Their Hazardous Materials Information Center can be reached at 1-800-HMR . Cushioning (if more than 1 primary receptacle, they must be individually wrapped). (d) Refrigerated or frozen specimens (ice, dry ice, and liquid nitrogen). A solid material that may become liquid during transportation must be transported in accordance with paragraph (b) of this section. Either set of regulations is compliant with theFederal Aviation Administration(FAA). You cant just use any old packaging, the packaging you choose must be packaging that has passed specific performance testing, well come on to that in a bit. In addition to Category B infectious substances, cultures . Pleasecontact your account representative or our Technical Sales Support Team for more information. Shipments of UN3373 can be declared online or by using the Purolator E-Ship Server by choosing the UN3373 option in the . This course is also for those shipping Biological Substances Category B with Dry Ice or Nitrogen. An infectious substance must be assigned to one of the . The outer packaging must be large enough to hold the secondary packaging(s) and correctly display the required external packaging markings and transport documents, such as the shipping label. (5) The following square-on-point mark must be displayed on the outer packaging on a background of contrasting color. For transportation by aircraft, the entire mark must appear on one side of the package. Category B substances are infectious substances which do not meet the criteria for inclusion in Category A. (7) The name and telephone number of a person who is either knowledgeable about the material being shipped and has comprehensive emergency response and incident mitigation information for the material, or has immediate access to a person who possesses such knowledge and information, must be included on a written document (such as an air waybill or bill of lading) or on the outer packaging. (9) A packaging containing inner packagings of Category B infectious substances may not contain other hazardous materials except -. An infectious substance which does not meet the criteria for inclusion in Category A. Many shippers classify their commodity as Biological substance, Category B, put the label on the package, and then clear as day put on their invoice something like: "tissue sample, not infectious". Category B is broadly defined as an "infectious substance which does not meet the criteria for inclusion in Category A." Genetically Modified Organisms and Microorganisms (GMO/GMMOs) Title 49 was last amended 11/03/2022. Any person involved in the packing or preparation of "Category A" Infectious Substances, UN2814 or UN2900. Exception to Infectious shipping. The packaging must be capable of successfully passing the drop test in 178.609(d) of this subchapter at a drop height of at least 1.2 meters (3.9 feet). (5) For shipments by aircraft, the maximum quantity contained in each primary receptacle, including any material used to stabilize or prevent degradation of the sample, may not exceed 1 L (34 ounces), and the maximum quantity contained in each outer packaging, including any material used to stabilize or prevent degradation of the samples, may not exceed 4 L (1 gallon). If you use any of the following clinical or Temp-Assure switch to drafting.ecfr.gov. This web site is designed for the current versions of A Category B infectious substance must be described as "Biological substance, Category B" and assigned identification number UN3373. If secondary packaging is not pre-labeled, add an international biohazard label to the secondary packaging. View the most recent official publication: These links go to the official, published CFR, which is updated annually. Liquid Category B infectious substances must be packaged in conformance with the following provisions: (1) The primary receptacle must be leakproof. 271 S Pleasant Street Objectives. Category B An infectious substance not in a form capable of causing permanent disability or life- If you continue browsing this website we will assume that you give your consent to receive cookies in your browser. (2) If several fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. As a They are assigned the following UN number and proper shipping name: UN 3373 - Biological Substance, Category B Clinical wastes containing Category B infectious substances must be assigned to UN 3291. Dry Ice (UN1845) 49 CFR 173.217. learn more about the process here. Identify who must receive training in packaging and shipping infectious materials, what must be included in the training, and what records must be maintained. Following the drop test, there must be no leakage from the primary receptacle, which must remain protected by absorbent material, when required, in the secondary packaging. the hierarchy of the document. Infectious Substances, Category A & Category B Packaging Explained, How to Read Hazmat Placards and Understand Their Markings, Air Sea USA to attend ICEID 7-10th August. (iii) Small quantities of Class 3, Class 8, Class 9, or other materials in Packing Groups II and III used to stabilize or prevent degradation of the sample, provided the quantity of such materials does not exceed 30 mL (1 ounce) or 30 g (1 ounce) in each inner packaging. here. Category B; An infectious substance which does not meet the criteria for inclusion in Category A. It is the responsibility of the shipper to ensure that they are aware of, and comply with, all . or existing codification. Each person who offers or transports a Category B infectious substance under the provisions of this section must know about the requirements of this section. Biological substance, Category B. Requisitions are available to download as fillable-PDFscan be ordered from ourSupply Storefront. When using overpacks, these shall be marked in the same way, except when the inscription remains visible. Unlike packaging for Category A Infectious Substances, packaging for Category B does not have to be UN approved, however, it does need to have demonstrated that it can pass certain performance tests. It is designed to prevent an exposure occurring in the event where the infectious substances primary receptacle is compromised, resulting in a leakage of the infectious substance. The official, published CFR, is updated annually and available below under Category A infectious substances have two shipping names: "Infectious substances, affecting humans" (UN 2814) or "Infectious substances, affecting animals" (UN 2900). (1) Ice or dry ice must be placed outside the secondary packaging or in an overpack. A "Biological Substance, Category B" is defined by default as a dangerous good/hazardous material that does not meet the criteria/definition of an "Infectious Substance, Category A" and which is not excepted or properly classified as a "Patient Specimen." Examples of materials properly classified as a "Biological Note: The proper shipping name of UN 3373 is Diagnostic specimens or Clinical specimens or Biological substance, category B. Such preservatives are not subject to the requirements of this subchapter. Substance in form capable of causing permanent disability or life-threatening injury to humans or animals. If more than one primary receptacle is being placed in the secondary packaging, use bubble wrap or other material for cushioning between the containers. Anthrax ( Bacillus anthracis) Botulism ( Clostridium botulinum toxin) Plague ( Yersinia pestis) Smallpox (variola major) Tularemia ( Francisella tularensis) Viral hemorrhagic fevers, including Filoviruses ( Ebola, Marburg) Arenaviruses ( Lassa, Machupo) Category B Definition Second highest priority agents include those that Thereof, what are Category A infectious substances? evaluation of vaccine induced immunity, diagnosis of autoimmune disease, etc. Request a Callback Category A; An infectious substance that if an exposure occurs when transported is capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans. This designated emergency contact person is accepting responsibility to be available during the regular business hours of your facility to provide accident mitigation information in case the package is damaged or the specimen leaks during transit. ( 2) Absorbent material must be placed between the primary receptacle and secondary packaging. The maximum quantity of Category A . Cleveland Clinic Laboratories offers online courses for those in need of training and certification in specimen transportation. Each primary receptacle containing a liquid must be leakproof and surrounded by absorbent . This is an automated process for Infectious substance means a material known or reasonably expected to contain a pathogen. Oberlin, OH 44074. Use the navigation links in the gray bar above to view the table of contents that this content belongs to. Specimen Collection & Handling Instructions, Code of Federal Regulations (CFR) Title 49, International Civil Aviation Organization. (1) A Category B infectious substance must be packaged in a triple packaging consisting of a primary receptacle, a secondary packaging, and a rigid outer packaging. (2) The package is marked Carbon dioxide, solid or Dry ice and an indication that the material being refrigerated is used for diagnostic or treatment purposes (e.g., frozen medical specimens). site when drafting amendatory language for Federal regulations: This page provides general guidelines for packaging Category B infectious substances; please consult the IATA websitefor additional information. On 1 January 2007, it is anticipated that the use of the shipping . At least one surface of the outer packaging must be 4 x 4 inches. Displaying title 49, up to date as of 11/04/2022. (3) The secondary packaging must be leakproof. Infectious Substances are defined as; substances which are known or are reasonably expected to contain pathogens. Enhanced content is provided to the user to provide additional context. Flexible secondary packaging is usually labeled 95 kPa by the manufacturer. Infectious substance means a material known or reasonably expected to contain a pathogen. This does not include regulated medical waste, which must be assigned identification number UN3291. If several fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. Exceptions; There are a number of exceptions listed in the regulations, for example; substances that are unlikely to cause disease in humans or animals, patient specimens where there is a minimum likelihood that pathogens are present, or medical equipment potentially contaminated with or containing infectious substances. This does not include regulated medical waste, which must be assigned identification number UN3291. A pathogen is a microorganism that can cause disease in humans or animals. (1) All shippers of COVID-19 related Infectious Substances Category B must obtain an authorization from the Postal Service prior to mailing. Mailing Standards for COVID-19 related Category B Infectious Substances. Regulated Medical Waste - a waste or reusable material derived from the medical treatment of an animal or human. Multiple secondary packaging in the same outer packaging is allowed, but the maximum quantity of total liquid allowed in the entire package is 4 L. Note: Add enough absorbent material in the secondary packaging to absorb the total volume of liquid being placed in it. Visit the. (e) Training. Be sure that the requisition is placedoutside of any secondary packaging. Category A Infectious Substances are infectious substances in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. Amdt. 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