Packaging and Shipping Laboratory Specimens

Training and Update Information on the IATA

Regulation Changes2010

Objectives

Understand the training requirements of DOT and IATA and how those requirements relate to anyone who packages and ships certain laboratory specimens.

Identify the regulators and their respective regulations, and their roles within their respective jurisdictions.

Objectives, cont’d

Classify, mark, label, and document Division 6.2 Hazardous Materials (Infectious Substances tagged UN 3373 and UN 2814).

Have a working knowledge of the exceptions to the regulations and list when they can be used.

Who are the Regulators and What are their Regulations?

United Nations– UN Committee of Experts (UNCOE)

International Civil Aviation Organization (ICAO)– the specialized agency of the United Nations

whose mandate is to ensure the safe, efficient and orderly evolution of international civil aviation. They are responsible for the Technical Instructions for aviation.

Who are the Regulators and What are their Regulations?

International Air Transport Association (IATA)– Promulgates the Dangerous Goods Regulation

(DGR), based on the Technical Instructions from ICAO

– IATA is organized in a two-tier format Trade Association (technical, legal, financial, traffic

services and most agency matters) Tariff Coordination (passenger fares, cargo rates, and

related conditions and charges)

Regulators, cont’d

US Department of Transportation (DOT)– Regulates any hazardous material traveling on the roadways,

waterways, and railways of the US– Promulgates regulations to the Code of Federal Regulations (CFR)

CFR Title 49 (specific for DOT) US Postal Service (USPS)

– Regulates all mail– Promulgates US Postal Regulations– New interim rule issued Nov 6, 2006

Centers for Disease Control and Prevention (CDC)– Regulates any other area not covered by DOT or USPS– Promulgates regulations to the Code of Federal Regulations (CFR)

CFR Title 42

Class 6, Division 6.2Definitions - IATA

Infectious Substances– Substances which are known or are reasonably

expected to contain pathogens. Pathogens are micro-organisms (including bacteria, viruses, rickettsiae, parasites, fungi) and other agents such as prions, which can cause disease in humans or animals.

IATA DGR 3.6.2.1.1

If it meets the definition, it’s an A or B

Class 6, Division 6.2Definitions

Patient Specimen– Human or animal materials collected directly from

humans or animals and transported for research, diagnosis, investigational activities, or disease treatment or prevention. Patient specimen includes excreta, secreta, blood and its components, tissue and tissue swabs, body parts, and specimens in transport media (e.g., transwabs, culture media, and blood culture bottles).

Class 6, Division 6.2Definitions

Culture– An infectious substance containing a pathogen

that is intentionally propagated. Culture does not include a human or animal patient specimen.

Shippers’ Responsibilities

You are ultimately responsible for the package from beginning to end.

Shippers’ Responsibilities

Identify: is the material hazardous? Classify: what kind of hazardous material is it? Package:

– Use certified packaging unit for 6.2 – Put the unit together using appropriate Packing

Instructions (PI)

Shippers’ Responsibilities

Marking: Ensure all markings are proper Labeling: Ensure all labels are correct Document:

– Complete the Shipper’s Declaration, if required

Nine Classifications of Hazardous Materials (all regs)

1 Explosives2 Gasses3 Flammable liquids4 Flammable solids5 Oxidizing

substances

6 Toxic/Infectious7 Radioactive8 Corrosive9 Miscellaneous

Class 6

Class 6 is divided into two Divisions– 6.1- Toxins/Poisons– 6.2- Infectious Substances

Category A Infectious Substances Category B Infectious Substances

Category A Infectious Substances

Category A – assigned UN 2814– An infectious substance which is transported in a

form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals.

– Proper Shipping Name– Infectious substance, affecting humans

Category B, Biological Substances

An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B must be assigned to UN 3373 except that cultures, as defined in 3.6.2.1.3, must be assigned to UN 2814 or UN 2900, as appropriate.

IATA and USPS Exemption

Exempt Human Specimens– A patient specimen unlikely to cause disease in humans or

animals or for which there is only a minimal likelihood that pathogens are present

– Subject to IATA and USPS packaging and marking requirements as

Exempt Human Specimen

– DOT does not recognize this category

IATA Guidance Document

• Pg 7

Category A Table

Table 3.6.D, IATA DGR– 49 listed organisms under UN 2814, Infectious

Substances affecting humans– 14 listed organisms under UN 2900, Infectious

Substances affecting animals

The same list appears in the DOT and USPS regulations.

Class 6.2 Divisions

Classifying what you have:

– This is a professional judgment call. Knowing the patient’s medical condition and status will determine how one decides to classify a substance.

Exempt Packaging Requirements

Three Components A leak-proof primary receptacle A leak-proof secondary packaging An outer packaging of adequate strength…

For Liquids Enough absorbent material around the primary

receptacles to absorb the entire contents For multiple primary receptacles, enough

cushioning to prevent contact, rattling, and breakage

Packing

Triple Packaging Concept

– Primary– Secondary– Outer

packaging

Certified Packaging for Category A, Infectious Substances

UN 6.2 Packaging for Infectious Substances must meet certain requirements of the regulation– Test standards– Marking standards– Triple packaging system

Leak-proof primary Leak-proof secondary Certified outer packaging Whole package must be used as a unit

Package Markings Category A

Manufacturers must mark their packages with– United Nations symbol– Packaging and construction code– “Class 6.2”– Last two digits of the year of manufacture– Country of manufacture– Certifying agency marks

4G/Class 6.2/02USA/+AX1852

UN

IATA Packing Instruction 602 Category A

Inner packaging– Watertight primary receptacle– Watertight secondary packaging

– Must be able to withstand internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi)

– Must be capable of withstanding temperatures in the range of -40ºC to +55ºC

PI 602, cont’d

For liquid specimens, there must be sufficient absorbent material to absorb the entire contents of the primary receptacles should they break. For more than one primary, there must be cushioning between the receptacles.

List of contents of the secondary package must be included between the secondary package and the outer package and must include proper shipping name and technical name (eg.-Suspected Category A Infectious Substance).

PI 602, cont’d

Rigid outer packaging must meet requirements

All packages containing infectious substances must be marked with the NAME and TELEPHONE NUMBER of the Responsible Person.

Package Labels Category A

Infectious Substance Label– Class 9 label, if dry ice is used

Orientation arrows Consignee name and address Shipper name, address, phone number

– Name and number of responsible person Proper Shipping Name, UN number, quantity

A note about the 24-hr Emergency Response Number-

“This 24-hr number must monitored at all times the Hazardous Material is in transit. It must be monitored by a person who is knowledgeable of the hazards and characteristics of the Hazardous Material, have comprehensive emergency response and accident litigation information or immediate access to someone who possesses such knowledge and information.”

Documentation

http://www.fedex.com/us/services/pdf/ShippersDecColumnsColorPrinter.pdf?link=4

Packaging for Category BBiological Substances

Triple Packaging concept with some changes

– Certified packaging is NOT required

New marking,

UN 3373– No Declaration of

Dangerous Goods required

UN3373

Biological Substance

IATA PI 650

Good quality packaging, strong enough to withstand normal shocks and loadings…

Triple packaging concept– Water-proof primary and secondary receptacles– Rigid outer packaging, at least one surface must

be 100 mm X100 mm (~4 in)– Primaries must be packed so that they should not

touch, break, or leak, and if they do, the cushioning or outer package is not compromised

IATA PI 650, con’t

For liquid substances– Quantity limit of 1L / primary receptacle,

4 L / outer package– Primary and secondary must be able to withstand,

without leaking, internal pressure of 95 kPa in the range of -40°C to +55°C.

– Absorbent material between primary and secondary, sufficient to absorb entire contents of primary

IATA PI 650, con’t

For solid substances– Primary and secondary must be sift-proof– Quantity limit of 1 kg / primary receptacle,

4 kg / outer package– Cushioning between primaries if more than one

MarkingsNew diamond with UN number, UN 3373Proper shipping name must be adjacent to the diamond marking

Biological Substance

IATA PI 650, con’t

UN3373

Itemized list of contents between secondary and outer packaging

Completed package must be able to withstand the drop test at 1.2 m. (3.9 ft.)

2010 Changes to PI 650

On the package:– Name & address of shipper– Name & address of consignee– Name & telephone number of responsible person (or on

the airway bill)– UN 3373 Marking with Proper Shipping Name, Biological

Substance, Category B On the waybill

– UN 3373 Biological Substance, Category B– Number of packages

IATA Packaging for Category B Infectious Substances

Quantity Limits for Infectious Substances

Category A, Infectious Substances– 50 ml or 50 g

Category B, Infectious Substances– 4 L or 4 kg

Shippers’ Responsibilities

You are ultimately responsible for the package from beginning to end.

Dry Ice on 6.2 Cat A

Use Class 9, Miscellaneous Hazard label

List Dry Ice on Declaration

– In Proper Shipping Name column

– Quantity in kilograms

Support inner packages Allow for escape of CO2

Air Waybill

Air Waybill: Box 6 Special Handling

Training

…before a consignment of dangerous goods is offered for air transport, all relevant persons involved in its preparation, must have received training to enable them to carry out their responsibilities as detailed in Subsection 1.5

IATA DGR 1.3.2.D

Training

Employer’s Responsibilities– Provide training or verify employee was trained– Test was given and passed– Document the training

Hazmat Safety Security

– Certify employee trained

Training: Who Needs To Be Trained?

Any persons who:– Packages a hazardous material

6.2 materials Dry ice

– Prepares materials or documentation Classifies, documents a 6.2 material

– Transports a hazardous material Courier in a motor vehicle (exceptions) Air plane Vessel

Training

Training shall include the following:– General awareness/familiarization of the

regulation– Function-specific training– Safety training

Emergency response Protective measures Proper procedures for handling hazardous material

– Security Awareness

Training, cont’d

Initial and Recurrent – Trained within 90 days of employment– Retrained every two years for IATA, every

three years for DOT– Training from a previous employer can be

transferred to new job

Training, cont’d

Recordkeeping– Record of Training

Employee name Most recent date trained Description of training Description of training materials/where kept Name and address of trainer

– Record of training kept as long as employed

Safety Training

Emergency Response– “Information that can used in the event of an

incident..” Basic description and technical name

– Proper shipping name on the Shipper’s Declaration Immediate hazards to health

– Inhalation or contact with substance may cause infection, disease, or death

Risk of fire or explosion– Some of these materials may burn, but none ignite easily

Safety Training

Emergency Response, cont Immediate precautions to be taken in the event of an

accident or incident– Don’t touch it, breathe it, or step in it– Do not touch spilled material or containers unless wearing

appropriate personal protective equipment/clothing– Don appropriate PPE

Respirators, gloves, coats, masks, etc

Safety Training

Emergency Response, cont Initial methods for handling spills or leaks

– Absorb spill with earth, sand, or other non-combustible material

– Cover spilled area or damaged container with damp toweling and keep wet with liquid bleach or other disinfectant

Safety Training

Emergency Response, cont

Preliminary first aid– Move victim to a safe, isolated area– Call 911 or emergency medical service– Remove and isolate contaminated clothing and shoes– Flush skin or eyes with running water for at least 20 min if

you are contaminated

Security Awareness

Should have a written Security Plan Plan should include:

– Assessment of transportation security risks Personnel security Unauthorized access En route security

– Copies made available to employees and revised and updated as needed 49 CFR Part 172, Subpart I

Summary

Packaging and Shipping

Questions?

Test

Apply the appropriate, proper labels and markings to the boxes and complete any required paperwork.

Lower Falls