ONLINE self-study

1
ONLINE self-study

• Shipping of Infectious Substances and Other
  Biomedical Materials Annual Update

2
Course Objectives

• The purpose of this program is to
• ensure the safe handling of hazardous materials
  using good sensible practices.
• recognize hazardous materials and realize there
  are special requirements
• Comply with Federal and International regulations
• The basic goal for this training is to provide a
  framework for decisions
• Is material to be shipped a dangerous good,
  genetically modified, biological substance
  category B, or an exempt human specimen?
• Upon completion you will receive certification to
  ship hazardous materials

3
Course Objectives

• This training will increase your awareness of
  safety and compliance issues. If you need more
  information or help with shipping your package
  you can e-mail the EHS Shipping Specialist. The
  training will cover the topics listed below.
  Classification, identification, and packaging are
  three of the most important topics covered.
• Regulatory Oversight
• Dangerous Goods/Hazardous Materials
• Training Requirements
• Shippers Operators Responsibilities
• Classification, Identification
• Packaging
• Shipping with dry ice and Overpacks
• Marking labeling packages
• Shipping documentation
• Emergency Response
• Laboratory Security
• Accept or reject shipments by use of checklist

4
What is a Dangerous Good/Hazardous Material?

• Federal Regulations
• U.S. Dept. of Transportation (DOT) 49 CFROther
  federal requirements CDC, OSHA, USDA, Department
  of Commerce, International Traffic and Arms
  (ITAR) and Toxic Substance Control Act (TSCA)
      
• DOT regulations primarily cover ground
  transportation. DOT is the organization that has
  the authority to fine you for violations. Their
  authority extends well beyond US boundaries.
  Import permits from the CDC or USDA may be needed
  if you are importing human etiological organisms
  or plant or animal pathogens. Department of
  Commerce licenses may be needed to export
  organisms, genetic elements, chemicals,
  technology or other commodities. TSCA
  Certification may be needed to import or export
  certain chemicals.
• International Regulations (Air shipments)
• International Civil Aviation Organization (ICAO)
• International Air Transport Association (IATA)
• Dangerous Goods Regulations (DGR)     
• Internationally, the UN Committee of Experts
  (CoE) develops recommended procedures for the
  transport of all types of dangerous good except
  Radioactive material. The International Civil
  Aviation Organization (ICAO) uses the UN
  recommendations as the basis for developing the
  regulations for the safe transport of dangerous
  goods by air. IATA is the international trade
  organization that interprets ICAO regulations and
  provides the Dangerous Goods Regulations (DGR).
  The IATA regulations are more stringent than DOT.
  This training program follows the IATA
  regulations. IATA regulations are minimal
  requirements - your carrier can be more
  stringent.

5
What is a Dangerous Good/Hazardous Material?

• Fines and Penalties
• "Violations contrary to the U.S. Code of Federal
  Regulations (CFR) 49, if substantiated, may
  result in the assessment of a civil penalty of up
  to 37,500 per violation, and deliberate
  violations may result in criminal prosecution of
  up to 500,000 and 5 years in prison."
• There has been an increase in the number of
  Federal Aviation Inspections (FAA) in response to
  the 1996 ValuJet crash, the September 11, 2001
  attacks, and the UPS package bomb scare in
  November 2010.
• If you are receiving a HazMat package it is your
  responsibility to ensure the sender packages it
  correctly.

Oxygen-generating canister like the ones on board
the ValuJet flight 592
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Definition

• Infectious Substance - Class 6.2 Definition
• Infectious substances are substances known to
  contain, or reasonably expected to contain,
  pathogens.
• Pathogens are defined as micro-organisms
  (including bacteria, viruses, rickettsia,
  parasites, fungi) and other agents such as prions
  which can cause disease in humans or animals.
• Critical to the infectious substance definition
  is the ability to cause disease.
• - Note the reliance on your professional judgment
  when the words reasonably expected are used.

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Definition

• The IATA definition for infectious substances
  leaves out toxins. Toxins are placed in a
  separate category. They are treated like
  chemicals.
• Toxins from plant, animal or bacterial sources
  which do not contain any infectious substances or
  toxins that are not contained in substances which
  are infectious substances should be considered
  for classification in Division 6.1 and assignment
  to UN 3172 (for liquids) or UN 3462 (for solids).
  
• Contact EHS if you are shipping toxins as
  instructions for shipping toxins is not covered
  in this training module. Please be aware that
  many toxins (if shipped out of the US) are
  regulated by the Department of Commerce. There
  are significant fines associated with exporting
  toxins without a license

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Definition

• Biological products are those products derived
  from living organisms which are manufactured and
  distributed in accordance with the requirements
  of appropriate national authorities, which may
  have special licensing requirements, and are used
  either for prevention, treatment, or diagnosis of
  disease in humans or animals, or for development,
  experimental or investigational purposes related
  thereto. They include, but are not limited to,
  finished or unfinished products such as vaccines.

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Definition

• Cultures     
• Laboratory stocks are the result of a process by
  which pathogens are intentionally propagated in
  order to generate high concentrations. This
  increases the risk of infection when exposure to
  them occurs. An example of this would be a
  patient sample of TB that has been cultured.

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Definition

• Patient Specimens     
• Patient Specimens are human or animal materials,
  collected directly from humans or animals,
  including, but not limited to, excreta, secreta,
  blood and its components, tissue and tissue fluid
  swabs, and body parts being transported for
  purposes such as research, diagnosis,
  investigational activities, disease treatment and
  prevention.

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Classification of Infectious Substances

• The three proper shipping names for infectious
  substances are
• Infectious substances, affecting humans, UN 2814
• Infectious substances affecting animals, UN 2900
• Biological Substances Category B, UN 3373 (This
  does not require a Dangerous Good Declaration to
  ship)

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Classification

• Category A Infectious Substances - an infectious
  substance which is transported in a form that
  when exposure occurs, is capable of causing
  permanent disability, life threatening or fatal
  disease in otherwise healthy humans or animals.
  Examples of substances that meet this criteria
  are located in this table Table 3.6.D.
• NOTE An exposure occurs when an infectious
  substance is released outside of the protective
  packaging, resulting in physical contact with
  humans or animals.

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Classification of Infectious Substances

• Infectious substances meeting the Category A
  criteria which cause disease in humans or both in
  humans and animals must be assigned to UN 2814
  (Infectious substance, affecting humans).
• Infectious substances which cause disease only in
  animals must be assigned to UN 2900 (Infectious
  substance, affecting animals).

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Classification of Infectious Substances

• Assignment to UN 2814 or UN 2900 must be based on
  the known medical history and symptoms of the
  source human or animal, endemic local conditions,
  or professional judgment concerning individual
  circumstances of the source human or animal.
• Example a patient from a foreign country is
  admitted to the hospital. You think they may have
  Ebola. You will ship all body fluids as
  infectious substances (Category A) using all the
  applicable packaging and paperwork.

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Classification of Infectious Substances

• Category B, biological substance is an infectious
  substance which does no meet the criteria for
  inclusion in Category A.
• An example of a Category B biological substance
  would be a patient's body fluid infected with
  mycobacterium tuberculosis. A culture of this
  same organism would be a Category A infectious
  substance.
• You must use your professional judgment in
  deciding if an infectious substance is a Category
  A or Category B infectious substance. Contact
  EHS if you need assistance determining your
  classification.

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Classification of Infectious Substances

•   Infectious substances in category B must be
  assigned to UN 3373 except those organisms on
  table 3.6.D - which must be assigned to UN 2814
  or UN 2900.
• The proper shipping name of UN 3373 is Biological
  Substance Category B.

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Classification of Infectious Substances

•     Exemptions under Biological Substance
  Category B
• Substances which do not contain infectious
  substances or substances which are unlikely to
  cause disease in humans or animals are not
  subject to these Regulations unless they meet the
  criteria for inclusion in another class i.e. you
  add ethanol to the sample.
• Substances containing micro-organisms, which are
  non-pathogenic to humans or animals are not
  subject to these Regulations unless they meet the
  criteria for inclusion in another class.
• Substances in a form that any present pathogens
  have been neutralized or inactivated such that
  they no longer pose a health risk are not subject
  to these Regulations unless they meet the
  criteria for inclusion in another class.
• Environmental samples (including food and water
  samples), which are not considered to pose a
  significant risk of infection are not subject to
  these Regulations, unless they meet the criteria
  for inclusion in another class.
• Dried blood spots, collected by applying a drop
  of blood onto absorbent material, or faecal
  occult blood screening tests and blood or blood
  components which have been collected for the
  purposes of transfusion or for the preparation of
  blood products to be used for transfusion or
  transplantation and any tissues or organs
  intended for use in transplantation are not
  subject to these Regulations.

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Classification of Infectious Substances

• Exemptions Patient Specimens
• Patient specimens for which there is minimal
  likelihood that pathogens are present are not
  subject to these Regulations if the specimen is
  packed to prevent any leakage and is marked with
  the words "Exempt human specimen" or "Exempt
  animal specimen", as appropriate. The packaging
  must meet the following conditions
• The packaging must consist of three components
• a leak-proof primary receptacle(s)
• a leak-proof secondary packaging and
• an outer packaging of adequate strength for its
  capacity, mass and intended use, and with at
  least one surface having minimum dimensions of
  100 mm x 100 mm
• For liquids, absorbent material in sufficient
  quantity to absorb the entire contents must be
  placed between the primary receptacle(s) and the
  secondary packaging so that, during transport,
  any release or leak of a liquid substance will
  not reach the outer packaging and will not
  compromise the integrity of the cushioning
  material
• When multiple fragile primary receptacles are
  placed in a single secondary packaging, they must
  be either individually wrapped or separated to
  prevent contact between them.
• Determining whether a patient specimen has a
  minimal likelihood that pathogens are present,
  should be based on the known medical history,
  symptoms and individual circumstances of the
  source, human or animal, and endemic local
  conditions. Examples of specimens which may be
  transported under this paragraph include the
  blood or urine tests to monitor cholesterol
  levels, blood glucose levels, hormone levels, or
  prostate specific antigens (PSA) tests required
  to monitor organ function such as heart, liver or
  kidney function for humans or animals with
  non-infectious diseases, or therapeutic drug
  monitoring tests conducted for insurance or
  employment purposes and are intended to determine
  the presence of drugs or alcohol pregnancy
  tests biopsies to detect cancer and antibody
  detection in humans or animals.

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Other Classifications

• Biological Products
• For the purposes of these Regulations, biological
  products are divided into the following groups
• Those which are manufactured and packaged in
  accordance with the requirements of appropriate
  national authorities and transported for the
  purposes of final packaging or distribution, and
  use for personal health care by medical
  professionals or individuals. Substances in this
  group are not subject to these Regulations. These
  include but are not limited to finished and
  unfinished products such as vaccines.
• Those which do not fall under paragraph (a) and
  are known or reasonably believed to contain
  infectious substances and which meet the criteria
  for inclusion in Category A or Category B.
  Substances in this group must be assigned to UN
  2814, UN 2900 or UN 3373, as appropriate.
• Note Some licensed biological products may
  present a biohazard only in certain parts of the
  world. In that case, competent authorities may
  require these biological products to be in
  compliance with local requirements for infectious
  substances or may impose other restrictions

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Other Classifications

• Genetically modified microorganisms are
  Organisms that do not meet the definition of
  infectious substances but posses genetic material
  that has been purposely altered through genetic
  engineering in a way that does not occur
  naturally.
• Assigned UN 3245
• UN 3245 label
• These items must be triple packaged (leak proof
  primary container, leak proof secondary
  container, strong outer container). Liquids must
  have sufficient absorbent material to absorb all
  contents outside of the primary container. Outer
  containers must have sender and receiver names,
  addresses, and phone number marked on the box.

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Other Classifications

• Infected Animals  
• A live animal which has been intentionally
  infected and is known or suspected to contain an
  infectious substance cannot be transported by air
  unless the infectious substance contained cannot
  be consigned by any other means. Infected animals
  can only be transported by certain carriers. With
  the shipment there must be a DOT letter of
  authorization.    
• In order to receive infected animals you must
  obtain an import permit from the USDA. Both a DOT
  letter of authorization and USDA Permit take
  weeks to obtain.

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Identification

• Category A Infectious Substance
• The table from the Dangerous Goods Regulations
  provides a lot of critical information. The
  entries for infectious substances are shown here.
  You will not find a microorganism listed by its
  scientific/technical name. There are two UN
  numbers UN 2814 and UN 2900 for Category A
  Infectious Substances (Column A). The asterisk
  beside infectious substances means you must put
  the technical name (specific name of the
  organism) on any paperwork. You do not put the
  technical name on the outside of the package.
  Column C gives the class or division and Column D
  gives the hazard label that will be affixed to
  the package. Columns J and L give the quantity
  limits per package type.
• 2011 Update Category A infectious substances are
  packed according to Packing Instruction 620

UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Cargo Aircraft Only Cargo Aircraft Only S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Ltd Qty Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Pkg Inst G Max Net Qty/Pkg H Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
2814 Infectious substance, affecting humans (solid) 6.2 Infectious subst. E0 -- -- 620 50 g 620 4 kg A81 A140 11Y
2814 Infectious substance, affecting humans (liquid) 6.2 Infectious subst. E0 -- -- 620 50 mL 620 4 L A81 A140 11Y
2900 Infectious substance, affecting animals only (solid) 6.2 Infectious subst. E0 -- -- 620 50 g 620 4 kg A81 A140 11Y
2900 Infectious substance, affecting animals only (liquid) 6.2 Infectious subst. E0 -- -- 620 50 mL 620 4 L A81 A140 11Y
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Identification

• Category A Infectious Substance
• This slide shows the packing instruction and
  maximum quantity per package. The limits are
  different for passenger and cargo aircraft.
• You are only allowed to ship 50mg/g per package
  on a passenger and cargo aircraft. You are only
  allowed to ship 50mL (liquid) or 50g (solid) per
  package on a passenger and cargo aircraft. With
  the "cargo aircraft only" label you can ship up
  to 4L (liquid) or 4 kg (solid) on a cargo
  aircraft only.
• Cargo Aircraft Only Label

Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Cargo Aircraft Only Cargo Aircraft Only
Ltd Qty Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L
Pkg Inst G Max Net Qty/Pkg H Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L
-- -- 620 50 g 620 4 kg
-- -- 620 50 mg 620 4 L
-- -- 620 50 g 620 4 kg
-- -- 620 50 mL 620 4 L
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Identification

• Biological Substance, Category B
• The UN number 3373 is in Column A.
• When shipping biological substances you have to
  use packing instruction 650 and you can ship up
  to 4 L per outer package (primary containers
  cannot exceed 1 L.)
• The 4L quantity excludes ice, dry ice or liquid
  Nitrogen when keeping specimens cold.

UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Cargo Aircraft Only Cargo Aircraft Only S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Ltd Qty Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Pkg Inst G Max Net Qty/Pkg H Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
3373 Biological substance, Category B 6.2 E0 -- -- --See 650-- --See 650-- --See 650-- --See 650-- 6L
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Identification

• Biological Products
• There is no UN number in the left hand column for
  biologicals. It states they are not restricted.  
  You do not need diamond shaped labels and you can
  ship as much as you want as long as no chemicals
  or infectious agents are present.

UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Cargo Aircraft Only Cargo Aircraft Only
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Ltd Qty Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Pkg Inst G Max Net Qty/Pkg H Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L
Biological products Manufactured and packaged in accordance with the requirements of national governmental health authorities and transported for the purposes of final packaging or distribution, and use for personal health care by medical professionals or individuals ----NOT RESTRICTED---- ----NOT RESTRICTED---- ----NOT RESTRICTED---- ----NOT RESTRICTED---- ----NOT RESTRICTED---- ----NOT RESTRICTED---- ----NOT RESTRICTED---- ----NOT RESTRICTED---- ----NOT RESTRICTED---- ----NOT RESTRICTED----
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Chemical Preservatives

• Solutions used to preserve biological samples may
  be regulated as dangerous goods.
• Ethanol, greater than 24 is assigned to UN1170,
  Class 3, Ethanol, PGII
• 10 to lt25 Formaldehyde is assigned to UN3334,
  Class 9, Aviation regulated liquid, n.o.s.
• Formaldehyde, not less than 25 assigned to
  UN2209, Class 8, Formaldehyde solution PGIII
• Formaldehyde combined with a flammable substance
  may qualify as UN1198, Class 3 (Sub risk 8),
  Formaldehyde solution, flammable.
• Call EHS for specific packaging and training
  before shipping chemicals

27
Packing Groups

• Packing groups apply to toxic substances and
  chemicals but not infectious substances,
  biological products or Category B biological
  substances. Here is an example of the packing
  group criteria for class 3 materials (flammable
  liquids).
• The packing groups pertain to performance test
  requirements. They are assigned with regard to
  the relative degree of danger of the article or
  substance. The IATA DGR establishes packing group
  assignments for all applicable classes based on
  the type of hazard. For example Class 8 materials
  are assigned packing groups based on corrosivity
  and Class 6.1 materials are assigned based on
  toxicity.

Packing Group Flash Point (closed cup) Initial Boiling Point
I Less than or equal to 35 C
II Less than 23 C Greater than 35 C
III Equal to or greater than 23 C but less than or equal to 60.5 C Greater than 35 C
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Packing Groups

• The packing group for a material is indicated on
  the table in the Dangerous Goods Regulations.
  Here is an example using the listing for Ethanol.
• Ethanol has two packing groups listed (column E).
  The flashpoint of your ethanol solution will
  determine which packing group and packing
  instructions to use. Check the MSDS for
  flashpoint information.

UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Cargo Aircraft Only Cargo Aircraft Only S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Ltd Qty Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Pkg Inst G Max Net Qty/Pkg H Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
1170 Ethanol 3 Flamm. liquid II III E2 E1 Y341 Y344 1 L 10 L 353 355 5 L 60 L 364 366 60 L 220 L A3 A58 A180 3L 3L
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Shipping With Formalin

• Shipper's Declaration for Dangerous Goods
• Many people ship large amounts of formalin to
  preserve their specimens. Here is an example of
  the Shippers Declaration for Dangerous Goods when
  shipping formalin. If you are shipping formalin
  or any other chemical, you need to call EHS at
  962 - 5507 for more in-depth training.

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Dangerous Goods in Excepted Quantities

• There is a provision in the Dangerous goods
  regulations that allows small quantities of some
  dangerous goods to be shipped as "dangerous goods
  in excepted quantities.
• This is very useful for small amounts of
  hazardous chemicals.
• Check the EQ column (column F) on the Dangerous
  Goods Table for the material to find the Excepted
  Quantity code.
• Reference table 2.7 to determine the quantity
  allowed under your item's code.
• Some materials are not allowed to ship as
  Excepted Quantities. These will have an E0 in
  column F
• For the EQ table, click here table 2.7

UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Cargo Aircraft Only Cargo Aircraft Only S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Ltd Qty Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Pkg Inst G Max Net Qty/Pkg H Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
2516 Carbon tetrabromide 6.1 Toxic III E1 Y645 10 kg 670 100 kg 677 200 kg 6L
31
Dangerous Goods in Excepted Quantities

• This form can be downloaded at http//ehs.unc.edu/
  ih/lab/docs/excepted.pdf.
• It needs to be printed on a color printer.
• In the upper box you will type the Class
  number(s), with sub risks in parenthesis. This is
  found in column C of the Dangerous Goods table.
• In the lower box you will type either your name
  and address or the recipient's name and address
  IF it is not already marked ON the package.
• This label along with an address label placed on
  a strong outer box is what is needed for shipping
  excepted quantities of chemicals not forbidden
  for transport.

The material must be in a leak proof primary
container. The primary container needs to be
taped closed. This primary container must be
securely packed in a secondary container with
absorbent/cushioning material in such a way that
the primary container will not break, puncture,
or otherwise release its contents. The secondary
container must be securely packed in a strong
rigid outer packaging (wood, cardboard, or other
equally strong material). Each outer package
must be large enough to apply all necessary
markings.
32
Dangerous Goods in Excepted Quantities

• Excepted Quantity Package Test
• The complete package must be capable of
  withstanding the following drop and load tests.
  This must be demonstrated by testing and
  appropriately documented using this form.
• Excepted Quantity Package Test Verification Form
  (http//ehs.unc.edu/ih/lab/docs/eq_test_form.pdf)
• For the purposes of testing you will use a
  substance with similar physical characteristics
  (mass, grain size, density, etc.) to the item you
  intend to ship. Fill the primary container to
  98 capacity.
• Triple package this substance in identical
  primary, secondary (including absorbent/cushioning
  ), and outer containers to what you intend to use
  for shipping and perform the following tests

33
Dangerous Goods in Excepted Quantities

• Drop Test
• From a height of 1.8 m (5.9 feet), perform each
  of the following drops onto a rigid,
  non-resilient flat and horizontal surface
• Flat on the base
• Flat on the top
• Flat on the longest side
• Flat on the shortest side
• On a corner
• Load Test
• Calculate the mass of identical size and weight
  packages as your test sample if stacked to a
  height of 3 m (10 feet). Apply this amount of
  force to the top surface of your package for 24
  hours.

34
Dangerous Goods in Excepted Quantities

• A successful package test results in no leakage
  or breakage of the inner containers and no
  significant reduction in effectiveness of any of
  the 3 layers of packaging.
• Remember to document this package test using this
  form (http//ehs.unc.edu/ih/lab/docs/eq_test_form.
  pdf)
• If you are using packing materials and specimens
  that you have previously tested and documented
  you do not need to re-test the package. You may
  use a copy of the package test verification form
  from a previous test of the same materials. Make
  sure you keep a copy of the package test
  verification form in your shipping records.

35
Dangerous Goods in Excepted Quantities

• Here is an example of the label for a package
  containing an excepted quantity of a Class 3
  flammable liquid.

36
Dangerous Goods in Excepted Quantities

• Many people ship their biological samples in
  formalin or ethanol to preserve them. Packing
  instructions 620 (UN2814 and 2900 Category A
  infectious substances) and 650 (UN3373 Biological
  Substances, Category B) allow for a quantity of
  30mL or less of dangerous goods in classes 3, 8,
  or 9 to be packed in each primary receptacle
  containing infectious substances. This includes
  commonly used preservatives such as formalin,
  ethanol, or formaldehyde.
• When these small quantities are packed with
  infectious substances using the packing method
  for that infectious substance, the excepted
  quantity label is not required. The infectious
  substance packaging will be sufficient.
• This does not include phenol which is a class 6
  chemical.

37
Biological Specimens Category B Packaging

• Selecting Proper Packaging
• Selecting the proper packaging is one of the most
  important functions of the shipper.
• The shipper is responsible for all aspects of the
  packing of dangerous goods.
• The carrier (FedEx, DHL, World Courier, etc.)
  will not help you package your material.

38
Biological Substance Category B Packaging

• Selecting Proper Packaging
• The shipper must comply with the following
  packing instructions
• When shipping UN2814 or UN2900 Category A
  infectious substances use Packing Instruction 620
  pdf
• When shipping UN3373 Category B infectious
  substances use Packing Instruction 650 pdf
• When shipping dry ice use Packing Instruction 954
  pdf
• Make sure the responsibilities for packing are
  complete when the package is given to the carrier
  for shipment

39
Biological Substances Category B Packaging

• Category B Infectious Specifications
• These are the minimum packaging requirements for
  Packing Instruction 650
• The packagings must be of good quality, strong
  enough to withstand the shocks and loadings
  normally encountered during transport, including
  trans shipments.
• "Packagings must be constructed and closed so as
  to prevent any loss of contents that might be
  caused under normal conditions of transport, by
  vibration or by changes in temperature, humidity
  or pressure."
• The packaging must consist of three components
• Primary receptacle(s)
• Secondary packaging(s)
• Rigid Outer Packaging

40
Biological Substance Category B Packaging

• Packaging Materials for Category B Substances
• This picture was taken from FedEx's Points to
  Consider brochure for mailing Category B
  substances. Category B substances can be shipped
  in a cardboard mailing tube or a plastic
  container. You do not need special absorbent.
  Cotton balls or paper towels may be used.

41
Biological Substance Category B Packaging

• Biological Substance, Category B Packaging
  Requirement
• Primary receptacle(s) must be leakproof and
  contain
• no more than 1L
• Secondary packaging must be leakproof
• If multiple fragile receptacles are in a single
  secondary
• package they must be individually wrapped or
  separated
• to prevent contact
• Sufficient absorbent material must be placed
  between
• the primary and secondary receptacles.

42
Biological Substance Category B Packaging

• Biological Substance, Category B Packaging
  Requirement
• Water tight packaging (above in photo)
• Pressure tested packaging (tyvek bag below in
  photo)
• The primary receptacle or the secondary packaging
  must be able to withstand without leakage an
  internal pressure test of 95 kPA in the range of
  -40 C to 55 C. When you are ordering shipping
  materials make sure you order primary or
  secondary containers that meet the 95 kPA.
• Notice the bio hazard symbol on the packaging. It
  is an OSHA (not an IATA) requirement when
  shipping blood or other potentially infectious
  material.

43
Biological Substance Category B Packaging

• Biological Substance, Category B Packaging
  Requirement
• Secondary packaging
• Itemized list of contents
• Placed in outer packaging
• Outer packaging must be marked with the
  followingThe name, address and telephone number
  of a responsible person. UN 3373 must be marked
  on the outside of the box adjacent to the words
  Biological Substance Category B.
• The completed package must be able to pass a drop
  test of 1.2 M on all sides.
• The biohazard symbol is not required on the outer
  box. 
• Make sure your specimens do not move about
  loosely in the box.
• It is useful many times when shipping out of the
  country to put "For Research Purposes Only" on
  the outside of the box.

44
Biological Substance Category B Packaging
45
Biological Substance Category B Packaging

• US Postal Service Label Requirement for Specimens
  OSHA "Biohazard Label"
• The U.S. Postal Service accepts Biological
  Substance Category B. You no longer display the
  Biohazard symbol on the outside. If you are
  shipping chemicals or blood or other potentially
  infectious materials using the U.S. postal
  service please call EHS at 962 - 5507.

46
Shipping With Dry Ice

• Use Packing Instruction 954
• Dry ice is always considered a
• Dangerous good
• It must always be declared by marking, labeling,
  (Class 9) and documentation.
• If there are no other dangerous goods in a
  shipment, a Shippers Declaration is not required
  (red hatch-mark form).
• It is very important that dry ice is never placed
  in a sealed container. The build-up in pressure
  will cause violent failure of the container.
• When shipping dry ice the following needs to be
  on the outside of the box "9 misc label, UN
  1845 and kg"
•  The package must be able to release vapor at all
  times. The lid of a Styrofoam cooler should not
  be taped in place. Tape the outer cardboard box. 
  Even when transporting dry ice by ground, basic
  safety precautions should be followed. Allow
  ventilation of the cooler and the vehicle. CO2
  can build up in a car with the windows rolled up.

47
Shipping With Dry Ice

• Identification
• Several of these entries for dry ice look alike.
  The one you want is UN 1845, Class 9. The Packing
  Instruction when filling out the Dangerous Goods
  Declaration is 954.
• 2011 Update Dry Ice is packed according to
  Packing Instruction 954

UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Passenger and Cargo Aircraft Cargo Aircraft Only Cargo Aircraft Only S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Ltd Qty Ltd Qty Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
UN/ ID no. A Proper shipping Name/Description B Class or Div. (Sub Risk) C Hazard Label(s) D PG E EQ F Pkg Inst G Max Net Qty/Pkg H Pkg Inst I Max Net Qty/Pkg J Pkg Inst K Max Net Qty/Pkg L S.P. See 4.4 M ERG Code N
1845 Carbon dioxide, solid 9 Miscellaneous E0 -- -- 954 200 kg 954 200 kg A48 A151 9L
48
Shipping With Dry Ice

• Here is an example of the "Special Handling" box
  of the Air Waybill (FedEx)
• The proper Shipping Name box should be checked
• The Class Number 9 (misc) is printed on the
  form-fill in the amount of dry ice
• The UN Number UN1845 should be on the form
• One of the following boxes must be checked
• Does this shipment contain dangerous goods?
• Wet ice or blue ice packs are not considered
  dangerous goods. Pack both so the package does
  not leak.
• If you are shipping Biological Substances
  Category B with wet ice, blue ice, dry ice, or at
  ambient temperatures you need to check the box.
  "Yes" (Shippers declaration not required). If you
  are shipping Infectious Substance Category A on
  dry ice you will check 'yes' (as per attached
  shipper's Declaration).

49
Shipping With Overpacks

• Overpacks are large packages capable of
  containing one or more smaller packages. Many
  people use the MediPak diagnostic shipper with an
  inner UN 6.2 infectious shipper box.
• Dangerous goods packages within the overpack must
  be correctly packed, marked, labeled and in
  proper condition.

50
Shipping With Overpacks

• The overpack must have on the outside of the box
  
• All necessary marks and labels.
• If the UN package specification marks are not
• visible, a statement that says "Overpack" must
• appear on the outside package.
• UN Package Specification MarksRequired on inner
  package of overpack containing infectious
  substances.

51
Shipping With Overpacks

• Labeling the Overpacks for Infectious Substances
• The overpack must be labeled in the following
  way
• A Division 6.2 Infectious Substance Hazard Label
  next to the proper shipping name and UN number
  (UN 2814)
• Net quantity of infectious substance adjacent to
  proper shipping name
• Package Orientation labels (up arrows) on
  opposite sides of the overpack if not pre-printed
  on the box.
• A Class 9 label (if Dry Ice is used).
• Other dangerous goods must not be packed in the
  same package as infectious substances unless they
  are needed for maintaining viability, stabilizing
  or preventing degradation or neutralizing the
  hazards of infectious substances. A quantity of
  30 mL or less of dangerous goods included in
  classes 3 (ethanol), 8 (formaldehyde), 9
  (formalin) may be packed in each primary
  receptacle containing infectious substances NO
  excepted quantity label is needed.
• An overpack does not need to be a UN certified
  package. It can be a strong, recycled box.
• An example of a much used overpack is the UN
  Certified smaller box inside the outer Medifreeze
  box.

52
Infectious Substances Packaging

• Packing Specifications Infectious Substances
  (Category A)
• With proper packaging you ensure the safety of
  those who may handle or unpack the contents of
  the package. Proper packaging ensures that the
  material is not released during transportation.
• Here are the most important requirements for
  Packing Instruction 620
• watertight primary receptacle
• watertight secondary packaging
• absorbent material, if liquid
• itemized list of contents between the secondary
  and outer container
• UN certified outer packaging
• at least 100mm x 100 mm (4 in x 4 in.)
• Either the primary or secondary container must be
  capable of withstanding without leakage an
  internal pressure producing a pressure
  differential of not less than 95 kPa and
  temperatures in the range of -40 C to 55 C.

53
Infectious Substances Packaging

• UN Certified Packaging
• There are several requirements for certified
  packaging. One requirement for certified
  packaging is a drop test.
• A prototype of the package, properly packed with
  its filled primary and secondary containers, is
  dropped from a height of 30 feet on all sides and
  a corner. It is then subjected to an hour of
  rainfall and dropped on all sides again.
  Following the drop test there must be no leakage
  from the primary receptacles which must remain
  protected by absorbent in the secondary
  packaging.  Another test to meet UN certified
  packaging is the puncture test.
• The UN certification stamp on the box certifies
  that the package has been subjected to and passed
  all required tests. The UN certification stamp
  looks like this

U 4G/CLASS 6.2/07 DK/ N SP-9989-ERIKSSON
54
Infectious Substances Packaging

• UN Certified Packaging
• Here is an example of an infectious substance
  shipper. The UN Certification Symbol is
  pre-printed on the tested boxes. Under no
  circumstances must you write the UN certification
  mark on the box.
• Packages are expensive but reusable. When
  shipping a box back to a collaborator, deface
  labels (do not tear them off) and mark it as
  empty.In order to reuse an infectious shipper
  cut the tape to open - do not tear the tape off
  the box.

55
Infectious Substances Packaging

• Packing Instruction 620 for Class 6.2
• An overview for the Packing and Labeling of
  Infectious Substances.Note the UN Specification
  marks on the box A UN Certified box is tested
  with a primary and secondary container. You do
  not want to change out the components of the box.
  Ship the box the way it was originally tested to
  ensure its integrity.

56
Infectious Substances Packaging

• Fisherbrand Biohazard Mailers
• Take care when selecting your packaging. You
  cannot ship infectious material from Category A
  in these cardboard tubes. You will notice there
  are no UN markings. These should only be used
  when shipping exempt specimens or Category B
  materials. When shipping Category B materials
  make sure the mailer you buy meets the 95kPa
  pressure test.

57
Infectious Substance Packaging (Category A)

• Requirements
• Primary containers must be glass, metal or
  plastic (leave room for expansion)
• Primary container wrapped in absorbent
• Positive means of ensuring a leak-proof seal must
  be provided such as heat seal, skirted stopper or
  metal crimp seal - if screw caps are used they
  must be secured with tape or parafilm. Make sure
  you have enough absorbent for all liquids. If
  multiple fragile primary receptacles are placed
  in a single secondary packaging they should be
  individually wrapped or separated to prevent
  contact between them. Plastic Primary receptacles
  capable of withstanding very low temperatures
  should be used when shipping with liquid
  nitrogen.

58
Infectious Substance Packaging (Category A)

• Requirements
• Place Primary Packaging in Secondary Packaging
• Water tight packaging (above in photo)
• secondary packaging (below in photo)
• Primary or secondary packaging has to meet the
  95kPa pressure test. The White Tyvek bag pictured
  meets these requirements

59
Infectious Substance Packaging (Category A)

• Requirements
• Put the secondary packaging along with the
  itemized list of contents in the support package.
  It supports the contents as the dry ice
  dissipates. All goes into a UN Certified outer
  package. You MUST use a Class 6.2 infectious
  Shipper to ship infectious substances
  (UN2814/UN2900).
• Click here to see an example of the UN Package
  Specification Mark http//ehs.unc.edu/training/se
  lf_study/shipping/images/unspecification.jpg

60
Infectious Substance Packaging (Category A)

• Requirements
• The interior support packaging secures the
  secondary package as the dry ice dissipates.   
• You do not want the contents of your package
  moving around inside the package unsecured.

61
Infectious Substance Packaging (Category A)

• Requirements
• Place insulated container inside certified outer
  packaging with UN Specification marks.
• Remember do not tape the lid of the insulated
  cooler. Tape the outer box.

62
Infectious Substance Packaging (Category A)

• Requirements
• Marking and Labeling of Outer Packaging for
  Infectious Substances Shipped with Dry Ice
• Class 6.2, infectious label
• Dry Ice name and quantity label
• Class 9, dry ice label
• UN packaging certification
• Orientation marks, 2 sides
• Consignee address and phone number
• Shipper with phone of person responsible
• Proper shipping name, technical name, UN
• number and net quantity of infectious substance

63
Infectious Substance Documentation

• Shipping Documentation
• Includes the following...
• Preparing the Shippers Declaration, Airway Bill,
  Shipping Document.
• Reviewing the Dangerous Goods Table in the
  appropriate regulations.
• Listing all classes of Dangerous Goods, remember
  that dry ice is a Class 9 Dangerous Good
• Include emergency response information.
• - When shipping out of the U.S. a commercial
  invoice is also required for customs.
• - An import permit from the country you are
  shipping to may also be needed when shipping.
• - A letter on UNC letterhead will aid your
  shipment through customs.

64
Infectious Substance Documentation

• Shipping Documentation
• The Shippers Declaration needs to be kept for 2
  years (domestic) / 5 years (international).
• All Shippers Declarations must be typed.
• A typed signature is unacceptable
• A signature can be handwritten, stamped or a
  facsimile
• A physical address is needed on the paperwork and
  box - no P.O. Boxes

65
Infectious Substance Documentation

• Shipper's Responsibilities
• Only the shipper is authorized to complete and
  sign the Shippers Declaration for Dangerous
  Goods
• Once signed, the document is a sworn statement to
  the carrier that the shipment has been prepared
  in accordance with the regulations
• As a legal document, the Declaration binds the
  shipper to its terms and conditions.
• The person who signs the DG Declaration should be
  trained and certified.
• If you are inexperienced at filling out these
  forms have someone review it and check for
  errors.
• You can call EHS at 962-5507 for assistance.

66
Infectious Substance Documentation

• Dangerous Goods Declaration

67
Infectious Substance Documentation

• Dangerous Goods Declaration
• A fillable template with instructions for
  completing it can be found here
  http//ehs.unc.edu/ih/lab/generic.shtml
•  
• As of January 10, 2011 FedEx will not accept a
  Dangerous Goods Declaration created using this
  template (all other carriers will). You must use
  a Dangerous Goods Declaration created using
  specific FedEx software. Contact EHS for more
  information on completing Dangerous Goods
  Declarations for FedEx shipments.

68
Infectious Substance Documentation

• 24-Hour Emergency Number
• Chemtrec is UNC-CHs 24 hour contact number in
  the event of an emergency
• 1-800-424-9300 within the U.S. when out of the
  country (703-527-3887)
• You must also put your non-emergency number on
  the shipping papers (in the to/from section).
• Not acceptable on shipping papers
• Pager number
• CDC reporting number
• Before shipping you must fax Chemtrec a Material
  Safety Data Sheet on your material (Fax number
  1-703-741-6037). You only fax it once. It is put
  into their database. Make sure you write
  UNC-Chapel Hill on the cover page of your fax. If
  you ship hazardous materials and you do not have
  an emergency number listed on the paperwork you
  can be subject to significant fines.

69
Infectious Substance Documentation

• MSDS for Emergency Response     
• Health Canada has a web site that provides
  material safety data sheets on infectious agents.
  You can find them at the following web site
  http//www.phac-aspc.gc.ca/msds-ftss/p
• If you cannot find what you need you can write
  your own.

70
Emergency Response

• Damaged Shipment
• How do you know that a package contains dangerous
  goods? Look for the red hatch marks on paperwork,
  UN and diamond shaped labels on box.
• A damaged package may be crushed or leaking.
• Do not sign for packages without seeing them
• Inspect package before signing
• Do not accept a package that is damaged
• Packages are the responsibility of the Shipper
  until accepted by recipient
• If the package is damaged or leaking offer
  assistance in cleaning up the spill (call EHS).
  The carrier should be prepared to deal with the
  spill.

71
Emergency Response

• Emergency Response for Damaged Package or Spill
  on Campus
• In a laboratory setting it is expected that staff
  are prepared to cope with a spill.
• All labs should have an emergency spill kit on
  hand and train all personnel in appropriate
  emergency response.
• Isolate spill or leak area immediately in all
  directions.
• Keep unauthorized personnel away.
• Obtain identity of substance involved if possible
  and report spill to appropriate authorities.
• Do not touch or walk through spilled material.
• Do not touch damaged containers or spilled
  material unless wearing appropriate protective
  clothing.
• If you need to, call EHS (962 - 5507) to help
  with spill clean up.

72
Emergency Response

• Emergency Response for Damaged Package or Spill
  on Campus     
• Be very careful to avoid contact with broken
  glass or sharp objects that may cause cuts or
  abrasions that could significantly increase the
  risk of exposure.
• Damaged packages containing solid CO2 as a
  refrigerant may produce water or frost from
  condensation of air. Do not touch this liquid as
  it could be contaminated by the contents of the
  package.

73
Emergency Response

• Emergency Response for Damaged Package or Spill
  on Campus
• Liquid nitrogen may be present and can cause
  severe burns.
• Absorb spilled materials with earth, sand or
  other non-combustible material while avoiding
  direct contact.
• Cover damaged package or spilled material with
  damp towel and keep wet with liquid bleach of
  other disinfectant
• Evaluate potential personal exposure
• Contact UNC Employee Occupational Health Clinic
  (966-9119) for post exposure follow-up

74
Security Plan

• If you ship High Consequence dangerous goods you
  should adopt, implement and comply with a
  security plan that addresses the elements
  specified in section 1.6.3.2 of the IATA
  Dangerous Goods Regulations
• High consequence Dangerous Goods are those that
  have the potential for misuse in a terrorist
  incident and which may as a result produce
  serious consequences. They include 1.1, 1.2, 1.3
  explosives 2.3, toxic gases 6.1 toxins 6.2
  infectious substances 7 radioactive materials.

75
Security Plan

• Labs need to take specific action in order to
  provide security against theft of highly
  hazardous materials, and to ensure compliance
  with new regulations.
• EHS urges each lab/clinic to review and develop
  procedures to ensure the security of hazardous
  materials in your area.

76
Security Plan

• Many of you already implement security measures
• Locking up controlled substances, syringes, and
  needles
• Securing radioactive material
• An easy way to increase laboratory security is to
  lock the lab whenever it is left unattended
• Keep records of dangerous good or types of
  dangerous goods transported
• Review how you store your dangerous goods
• Put in place procedures for reporting and dealing
  with security threats, breaches of security, or
  security incidents

77
Security Plan

• You should control access to areas where
  hazardous chemicals are used and stored
• Lock freezers, refrigerators where biological
  agents, hazardous chemicals or radioactive
  materials are stored
• Approach anyone you don't recognize who appear to
  be wandering in lab areas
• Assign security responsibility to one employee in
  your lab. Give them appropriate authority to
  carry out their responsibilities.

78
Security Plan

• Use a log book to sign highly hazardous materials
  in and out of secure storage
• Take a periodic inventory of highly hazardous
  chemicals, biological agents/toxins, radioactive
  material and controlled substances
• This could be as simple as frequently looking at
  your chemical containers to make sure none are
  missing
• Track the use and disposal of hazardous
  materials. Report any missing inventory to Public
  Safety or EHS.
• Know what materials are being ordered and being
  brought into the laboratory
• Consider having all lab staff wear identification
  badges

79
Contact for Packaging Materials

• inmark, inc.Atlanta, GA800-646-6275www.inmarkin
  c.com
• SAF-T-PAKEdmonton, Alberto, Canada800-814-7480w
  ww.saftpak.com
• CARGOpak, Corp.Raleigh, NC800-266-0652www.cargo
  pak.com
• Fisher Scientific800-766-7000www.fishersci.com
• Contact your carrier for specific information
  regarding the shipment of Category B and Category
  A infectious substances.
• Your carrier can have more stringent requirements
  than IATA i.e. FedEx requires you to create the
  Dangerous Goods Declaration using their specific
  software.

80
Other Regulatory Requirements

• When importing pathogens that affect poultry or
  livestock a USDA permit is needed from the Animal
  and Plant Health Inspection Service (APHIS)
• When importing plants, animals, insects,
  earthworms, soil, etc., you also need an import
  permit.
• For items not needing an APHIS import permit
  (human cell, culture, serum, blood) a guideline
  letter is required
• The letter will aid your shipment through
  customs.
• Centers for Disease Control Prevention
• A permit is required for the importation of
  certain etiological agentsSelect agent transfers
  require a Form 2 permit.
• Facilities transferring or receiving select
  agents must be registered with CDC
• Each transfer of a select agent must be
  documented
• Contact EHS for more information
• Department of Commerce licenses are required when
  exporting specific biological agents, genetic
  elements of these agents, toxins, certain
  chemicals and equipment. Contact EHS prior to
  exporting materials from your lab for an Export
  Control evaluation.
• OSHA Blood Bloodborne pathogens training is
  required if you work with blood, other
  potentially infectious substances, or human cell
  culture. (if you have complied with OSHA's BBP
  you have not complied with shipping regulations)
• Shipping overseas can be quite complicated
  because you need to consider the requirements of
  the receiving country.
• These additional requirements can take up to a
  month to accomplish - plan your shipment!    
• Call the EHS Shipping Specialist for help.

81
Vapor Shipper

• Liquid Nitrogen
• Liquid Nitrogen is a dangerous good that has
  specific package requirements
• It is a class 2.2 Non-flammable, non-toxic gas
  assigned to UN 1977 Nitrogen, refrigerated liquid
  (If packaged with the vapor shipper it is exempt.
  You do not need a non flammable 2.2 label. Nor do
  you declare the liquid nitrogen on the shipping
  papers)
• Insulated packagings (vapor shipper) containing
  refrigerated liquid nitrogen fully absorbed in a
  porous material and intended for transport, at
  low temperature are not regulated.
• When using a vapor shipper the words "Not
  Restricted" and the special provision number
  "A152" must be included in the description of the
  substance on the airway bill.
• A152 must also be typed in the "authorization"
  column of the Dangerous Goods Declaration.

82
Vapor Shipper

• Follow manufacturers directions to properly
  prepare vapor shipper. The blue layer is porous.
  After charging the shipper, pour off the excess
  liquid nitrogen. They cost from 600 - 5000.
  Vapor shippers can maintain freezing temperatures
  for up to three weeks.
• If you are shipping infectious substances in a
  vapor shipper make sure the shipper is IATA/ICAO
  certified to ship infectious substances.
• The 6.2 label and proper shipping name are
  required on the outside of the shipper when
  transporting infectious substance.

83
Examples

• Decide whether sample should be shipped as
  infectious substance or exempt specimen.

84
Examples

• Example 1
• A patient (from South Africa) is ill with
  symptoms of hemorrhagic fever. You are given the
  task of sending blood samples for confirmation of
  Ebola to the Centers for Disease Control and
  Prevention in Atlanta, GA.
• Category A Infectious Substance
• Category B Biological Substance
• Exempt Human Specimen

85
Examples

• Example 2
• In a clinical lab you are given a pleural sample
  to be tested for M. tuberculosis. You culture it
  then send it off for confirmation. When sending
  it off are you going to classify as infectious or
  diagnostic?
• Category A Infectious Substance
• Category B Biological Substance
• Exempt Human Specimen

86
Examples

• Example 3
• Your collaborator sent you the laboratory strain
  of Francisella tularensis you wanted the live
  vaccine strain you need to send it back to them.
• Category A Infectious Substance
• Category B Biological Substance
• Exempt Human Specimen

87
Examples

• Example 4
• Your lab has been told to send off for
  investigational purposes spinal fluid taken from
  a hospital patient. You are asked to send it off
  to test for several diseases including
  meningitis.
• Category A Infectious Substance
• Category B Biological Substance
• Exempt Human Specimen

88
Examples

• Example 5
• Your lab is conducting a study on the effect of
  folic acid and early pregnancy in 120 healthy
  women. You are required to send off blood,
  saliva, and fecal materi