Transporting Dangerous Goods - Recherche Clinique Paris Centre · 2016-11-29 · Transporting Dangerous Goods September 2014 5 What are dangerous goods? • Dangerous goods are articles

Transporting Dangerous Goods

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Welcome to Mayo Medical Laboratories’ Transporting Dangerous Goods training.

Disclaimer

This training is provided as a service to Mayo Medical Laboratories clients and couriers. It is limited to shipping of medical specimens for diagnostic testing, including Category A Infectious Substances and Category B Biological Substances. Although we strive to ensure that the information is current and accurate, we remind you that it is the employer’s responsibility to perform and verify the training of their employees.

No training is endorsed or "certified" by ICAO, FAA, TSA, IATA, DOT, or any other association or agency. Parts of this training apply only to shipments originating or ending in the United States. Only Mayo Medical Laboratories

clients and couriers should use this training. Non-Mayo Medical Laboratories clients and couriers are encouraged to use one of the many commercial vendors specializing in IATA and DOT training


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Our presenter for this training is Ranee Rasmussen, Quality Assurance Assistant in the Laboratory Compliance Unit in the Department of Laboratory Medicine and Pathology at Mayo Clinic in Rochester, Minnesota.


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• Welcome to training on how to ship “Dangerous Goods.”

• We are going to help you understand how to legally and safely ship medical specimens—Infectious Substance, Category A and Biological Substance, Category B.


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Dangerous Goods: Overview


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What are dangerous goods?

• Dangerous goods are articles or substances which are capable of posing a risk to health, safety, property or the environment, and which are shown in the list of dangerous goods in the IATA regulations or in the HazMat table in 49CFR. Generally, the term “DG” or “Dangerous Goods” is used when shipping via air under IATA

regulations, and the term “HazMat” or “Hazardous Material” is used when shipping via air or ground within the United States under 49CFR regulations. For purposes of this training, “DG” and “HazMat” are equivalent terms.


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Why am I here? Why is this presentation important?

• Legally, anyone who is involved with shipping dangerous goods must follow the regulations.

• It’s imperative to follow the regulations and to follow them correctly. If they are, your specimen will not leak or be crushed in transit.

• The U.S. government can assess substantial penalties for violations of these regulations.

• Keep in mind that there are numerous regulations that change all the time. One person cannot understand or remember all the regulations, so don’t be afraid to ask or call someone if you are unsure.


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Who determines these regulations?

• Various federal and state agencies

These agencies are often referred to by acronyms, which are used throughout this presentation:

• ICAO is the International Civil Aviation Organization. ICAO is a specialized agency of the United Nations that develops and maintains principles and arrangements to ensure the safety of international civil aviation. ICAO is the law.

• IATA is the International Air Transport Association, which is an association of airlines. IATA is not the law although you must follow their regulations if you want the airline to take your shipment. IATA closely follows ICAO’s regulations. IATA publishes dangerous goods regulations every year. These regulations are the easiest to read and follow.

• DOT is the U.S. Department of Transportation.

• 49 CFR is the code of Federal Regulations—it is a document published by the US Government with regulations regarding transporting hazardous materials focusing mostly on ground transportation. However, it also contains information regarding transporting hazmat by air, rail, and boat. 49 CFR is the law in the United States. The CFR is modified periodically and the changes are written in the Federal Register. We subscribe to a service that reads the Federal Register for us and lets us know when any changes may pertain to us.


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What are these regulations?

• The regulations imposed on most laboratories are related to specimen classification, packaging, labeling, documentation, and the proper training of staff.

• This presentation covers each of these regulations in detail.

• Every mode of transportation has its own rules that we must follow in addition to the legal regulations.

• It’s the responsibility of the sendout staff to follow regulations, and it’s the employer’s responsibility to train the individual to follow the regulations.

• The IATA Dangerous Goods Regulations and the 49 CFR guidelines can help you prepare a specimen for shipment.


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Dangerous Goods: Proper Classification of Specimens


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First, Dangerous goods must be classified into the correct hazard class:

• There are 9 hazard classes. If a hazard class is wide in scope, it may be divided into additional divisions.

• For training purposes, you should know all 9 hazard classes exist. But generally, you will only use 2 of these hazard classes.

• Infectious substances fall under Class 6, Division 6.2. Dry ice falls under Class 9, Miscellaneous.

• When preparing a specimen for shipping, you must know the hazard class to complete the packaging and documentation correctly.


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In addition to the 9 hazard classes most hazardous substances are further assigned to a packing Group

• The 3 packing groups indicate the degree of hazard the substance presents.

• For training purposes, you should know the packing groups exist, however when shipping medical specimens you will not need to refer to a packing group, as neither 6.2 Infectious substances, nor Biological Substance Category B are assigned to a packing group.

• You must specify a packing group if you ship an acid, corrosive, or flammable substance.


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Infectious substances are substances which are known or are reasonably expected to contain pathogens. Infectious substances are classified in Division 6.2.

Class 6, Division 6.2 Infectious substances are divided into two categories:

• Category A, Infectious

• Category B, Biological Substance

• Rules for packaging and shipping are determined by how an infectious substance is categorized


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Category A Infectious substances:

•Category A is an infectious substance transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease to humans or animals. (Note: An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals.)

• 49 CFR and IATA require a Hazard Class 6 label

• IATA packing instruction 620

• The proper shipping name is “Infectious substance Affecting Humans”


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Category B Infectious substances:

• Category B is an infectious substance, referred to as a biological substance, that does not meet the criteria for Category A.

• 49 CFR and IATA require a UN3373 marking

• IATA packing instruction 650

• The proper shipping name is “Biological substance, Category B”


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How do you know if a substance is Category A, Infectious or Category B, Biological?

• It is the responsibility of the laboratory staff to classify the specimen.

• This slide lists some examples of Category A, Infectious or Category B, Biological substances.


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The proper shipping name for Category A is “Infectious Substance, affecting humans.” When the infectious substances to be transported are unknown but suspected of meeting the criteria for inclusion in Category A, the technical name is “Suspected Category A Infectious Substance.” Per IATA regulations, if there is doubt as to whether or not a substance meets the criteria, it must be included in Category A.

This slide lists Category A, Infectious examples from IATA regulations.

The regulations for possessing, using, or transferring Select Agents from, to, or within the United States are found in 42CFR, Parts 73.0 through 73.21. Most diagnostic testing laboratories would not be involved with these agents and toxins. Thus, it is beyond the scope of this presentation to cover this material. Please refer to the Centers for Disease Control website: www.cdc.gov for more information.


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IATA paragraph 3.6.2.2.3.5 classifies patient specimens for which there is minimal likelihood that pathogens are present as “Exempt Human Specimens.” Examples include:

• Dried blood spots

• Blood or blood components that have been collected for the purpose of transfusion

• Blood or urine tests to monitor cholesterol levels, blood glucose levels, or hormone levels

• Tests conducted for insurance or employment purposes to determine the presence of drugs or alcohol

• Pregnancy tests

The classification of “Exempt Human Specimen” applies only to shipments by aircraft. The US Department of Transportation considers these samples to be outside of their regulations and thus does not assign them a classification at all.


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Cultures:

• Cultures are the result of a process by which pathogens are intentionallyamplified or propagated in order to generate high concentrations. As such, the risk of infection is increased if exposure occurs. This definition does not include cultures intended for diagnostic and clinical purposes.

Cultures can be classified as Category A, Infectious or Category B, Biological Substance:

• Any culture intended for the intentional generation of pathogens as well as any culture shipped for identification purposes must be shipped as Category A, Infectious.

• Cultures can be shipped as Category B, Biological if they aren’t intended for the intentional generation of pathogens and are not found in the Category A list in the IATA regulations.


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Dangerous Goods: Proper Packaging & Labeling of Specimens


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All dangerous goods shipped by air are assigned a packing instruction:

• Instructions for shipping by air are found in the yellow pages of the IATA regulations.

Category A, Infectious substances use Packing Instruction 620.

Category B, Biological substances use Packing Instruction 650.

Dry Ice uses Packing Instruction 954.


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Packing Instruction 620 for Category A, Infectious substances requires UN-certified packaging:

UN-certified packaging is a combination package consisting of inner and outer containers that have passed a series of tests required by IATA and the DOT.

Tests include puncture tests, drop tests, and stacking tests.

UN-certified packing is tested as a combination package. The containers by themselves are not considered UN-certified and are illegal to ship in individually. You must always use the appropriate combination of containers to ensure UN-certification.

NOTE: State Health Departments and the CDC may furnish their own containers and documentation if you ship to them.


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Packing Instruction 620 for Category A, Infectious substances has additional requirements:

• Ensure the box is marked UN-certified, as indicated on the slide. This marking tells the carrier that this box has been certified to carry an infectious substance.

• The Category A, Infectious substance must be packaged by itself in a certified container. The preferred container is our small white certified shipping container, MML supply number T-570.

• You must use a box big enough to accommodate all the proper markings and labels for the contents of the box. These labels must not overlap, be obscured, or be folded over a corner. If there are any old/previous markings or labels on your box, they must be completely removed or blacked out before reuse.

• See the slide for an example of a certified container.


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• It must arrive in good condition without presenting a hazard to the public.

• You must pack it in leak-proof primary and secondary packaging with enough absorbent material to soak up entire contents of the bag.

• It must include an itemized list of contents between the secondary packaging and outer packaging.

• It must withstand a barometric pressure differential of not less than 95kPa and temperatures in the range of -40F to +130F.


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• It must fit in a box with a smallest external dimension no less than 100 mm (4 inches).

• Not be consolidated with any other types of specimens.

• Outside of the package must be marked durably and legibly with the name and telephone number of a responsible contact person.

• Ambient temperature samples must have a positive means of closure, such as heat seal, skirted stopper, or metal crimp seal. If screw caps are used, these must also be secured by positive means, such as tape, paraffin sealing tape, or manufactured locking closure.


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In addition to the proper packaging, Category A, Infectious substances must be labeled a certain way:

• It must be marked with the proper shipping name, “Infectious Substance Affecting Humans.”

• Use the UN-certified number, UN2814, as well as the name and address of the shipper and consignee.

• Place a 6.2 Infectious Substance label on the box.

• If the box contains over 50 mL or 50 grams of a Category A, Infectious substance, it must also be marked with a cargo-only aircraft label.


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When shipping Category A, Infectious substances, you must use the proper label:

• You must always use the 6.2 Infectious Substance label, as shown on the left.

• If you are shipping over 50 mL or 50 grams of a Category A, Infectious substance, the box must also be marked with a cargo-only aircraft label, as shown on the right.


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Packing Instruction 650 for Category B, Biological substances has the following requirements:

• Ensure the box is marked with the diamond-shaped mark, shown on the slide. The mark must be at least 2” X 2” and include the marking UN3373.

• The proper shipping name “Biological Substance, Category B” must be marked on the box, adjacent to the diamond-shaped mark.

• You do not need to ship Category B, Biological substances in a UN-certified box.


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Packing Instruction 650 for Category B, Biological substances has additional requirements for air transport:

• It must be triple packaged with a primary receptacle, secondary packaging, and rigid outer packaging.

• You must pack it in leak-proof primary receptacle containing no more than 1 L of any liquid, as well as leak-proof secondary packaging.

• If your vials are glass, you must wrap them in bubble wrap or rubber band them together so that they do not break in transit.

• The package must contain enough absorbent material to soak up the entire contents of the bag.


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Packing Instruction 650 for Category B, Biological substances has additional requirements for air transport:

• It must withstand a pressure differential of not less than 95kPa and temperatures between -40°F and +130°F.

• It must contain no more than 4L in the outer packaging, excluding ice.

• It must include an itemized list of contents between the secondary packaging and outer packaging. In the case of medical specimen shipments, the vial is the primary container and the styro/box combination is the outer packaging. The test requisition form (batch sheet) serves as the itemized list of contents.

• Use the proper shipping name, “Biological Substance, Category B”.

• Outside of the package must be marked durably and legibly with the name and telephone number of a responsible contact person.


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49 CFR for Category B, Biological substances has additional requirements for ground transport:

Shipping by ground is very similar to shipping by air, with many of the same requirements.

• It must be triple packaged with a primary receptacle, secondary packaging, and rigid outer packaging.

• You must pack it in leak-proof primary receptacle containing no more than 1 L of any liquid, as well as leak-proof secondary packaging.

• If your vials are glass, you must wrap them in bubble wrap or rubber band them together so that they do not break in transit.

• The package must contain enough absorbent material to soak up the entire contents of the bag.

• The box must be capable of passing a drop test from the height of 4 feet.


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When shipping Category B, Biological substances, you must use the proper markings and labels:

• You must always use the UN3373 marking, as shown on the left. Place the mark next to the words “Biological Substance, Category B.”

• If your specimen needs to be shipped on dry ice, use a dry ice label. This label must include the weight of the dry ice, marked in kilograms.


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This slide shows an example of a box marked with the proper shipping name, “Biological Substance, Category B” next to the UN3373 marking.

These are the only markings required for air or ground shipments.

If the specimen is liquid, your boxes needs to display orientation labels on opposite sides. Since most of our shipments contain liquid, our boxes are preprinted with these arrows.


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When packing microbiology cultures:

• Both Category A, Infectious substances and Category B, Biological cultures should be sent in a Mayo Medical Laboratories (MML)-supplied secondary container. Doing so ensures the safety of lab personnel.

• For Category A, Infectious cultures, the secondary container must be placed in the appropriate temperature color-coded bag and in a UN-certified box.

• For Category B, Biological cultures, the secondary container must be placed in the appropriate temperature color-coded bag. Place a blue “C” label on the bag.

Note: The blue “C” label is a Mayo Medical Laboratories supply item. Use of the blue “C” label is not a regulatory requirement; rather Mayo Medical Laboratories requests our clients to use this label on Category B

culture shipments.


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When shipping Category A, Infectious cultures:

• Package Category A, Infectious cultures according to Packing Instruction 620.

• Use a certified combination box.

• You can combine Category A, Infectious with other Category A, Infectious cultures, but Category A, Infectious should not be packed with Category B, Biological cultures.


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When shipping Category B, Biological cultures:

• You can combine Category B, Biological with other Category B, Biological substance specimens. If the culture is Category B, Biological, it may be packed with other Category B specimens.

• Place a blue “C” label on the bag and Styro containing the Category B culture, as well as on the outside of the box.

• If you have a courier pickup, they will take care of labeling the Styro and box.

• Mayo Medical Laboratories requests that you put the blue “C” label on the outside of the bag.


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Dangerous Goods: Methods of Transportation & Documentation of Specimen Shipments


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If you send specimens by U.S. Mail:

• Follow the Post Office’s Dangerous Goods regulations. These closely follow the DOT regulations in 49 CFR, but may include additional restrictions.

• For details, contact the USPS for their Dangerous Goods regulations. They can also refer you to their hazmat expert if necessary.


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If you send specimens by air:

• Follow the IATA/ICAO Dangerous Goods regulations.

• Call the IATA hotline if you need assistance.


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If you send specimens by ground carrier:

• Follow the DOT Dangerous Goods regulations, found in 49 CFR.

• Call the DOT hotline if you need assistance.

• Also, review the federal safety requirements on the Office of Hazardous Materials Safety website.


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If you operate your own private courier system or contract with a dedicated contract courier:

Follow the DOT regulations for all Category A, Infectious substances.

For Category B, Biological substances by ground, you are exempt from DOT regulations.

Substances exempt from DOT regulations must still follow OSHA requirements, as stated in 29 CFR. This includes placing biohazard labels on at least one of the containers.


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To ship legally and safely, it is important to identify the substance you are shipping. To identify your substance correctly on your package and paperwork:

• You must use the proper shipping name when shipping. The proper shipping name is a standard name used to identify the article or substance on the outside of the package and on the Shipper’s Declaration Form.

• In the case of an infectious substance, you must know the technical name of the substance as well. The technical name is a recognized chemical name–currently used in scientific and technical handbooks, texts, journals–which must accompany the proper shipping name when indicated in the IATA or DOT regulations.


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Dangerous Goods regulations in both 49 CFR and IATA indicate when a substance requires a technical name:

• In IATA, substances followed by a bold star (*) need a technical name included in the documentation.

• In 49 CFR, substances marked by the letter “G” in column 1 need a technical name. The slide shows this indication.


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When shipping Category A, Infectious substances, a Shipper’s Declaration for Dangerous Goods is required:

• The Shipper’s Declaration describes the contents of the consignment. By signing the shippers declaration, the shipper declares the consignment is classified, packaged, marked, and labeled according to international and national government regulations.

• If this form is filled out incorrectly in any way, your shipment will be rejected. At least two copies of the declaration must be given to the airline.

• You must retain a copy of the Shipper’s Declaration for two years.

• The following information must be filled in:

• The name and address of the shipper and the consignee.

• The airway bill number, along with page 1 of 1.

• Cargo aircraft only must be crossed (X’d) out if you have 50 mL or 50 grams or less of an infectious substance.

• The airport of departure and the airport of destination must be filled in.

• The word “radioactive” must be crossed (X’d) out, leaving “non-radioactive” showing.

• The proper shipping name must be listed exactly the same as in the IATA regulations.

• The technical name must be filled in parenthesis.

• The class or division must be filled in, such as 6.2, as well as the UN number.

• Under the quantity and type of packaging, you must fill in the quantity of the infectious substance and the number and type of packaging.

• An emergency contact number must be listed on the paperwork. This must be a 24-hour emergency response number that is monitored at all times by a person knowledgeable about the dangers or characteristics of substance being transported. Minimally, this person must have immediate access to a person who possesses such knowledge.

• The name and title of the shipper, as well as the date must be filled in.


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When shipping Category B, Biological substances:

• The only paperwork required is a domestic airway bill.

• Each airline has its own airway bill. This slide shows an example of a FedEx airway bill.


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Dangerous Goods: Proper Training of Employees


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Employee training is an important element when shipping dangerous goods:

• If you are audited by the FAA, your training records are typically evaluated first.

• Training requirements state that an employee may only be certified in areas in which they can successfully perform their duties.

• Training is required within 90 days of employment for all laboratory employees who ship dangerous goods. Earlier training is recommended.

Self-training is acceptable as long as it meets the requirements of Security Awareness Training, as described in the next few slides.

Training must include general familiarization, function-specific information, safety training, and security awareness training.

Training must be repeated every 2 years per IATA, every 3 years per 49 CFR


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Accurate training records must be retained in the event of an audit:

• In general, these records must include: the employee’s name, the most recent training completion date, and a description or copy of the training materials used, such as a copy of this presentation.

• While it is the hazmat employer’s responsibility to ensure that a hazmat employee is properly trained and tested, the employer may designate an outside source to train, test, and certify employees on their behalf. The employer must determine a trainer’s qualifications based on the employer’s need. Once the training is completed, the name and address of the that training organization must be retained.

• A test that ensures the employee can perform the assigned duties in compliance with the regulations is required. No specific format must be used, however. Training and testing may be accomplished in a variety of ways—performance, written, verbal, or a combination. Once the test is completed, a copy of the certification issued must be retained.


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Security Awareness Training is required for all employees who ship dangerous goods:

Fulfills the requirements of 49 CFR 172.704 (a)(4).

Required within 90 days of employment.

Recommended as soon as possible.


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Security Awareness Training must include:

Risks of transporting dangerous goods.

Methods of enhancing transport security.

Ways to recognize security risks.

Steps for responding to security threats.

The US Department of Transportation has training materials available to satisfy these requirements. Use the link http://www.phmsa.dot.gov/staticfiles/PHMSA/Hazmat/digipak/ to access the Security Awareness Training website.


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Per 49 CFR, employees must be knowledgeable in emergency response information for all infectious substances. This includes:

Proper shipping name of the substance, “Infectious Substance Affecting Humans.”

Technical name of the substance.

Telephone number for use in the event of an accident or other emergency.

Ensure the Shipper’s Declaration for Dangerous Goods or the shipping paper is stored in the vehicle when transporting by ground carrier. Three copies of the Shipper’s Declaration for Dangerous Goods must be included when transporting by air.


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Employees can protect themselves when shipping dangerous goods by:

• Participating in training--including the employer’s lab safety training, OSHA training, and Employee Right to Know training.

• Wearing gloves at all times.

• Treating all spills as infectious substances.


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Dangerous Goods: Contact Us


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If you have questions about transporting your specimen, contact the Mayo Clinic Laboratory Compliance Unit by phone or email.

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Transporting Dangerous Goods - Recherche Clinique Paris Centre · 2016-11-29 · Transporting Dangerous Goods September 2014 5 What are dangerous goods? • Dangerous goods are articles