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ONLINE SELF-STUDY Shipping of Infectious Substances and Other Biomedical Materials Annual Update.

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Presentation on theme: "ONLINE SELF-STUDY Shipping of Infectious Substances and Other Biomedical Materials Annual Update."— Presentation transcript:

1 ONLINE SELF-STUDY Shipping of Infectious Substances and Other Biomedical Materials Annual Update

2 Course Objectives The purpose of this program is to: ensure the safe handling of hazardous materials using good sensible practices. recognize hazardous materials and realize there are special requirements Comply with Federal and International regulations The basic goal for this training is to provide a framework for decisions Is material to be shipped a dangerous good, genetically modified, biological substance category B, or an exempt human specimen? Upon completion you will receive certification to ship hazardous materials

3 Course Objectives This training will increase your awareness of safety and compliance issues. If you need more information or help with shipping your package you can the EHS Shipping Specialist. The training will cover the topics listed below. Classification, identification, and packaging are three of the most important topics covered.EHS Shipping Specialist Regulatory Oversight Dangerous Goods/Hazardous Materials Training Requirements Shippers & Operators Responsibilities Classification, Identification Packaging Shipping with dry ice and Overpacks Marking & labeling packages Shipping documentation Emergency Response Laboratory Security Accept or reject shipments by use of checklist

4 What is a Dangerous Good/Hazardous Material? Federal Regulations: U.S. Dept. of Transportation (DOT) – 49 CFR Other federal requirements: CDC, OSHA, USDA, Department of Commerce, International Traffic and Arms (ITAR) and Toxic Substance Control Act (TSCA) DOT regulations primarily cover ground transportation. DOT is the organization that has the authority to fine you for violations. Their authority extends well beyond US boundaries. Import permits from the CDC or USDA may be needed if you are importing human etiological organisms or plant or animal pathogens. Department of Commerce licenses may be needed to export organisms, genetic elements, chemicals, technology or other commodities. TSCA Certification may be needed to import or export certain chemicals.CDCUSDA International Regulations (Air shipments) International Civil Aviation Organization (ICAO) International Air Transport Association (IATA) Dangerous Goods Regulations (DGR) Internationally, the UN Committee of Experts (CoE) develops recommended procedures for the transport of all types of dangerous good except Radioactive material. The International Civil Aviation Organization (ICAO) uses the UN recommendations as the basis for developing the regulations for the safe transport of dangerous goods by air. IATA is the international trade organization that interprets ICAO regulations and provides the Dangerous Goods Regulations (DGR). The IATA regulations are more stringent than DOT. This training program follows the IATA regulations. IATA regulations are minimal requirements - your carrier can be more stringent.

5 What is a Dangerous Good/Hazardous Material? Fines and Penalties "Violations contrary to the U.S. Code of Federal Regulations (CFR) 49, if substantiated, may result in the assessment of a civil penalty of up to $37,500 per violation, and deliberate violations may result in criminal prosecution of up to $500,000 and 5 years in prison." There has been an increase in the number of Federal Aviation Inspections (FAA) in response to the 1996 ValuJet crash, the September 11, 2001 attacks, and the UPS package bomb scare in November If you are receiving a HazMat package it is your responsibility to ensure the sender packages it correctly. Oxygen-generating canister like the ones on board the ValuJet flight 592

6 Definition Infectious Substance - Class 6.2 Definition: Infectious substances are substances known to contain, or reasonably expected to contain, pathogens. Pathogens are defined as micro-organisms (including bacteria, viruses, rickettsia, parasites, fungi) and other agents such as prions which can cause disease in humans or animals. Critical to the infectious substance definition is the ability to cause disease. - Note the reliance on your professional judgment when the words reasonably expected are used.

7 Definition The IATA definition for infectious substances leaves out toxins. Toxins are placed in a separate category. They are treated like chemicals. Toxins from plant, animal or bacterial sources which do not contain any infectious substances or toxins that are not contained in substances which are infectious substances should be considered for classification in Division 6.1 and assignment to UN 3172 (for liquids) or UN 3462 (for solids). Contact EHS if you are shipping toxins as instructions for shipping toxins is not covered in this training module. Please be aware that many toxins (if shipped out of the US) are regulated by the Department of Commerce. There are significant fines associated with exporting toxins without a license

8 Definition Biological products are those products derived from living organisms which are manufactured and distributed in accordance with the requirements of appropriate national authorities, which may have special licensing requirements, and are used either for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto. They include, but are not limited to, finished or unfinished products such as vaccines.

9 Definition Cultures Laboratory stocks are the result of a process by which pathogens are intentionally propagated in order to generate high concentrations. This increases the risk of infection when exposure to them occurs. An example of this would be a patient sample of TB that has been cultured.

10 Definition Patient Specimens Patient Specimens are human or animal materials, collected directly from humans or animals, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention.

11 Classification of Infectious Substances The three proper shipping names for infectious substances are: Infectious substances, affecting humans, UN 2814 Infectious substances affecting animals, UN 2900 Biological Substances Category B, UN 3373 (This does not require a Dangerous Good Declaration to ship)

12 Classification Category A Infectious Substances - an infectious substance which is transported in a form that when exposure occurs, is capable of causing permanent disability, life threatening or fatal disease in otherwise healthy humans or animals. Examples of substances that meet this criteria are located in this table: Table 3.6.D.Table 3.6.D NOTE: An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals.

13 Classification of Infectious Substances Infectious substances meeting the Category A criteria which cause disease in humans or both in humans and animals must be assigned to UN 2814 (Infectious substance, affecting humans). Infectious substances which cause disease only in animals must be assigned to UN 2900 (Infectious substance, affecting animals).

14 Classification of Infectious Substances Assignment to UN 2814 or UN 2900 must be based on the known medical history and symptoms of the source human or animal, endemic local conditions, or professional judgment concerning individual circumstances of the source human or animal. Example: a patient from a foreign country is admitted to the hospital. You think they may have Ebola. You will ship all body fluids as infectious substances (Category A) using all the applicable packaging and paperwork.

15 Classification of Infectious Substances Category B, biological substance is an infectious substance which does no meet the criteria for inclusion in Category A. An example of a Category B biological substance would be a patient's body fluid infected with mycobacterium tuberculosis. A culture of this same organism would be a Category A infectious substance. You must use your professional judgment in deciding if an infectious substance is a Category A or Category B infectious substance. Contact EHS if you need assistance determining your classification.

16 Classification of Infectious Substances Infectious substances in category B must be assigned to UN 3373 except those organisms on table 3.6.D - which must be assigned to UN 2814 or UN 2900.table 3.6.D The proper shipping name of UN 3373 is Biological Substance Category B.

17 Classification of Infectious Substances Exemptions under Biological Substance Category B Substances which do not contain infectious substances or substances which are unlikely to cause disease in humans or animals are not subject to these Regulations unless they meet the criteria for inclusion in another class i.e. you add ethanol to the sample. Substances containing micro-organisms, which are non-pathogenic to humans or animals are not subject to these Regulations unless they meet the criteria for inclusion in another class. Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk are not subject to these Regulations unless they meet the criteria for inclusion in another class. Environmental samples (including food and water samples), which are not considered to pose a significant risk of infection are not subject to these Regulations, unless they meet the criteria for inclusion in another class. Dried blood spots, collected by applying a drop of blood onto absorbent material, or faecal occult blood screening tests and blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation are not subject to these Regulations.

18 Classification of Infectious Substances Exemptions: Patient Specimens Patient specimens for which there is minimal likelihood that pathogens are present are not subject to these Regulations if the specimen is packed to prevent any leakage and is marked with the words "Exempt human specimen" or "Exempt animal specimen", as appropriate. The packaging must meet the following conditions: The packaging must consist of three components: a leak-proof primary receptacle(s); a leak-proof secondary packaging; and an outer packaging of adequate strength for its capacity, mass and intended use, and with at least one surface having minimum dimensions of 100 mm x 100 mm; For liquids, absorbent material in sufficient quantity to absorb the entire contents must be placed between the primary receptacle(s) and the secondary packaging so that, during transport, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material; When multiple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. Determining whether a patient specimen has a minimal likelihood that pathogens are present, should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. Examples of specimens which may be transported under this paragraph include the blood or urine tests to monitor cholesterol levels, blood glucose levels, hormone levels, or prostate specific antigens (PSA); tests required to monitor organ function such as heart, liver or kidney function for humans or animals with non-infectious diseases, or therapeutic drug monitoring; tests conducted for insurance or employment purposes and are intended to determine the presence of drugs or alcohol; pregnancy tests; biopsies to detect cancer; and antibody detection in humans or animals.

19 Other Classifications Biological Products For the purposes of these Regulations, biological products are divided into the following groups: Those which are manufactured and packaged in accordance with the requirements of appropriate national authorities and transported for the purposes of final packaging or distribution, and use for personal health care by medical professionals or individuals. Substances in this group are not subject to these Regulations. These include but are not limited to finished and unfinished products such as vaccines. Those which do not fall under paragraph (a) and are known or reasonably believed to contain infectious substances and which meet the criteria for inclusion in Category A or Category B. Substances in this group must be assigned to UN 2814, UN 2900 or UN 3373, as appropriate. Note: Some licensed biological products may present a biohazard only in certain parts of the world. In that case, competent authorities may require these biological products to be in compliance with local requirements for infectious substances or may impose other restrictions

20 Other Classifications Genetically modified microorganisms are: Organisms that do not meet the definition of infectious substances but posses genetic material that has been purposely altered through genetic engineering in a way that does not occur naturally. Assigned UN 3245 UN 3245 label: These items must be triple packaged (leak proof primary container, leak proof secondary container, strong outer container). Liquids must have sufficient absorbent material to absorb all contents outside of the primary container. Outer containers must have sender and receiver names, addresses, and phone number marked on the box. UN3245

21 Other Classifications Infected Animals A live animal which has been intentionally infected and is known or suspected to contain an infectious substance cannot be transported by air unless the infectious substance contained cannot be consigned by any other means. Infected animals can only be transported by certain carriers. With the shipment there must be a DOT letter of authorization. In order to receive infected animals you must obtain an import permit from the USDA. Both a DOT letter of authorization and USDA Permit take weeks to obtain.

22 Identification Category A Infectious Substance The table from the Dangerous Goods Regulations provides a lot of critical information. The entries for infectious substances are shown here. You will not find a microorganism listed by its scientific/technical name. There are two UN numbers: UN 2814 and UN 2900 for Category A Infectious Substances (Column A). The asterisk beside infectious substances means you must put the technical name (specific name of the organism) on any paperwork. You do not put the technical name on the outside of the package. Column C gives the class or division and Column D gives the hazard label that will be affixed to the package. Columns J and L give the quantity limits per package type Update: Category A infectious substances are packed according to Packing Instruction 620 UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Cargo Aircraft Only S.P. See 4.4 M ERG Code N Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L Pkg Inst G Max Net Qty/Pkg H 2814 Infectious substance, affecting humans * (solid) 6.2 Infectious subst. E g6204 kg A81 A140 11Y 2814 Infectious substance, affecting humans * (liquid) 6.2 Infectious subst. E mL6204 L A81 A140 11Y 2900 Infectious substance, affecting animals * only (solid) 6.2 Infectious subst. E g6204 kg A81 A140 11Y 2900Infectious substance, affecting animals * only (liquid) 6.2Infectious subst. E mL6204 LA81 A140 11Y

23 Identification Category A Infectious Substance This slide shows the packing instruction and maximum quantity per package. The limits are different for passenger and cargo aircraft. You are only allowed to ship 50mg/g per package on a passenger and cargo aircraft. You are only allowed to ship 50mL (liquid) or 50g (solid) per package on a passenger and cargo aircraft. With the "cargo aircraft only" label you can ship up to 4L (liquid) or 4 kg (solid) on a cargo aircraft only. Cargo Aircraft Only Label Passenger and Cargo Aircraft Cargo Aircraft Only Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L Pkg Inst G Max Net Qty/Pkg H g6204 kg mg6204 L g6204 kg mL6204 L

24 Identification Biological Substance, Category B The UN number 3373 is in Column A. When shipping biological substances you have to use packing instruction 650 and you can ship up to 4 L per outer package (primary containers cannot exceed 1 L.) The 4L quantity excludes ice, dry ice or liquid Nitrogen when keeping specimens cold. UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Cargo Aircraft Only S.P. See 4.4 M ERG Code N Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L Pkg Inst G Max Net Qty/Pkg H 3373 Biological substance, Category B6.2E0-- --See L

25 Identification Biological Products There is no UN number in the left hand column for biologicals. It states they are not restricted. You do not need diamond shaped labels and you can ship as much as you want as long as no chemicals or infectious agents are present. UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Cargo Aircraft Only Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L Pkg Inst G Max Net Qty/Pkg H Biological products + Manufactured and packaged in accordance with the requirements of national governmental health authorities and transported for the purposes of final packaging or distribution, and use for personal health care by medical professionals or individuals ----NOT RESTRICTED----

26 Chemical Preservatives Solutions used to preserve biological samples may be regulated as dangerous goods. Ethanol, greater than 24% is assigned to UN1170, Class 3, Ethanol, PGII 10% to <25% Formaldehyde is assigned to UN3334, Class 9, Aviation regulated liquid, n.o.s. Formaldehyde, not less than 25% assigned to UN2209, Class 8, Formaldehyde solution PGIII Formaldehyde combined with a flammable substance may qualify as UN1198, Class 3 (Sub risk 8), Formaldehyde solution, flammable. Call EHS for specific packaging and training before shipping chemicals

27 Packing Groups Packing groups apply to toxic substances and chemicals but not infectious substances, biological products or Category B biological substances. Here is an example of the packing group criteria for class 3 materials (flammable liquids). The packing groups pertain to performance test requirements. They are assigned with regard to the relative degree of danger of the article or substance. The IATA DGR establishes packing group assignments for all applicable classes based on the type of hazard. For example Class 8 materials are assigned packing groups based on corrosivity and Class 6.1 materials are assigned based on toxicity. Packing GroupFlash Point (closed cup) Initial Boiling Point I Less than or equal to 35° C II Less than 23° C Greater than 35° C III Equal to or greater than 23° C but less than or equal to 60.5° C

28 Packing Groups The packing group for a material is indicated on the table in the Dangerous Goods Regulations. Here is an example using the listing for Ethanol. Ethanol has two packing groups listed (column E). The flashpoint of your ethanol solution will determine which packing group and packing instructions to use. Check the MSDS for flashpoint information. UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Cargo Aircraft Only S.P. See 4.4 M ERG Code N Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L Pkg Inst G Max Net Qty/Pkg H 1170Ethanol3 Flamm. liquid II III E2 E1 Y341 Y344 1 L 10 L L 60 L L 220 L A3 A58 A180 3L

29 Shipping With Formalin Shipper's Declaration for Dangerous Goods Many people ship large amounts of formalin to preserve their specimens. Here is an example of the Shippers Declaration for Dangerous Goods when shipping formalin. If you are shipping formalin or any other chemical, you need to call EHS at for more in-depth training.

30 Dangerous Goods in Excepted Quantities There is a provision in the Dangerous goods regulations that allows small quantities of some dangerous goods to be shipped as "dangerous goods in excepted quantities. This is very useful for small amounts of hazardous chemicals. Check the EQ column (column F) on the Dangerous Goods Table for the material to find the Excepted Quantity code. Reference table 2.7 to determine the quantity allowed under your item's code.table 2.7 Some materials are not allowed to ship as Excepted Quantities. These will have an E0 in column F For the EQ table, click here: table 2.7table 2.7 UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Cargo Aircraft Only S.P. See 4.4 M ERG Code N Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L Pkg Inst G Max Net Qty/Pkg H 2516Carbon tetrabromide 6.1ToxicIIIE1Y64510 kg kg kg6L

31 Dangerous Goods in Excepted Quantities This form can be downloaded at It needs to be printed on a color printer. In the upper box you will type the Class number(s), with sub risks in parenthesis. This is found in column C of the Dangerous Goods table. In the lower box you will type either your name and address or the recipient's name and address IF it is not already marked ON the package. This label along with an address label placed on a strong outer box is what is needed for shipping excepted quantities of chemicals not forbidden for transport. The material must be in a leak proof primary container. The primary container needs to be taped closed. This primary container must be securely packed in a secondary container with absorbent/cushioning material in such a way that the primary container will not break, puncture, or otherwise release its contents. The secondary container must be securely packed in a strong rigid outer packaging (wood, cardboard, or other equally strong material). Each outer package must be large enough to apply all necessary markings.

32 Dangerous Goods in Excepted Quantities Excepted Quantity Package Test The complete package must be capable of withstanding the following drop and load tests. This must be demonstrated by testing and appropriately documented using this form. Excepted Quantity Package Test Verification Form (http://ehs.unc.edu/ih/lab/docs/eq_test_form.pdf)http://ehs.unc.edu/ih/lab/docs/eq_test_form.pdf For the purposes of testing you will use a substance with similar physical characteristics (mass, grain size, density, etc.) to the item you intend to ship. Fill the primary container to 98% capacity. Triple package this substance in identical primary, secondary (including absorbent/cushioning), and outer containers to what you intend to use for shipping and perform the following tests:

33 Dangerous Goods in Excepted Quantities Drop Test: From a height of 1.8 m (5.9 feet), perform each of the following drops onto a rigid, non-resilient flat and horizontal surface: Flat on the base Flat on the top Flat on the longest side Flat on the shortest side On a corner Load Test: Calculate the mass of identical size and weight packages as your test sample if stacked to a height of 3 m (10 feet). Apply this amount of force to the top surface of your package for 24 hours.

34 Dangerous Goods in Excepted Quantities A successful package test results in no leakage or breakage of the inner containers and no significant reduction in effectiveness of any of the 3 layers of packaging. Remember to document this package test using this form (http://ehs.unc.edu/ih/lab/docs/eq_test_form.pdf)http://ehs.unc.edu/ih/lab/docs/eq_test_form.pdf If you are using packing materials and specimens that you have previously tested and documented you do not need to re-test the package. You may use a copy of the package test verification form from a previous test of the same materials. Make sure you keep a copy of the package test verification form in your shipping records.

35 Dangerous Goods in Excepted Quantities Here is an example of the label for a package containing an excepted quantity of a Class 3 flammable liquid.

36 Dangerous Goods in Excepted Quantities Many people ship their biological samples in formalin or ethanol to preserve them. Packing instructions 620 (UN2814 and 2900 Category A infectious substances) and 650 (UN3373 Biological Substances, Category B) allow for a quantity of 30mL or less of dangerous goods in classes 3, 8, or 9 to be packed in each primary receptacle containing infectious substances. This includes commonly used preservatives such as formalin, ethanol, or formaldehyde. When these small quantities are packed with infectious substances using the packing method for that infectious substance, the excepted quantity label is not required. The infectious substance packaging will be sufficient. This does not include phenol which is a class 6 chemical.

37 Biological Specimens Category B Packaging Selecting Proper Packaging Selecting the proper packaging is one of the most important functions of the shipper. The shipper is responsible for all aspects of the packing of dangerous goods. The carrier (FedEx, DHL, World Courier, etc.) will not help you package your material.

38 Biological Substance Category B Packaging Selecting Proper Packaging The shipper must comply with the following packing instructions: When shipping UN2814 or UN2900 Category A infectious substances use Packing Instruction 620 pdfPacking Instruction 620 pdf When shipping UN3373 Category B infectious substances use Packing Instruction 650 pdfPacking Instruction 650 pdf When shipping dry ice use Packing Instruction 954 pdfPacking Instruction 954 pdf Make sure the responsibilities for packing are complete when the package is given to the carrier for shipment

39 Biological Substances Category B Packaging Category B Infectious Specifications These are the minimum packaging requirements for Packing Instruction 650: The packagings must be of good quality, strong enough to withstand the shocks and loadings normally encountered during transport, including trans shipments. "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: Primary receptacle(s) Secondary packaging(s) Rigid Outer Packaging

40 Biological Substance Category B Packaging Packaging Materials for Category B Substances This picture was taken from FedEx's Points to Consider brochure for mailing Category B substances. Category B substances can be shipped in a cardboard mailing tube or a plastic container. You do not need special absorbent. Cotton balls or paper towels may be used.

41 Biological Substance Category B Packaging Biological Substance, Category B Packaging Requirement Primary receptacle(s) must be leakproof and contain no more than 1L Secondary packaging must be leakproof If multiple fragile receptacles are in a single secondary package they must be individually wrapped or separated to prevent contact Sufficient absorbent material must be placed between the primary and secondary receptacles.

42 Biological Substance Category B Packaging Biological Substance, Category B Packaging Requirement Water tight packaging (above in photo) Pressure tested packaging (tyvek bag; below in photo) The primary receptacle or the secondary packaging must be able to withstand without leakage an internal pressure test of 95 kPA in the range of -40° C to 55° C. When you are ordering shipping materials make sure you order primary or secondary containers that meet the 95 kPA. Notice the bio hazard symbol on the packaging. It is an OSHA (not an IATA) requirement when shipping blood or other potentially infectious material.

43 Biological Substance Category B Packaging Biological Substance, Category B Packaging Requirement Secondary packaging Itemized list of contents Placed in outer packaging Outer packaging must be marked with the following: The name, address and telephone number of a responsible person. UN 3373 must be marked on the outside of the box adjacent to the words Biological Substance Category B. The completed package must be able to pass a drop test of 1.2 M on all sides. The biohazard symbol is not required on the outer box. Make sure your specimens do not move about loosely in the box. It is useful many times when shipping out of the country to put "For Research Purposes Only" on the outside of the box.

44 Biological Substance Category B Packaging

45 US Postal Service Label Requirement for Specimens OSHA "Biohazard Label" The U.S. Postal Service accepts Biological Substance Category B. You no longer display the Biohazard symbol on the outside. If you are shipping chemicals or blood or other potentially infectious materials using the U.S. postal service please call EHS at outside

46 Shipping With Dry Ice Use Packing Instruction 954 Dry ice is always considered a Dangerous good It must always be declared by marking, labeling, (Class 9) and documentation. If there are no other dangerous goods in a shipment, a Shippers Declaration is not required (red hatch-mark form). It is very important that dry ice is never placed in a sealed container. The build-up in pressure will cause violent failure of the container. When shipping dry ice the following needs to be on the outside of the box: "#9 misc label, UN 1845 and # kg" The package must be able to release vapor at all times. The lid of a Styrofoam cooler should not be taped in place. Tape the outer cardboard box. Even when transporting dry ice by ground, basic safety precautions should be followed. Allow ventilation of the cooler and the vehicle. CO 2 can build up in a car with the windows rolled up.

47 Shipping With Dry Ice Identification Several of these entries for dry ice look alike. The one you want is UN 1845, Class 9. The Packing Instruction when filling out the Dangerous Goods Declaration is Update: Dry Ice is packed according to Packing Instruction 954 UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Cargo Aircraft Only S.P. See 4.4 M ERG Code N Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L Pkg Inst G Max Net Qty/Pkg H 1845Carbon dioxide, solid 9MiscellaneousE kg kgA48 A151 9L

48 Shipping With Dry Ice Here is an example of the "Special Handling" box of the Air Waybill (FedEx): The proper Shipping Name box should be checked The Class Number 9 (misc) is printed on the form-fill in the amount of dry ice The UN Number UN1845 should be on the form One of the following boxes must be checked Does this shipment contain dangerous goods? Wet ice or blue ice packs are not considered dangerous goods. Pack both so the package does not leak. If you are shipping Biological Substances Category B with wet ice, blue ice, dry ice, or at ambient temperatures you need to check the box. "Yes" (Shippers declaration not required). If you are shipping Infectious Substance Category A on dry ice you will check 'yes' (as per attached shipper's Declaration).

49 Shipping With Overpacks Overpacks are large packages capable of containing one or more smaller packages. Many people use the MediPak diagnostic shipper with an inner UN 6.2 infectious shipper box. Dangerous goods packages within the overpack must be correctly packed, marked, labeled and in proper condition.

50 Shipping With Overpacks The overpack must have on the outside of the box: All necessary marks and labels. If the UN package specification marks are not visible, a statement that says "Overpack" must appear on the outside package. UN Package Specification Marks Required on inner package of overpack containing infectious substances.

51 Shipping With Overpacks Labeling the Overpacks for Infectious Substances The overpack must be labeled in the following way: A Division 6.2 Infectious Substance Hazard Label next to the proper shipping name and UN number (UN 2814) Net quantity of infectious substance adjacent to proper shipping name Package Orientation labels (up arrows) on opposite sides of the overpack if not pre-printed on the box. A Class 9 label (if Dry Ice is used). Other dangerous goods must not be packed in the same package as infectious substances unless they are needed for maintaining viability, stabilizing or preventing degradation or neutralizing the hazards of infectious substances. A quantity of 30 mL or less of dangerous goods included in classes 3 (ethanol), 8 (formaldehyde), 9 (formalin) may be packed in each primary receptacle containing infectious substances NO excepted quantity label is needed. An overpack does not need to be a UN certified package. It can be a strong, recycled box. An example of a much used overpack is the UN Certified smaller box inside the outer Medifreeze box.

52 Infectious Substances Packaging Packing Specifications Infectious Substances (Category A) With proper packaging you ensure the safety of those who may handle or unpack the contents of the package. Proper packaging ensures that the material is not released during transportation. Here are the most important requirements for Packing Instruction 620: watertight primary receptacle watertight secondary packaging absorbent material, if liquid itemized list of contents between the secondary and outer container UN certified outer packaging at least 100mm x 100 mm (4 in x 4 in.) Either the primary or secondary container must be capable of withstanding without leakage an internal pressure producing a pressure differential of not less than 95 kPa and temperatures in the range of -40° C to 55° C.

53 Infectious Substances Packaging UN Certified Packaging There are several requirements for certified packaging. One requirement for certified packaging is a drop test. A prototype of the package, properly packed with its filled primary and secondary containers, is dropped from a height of 30 feet on all sides and a corner. It is then subjected to an hour of rainfall and dropped on all sides again. Following the drop test there must be no leakage from the primary receptacles which must remain protected by absorbent in the secondary packaging. Another test to meet UN certified packaging is the puncture test. The UN certification stamp on the box certifies that the package has been subjected to and passed all required tests. The UN certification stamp looks like this: U4G/CLASS 6.2/07 DK/ NSP-9989-ERIKSSON

54 Infectious Substances Packaging UN Certified Packaging Here is an example of an infectious substance shipper. The UN Certification Symbol is pre-printed on the tested boxes. Under no circumstances must you write the UN certification mark on the box. Packages are expensive but reusable. When shipping a box back to a collaborator, deface labels (do not tear them off) and mark it as empty. In order to reuse an infectious shipper cut the tape to open - do not tear the tape off the box.

55 Infectious Substances Packaging Packing Instruction 620 for Class 6.2 An overview for the Packing and Labeling of Infectious Substances. Note the UN Specification marks on the box: A UN Certified box is tested with a primary and secondary container. You do not want to change out the components of the box. Ship the box the way it was originally tested to ensure its integrity.

56 Infectious Substances Packaging Fisherbrand Biohazard Mailers Take care when selecting your packaging. You cannot ship infectious material from Category A in these cardboard tubes. You will notice there are no UN markings. These should only be used when shipping exempt specimens or Category B materials. When shipping Category B materials make sure the mailer you buy meets the 95kPa pressure test. Category A

57 Infectious Substance Packaging (Category A) Requirements Primary containers must be glass, metal or plastic (leave room for expansion) Primary container wrapped in absorbent 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 they must be secured with tape or parafilm. Make sure you have enough absorbent for all liquids. If multiple fragile primary receptacles are placed in a single secondary packaging they should be individually wrapped or separated to prevent contact between them. Plastic Primary receptacles capable of withstanding very low temperatures should be used when shipping with liquid nitrogen.

58 Infectious Substance Packaging (Category A) Requirements Place Primary Packaging in Secondary Packaging Water tight packaging (above in photo) secondary packaging (below in photo) Primary or secondary packaging has to meet the 95kPa pressure test. The White Tyvek bag pictured meets these requirements

59 Infectious Substance Packaging (Category A) Requirements Put the secondary packaging along with the itemized list of contents in the support package. It supports the contents as the dry ice dissipates. All goes into a UN Certified outer package. You MUST use a Class 6.2 infectious Shipper to ship infectious substances (UN2814/UN2900). Click here to see an example of the UN Package Specification Mark:

60 Infectious Substance Packaging (Category A) Requirements The interior support packaging secures the secondary package as the dry ice dissipates. You do not want the contents of your package moving around inside the package unsecured.

61 Infectious Substance Packaging (Category A) Requirements Place insulated container inside certified outer packaging with UN Specification marks. Remember do not tape the lid of the insulated cooler. Tape the outer box.

62 Infectious Substance Packaging (Category A) Requirements Marking and Labeling of Outer Packaging for Infectious Substances Shipped with Dry Ice 1. Class 6.2, infectious label 2. Dry Ice name and quantity label 3. Class 9, dry ice label 4. UN packaging certification 5. Orientation marks, 2 sides 6. Consignee address and phone number 7. Shipper with phone # of person responsible 8. Proper shipping name, technical name, UN number and net quantity of infectious substance

63 Infectious Substance Documentation Shipping Documentation Includes the following... Preparing the Shippers Declaration, Airway Bill, Shipping Document. Reviewing the Dangerous Goods Table in the appropriate regulations. Listing all classes of Dangerous Goods, remember that dry ice is a Class 9 Dangerous Good Include emergency response information. - When shipping out of the U.S. a commercial invoice is also required for customs. - An import permit from the country you are shipping to may also be needed when shipping. - A letter on UNC letterhead will aid your shipment through customs.

64 Infectious Substance Documentation Shipping Documentation The Shippers Declaration needs to be kept for 2 years (domestic) / 5 years (international). All Shippers Declarations must be typed. A typed signature is unacceptable A signature can be handwritten, stamped or a facsimile A physical address is needed on the paperwork and box - no P.O. Boxes

65 Infectious Substance Documentation Shipper's Responsibilities Only the shipper is authorized to complete and sign the Shippers Declaration for Dangerous Goods o Once signed, the document is a sworn statement to the carrier that the shipment has been prepared in accordance with the regulations o As a legal document, the Declaration binds the shipper to its terms and conditions. o The person who signs the DG Declaration should be trained and certified. o If you are inexperienced at filling out these forms have someone review it and check for errors. You can call EHS at for assistance.

66 Infectious Substance Documentation Dangerous Goods Declaration

67 Infectious Substance Documentation Dangerous Goods Declaration A fillable template with instructions for completing it can be found here: As of January 10, 2011 FedEx will not accept a Dangerous Goods Declaration created using this template (all other carriers will). You must use a Dangerous Goods Declaration created using specific FedEx software. Contact EHS for more information on completing Dangerous Goods Declarations for FedEx shipments.

68 Infectious Substance Documentation 24-Hour Emergency Number Chemtrec is UNC-CHs 24 hour contact number in the event of an emergency Chemtrec within the U.S. – when out of the country ( ) You must also put your non-emergency number on the shipping papers (in the to/from section). Not acceptable on shipping papers: Pager number CDC reporting number Before shipping you must fax Chemtrec a Material Safety Data Sheet on your material (Fax number: ). You only fax it once. It is put into their database. Make sure you write UNC-Chapel Hill on the cover page of your fax. If you ship hazardous materials and you do not have an emergency number listed on the paperwork you can be subject to significant fines.

69 Infectious Substance Documentation MSDS for Emergency Response Health Canada has a web site that provides material safety data sheets on infectious agents. You can find them at the following web site: If you cannot find what you need you can write your own.

70 Emergency Response Damaged Shipment How do you know that a package contains dangerous goods? Look for the red hatch marks on paperwork, UN # and diamond shaped labels on box. A damaged package may be crushed or leaking. Do not sign for packages without seeing them Inspect package before signing Do not accept a package that is damaged Packages are the responsibility of the Shipper until accepted by recipient If the package is damaged or leaking offer assistance in cleaning up the spill (call EHS). The carrier should be prepared to deal with the spill.

71 Emergency Response Emergency Response for Damaged Package or Spill on Campus In a laboratory setting it is expected that staff are prepared to cope with a spill. All labs should have an emergency spill kit on hand and train all personnel in appropriate emergency response. Isolate spill or leak area immediately in all directions. Keep unauthorized personnel away. Obtain identity of substance involved if possible and report spill to appropriate authorities. Do not touch or walk through spilled material. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. If you need to, call EHS ( ) to help with spill clean up.

72 Emergency Response Emergency Response for Damaged Package or Spill on Campus Be very careful to avoid contact with broken glass or sharp objects that may cause cuts or abrasions that could significantly increase the risk of exposure. Damaged packages containing solid CO2 as a refrigerant may produce water or frost from condensation of air. Do not touch this liquid as it could be contaminated by the contents of the package.

73 Emergency Response Emergency Response for Damaged Package or Spill on Campus Liquid nitrogen may be present and can cause severe burns. Absorb spilled materials with earth, sand or other non-combustible material while avoiding direct contact. Cover damaged package or spilled material with damp towel and keep wet with liquid bleach of other disinfectant Evaluate potential personal exposure Contact UNC Employee Occupational Health Clinic ( ) for post exposure follow-up

74 Security Plan If you ship High Consequence dangerous goods you should adopt, implement and comply with a security plan that addresses the elements specified in section of the IATA Dangerous Goods Regulations High consequence Dangerous Goods are those that have the potential for misuse in a terrorist incident and which may as a result produce serious consequences. They include 1.1, 1.2, 1.3 explosives; 2.3, toxic gases; 6.1 toxins; 6.2 infectious substances; 7 radioactive materials.

75 Security Plan Labs need to take specific action in order to provide security against theft of highly hazardous materials, and to ensure compliance with new regulations. EHS urges each lab/clinic to review and develop procedures to ensure the security of hazardous materials in your area.

76 Security Plan Many of you already implement security measures Locking up controlled substances, syringes, and needles Securing radioactive material An easy way to increase laboratory security is to lock the lab whenever it is left unattended Keep records of dangerous good or types of dangerous goods transported Review how you store your dangerous goods Put in place procedures for reporting and dealing with security threats, breaches of security, or security incidents

77 Security Plan You should control access to areas where hazardous chemicals are used and stored Lock freezers, refrigerators where biological agents, hazardous chemicals or radioactive materials are stored Approach anyone you don't recognize who appear to be wandering in lab areas Assign security responsibility to one employee in your lab. Give them appropriate authority to carry out their responsibilities.

78 Security Plan Use a log book to sign highly hazardous materials in and out of secure storage Take a periodic inventory of highly hazardous chemicals, biological agents/toxins, radioactive material and controlled substances This could be as simple as frequently looking at your chemical containers to make sure none are missing Track the use and disposal of hazardous materials. Report any missing inventory to Public Safety or EHS. Know what materials are being ordered and being brought into the laboratory Consider having all lab staff wear identification badges

79 Contact for Packaging Materials inmark, inc. Atlanta, GA SAF-T-PAK Edmonton, Alberto, Canada CARGOpak, Corp. Raleigh, NC Fisher Scientific Contact your carrier for specific information regarding the shipment of Category B and Category A infectious substances. Your carrier can have more stringent requirements than IATA; i.e. FedEx requires you to create the Dangerous Goods Declaration using their specific software.

80 Other Regulatory Requirements When importing pathogens that affect poultry or livestock a USDA permit is needed from the Animal and Plant Health Inspection Service (APHIS)Animal and Plant Health Inspection Service (APHIS When importing plants, animals, insects, earthworms, soil, etc., you also need an import permit. For items not needing an APHIS import permit (human cell, culture, serum, blood) a guideline letter is requiredguideline letter is required The letter will aid your shipment through customs. Centers for Disease Control & Prevention A permit is required for the importation of certain etiological agents Select agent transfers require a Form 2 permit. Facilities transferring or receiving select agents must be registered with CDC Each transfer of a select agent must be documented Contact EHS for more information Department of Commerce licenses are required when exporting specific biological agents, genetic elements of these agents, toxins, certain chemicals and equipment. Contact EHS prior to exporting materials from your lab for an Export Control evaluation. OSHA – Blood & Bloodborne pathogens training is required if you work with blood, other potentially infectious substances, or human cell culture. (if you have complied with OSHA's BBP you have not complied with shipping regulations) Shipping overseas can be quite complicated because you need to consider the requirements of the receiving country. These additional requirements can take up to a month to accomplish - plan your shipment! Call the EHS Shipping Specialist for help.EHS Shipping Specialist

81 Vapor Shipper Liquid Nitrogen Liquid Nitrogen is a dangerous good that has specific package requirements: It is a class 2.2 Non-flammable, non-toxic gas assigned to UN 1977 Nitrogen, refrigerated liquid (If packaged with the vapor shipper it is exempt. You do not need a non flammable 2.2 label. Nor do you declare the liquid nitrogen on the shipping papers) Insulated packagings (vapor shipper) containing refrigerated liquid nitrogen fully absorbed in a porous material and intended for transport, at low temperature are not regulated. When using a vapor shipper the words "Not Restricted" and the special provision number "A152" must be included in the description of the substance on the airway bill. A152 must also be typed in the "authorization" column of the Dangerous Goods Declaration.

82 Vapor Shipper Follow manufacturers directions to properly prepare vapor shipper. The blue layer is porous. After charging the shipper, pour off the excess liquid nitrogen. They cost from $600 - $5000. Vapor shippers can maintain freezing temperatures for up to three weeks. If you are shipping infectious substances in a vapor shipper make sure the shipper is IATA/ICAO certified to ship infectious substances. The 6.2 label and proper shipping name are required on the outside of the shipper when transporting infectious substance.

83 Examples Decide whether sample should be shipped as infectious substance or exempt specimen.

84 Examples Example #1 A patient (from South Africa) is ill with symptoms of hemorrhagic fever. You are given the task of sending blood samples for confirmation of Ebola to the Centers for Disease Control and Prevention in Atlanta, GA. Category A Infectious Substance Category B Biological Substance Exempt Human Specimen

85 Examples Example #2 In a clinical lab you are given a pleural sample to be tested for M. tuberculosis. You culture it then send it off for confirmation. When sending it off are you going to classify as infectious or diagnostic? Category A Infectious Substance Category B Biological Substance Exempt Human Specimen

86 Examples Example #3 Your collaborator sent you the laboratory strain of Francisella tularensis you wanted the live vaccine strain: you need to send it back to them. Category A Infectious Substance Category B Biological Substance Exempt Human Specimen

87 Examples Example #4 Your lab has been told to send off for investigational purposes spinal fluid taken from a hospital patient. You are asked to send it off to test for several diseases including meningitis. Category A Infectious Substance Category B Biological Substance Exempt Human Specimen

88 Examples Example #5 Your lab is conducting a study on the effect of folic acid and early pregnancy in 120 healthy women. You are required to send off blood, saliva, and fecal material for folic acid level analysis. Category A Infectious Substance Category B Biological Substance Exempt Human Specimen

89 Examples Example #6 You are involved in a drug study on campus that involves 50 research subjects. Seven of those patients are positive for having syphilis. The other 43 people are healthy adults. How will you send this shipment? Category A Infectious Substance Category B Biological Substance Exempt Human Specimen

90 Summary Compliance with the hazardous materials shipping regulation is not easy. Work out the details Don't hesitate to ask for assistance (call FedEx, Airborne, UPS, etc. Call EHS ( ) Protect yourself, your coworkers, the public Hazard communication is fundamental (labeling, labeling, labeling) In order to receive credit for this training, you must complete the post-testpost-test


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