Category A infectious substances are human and animal pathogens which, when exposed, are capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans and which are listed as Category A infectious substances (ADR 2.2.62.1.4.1 / IATA).They include, but are not limited to: Category B: An infectious substance that does not meet the criteria for inclusion in Category A. Quotes? (3) Secondary packagings must be secured in rigid outer packagings with suitable cushioning material such that any leakage of the contents will not impair the protective properties of the cushioning material or the outer packaging. (4) 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. . - 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. learn more about the process here. Transporting Infectious . This certainly is subject to questioning by Customs officials and airline staff. The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. A Category B substance is an infectious substance which does not meet the criteria for inclusion in Category A. here. Specimen Collection & Handling Instructions, Code of Federal Regulations (CFR) Title 49, International Civil Aviation Organization. An element of professional judgment is required to determine if a substance is exempt under this paragraph. Such preservatives are not subject to the requirements of this subchapter. eDoc Technical Support for Mailers, Mailers' Technical Advisory Committee (MTAC), MTAC Meeting Agendas, Presentations and Webinars, Membership and Administrative Information, User Group, Work Group, and Task Team Information, PCC Postal Administrators Quick Start Guide. 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. (5) Except for packages containing body parts, organs, or whole bodies, for shipment by aircraft, the outer packaging may not contain more than 4 kg (8.8 pounds), including any material used to stabilize or prevent degradation of the samples. 5101-5128, 44701; 49 CFR 1.81, 1.96 and 1.97. The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. This content is from the eCFR and may include recent changes applied to the CFR. Category A infectious substances should not be transported at all, but labeled as such if done, bearing a UN number 2814. This information can be provided as part of the return address or as a separate package notation. is available with paragraph structure matching the official CFR the hierarchy of the document. In addition to Category B infectious substances, cultures . Their Hazardous Materials Information Center can be reached at 1-800-HMR . Cultures . What is an Infectious Substance, Category B (also known as Biological Substance, Category B)? Category B An infectious substance not in a form capable of causing permanent disability or life- Biological Substances Category B. You contact the publishing agency. Category B infectious substances offered for transportation or transported under the provisions of this section are subject to the incident reporting requirements in 171.15 and 171.16 of this subchapter and to the requirements in 175.75(b) of this subchapter concerning cargo location. Contact EHS, (831) 459-2553. A mailpiece known or suspected to contain a Category B infectious substance must bear the proper shipping name "Biological Substance, Category B" and must be assigned to and marked with identification number UN3373 (as shown in Exhibit 346.12 a . The outer packaging limitation does not include ice, dry ice, or liquid nitrogen when used to maintain the integrity of the material. This does not include regulated medical waste, which must be assigned identification number UN3291. Except as provided in paragraph (a)(9) of this section, a Category B infectious substance meeting the definition of a hazard class other than Division 6.2 must be offered for transportation or transported in accordance with applicable requirements of this subchapter. All Category B specimens must be packed, labeled and documented according to the US Department of Transportation (DOT) Hazardous Material Regulations (HMR) 49 CFR 100-185 Infectious substance (specimen) Absorbent material (for liquids) Biohazard symbol must be present on primary or secondary container. The in-page Table of Contents is available only when multiple sections are being viewed. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. 49 U.S.C. An infectious substance which, when exposure to it occurs, is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals. or existing codification. Category B Infectious Substances Category B Infectious Substances Infectious substance means a material known or reasonably expected to contain a pathogen. (d) Refrigerated or frozen specimens (ice, dry ice, and liquid nitrogen). This course may be taken by those needing Initial or Recurrent training. 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) Category B Infectious substance. The primary receptacle and secondary packaging must maintain their integrity at the temperature of the refrigerant used, as well as the temperatures and pressures of transport by aircraft they could be subjected to if refrigeration were lost, and sufficient absorbent material must be provided to absorb all liquid, including melted ice. If you have questions or comments regarding a published document please 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. In order to ship compliantly, the shipper must use the correct packaging for Category A and Category B Infectious Substances and ensure it is assembled as per the packaging manufacturers instructions. substances which are known or a reasonably expected to contain pathogens. Category B Infectious Substances . Regulated Medical Waste - a waste or reusable material derived from the medical treatment of an animal or human. Category B Infectious Substances are Infectious Substances that do not meet the criteria for inclusion in Category A. At least one surface of the outer packaging must be 4 x 4 inches. ). An infectious substance must be assigned to one of the following two packaging categories: Category A: Category A infectious substances are not mailable. Amdt. Exception to Infectious shipping. 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) Shipments of UN3373 can be declared online or by using the Purolator E-Ship Server by choosing the UN3373 option in the . However, this packaging can also be used to transport Category B infectious substances and clinical, (bio) medical or regulated waste. Category B substances are infectious substances which do not meet the criteria for inclusion in Category A. 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. Dry Ice (UN1845) 49 CFR 173.217. A pathogen is a microorganism that can cause disease in humans or animals. Thereof, what are Category A infectious substances? This content is from the eCFR and is authoritative but unofficial. 271 S Pleasant Street Read more. (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). Visit the. Examples of pathogens include bacteria, viruses, fungi, and other infectious agents. Once the relevant state of approval authority verifies the packages performance and is happy the packaging adheres to all requirements, a UN mark is assigned to the packaging and a certification is issued. A mailpiece known or suspected to contain a Category B infectious substance is mailable as described in, 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 in, For ideas on new or existing Promotions, please fill out, Looking to implement tech in your mail? Cookies are used for personalised advertising.Learn More. 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. (b) Liquid Category B infectious substances. Mailing Standards for COVID-19 related Category B Infectious Substances. Let us know, we're here to help, Air Sea USA 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. Category B infectious substances. If ice is used, the outside packaging must be leakproof or must have a leakproof liner. Learn more about the eCFR, its status, and the editorial process. Vacuum-filled receptacles (e.g., blood tubes) generally meet 95 kPa; however, check with the manufacturer to ensure that they meet the requirement. A copy or electronic image of these instructions must be retained by the manufacturer and subsequent distributors for at least one year from the date of issuance, and made available for inspection by a Federal or state government representative upon request. Infectious substances in Category B must be assigned to UN 3373." (Dangerous Goods Regulations, 3.6.2.2.2.2) (e) Training. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. Infectious substances assigned to UN 3373, which are packed and marked in accordance with this packing instruction are Browse special provision A82 (8) Packing Authorizations (173. This packaging is intended to transport an infectious substance of Category A in a form of culture or infectious substance of Category A meeting the requirements of Subsection 2.36 (3) of the TDG Regulations. They are assigned the following UN numbers and proper shipping names: UN 2900 - Infectious Substance, affecting animals only. 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. Category B infectious substances offered for transportation or transported under the provisions of this section are subject to the incident reporting requirements in 171.15 and 171.16 of this subchapter and to the requirements in 175.75(b) of this subchapter concerning cargo location. A separate drafting site (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). 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. Clinical or medical waste that contains category B infectious substances (with the exception of cultures), or that only has a low probability of containing infectious substances, is. This web site is designed for the current versions of Infectious human or animal patient specimens: Any material collected directly from a human or animal that is known or expected to be infectious. (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. Concerns? Solid Category B infectious substances must be packaged in a triple packaging, consisting of a primary receptacle, secondary packaging, and outer packaging, conforming to the following provisions: (1) The primary receptacle must be siftproof. formatting. One of our team will get back to you as soon as possible. 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 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. (8) For transportation by aircraft, each package, overpack, pallet, or unit load device containing a Category B infectious substance must be inspected for leakage when it is unloaded from the aircraft. Examples of pathogens include bacteria, viruses, fungi, and other infectious agents. The Dangerous Goods section of the International Air Transport Association (IATA) website provides a "Classification of Infectious Substances" document (pdf). Contact Form. They don't cause permanent disability, life-threatening or fatal diseases in otherwise healthy 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. A solid material that may become liquid during transportation must be transported in accordance with paragraph (b) of this section. Biological Substance, Category Bmeans an infectious substancethat is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. 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. UN approved packaging used incorrectly will invalidate the performance certification. Infectious substance means a material known or reasonably expected to contain a pathogen. 001 412 308 5888 It is not an official legal edition of the CFR. Except as provided in paragraph (a)(9) of this . (4) The completed package must be designed, constructed, maintained, filled, its contents limited, and closed so that under conditions normally encountered in transportation, including removal from a pallet or overpack for subsequent handling, there will be no release of hazardous material into the environment. It is the responsibility of the shipper to determine the classification of any infectious substance. (a) Required Shipper Authorization. Infectious substances in Category B must be assigned to UN 3373. 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). At least one surface of the outer packaging must have a minimum dimension of 100 mm by 100 mm (3.9 inches). 3.6.2.2.2.2 Category B: An infectious substance which does not meet the criteria for inclusion in Category A. (2) Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents into the secondary packaging. Displaying title 49, up to date as of 11/04/2022. So, you know you are purchasing compliant packaging, you may want to ask your packaging manufacturer to provide you proof of certification that their packaging meets the require testing standards for shipping infectious substances. The absorbent material must be of sufficient quantity to absorb the entire contents of the primary receptacles and not compromise the integrity of the cushioning material or the outer packaging. If you use any of the following clinical or Temp-Assure (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. Category A Infectious Substances. switch to drafting.ecfr.gov. What is Category B infectious substances? (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. Either set of regulations is compliant with theFederal Aviation Administration(FAA). If dry ice is used, the outside packaging must permit the release of carbon dioxide gas and otherwise meet the provisions in 173.217. An important note but one often overlooked is that when using UN approved packaging, it must be assembled and the infectious substance packed in the exact same way that the packaging was tested for. Package effectiveness must not be substantially reduced for minimum and maximum temperatures, changes in humidity and pressure, and shocks, loadings and vibrations normally encountered during transportation. HMZ Hazardous Materials Regulation. Request a Callback [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]. Category B: An infectious substance that does not meet the criteria for inclusion in Category A. If you are reusing a box, please remove or obscure any old labels from previous uses. Category B Infectious Substances. (Air shipments). 2. This document is available in the following developer friendly formats: Information and documentation can be found in our Medical equipment which has been drained of free liquid and meets the requirements of this. (9) A packaging containing inner packagings of Category B infectious substances may not contain other hazardous materials except -. (3) The secondary packaging must be siftproof. 173.199 Category B infectious substances. 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) (2) Absorbent material must be placed between the primary receptacle and secondary packaging. ***) (8A) Exceptions: 134 . Click "" to place only functional and analytical cookies. They include: Cultures, patient specimens and biological material containing or consisting of: If you are unsure if your shipment is considered an infectious substance, EHS will research your item and advise you. An infectious substance which does not meet the criteria for inclusion in Category A. . You must refer to the relevant regulations to identify whether your substance falls under exceptions as some exceptions do require specific packaging when transporting. If secondary packaging is not pre-labeled, add an international biohazard label to the secondary packaging. High-priority agents include organisms that pose a risk to national security because they can be easily disseminated or 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! Examples of Infectious Substances/ (Category A and B) Page 1 Last Updated: 06/14/2017 Examples of Infectious/Biological Substances Included in Category A or Category B (*only when cultured) Microorganism Category A Category B UN Number African swine fever virus X* X 2900 Avian paramyxovirus Type 1 - Velogenic Newcastle disease virus X* X 2900 . 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). Cleveland Clinic Laboratories offers online courses for those in need of training and certification in specimen transportation. Differentiation between the two categories lies in the definitions stated above. Identify who must receive training in packaging and shipping infectious materials, what must be included in the training, and what records must be maintained. evaluation of vaccine induced immunity, diagnosis of autoimmune disease, etc. All Class 6 Infectious Substances (Division 6.2), are or will be assigned to one of four UN Numbers; UN2814, Infectious substance, affecting humans, UN2900, Infectious substance affecting animals, UN3291, Clinical waste unspecified n.o.s or (Bio) medical waste n.o.s or Regulated medical waste n.o.s. To gain UN approval, the manufacturers designed package is sent to and tested by an independent testing company, if the packaging successfully passes the tests, it is then sent for verification to the relevant state approval authority for approval. 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). Examples of Infectious and Biological Substances (Category A and B) Examples of Infectious Substances and Biological Substances (Category A and B) Page 2 Last Updated: 07/17/2019 Hantavirus causing haemorrhagic fever with renal syndrome X Hendra virus X Hepatitis B virus cultures X (Always) Other materials containing the Hepatitis B virus X .