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This page provides copies of documents and links relating to the regulations governing the transport of food and of biological specimens.
Hazardous Materials: Revisions to Standards for Infectious Substances Federal Register : Revision to Standards for Infectious Substances; Final Rule
IATA Packaging Instructions (2001)
UN Secretariat Committee of experts on the transport of dangerous goods and on the globally harmonised system of classification and labelling of chemicals.
Federal Hazardous
Material Transportation law
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Hazardous Materials: Revisions to Standards for Infectious Substances (“HM226”) Background Spring 1991: The Institute of Medicine, a component of the National Academy of Sciences, issued a press release that was first published by the Washington Post and reprinted in the Los Angeles Times. The announcement indicated that U.S. federal health officials were alarmed by the global threat from the spread of infectious diseases. Prior to the Institute of Medicine announcement, shipments of diagnostic specimens were unregulated in the United States. After the publication, a federally sponsored assessment of the resurgence of infectious diseases was initiated, with consultation of interested parties, and coordination with the United Nations. In the first week of October 1994, the late Dr. Richard C. Knudsen, of the U.S. Centers for Disease Control, finalized a plan that reflected the views of the U.S. Department of Transportation and CDC. This document proposed that U.S. diagnostic specimen shipments should be regulated and that diagnostic specimen shipments using air transportation should be required to meet the standards of IATA Packing Instruction 650. The proposal was the beginning of HM226: an alignment of more stringent U.S and international rules. In December 1994, U.S. federal regulations were initiated to regulate Infectious Substance shipments in the U.S. On August 12, 2002, the U.S. Department of Transportation (“DOT”) issued a Final Rule under U.S. transportation regulations. The rule affects the way in which the broad categories of infectious substances, diagnostic specimens, biological products, and regulated medical waste are defined, classified, packaged, and transported. This regulation affects all shipments, by air or ground transportation within and between the United States and generally effect the alignment of U.S. DOT regulations (Title 49 CFR) with the international rules for air shipment of Infectious Substances and Diagnostic Specimens: the ICAO Technical Instructions. The effective date for this new final rule has been extended from the initial effective date of October 1, 2002 to date. Infectious Substances Under the HM226 requirements, health care organizations must first reach a determination that establishes: (1) when a specimen or material is considered an Infectious Substance, (2) when a specimen or material is considered a Diagnostic Specimen, or (3) when a specimen or material is excepted from the regulations New Definition for Infectious Substances: Under the new rules, an Infectious Substance is a material “known to contain or suspected of containing a pathogen. A pathogen is a virus, or micro-organism (including its viruses, plasmids, or other genetic elements, if any) or a proteinaceous infectious particle (Prion) that has the potential to cause disease in humans or animals. A division 6.2 material must be assigned a World Health Organization Risk Group (Risk Group I through Risk Group IV). ‘Assignment to a risk group’ is based on: · Known medical condition and history of the source patient or animal, · Endemic local conditions, · Symptoms of the source patient or animal, · Or professional judgment concerning individual circumstances of the source patient or animal” · Known infectious substances assigned to Risk Group 1 are excepted from the HMR under the HM226 Final Rule
Classification of Infectious Substances According to Risk Groups WHO Risk Groups: Risk Group IV: 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. Risk to Individuals: High Risk to the Community: High Risk Group III: 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. Risk to Individuals: High Risk to the Community: Low Risk Group II: A pathogen that can cause human or animal diseases 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 infectious is limited. Risk to Individuals: Moderate Risk to the Community: Low Risk Group I: A microorganism that is unlikely to cause human or animal disease. A material containing only such microorganisms is not subject to the requirements of the subchapter. Risk to Individuals: None or very low Risk to the Community: None or very low New Responsibilities Imposed on Manufacturers of Class 6.2 Packaging · A Division 6.2 label in compliance as of 9-30-02 may be used until 10-1-05 · Adoption of United Nations Division 6.2 certification markings (UN/4G Class 6.2) · A water spray test is adopted into U.S. regulations replacing the water immersion test in the battery of Division 6.2 packaging performance qualification tests under Title 49 CFR, Subchapter C, part 178.609, · Sec 178.609 requires a new standard for performance involving the puncture test: if the puncture rod penetrates the secondary packaging and penetrates any primary receptacles, the packaging, under these new standards, fails the packaging qualification test Packaging Requirements for Division 6.2 Infectious Substances (Sec. 173.196) · A triple packaging meeting the test standards of Sec. 178.609 · Marked as a UN/4G Class 6.2 packaging in conformance with Sec 178.503(f) · Consisting of the following components: · A watertight primary receptacle. · A watertight secondary packaging. · For multiple fragile primary receptacles placed in a single secondary packaging, they must be wrapped individually to prevent contact between them. · An outer packaging of adequate strength for its capacity, mass, and intended use. The outer packaging must measure at least 100 mm (3.9 inches) at its smallest overall external dimension. · For liquid diagnostic specimens, an absorbent material placed between the primary receptacle and the secondary packaging. The absorbent material must be sufficient to absorb the entire contents of all primary receptacles. · An itemized list of the contents enclosed between the secondary packaging and the outer packaging. · The primary receptacle or secondary packaging used for infectious substances must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi). · The primary receptacle or secondary packaging used for infectious substances must be capable of withstanding without leakage temperatures in the range of –40 deg. C to +55 deg. C (-40 deg. F to +131 deg. F). · Infectious substances must be packed according to. …Additional requirements listed in HM226. Please refer to Sec. 173.196 of the Final Rule for additional information. · This document is listed at: www.therapak.com; www.therapak.com and www.aqui-pak.com Reuse of Class 6.2 Packaging: · A Division 6.2 packaging to be reused must be disinfected prior to reuse by any means effective for neutralizing the infectious substance the packaging previously contained. · A secondary packaging or outer packaging…. need not be disinfected prior to reuse if no leakage from the primary receptacle has occurred” Diagnostic Specimens Status of Diagnostic Specimens As Hazardous Materials: The category “Diagnostic Specimens” is now listed in the Hazardous Material Tables of Title 49 CFR (U.S. Department of Transportation regulations) without being designated a UN identification number. Diagnostic Specimens are defined as hazardous materials. New Definition of Diagnostic Specimens: Diagnostic Specimen “means any human or animal material, including excreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected humans or animals. A diagnostic specimen is not assigned a UN identification number unless the source patient or animal has or may have a serious human or animal disease from a Risk Group 4 pathogen. [In this case], it must be: · Classed as Division 6.2, · Described as an Infectious Substance, · And assigned to UN 2814 or UN 2900, as appropriate. “Assignment to UN 2814 or UN 2900 is based on · Known medical condition and history of the patient or animal, · Endemic local conditions, · Symptoms of the source patient or animal, · Or professional judgment concerning individual circumstances of the source patient or animal. Packaging Required For Shipment of Diagnostic Specimens: General Requirements Generally, unless Diagnostic Specimens are transported by ground-based private or contract carriers using dedicated vehicles, these materials must conform to the following standards: (1) Diagnostic Specimens are excepted from all other requirements of [the requirements of Title 49 CFR (all of it), when offered for transportation or transported” when packaged as described below (diagnostic specimens shipped by aircraft are subject to incident reporting) (2) A Diagnostic Specimen, meeting the definition of a hazard class other than Division 6.2 (Infectious Substances) must be offered for transportation or transported [as described below]: · Diagnostic Specimens must be packaged in triple packaging consisting of · A primary receptacle, · A secondary packaging, & · An outer packaging 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 · Secondary packaging(s) must be secured in outer packaging(s) 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. · The completed package must be capable of successfully passing the drop test at a drop height of at least 1.2 meters (3.9 Feet) · The outer packaging must be clearly and durably marked with the words “Diagnostic Specimen” · International Biohazard Symbol: The orange-black international biohazard label is a requirement of OSHA for domestic shippers of diagnostic specimens. In the normal course of business, Air carriers usually inform their customers of the need for this warning label because their terminal facilities are subject to inspection by OSHA with authority to locate shippers and issue fines for violation of the universal precautions standard. · Liquid Diagnostic Specimens - must be packaged where the: · Primary receptacle must be leak-proof with a volumetric capacity of not more than 500 ml (16.9 ounces). · Absorbent material must be placed between the primary receptacle and secondary packaging. · If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them. · The absorbent material must be of sufficient quantity to absorb the entire contents of the primary receptacles. · The secondary packaging must be leak-proof · Diagnostic Specimen Shipments by Air: · Shipments by aircraft have an additional special requirement: · The primary receptacle or the secondary container must be capable of withstanding without leakage an internal pressure of 95 kpa (14 psi) · The outer packaging may not exceed 4 L (1 gallon) Diagnostic Specimen capacity · Solid Diagnostic Specimens: · Must be packaged in a triple packaging · Consisting of a sift-proof primary receptacle (capacity not greater than 500 g (1.1 pounds) · If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them · A leak-proof secondary packaging is required · For several primary receptacles in one secondary packaging, the outer packaging may not exceed 4 kg (8.8 pounds) · Training Requirements – Shipment of Diagnostic Specimens: Shippers involved in packing diagnostic specimens are exempted from formal hazardous materials training and certification under Title 49 CFR. This area is also excepted from record keeping and certification training requirements for hazardous materials. There is a requirement that persons preparing or transporting diagnostic specimens “must know about and be able to apply the requirements of Sec. 173.199 {Title 49 CFR} to specific shipments”. The record-keeping and certification requirements for training under Subpart H of part 172 are also excepted. Biological Products: The Definition of a Biological Product under HM226 “Biological Product means a virus, therapeutic serum, toxin, product, or analogous product used in the prevention, diagnosis, treatment, or cure of diseases in humans or animals. A biological product includes a material manufactured and distributed in accordance with” government regulation. (Federal Register Vol. 67, No. 157, p. 53138) “A Biological Product known to contain or suspected of containing a pathogen in Risk Group 2, 3, or 4 must be classed as Division 6.2, described as an infectious substance, and assigned to UN 2814 or UN 2900, as appropriate, unless otherwise excepted”. The Materials of Trade Exception and the exceptions granted to dedicated vehicles apply to Biological Products based upon their status as either (1) infectious, (2) diagnostic, or (3) total exception based upon the absence of any pathogens or a Risk Group 1 pathogen. Materials Excepted from the HMR Under HM226 Materials of Trade Exceptions (MOTS): The Materials of Trade exception that has been in effect has been expanded to include: · Certain biological products, · Diagnostic specimens · Regulated medical waste · Cultures and stocks · & Infectious Substances MOTS Exception for Infectious Substances Now Requires Performance Packaging for Purposes Materials Excepted & Types of Packaging · A Division 6.2 material, other than a Risk Group 4 material that is a diagnostic specimen, biological product, or regulated medical waste. The material must be contained in a combination packaging. · For Liquids, the inner packaging(s) of combination packages must be leak tight, · The outer packaging must contain absorbent material sufficient to absorb the entire contents of the inner packaging(s) · For sharps that can pierce certain types of packaging, the inner packaging of the combination packaging must be constructed of a rigid, puncture-resistant material · For all Division 6.2 materials, the outer packaging must be a strong, tight packaging that is securely sealed · All Division 6.2 packages under the MOTS exception must be marked with a common name or proper shipping name, and motor vehicle operators must be informed of the presence of hazardous material · For a diagnostic specimen or biological product, combination packaging(s) must conform to the following capacity limitations: · (A) One or more inner packaging(s) where the gross mass or capacity of each inner packaging does not exceed 0.5 kg (1.1 pound), or 0.5 L (17 ounces), and an outer packaging having a gross mass or capacity not exceeding 4 kg (8.8 pounds) or 4 L (1 gallon); or · (B) A single inner packaging with a gross mass or capacity not exceeding 16 kg (35.2 pounds) or 16 L (4.2 gallons) in a single outer packaging · (ii)) For a regulated medical waste, a combination packaging must consist of one or more inner packaging(s) having a gross mass or capacity not exceeding 4kg (8.8 pounds) or 4 L (1 gallon), and an outer packaging having a gross mass or capacity not exceeding 16 kg (35.2 pounds or 16 L (4.2 gallons)
Exceptions – Dedicated Vehicles in Ground Transport · Diagnostic Specimens transported by private and contract carriers using dedicated vehicles are exempt as long as the specimens are within Risk Group 2 or Risk Group 3. · Risk Group IV Diagnostic Specimens must conform to Division 6.2 standards of packaging.
Exceptions to Division 6.2 Requirements:
· “The following are generally excepted from the requirements of Division 6.2: · “A Biological Product known to contain or suspected of containing a micro-organism in Risk Group I, or that does not contain a pathogen. · A Diagnostic Specimen known to contain or suspected of containing a micro-organism in Risk Group I, or that does not contain a pathogen, or a diagnostic specimen in which the pathogen has been neutralized or inactivated so it cannot cause disease when exposure to it occurs · A 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 of the Department of Health and Human Services or the U.S. Department of Agriculture · Blood (A-81 Exception) collected for the purpose of blood transfusion or the preparation of blood products; blood products; tissues or organs intended for use in transplant operations; 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. · Blood (A-81 Exception) collected for the purpose of 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 a reason to believe it contains an infectious substance, in which case the test sample must be shipped in accordance with Sec. 173.199 · A Diagnostic Specimen or Biological Product when transported by a private or contract carrier in a motor vehicle used exclusively to transport Diagnostic Specimens or Biological Products. · Medical or clinical equipment and laboratory products may be transported aboard the same vehicle provided they are properly packaged and secured against exposure or contamination. If a Diagnostic Specimen or Biological Product meets the definition of regulated medical waste in paragraph (a) (5) of this section, it must be offered for transportation and transported in conformance with the appropriate requirements for regulated medical waste
Regulated medical waste shipped by ground or air, Environmental diagnostic specimens such as mold contaminated building materials, Waste cultures and stocks, Materials of trade exceptions, Forensic materials, Medical waste generated from households, Animal waste, sewage, and other materials that can be reviewed directly in HM226
U.S. Postal Service
The U.S. Postal Service is a substantial carrier of specimen material, including Diagnostic Specimens, Infectious Substances, and clinical specimens.
Under U.S. law, only the Postal Service can propose regulations for mailing hazardous materials, and presently, the Postal Service is considering changing government postal service packaging requirements in parallel with the Title 49 CFR (HM226) changes.
Presently, parcels of specimens that are shipped within Postal Zones 1 through 4 are mailed within a radius of 500 miles from their origin and can be carried, by first class mail, entirely by ground transport on U.S. Postal Service Trucks.
Parcels that are mailed to destinations in zones higher than Zone 4 generally exceed 500 miles distance from their origin and require air transport, if they are mailed “first class” or at a higher premium postage for priority mail or express mail service.
Recent restrictions by the Federal Aviation Administration and the self-imposed rules of the air carriers are complicating postal service operations due to restrictions.
A Notice of Proposed Rulemaking may be forthcoming by mid-December 2002, in order to complete the regulatory cycle by the February 14, 2003 effective date of HM226. U.S. Department of Transportation Questions & Requests for Letters of Interpretation of Final Rules The hazardous materials information telephone number is 800 467 4922. This office fields questions from the public concerning the packaging and transport of hazardous materials in the U.S. In addition to this facility, DOT will respond to letters requesting the interpretation of the hazardous materials regulations within Title 49 CFR. Requests for “Letters of Interpretation” should be addressed to the U.S. Department of Transportation:
Ms. Ed Mazzullo, Director DHM-10 DOT/RSPA/OHMS 400 7th Street SW Washington, D.C. 20590
The information contained in this summary is condensed from the Federal Register dated August 14, 2002, (Vol. 67, Number 157). It is only a summary and the information contained herein should be construed in light of the regulation (HM226) in its entirety, as published in the Federal Register.
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 IATA Packaging Instructions (2001) Infectious Substances IATA PACKING INSTRUCTION 602 -2001 STATE VARIATIONS: AUG-03,CAG-04, USG-13, VUG-02 OPERATOR VARIATIONS: AF-04, AS-02/08, CI-01, CO-07/08, CS-07,FX-09, SW-01,US-O8 The General Packing Requirements of Subsection 5.0.2 must also be met. General Requirements Shippers of Infectious substances must comply with these Regulations and must ensure that shipments are prepared in such a manner that they arrive at their destination in good condition and that they present no hazard to persons or animals during shipment. The packaging must include: (a) inner packagings comprising: Multiple primary receptacles placed in a single packaging must be wrapped individually or for infectious substances transported in liquid nitrogen, separated and supported to ensure that contact between them is prevented. The absorbing material, for example cotton wool, must be sufficient to absorb the entire contents of all primary receptacles. (b) an outer packaging of sufficient strength meeting the design type tests found in Subsection 6.5 and bearing the Specification Markings as required by 6.0.6 for shipments of infectious substances other than those containing large body parts and whole organs which require special packaging. Also infectious substances shipped on liquid nitrogen in packagings that meet the requirements of Packing Instruction 202 are excluded from the testing requirements of Subsection 6.5 and the marking requirements of 6.0.6. Note: Packagings of the type known as "dry shipper" (see Appendix A) when used to ship infectious substances must meet the testing requirements of Subsection 6.5 and the marking requirements of 6.0.6. Packages must be at least 100mm (4 in) in the smallest overall external dimension. For all packages containing infectious substances other than those containing large body parts or whole organs which require special packaging, an itemized list of contents must be enclosed between the secondary packaging and the outer packaging. The primary receptacle or the secondary packaging used for infectious substances must be capable of withstanding, without leakage, an internal pressure which produces a pressure differential of not less than 95 kPa (0.95 bar, 13.8lb/in2) in the range of -40.oC to + 55oC (- 40.oF to 130.oF). All packages containing infectious substances must be marked durably and legibly on the outside of the package with the NAME and TELEPHONE NUMBER OF A PERSON RESPONSIBLE FOR THE SHIPMENT. Shipments of Infectious Substances of Division 6.2 require the shipper to make advance arrangements with the consignee and the operator to ensure that the shipment can be transported and delivered without unnecessary delay. The following statement required by 8.1.6.11.2 must be included in the Additional Handling Information area of the Shipper's Declaration: "Prior arrangements as required by the lATA Dangerous Goods Regulations 1.3.3.1 have been made." Specific Requirements Substances shipped at ambient temperatures or higher. - Primary receptacles may only be of glass, metal or plastic. Positive means of ensuring a leak-proof seal must be provided, such as heat seal, skirted stopper or metal crimp seal. If screw caps are used, these must be reinforced with adhesive tape. Substances shipped refrigerated or frozen (wet ice. pre frozen packs, Carbon dioxide, solid [dry ice]): Ice, Carbon dioxide, solid (dry ice) or other refrigerant must be placed outside the secondary packaging(s) or alternatively in an overpack with one or more complete packages marked in accordance with 6.0.6. Interior support must be provided to secure the secondary packaging(s) in the original position after the ice or Carbon dioxide, solid (dry ice) has been dissipated. If ice is used, the packaging must be leak-proof. If Carbon dioxide, solid (dry ice) is used, the outer packaging must permit the release of carbon-dioxide gas. The primary receptacle and the secondary packaging must maintain their containment integrity at the temperature of the refrigerant used as well as at the temperatures and pressure( s) of air transport to which the receptacle could be subjected if refrigeration were to be lost Substances shipped in liquid nitrogen: Plastic primary receptacles capable of withstanding very low temperatures must be used. Secondary packaging must also withstand very low temperatures and in most cases will need to be fitted over individual primary receptacles. Requirements for shipment of liquid nitrogen must also be observed. The primary receptacle must maintain its containment integrity, at the temperature transport to which the receptacle could be subjected if refrigeration were to be lost. Where multiple primary receptacles are contained in a single secondary packaging, they must be separated and supported to ensure that contact between them is prevented. Lyophylized substances: Primary receptacles must be either flame-sealed glass ampoules or rubber-stoppered, glass vials with metal seats.
STATE VARIATIONS: USG-13 OPERATOR VARIATIONS: CO-08 The General Packing Requirements of Subsection 5.0.2 must also be met. Genetically modified micro-organisms must be packed according to Packing Instruction 602, except that the packagings need not be tested as provided in Subsection 6.5. The maximum quantity in a primary receptacle must not exceed 100 mL or 100g. IATA PACKING INSTRUCTION 650 -2001 OPERATOR VARIATIONS: AS-02, CO-07/08, CS-07, FX-09, QF-05 The General Packing Requirements of Subsection 5.0.2 must also be met. General Requirements Shippers of diagnostic specimens where a relatively low probability exists that infectious substances are present must comply with Packaging Instruction 650 of these regulations. Diagnostic specimens being transported for the purpose of initial diagnosis may be considered to fall under this category where a low probability exists that infectious substances are present. The shipper must also ensure that shipments are prepared m such a manner that they arrive at their destination in good condition and that they present no hazard. to persons or animals during shipment. In the absence of other dangerous shipments, (a) inner packagings comprising: If multiple primary receptacles are placed in a single secondary packaging they must be wrapped individually or for those transported in liquid nitrogen, separated and supported to ensure that contact between them is prevented. The absorbing material, for example cotton wool, must be sufficient to absorb the entire contents of all primary receptacles. (b) an outer packaging of adequate strength for its capacity, weight and intended use. However, each completed package must be capable of successfully passing the drop test described in 6.5.1, except that the height of the drop must not be less than 12m. The primary receptacle or the secondary packaging used
for liquid diagnostic specimens must be capable of
withstanding without leakage, an internal pressure which
produces a pressure differential of not less than 95 kPa
(0.95 bar, 13.8lb/in2) in the range of -40.oC to +
55.oC(-40.oF to 130.oF). It is not necessary for the primary
or secondary packaging to be capable of withstanding 95 kPa
pressure differential when solid diagnostic specimens are
being shipped. An itemized list of contents must be enclosed between the secondary packaging and the outer packaging. Each package and the "Nature and Quantity of Goods" box of the air waybill must show the text "DIAGNOSTIC SPECIMEN PACKED IN COMPLIANCE WITH IATA PACKING INSTRUCTION 650". A Shipper's Declaration for Dangerous Goods is not required. Specific Requirements Although exceptional cases, (for example, the shipment of whole organs). may require special packaging, the great majority of diagnostic specimens can and must be packaged according to the following guidelines. Substances shipped at ambient temperatures or higher- Primary receptacles include those of glass, metal or plastic. Positive means of ensuring a leak-proof seal, such as heat seal, skirted stopper or metal crimp seal must be provided. If screw caps are used these must be reinforced with adhesive tape. Substances shipped refrigerated or frozen (wet ice, prefrozen packs, Carbon dioxide, solid [dry ice]: Ice, Carbon dioxide, solid (dry ice) or other refrigerant must be placed outside the secondary packaging(s) or alternatively in an overpack with one or more completed packagings. Interior support must be provided to secure the secondary packaging(s) in the original position after the ice or Carbon dioxide, solid (dry ice) has been dissipated. If ice is used the packaging must be leak-proof. If Carbon dioxide, - solid (dry ice) is used the outer packaging must permit the release of carbon-dioxide gas. The primary receptacle must maintain its containment integrity at the temperature of the refrigerant as well as at the temperatures and pressure of air transport to which the receptacle could be subjected if refrigeration were to be lost. Substances shipped in liquid nitrogen: Plastic capable of withstanding very low temperatures must be used instead of glass receptacles. Secondary packaging must also with stand very low temperatures and in most cases will need to be fitted over individual primary receptacles. Requirements for shipment of liquid nitrogen must also be observed. The primary receptacle must maintain its containment integrity at the temperature of the refrigerant used as well as at the temperatures and pressure of air transport to which the receptacle could be subjected if refrigeration were to be lost. Lyophilized substances: Primary receptacles must be either flame-sealed glass ampoules or rubber-stoppered glass vials with metal seals. IATA PACKING INSTRUCTION 904-2001 STATE VARIATIONS: USG-13 OPERATOR VARIATIONS: CO-08, HP-02, IC-08, SW-01 The General Packing Requirements of Subsection 5.0.2 must also be met. Carbon dioxide, solid,( dry, ice), when offered for transport by air, must be in packaging designed and constructed to permit the release of carbon dioxide gas and to prevent a build-up of pressure that could rupture the packaging. The net weight of the Carbon dioxide, solid (dry ice) must be marked on the outside of the package. Arrangements between shipper and operators must be made for each shipment, to ensure ventilation safety procedures are followed. The Shipper's Declaration requirements of Subsections 8.1 and 10.8.1. are only applicable when the Carbon dioxide, solid (dry ice) is used as a refrigerant for dangerous goods that require a Shipper's Declaration. When a Shipper's Declaration is not required, the information as required by 8.2.3 for the Carbon dioxide, solid ,(dry ice) must be contained in the "Nature and Quantity of Goods" box on the air waybill, excluding the packing instruction number and packing group. Note 1: Refer to the relevant airline's loading procedures for Carbon dioxide, solid (dry ice) limitations. Note 2: For Air Waybill requirements see 8.2.3. For loading instructions see 9,3.12. Note 3: For cooling purposes, an overpack may contain Carbon dioxide, solid (dry ice), provided that the overpack meets the requirements of Packing Instruction 904. PACKING INSTRUCTION 650 STATE VARIATION: DQG-03 OPERATOR VARIATIONS: AF-04, AO-03, AS-08, CO-07, CS-07, FX-09, JJ-06, JW-03, LA-07, LH-12, PX-08, QF-03, US-09 This packing instruction applies to UN 3373 on passenger and cargo aircraft and CAO. General Requirements The packagings must be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport, including trans-shipment between transport units and between transport units and warehouses as well as any removal from a pallet or overpack for subsequent manual or mechanical handling. Packagings must be constructed and closed so as to prevent any loss of contents that might be caused under normal conditions of transport, by vibration, or by changes in temperature, humidity or pressure. The packaging must consist of three components: a) a primary receptacle; b) a secondary packaging; and c) a rigid outer packaging. Primary receptacles must be packed in secondary packagings in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents into the secondary packaging. Secondary packagings must be secured in outer packagings with suitable cushioning material. Any leakage of the contents must not compromise the integrity of the cushioning material or of the outer packaging. Packages must be prepared as follows: (a) For liquid substances: • The primary receptacle(s) must be leak-proof and must not contain more than 1 L; • The secondary packaging must be leak-proof; • If multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them; • Absorbent material must be placed between the primary receptacle and the secondary packaging. The absorbent material, such as cotton wool, must be in sufficient quantity to absorb the entire contents of the primary receptacle(s) so that any release of the liquid substance will not compromise the integrity of the cushioning material or of the outer packaging; The primary receptacle or the secondary packaging must be capable of withstanding without leakage an internal pressure of 95 kPa in the range of -40°C to+55°C (-40°F to 130°F); • The outer packaging must not contain more than 4 L. This quantity excludes ice, dry ice, or liquid nitrogen when used to keep specimens cold. (b) For solid substances: • The primary receptacle(s) must be sift-proof and must not exceed the outer packaging weight limit; • The secondary packaging must be sift-proof; • If multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them; • Except for packages containing body parts, organs or whole bodies, the outer packaging must not contain more than 4 kg. This quantity excludes ice, dry ice or liquid nitrogen when used to keep specimens cold; • If there is any doubt as to whether or not residual liquid may be present in the primary receptacle during transport then a packaging suitable for liquids, including absorbent materials, must be used. An itemized list of contents must be enclosed between the secondary packaging and the outer packaging. At least one surface of the outer packaging must have a minimum dimension of 100 mm x 100 mm. The completed package must be capable of successfully passing the drop test described in 6.6.1 except that the height of the drop must not be less than 1.2 m. For transport, the mark illustrated below must be displayed on the external surface of the outer packaging on a background of a contrasting colour and must be clearly visible and legible. The mark must be in the form of a square set an angle of 45°(diamond-shaped) with each side having a length of at least 50 mm, the width of the line must be at least 2 mm, and the letters and numbers must be at least 6 mm high. The proper shipping name “Diagnostic specimen”, “Clinical specimen” or “Biological substance category B” in letters at least 6mm high must be marked on the outer package adjacent to the diamond-shaped mark. UN3373 Unless all package markings are clearly visible, the following conditions apply when packages are placed in an overpack: the overpack must be marked with the word “Overpack” ; and the package markings must be reproduced on the outside of the overpack. A Shipper's Declaration for Dangerous Goods is not required. Specific Requirements Refrigerated or frozen specimens: Ice, dry ice and liquid nitrogen • When dry ice or liquid nitrogen is used to keep specimens cold, all applicable requirements of these Regulations must be met. When used, ice or dry ice must be placed outside the secondary packagings or in the outer packaging or an overpack. Interior supports must be provided to secure the secondary packagings in the original position after the ice or dry ice has dissipated. If ice is used, the outside packaging or overpack must be leak- proof. If carbon dioxide, solid (dry ice) is used, the packaging must be designed and constructed to permit the release of carbon dioxide gas to prevent a build-up of pressure that could rupture the packagings. • The primary receptacle and the secondary packaging must maintain their integrity at the temperature of the refrigerant used as well as the temperatures and the pressures, which could result if refrigeration were lost. Infectious substances assigned to UN 3373, which are packed and marked in accordance with this packing instruction are not subject to any other requirement of these Regulations except for the following: • The name, address and telephone number of a responsible person must be provided on the air waybill or on the package; • Classification must be in accordance with 3.6.2; • The incident reporting requirements in 9.6.1 must be met; and • The inspection for damage or leakage requirements in 9.4.1 and 9.4.2. Passengers and crew members are prohibited from transporting infectious substances either as or in carry-on baggage or checked baggage or on their person. If an air waybill is used, the “Nature and Quantity of Goods” box must show the text “DIAGNOSTIC SPECIMENS” “CLINICAL SPECIMENS” or “BIOLOGICAL SUBSTANCE CATEGORY B” and “UN 3373”. Clear instructions on filling and closing such packages must be provided by packaging manufacturers and subsequent distributors to the shipper or to the person who prepares the package (e.g. patient) to enable the package to be correctly prepared for transport. Other dangerous goods must not be packed in the same packaging as Division 6.2 infectious substances unless they are necessary for maintaining the viability, stabilizing or preventing degradation or neutralizing the hazards of the infectious substances. A quantity of 30 mL or less of dangerous goods included in Classes 3, 8 or 9 may be packed in each primary receptacle containing infectious substances. When these small quantities of dangerous goods are packed with infectious substances in accordance with this packing instruction no other requirements in these Regulations need be met.
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