HAZARDOUS MATERIALS
SHIPPING OVERVIEW
Life Sciences Compliance Curriculum
July 26, 2012
OVERVIEW
The Department of Transportation (DOT) requires that
hazardous materials be prepared for transportation and
transported in such a way that minimizes the possibility of an
accident or incident that could threaten human health,
property or the environment
A material meeting the definition of a
infectious substance is regulated as a
hazardous material.
OVERVIEW
Other common DOT-regulated hazardous materials
shipped from Life Sciences facilities:
Dry Ice
Infectious Materials (containing or reasonably expected to be
containing pathogens)
Drugs and medicines
Biological Samples in alcohol or formaldehyde
Hazardous waste
Biological (“red bag”) waste
Lithium and Lead-Acid Batteries
Applicable to:
SHIPPERS- those who prepare the material for
shipment and offer it to a transporter (this includes
hazardous waste generators)
CARRIERS- those who transport the hazardous
material by highway, rail, air or water (Referred to as
“Operators” in the IATA air regulations)
Regulatory Perspective
“Dangerous Goods” is an international term for,
and synonymous with, “Hazardous Materials.”
They are materials which when offered for transport,
have properties that pose a risk to safety, property,
or the environment.
In the U.S., all shipments of hazardous materials
transported by highway, air, water, or rail are
regulated by the Department of Transportation
(DOT) under 49 CFR, Parts 100-185.
Regulatory Perspective
49 CFR HMR
ICAO Tech. Instr.
In the 49 CFR hazardous materials regulations
(HMR), DOT allows the use of the International Civil
Aviation Organization (ICAO) technical instructions to
be followed for international air shipments.
Regulatory Perspective
49 CFR HMR
ICAO Tech. Instr.
IATA DGR
The majority of the commercial air carriers (e.g., FedEx, US Air) follow
the International Air Transport Association (IATA) Dangerous Goods
Regulations by policy for both domestic and international. IATA
complies with all of the provisions of ICAO, and then some.
Regulatory Perspective
UPS Ground (IF UNDER CONTRACT)
49 CFR + UPS HAZMAT SHIPPING
GUIDELINES
FEDEX GROUND and Other
HIGHWAY CARRIERS
49 CFR
Regulatory Perspective
UPS DOMESTIC
AIR (IF UNDER CONTRACT)
UPS INTERNATIONAL
AIR (UPON SPECIAL REQUEST)
49 CFR + UPS HAZMAT SHIPPING
GUIDELINES
IATA DGR
Regulatory Perspective
INTERNATIONAL
AND
DOMESTIC AIR
IATA DGR
Enforcement- Penalties
Violators of the hazardous-materials regulations can be
fined up to $55,000 per civil violation ($110,000 if an
injury results), and there are usually multiple violations
in any one case.
Enforcement Trends
Most Common DOT Inspections at Shipper’s Facilities
Random & Unannounced FAA Visits
• Selecting Declarations at Operator (e.g., FedEx) Offices
• Discovery of Highly Hazardous Materials En-Route
Incident- Driven FAA Visits
• Discovery of Non-Compliant Shipments En-Route
• Discovery of Damaged or Leaking Packages En-Route
Most Common Material Resulting in Violations
• Lithium Batteries
Enforcement
DOT/IATA CLASSIFICATION
1
2
Explosives
Gases
1.1
Explosives with a mass explosion hazard
1.2
Explosives with a projection hazard
1.3
Explosives with a predominantly fire hazard
1.4
Explosives with no significant blast hazard
1.5
Very Insensitive Explosives; Blasting Agents
1.6
Extremely Insensitive Detonating Substances
2.1
Flammable Gas
2.2
Non-Flammable Compressed Gas
2.3
Poisonous Gas
4.1
Flammable Solid
4.2
Spontaneously Combustible Material
4.3
Dangerous When Wet Material
5.1
Oxidizers
5.2
Organic Peroxide
6.1
Poisonous Materials
6.2
Infectious Substances
3 Flammable Liquids
4 Flammable Solids
5
6
Oxidizers
Poisons
7
Radioactives
_
8
Corrosives
_
9
Miscellaneous
_
Infectious Substances
Classification & Definitions
Infectious substance means a material known or
reasonably expected to contain a pathogen.
Pathogen being defined as a micro-organism or other
agent, such as a prion, that can cause disease in
humans or animals
Infectious Substances
Classification & Definitions
CATEGORY A• Infectious Substances, Affecting Humans
• Infectious Substances, Affecting Animals (only)
CATEGORY B
• Biological Substances, Category B
WASTE (must not include Category A waste)
• Regulated Medical/Clinical/Biological Waste
UN2814
UN2900
UN3373
UN3291
PACKING (PACKAGING)
Shipper's General
Packaging Responsibilities
(49 CFR 173.24a/DGR Sec. 5.1-5.4 )
Shippers must ensure that the hazardous material packaging is
prepared in such a way that there is no breakage, leakage or other
failure of the packaging during normally anticipated conditions of
transport.
Issues such as survivability, protection of inner containers,
prevention of leakage from damaged containers, compatibility,
temperature and pressure ranges, change of state, vibration, and
loading practices, all must be considered.
DOT and IATA Specific
Packaging Responsibilities
(DOT Packaging Authorizations/ DGR Packing Instructions)
Specifically- authorized container types, and in some
cases, component specifications and assembly
instructions. Containers may also have components and
instructions required by the manufacturer.
UN-Specification Package
Testing
UN Test Marking Example:
Non-Bulk for solids or inner pkgs.
u
n
4G
X
22
S
11
USA
+AC9877
4G/X22/S/11/USA/+AC9877
Fibreboard box
For Packing Groups I, II and III
Maximum gross mass of 22 kg.
For solids and inner packagings only
Manufactured in 2011
Manufactured and marked in the U.S.
Symbol of manufacturer/tester
Hazard Labeling
Labels (Hazard Labels)
Square-on-point 4 inch decals
which communicate the hazard of
a material from a distance using
standardized colors, patterns, and
symbols.
Designed for easy identification of
hazards by emergency responders
from a distance
Markings and Handling
Labels
Text and graphics that communicate specific
hazard information on the exterior of the
packaging.
Example
Shipping Papers
Shipping Paper Basics
Properly formatted shipping
description: for example,
UN1090, Acetone, 3, II
Supplementary Emergency
Response Information and 24-Hour
Telephone Number
Signed Certification Statement
Administrative Requirements
Annual Registration- each July 1
for certain shippers
Recordkeeping- past shipping
papers and training records
Security Planning- written plan
required for certain shippers
Resources
DOT Hazmat Website: www.phmsa.dot.gov
then select the “Hazmat Safety Community” tab
IATA Website: www.iata.org
DOT Hazmat Hotline: 800-467-4922
Triumvirate Environmental
www.triumvirate.com
THANK YOU!
Doug Graham, CHMM
(800) 966-9282 office
(617) 285-1257 cell
[email protected]