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343.22 Requirements for Combustible LiquidsThe following conditions apply: a. International Mail. Combustible liquid is prohibited. b. Domestic Mail via Air Transportation. Combustible liquid is permitted if the material can qualify as an ORM-D material and meet the criteria in Exhibit 343.22. Packaging Instruction 3B in Appendix C must be followed, as applicable. c. Domestic Mail via Surface Transportation. Combustible liquid is permitted if the material can qualify as an ORM-D material and meet the criteria in Exhibit 343.22. Packaging Instruction 3B in Appendix C must be followed, as applicable. Combustible Liquids
343.23 Nonmailable Flammable and Combustible LiquidsWhen flammable liquids and combustible liquids that are nonmailable under 343.21 or 343.22 and DMM 601.10.13. 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. When there is no immediate threat to persons or property, follow the procedures in POM 139.118. The following materials are nonmailable: a. All flammable liquids having a flashpoint of 20° F (-7° C) or below are prohibited from mailing. b. Gasoline (UN1203) is a flammable liquid that normally has a flashpoint of -50° F. Gasoline is nonmailable under any circumstances. 343.24 Mailable Flammable and Combustible LiquidsThe following are mailable: a. Paint or a related item (UN1263) classified as a flammable or combustible liquid is generally acceptable for mailing provided the material can qualify as an ORM-D material and is sent within the quantity limitations and packaging requirements stated in 343.21 or 343.22, as applicable. Also see 343.26. Mailpieces must be prepared following Packaging Instruction 3A or 3B in Appendix C, as applicable. b. Latex Paint or a similar water-based paint product that is not flammable or combustible is not regulated as a hazardous material, and therefore is not restricted. Also see 343.26. Mailpieces must be properly packaged under DMM 601.1 through 601.8. c. Canned Heat (Sterno) is a flammable liquid that normally has a flashpoint from 40° F (4° C) to 80° F (27° C). It is permitted only in domestic mail via surface transportation provided the liquid can qualify as an ORM-D material and is sent within the quantity limitations and packaging requirements stated in 343.21. Mailpieces must be prepared following Packaging Instruction 3A in Appendix C. d. Cigarette Lighter Fluid is a flammable liquid that normally has a flashpoint between 20° F (-7° C) and 55° F (13° C). It is permitted only in domestic mail via surface transportation provided the fluid can qualify as an ORM-D material and is sent within the conditions of 343.21. Mailpieces must be prepared following Packaging Instruction 3A in Appendix C. e. Diesel Fuel (NA1993) is a combustible liquid that normally has a flashpoint between 110° F (43° C) and 190° F (88° C). It is acceptable for mailing provided the fluid can qualify as an ORM-D material and the liquid is sent within the conditions in 343.22. Mailpieces must be prepared following Packaging Instruction 3B in Appendix C. f. Fuel Oil (NA1993) is a flammable liquid that normally has a flashpoint below 100° F (38° C). The specific flashpoint must be accurately identified by the mailer before a mailability determination can be made. Fuel oil is acceptable in the domestic mail via surface transportation only. provided the liquid can qualify as an ORM-D material and is sent within the conditions of 343.21 or 343.22, as applicable. Mailpieces must be prepared following Packaging Instruction 3A in Appendix C. g. Adhesives and Cements (UN1133) that are classified as flammable or combustible liquids are mailable only if the material can qualify as an ORM-D material and the applicable conditions in 343.21 or 343.22 are met. Mailpieces must be prepared following Packaging Instruction 3A or 3B in Appendix C, as applicable. Note: Some adhesives and cements are extremely toxic and may be classified as Division 6.1 toxic substances. Division 6.1 materials are mailable only as permitted in 346.21. h. Cleaning Agents and Solvents that are classified as flammable liquids are mailable only if the material can qualify as an ORM-D material and the applicable conditions in 343.21 can be met. Mailpieces must be prepared following Packaging Instruction 3A in Appendix C. Note: Some cleaning agents and solvents are extremely toxic or corrosive and may be classified as either a Division 6.1 toxic substance or a Class 8 corrosive. Division 6.1 toxic materials and Class 8 corrosives are permitted only within the conditions of 346.21 and 348.2, respectively. i. Model Fuel (for glow-plug engines) is a flammable liquid that has a flashpoint ranging from 65° F to 75° F. It is acceptable only in the domestic mail via surface transportation, provided the material can qualify as an ORM-D material and the applicable conditions in 343.21 are met. Mailpieces must be prepared following Packaging Instruction 3A in Appendix C. j. Waxes and Polishes have a wide range of flashpoints. The flashpoint and toxicity must be accurately identified by the mailer before mailability can be determined. Any waxes or polishes that are flammable or combustible liquids are permitted to be mailed, provided the material can qualify as an ORM-D material and the applicable conditions in 343.21 and 343.22 are met. Mailpieces must be prepared following Packaging Instruction 3A or 3B in Appendix C, as applicable. 343.25 Cigarette LightersA cigarette lighter equipped with an ignition element and containing fuel is classified as a Class 3 flammable liquid. A cigarette lighter containing a flammable gas is classed as a Division 2.1 flammable gas. A cigarette lighter that contains either flammable liquid or flammable gas is permitted only in the domestic mail via surface transportation with prior written approval and within these conditions: a. The design of the lighter and its packaging are approved by the DOT Associate Administrator for Hazardous Materials Safety, per 49 CFR 173.21(i) and 173.308, and a DOT Approval Number (T-Number) is issued. b. The prospective mailer of the lighter submits to the PCSC manager a written request for authorization to mail the lighter, accompanied by a legible photocopy of the official DOT notice conveying the approval described in 343.25a, along with a specimen of the actual lighter, the packaging materials in which each lighter is to be mailed, and the number of mailpieces and mailing location; the mailer receives from the PCSC manager a letter approving the requested authorization for mailing. c. The packaging must be designed to protect the lighter's sparking mechanism from accidental ignition caused by friction or external pressure during transport. Packaging Instruction 3C in Appendix C must be followed. d. When presented for mailing, the address side of the mailpiece must prominently display the proper shipping name "Lighter(s)" or "Lighter(s) for Cigarette" followed by the T-Number and the marking "Surface Only" or "Surface Mail Only," all preparation and packaging requirements in the PCSC manager's approval letter must be met. A legible photocopy of the PCSC manager's approval must accompany the mailing at the time of deposit. e. A shipper's declaration for dangerous goods is not required. 343.26 Paints, Paint-Related Materials, and InksThe following definitions apply: a. Paint (UN1263) is the proper shipping name and description for paint, lacquer, enamel, stain, shellac, varnish, liquid aluminum, liquid bronze, liquid gold, liquid wood filler, and liquid lacquer base. Paint-related material (UN1263) is the proper shipping name and description for a paint-thinning, paint-drying, paint-reducing, or paint-removing compound. See 343.24a and 343.24b for mailability. b. Inks are defined as colored liquids used for writing, drawing, etc., and liquids and pastes used in printing. Printing inks usually are mixtures of finely divided pigments, such as carbon black suspended in a drying oil. Inks having hazardous characteristics are generally classified as combustible or flammable liquids and are mailable, provided they can qualify as an ORM-D material and meet the applicable requirements in 343.21 or 343.22. Mailpieces must be prepared using Packaging Instruction 3A or 3B in Appendix C, as applicable. In addition, the following conditions apply: (1) Regardless of the size or type of container, the primary receptacle(s) containing inks must be cushioned with sufficient absorbent material to take up all liquid contents in case of leakage. (2) The primary receptacle(s) and the absorbent cushioning material must be packed within a sealed, leakproof outer packaging. (3) Inks that are flammable or combustible liquids must meet the quantity restrictions, packaging requirements, and air or surface transportation conditions that apply under 343.2. Note: Inks that do not possess any hazardous characteristics are not regulated as hazardous materials and are mailable if properly prepared under the requirements for packaging liquids in DMM 601.1 through 601.8. 343.3 Marking and DocumentationFor air transportation, parcels containing mailable Class 3 materials must be plainly and durably marked on the address side with "ORM-D AIR" immediately following or below the proper shipping name (e.g., Consumer Commodity). A properly completed shipper's declaration for dangerous goods prepared in triplicate must be affixed to the outside of the mailpiece. For surface transportation, parcels containing mailable Class 3 materials must be plainly and durably marked on the address side with "Surface Mail" or "Surface Mail Only" and "ORM-D" immediately following or below the proper shipping name (i.e., consumer commodity). A shipper's declaration for dangerous goods is not required for mailable Class 3 materials sent via surface transportation. Cigarette lighters must be marked as specified in 343.25. 344 Flammable Solids (Hazard Class 4)344.1 DefinitionHazard Class 4 consists of three divisions: a. Division 4.1, Flammable Solids. Any solid material other than one classed as an explosive that, under conditions normally incident to transportation, is likely to cause fires through friction or retained heat from manufacturing or processing, or that can be ignited readily and, when ignited, burns so vigorously and persistently as to create a serious transportation hazard. b. Division 4.2, Spontaneously Combustible. A liquid or solid pyrophoric material that even in small amounts and without an external ignition source can ignite within 5 minutes after coming in contact with air, or a self-heating material that when in contact with air and without an energy supply is liable to self heat. c. Division 4.3, Dangerous When Wet. A material that, by contact with water, is likely to become spontaneously flammable or to give off flammable or toxic gas at a rate greater than 1 liter per kilogram of the material per hour. Examples of flammable solids include certain metallic hydrides, metallic sodium and potassium, oily fabrics, processed metals, matches, and nitrocellulose products. 344.2 MailabilityThe following conditions apply: a. International Mail. All flammable solids are prohibited. b. Domestic Mail via Air Transportation. All flammable solids are prohibited. c. Domestic Mail via Surface Transportation. A flammable solid that can qualify as an ORM-D material is permitted. 344.21 Nonmailable Flammable SolidsWhen flammable solids that are nonmailable under 344 and DMM 601.10.14 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. When there is no immediate threat to persons or property, follow the procedures in POM 139.118. Strike-anywhere matches are nonmailable in international mail and domestic mail. Safety matches (book, card, or strike-on-box) are nonmailable in international and domestic mail via air transportation. 344.22 Mailable Flammable SolidsThe following are mailable: a. Flammable solids that are eligible to be reclassed as ORM-D materials are permitted in the domestic mail via surface transportation. b. Safety matches (book, card, or strike-on-box) are permitted only in domestic mail via surface transportation. 344.3 Packaging, Marking, and DocumentationThe following conditions apply: a. Mailable Flammable Solids. The conditions in Packaging Instruction 4A in Appendix C must be followed. Mailpieces containing mailable Class 4 materials must be plainly and durably marked on the address side with "ORM-D" immediately following or below the proper shipping name (i.e., Consumer Commodity). A shipper's declaration for dangerous goods is not required. b. Safety Matches. The conditions in Packaging Instruction 4B in Appendix C must be followed. Mailpieces must be plainly and durable marked on the address side with "Surface Only" or "Surface Mail Only" and, as applicable, "Book Matches," "Strike-on-Card Matches," or "Card Matches." A shipper's declaration for dangerous goods is required. 345 Oxidizing Substances, Organic Peroxides
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| Risk Group | Pathogen | Risk to Individuals | Risk to 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 microorganism that is unlikely to cause human or animal disease. A material containing only such microorganisms is not subject to regulation as a hazardous material, but it is subject to the packaging requirements in 601.10.17.10, unless otherwise noted in 601.10.17. | None or Very Low | None or Very Low |
The following conditions apply:
a. International Mail. Division 6.1 toxic substances or poisons and irritating materials are prohibited.
b. Domestic Mail via Air or Surface Transportation. A Division 6.1 toxic substance or poison that can qualify as an ORM-D material is permitted when packaged under the applicable requirements in Appendix C, 6A. Certain other poisonous materials are permitted to be mailed only between authorized parties under specific conditions as specified in 346.231b.
a. International Mail. Infectious and noninfectious biological substances are permitted in international mail only when sent as registered airmail letter packages and sent when they are intended for medical or veterinary use, research, or laboratory certification related to the public health; and only when such materials are properly prepared for mailing to withstand shocks, pressure changes, and other conditions related to ordinary handling in transit. The mailer must receive writen approval from the office of Mailing Standards prior to mailing. See Chapter 6 and IMM 135 for specific requirements. Infectious substances are prohibited in international mail via surface transportation.
b. Domestic Mail via Air Transportation. Infectious substances (etiologic agents), diagnostic (clinical) specimens, and biological products, 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. Unless otherwise noted, all mailable Division 6.2 materials in Risk Groups 2, 3, or 4 must be prepared to meet the requirements for air transportation. Infectious substances may be sent only in the quantities allowed in DMM 601.10.17. The following conditions also apply:
(1) Infectious Substances (etiologic agents), biological products, cultures or stocks, and toxins known or suspected to contain a Risk Group 2, 3, or 4 pathogen, and including diagnostic specimens known or suspected to contain a Risk Group 4 pathogen are subject to the requirements in 49 CFR 173.196 and DMM 601.10.17.5. Each mailpiece must be sent as Priority Mail or First-Class Mail. Those specific Risk Group 4 materials that contain select agents listed in 42 CFR 73.4 or 73.5 must be sent Registered First-Class Mail with a return receipt.
(2) Diagnostic Specimens (clinical) classified in Risk Group 2 or 3 that meet the definition in DMM 601.10.17.2d, are subject to the requirements in DMM 601.10.17.6. Mailable materials must be sent as Express Mail, Priority Mail, or First-Class Mail.
(3) Sharps are permitted, subject to the requirements in DMM 601.10.17.7, and must be mailed Priority Mail or First-Class Mail using merchandise return service. An authorization is required prior to mailing as stated in 346.233 and DMM 601.10.17.7a.
(4) Used Health Care Products known or suspected to contain a Risk Group 4 pathogen are nonmailable. A used health care product meeting the definition in DMM 601.10.17.2i, and meeting the requirements in DMM 601.10.17.8, classified in Risk Group 1, 2, or 3, and being returned to the manufacturer or manufacturer's designee, is mailable as First-Class Mail, Priority Mail, or Express Mail.
(5) Forensic Material known or suspected to contain a Risk Group 2 or 3 pathogen is mailable as First-Class Mail, Priority Mail, or Express Mail when meeting the requirements in DMM packaging 601.10.17.9. Forensic material known or suspected to contain a Risk Group 4 infectious substance must be packaged using DMM packaging 601.10.17.5 Forensic material in Risk Group 1 sent on behalf of a U.S. government, state, local, or Indian tribal government agency must be packaged under 601.10.17.10.
(6) Risk Group 1 Materials are not subject to regulation as hazardous materials, but when presented for mailing must be properly packaged. All Risk Group 1 materials are mailable as First-Class, Priority Mail, Express Mail or Package Services.
When hazardous materials that are nonmailable under 346.2 and DMM 601.10.16 and 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.
The following Division 6.1 materials are nonmailable:
a. 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).
b. 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.
Division 6.2 materials are nonmailable as follows:
a. Blood for transfusion known or suspected to contain a Risk Group 4 pathogen is nonmailable.
b. Infectious substances (etiologic agents) containing a total volume of more than 50 ml for liquids (1.66 oz) or 50 g of solids are prohibited.
c. Diagnostic (clinical) specimens containing a total volume of more than 4,000 ml of liquid or 4 Kg (8.8 lb.) of solid (or dried) per mailpiece are prohibited.
d. Sharps medical waste and regulated medical waste that contain a Risk Group 4 pathogen are nonmailable. Mailpieces that exceed 25 pounds in weight or do not have the required authorization are prohibited.
e. Used Healthcare products that contain Risk Group 4 pathogen are nonmailable. Mailpieces that exceed 25 pounds in weight are prohibited.
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.
a. ORM-D Materials. A Division 6.1 toxic substance that can qualify as an ORM-D material is mailable when all applicable conditions are met.
b. 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 483.6
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.
a. Liquids. Restrictions are as follows, subject to the general packaging requirements in DMM 601.1 through 601.8:
(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.
b. 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.
Infectious substances (etiologic agents), diagnostic (clinical) specimens, biological products, cultures and stocks, sharps medical waste, regulated medical waste, used health care products, and forensic material are permitted to be mailed within specific quantity limits and packaging conditions specified in 346.3 and DMM 601.10.17.
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 6H in Appendix C and DMM 610.10.17.10 are met:
a. A diagnostic (clinical) specimen known to contain or suspected of containing a microorganism in Risk Group 1, or that does not contain a pathogen. Also, a diagnostic specimen in which the pathogen has been neutralized or inactivated so that exposure to it cannot cause disease.
b. A biological product known to contain or suspected of containing a microorganism in Risk Group 1, or that does not contain a pathogen. Also any biological product, including an experimental product or component of a product, subject to Federal approval, permit, or licensing requirements, such as those required by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) or the U.S. Department of Agriculture (USDA).
c. Blood collected for blood transfusion or the preparation of blood products; blood products; tissues intended for use in surgical procedures; and human cell, tissues, and cellular and tissue-based products regulated under authority of the Public Health Service Act and/or the Food, Drug, and Cosmetic Act. Also, blood collected for blood transfusion or the preparation of blood products and sent for testing as part of the collection process, except where the person collecting the blood has reason to believe it contains a pathogen in Risk Group 2 or 3, in which case the test sample must be packaged under DMM 601.10.17.6.
d. A material, including a Division 6.2 waste, 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 in Risk Group 2, 3, or 4.
e. Forensic material in Risk Group 1 transported on behalf of a U.S. government, state, local, or Indian tribal government agency.
f. Environmental microbiological samples, such as samples of dust from a ventilation system or mold from a wallboard, collected to evaluate occupational and residential exposure risks.
Mailable toxic substances must be prepared as follows:
a. ORM-D Materials. The applicable requirements specified in 346.211 and 346.231 must be met. Packaging Instruction 6A in Appendix C must be followed. Each mailpiece must be plainly and durably marked on the address side with "ORM-D" or "ORM-D AIR," as applicable, immediately following or below the proper shipping name (Consumer Commodity). For air transportation, each mailpiece must bear a shipper's declaration for dangerous goods. Mailable material sent via surface transportation must be marked on the address side as "Surface Mail Only" or Surface Only."
b. 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 601.11.11.2). Mailable materials sent via surface transportation must be marked on the address side as "Surface Mail Only" or "Surface Only." For air or surface transportation, each mailpiece must bear a shipper's declaration for dangerous goods (i.e., shipping paper).
The proper packaging, marking, labeling, and documentation for mailable Division 6.2 materials are as follows:
a. Infectious Substances and Biological Products, Risk Group 2, 3, or 4 - Packaging Instructions are in Appendix C, 6C and DMM 601.10.17.5
Division 6.2 materials include infectious substances (etiologic agents), biological products, cultures or stocks, and toxins known or suspected to contain a Risk Group 2, 3, or 4 pathogen. Division 6.2 also includes diagnostic specimens known or suspected to contain a Risk Group 4 pathogen. Mailable infectious substances, as specified in 346.212, must be prepared using Packaging Instruction 6C in Appendix C. An example of the required packaging is shown in display 346.32a.
(1) All Division 6.2 materials must meet the packaging requirements in 49 CFR 173.196. Either the primary receptacle or the secondary container must be capable of withstanding, without leakage, an internal pressure that produces a pressure differential of not less than 0.95 bar, 14 psi (95 kPa), and temperatures in the range of -40°F to 131°F (-40°C to 55°C), as required by 49 CFR 173.196.
(2) The material must be packaged in a securely sealed and watertight primary receptacle (such as test tube or vial) that is enclosed in another watertight and durable secondary container that is securely sealed. Several primary receptacles may be enclosed in the secondary container if there is adequate cushioning material between them to prevent breakage during normal handling, and if the total volume of the material in all enclosed primary receptacles does not exceed 50 ml for liquids or 50 g for solids. The primary receptacle(s) and the secondary container must be marked with the international biohazard symbol as shown in Exhibit 346.32e.
(3) The space between the primary receptacle(s) and the secondary container at the top, bottom, and sides must contain enough absorbent material to take up the entire contents of the primary receptacle(s) in case of breakage or leakage.
(4) The primary receptacle(s) and the secondary container must be securely enclosed in an outer shipping container constructed of fiberboard or other equivalent material. No external surface of the outer shipping container may be less than 3.9 inches (100 mm) as required by 49 CFR 173.196. An itemized list of the contents of the primary receptacle(s) must be enclosed between the secondary container and the outer shipping container.
(5) Each mailpiece must be designed and constructed so that, if it were subject to the environmental and test conditions in 49 CFR 178.609, there would be no release of the contents to the environment and no significant reduction in the effectiveness of the packaging.
(6) All mailpieces sent under DMM 601.10.17.5 (Packaging Instruction 6C) must be sent First-Class Mail or Priority Mail and must be marked on the address side with the proper shipping name and UN number of the material (e.g., "UN 2814, Infectious Substances, Affecting Humans" or "UN 2900, Infectious Substances, Affecting Animals"). Each mailpiece must bear a DOT Class 6 label for infectious substances (etiologic agents) see Exhibit 346.32d, proper UN package specification markings, and orientation markings. A shipping paper is required. Any mailpiece classified as a Risk Group 4 material and that contains any of the select agents or toxins listed in 42 CFR 73.3 and CFR or 73.4 must meet all requirements in 42 CFR 72 and must also be sent using Registered Mail service.
(7) Articles that include dry ice as a refrigerant for the infectious substance must meet the requirements in 49 CFR 173.196(b)(2)(ii).
Exhibit 346.32a
Infectious Substance Packaging
b. Diagnostic (clinical) Specimens in Risk Group 2 or 3 - Packaging Instructions are in Appendix C, 6D and DMM 601.10.17.6
A diagnostic (clinical) specimen known or suspected to contain a Risk Group 4 pathogen must be packaged under DMM 601.10.17.5 (Packaging Instruction 6D). A diagnostic specimen classified in Risk Group 1 must be packaged under DMM 601.10.17.10 (Packaging Instruction 6H). A diagnostic specimen classified in Risk Group 2 or 3 and that meets the definition in 601.10.17.2d (346.12d) must be packaged in triple packaging, consisting of a primary receptacle, secondary container, and outer shipping container, and be prepared using Packaging Instruction 6D in Appendix C.
Liquid Diagnostic (Clinical) Specimens.
(1) The specimen must be contained in a leakproof and securely sealed primary receptacle. A single primary receptacle may not contain more than 500 ml of a specimen. Multiple primary receptacles are permitted in a single mailpiece if the mailpiece does not contain more than 4,000 ml. The primary receptacle(s) must be surrounded with sufficient cushioning material to withstand shock and pressure changes and with absorbent material capable of taking up the entire liquid contents should the primary receptacle(s) leak.
(2) The primary receptacle(s) and the absorbent material must be securely packed within a secondary container in such a way that, under normal conditions of transport, the primary receptacle cannot break, be punctured, or leak its contents into the secondary container.
(3) The secondary container must be leakproof, securely sealed, and placed within a strong outer shipping container having suitable cushioning material such that any leakage of the contents does not impair the protective properties of the cushioning material or the outer shipping container. The secondary container must be marked with the international biohazard symbol as shown in Exhibit 346.32e.
(4) The primary receptacle(s) or the secondary container must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 0.95 bar, 14 psi (95 kPa). The completed mailpiece must be capable of successfully passing the drop test in 49 CFR 178.603 at a drop height of at least 1.2 meters (3.9 feet). The address side of the outer shipping container must be clearly and durably marked "Diagnostic Specimen." A shipping paper is not required.
Solid (or Dried) Diagnostic Specimens
(5) The primary receptacle must be siftproof with a capacity of not more than 500 g (1.1 pounds).
(6) If several fragile primary receptacles are placed in a single secondary container, they must be individually wrapped or separated with sufficient cushioning material to prevent contact between them. The secondary container must be siftproof to contain the contents should the primary receptacle(s) leak. The secondary container must be marked with the international biohazard symbol as shown in Exhibit 346.32e. The outer shipping container may not exceed 4 kg (8.8 pounds) capacity. The outer shipping container must be clearly and durably marked "Diagnostic Specimen." A shipping paper is not required.
c. Sharps Waste and Other Mailable Regulated Medical Waste - Packaging Instructions are in Appendix C, 6E and DMM 601.10.17.7
Regulated medical waste and sharps waste known to contain or suspected of containing an infectious substance in Risk Group 4 are nonmailable. Regulated medical waste and sharps waste as defined in DMM 601.10.17.2e (346.12e) and DMM 601.10.17.2g (346.12g) and classified in Risk Group 1, 2, or 3, are mailable, only if merchandise return service is used (see DMM 507.9.) with First-Class Mail or Priority Mail.
Prior authorization is required to mail sharps and other regulated medical waste, as stated in 346.233 and DMM 601.10.17.7a. Approved mailing of sharps and other regulated medical waste containers must be prepared following Packaging Instruction 6E in Appendix C.
(1) Authorization. Each distributor or manufacturer 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 USPS prior to mailing. Before applying for authorization, each type of mailing container system must be tested and certified under the standards in DMM 601.10.17.7d by an independent testing facility. The manufacturer or distributor in whose name the authorization is being sought must submit a written request to the Manager, Mailing Standards, USPS Headquarters (see DMM 608.8 for address). The request for authorization must contain the following:
(a) An irrevocable $50,000 surety bond or letter of credit as proof of sufficient financial responsibility to cover disposal costs if the manufacturer (or distributor) 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 USPS possession. The surety bond or letter of credit must be issued in the name of the manufacturer or distributor seeking the authorization and must name the USPS as the beneficiary or obligee, as appropriate.
(b) Address of the headquarters or general business office of the distributor or manufacturer seeking the authorization.
(c) Address of each disposal and storage site.
(d) List of all types of mailing container systems to be covered by the request, a complete sample of each mailing container system, and certification by an independent testing facility that it has subjected the packaging materials to the testing requirements in DMM 601.10.17.7d.
(e) Copy of the proposed waste manifest (shipping paper) to be used with each mailing container system.
(f) 24-hour, toll free telephone number for emergencies.
(g) List of the types of waste to be mailed for disposal in each mailing container system.
(h) Copy of the merchandise return service label to be used with each mailing container system.
Applicants who successfully fulfill all requirements receive a written approval letter from the Manager, Mailing Standards and are assigned a unique authorization number that must be displayed on all sharps medical waste and other regulated medical waste mailing container systems distributed for mail-back purposes.
(2) Packaging. Regulated medical waste and sharps waste in Risk Group 4 are nonmailable. A waste material treated by steam sterilization, chemical disinfection, or other appropriate method, so it no longer meets the definition of an infectious substance in Risk Group 2, 3, or 4, must be packaged under DMM 601.10.17.10 (Packaging Instruction 6D). The packaging for regulated medical waste and sharps waste in Risk Group 1, 2, or 3 is subject to these standards:
(a) Regulated medical waste and sharps waste meeting the definitions in DMM 601.10.17.2e (346.12e) and 601.10.17.2g (346.12g) respectively, must be collected in a rigid, securely sealed, and leakproof primary receptacle. For sharps waste, the primary receptacle must also be puncture resistant and must not have a maximum capacity that exceeds 3 gallons in volume. For regulated medical waste, the primary receptacle must 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 346.32e. Each primary receptacle must maintain its integrity when exposed to temperatures between 0° and 120°F.
(b) 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, it must be at least 3 mm in thickness and be used in conjunction with a strong 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.
(c) 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 (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.
(d) There must be enough material within a watertight barrier to absorb and retain three times the total liquid allowed within the primary receptacle (150 ml per primary receptacle) in case of leakage.
(e) Each mailpiece must not weigh more than 25 pounds.
(f) In each mailing container system, the authorized manufacturer or distributor 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 users to contact if they have assembly questions or find that a component part is missing.
(3) Mailpiece Labeling, Marking, and Documentation. Regulated medical waste and sharps waste must meet the following requirements:
(a) Each primary receptacle and outer shipping container must bear a label, which cannot be detached intact, showing: (a) the company name of the manufacturer or the distributor to which the mailing authorization is issued; (b) the USPS Authorization Number, and; (c) the container ID number (or unique model number) signifying that the packaging material is certified and that the manufacturer or distributor obtained the authorization required by 601.10.17.7a.
(b) 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 346.32e.
(c) Each mailpiece must have a four-part waste manifest, which also serves as the shipping paper. The manifest 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 manifest 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 346.32b must be on the manifest.
Shipping Paper for Regulated Medical Waste and Sharps Waste Containers
| Shipping Paper for Regulated Medical Waste and Sharps Waste Containers |
| blank |
| 1. Generator (Mailer) |
|
a. Name. b. Complete street address (not a Post Office box). c. Telephone number. d. Description of contents of mailing container. "Regulated Medical Waste" or "Regulated Medical Waste-Sharps" is required as appropriate. e. Date container was mailed. f. State permit number of approved facility in which contents are to be disposed of. |
| 2. Destination Facility (Disposal Site) |
| Complete street address (not a Post Office box). |
| 3. Generator's (Mailer's) Certification |
| The following certification statement must be printed on manifest: "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 USC 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. |
| 4. Destination Facility (Storage or Disposal Site) |
| The following certification statement of receipt, treatment, and disposal must be printed on manifest: "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. |
| 5. Transporter Intermediate Handler Other Than the Postal Service (If Different From Destination Facility) |
|
a. Name. b. Complete address (not a Post Office box). c. Printed or typewritten name of transporter or intermediate handler. d. Signature of transporter or intermediate handler and date signed. |
| 6. Serialized Waste Manifests |
| Each waste manifest or mail disposal service shipping record must be serialized using a unique numbering system for identification purposes. |
| 7. Comment Area |
| Each manifest must contain an area designated for entering comments or noting discrepancies. |
| 8. Completion and Distribution of Waste Manifest |
| Each manifest must contain instructions for properly completing the four-part form. Copies of the form must be distributed as follows: a. One copy must be kept by generator (mailer). b. One copy must be kept by transporter or intermediate handler for 90 days. c. One copy must be kept by destination facility for 90 days. d. One copy must be mailed to generator by destination facility. |
| 9. Emergency Telephone Number |
| Each manifest must bear the following statement with appropriate information: "IN CASE OF EMERGENCY, OR THE DISCOVERY OF DAMAGE OR LEAKAGE, CALL 1-800-###-####." |
(d) The outer shipping container must bear a properly prepared merchandise return service label (see DMM 507.9). The merchandise return service permit must be held in the same name as that of the authorized medical waste manufacturer or distributor.
(e) The outer shipping container must be marked on two opposite side walls with the package orientation marking shown in 49 CFR 172.312 to identify the proper upright position of the mailpiece during handling.
(f) Mailpieces containing regulated medical waste or sharps waste must be marked on the address side with the correct UN number and proper shipping name (for example, "Regulated Medical Waste, UN 3291" or "Regulated Medical Waste-Sharps, UN 3291").
Package Testing. Testing must be performed by an independent testing facility on one sample of each type of mailing container system to prove compliance with DMM 601.10.17.7a. The sample mailing container system must withstand the tests in 49 CFR 178.604 (leakproof test), 178.606 (stacking test), 178.608 (vibration standard), and 178.609(e), (f), and (h) (test requirements for packaging for infectious substances). In addition, the absorbent material must withstand an absorbency test that satisfies the requirements in DMM 601.10.17.7b4. The test results must show that, if every container system prepared for mailing were to be subject to the environmental and test conditions in 49 CFR, there would be no release of the contents to the environment and no significant reduction in the effectiveness of the packaging. Periodic retesting must be performed whenever a change is made to the design of the container system, or every 24 months, whichever occurs first.
d. Used Health Care Products - Packaging Instructions are in Appendix C, 6F and DMM 601.10.17.8
A used health care product known or suspected to contain a Risk Group 4 pathogen is nonmailable. A used health care product meeting the definition in DMM 601.10.17.8, classified in Risk Group 1, 2, or 3, and being returned to the manufacturer or manufacturer's designee is mailable as First-Class Mail, Priority Mail, or Express Mail. . Packaging for used health care products is subject to the requirements for Packaging Instruction 6F in Appendix C.
(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 as shown in Exhibit 346.32e.
(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, as shown in Exhibit 346.32e.
(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.
e. Packaging of Forensic Material in Risk Groups 2 and 3 - Packaging Instructions are in Appendix C, 6G and DMM 601.10.17.9
Forensic material in Risk Group 1 sent on behalf of a U.S. government, state, local, or Indian tribal government agency must be packaged under DMM 601.10.17.9. Forensic material known or suspected to contain a Risk Group 4 infectious substance must be packaged under DMM 601.10.17.5. Forensic material known or suspected to contain a Risk Group 2 or 3 pathogen is mailable as First-Class Mail, Priority Mail, or Express Mail when packaged in a triple packaging consisting of a primary receptacle, secondary container, and outer shipping container. Packaging for forensic material is subject to the requirements for Packaging Instruction 6F in Appendix C.
(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, as shown in Exhibit 346.32e.
(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, as shown in Exhibit 346.32e.
(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.
f. Packaging for Risk Group 1 Materials - Packaging Instructions are in Appendix C, 6H and DMM 601.10.17.10
Risk Group 1 materials are not subject to regulation as hazardous materials (see 346.234 and DMM 601.10.17.3), but when presented for mailing, they must be properly packaged. Regulated medical waste, sharps waste, and used health care products classified in Risk Group 1 must be packaged and mailed under the applicable requirements in 601.10.17.7 or 601.10.17.8. All other Risk Group 1 materials are mailable as First-Class Mail, Priority Mail, Express Mail, or Package Services. Such materials must be held within a securely sealed primary receptacle. Risk Group 1 diagnostic specimens and biological products are subject to the requirements for Packaging Instruction 6H In Appendix C.
(1) Liquid Diagnostic (Clinical) Specimens and Biological Products. A diagnostic (clinical) specimen in Risk Group 4 or a biological product in Risk Group 2, 3, or 4 must be packaged under 601.10.17.5. A diagnostic specimen in Risk Group 2 or 3 must be packaged under 601.10.17.6. The packaging of a diagnostic specimen in Risk Group 1 (e.g., a urine specimen or blood specimen used in drug testing programs or for insurance purposes) or a biological product (e.g., polio vaccine) in Risk Group 1 is subject to the following standards:
(a) Not Exceeding 50 ml. A diagnostic 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 having 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 provided it has sufficient strength to withstand ordinary postal processing. The secondary container must be marked with the international biohazard symbol as shown in Exhibit 346.32e, 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 container. A shipping paper and content marking on the outer shipping container are not required.
(b) Exceeding 50 ml. A clinical specimen 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 having 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 as shown in Exhibit 346.32e. 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. The maximum amount of a specimen that may be enclosed in a single mailpiece must not exceed 4,000 ml. A shipping paper and a content marking on the outer shipping container are not required.
(2) Solid (or Dried) Specimens. A solid or dry specimen, such as a saliva swab, blood spot, or fecal smear in Risk Group 1 must be completely dried prior to placing it in or on a secure primary receptacle. Cushioning material to withstand shock and pressure changes is required only if the dry specimen is held in a breakable primary receptacle. When required, the cushioning material must surround the primary receptacle to prevent breakage or damage to the primary receptacle. The primary receptacle (and cushioning material, if required) must be enclosed in a secondary container having a leakproof 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 provided it has sufficient strength to withstand ordinary postal processing. The secondary container must be marked with the international biohazard symbol as shown in Exhibit 346.32e, 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 container. A shipping paper and content marking on the outer shipping container are not required.
Exhibit 346.32c
Packaging References for Mailable Materials, Infectious Substances (Hazard Class 6, Division 6.2)
| Material | Risk Group 1 | Risk Group 2 | Risk Group 3 | Risk Group 4 |
| Blood for Transfusion | 601.10.17.10 | 601.10.17.6 | 601.10.17.6 | nm |