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Biological Substance, Category B (UN 3373) Marking Requirements Clearly mark "Biological Substance, Category B" in 6-mm-high text on the outer package adjacent to a properly sized UN 3373 diamond-shaped marking. Packaging . (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. 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. Browse special provision A82 (8) Packing Authorizations (173. (i) Refrigerants, such as dry ice or liquid nitrogen, as authorized under paragraph (d) of this section; (ii) Anticoagulants used to stabilize blood or plasma; or. Category A infectious substances must be tripled packaged and compliant with IATA Packin g Instruction 602 diagrammed below. Category B Infectious Substances Category B Infectious Substances Infectious substance means a material known or reasonably expected to contain a pathogen. These shipments must follow Packing Instructions 650. Infectious human or animal patient specimens: Any material collected directly from a human or animal that is known or expected to be infectious. [67 FR 53142, Aug. 14, 2002, as amended at 71 FR 32261, June 2, 2006; 72 FR 55693, Oct. 1, 2007; 78 FR 1088, Jan. 7, 2013; 80 FR 1160, Jan. 8, 2015; 80 FR 72927, Nov. 23, 2015; 81 FR 35542, June 2, 2016; 85 FR 83399, Dec. 21, 2020; 87 FR 44994, July 26, 2022]. If you are reusing a box, please remove or obscure any old labels from previous uses. substances which are known or a reasonably expected to contain pathogens. Infectious Substances that fall in both Category A and Category B (excluding UN3291) require triple packaging; this consists of: Leakproof primary receptacle (s) Leakproof secondary packaging Absorbent material Cushioning (if more than 1 primary receptacle, they must be individually wrapped) (3) The secondary packaging must be leakproof. This course may be taken by those needing Initial or Recurrent training. Pre-labeled outer packaging and Category B Substance labels can be ordered from ourSupply Storefront or purchased from multiple vendors. The total maximum quantity for a package containing Category B infectious substances is 4 L (liquids) or 4 kg (solids). (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. You can learn more about the process (2) Absorbent material must be placed between the primary receptacle and secondary packaging. In addition to complying with the requirements in this paragraph (d), dry ice and liquid nitrogen must be offered for transportation or transported in accordance with the applicable requirements of this subchapter. Infectious substances assigned to UN 3373, which are packed and marked in accordance with this packing instruction are This field is for validation purposes and should be left unchanged. Emergency Response Guide No. You can Infectious substances in Category B must be assigned to UN 3373. Category B: Shipping Label for Biological Substances The label below should print with the proper dimension of an Infectious Substance label (minimum dimensions: 50 mm on a side, and the proper shipping name, "Biological Substance, Category B" must be in letters at least 6 mm high). This information can be provided as part of the return address or as a separate package notation. ). A Category A infectious substance is one in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. (a) Required Shipper Authorization. (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). You are using an unsupported browser. 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. 001 412 308 5888 . Category B Infectious Substances (USPS) Proper Shipping Name and ID Number All Category B infectious substances must meet the triple packaging requirements of USPS Publication 52, Packaging Instruction 6C, DOT 49 CFR, Section 173.199 and be sent as Express Mail, Priority Mail, or First-Class Mail service. Infectious Substances, Category A (UN 2814 and UN 2900), Biological Substances, Category B (UN 3373), Patient Specimens, and Carbon dioxide, solid (dry ice), Class 9 (UN 1845) The course meets the requirements for training as specified in 49 CFR 172 Subpart H, including testing of participants. Microsoft Edge, Google Chrome, Mozilla Firefox, or Safari. If you are unsure if your shipment is considered an infectious substance, EHS will research your item and advise you. Infectious substance means a material known or reasonably expected to contain a pathogen. contact the publishing agency. The in-page Table of Contents is available only when multiple sections are being viewed. (c) Medical devices or equipment contaminated with or containing other dangerous goods that meet the definition of another hazard class, medical devices or equipment potentiallycontaminated with or containing infectious substances which are being transported for disinfection, cleaning, sterilization, repair, or equipment evaluation are not subject to theprovisions of these Regulations if packed in packagings designed and constructed in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents. Biological Substances Category B. If you work for a Federal agency, use this drafting Ground transportation:Specimens via ground transportation can be shipped using the Code of Federal Regulations (CFR) Title 49. - Other Regulations Relating to Transportation, - Pipeline and Hazardous Materials Safety Administration, Department of Transportation, - Shippers - General Requirements for Shipments and Packagings, - Non-bulk Packaging for Hazardous Materials Other Than Class 1 and Class 7, https://www.ecfr.gov/current/title-49/subtitle-B/chapter-I/subchapter-C/part-173/subpart-E/section-173.199. Flexible secondary packaging is usually labeled 95 kPa by the manufacturer. Classification of Division 6.2 Infectious Substances 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. This contact form is only for website help or website suggestions. The eCFR is displayed with paragraphs split and indented to follow Certain limited quantities of flammable liquids and solids containing ethyl alcohol are permitted in the domestic mail via air transportation, with special authorization from the manager, Product Classification when all applicable requirements in343.27are met. Exception to Infectious shipping. (1) Ice or dry ice must be placed outside the secondary packaging or in an overpack. Category B: An infectious substance that does not meet the criteria for inclusion in Category A. Category B - An infectious substance not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. A47 - Genetically modified micro-organisms and genetically modified organisms, which meet the definition of an infectious substance and the criteria for inclusion in Division 6.2 (Category A or Category B Infectious Substances), must be transported as UN 2814, UN 2900 or UN 3373, as appropriate. Except as provided in this paragraph (a), Category B infectious substances are excepted from all other requirements of this subchapter when offered for transportation or transported in accordance with this section. Subscribe to: Changes in Title 49 :: Subtitle B :: Chapter I :: Subchapter C :: Part 173 :: Subpart E :: Section 173.199. Air transportation:When shipping via air transportation, there are more detailed instructions found in theInternational Civil Aviation Organization(ICAO) technical instructions, or the more commonly usedInternational Air Transport Association(IATA) regulations. A Category B infectious substance must be described as "Biological substance, Category B" and assigned identification number UN3373. developer resources. In addition to pathogens, this category includes human or animal material such as excreta, secreta, blood, tissue, tissue fluids and body parts transported for research, diagnosis, disease treatment or prevention. Infectious Substances that fall in both Category A and Category B (excluding UN3291) require triple packaging; this consists of: Leakproof primary receptacle (s) Leakproof secondary packaging Absorbent material Cushioning (if more than 1 primary receptacle, they must be individually wrapped) Comments or questions about document content can not be answered by OFR staff. 2. (4) If residual liquid may be present in the primary receptacle during transportation, then the material must be transported in accordance with requirements in paragraph (b) of this section. Category B Infectious Substance Packaging Instructions Category B infectious substances are infectious but do not meet the criteria for Category A (i.e., they are not capable of causing permanent disability, life-threatening, or fatal disease when exposed to humans or animals). Category A Agents The U.S. public health system and primary healthcare providers must be prepared to address various biological agents, including pathogens that are rarely seen in the United States. If ice is used, the outside packaging must be leakproof or must have a leakproof liner. High-priority agents include organisms that pose a risk to national security because they can be easily disseminated or Substance in form capable of causing permanent disability or life-threatening injury to humans or animals. (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. Differentiation Between Category A and Category B Infectious Substances . Examples of biological material that would be shipped in this category include: Adenovirus (replication competent). Use the navigation links in the gray bar above to view the table of contents that this content belongs to. learn more about the process here. must Interior supports must be provided to secure the secondary packagings in the original position. (2) Absorbent material must be placed between the primary receptacle and secondary packaging. Category B infectious substances. 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 proper shipping name "Biological Substance, Category B" in letters at least 6mm high must be marked on the outer packaging adjacent to the diamond-shaped mark. This does not include regulated medical waste, which must be assigned identification number UN3291. UN approved packaging used incorrectly will invalidate the performance certification. Visit the. It is the responsibility of the shipper to ensure that they are aware of, and comply with, all . 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. Required prior written Authorization must be obtained from: PCC Postal Administrators Award Spreadsheets, Area Inspiring Mail (AIM) National Meeting - July 28, 2021, Hazardous, Restricted, and Perishable Mail Instructions, Correct and Standardize Your Address List, Undeliverable-as-Addressed (UAA) Mail Statistics, Acceptance of Returned International Mail, Mailer Diversion Notification and Request Log, Informed Delivery PostalOne! If you would like to comment on the current content, please use the 'Content Feedback' button below for instructions on contacting the issuing agency. This content is from the eCFR and may include recent changes applied to the CFR. result, it may not include the most recent changes applied to the CFR. Each primary receptacle containing a liquid must be leakproof and surrounded by absorbent . You should always consult with the DOT if you are unsure if a substance is classified as a Category A or a Category B. This is an automated process for Category B An infectious substance not in a form capable of causing permanent disability or life- Examples of pathogens include bacteria, viruses, fungi, and other infectious agents. This document is available in the following developer friendly formats: Information and documentation can be found in our Atlanta, GA 30329 Phone: 404.639.4129 Category B Infectious Substance Package, label, and ship low- or moderate-risk specimens as a Category B infectious substance (UN 3373) in accordance with the U.S. Department of Transportation's Hazardous Materials Regulations and the International Air Transport Association Dangerous Goods Regulations. . Questions? Please do not provide confidential Biological Substance, Category A: an infectious substance which 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. Title 49 was last amended 11/03/2022. Examples of pathogens include bacteria, viruses, fungi, and other infectious agents. whole organs or whole bodies known to contain or suspected of containing an infectious substance. "Published Edition".
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