Shipping with Dry Ice, Exempt Specimens and Excepted Quantities of Dangerous Goods TC0076. Biosafety

Shipping with Dry Ice, Exempt Specimens and Excepted Quantities of Dangerous Goods – TC0076 Biosafety www.ehs.columbia.edu Overview 2  This modu...
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Shipping with Dry Ice, Exempt Specimens and Excepted Quantities of Dangerous Goods – TC0076

Biosafety www.ehs.columbia.edu

Overview

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 This module provides Columbia University personnel with training to safely and legally ship the following Dangerous Goods (also known as hazardous material). Please note – The terms “Dangerous Goods” and “Hazardous Materials” (“HAZMATs”) are used interchangeably throughout this presentation. - Dry ice - Hazardous chemicals in excepted quantities  This module also provides Columbia University personnel with training to safely and legally ship the following exempt or non-regulated materials - Exempt human specimens - Exempt animal specimens - Non-regulated biological material  The law (49 CFR) define a hazardous materials employee as anyone who prepares hazardous materials for transportation. All persons involved in any aspect of the transport of Dangerous Goods including packing, labeling and preparing shipping documents, must receive training based on US and international regulations.  This training and certification course must be taken before any shipping is done and must be renewed every two years Biosafety www.ehs.columbia.edu

Training Requirements  Individuals wishing to ship dry ice and hazardous chemicals in excepted quantities must take this training and certification course.  Individuals wishing to ship exempt human/animal specimens’ (specimens) must take this training and certification course and also complete separate Biosafety/Bloodborne Pathogens training (TC0509 or TC0025) in order to understand the hazards posed by these materials and the corresponding safety practices that must be used to reduce or eliminate those hazards.  Following completion of this module, a short quiz must be satisfactorily completed in order to be authorized to prepare packages, sign shipping documents, or perform any other shipping function discussed in this module involving dry ice or specimens.  Individuals viewing this presentation outside of RASCAL, if unable to complete the related quiz in RASCAL, must contact [email protected] to obtain a hard copy of the quiz.  Please note – certification to ship other dangerous goods requires separate training not satisfied by this module. Please contact EH&S with specific questions. Biosafety www.ehs.columbia.edu

Course overview

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This training and certification course will cover the following areas:  Classifying biological materials for shipment,  Determining appropriate packing instructions,  Selecting materials for packaging,  Marking and labeling of packages,  Completing documents,  Securing packages prior to releasing them to a courier,  Records retention and inspections  Intercampus transport

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General HAZMAT Awareness

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A number of entities regulate shipment of biological materials that may be capable of transmitting infectious disease; the two with the most important roles are:  US Department of Transportation (DOT) – rules apply for ground shipments only.  International Air Transportation Association (IATA) – an organization of the world’s commercial air carriers, their regulations are based on UN requirements and are applicable for all air transport of Dangerous Goods. Shipments by air are subject to more stringent regulation. For example, dry ice is only regulated as a hazardous material when shipped by air. Most couriers, including FedEx, ship by air. This training course will certify you to ship by air and meet these more stringent standards.  The Federal Aviation Authority (FAA) – inspects packages at airports. Violations can result in up to $250,000 and up to a year jail for the individual shipper, and up to $500,000 per incident for the organization  Improperly shipped packages can elicit an FAA inspection of the shipper’s university. Such an event triggered an inspection at Columbia in June 2016. Biosafety www.ehs.columbia.edu

Function Specific and Safety Information

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Following the sequence of steps below will ensure that your package is safe, secure and can be transported according to applicable laws:  Classification – Does the product meet the definition of an exempt or non-regulated material?  Packaging – The correct packaging must be used and the materials must be packaged properly to achieve the goal of risk reduction.  Marking & Labeling – Appropriate hazard awareness information must be provided to those transporting the shipment  Shipping documentation – Airway bills, commercial invoices, permits  Security – Retaining package prior to shipment Any and all these of functions must be performed by trained and certified personnel (“hazardous materials employee”). For example, it is not acceptable to have an untrained person complete the air waybill. Shipping companies (e.g., FedEx, UPS) are legally required to refuse to transport any shipment that is improperly packaged, labeled, or accompanied by incorrect shipping documents. Biosafety www.ehs.columbia.edu

Classification information – Exempt Specimens  Patient or animal specimens for which there is a minimal likelihood that pathogens are present are not subject to DOT or IATA shipping regulations, provided that the specimens are packaged in a way that will prevent leakage during transport. Packages of this type must display the words “Exempt Human Specimen” or “Exempt Animal Specimen”.  The terms “clinical specimens” or “diagnostic specimens” are no longer acceptable terminology, and must not appear on the package. Please contact EH&S for further guidance on shipping potentially infectious materials.

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Classification information – Exempt Specimens  Exempt Human Specimens or Exempt Animal Specimens, according to 49 CFR include any “human or animal sample (including, but not limited to, secreta, excreta, blood and its components, tissue and tissue fluids, and body parts) being transported for routine testing not related to the diagnosis of an infectious disease, such as for drug/alcohol testing, cholesterol testing, blood glucose level testing, prostate specific antibody testing, testing to monitor kidney or liver function, or pregnancy testing, or for tests for diagnosis of non-infectious diseases, such as cancer biopsies, and for which there is a low probability the specimen is infectious.” Human and animal cell lines that are not reasonably suspected to contain pathogens can be classified as exempt specimens.  The ‘exempt’ designation allows for the shipment of low risk material with fewer restrictions/requirements than ‘infectious’ materials.  Material transported for testing related to the diagnosis of infectious disease may not be classified as exempt and must be shipped as Category A or B infectious materials. For training regarding the shipment of Biological Substances Category B, UN3373, take RASCAL module “TC0507 – Shipping Biological (infectious and potentially infectious) Materials and Genetically Modified Microorganisms” Biosafety www.ehs.columbia.edu

Classification Information – Non-regulated Material

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 Non-regulated material: Substances which do not contain infectious substances or are unlikely to cause disease in humans or animals: – Isolated nucleic acids, antibodies – Microorganisms typically handled at BSL-1 which are non-pathogenic to humans or animals (e.g., E. coli K12) – Substances containing pathogens that have been neutralized or inactivated so they do not pose a health risk (e.g., autoclaved material) – Environmental samples (water, soil, food) – Blood or blood components collected for transfusion, organs for transplantation, dried blood spots (newborn screening) and fecal occult blood tests (stool for colorectal cancer testing) – Biological products derived from living organisms which are used for the prevention, treatment, or diagnosis of disease in humans or animals and that have received approval from the FDA (e.g., vaccines) These materials must be packaged in accordance with their approval. Biosafety www.ehs.columbia.edu

Function Specific and Safety Information

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Classification quiz…. Question: How is a blood sample sent for HIV testing classified? Answer: “Biological Substance, Category B.” The testing exception would not apply because the testing is related to infectious disease diagnosis. Question: How is a blood sample sent for cholesterol testing classified? Answer: “Exempt human specimen.” The testing exception would apply because the testing is not related to infectious disease diagnosis. Question: How is a blood sample from an HIV-positive patient sent for cholesterol testing classified? Answer: “Biological Substance, Category B.” The testing exception would not apply because the blood may contain infectious disease. Biosafety www.ehs.columbia.edu

General Packaging Information

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Exempt human or animal specimens and non-regulated biological materials require packaging capable of protecting against accidental release – “Triple performance packaging”. 1. Primary Receptacle  Leakproof (no petri plates)  Labeled with the name of the contents (Specimen ID Label)  Individual cushioning - wrap multiple primary containers to prevent contact between them and prevent breakage 2. Secondary Container  Leakproof  Absorbent material enough to absorb ALL of the liquid from the primary receptacle(s). 3. Durable Outer Container  Typically a fiberboard box Biosafety www.ehs.columbia.edu

Proper shipping name – Exempt Specimens  Packages must be identified with the proper shipping name . No proper shipping name is required on the package.  “Exempt Human Specimen” or “Exempt Animal Specimen” is the proper shipping name. These words must be in full with no shorthand or abbreviations. Can be on an adhesive label (example below), printed or handwritten.  Shipping labels available at no cost from EH&S: email [email protected]

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Exempt Specimen Packaging Requirements

Proper shipping name

International biohazard symbol may be on the primary or secondary container if the shipment consists of human blood/body fluids, BUT hazmat package exteriors should not be labeled with the biohazard symbol. This is not a recognized hazmat shipping label or marking and its similarity to a Category A infectious material symbol may only serve to confuse the carrier and lead to return of packages that do not meet other Category A requirements.

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Packaging – Non-Regulated Biological Materials  No proper shipping name is required on the package.

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Markings and Labels – Exempt Specimen A – Ship to/from info B – Proper Shipping Name Exempt Human Specimen or Exempt Animal Specimen

Jane Doe Columbia University Med. Ctr. 601 W 168th St. Room 53 New York, NY 10032

Fedex clinical pak used only as an overpack for multiple small boxes. Do not use regular fedex packaging for sending patient specimens.

John Doe ABC Laboratories 123 Main Street Detroit, MI 48203

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Markings and Labels Non-regulated biological materials

A – Ship to/from info Jane Doe Columbia University Med. Ctr. 601 W 168th St. Room 53 New York, NY 10032

John Doe ABC Laboratories 123 Main Street Detroit, MI 48203

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Shipping Documents - Exempt Patient Specimens and Non-Regulated Biological Material

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 There are no specific paperwork requirements for exempt specimens or non-regulated biological material.  Air shipments require an “Air Waybill.” See FedEx example in next slide. – Next business day shipment is recommended for temperaturesensitive packages. – Packaging - Select “other” – On the FedEx waybill, where the question, “Does this shipment contain dangerous goods” appears, select “No”. – Enter number of packages and total weight (lbs)

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FedEx Air waybill - Exempt Patient Specimens and NonRegulated Biological Material 18 FedEx Domestic Air Waybill

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Safety - Hazards of Exempt Specimens  By definition, ‘minimal likelihood’ exists that exempt specimens contain materials capable of causing infectious disease.  Remember, the operative term is ‘likelihood’; it would be impossible to guarantee sterility and an individual’s health status may negatively impact resistance to infection.  Because these specimens arise from animals or humans, Universal Precautions (barrier precautions) should be observed when handling exempt specimens.  Always wear a lab coat, single use nitrile or vinyl gloves and eye protection when splash potential exists. Biosafety www.ehs.columbia.edu

Safety – Exempt Specimen Leaks and Spills In the event of a release of exempt specimen materials, treat the situation as a biological spill of low risk microbiological material.  Wear a lab coat, single use nitrile gloves and eye protection.  Cover spilled materials with paper towels or other absorbent material.  Apply a 1:10 dilution of household bleach in a volume approximating the quantity released.  Dispose of clean-up material in regulated medical waste bags.

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Introduction – Dry Ice  The US Department of Transportation (DOT) and the International Air Transport Association (IATA) both regulate shipments of packages containing dry ice as a “Dangerous Good” when transported by air.  May 25, 2001 Incident  Pilots nearly overcome by asphyxiation on runway by improperly loaded package of frozen shrimp packed on dry ice.  This and similar incidents that have occurred due to improperly packaged or undeclared shipments of dry ice illustrate the need to ensure the safe handling of dry ice and other hazardous materials in transit. Biosafety www.ehs.columbia.edu

General HAZMAT Awareness - Identifying Hazardous Materials

Class 9 “Miscellaneous” Placard used for Dry Ice shipments

Examples of HAZMAT Communication and Signage – These placards may appear as placards on vehicles transporting HAZMATs and/or may appear as smaller labels on packages of HAZMATs, including dry ice. Biosafety www.ehs.columbia.edu

Packaging - Dry Ice  Ventilation  Packages must permit for the release of carbon dioxide gas during transit. To prevent dangerous pressure build-up, dry ice must never be placed inside an airtight, unvented container.  Always use insulated gloves when handling dry ice.  Package Integrity  Shipments containing dry ice must be packaged to withstand the normal rigors encountered in transit, including vibration, rough handling or dropping during loading and unloading, and any changes in temperature, humidity and altitude.  A fiberboard outer box that encloses a Styrofoam box will provide the most durability; however, it is acceptable to use a Styrofoam shipper as the outermost packaging.  Reusing a dry ice box is a good use of resources. If you choose to reuse a box, completely obliterate all unnecessary marking such as hazard labels, addresses, FedEx (or other courier) labels and barcodes. Use caution if reusing a box that has been used to ship infectious material or diagnostic specimens. Only reuse a box if you can personally verify it is not contaminated and its integrity is intact. A box should not be reused if it is torn, cut, stained, or if the insulation is cracked or broken. Biosafety www.ehs.columbia.edu

Packaging - Dry Ice  Packaging Materials  Dry ice must be shipped in containers that are able to withstand its extremely low temperature. Accordingly, plastics that can become brittle or permeable at these temperatures should not be used.  Check manufacturers’ recommendations to ensure your packing materials are compatible with dry ice.

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Packaging Dry Ice  Secure your samples in such a way that when the dry ice sublimates, they will not move freely inside of the insulated box. This can be accomplished by wedging your samples in place with cardboard or Styrofoam. Fragile containers such as glass tubes or vials should be wrapped with cushioning material and placed in a secondary container.  Minimize the volume of air to which the dry ice is exposed in order to slow the rate of sublimation. If there is any air space after you fill your package with dry ice, fill it with packing peanuts or other material to reduce the volume of air space.

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Packaging Dry Ice  Carriers generally recommend that shipments contain 5 -10 pounds (3 5 kg) of dry ice per 24 hours in transit. Refer to your package manufacturer’s recommendations. Make arrangements with your consignee to make sure your package will be received on its intended delivery date. Take into account local holidays or closings that might delay package receipt.  Dry ice shipments can be made with FedEx and DHL.  UPS and the U.S. Postal Service have extremely restrictive policies concerning shipments of HAZMATs; therefore, do not ship dry ice with UPS or the U.S. Postal Service.

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Markings, Labels and Proper Shipping Name – Dry Ice Dry ice (UN1845) is regulated as a Class 9, “miscellaneous” hazard class by DOT and IATA.  The class 9 hazard designation is the label  UN1845 is the marking. Can be printed or handwritten  “Dry Ice” or “Carbon Dioxide, solid” is the proper shipping name. These words must be in full with no shorthand or abbreviations. Can be printed or handwritten.  The label, marking and proper shipping name may be on the same sticker or may be preprinted on the fiberboard box Biosafety www.ehs.columbia.edu

Weight of dry ice, Names and Addresses  The outermost container must also display the names and address of the shipper and consignee. Can be printed or handwritten.  The outermost container must also display the net weight of dry ice, in kilograms. Can be printed or handwritten. The maximum allowable quantity of dry ice allowed in a package is 200 kg.

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New Class 9 Dry Ice Labels  Please be aware that as of October 1, 2014 the USDOT, IATA and ICAO introduced new labels for placement on packages shipping Dangerous Goods.  The new Class 9 Dry Ice label removes the black horizontal line at the bottom of the vertical lines. Pictured below is the old label and 2 images of the new label:

OR

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Hazardous Materials Labels  Hazardous materials labels are required to meet specific performance standards (size, durability, self-adhesiveness) and should not be self-printed and attached with clear tape by the shipper.  Class 9 labels are available for purchase through the vendors listed at the end of this module. EH&S can provide, at no cost, labels for shippers who are waiting for ordered labels to arrive or performing only occasional shipments email [email protected]. Biosafety www.ehs.columbia.edu

Affixing Hazardous Materials Label The outermost container must display the Hazard Class 9. This label must be affixed to a vertical side of the box, not the top or bottom, and must appear in a vertical position, not on its side. The label must not cover any other required markings or wrap around the side of the box.

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Marking – Dry Ice  UN1845 Marking Requirements:  Packages that have greater than 30 kg (66 lbs.) of dry ice require a 12mm type face or larger for the package marking UN1845.  Packages that are between 5 kg (11 lbs.) and 30 kg (66 lbs.) require 6mm type face or larger for the package marking UN1845.  Packages that are less than 5 kg (11 lbs.) only require that the package marking UN1845 be of adequate size.

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Markings and Labels – Dry Ice A – Ship to/from info B – Proper Shipping Name

Dry Ice, UN1845 or Jane Doe Columbia University Med. Ctr. 601 W 168th St. Room 53 New York, NY 10032

John Doe ABC Laboratories 123 Main Street Detroit, MI 48203

Carbon Dioxide, Solid UN1845 C – Net Weight of Dry Ice in kilograms D – Class 9 Label • Must be 4”x 4” in size • Use only pre-printed shipping labels • Package large enough for the label to fit on one side

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Shipping Documents – Dry Ice 34

 Air shipments require an “Air Waybill.” See FedEx example in next slide. – Next business day shipment is recommended for temperaturesensitive dry ice packages. – Packaging - Select “other” – On the FedEx waybill, where the question, “Does this shipment contain dangerous goods” appears, select “Yes, Shipper’s Declaration not required.” – Enter number of packages X net weight of dry ice (kg) – Enter number of packages and total weight (lbs)

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FedEx Air waybill – Dry Ice 35

FedEx Domestic Air Waybill

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Biosafety www.ehs.columbia.edu

Safety - Hazards of Dry Ice  Explosion  Dry ice releases large volumes of carbon dioxide gas as it sublimates. If enclosed in a sealed container, this release of gas can cause a dangerous build-up of pressure, and ultimately, an explosion.

 Suffocation  The presence of a large volume of carbon dioxide in a confined or poorly-ventilated space can pose an asphyxiation hazard due to a lack of available oxygen.

 Temperature  Carbon dioxide exists as a solid at approximately -110º F. This extremely low temperature can rapidly cause severe frostbite in contact with exposed skin.

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Safety – Dry Ice Releases  In the event of a release of dry ice during package handling or preparation:  Do not handle dry ice with bare hands as this may result in rapid frostbite or injury  Ventilate the area where the dry ice has spilled/leaked, and be aware of potentially hazardous concentrations of CO2 gas  CO2 is heavier than ambient air and will remain in low areas without adequate forced ventilation

 Use heavy gloves and tongs or other means to remove pellets to an insulated container, or to a well ventilated area to sublime  Never store or use dry ice in a cold room. The re-circulated atmosphere can concentrate CO2 to dangerous levels.

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Excepted Quantities - Specimens in Preservative  Specimen shipments may require inclusion of an appropriate preservative. This section addresses the shipment of specimens using small quantities of chemical preservative; ethanol or formalin.  This section is also applicable to the off-site shipment of pre-filled vials containing these materials for subsequent specimen collection and return.  ‘Excepted Quantities’ are still Dangerous Goods when offered for transport. As such, all training requirements, including the need for biennial refresher training through RASCAL, remain in effect.

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Excepted Quantities - Specimens in Preservative  In large quantities, ethanol and formalin are fully regulated when offered for transport. However, when shipping the quantities typically used for preserving specimens, ‘small quantity exceptions’ apply, allowing for a more streamlined shipping process.  The table below, taken from the ICAO/IATA handbook, defines quantity limits for these preservatives.  For formalin and for the most commonly available packaging used to send samples in ethanol, Excepted Quantity Code E2 applies, limiting inner packages to a volume of 30 ml and outer packages to an aggregate volume of 500 ml. Code E1 E2

Maximum net quantity  Maximum net quantity  per inner packaging per outer packaging 30 g/30 ml 1 kg/1 L 30 g/30 ml 500 g/500 ml Biosafety www.ehs.columbia.edu

Classification - Chemical Preservatives Classification of chemical preservatives is governed by the concentration of the chemical and the primary hazard class in any mixtures. For example: – Flammable Liquid (Class 3)  e.g. ethyl alcohol, formaldehyde in methanol

– Corrosive (Class 8)  e.g. acetic acid, formaldehyde solution (20-37.5%)

– Miscellaneous dangerous goods (Class 9)  e.g. formaldehyde solution (10-20%)

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Excepted Quantities - Scope  At effective preservative concentrations, ethanol is subject to shipping regulations, including when it is used in small volumes.  Only shipments of 10% or more of formaldehyde (~25% formalin) are subject to DOT and IATA regulations. Therefore, 10% formalin (4% formaldehyde) is exempt from shipping regulations in any quantity.  However, due to the potential for a release of even dilute solutions to disrupt shipping, the University requires adherence to specific packaging requirements. Biosafety www.ehs.columbia.edu

Excepted Quantities - Specimens in Preservative  The requirements for shipping an example Dangerous Good, Ethanol, will be presented first.  At the end of this section there will be an explanation of the requirements for shipping 10% formalin (Not regulated).

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Excepted Quantities - Specimens in Preservative (Ethanol)  Ethanol is regulated as a dangerous good because of its inherent flammability.  This section applies to ethanol shipments only when:     

inner/primary containers contain < 30ml, the total volume of ethanol in all containers in the package is < 500ml, no other hazardous material is present, the specimen did not contain any infectious materials; or it can be reasonably concluded that the ethanol rendered any infectious materials that may have been present noninfectious.

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Packaging - Excepted Quantities - Specimens in Ethanol The following practices must be observed when preparing shipments of ethanolpreserved samples:  The primary container (tube, specimen vial) must not be more than 90% full.  Cap(s) must be positively secured with tape or wire.  Primary containers must be cushioned to avoid breakage.  Secondary packaging must be leak proof (zip-lock bag) and able to contain entire contents of primary container(s).  Place sufficient absorbent such as spill pads between primary and secondary containers to absorb the entire contents of the primary containers.  Materials must be chosen to avoid dangerous reactions between the packaging materials and items being shipped.  Outer packaging must be wood, fiber board or other equally strong material. Biosafety www.ehs.columbia.edu

Labeling - Excepted Quantities - Specimens in Ethanol Attach the ‘Excepted Quantity’ Package Mark to the outer package. * Insert: DOT Hazard Class for ethanol, “3”.

Minimum dimensions of marking: 4” x 4”. Must be black or red.

** Name and address of consignee or shipper, if not elsewhere on the package. Biosafety www.ehs.columbia.edu

Markings and Labels Exempted Quantities – Specimens in Ethanol

Jane Doe Columbia University Med. Ctr. 601 W 168th St. Room 53 New York, NY 10032

A – Ship to/from info B – Exempted quantity label • Must be 4”x 4” in size • Use only pre-printed shipping labels • Package large enough for the label to fit on one side

John Doe ABC Laboratories 123 Main Street Detroit, MI 48203

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B

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Shipping Documents – Exempted Quantities 47

 Air shipments require an “Air Waybill.” See FedEx example in next slide. – No specific shipping paper is required for ground transport. But if transported by air, the Air Waybill must include the statement, “Dangerous Goods in Excepted Quantities”. – Packaging - Select “other” – On the FedEx waybill, where the question, “Does this shipment contain dangerous goods” appears, select “Yes, Shipper’s Declaration not required.” – Enter number of packages and total weight (lbs)

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FedEx Air waybill - Excepted Quantities 48

FedEx Domestic Air Waybill Dangerous Goods in Excepted Quantities

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Excepted Quantities - Specimens in Preservative (Ethanol) Package Tests  A representative complete package must be able to withstand, without loss of contents, drops from 1.8 meters on its base, top, longest and shortest sides, and a corner. It must also be able to withstand a 24 hour test applying a force equivalent to the weight of identical packages stacked to a height of 3 meters.  While individuals may perform such tests, it is more practical to purchase packaging systems from vendors who will certify that their products meet these criteria (see “Supplies” section). Biosafety www.ehs.columbia.edu

Excepted Quantities - Specimens in Preservative (Formalin) The 10% formalin solutions most commonly used for tissue preservation are not regulated by DOT or IATA. However, the corrosivity and irritation potential from a formalin release indicate the need for special shipping practices. To ship small amounts of formalin follow all of the previously described requirements for ethanol except:  DO NOT use Excepted Quantity Package Mark.  DO NOT use the “Dangerous Goods in Excepted Quantities” statement on any shipping documents.  If using FedEx, DO NOT make any statements indicating the presence of Dangerous Goods.  DO package material as described to ensure that contents arrive at their destination intact. Biosafety www.ehs.columbia.edu

HAZMAT Shipment Safety and Security

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 Improperly handled HAZMATs have the potential to cause harm to human health and the environment in transit. Incidents involving HAZMATs in transit can affect the integrity of roads, bridges, tunnels, transportation routes and other vulnerable facilities. HAZMATs are often loaded onto passenger aircraft for transportation. Improperly prepared packages can endanger passengers and vehicles.  Several areas of potential security vulnerability are important to consider when offering HAZMATs for shipment.  For example, shippers of hazardous materials must limit access to their packages to trained personnel only, and must ensure their package remains in their possession until it is transferred to the carrier (or secured in a designated mailroom).  Shippers must not leave packages containing hazardous materials at drop boxes.  Immediately report to Public Safety any suspicious persons or activity in your laboratory or in any area where hazardous materials may be present. Biosafety www.ehs.columbia.edu

FAA Inspections and Records Retention

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Improperly shipped packages can elicit an FAA inspection of the shipper’s university. Such an event triggered an inspection at Columbia in June 2016. If the FAA inspect your operations, they will likely review shipping documents and training certificates. Centrally maintain and keep all documents readily available.  Shipping documents (2 years) – Commercial Invoices – FedEx Air Waybills – Applicable Import / Export Permits  Training Certificate (3 years) – Can generate certificate in RASCAL (My RASCAL  My test history  Generate transcript) Biosafety www.ehs.columbia.edu

Inter-campus transport between Columbia University campuses

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 Investigator-mediated transport of Category A or B infectious material between Columbia University campuses is prohibited by University Policy.  Investigator-mediated transport of classifications of biological materials that are NOT classified as hazardous materials/dangerous goods by the DOT, when transported by road is permissible:  Exempt human/animal specimen, Non-regulated biological material, Preserved Biologicals, Dry ice and Genetically Modified Microorganisms (GMMO) are permitted, provided the following conditions are met: – Materials are transported in a taxi cab, personal vehicle or University-operated vehicle including shuttle bus. Transport on mass transit (MTA bus or subway) is prohibited, – Materials are triple performance packaged according to the directions in this training material – Transport must be direct from campus to campus (no stops or detours). – Package must stay in custody of shipper throughout transport and delivered on the same day. – Shipper must bring a pair of disposable nitrile or latex gloves in their pocket or bag. These are to be donned ONLY in the event that the package is compromised, e.g. leaks. They are NOT to be used to carry the package. – Applicable training and certification course must be taken prior to transporting any materials between campuses.

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Need More Help?

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Need help with classification (or any other aspect of hazardous material shipping)? Read the Columbia Biological Materials Shipping Manual: http://ehs.columbia.edu/BiologicalMaterials ShippingManual.pdf Complete an “intent to ship” form: http://www.ehs.columbia.edu/IntentToShip HazardousMaterialsForm.pdf Contact EH&S by email: [email protected]

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Supplies The following companies market packaging materials for the safe and legal transport of diagnostic specimens. This list is strictly informational; inclusion does not constitute an endorsement or recommendation by Columbia University.

SAF-T-PAK* 800-814-7484 http://www.saftpak.com

Therapak Corp. 888-505-7377 http://therapak.com

HazMatPak 800-347-7879 http://www.hazmatpac.com

Inmark 800-646-6275 http://www.inmarkinc.com

EXAKT Technol. 800-923-9123 http://exaktpak.com

ThermoSafe Brands 800-323-7442 http://www.thermosafe.com

Source Packaging of New England 800-200-0366 http://sourcepakinc.com

Air Sea Atlanta 404-351-8600 http://airseaatlanta.com

Berlin Packaging 800-229-7546 http://www.berlinpackaging.com

*This vendor has been a particularly reliable contact for CU EH&S and others

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CONGRATULATIONS You’ve come to the end of the course material. You can now take quiz. Good luck!

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