1. Shipping Dangerous Goods

2. Course Content Background information Infectious substances
Category A: classification, packaging, labeling and documentation
Category B classification, packaging, labeling and documentation
Exempt human specimens
Class 9 shipping
Dry Ice

3. 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.

4. 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

5. 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)

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

7. IATA Dangerous Goods Regulations
Key Points
Based on UN Model
In general, are the most restrictive
DOT will accept
Post Office will accept

8. 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;
General Awareness/Familiarization Training – Training designed to provide familiarity with the general requirements of dangerous goods regulations
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
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 ) may be used to meet DOT requirements

9. 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

10. Responsible Parties
Shippers
Carrier/Operator
Receiver

11. Shipper’s Responsibilities
Classify
Identify
Select proper packaging
Packing
Mark and label
Document
Make arrangements

12. 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

13. 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

14. List of Dangerous Goods
Excerpt from Table

15. 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

16. 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
Life threatening or fatal to other wise healthy humans or animals
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

17. Examples of Category A Substances
Bacillus anthracis (cultures only) Dengue virus (cultures only)
Coccidioides immitis (cultures only) Rabies virus (cultures only)
Lassa virus Hepatitis B virus (cultures only)
Shigella dysenteriae type 1 (cultures only) Yersinia pestis (cultures only)
Examples of Category B Substances
Staphylococcus aureus Escherichia coli, verotoxigenic,
Cryptococcus neoformans Streptococcus pneumoniae
Rabies virus Streptococcus pyogenes
Hepatitis B virus 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

18. 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

19. Classification Flow Chart

20. Using the Dangerous Goods List
Name (Proper Shipping Name)
UN No.
Class or division
Subsidiary risk
Hazard Labels
Special provisions
UN packing group
Biological substance, Category B
3373
6.2
None
Infectious substance, affecting humans
2814
Infectious
A A140
Infectious substance, affecting animals, only
2900
Dry ice
1845 9
Miscellaneous
A A151
 No longer III

21. Proper Shipping Name UN Numbers Hazard Labels Special Provisions
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

22. Special Provisions A 48 The completed package does not require testing
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.

23. 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
Biological substance, Category B
3373
6.2
None EO
650
1 L primary 4 L or 4 kg
Infectious substance, affecting humans
2814
Infectious
A A140
620
50 ml or g
4 L or 4 kg
Infectious substance, affecting animals, only
2900
Dry ice
1845 9
Miscellaneous
A A151
954
200 kg

24. 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

25. Comparison Chart of Sample Handling & Packaging
Step
Biological Substance, Cat.B (UN3373) PI650
Solid CO2/Dry Ice PI954
Infectious Substance (UN2814 or UN2900) PI620 1
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.
If shipped by ground--not regulated, else it must be put in a container that allows the release of pressure and prevents rupture.
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. 2
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 -400to 550C.
Place the dry ice outside the secondary packaging.
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. Either primary receptacle or secondary must be able to withstand an internal pressure of 95kPa and a temperature range of -400to 550C. 3
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.
Mark the net weight of the solid dry ice on the outside of the package in kilograms.
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. 4
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 Dangerous Goods (DG) label with complete shipping name and UN ID# UN1845. •Use a Class 9 Miscellaneous DG label.
Place the above in an outer rigid packaging. Examples are corrugated cardboard box, rigid plastic cooler, rigid plastic box. The smallest external dimension must be at least 100mm. Outer packaging must bear the UN specification mark. 5
Enclose an itemized list of contents between the secondary packaging and outer packaging.
N/A 6
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 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. 7
Place a UN3373 diamond shaped sticker on outside of box. Orientation labels should be on opposing sides.
Class 9 Miscellaneous Hazard label. Class 9 Proper Shipping Name, UN Number and quantity label on the outside of the package.
Place: 1. Proper shipping Name and UN 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.

26. 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)

27. 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

28. 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.

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

30. Hazard & Handling Labels
Category A
Infectious substances, affecting humans
UN2814
x ________________ mls.
Biological Substance, Category B
Exempt Human Specimen
Dry ice

31. 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

32. Example of a Category A Shipment Without Dry Ice
Infectious substances, affecting humans
UN2814 ( )
Shipper
Consignee
Responsible Person
Name & telephone No. U N

33. Example of a Category A Shipment With Dry Ice
Infectious substances, affecting humans
UN2814 ( )
mls
Shipper
Consignee
Responsible Person
Name & telephone No. U N

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

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

36. Example of Exempt Patient Specimen Without Dry Ice
Shipper
Consignee

37. 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

38. 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

39. 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

40. 620
954

41. 3 Fibreboard boxes X 150 ml
620
954
Overpack used

42. 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

43. 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:
Name of reporter
Name and address of person represented by reporter
Phone number where reported can be contacted
Date, time, location of incident
The extent of injury, if any;
Class or division, proper shipping name and quantity of hazardous materials involved, if such information is available; and
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:
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;
Fire, breakage, spillage, or suspected contamination occurs involving an infectious substance other than a regulated medical waste;
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

44. Detailed Incident Reports
49CFR
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 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:
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

45. 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

46. 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.

47. 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

48. 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