{"operation":"document","citation":"15-0170","title":"Inmark Packaging — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2016-02-10","effective_on":null,"summary":"15-0170 response to Inmark Packaging concerning 178.609.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0170.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0170.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-15-0170","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2016/150170.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nFEB l O 2016\nMr. Jay Johnson\nRegulatory Compliance\nInmark Packaging\n675 Hartman Road, Suite 100\nAustell, GA 30168\nRef. No.: 15-0170\nDear Mr. Johnson:\nThis is in response to your August 5, 2015 email requesting clarification of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 171-180) concerning the testing of specification\npackagings. Specifically you seek confirmation of your understanding that packagings for\nCategory A infectious substances tested with liquids can be used with a solid material.\nFor the purposes of testing a packaging for infectious substances, each primary receptacle\nmust be filled with a liquid even ifthe package is intended to contain a solid material. In\naccordance with§ 178.609(b) samples of each packaging must be prepared as for transport\nexcept that a liquid or solid infectious substance should be replaced by water or where\nconditioning at -18 °C (0 °F) is specified by water/antifreeze.\nI hope this information is helpful. If you have further qu~stions, please do not hesitate to\ncontact this office.\nSincerely,\n~~~ ~. lftC-l\nDuane A. Pfund V \\\nInternational Standards Coordinator\nStandards and Rulemaking Division\n\n<<<PAGE 2>>>\n\nGoodall, Shante CTR (PHMSA)\nFrom:\nSent:\nTo:\nSubject:\nAttachments:\nFoster, Glenn (PHMSA)\nFriday, August 07, 2015 11:22 AM\nDodd, Alice (PHMSA); Goodall, Shante CTR (PHMSA)\nQuestion about Category A infectious packaging\n043-0125-e-ne-cd-01_2015-05-15.pdf; TC CGSB 43-125-99.pdf\nAlice /Shante,\nJay Johnson replied with his missing attachment per my request below. Please use this email and the supporting\ndocumentation to create and assign a new lnterp letter.\nThanks,\nGlenn\nFrom: Jay Johnson [mailto:jayj@inmarkinc.com]\nSent: Friday, August 07, 2015 11:12 AM\nTo: Foster, Glenn (PHMSA)\nSubject: RE: Question about Category A infectious packaging\nHello Glenn\nHere are the attachments.\nKind Regards,\nJay Johnson, DGSA I Regulatory Compliance Manager\nIEXAKTl.il!1.:I\nAN INMARK BRAND\n675 Hartman Road, Suite 100 Austell GA 30168\no 770-373-3300 Id 770-373-3356 I m770-377-0205 If 770-373-3357 f e iayj@inmarkpackaging.com\nFollow us at:\nC!fmO\nVisit our website or lnmarkPackaging.com to learn more about our products and services.\nPlease consider the environment before printing this e-mail.\nConfidentiality Notice:\nThis communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 U.S.C. Section 2510,\nand its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, and any attachments, may contain\nconfidential information. If you are not the intended recipient, any disclosure, copying, distribution or use of any of the information contained in or\n1\n\n<<<PAGE 3>>>\n\nattached to this transmission is STRICTLY PROHIBITED. Please contact us immediately by return e-mail or at +1-770-373-3300 and destroy the original\ntransmission and its attachments without reading or saving in any manner.\nFrom: Glenn.Foster@dot.gov [mailto:Glenn.Foster@dot.gov]\nSent: Thursday, August 06, 2015 12:16 PM\nTo: Jay Johnson\nSubject: RE: Question about Category A infectious packaging\nJay,\nThe scan you mentioned attaching did not come through. Can you re-send?\nThanks,\nGlenn\nFrom: Jay Johnson [mailto:jayj@inmarkinc.com]\nSent: Wednesday, August 05, 2015 12:38 PM\nTo: Foster, Glenn (PHMSA); Stevens, Michael (PHMSA); Supko, Ben (PHMSA)\nCc: Betts, Charles (PHMSA); Frank Orvino; David Creighton; Goodall, Shante CTR (PHMSA); Dodd, Alice (PHMSA)\nSubject: RE: Question about Category A infectious packaging\nHey Glenn,\nThanks for addressing this question of Canadian Approval.\nI have attached a scan of the CGSB 43.125-99. I believe the section they are currently looking at is 4.2.2.1.\nThere is an update in the review process (also attached). The update clearly outlines the liquid/solid situation in 7.2.1.2\nof the Canadian Regulations on page 17 by requiring that infectious packaging (liquid or solid) be tested with water.\n\"7.2.1.2 Each primary receptacle shall be filled not less than 98% of its capacity. Liquid or solid infectious substance shall\nbe replaced by water or, where conditioning at-18°C is specified, by water/antifreeze with a minimum specific gravity of\n0.95.\"\nBest regards,\nJay\nFrom: Glenn.Foster@dot.gov [mailto:Glenn.Foster@dot.gov]\nSent: Wednesday, August 05, 2015 12:20 PM\nTo: Jay Johnson; michael.stevens@dot.gov; Ben.Supko@dot.gov\nCc: charles.betts@dot.gov; Frank Orvino; David Creighton; shante.goodall.ctr@dot.gov; Alice.Dodd@dot.gov\nSubject: RE: Question about Category A infectious packaging\nHello Jay,\nWe will have your inquiry checked in as a request for a letter of Interpretation.\nThanks,\nGlenn\n2\n\n<<<PAGE 4>>>\n\nFrom: Jay Johnson [mailto:iavi(a)inmarkinc:.com]\nSent: Wednesday, August 05, 2015 11:56 AM\nTo: Stevens, Michael (PHMSA); Supko, Ben (PHMSA); Foster, Glenn (PHMSA)\nCc: Betts, Charles (PHMSA); Frank Orvino; David Creighton\nSubject: Question about Category A infectious packaging\nGood Morning,\nI have a quick question about UN specification packaging. We have an infectious packaging system (STP-100) that has\nbeen UN certified in Canada for 30 plus years.\nThe packaging system relies on a secondary pressure canister and has been tested with a wide variety of primaries. The\nsystem successfully passed all of the test requirements with liquid inside the primaries without failure. We have been\nasked by a DOT Inspector in TX if our packaging system can be used to ship solid media cultures since it was tested with\nliquids instead of solid cultures.\nI sent he following question to Transport Canada about our Division 6.2 packaging system certified in Canada:\nWe have been asked by a DOT inspector if the packaging system can be used to ship solid media cultures since it\nwas tested with liquids instead of solid cultures.\nThe stringent requirements for Category A infectious substance packaging do not differentiate between liquid\nand solid on the UN specification marking for 4G so the question to you would be:\nCan shippers use all the different primaries that were tested in the system with the volume limitations indicated\nin the packaging instructions but fill the vials with solid/semi-solid culture media instead of liquid?\nHere is the response from Transport Canada:\nFrom: Bernier, France [mailto:france.bernier@tc.gc.ca]\nSent: Wednesday, August 05, 2015 9:02 AM\nTo: Jay Johnson\nCc: Garneau, Stephane\nSubject: RE: Question about category A infectious packaging\nGood morning Mr. Johnson,\nYes, it is possible. There is no prohibition in the CGSB-43.125-99 standard against using a packaging tested for liquids to\ntransport solids.\nRegards,\nFrance Bernier\nDangerous Goods Container Specialist I Specialiste de contenants pour les marchandises dangereuses\nPh/Tel: (613) 998-0798\nfrance.bernier@tc.gc.ca\nTransport Canada, Transport Dangerous Goods I Transports Canada, Transport des marchandises dangereuses\nPlace de Ville tower \"C' 9th floor I tour \"C\" 9ieme etage\n330 Sparks Street 1330 rue Sparks, Ottawa ON K1A ON5\nI.I iran:spcrl Tfansporis\nCanada C3nada\nDoes this answer from Canada satisfy the question from the DOT Inspector in TX about how our infectious packaging\nwas tested and approved in Canada for use with solids while tested with a liquid?\n3\n\n<<<PAGE 5>>>\n\nDo any of the US regulations contradict this answer or require us to do anything different when using this Canadian\nApproved UN specification packaging in the United States?\nKind Regards,\nJay Johnson, DGSA I Regulatory Compliance Manager\nIEXAKTI iltl :1\nAN INMARK BRAND\n675 Hartman Road, Suite 100 Austell GA 30168\no 770-373-3300 I d 770-373-3356 I m770-377-0205 If 770-373-3357 I e jayj@inmarkpackaging.com\nFollow us at:\nmono\nVisit our website or lnmarkPackaging.com to learn more about our products and services.\nPlease consider the environment before printing this e-mail.\nConfidentiality Notice:\nThis communication constitutes an electronic communication within the meaning of the Electronic Communications Privacy Act, 18 U.S.C. Section 2510,\nand its disclosure is strictly limited to the recipient intended by the sender of this message. This transmission, and any attachments, may contain\nconfidential information. If you are not the intended recipient, any disclosure, copying, distribution or use of any of the information contained in or\nattached to this transmission is STRICTLY PROHIBITED. Please contact us immediately by return e-mail or at +1-770-373-3300 and destroy the original\ntransmission and its attachments without reading or saving in any manner.\n4\n\n<<<PAGE 6>>>\n\nCAN/CGSB-43.125-99\nSupersedes CAN/CGSB-43.l 25-M90\nCANADIAN GENER-\\L STANDARDS BOARD\nPACKAGING OF INFECTIOUS SUBSTANCES, DIAGNOSTIC SPECIM:ENS,\nBIOLOGICAL PRODUCTS AND BIOl\\1EDICAL \\VASTE FOR TRANSPORT\n1. SCOPE\n1. I This standard contains requirements for the design, manufacturing and marking for three types of means of\ncontainment used for the transportation of Class 6.2 dangerous goods (infectious substances), diagnostic specimens,\nbiological products and biomedical waste.\nType IA (high integrity)\nType 1 B (routine)\nType JC (waste).\n1.2 This standard includes the performance-based design criteria and marking requirements from Chapter 6.3 of the UN\nRecommendations on the Transpdn of Dangerous Goods, Model Regulations.\n1.3 This standard does not inform shippers as to which of these packaging types must be used for their particular\nshipment. The l4TA Dangerous Goods Regulations (for international or domestic air transport) or the TDC\nRegulations (for domestic transport, all modes) must be consulted to determine which packaging type (IA, IB, l C)\nis required.\n1 A The testing and evaluation of a product against this standard may require the use of materials and/or equipment that\ncould be hazardous. This document does not purport to address all the safety aspects associated with its use. Anyone\nusing this standard has the responsibility to consult the appropriate authorities and to establish appropriate health\nand safety practices in conjunction with any applicable regulatory requirements prior to its use.\n2. REFERENCED PUBLICATIONS\n2.1 The following publications are referenced in this standard:\n2.1.1 Canadian General Standards Board (CGSB)\nCAN/CGSB-43.150-97 - Performance Packagings for Transportation of Dangerous Goods.\n2.1.2 Canadian Standards Association (CSA)\nCAN/CSA-ISO 9003-94 - CSA Z3l 6.6-95 - Quality Systems - Model for Quality Assurance in Final Inspection and Test\nEvaluation of Single Use Medical Sharps Containers for Biohazardous and Cytotoxic Waste.\n2.1.3 Department of Transport {Transport Canada)\nTransportation of Dangerous Goods Act, 1992 (including amendments)\nTransportation of Dangerous Goods Regulations (including amendments).\n2.1.4 Railway Association of Canada (RAC)\nRAC 6000-A -- Railway Packaging Standards.\n2.1.5 American Society for Testing and Materials (AS1M)\nD 951-94 - Standard Test Method for Water Resistance of Shipping Containers by Spray Method\nD 1709-97 - Standard Test Methods for Impact Resistance of Plastic Film by the Free-Falling Dart Method\nl\n\n<<<PAGE 7>>>\n\nf-\" 1922-94a --- Standard Test Method for Propagar.ion Tear Resistance of Plastic Film and Thin Sheeting by\nPendulum Method\nD 499 -94 - Standard Tes! Method for Leakage Testing of Empty Rigid Containers by Vacuum Method\nD 5276-94 - S1andard Test Method for Drop Tesr of Loaded Containers by Free Fall.\n2.1.6 International Air Transport Association (IATA)\nDangerous Goods (39th edition).\n2.1.7 Technical Association of Pulp and Paper Industry (TAPPI)\nT802 OM-91 - Drop Test for Fibreboard Shipping Containers\nT8!0 OM-92 - Strength of Corrugated and Solid Fiberboard\nT8 l 1 OM-95 - Edgewise Compressive Strength of Corrugated Fiberboard (Short Column Test).\n2.1.8 United Nations\nRecommendations on the Transport of Dangerous Goods, Model Regulations (tenth revised edition).\n2.1.9 United States Department of Defense\nMIL-D-6055C-1970 - Drums, Metal. Reusable Shipping and Storage (Capacity from 88 to 510 Cubic Inches).\n2.2 The sources of these publications are shown in the Notes section.\n3. DEFL'\\IITIONS\nThe following definitions apply in this standard. Where there is a conflict between the definition in this standard and\nthat of the TDG Regulations, the definition in the TDG Regulations shall apply.\nBiological Product (Produit biologique)\nA product derived from living organisms that is used to prevent, treat or diagnose disease in humans or animals or\nthat is used for developmental, experimental or investigational purposes.\nBiomedical Waste (Dechets b10medicaux)\nMedical waste that is derived from animals or humans or from bio-research;\nCombination Packaging (Emballage combine)\nA packaging consisting of one or more inner packagings contained in an outer packaging for transport.\nDiagnostic Specimen (Echantillon de diagnostic)\nAny human or animal material including excreta, secreta, blood and its components, tissue and tissue fluids that is\nbeing offered for transport.\nDirector (Directeun\nDirector, Regulatory Affairs Branch, Transport Dangerous Goods Directorate, Transport Canada.\nInfectious Substances (Matieres infectieuses)\nSubstances known or reasonably expected to contain pathogens that are micro-organisms that are known or\nreasonably expected to cause disease in humans or animals as defined by the TDC Regulations.\nInner Packaging (Emballage interieur)\nA packaging for which an outer packaging is required for transport.\nMedical Professional (Professionnel de la same)\nA doctor, scientist. veterinarian, epidemiologist, genetic engineer, microbiologist, pathologist, nurse, coroner,\nlaboratory technologist or laboratory technician.\nOuter Packaging (Emballage extfoeur)\nThe outer protection of a combination packaging (excluding an overpack) together with any absorbent materials,\ncushioning and any other components necessary to contain and protect primary receptacles or inner packagings.\n2\nCAN/CGSB-43.125-99\n\n<<<PAGE 8>>>\n\nI\nThe of the packing operation, consis1ing of the packaging and its contents prepared for transport.\nPackaging (EmballageJ\nA receptacle and any other components or material~ necessary for the receptacle to perform its containment\nfunction.\nPackage Design type d'emballage)\nPackaging of the same design size, materials and thickness, manner of construction (including the inner and outer\npackagings) and packing.\nPrimary Receptacle primaire)\nA receptacle in contact with the substances or articles w be shipped.\nRisk (Groupes de risques)\nA group into which infectious substances are assigned in accordance with the TDG Regulations based on\nability to cause disease, their ability to spread that disease and the severity of that disease.\ntheir\nSecondary Inner (Emballage interieur secondaire)\nAn inner packaging that provides additional protection for the primary receptacle(s) and the absorbent material.\n4. REQUIREMENTS FOR TYPE IA\n4.1 Description - Type IA is used where a high integrity package is required. Type IA is based on the design and\nmarking requirements of Chapter 6.3 and Packing Instruction 620 of the UN Recommendations on the Transport of\nDangerous Goods, Model Regulations and Packing Instruction 602 of the JATA Dangerous Goods _Regulations.\n4.2 Components\n4.2.1 The package shall include:\na. An inner packaging comprising:\nL watertighi primary receptacle(s)\nii. watertight secondary packaging\nm. absorbent material in sufficient quantity to absorb the entire contents of the primary receptacle(s), which is\nplaced between the primary receptacle(s) and the secondary packaging. If multiple primary receptacles are\nplaced in a single secondary packaging, they shall be individually wrapped or separated to prevent contact\nbetween them. The manufacturer shall notify the purchaser (user of the container) of this requirement and,\nwhere the manufacturer provides the absorbent, of its adsorption properties; and\nb. an outer packaging of adequate strength for its capacity, mass and intended use of which the smallest external\ndimension is at least l 00 mm.\n4.2.2 Other than for exceptional consignments (e.g. whole organs that require special packaging), substances shall be\npacked in accordance with the following.\n4.2.2. J Liquid or Solid Substances\nSubstances Consigned at Ambient Temperature or Higher -- The primary receptacles shall be made of glass, metal\nor plastics. A positive means of ensuring a leakproof seal shall be provided.\nSubsiances Consigned Refrigerated or Frozen - Ice or dry ice shall be placed outside the secondary packaging(s).\nInterior suppons shall be provided w secure secondary packaging(s) in position after the ice or dry ice has\ndissipated. If ice is used, the outer packaging shall be leakproof. If dry ice is used, the outer packaging shall permit\ntbe release of carbon dioxide gas. The primary receptacle and the secondary packaging shall maintain their integrity\nat the temperature of the refrigerant used.\nSubstances Consigned in Liquid Nitrogen - Plastic primary receptacles shall be capable of withstanding very low\ntemperatures. The secondary packaging shall also be capable of withstanding very low temperatures. Provisions for\nCAN/CGSB-43.125-99 3\n\n<<<PAGE 9>>>\n\ntue consignment of nitrogen shall also be fulfilled. The primary recepmcl e and the secondary packaging shall\nmaintain their rntegrity at the temperature of the liquid nitrogen.\n4.3 Temperature Resistance - Whatever the intended temperature of the consignment, the primary receptacle or the\nsecondary packaging shall be capable of withstanding temperatures in the range of -40 to +55°C 1\n•\n4.4 Internal Pressure - The primary receptacle or the secondary packaging shall withstand an internal air pressure or\npressure differential of not less than 95 kPa without leakage when tested in accordance with ASTM D 4991-94 for\nrigid packaging or in accordance with par. 7.1.\n4.5 Drop and Impact Resistam:e\n4.5.1 Packages shall be subjected to the tests .in Table 1, which for test purposes categorizes packagings according to their\nmaterial characteristics. For outer packagings, the headings in the table relate to fibreboard or similar materials\nwhose performance may be rapidly affected by moisture; plastics that may embrittle at low temperatures; and other\nmaterials (such as metal) whose perfonnance !snot affected by moisture or temperature. If a primary receptacle and\na secondary packaging of an inner packaging are made of different materials, the material of the primary receptacle\ndetermines the appropriate test. When a primary receptacle is made of two materials, the material most liable to\ndamage detem1ines the appropriate test\nTABLE I\nDrop and Impact Tests for Type IA Packages\nComponent of Combination Packaging Requirernents 1\nI Inner\nImpact Test\nOuter Packaging I Packaging Drop Tests (par. 7.3)\nI\nFibre-\nboard Plastic Other Plastic Other (par. 7.2.2) (par. 7.2.3) (par. 7 .2.4) (par. 7.2.5)\nx - - x - x x x to be x\nx x x x conducted x - - - -\nwhen dry\n- x - x - x - x ice is used x\n- x ! - - x i x - x x\n- - x x - x - x x\nI - - x - x x - - x\nNote:\n4.5.2 1 Prior to conducting the drop rests and impact test, paclwges shail be prepared in accordance with par. 72.J.\nDrop Resistance - There shall be no leakage from the primary receptacle(s) which shall remain protected by\nabsorbent material in the secondary packaging after conducting the appropriate drop sequence in accordance with\npar. 7.2.2.\n4.5.3 Impact Resistance - Following each impact of the steel rod, penetration of the secondary packaging is acceptable\nprovided that there is no leakage from the primary receptacle(s) after conducting the test in accordance with par. 7.3.\n4.6 Quality Assurance\n4.6.1 The requirements of this paragraph apply to all packages manufactured after December 31, 1993.\n4.6.2 A Package Design Report shall be completed in the form prescribed in Appendix A for each package design type\nmeeting the requirements for a Type lA packaging.\n4.6.3 Every manufacturer of a Type l A package meeting this standard shall ensure that the details of the design specified\nin the Package Design Report are maintained during production by having and maintaining a quality assurance\n1 It is not required to perfonn the tests at these temperatures.\n4 CAN/CGSB-43.125-99\n\n<<<PAGE 10>>>\n\n4.7\n4. 7. J 4.7.2 4.7 .3 4. 7.4 4.8 4.8.1 4.8.2 system for each facility manufact.uring the packages. The quality assurance system shall meet the requirements of\nCAN/CSA-ISO 9003-94.\nDepartment of (Transport Canada) Certificate of Registration\nA Certificate of Registration shall be issued by the Director or a person designated by the Director, to manufacturers\nof packages meeting the design and production requirements for Type lA packages. 111e Director may issue a\nprovisional Cenificate of Registration. Conformance with the requirements of this standard shall be assessed by\n·Transport Canada or a competent facility designated by the Director. Requests for registration of designs shall be\nsent to the Director, Regulatory Affairs Branch (ASDD), Department of Transport, Ottawa, Ontario KIA ONS.\nProduction of packages, other than test samples, shall not begin umil the manufacturer has been issued a Certificate\nof Registration for the design by Transpon Canada.\nProduction of packages shall not continue more than three years past the date of issue of the Certificate of\nRegistration for the design unless a renewal of the certificate has been issued by the Department of Transport.\nIf an application for the renewal of the Certificate of Registration has been filed at least 60 days prior to its\nexpiration, the production of packages may continue until notification is received from the Department of Transport\nrelating to the renewal. Packages produced up to the receipt of the notice may be used up.\nVariations within a Desi.gn Type\nProvided that an equivalent level of perfonnance is maintained, the following variations in the primary receptacles\nplaced within a secondary packaging are allowed without further testing of the completed package;\na. Primary receptacles of equivalent or smaller size as compared to the tested primary receptacles may be used\nprovided:\nL the primary receptacles are of similar design to the tested primary receptacle (e.g. shape: round, rectangular,\nere.);\nII. the material of construction of the primary receptacle (glass, plastics, metal, etc.) offers resistance to impact\nand stacking forces equal to, or greater than, that of the originally tested primary receptacle;\niii. the primary receptacles have the same or smaller openings and the closure is of similar design (e.g. screw\ncap, friction lid, etc.);\niv. sufficient additional cushioning material is used to take up void spaces and to prevent significant movement\nof the primary receptacles; and\nv. primary receptacles are oriented within the secondary packaging in the same manner as in the tested package.\nb. A lesser number of the tested primary receptacles, or of the alternative types of primary receptacles identified in\npar. 4.8.1 a., may be used provided sufficient cushioning is added to fill the void space(s) and to prevent\nsignificant movement of the primary receptacles.\nInner receptacles of any type may be assembled within a secondary packaging and transported without testing in the\nouter packaging under the following conditions:\na. The secondary and outer packaging combination shall have been successfully tested in accordance with par. 7.3\nwith fragile (e.g. glass) inner receptacles;\nb. The total combined gross mass of inner receptacles shall not exceed one half the gross mass of inner receptacles\nused for the test mentioned in par. 4.8.2 a.;\nc. The thickness of cushioning between inner receptacles and between inner receptacles and the outside of the\nsecondary packaging shall not be reduced below the corresponding thicknesses in the originally tested packaging;\nand if a single inner receptacle was used in the original test, the thickness of cushioning between inner\nreceptacles shall not be less than the thickness of cushioning between the outside of the secondary packaging and\nthe inner receptacle in the original test. When either fewer or smaller inner receptacles are used (as compared to\nthe inner receptacles used in rhe drop test), sufficient additional cushioning material shall be used to take up the\nvoid;\nCAN/CGSB-43.125-99 5\n\n<<<PAGE 11>>>\n\nd. rhe empty outer packaging shall have successfully passed the stacking test in par- 9.6 of CA..L\"\"l/CGSB-43.150-97.\nThe totai mass of identical packages shall be based on the combined mass of inner receptacles used in the test\nmentioned in par. 4.8.2 a.;\ne. For inner receptacles containing liquids, an adequate quantity of absorbent material to absorb the entire liquid\ncontent of the inner receptacles shall be present;\nf. If the outer packaging is intended to contain inner receptacles for liquids and is not leakproof, or is intended to\ncontain inner receptacles for solids and is not siftproof, a means of containing any liquid or solid contents in the\nevent ofleakage shall be provided in the form of a leakproofliner, plastic bag or other equally effective means of\ncontainment.\n4.9 Marking\n4.9 .1 The outer surface of a package that meets the requirements of par. 4.1 to 4.8 shall be marked with:\na. the United Nations packaging symbol;\nb. the code designating the type of package in accordance with the provisions of section 8 of\nCA.N/CGSB-43.150-97;\nc. the text - \"CLASS 6.2\";\nd. the last two digits of the year of manufacture of the package;\ne. the st;;ite authorizing the allocation of the mark (e.g. \"CAN\" for packages manufactured in Canada);\nf. the name or symbol of the manufacturer and the Transport Canada Design Registration Number;\ng. for packages meeting the requirements of par. 4.8.2, the letter \"U\" shall be inserted immediately following the\nmarking required in par. 4.9J b.\nExamples of marking:\n®\n4G/CLASS 6.2/98\n(as in par. 4.9. I a., b., c. and\nCAN/ABC 8-999\n(as in par. 4. 9. J e. and f)\n4.9.2 Symbols used shall be registered with the Department of Transport, Transport of Dangerous Goods, Ottawa, Ontario\nKIA ON5.\n5. REQUIREMENTS FOR TYPE 1B\n5, l Description - Type 1B is suitable for routine shipments (e.g. diagnostic specimens) and is based on Packing\nInstruction 650 of the IATA Dangerous Goods Regulations.\n5.2 Components\n5.2.l The package shall consist of the following components:\na. watertight primary receptacle(s);\nb. watertight secondary packaging;\nc. absorbent material between· the primary receptacle(s) and the secondary packaging. Several primary receptacles\nmay be inside a single secondary inner packaging if each is wrapped individually or separated to prevent contact\nbetween them. Enough absorbent material, such as cotton wool, shall be used to absorb the entire contents of the\nprimary receptacles; and\nd. strong outer packaging.\n6\nCAN/CGSB-43.125-99\n\n<<<PAGE 12>>>\n\n©CGSB 2015 - All rights reserved\nCD-01\nDraft Date: 2015-05-15\nCAN/CGSB-43.125-20XX\nSupersedes CAN/CGSB-43.125-2003\nCGSB Committee 43/27.8\nPackaging of Category A and Categ\n6.2) and clinical a\nectious substances (Class\nmedical waste\nJCS 13.300\n\n<<<PAGE 13>>>\n\nCAN/CGSB-43.125-20XX CD-01\nWarning\nThis document is not a National Standard of Canada. It is a draft distributed to CGSB committee\nmembers and other interested persons for review and comment. This draft is subject to change\nwithout notice and shall not be referred to as a National Standard of Canada.\nRecipients of this document are invited to submit their comments, to advise the CGSB commit e\nof any relevant patent rights that they are aware of, and to provide supporting documenta ·\nThis information should be provided on or before 2015-07-13, to:\nRobert Long\nCanadian General Standards Board\nOttawa, ON\nKlA 1G6\n©CGSB 201S -All rights reserved\n\n<<<PAGE 14>>>\n\nCAN/CGSB-43.125-20XX CD-01\nCopyright notice\n©HER MAJESTY THE QUEEN IN RIGHT OF CANADA, as represented by the Minister of Public\nWorks and Government Services, the Minister responsible for the Canadian General\nStandards Board 2015.\nThis Canadian General Standards Board (CGSB) document is a draft standard. Thi\nmay be reproduced by CGSB committee members participating in its develo\npurposes of this development only. No other reproduction, transmission, t\nor publication of whole or any part of this document may be undert\nwritten permission of CGSB.\nRequests for permission to reproduce, transmit, communic\npublish or otherwise exploit the copyright in the whole\nbe addressed to CGSB at the address or co-ordinates s\nManager, Strategic Standardization Group\nCanadian General Standards Board\nGatineau (Quebec) KlA 1G6\nCANADA\nt\nlating to the reproduction or publication of the whole or any part of this\nt for purposes of sale may be made conditional upon the requester's entering into a\ncensing agreement and the payment of royalties.\n©CGSB 2015 -All rights reserved iii\n\n<<<PAGE 15>>>\n\nCAN/CGSB-43.125-20XX CD-01\nContents Page\nIntroduction ............................................................................................................................................ v\n1\nScope......................................................................................................................... .. ............ 1\n2\nNormative references .................................................................................................... . .......... 2\n3\nTerms and Definitions ................................................................................... .. .. ............... 4\n4\nGeneral requirements ........................................................................ .\n5\nCertification safety mark .................................................................. .. ............................. 10\n6 Construction.......................................................................... .. ....................................... 13\n7. Testing.......................................................................... .. ........................................... 17\n8 Permitted design variations .................................... .. ................................................. 26\n9. Quality management system........................... . ............................................................. 27\n10.\nRegistrat.ion ............................................... . . .................................................................. 27\n11\nGeneral requirements ........................ .. ........................................................................ 30\n12\nGeneral ..................................... . ......................................................................................... 32\n0 packagings ................................................................ 39\niv\n©CGSB 2015 -All rights reserved\n\n<<<PAGE 16>>>\n\nCAN/CGSB-43.125-20XX CD-01\nIntroduction\nThis is the fourth edition of CAN/CGSB-43.125, Packaging of Category A and Category Bi\nsubstances (Class 6.2) and clinical and (bio) medical waste It supersedes the previous e\nin 2003 Design and Manufacture of Packaging for the Transportation of Infectious\nDiagnostic Specimens, Biological Products or (Bio) Medical Waste that has neve\nTransportation of Dangerous Goods (TOG) Regulations.\nThis standard is intended for incorporation by reference into the TD\ndifferences between the requirements ofthe TOG Regulations an\nprevail, unless specified otherwise, to the extent of the differ\nto adopt this edition of the standard, an earlier edition ma b\nns. Where there are\nard, the TOG Regulations\nhe Regulations are amended\ne legally in effect in Canada.\nThis standard sets out requirements for designing, m\ncontainment for the transportation of Category\nclinical and (bio) medical waste. It is based on t\nGoods, Model Regulations, 18th edition, p . hed\nry B infectious substances in Class 6.2 and\nmendations on the Transport of Dangerous\nthe United Nations (UN).\n©CGSB 2015 -All rights reserved v\n\n<<<PAGE 17>>>\n\nFOR PUBLIC REVIEW ONLY\n\n<<<PAGE 18>>>\n\nCAN/CGSB-43.125-20XX CD-01\nPackaging of Category A and Category B infectious substances (Class\n6.2) and clinical and (bio) medical waste\n1 Scope\n1.1 Organization and content\nThis standard sets out requirements for designing, manufacturing, marking, testing and\ncontainment for the transportation of Category A and Category B infectious subst\nclinical and (bio) medical waste. This standard consists of three parts and one a\nPart I contains the requirements for the design, test and manufacture of infectious substances of category A and category B.\ns of containment for\nPart II contains the requirements for the selection and use of\nsubstances of Category A and Category B.\nPart Ill contains the requirements for the selection an\nof containment for the transport of Category A an\ndisposal as well as (bio) medical and clinical wa\nndardized and non-standardized means\ninfectious substances intended for\nAnnex A contains a design report for typ ackagings.\n1.2 Application\nThis standard applies to both sta the TDG Regulations.\nnd non-standardized means of containment as defined in\n1.3 Minimum requireme,\nThis standard sets o testing of means of co judgment in inimum requirements for designing, manufacturing, selecting, using, and\nnment. It is essential to exercise competent technical and engineering\nction with this standard.\non of Dangerous Goods Act and Regulations prevalence\n992, and the TDG Regulations may call for additional requirements regarding the design,\nure, selection, use, and test of means of containment. Where there is an inconsistency\nbetween the requirements of this standard and those of the TDG Act or TDG Regulations, the Act or\nRegulations prevail to the extent of the inconsistency.\n1.5 Safety - The testing and evaluation of a product against this standard may require the use of\nmaterials and/or equipment that could be hazardous. This document does not purport to address all the\nsafety aspects associated with its use. Anyone using this standard has the responsibility to consult the\n©CGSB 2015 -All rights reserved 1\n\n<<<PAGE 19>>>\n\nCAN/CGSB-43.125-20XX CD-01\nappropriate authorities and to establish appropriate health and safety practices in conjunction with any\nrequirements prior to its use.\n1.6 Units\nQuantities and dimensions used in this standard are given in metric units.\n1.7 Interpretation ofTables and Figures\nNotes to tables and figures are considered part of the table or figure and may be written as\nrequirements.\n1.8 Classification\nDangerous goods are classified in accordance with Part 2 of the TOG Regulatio\nshipping names and -corresponding particulars (UN number and descriptio\npacking group, as applicable) selected from Schedule 1 of the TDG Re u\n2 Normative references\nThe following normative documents contain provision\nprovisions of this National Standard of Canada. The\nsources noted below.\nNOTE The addresses provided below were v\nAn undated reference is to the latest e\nho·\nugh reference in this text, constitute\ndocuments may be obtained from the\nof publication of this standard.\nevision of the reference or document in question,\npplying this method. A dated reference is to the specified\nesign, manufacture and use of intermediate bulk containers and fuel\nment for the transportation of dangerous goods\nTh e may be obtained from the Canadian General Standards Board, Sales Centre, Gatineau,\n1A 1G6. Telephone 819-956-0425 or 1-800-665-2472. Fax 819-956-5740. E-mail ncr.cgsb-\nongc@tpsgc-pwgsc.gc.ca. Web site www.tpsgc-pwgsc.gc.ca/ongc-cgsb.\n2.2 Canadian Standards Association (CSA)\nCSA Z316.6-95 - waste.\nEvaluation of single use medical sharps containers for biohazardous and cytotoxic\n2 ©CGSB 2015 -All rights reserved\n\n<<<PAGE 20>>>\n\nCAN/CGSB-43.125-20XX CD-01\n2.2.1 Source\nThe above may be obtained from CSA Group, Standards Sales, 178 Rexdale Blvd., Toronto, Ontario M9W\n1R3 Canada. Telephone 416-747-4000or1-800-463-6727. Fax 416-747-2473. E-mail\nsales@csagroup.org. Web site csagroup.org.\n2.3 Transport Canada\nTransportation of Dangerous Goods Act, 1992 (including amendments)\nTransportation of Dangerous Goods Regulations (including amendments)\nTP 14850 - Small Containers for Transport of Dangerous Goods, classes 3, 4, 5, 6\nCanada Standard.\n2.3.1 Source\nThe above may be obtained from the Publications page of the Tra\ntc.gc.ca/eng/publications-menu.htm. The Transport Canada pu\nthe Transport Canada Publications Order Desk at tc.gc.ca/en\nada Web site\n14850 may be ordered from\n2.4 ASTM International\nD951-99(2010) -Standard test method for wate D1709-15 -Standard test methods for im of shipping containers by spray method\nce of plastic film by the free-falling dart method\non test resistance of plastic film and thin sheeting by\npendulum method\nitioning Containers, Packages, or Packaging Components for\nTesting\nmethod for leakage testing of empty rigid containers by vacuum method\nndard test method for drop test of loaded containers by free fall.\nTh e may be obtained from ASTM International, 100 Barr Harbor Drive, West Conshohocken, PA\n59, U.S.A., Web site www.astm.org, or from IHS Global Canada Ltd., 200-1331 Macleod Trail\nSE, Calgary, Alberta T2G OK3, telephone 613-237-4250 or 1-800-267-8220, fax 613-237-4251,Web site\nwww.global.ihs.com.\n2.5 Technical Association of the Pulp and Paper Industry (TAPPI}\nT802 OM-12 - Drop test for fiberboard shipping containers\n©CGSB 2015 -All rights reserved 3\n\n<<<PAGE 21>>>\n\nCAN/CGSB-43.125-20XX CD-01\nT810 OM-11- Bursting strength of corrugated and solid fiberboard\nT811 OM-11- Edgewise compressive strength of corrugated fiberboard (short column test)\nT839 OM-12 - Edgewise compressive strength of corrugated fiberboard using the clamp method (short\ncolumn test).\n2.5.1 Source\nThe above may be obtained from Technical Association of the Pulp and Paper Industry, T\nBox 933644, Atlanta, GA 31193-3644, U.S.A., telephone 1-800-446-9431 (Canada), 1-8\n(U.S.A.), 770-446-1400 (Worldwide), fax 770-209-7206, e-mail memberconnection\nwww.tappi.org/.\n2.6 United Nations (UN)\nRecommendations on the Transport of Dangerous Goods, Mo_del R\n2.6.1 Source\nThe above may be obtained from distributors of un·\nPublications Customer Service, PO Box 960, Her\n1-703-996-1010. E-mail order@un.org. Web site\nhttp://www.unece.org/trans/danger/publ\" rec/re\n3 Terms and Definitions\ns Publications or from the United Nations\n172, U.S.A. Telephone 1-703-661-1571. Fax\nof Canada, the following terms and definitions apply. Where\nefinition in this standard and that of the TOG Regulations, the\nthere is a conflict between\ndefinition in the TOG Re\n3.1\nall apply.\n\"nica astes\nimals or humans or from bio-research.\ninfectious substance that is transported in a form such that, when it is released outside of its\nmeans of containment and there is physical contact with humans or animals, it is capable of\ncausing permanent disability or life-threatening or fatal disease to humans or animals.\n[SOURCE: Transportation of Dangerous Goods Regulations (including amendments)]3.3\ncategory B\n4 ©CGSB 2015 -All rights reserved\n\n<<<PAGE 22>>>\n\nCAN/CGSB-43.125-20XX CD-01\ninfectious substance that does not meet the criteria for inclusion in Category A.\n[SOURCE:Transportation of Dangerous Goods Regulations (including amendments)]\n3.4\nculture\nresult of a process by which pathogens in a specimen are intentionally propagated. This definition does\nnot include specimens taken from a human or animal patient and that are intended to be proce\nlaboratory.\n[SOURCE:Transportation of Dangerous Goods Regulations (including amendments)]\n3.5\ncombination packaging\npackaging consisting of one or more inner packagings contained in an o ackaging for transport.\n[SOURCE: CGSB-43.125-99]3.6\ndirector\ndirector, Regulatory Affairs Branch, Transport Dangerous Goo\n[SOURCE: CGSB-43.125-99]\n3.7\ninfectious substances\nsubstance known or reasonably believed\nrickettsia, parasites, fungi and other a\ncause disease in humans or anim","truncated":true,"body_characters":83011}