Transcript Slide 1

2007 Shipping Regulation Updates
Deb Howard, CBSP
UNC Environment Health and Safety
Objectives
• DOT Final Rule Effective October 2006
• IATA Changes
– Instructor Qualifications Section 1.5.5.1
– Security Section 1.6.3
– Dangerous Goods in Airmail Section 2.4.2
– Packing PI 602
– Documentation Section 8.1.6.9.1/8.1.6.9.2
– Labeling PI 650
DOT Final Rule
Vol. 71 FR 32246, June 2, 2006, effective 10/1/2006
• Harmonizes DOT rules with UN Model
Regulations
• DOT rules for shipment of infectious substances
are more similar to IATA rules
• Classification system for Division 6.2 materials
was revised from the current four-tiered risk
group system to a two tiered system—Category A
and Category B.
• Replaces proper shipping names - Diagnostic
Specimens/Clinical Specimens with Biological
Substance, Category B
• Responsible Party telephone number identified
on paperwork or package for each shipment
DOT Final Rule
Vol. 71 FR 32243
• Materials will be classified as Infectious
substances (UN2814, UN2900), Biological
substance, Category B (UN3373)
• Requires people offering for transportation select
agents regulated under 42 CFR part 73 or 9
CFR part 121 to develop and implement a
transportation security plan
• Patient Specimens defined and given broad
exemption
• Final rule available at
– http://hazmat.dot.gov/regs/notices/rulemake.htm
Patient Sample Exemption
• “Patient specimen means human or animal
material collected directly from humans or
animals and transported for research, diagnosis,
investigational activities, or disease treatment or
prevention. Patient specimens include excreta,
secreta, blood and its components, tissue and
tissue swabs, body parts, and specimens in
transport media (e.g. transswabs, culture media,
and blood culture bottles).”
Category A Infectious Substances
• An infectious substance in a form capable
of causing permanent disability or lifethreatening or fatal disease in otherwise
healthy humans or animals when
exposure to it occurs.
Category B Infectious Substance
• An infectious substance that is not in a
form generally capable of causing
permanent disability or life-threatening or
fatal disease in otherwise healthy humans
or animals when exposed to it. This
includes substances transported for
diagnostic or investigational purposes.
DOT Courier Exemption
• There is a broad DOT exemption for researchers
shipping infectious materials using a “private, or contract
carrier used exclusively to transport these materials.”
• Until, October 2006, couriers could ship any material in
RG 2 and 3, including cultures.
• Now the only material that you can ship as “non
regulated” is patient specimens. (Does not include
Category A substances)
• You can ship Category A Substances & Category B
cultures with a courier if you package them correctly –
– However, the driver needs to be trained in the Hazardous Materials
Regulations
• see page 12 for a non-exhaustive list of Category A Substances
http://hazmat.dot.gov/training/Transporting_Infectious_Substances_
Safely.pdf.
Scenarios
• A patient has been admitted to the hospital
with signs and symptoms of having Ebola.
You are going to use a courier under
contract to transport his blood sample to
the State Lab.
• Is it regulated?
Answer
• It is regulated because it is a Category A
infectious substance. You will have to
package it correctly using a UN certified
outer box and the correct labels for the
courier to transport it.
Scenarios
• You need to ship a blood sample taken
from a patient known or suspected to have
HIV (a Category B infectious substance)
using a private courier.
• Is it subject to the regulations? Do you
need to label it and package it using the
triple packaging method?
Answer
• Because it is a patient sample (not a
culture) you are not regulated when using
a private or contract courier. No special
packaging or labeling needed.
Scenario
• The micro lab in the hospital has cultured
Staphylococcus aureus and is going to
send it to a lab in RTP for further testing
using a contract courier.
• Is it regulated?
Answer
• Yes it is. It is a culture of a Biological
Substance Category B. You will need to
triple package it and use the UN3373 label
along with the words “Biological
Substance, Category B”
Packaging Category A infectious
Substances for a Courier
• Category A
– Primary receptacle
– Secondary packaging w/ absorbent
– Primary or secondary packaging have to
maintain their integrity after being subjected to
pressure changes in an aircraft.
– UN certified outer package
– Labeling 6.2 - #9 if dry ice used
Packaging Category B Infectious
Substances Cultures for a Courier
•
•
•
•
Primary receptacle
Secondary w/ absorbent
Rigid outer package
UN3373 Biological Substances, Category B
The DOT new rules will affect…
• Those who use UPS for shipping
infectious substances
• Researchers shipping specimens in
company vehicles using the materials of
trade exception (Certain hazardous materials transported
in small quantities as part of a business are subject to less
regulation because of the limited hazard. These are known as MOT
– diagnostic specimens along with other classes of hazardous
materials fall under MOT –
http://hazmat.dot.gov/pubs/hm200/mots05.pdf
• Those using a courier service
Federal, State, Local Government
• The Hazardous Materials Regulations do
not apply to the transportation of a
hazardous material in a motor vehicle,
aircraft or vessel owned and operated by a
Federal, State of local government
employee used for noncommercial
governmental purposes, because it is
considered not in commerce. See letter of
interpretation - http://dms.dot.gov/rspa/2006-11/060225.pdf
Federal, State and Local Government
• A government employee transporting
diagnostic specimens in a personal vehicle
for government purposes is not considered
to be “in commerce”. Therefore, the
shipment is not subject to the regulations –
See letter of interpretation - http://dms.dot.gov/rspa/200507/050116.pdf
IATA Changes for 2007
Instructor Qualifications
Section 1.5.5.1
• Instructors of initial and recurrent
dangerous goods training program must
have adequate instructional skills and
have successfully completed a dangerous
goods training program in the applicable
category or category 6 of table 1.5.A prior
to delivering a training program.
Instructor Qualifications
• Instructors delivering initial and recurrent
training must at least every 24 months
deliver a course, or in the absence of this
attend recurrent training.
Security Plan
Section 1.6.3
• 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.
Elements of a Security Plan
Section 1.6.3.2
• Allocate responsibilities for security to a qualified person
who has the authority to carry out responsibilities
• Keep records of transported goods
• Review current operations – assess vulnerabilities such
as temporary transit
• Clear statement of measures to include training policies,
operation practices, equipment & resources used to
reduce security risk
• Effective and up-to-date procedures for reporting and
dealing with security threats, breaches of security or
security incidences
Elements of a Security Plan
Section 1.6.3.2
• Procedures for evaluating and testing security
plan.
• Measures to ensure the security of transport
information contained in the plan
• Measures to ensure that the security of the
distribution of transport documentation is limited
as far as possible
• You may already have some of these plans in place for certain
groups that you can adapt for other groups i. e. DOT Security Plan/
elements of Select Agent Security Plan
Air Mail
Section 2.4.2
• Patient samples can be shipped using air
mail provided that they are packaged
using the triple packaging method and
marked as “Exempt Human Specimens”.
Air Mail
• Category B infectious substances (UN3373)
along with dry ice can be shipped in air mail. You
have to package it using the packing instruction
650.
–
–
–
–
–
Primary receptacle
Secondary receptacle
Primary or secondary has to meet the 95 kPa test
Rigid outer package
All labeling for UN3373 applies
Packing - PI602
• Infectious substances (UN2814, UN2900)
can be shipped with 30 mL of
preservatives (formalin, ethanol, etc,) with
no added requirements – (no Excepted
Quantity Label), just as you can do with
Category B infectious substances under
packing instruction 650.
Physical Address Required
Phone number required for shipping infectious substances
Section 8.1.6.1.1.4
Physical Address Required
Phone number required for shipping infectious substances
Not required
Not required
Notice different
sequence – this form
required January 2007
You no
longer can
type 4G –
you need to
put
fiberboard
box
i.e 1
fiberboard
box x 30 ml
No more prior arrangements statement
Labeling PI650
• All packages containing infectious
substances Category A or Category B
must be marked durably and legibly on the
outside of the package with the name and
telephone number of a responsible
person.
Labeling
• The proper shipping name Diagnostic
Specimens and Clinical Specimens is no
longer allowed on the outside of the box
when shipping patient samples. It has
been replaced with “Biological
Substances, Category B.”
Labeling
• The UN3373
label must be
on the
outside
of the
package
when shipping
patient
samples using a
freight forwarder
(FedEx, DHL)
UN3373
Questions?
Call or email
Deb Howard
[email protected]
962-5722
Sources:
2007 IATA DGR
DOT Hazmat 71 FR 32243