Shipping Dangerous Goods

Course Content

I. Background information II. Infectious substances – Category A: classification, packaging, labeling and documentation – Category B classification, packaging, labeling and documentation – Exempt human specimens III. Class 9 shipping – Dry Ice

Dangerous Goods, Definition:

Materials or substances having hazardous properties which, if uncontrolled, are capable of posing a risk to health, safety, property or the environment.

If you don’t value life, other reasons for concern: •Civil penalty for individual up to $50,000 for each violation •Criminal penalty for individual up to $500,000 and/or imprisonment up to 5 years •Penalties double if there is serious injury or death •In addition to the individual, the institution may be charged

Regulatory Authorities •UN International Civil Aviation Organization (ICAO) •International Air Transport Association (IATA) •Department of Transportation (DOT)/Federal Aviation Administration (FAA) •United States Post Office (USPS) •Individual Air Carriers (FedEx, Alaska Airlines)

Regulations IATA Dangerous Goods Regulations Department of Transportation 49 CFR.171-180 Domestic Mail Manual – Publication 52

IATA Dangerous Goods Regulations

Key Points • Based on UN Model • In general, are the most restrictive • DOT will accept • Post Office will accept

Training Requirements

Anyone who handles, offers for transport, or transports dangerous goods must be trained to perform the duties required by their employer. Three areas of training are required; 1. General Awareness/Familiarization Training – Training designed to provide familiarity with the general requirements of dangerous goods regulations 2. Function Specific Training – Training that specifically addresses the functions the employee performs: for example, preparing and offering a shipment of infectious substances and the use of dry ice in transport 3. Safety Training – Training that instructs the employee of hazards associated with dangerous goods as well as safe handling and emergency response procedures – OSHA Blood Borne Pathogen (BBP) standard (29 CFR 1910.1020) may be used to meet DOT requirements

Employer Certification Requirements Testing Demonstration Oral Written Certificate of Training Employer must have for each employee Trainee’s name Date of exam Description of training materials used to meet training requirements Name and address of trainer Test Score Specific topics for which the employee is trainee Certificate Validity 2 years for IATA 3 years for DOT As needed

Responsible Parties

Shippers Carrier/Operator Receiver

Shipper’s Responsibilities

• Classify • Identify •Select proper packaging • Packing • Mark and label • Document • Make arrangements

Operator’s Responsibilities

• Must detect errors • Use acceptance checklist • Ensure safe loading, storage, and transport • Inspect for damage or leaks • Report any problems to the proper authorities

Receiver’s Responsibilities

• Help obtain import permits, if needed • Inspect package for damage or leaks • Verify itemized list of contents • Report back to shipper • Report leaking packages to appropriate authority

List of Dangerous Goods

Classes of Dangerous Goods Nine classes of dangerous goods (class indicates type of hazard not degree) Class 6 Toxic and Infectious Substances Division 6.2 Infectious Substances Class 9 Miscellaneous Dry Ice

Infectious Substances A material

known or reasonably expected to contain a pathogen

Pathogen – a microorganism (including bacteria, viruses, rickettsiae, parasites, fungi) or other agent, such as a proteinaceous infectious particle (prion), that can cause disease in humans or animals Infectious substances come in 2 forms: Cultures – an infectious substance containing a pathogen that is intentionally propagated Patient Specimens – human or animal material collected directly form humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and it components, tissue and tissue swabs, body parts, and specimens in transport media. Infectious substances have multiple categories: Category A – An infectious substance in a form capable of causing Permanent disability Life threatening or fatal to otherwise healthy humans or animals Occurs upon exposure Category B – An infectious substance that is not in a form generally capable of causing Permanent disability Life threatening or fatal to other wise healthy humans or animals Occurs upon exposure Exempt Human Specimens – Specimens that do not, or are not likely to contain an infectious substance, are not subject to the regulations if the specimen is packed in a manner that prevents leakage

Examples of Category A Substances

Bacillus anthracis

(cultures only)

Coccidioides immitis

(cultures only) Lassa virus

Shigella dysenteriae type 1

(cultures only) Dengue virus (cultures only) Rabies virus (cultures only) Hepatitis B virus (cultures only)

Yersinia pestis

(cultures only) Examples of Category B Substances

Staphylococcus aureus Cryptococcus neoformans

Rabies virus Hepatitis B virus

Escherichia coli

, verotoxigenic,

Streptococcus pneumoniae Streptococcus pyogenes Stenotrophomonas maltophilia

Examples of Exempt Human Specimens Blood or urine specimens for cholesterol Urine screening for drugs or alcohol Biopsies to detect cancer Specimens for antibody detection

Non-Regulated Materials Unless the following meet the criteria for inclusion in another class or division, are not subject to the regulations: • Substances with a low probability of containing an infectious substance, or where the concentration of the infectious substance is at a level naturally occurring in the so it cannot case disease when exposure to it occurs • Micro-organisms that do not cause disease in humans or animals • Substances that have been treated so that the pathogens have been neutralized or deactivated • Foodstuffs and environmental samples, such as water or a sample of dust or mold which would not be considered a significant source of infection • Dried blood spots or specimens for fecal occult blood detection placed on absorbent filter paper or other material and blood, blood components, tissues or organs collected for the purpose of transfusion or transplantation

Classification Flow Chart

Using the Dangerous Goods List Name (Proper Shipping Name) UN No.

Biological substance, Category B

3373

Infectious substance, affecting humans Infectious substance,

affecting animals, only 2814 2900 Class or division Subsidiary risk 6.2

6.2

6.2

Dry ice

1845 9 Hazard Labels Special provisions UN packing group None Infectious Infectious Miscellaneous A81 A140 A81 A140 A48 A151 No longer III

Proper Shipping Name

• All dangerous goods must be assigned a proper shipping name • Proper shipping names must be spelled exactly as they appear on the list of dangerous goods

UN Numbers

• Each proper shipping name is assigned a UN number • The UN number can be used to identify the dangerous good • The UN number is useful when English is not the native language • The UN number appears alongside the proper shipping name

Hazard Labels

• Hazard labels indicate the class or division of dangerous goods

Special Provisions

• Special provisions give detailed information in the handling of packages containing the specific dangerous good

Special Provisions A 48 The completed package does not require testing A81 Shipments involving body parts, organs or whole bodies infected with a Category A Infectious substances may exceed the quantity limits for Passenger or Cargo aircraft A140 The proper shipping name for Category A Infectious substances must be supplemented with the technical name (scientific name) on the Shipper’s Declaration for Dangerous goods. The technical name is not recommended to be marked on the outside of the package. If the technical name is not known or if the specimen is proficiency testing, the technical name “suspected Category A Infectious substance” must be included.

A151 Quantity limits for dry ice do not apply when dry ice is used as a refrigerant in pallets.

Proper Packaging Dangerous goods need to be packed in such a way that the specimen is protected against leakage or spillage during transport Quantity Limits and Packing Instructions Passenger Aircraft Cargo Aircraft Name (Proper Shipping Name) UN No.

Class or division Subsidiary risk Hazard Labels Special provisions Excepted Quantity Packing instruction Max net quantity per package Packing instruction Max net quantity per package

Biological substance, Category B

3373

Infectious substance, affecting humans

2814

Infectious substance, affecting

animals, only 2900 6.2

6.2

6.2

Dry ice

1845 9 None EO Infectious A81 A140 EO Infectious A81 A140 EO Miscellaneous A48 A151 EO 650 1 L primary 4 L or 4 kg 650 1 L primary 4 L or 4 kg 620 50 ml or 50 g 620 4 L or 4 kg 620 50 ml or 50 g 620 4 L or 4 kg 954 200 kg 954 200 kg

Proper Packaging Continued Triple packaging required for: Category A Category B Exempt human specimen UN specific packaging required for Category A Manufacturer’s test packaging systems and copies of these reports must be shown to the inspectors upon request

Step 1 2 3 4 5 6 7

Comparison Chart of Sample Handling & Packaging

Biological Substance, Cat.B (UN3373) PI650

Place sample in a

leakproof primary receptacle or vial.

Vial caps must be sealed with tape, paraffin, parafilm. The volume must be 1L or less.

Solid CO2/Dry Ice PI954

If shipped by ground--not regulated, else it must be put in a container that allows the release of pressure and prevents rupture.

Infectious Substance (UN2814 or UN2900) PI620

Prepare a

Dangerous Goods (DG)

Declaration. Packaging must be UN certified. Place sample in a

leakproof primary receptacle or vial

. Vial caps must be sealed with tape , paraffin, parafilm. Sample vial is then placed in a

leakproof secondary packaging.

Examples of secondary packaging are: plastic canister, sealed plastic bag, sealed styrofoam, screw cap can. Total volume of samples must be 4L or less. Primary or secondary package must be able to withstand and internal pressure of 95 kPa and a temperature range of -40 0 to 55 0 C.

Place

absorbent material

between primary receptacle and secondary packaging. Examples of absorbent material are: cellulose wadding, cotton balls, paper towels, commercial absorbent packets. Cushioning is required if multiple primary containers are present.

Enclose an

itemized list of contents

between the secondary packaging and outer packaging. Place the dry ice outside the secondary packaging.

Mark the net weight of the solid dry ice on the outside of the package in kilograms.

N/A Sample vial is then placed in a

secondary packaging.

leakproof

Examples of secondary packaging are: plastic canister, sealed plastic bag, sealed styrofoam, screw cap can. Either primary receptacle or secondary must be able to withstand an internal pressure of 95kPa and a temperature range of -40 0 to 55 0 C.

Place

absorbent material

between primary receptacle and secondary packaging. Examples of absorbent material are: cellulose wadding, cotton balls, paper towels, commercial absorbent packets. Multiple primary receptacles must be cushioned.

Place the above in an

outer packaging.

Examples are corrugated cardboard box, wood box, rigid plastic cooler, rigid plastic box. Side of box must not be less than 100 mm. Entire package must be able to pass drop test of 1.2 meters.

For infectious substances (column on right): •Declare the dry ice on the Place the above in an outer rigid packaging. Examples are corrugated Dangerous Goods (DG) label with complete shipping name and UN ID# UN1845. •Use cardboard box, rigid plastic cooler, rigid plastic box. The smallest external a Class 9 Miscellaneous DG label.

dimension must be at least 100mm. Outer packaging must bear the UN specification mark.

Enclose an

itemized list of contents

between the secondary packaging and outer packaging. If air waybill is used, under Nature and Quantity of goods write Biological Substance, cat. B UN3373. Write the Name and Telephone number of person N/A responsible for shipment on outside of package or airway bill.

Write the Name and Telephone number of person responsible for shipment on outside of package. Write shipper and consignee information on outside of package. Orientation labels should be on opposing sides.

Place a UN3373 diamond shaped sticker on outside of box. Orientation labels should be on opposing sides.

Class 9 Miscellaneous Hazard label. Class Place: 1. Proper shipping Name and UN 9 Proper Shipping Name, UN Number and quantity label on the outside of the package.

no. label on the outside of the package. 2.The division 6.2 Hazard Label on the outside of the package. 3. complete dangerous goods form.

Packaging for Exempt Human Specimens The following is required for shipping exempt human specimens: • Triple packaging consisting of • Leakproof primary receptacle • Leakproof secondary packaging • Outer packaging must be strong enough to safely contain contents throughout the trasport.

• minimum size for outer package is 100mm on one surface • Absorbent material must be placed between the primary and secondary packaging • Multiple primary receptacles must be cushioned • Primary receptacles must be secured with positive means (tape, paraffin, parafilm)

Miscellaneous General Packaging Rules

Reuse is allowed if outer shipper is in good condition Other dangerous goods cannot be packed with infectious substances except for: Preservatives & transport media < 30 ml per primary receptacle Dry ice

Packaging Consideration for Refrigerants Types of refrigerants that may be used: Dry ice Gel packs or phase change material (PCM) packs Liquid nitrogen Wet ice All refrigerants are to be placed outside the secondary packaging If wet ice is used, it must be placed in a leakproof container Dry ice must never be placed inside a sealed primary receptacle or sealed secondary packaging due to the risk of explosion. The packaging must permit the safe release of carbon dioxide gas.

If liquid nitrogen is used, the liquid nitrogen must be absorbed in porous material such that there is no free standing liquid nitrogen – “dry shipper.” Other special conditions apply when shipping with liquid nitrogen where there is free standing liquid nitrogen in the package.

No shipper’s declaration is required if dry ice is used to refrigerate category B substances.

Marking and Labeling Shipping information required Shipper information Consignee Information Name and telephone number of responsible person Appropriate hazard labels Appropriate handling labels

Category A Hazard & Handling Labels

Infectious substances, affecting humans UN2814 x ________________ mls.

Biological Substance, Category B Exempt Human Specimen Dry ice

Handling Labels Orientation label for liquid dangerous goods NEW (1/1/2013) OLD Cargo aircraft only – Required when primary container of Category A is > 50 ml

Example of a Category A Shipment Without Dry Ice Shipper Consignee Responsible Person Name & telephone No.

Infectious substances, affecting humans UN2814 ( )

Example of a Category A Shipment With Dry Ice Shipper Consignee Responsible Person Name & telephone No.

Infectious substances, affecting humans UN2814 ( ) mls

Example of a Category B Shipment Without Dry Ice Shipper Consignee Person Responsible Telephone No.

Example of Category B Shipment With Dry Ice Shipper Consignee Person Responsible Telephone No.

Example of Exempt Patient Specimen Without Dry Ice Shipper Consignee

Overpacks Each package placed into an overpack must be individually marked, labeled and addressed as if it were being shipped independently. Once packages are placed in the overpack, the marks, labels and other information has to be reproduced on the overpack.

Shipper Consignee Person Responsible Telephone No.

OVERPACK

Shipper’s Declaration A document called the “Shipper’s Declaration for Dangerous Goods” must accompany every Category A package. At least 3 copies must be must be prepared The shipper keeps one copy The carrier takes 2 and delivers one to the consignee The shipper must keep the Shipper’s Declaration at least 2 years and include the date of acceptance by the initial carrier A Shipper’s Declaration is not required for dry ice UN 1845 unless it is used as a refrigerant for dangerous goods which require a Shipper’s Declaration

FedEx Requirements for Shipper’s Declaration FedEx requires all Shipper’s Declarations to be prepared using only the following methods • FedEx approved vendor software application • Preapproved shipper proprietary software, or • FedEx Express Automated Shipping Solutions that have dangerous goods error checks

620 954

3 Fibreboard boxes X 150 ml 620 954 Overpack used

Emergency Response for Infectious Substances Any person responsible for carriage or receipt of packages containing infectious substances who becomes aware of damage to or leakage from such a package, must: Avoid handling the package unless wearing appropriate PPE Inform the appropriate local Public Health authority Notify the shipper and the consignee and person responsible In case of incidents involving Category A Infectious substances, call the 24 hour emergency response number indicated on the Shipper’s Declaration Keep unauthorized personnel away Do not allow clean-up of the spill or disposal of the material except under the supervision of an expert

Incident Reporting Anyone who is in contact with a dangerous good when an incident occurs must report the incident to the appropriate authorities in accordance with the authority’s requirements. The following information needs to be relayed: 1. Name of reporter 2. Name and address of person represented by reporter 3. Phone number where reported can be contacted 4. Date, time, location of incident 5. The extent of injury, if any; 6. Class or division, proper shipping name and quantity of hazardous materials involved, if such information is available; and 7. Type of incident and nature of hazardous material involvement and whether a continuing danger to life exists at the scene.

Telephone reporting is required whenever: 1. A hazardous material has been directly involved in: The death of a person A person receiving an injury required hospitalization The general public is evacuated for one hour or more; A major transportation artery or facility was closed or shut down for one hour or more; or The operational flight pattern or routine of an aircraft was altered; 2. Fire, breakage, spillage, or suspected contamination occurs involving an infectious substance other than a regulated medical waste; 3. A situation exists of such a nature that, in the judgment of the person in possession of the hazardous material, it should be reported to the CDC even though it does not meet the above criteria

Detailed Incident Reports 49CFR 171.16

Each person in physical possession of a hazardous material at the time that any of the following incidents occurs during transportation (including loading, unloading, and temporary storage) must submit a Hazardous Materials Incident Report on DOT Form F 5800.1 within 30 days of discovery of the incident.

Examples of incidents requiring detailed incident reports • Any of the immediate reporting incidents • An unintentional release of hazardous material • An undeclared hazardous material is discovered Online copies of the report are available at: https://hazmatonline.phmsa.dot.gov/incident/ An incident report must be retained for 2 years at the reporter’s place of business. The report must be updated within the first year if: • A death occurs from injury caused by the hazardous material • There was a misidentification of the hazardous material • Additional damage, loss or related cost was incurred and not know at the time of the incident

Security Awareness Training Any company or institution who handles or transports dangerous goods should train any staff in contact with the dangerous goods concerning the potential security risks associated with the dangerous goods.

Dangerous goods should only be offered to operators that have been appropriately identified.

This training should include all aspects of security risks including: • Nature of the risks • Recognition of risks • Practices used to reduce risks • Procedures for a security breach Security training must be in accordance with a national security plan or equivalent level of training Initial training for hazmat employees should occur within 90 days after employment Recurrent training should be performed whenever there are changes to the security protocols or at least every 2 years and the employer must retain records of security training The following are suggested areas for security awareness and best practices: Restrict access to dangerous goods only to trained and qualified staff Escort visitors and other unauthorized personnel Record entry into sensitive areas and the purpose of the visit Record the identity of the escort and the times of entry and exit Ensure that doors and cabinets are locked when staff is not present Monitor area remotely when staff is not in the area Protect the chain of custody by using tamper-evident methods as it relates to your package Create an audit trail for specimens Consider using serialized packaging

Security Plan Any shipper or operator who handles and/or transports Category A infectious substances should adopt a security plan to guard against potential incidents.

The security plan must include an assessment of transportation security risks for shipments of hazardous materials, including site-specific or location-specific risks associated with facilities where the hazardous materials are prepared for transportation, stored, or unloaded incidental to movement, and appropriate measures to address the assessed risks. At a minimum, the security plan must include: Measures to confirm information provided by job applicants hired for positions that involve access to and handling of the hazardous materials covered by the plan Measures to address the assessed security risks of shipments of dangerous goods covered by the security plan enroute from origin to destination, including shipments stored incidental to movement.

Identification by job title of the senior management official responsible for overall development and implementation of the security plan.

Security duties for each position or department that is responsible for implementing the plan or a portion of the plan and the process of notifying employees when specific elements of the security plan must be implemented.

A plan for training dangerous goods employees in accordance with the regulations.

Security Plan, Continued The security plan must include: Transportation security risk assessment Be in writing Be reviewed annually and revised/updated as necessary Be available to employees who are responsible for implementing it and be consistent with personnel security clearance or background investigation restrictions and a demonstrated need to know Notification of employees when the plan is updated or revised Be available to appropriate officials when requested

References IATA Dangerous “Goods Regulations, 52 Edition, Canada, 2011 SafTPak, Compliance Training Reference Manual for the Safe Transport of Division 6.2 Infectious Substances, Biological Specimens, Dry Ice and Related materials, Edmonton, Alberta, 2011 Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules and Regulations, 49CFR 172.101