Packaging

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Packaging Shipping of Hazardous Materials
Dr. Bob Garrison Wisconsin State Laboratory of
Hygiene April 16, 2003
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Purpose (why are we discussing this?)

• Regulations governing the packaging and labeling
  of clinical specimens and related materials have
  changed
• These changes have not been well
• publicized !
• We want to assist you in getting up to speed on
  the changes

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Focus for today

• Changes to DOT regulations
• these address shipping specimens by commercial
  GROUND transportation (UPS, Spee Dee, Airborne
  Express Ground, FedEx Ground, Dunham, Greyhound
  bus, taxi)
• PROPOSED changes to postal regulations

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Background--alphabet soup

• ICAO Intl Civil Aviation Organization
• UN organization which develops regulations for
  safe transport of dangerous goods by air
• IATA Intl Air Transport Association
• A trade association made up up of airlines and
  air cargo carriers. Publishes IATA Dangerous
  Goods regulations, which INTERPRET and add to the
  ICAO regulations to reflect industry practices
• DOT U.S. Dept of Transportation
• Mainly regulates transport by ground
• USPS U.S. Postal Service

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Background

• In 2003, all three agencies will be implementing
  changes in their regulations
• Dates they take effect
• IATA January 1, 2003
• DOT February 14, 2003
• USPS TBD will likely be late 2003
• USPS regulations will take effect sometime after
  the date that the FINAL rule is issued

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Background

• Why the changes ?
• Attempt to standardize U.S. hazardous materials
  shipping regulations with those followed
  elsewhere
• Consequence, partly, of 9/11 and anthrax scares
  of 2001-- mystery specimens no longer tolerated

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Clarifications

• Private or contract couriers are EXEMPT from the
  DOT regulations
• Motor vehicle must be used to transport
  diagnostic specimens or biological products ONLY
  (cant haul people also)
• Medical equipment and lab products can also be
  transported if theyre protected from
  contamination

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Major changes summarized

• Diagnostic specimens now have specific packaging
  and labeling requirements
• Specimens of all types need to be assigned to a
  WHO risk group
• Misinformation about actual implementation date
  of new regulations
• CONFUSION ABOUNDS !

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THE sources of information

• Federal Register, 8/14/02, part III
• The official publication of the Final Rule on
  the revised Hazardous Materials Regulations found
  in 49 CFR Parts 171-180
• Federal Register, 12/19/02, pp. 77726-37
• The official publication of the proposed changes
  to the Domestic Mail Manual regarding mailing of
  hazardous materials
• (not for the faint of heart !)

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If you like to read.
Both documents are available electronically at
http//www.access.gpo.gov/su_docs/fedreg/frcont02.
html
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Definitions (a necessary evil)

• Diagnostic specimen
• Any animal or human material, including excreta,
  secreta, blood and its components, tissue and
  tissue fluids being transported for diagnostic or
  investigational purposes, but excluding live
  infected animals.
• Some diagnostic specimens must be identified as
  Infectious Substances for shipping purposes (very
  unusual, though)

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Examples of Diagnostic Specimens

• Urine
• Chlamydia swabs in transport medium
• Blood
• CSF
• Stool
• Sputum
• Animals (whole or heads only) submitted for
  rabies testing

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Definitions

• Cultures and stocks
• A material prepared and maintained for growth
  and storage and containing a Risk Group 2, 3 or 4
  infectious substance.

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Examples of Cultures and Stocks

• Mycobacterium spp. culture sent for
  identification, drug susceptibility testing, etc.
• Salmonella spp. isolates sent on slants for
  pulse-field gel electrophoresis
• Virus specimens grown in cell culture, sent for
  identification or subtyping

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Definitions

• Division 6.2 infectious substance
• A material known to contain or suspected to
  contain a pathogen.that has the potential to
  cause disease in humans or animals.
• A division 6.2 material must be assigned to a
  risk group

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Definitions

• Risk Group
• A ranking of a microorganisms ability to cause
  injury through disease. A risk group is defined
  by criteria developed by the World Health
  Organization (WHO) based on several factors.
• Risk Groups are 1-4, with 4 the worst

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Definitions

• MAJOR point of confusion
• WHO defines the Risk Groups, but doesnt say
  which organisms are in each group !
• The Federal Register final rule which describes
  changes in DOT regulations refers readers to the
  NIH Risk Groups--the criteria are identical, but
  NIH lists organisms !
• See the list at www4.od.nih.gov/oba/rac/guidelines
  /guidelines.html

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Confusion cleared up (I hope)

• For you, our customers who ship specimens to the
  WSLH, almost all samples can be categorized as
  either
• DIAGNOSTIC SPECIMENS
• or
• STOCKS and CULTURES
• How do you decide if they need to be shipped as
  Infectious Substances or Diagnostic Specimens?

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How do I decide ?
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Packaging liquid diag specimen (mail)

• Triple-packaged means primary, secondary and
  outer containers are required
• Primary container what has the specimen within
  it
• Must be leakproof seal lid with tape or Parafilm
• Wrap primary container with enough absorbent
  material that if contents leaked out, all would
  be absorbed
• Single specimens cant exceed 500 ml / container
• Must be packed in such a way that under normal
  conditions of transport, they cannot break, be
  punctured, or leak

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Packaging liquid diag specimen (mail)

• Secondary container
• Must be leakproof and securely sealed
• Pad with enough cushioning material that it wont
  shift in the outer container
• Must be marked with international biohazard
  symbol (black on orange)
• Primary and/or secondary containers must be
  capable of
• withstanding a pressure differential of 95 kPa
  (14 psi) without leaking

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Packaging liquid diag specimen (mail)

• Outer (shipping) container
• Total volume of liquid permitted is 4 L
• Must be strong enough for entire package to pass
  5-way drop test
• Package is dropped from 4 feet five different
  ways no leakage of liquid or cushioning
  material is permitted, and package must remain
  substantially undamaged

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Shipping liquid diag specimen (mail)

• Package must be clearly and durably marked with
  the words Diagnostic Specimen
• Must be sent as First-Class or Priority Mail

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Packaging solid diag specimen (mail)

• Triple packaging
• Primary container
• must be siftproof
• cant exceed 500 g (1.1 lbs.)
• Secondary container
• must also be siftproof to contain contents if
  primary container leaks
• marked with international biohazard symbol

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Packaging solid diag specimen (mail)

• Outer (shipping) container
• Total weight permitted is 4 kg (8.8 lbs)
• Drop test NOT required, although a good idea
  (dont send flimsy packaging)
• Package must be clearly and durably marked with
  the words Diagnostic Specimen
• Must be sent as First-Class or Priority Mail

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Packaging liquid and solid diagnostic specimens
(GROUND)

• Almost the same as postal requirements
• Triple packaging required
• Same volume / weight restrictions
• Liquid specimens pressure test NOT reqd for
  packaging
• Biohazard symbol NOT reqd on 2 container
• Drop test reqd for packaging containing either
  liquid or solid specimens

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Packaging infectious substances (mail)

• Triple packaging required
• Primary and secondary containers leakproof and
  enough absorbent material present
• Primary and secondary containers labeled with
  biohazard symbol
• Several other specific requirements must be met
  for packaging

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Packaging infectious substances (mail)

• Primary and/or secondary containers must be
  capable of
• withstanding a pressure differential of 95 kPa
  (14 psi) without leaking
• not leaking between -40 F and 131 F
• passing the puncture test and the drop test
• Volume / Weight restrictions
• For liquids, total volume of material in all
  primary containers cant exceed 50 ml
• For solids, total weight cant exceed 50 g

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Packaging infectious substances (mail)

• An itemized list of contents must be enclosed
  between the secondary and outer packaging
• The outer packaging must be no smaller than 4
  inches in its smallest dimension

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Packaging infectious substances (mail)

• Cant use the inner packaging from one kit with
  the outer packaging from another unless
  manufacturers give their OK (no mixing and
  matching allowed)
• Must use packaging according to manufacturers
  recommendations
• Disinfection of packaging no requirements

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Labeling and shipping infectious substances
(mail)

• The manufacturer must mark each outer container
  with several markings specified for infectious
  substances packaging, including
• UN symbol and UN number of the material
• the words CLASS 6.2
• orientation markings (up arrows)
• If it isnt marked with the UN markings, it isnt
  verified as 6.2 approved, and you cant use it

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Labeling and shipping infectious substances
(mail)

• Return address label
• Infectious Substance diamond label with CDC
  24-hour phone number
• Etiologic Agents/Biohazard Material label on the
  address side of the package
• Must be shipped First-Class or Priority Mail
• Must be sent as Registered Mail

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Packaging infectious substances (GROUND)

• Same triple packaging, absorbent material,
  pressure test, puncture-proof, drop test, minimum
  size of package, itemized list
• Different
• Biohazard symbol NOT reqd on primary and
  secondary containers
• NO 50 ml/50 g limitation on 1 containers
• Disinfection of packaging required if primary
  container leaks
• Ice packs must be placed outside the secondary
  packaging or in an overpack

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Labeling and shipping infectious substances
(GROUND)

• Same manufacturer markings on outer container,
  return address label, Infectious Substance
  diamond label with CDC 24-hour phone number
• Different
• Etiologic Agents/Biohazard Material label NOT
  required on outer packaging
• Dangerous Goods Form (may be required by various
  commercial carriers)

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Training

• Staff assigned to package specimens must receive
  training every 3 years for DOT purposes (every 2
  years for IATA)
• Proposed USPS regulations do not require periodic
  employee training
• Good news only if the mail is the only way you
  ship specimens
• Documentation of training should be kept on file
  for review by inspectors

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Training

• Training can be accomplished several ways,
  including home-grown
• Several commercial vendors offer training
  packages (CD-ROM based)
• The usual disclaimer--WSLH does not endorse any
  of the companies listed below
• www.exaktpak.com
• www.saftpak.com
• www.inmarkinc.com
• www.casingcorp.com

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Shippers responsibilities

• All aspects of the sample packaging
• The packages integrity until it reaches the
  final destination
• Accurately completing all necessary labeling and
  documentation
• Periodic employee training
• (borrowed from Terry Oldfield, Illinois DPH)

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What about non-compliance ?

• OUCH OUCH OUCH
• Knowingly violating hazardous material
  transportation laws can result in fines of up to
  27,500 per violation
• Seeing your labs name on the front page of the
  newspaper bad public relations

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Questions ?
Dr. Bob Garrison Communicable Disease
Division [phone] garrisrd_at_mail.slh.wisc.edu