibit 346.321.
  2. Each primary receptacle must be placed inside a watertight secondary container designed and constructed to ensure that it remains intact under normal conditions of transport. The secondary container must also be marked with the international biohazard symbol shown in Exhibit 346.321.
  3. The secondary container must be placed inside an outer shipping container with sufficient cushioning material to prevent movement between the secondary container and the outer shipping container. An itemized list of the contents of the primary receptacle and information concerning possible contamination with a Division 6.2 material, including its possible location on the product, must be placed between the secondary container and the outer shipping container. A shipping paper and a content marking on the outer shipping container are not required.
346.324 Forensic Material in Category B

Note: See Packaging Instructions 6F in Appendix C and DMM 601.10.17.7.

Forensic material containing a biological material, such as tissue, body fluid, excreta, or secreta, and sent on behalf of a federal, state, local, or Indian tribal government agency must be packaged under 346.325 when it is not known or suspected to contain a Category A or Category B infectious substance. Forensic material known or suspected to contain a Category A infectious substance is nonmailable. Forensic material known or suspected to contain a Category B infectious substance as identified in 346.321 is mailable with First-Class Mail, Priority Mail, or Priority Mail Express service when triple-packaged in a primary receptacle, secondary container, and a rigid outer shipping container as follows:

  1. The forensic material must be held within a securely sealed primary receptacle. The primary receptacle must be surrounded by sufficient absorbent material (for liquids) and cushioning material to protect the primary container from breakage. The absorbent material must be capable of taking up the entire liquid contents of the primary receptacle in case of leakage. The primary receptacle must be marked with the international biohazard symbol shown in Exhibit 346.321.
  2. The primary receptacle and the absorbent and cushioning material must be enclosed in a watertight and securely sealed secondary container. The secondary container must also display the international biohazard symbol shown in Exhibit 346.321.
  3. The secondary container must be firmly and snugly packed within a strong outer shipping container that is securely sealed. A shipping paper and a content marking on the outer shipping container are not required.
346.325 Nonregulated Materials

Note: See Packaging Instructions 6G in Appendix C and DMM 601.10.17.8.

Nonregulated materials as defined in 346.234 are not subject to regulation as hazardous materials but must be properly packaged when presented for mailing. Regulated medical waste and sharps medical waste must be packaged and mailed under 346.322, and used health care products must be packaged and mailed under 346.323. Exempt human and animal specimens must be packaged under 346.326. Nonregulated materials are mailable as Priority Mail Express, Priority Mail, First-Class Mail, First-Class Package Service, Parcel Select, or Standard Post. Such materials must be held within a securely sealed primary receptacle. The primary receptacle must be surrounded by sufficient absorbent material (for liquids) and cushioning material to protect the primary receptacle from breakage. The absorbent material must be capable of taking up the entire liquid contents of the primary receptacle in case of leakage. Either the primary receptacle or the inner packaging must be marked with the international biohazard symbol shown in Exhibit 346.321. The primary receptacle and the absorbent and cushioning material must be snugly enclosed in a rigid outer shipping container that is securely sealed. A shipping paper and a content marking on the outer shipping container are not required. Nonregulated material specimens and biological products are subject to the following packaging standards:

  1. Liquid Patient Specimens and Biological Products. Mailers must package a liquid nonregulated patient specimen, a forensic specimen, or a biological product (such as polio vaccine) as follows:
    1. Not exceeding 50 ml. A patient specimen or biological product consisting of 50 ml or less per mailpiece must be packaged in a securely sealed primary receptacle. Two or more primary receptacles whose combined volume does not exceed 50 ml may be enclosed within a single mailpiece. Sufficient absorbent material and cushioning material to withstand shock and pressure changes must surround the primary receptacle(s), or be otherwise configured to take up the entire liquid contents in case of leakage. The primary receptacle(s) and the absorbent cushioning must be enclosed in a secondary container with a leakproof barrier that can prevent failure of the secondary container if the primary receptacle(s) should leak during transport. The secondary container must be securely sealed, and it may serve as the outer shipping container if it has sufficient strength to withstand ordinary postal processing. The secondary container must be marked with the international biohazard symbol shown in Exhibit 346.321, except when the secondary container also serves as the outer shipping container. In that case, the biohazard symbol must appear on the inner packaging or on the primary container. A shipping paper and a content marking on the outer shipping container are not required.
    2. Exceeding 50 ml. A liquid patient specimen, forensic material, or biological product that exceeds 50 ml must be packaged in a securely sealed primary receptacle. A single primary receptacle must not contain more than 500 ml of specimen. Two or more primary receptacles whose combined volume does not exceed 500 ml may be enclosed in a single secondary container. Sufficient absorbent material and cushioning material to withstand shock and pressure changes must surround the primary receptacle(s), or be otherwise configured to take up the entire liquid contents in case of leakage. The primary receptacle(s) and the absorbent cushioning must be enclosed in a secondary container with a leakproof barrier that can prevent failure of the secondary container if the primary receptacle(s) should leak during transport. The secondary container cannot serve as the outer shipping container. The secondary container must be marked with the international biohazard symbol shown in Exhibit 346.321. The secondary container must be securely and snugly enclosed in a fiberboard box or container of equivalent strength that serves as the outer shipping container. A shipping paper and a content marking on the outer shipping container are not required.
  2. Solid or Dry Specimen. A solid or dry specimen, such as a saliva swab, blood spot, fecal smear, culture or stock, or forensic material, must be completely dried before packaging in a mailing container or envelope. Cushioning material to withstand shock and pressure changes is required only if the dry specimen is placed in a breakable primary receptacle. When required, the cushioning material must surround the primary receptacle. The primary receptacle (and cushioning material, if required) must be enclosed in a secondary container with a siftproof barrier that can prevent failure of the secondary container if the primary receptacle breaks during shipment. The secondary container must be securely sealed, and it may serve as the outer shipping container if it has sufficient strength to withstand ordinary postal processing. The secondary container must be marked with the international biohazard symbol shown in Exhibit 346.321, except when the secondary container also serves as the outer shipping container. In that case, the biohazard symbol must appear either on the inner packaging or on the primary receptacle. A shipping paper and a content marking on the outer shipping container are not required.
346.326 Exempt Human or Animal Specimens

Note: See Packaging Instructions 6H in Appendix C and DMM 601.10.17.9.

Exempt human or animal specimens as defined in 346.12d are not subject to regulation as hazardous materials but when presented for mailing must be triple-packaged in leakproof (for liquids) or siftproof (for solids) primary receptacles. Sufficient cushioning and absorbent materials must surround each primary receptacle containing liquid. Secondary containers for liquids must be leakproof. Secondary containers for solids must be siftproof. The primary and secondary packaging must be enclosed in a rigid outer shipping container. A single primary receptacle must not contain more than 500 ml of a liquid specimen or 500 grams of a solid specimen. Two or more primary receptacles whose combined volume does not exceed 500 ml (for liquids) or 500 grams (for solids) may be enclosed in a single secondary container. The secondary container cannot serve as the outer shipping container. The secondary container must be marked with the international biohazard symbol shown in Exhibit 346.321. The secondary container must be securely and snugly enclosed in a fiberboard box or container of equivalent strength that serves as the outer shipping container. A shipping paper is not required. The outer shipping container must be marked on the address side with the words “Exempt human specimen” or “Exempt animal specimen,” as appropriate. In addition, at least one surface of the outer packaging must have a minimum dimension of 3.9 inches by 3.9 inches (100 mm by 100 mm). Exempt human and animal specimens are mailable as Priority Mail Express, Priority Mail, First-Class Mail, First-Class Package Service, Parcel Select, or Standard Post.

346.327 Proper Packaging of Mailable Materials

All mailable materials as identified in 346.212 must be properly packaged.

Exhibit 346.327 lists the specific reverence in 346 under which each type of mailable material must be packaged.

Exhibit 346.327 

Packaging References for Mailable Materials, Infectious Substances (Hazard Class 6, Division 6.2)

 

Material Being Mailed

Packaging Standards1

Nonregulated

Category A

Category B

Blood for Transfusion

346.325

nm

346.321

Biological Product

346.325

nm

346.321

Culture or Stock

346.325

nm

346.321

Patient Specimen

346.325

nm

346.321

Exempt Human or Animal Specimen

346.326

n/a

n/a

Forensic Material

346.325

nm

346.321

Regulated Medical Waste

346.322

nm

346.322

Sharps Waste

346.322

nm

346.322

Toxin2

346.31

nm

346.321

Treated Medical Waste

346.325

n/a

n/a

Used Health Care Product

346.323

nm

346.323


nm = Nonmailable.
n/a = Not applicable.

Toxin means a Division 6.1 material from a plant, animal, or bacterial source. A toxin containing an infectious substance or a toxin contained in an infectious substance must be classified as Division 6.2; described as an infectious substance; and assigned to UN2814, UN2900, or UN3373, as appropriate. A Division 6.1 toxin that can qualify as an ORM-D material is permitted when packaged under 346.231 or 346.31.

346.4 Damaged Parcels

If a mailpiece containing a Class 6 material is found to be damaged or leaking during Postal Service handling, the incident must be reported in accordance with POM 139.117 and 139.118 and Handbook EL-812, Hazardous Materials and Spill Response (in Part VII, “Response to Hazardous Material Incidents and Emergencies,” see the section titled “Hazardous Materials Incident Reports”), as appropriate. The local Postal Service safety officer (or designee) must immediately initiate the spill response procedures in Handbook EL-812. For spills involving infectious substances (etiologic agents), the following containment and cleanup steps must also be followed:

  1. Wear rubber gloves throughout the spill cleanup procedure.
  2. Surround the leaking package with absorbent material.
  3. Place the leaking package in another box and seal the box.
  4. Place the sealed box in a plastic bag and seal the bag.
  5. Flood affected surfaces and rinse rubber gloves with household chlorine bleach, diluted 1 ounce to 1 gallon of water, and let stand for 5 minutes. Use caution with the chlorine bleach because it is a mildly corrosive oxidizer. Wipe surfaces dry with an absorbent material, place the absorbent material in a plastic bag, and incinerate.
  6. Report the damaged parcel to the Centers for Disease Control and Prevention (CDC) at the telephone number listed in 246.
  7. Never dispose of etiologic agents in the trash. Contact the area environmental compliance specialist for specific information on the appropriate disposal procedures.