Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labelling of Chemicals 1 June 2021 Sub-Committee of Experts on the Transport of Dangerous Goods Fifty-eighth session Geneva, 28 June-2 July 2021 Item 3 of the provisional agenda Listing, classification and packing Problems with the practical implementation of P650 Transmitted by the expert from Spain Introduction 1. During the last year there has been a big increase in transport of UN 3373 “BIOLOGICAL SUBSTANCE, CATEGORY B”, linked to the transport of samples due to testing against COVID-19. This situation has introduced into the transport chain many consignors and transport companies that traditionally have not been transporting biological products and the Spanish experts have witnessed some practices for the transport of UN 3373 related to an improper application of packing instruction P650. Discussion 2. Transport under UN 3373 covers a wide range of substances that shall be transported, for example diagnostic specimens assigned to UN 3373 which are human or animal materials that are being transported only for the purpose of diagnosis or investigation. Such materials may include excreta, blood and its components, tissue samples of all kinds (fresh, fixed in formalin or embedded in paraffin), DNA extracted from blood / tissue, citrated or EDTA blood, serum, plasma, bone marrow, urine, saliva, cerebrospinal fluid, maternal blood, biopsies of all kinds, hair, nails, exudates of all kinds, cell lines of all kinds, immunoglobulins, bacterial or viral strains (lyophilized, frozen, refrigerated), respiratory samples of SARS CoV2 (nasal exudate, nasal swab, bronchial aspirate… ), recombinant antibodies, proteins, as well as other tissues and fluids. 3. Transport of UN 3373 shall be done only according to P650, and not to any additional general requirements included into other parts of the Model Regulations (see special provision 319). This inter alia means that the packaging defined in P650 has no UN mark and therefore is not handled, from the point of view of control and approval, as other packagings. 4. A package according to P650 shall consist of three components (see figure (a) a primary receptacle; (b) a secondary packaging; and (c) an outer packaging. 1): Figure 1: Triple packaging for UN 3373 (Source: Guidance on regulations for the transport of infectious substances 2019– 2020. WHO/WHE/CPI/2019.20 World Health Organization 2019) 5. Of the different requirements included in P650, the Spanish experts would like to specifically focus on the drop test and the pressure test. According to P650 (6), the complete package (including all three components) shall pass a drop test. Additionally, the pressure test according to P650 (7e) (mandatory for transport of liquids) can be either carried out on the primary receptacle, or on the secondary packaging. 6. Many different primary receptacles are designed for many different uses (see paragraph 2 above), adapting to the different size and properties of the biological material to be transported. Therefore, primary receptacles have differing forms and are needed for different purposes, adapting the material, shape and closing system to the specific need (see figure 2). Test tubes. Diagnosis use. Petri dish. Cultures use UN/SCETDG/58/INF.9 UN/SCETDG/58/INF.8 Urine collection Urine tests use. Eppendorf Tube: Diagnosis use. cup. Falcon Tube Cultures use Assaig Tube: Diagnosis use Figure 2: Different primary receptacles UN/SCETDG/58/INF.8 7. To fulfill the criteria established in P650 (6), the manufacturer of the packaging could pass the drop test with a secondary and outer packaging, containing different primaries receptacles, to adapt to this variety in primary receptacles. 8. Additionally, the pressure test indicated in P650 (7e) could be passed alternatively with the secondary packaging, or with all the single different primary receptacles that are needed. 9. Nevertheless, it seems quite common that the primary receptacle is not provided by the manufacturer of the secondary and outer packaging. This makes it impossible to know if the complete package would pass the drop test as mentioned in P650 (6). Additional difficulties arise when, for example, the consignor has not the information if the manufacturer has passed the pressure test with the primary receptacle or with the secondary packaging, so he can end up making unsafe combinations mi