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 RuleVol. 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 RuleVol. 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 life-threatening 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/2005-07/050116.pdf

IATA Changes for 2007

Instructor QualificationsSection 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 PlanSection 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 PlanSection 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 PlanSection 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 MailSection 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.

Obs

olet

e Fo

rm

Phone number required for shipping infectious substances

Section 8.1.6.1.1.4

Phone number required for shipping infectious substances

Not required

Not required

Physical Address Required

Physical Address Required

No more prior arrangements statement

You no longer can type 4G – you need to put fiberboard box

i.e 1 fiberboard box x 30 ml

Notice different sequence – this form required January 2007

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

Biolo

gical

Subst

ance

Cat

egory

B

Questions?Call or email Deb Howard

dmhoward@ehs.unc.edu962-5722

Sources:

2007 IATA DGR

DOT Hazmat 71 FR 32243