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International transport of biological material

Updated: Feb 7


 

 

Introduction


Biological material, including diagnostic samples, is subject to certain stringent transport conditions. These arise not only from the need to preserve the physicochemical properties of the material or sample, but also for reasons of public safety. In order to ensure the safety of those involved in transportation, but also of those directly and indirectly associated with them, and thus of the population as a whole, the rules set forth in the regulations on the transportation of dangerous goods must be applied.

 

The transport of dangerous goods requires special care and compliance with strict regulations. All participants in the process - shippers, carriers and consignees - bear responsibility for complying with the safety standards set out in the legislation. Proper classification, packaging, labelling and transport documentation are key elements in ensuring the lawful transport of hazardous materials.

The transport of this type of material in international transport is regulated by international agreements. Depending on the mode of transport, the legal basis will be the European Agreement concerning the International Carriage of Dangerous Goods by Road" (commonly known as ADR), the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (commonly known as ADN), the Regulations concerning the International Carriage of Dangerous Goods by Rail (commonly known as RID) and the Act on the Transport of Dangerous Goods by Air and the IATA Dangerous Goods Regulations, which were developed by the ICAO (International Civil Aviation Organization) Committee of Experts, as well as the Act on the Transport of Dangerous Goods.

 

 

Dangerous goods, diagnostic samples and biological material - general principles

 

The ADR, ADN and RID regulations describe in detail the dangerous goods that are not authorised for international carriage and the dangerous goods that are authorised for international carriage, as well as the conditions attached to them (including exemptions), concerning in particular: the classification of goods, including classification criteria and relevant test methods, the use of packaging, the use of tanks (including filling), shipment procedures (including the marking and use of warning labels on consignments, the marking of vehicles and wagons accepted on board, the marking of ships, as well as the required documents and information), provisions on the construction, testing and approval of packaging and tanks, the use of means of transport (including loading, loading together and unloading).

 

"Dangerous goods" is a material or object (thing) which, according to the ADR, ADN or RID agreements, is not permitted for international carriage or is permitted for such carriage under the conditions set out in these agreements and on the basis of well-defined procedures. In contrast, under the regulations on the carriage of hazardous materials by air, some substances are considered too dangerous to be transported by aircraft, while others must be approved for transport by the countries involved.


Diagnostic specimens or clinical specimens have been classified by ADR, ADN and RID agreement regulations as authorised, although subject to specific packaging and labelling procedures as infectious materials. Infectious materials are classified into Class 6.2 and are divided into :

 

1.       Infectious materials for humans

2.       Infectious materials for animals only

3.       Clinical waste

4.       Biological materials

 

Infectious materials are classified as high-risk dangerous goods. According to the provisions of international agreements, these are goods which could be used, contrary to their intended use, in terrorist attacks and thus cause serious consequences in terms of numerous victims or mass destruction. In addition to infectious materials, such goods include explosives or radioactive agents.

Infectious materials are materials that are known or reasonably suspected to contain pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, mycoplasmas, parasites and fungi) and other agents such as prions that can cause disease in humans or animals.


Medical or clinical waste is waste arising from the veterinary treatment of animals,

human treatment or biological research; Biological materials are products derived from living organisms for which special authorisation is required and which are manufactured and distributed in accordance with national legislation and , which are used for the prevention, treatment and diagnosis of human or animal disease or for scientific and experimental purposes. These include, but are not limited to, finished products such as vaccines and/or intermediates.


ADR, ADN and RID also define patient samples. These are human or animal materials that are directly taken from humans or animals, but not limited to: faeces, secretions, blood and its components, tissue and smears from tissue fluids, as well as body parts, transported specifically for research, diagnostic, investigative, therapeutic or prophylactic purposes.


Human or animal samples (patient samples) that are minimally likely to contain pathogens are not subject to the provisions of the RID, ADN and ADR. Such samples shall be transported in packaging that will prevent their release and shall be labelled "MEDICAL SAMPLE EXCLUDED" or "VETERINARY SAMPLE EXCLUDED".  Disposed medical or clinical waste is also not subject to ADR, ADN and RID regulations if does not meet the criteria of the other classes.


The regulations further emphasise that if material is to be subject to such an exemption then an expert opinion from an authorised specialist is required. This expertise should be based on knowledge of the disease history, symptoms and individual condition of the source, human or animal, and local endemic conditions. Samples that may be transported under this subsection include.: blood and urine samples taken for tests to monitor cholesterol levels, serum glucose levels, hormone levels or prostate-specific antigen (PSA) assessment; this is necessary for monitoring the function of organs such as the heart, liver or kidneys in humans or animals with non-communicable diseases, or for therapeutic monitoring of drug levels in the blood; tests conducted for insurance or employment purposes are used to determine the presence of drugs and alcohol in the body, to confirm pregnancy, biopsies to detect cancer, and to detect antibodies in humans or animals.

ADR, ADN and RID divide infectious materials into categories A and B. However, the tables are not an exhaustive catalogue. Infectious materials containing new or emerging pathogenic micro-organisms that are not included in the table, but which meet the same criteria, should be categorised as Category A. In addition, if there is doubt as to whether a material does or does not meet these criteria, it should be categorised as Category A. The correct shipping name for Category A materials is "INFECTIVE MATERIAL, HUMAN ACTIVE". The correct shipping name for Category B materials is "BIOLOGICAL MATERIAL, CATEGORY B.


It should be borne in mind that any diagnostic sample, biological material is potentially considered as genetic data and should be treated as so-called special personal data subject to protection under Article 4(13) of the General Data Protection Regulation (hereinafter RODO). This is understood as personal data concerning the inherited or acquired genetic characteristics of a natural person, which reveal unique information about the physiology or health of that person and which result in particular from the analysis of a biological sample from that person. The free flow of data within the European Union and more broadly within the European Economic Area is a necessary requirement of Poland's membership of EU structures. These countries have implemented the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data in their internal legal orders.


When transferring data outside the European Economic Area, the provisions for transferring data to third countries should be taken into account. When transporting, a standard operating procedure should be developed for each biological material transported. In the case of transfer of cells or tissues from a country outside the European Union, the legal basis authorising the transport of such material should be indicated. Personal data are subject to the obligation of the research subject's (or legal representative's) informed and free consent for their processing. In research, personal data should not be obtained beyond that required to reliably document the research conducted - in accordance with the principle of minimising personal data. In a research entity, in order to ensure the lawful protection of personal data of both research participants and research subjects, it is recommended that the researcher cooperate closely with the Data Protection Officer (DPO).


 

Carriage of hazardous materials by road

 

The rules for the transport of materials for the national and international carriage of dangerous goods by road, as well as the authorities and bodies carrying out tasks related to this carriage, are regulated by the Law on the Carriage of Dangerous Goods of 19 August 2011 and the European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), drawn up in Geneva on 30 September 1957.


Countries which have acceded to the ADR agreement are obliged to observe certain rules for the transport of dangerous goods and loads, which obliges, in addition to consignors, shippers, unloaders, receivers, also transport companies to observe a number of procedures related to transport. The annexes to the ADR agreement are updated every two years, so it is important to keep up to date with the current regulations. The ADR regulations detail what must be on each transport vehicle carrying a hazardous material. The ADR specifies the emergency equipment and safety equipment depending on the hazards of the dangerous vehicle load being transported, as well as the number of fire extinguishers and the amount of fire extinguishing agent. Organising an ADR transport involves certain difficulties not only by having to comply with a number of safety requirements, but also because of the paperwork. First and foremost, the transport of hazardous materials must be carried out by an approved vehicle, so that in the event of any problems, you know where and when there may be a risk of an accident much more dangerous than an accident with ordinary vehicles. In order for a vehicle to be authorised for the transport of dangerous goods, an application for an ADR vehicle authorisation certificate must be submitted to the Territorial Branch of the Transport Technical Supervision or to the Team of TDT Inspectors. Before starting the transport, a package of necessary documents must be completed, including, among others, the shipper's declaration, transport documents and written instructions. In addition, before transporting a hazardous material, instructions on classification, packaging, labelling, documentation, vehicle equipment, driver training and many other aspects related to the transport of hazardous materials must be prepared in accordance with the ADR agreement. The ADR agreement also specifies the conditions assigned to the various goods, such as their classification, the use of packaging, the use of tanks, the shipment procedures (including the marking and use of warning stickers on the consignment pieces and on the means of transport, as well as the required documents and information).


Any driver transporting cargo and dangerous goods must be duly licensed. The rules for obtaining an ADR certificate are set out in the Transport of Dangerous Goods Act. A person holding an ADR "basic" certificate may undertake loads with packaged dangerous goods of all classes except Class 1 (explosives) and Class 7 (radioactive materials). In order to transport class 1 or class 7 dangerous goods and dangerous goods in tanks, the driver must hold an ADR 'specialised' certificate.

The participant in the carriage of dangerous goods shall be obliged to appoint, at his own expense, at least one adviser on the safety of the carriage of dangerous goods, competent for the scope of the carriage to be carried out or the activities connected therewith, as respectively defined in the ADR. The adviser shall prepare an annual report in duplicate, signing it with his name and indicating the number of the adviser's certificate. In addition, the participant in the transport operation is obliged, by 28 February of each year following the year to which the report relates, to send the report to the provincial road transport inspector competent for the seat or place of residence of the participant in the transport of dangerous goods and to keep the second copy of the annual report in his office for a period of 5 years from the date of its dispatch.


If a serious accident or incident within the meaning of ADR has occurred in connection with the transport of dangerous goods, the participant in the transport shall, within 14 days of the occurrence of the incident, transmit a report to the competent supervising authority.


The shipper of dangerous goods is always obliged to make sure that the dangerous goods are classified and authorised for transport in accordance with ADR.  He should describe precisely to the carrier the danger presented by the goods entrusted to him and indicate the precautions to be taken (so-called information obligation). A consignment note should be prepared containing all this information....


 

Carriage of hazardous materials by water

 

Similar to the transport of hazardous materials by land, transport by water is regulated by the Act on the Transport of Dangerous Goods of 19 August 2011. In addition, the European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (commonly known as ADN) provides detailed regulations.


The participant in the carriage of dangerous goods shall be obliged to appoint, at its own expense, at least one adviser on the safety of the carriage of dangerous goods, competent for the scope of the carriage to be carried out or the activities related thereto, as respectively defined in the ADN. The adviser shall prepare an annual report in duplicate, signing it with his name and indicating the number of the adviser's certificate.  In addition, the participant in the transport shall, by 28 February of each year following the year to which the report relates, forward the report to the director of the inland waterway authority having jurisdiction over the registered office or place of residence of the participant in the transport of dangerous goods and keep a second copy of the annual report at its registered office for a period of 5 years from the date of dispatch. According to the ADN regulations, a safety adviser means a person who, in his or her activity involving the transport or packaging, loading, filling or emptying of dangerous goods transported by inland waterways, is responsible for assisting in the prevention of risks associated with the transport of dangerous goods.


An expert for the safe carriage of dangerous goods by inland waterway vessels, known as an ADN expert, should additionally be present on an inland waterway vessel carrying dangerous goods. The Carriage of Dangerous Goods Act defines in detail who can become an expert and what conditions must be met in order to pass the exam....


The provisions of the ADN stipulate that transport should take place in a manner that does not endanger the safety of maritime traffic and eliminates pollution and contamination of the environment. Countries that have acceded to the ADN agreement are obliged to follow certain rules for the transport of dangerous goods and cargo, which obliges, in addition to shippers, shippers, unloaders and consignees, also transport companies to follow a number of procedures related to transport. The ADN divides goods into classes. In total, it distinguishes nine classes, such as infectious materials, explosives, flammable substances, for example. This classification allows the handling of goods marked with a particular class to be adjusted. Goods must be secured in appropriate packaging, which is described in the ADN agreement. This prevents situations such as damage or leakage of hazardous substances. The European Agreement concerning the International Carriage of Dangerous Goods by Road standardises many issues so that transport can take place in compliance with all the most important safety rules and regulations. One of the basic documents in the context of the ADN is the dangerous goods declaration. It contains the most important information on the type of goods, such as the name and type of load, the UN identification number, the hazard class or the quantity of the goods. The transport of dangerous goods may also require additional documentation. Depending on the specific case, an information sheet may be required, which contains a detailed description of the type of substance being transported, as well as a diagram of what to do in the event of leakage or damage to the cargo. The provisions included by the ADN guarantee safety at every stage of the transport chain. Thanks to standards such as, among others, the need for the driver transporting hazardous cargo to be ADN-certified, the risk of complications during transport is greatly reduced.


 

Carriage of hazardous materials by rail

 

As with the transport of hazardous materials by land and sea, transport by water is regulated by the Act on the Transport of Dangerous Goods of 19 August 2011. In addition, detailed regulations are contained in the Convention concerning International Carriage by Rail (COTIF) and its Annex C - Regulations concerning International Carriage of Dangerous Goods by Rail (commonly known as RID). Additionally, in Poland, rail transport is regulated by the Railway Transport Act.

The RID regulations define dangerous goods that are not authorised for international carriage and dangerous goods that are authorised for international carriage and the conditions attached to them. Dangerous goods may only be carried on goods trains with the exception of goods authorised for other carriage by RID or dangerous goods carried under special conditions in accordance with RID.


A participant in the carriage of dangerous goods is obliged to appoint, at its own expense, at least one adviser on the safety of the carriage of dangerous goods, competent for the scope of the carriage to be carried out or activities related thereto, respectively, as defined in the RID called RID adviser. The adviser shall prepare an annual report in duplicate, signing it with his name and indicating the adviser's certificate number. In addition, the participant in the transport of dangerous goods is obliged to send one copy of the participant's annual report on its activities to the President of the Railway Transport Office, with regard to the transport of dangerous goods and related activities, called the annual report, by 28 February of each year following the year to which the report relates. In addition, it is obliged to keep a second copy of the annual report at its registered office for a period of 5 years from the date of its dispatch.


If a serious accident or breakdown within the meaning of the RID has occurred in connection with the transport of dangerous goods, the participant in the transport shall, within 14 days of the occurrence of the event, submit a report to the President of the Railway Transport Office.


The shipper of dangerous goods is always obliged to ensure that the dangerous goods are classified and authorised for carriage in accordance with RID.  He should describe precisely to the carrier the danger presented by the goods entrusted to him and indicate the precautions to be taken (so-called information obligation). In the case of carriage by rail, a number of RID obligations must additionally be met. Amongst other things, check that wagons are not overloaded, make sure that warning stickers are in place, make sure that there are instructions and appropriate equipment in the driver's cab.


 

Summary


In Polish law, road transport of dangerous goods is regulated by the Act of 19 August 2011 on the carriage of dangerous goods. This document sets out the general rules for the transport of hazardous materials and refers to the international agreements ADR, ADN and RID for international transport. Not every biological product, culture, medical or clinical waste or even samples from patients must be classified as infectious materials. Only those known or reasonably suspected to contain pathogens should be classified as such. The international regulations will therefore only apply if the sample or swab is classified as infectious or has a high probability of being infectious.


The ADR, ADN and RID agreements not only describe in detail the procedures, requirements for participants in the transport of dangerous goods, but also precisely classify the goods so that the participant is in no doubt as to whether the goods fall under the provisions of the international agreements or not. It is important to remember that if the goods you want to transport are not listed in the catalogue, you should always consider the risk posed by the potential pathogen in terms of the hazard and the risk that could occur if the goods were infectious. Always when deciding that a commodity is not subject to the provisions of international agreements, one should take into account whether the commodity does not meet the criteria of other classes and whether it would nevertheless be considered dangerous for another reason.


 

Legal basis :

- Regulation on the protection of natural persons in relation to the processing of personal data of 4 May 2016.

- Act of 19 August 2011 on the carriage of dangerous goods

- European Agreement concerning the International Carriage of Dangerous Goods by Road" (ADR), done at Geneva on 30 September 1957

- European Agreement concerning the international carriage of dangerous goods by inland waterways (ADN), concluded in Geneva on 26 May 2000.

- Regulations concerning the International Carriage of Dangerous Goods by Rail (RID), being Appendix C to the Convention concerning International Carriage by Rail (COTIF), done at Berne on 9 May 1980

 

 

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