For information about mailing Newborn Screening samples only, see the Newborn Screening Practitioner's Manual.
The OSPHL Courier Guidebook contains packaging instructions for specimens picked up by OSPHL couriers.
Specimens transported by ground, air, rail and water transportation are subject to the regulations of the Department of Transportation (DOT).
1. Specimens transported by air are also subject to the regulations of the International Air Transport Association (IATA).
2. The shipper is responsible for the proper packaging and shipping of all specimens. Shippers must be trained and certified by their employer to be able to prepare and ship packages containing Category A and B infectious substances.
3. The following information is given only as a guideline and is in compliance with regulations as of December 2006.
4. Regulations change frequently. All shippers are responsible for knowing and complying with current regulations that must be followed. Training for the following must be documented for any person packaging and shipping infectious substances:
a. U.S. Department of Transportation: 49 CFR Parts 171 through 179
b. U.S. Postal Service: 39 CFR Part 111 and Domestic Mail Manual (DMM) CO23 Hazardous Materials
c. CDC: 42 CFR Parts 72 and 73.
The information on the following pages will help you determine how to properly pack and ship specimens. For questions and further assistance contact the OSPHL at 503-693-4130.
Preparing, Packaging and Shipping Specimens to the OSPHL
1. Determine if the specimens are non-infectious or unregulated or Category B, or Category A infectious substances.
a. According to DOT 49 CFR updated in June 2006, infectious substances are identified as Category A and Category B (proper shipping name - Biological substance, Category B) substances: see page 12-19 of DOT Trasnport of Infectious Sustances Safely document.
b. If specimens do not fall into Category A or B, IATA requires 'Exempt Human Specimen" be marked on the packaging.
Packaging and Shipping Room Temperature Category B infectious substances
NOTE: Category A infectious substances are not acceptd by the USPS as of November 2006.
Directions for shipping by United States Postal Services (USPS) using packaging material provided by OSPHL:
1. All Category B infectious substances must be triple packaged.
2. Primary specimen receptacles containing liquids must be leakproof and should be sealed shut with adhesive tape.
3. Place the primary specimen receptacle, with an appropriate amount of absorbent, in a biohazard-labeled specimen bag. NOTE: When more than one primary specimen container is to be sent in the same secondary container, sufficient absorbent material to absorb the entire contents of the liquid and cushioning to prevent breakage of the individual samples should be placed in the biohazard-labeled specimen bag. NOTE: Total volume must not exceed 1 liter for liquid Category B specimens and 4 kg for solid Category B specimens.
4. Place the biohazard-labeled specimen bag, which contains the primary specimen receptacle(s) and absorbent/cushioning, in the metal tube (secondary packaging container) with the rubber gasket in the cap. This container must have a biohazard label on it.
5. When sending specimens to the OSPHL using OSPHL packaging material, place the metal tube (secondary container) and the paperwork in the cardboard mailing tube (outer packaging).
6. Place the cardboard mailing tube(s) (outer packaging) in the labpack bag (colored mailer) with the OSPHL address on it. This bag has the label "Biological substances, Category B" on it. Seal the bag appropriately by using the adhesive closure mechanism contained on one edge of the bag. This bag may only be sent using the USPS.
7. Label the colored mailer with your return address.
8. Apply first class postage and mail. NOTE: When sending Category B infectious substances to OSPHL by routes other than USPS, use triple packaging. By air, either the primary receptacles or secondary container must be certified to withstand an internal pressure of 95 kPa without leaking and a temperature range of -40º F to 131º F. Outer shipping containers must pass drop test requirements. Wet ice or dry ice must always be placed in a cooler such as Styrofoam, then in an outer shipping container.
NOTE: Styrofoam is not an acceptable outer shipping container.
NOTE: As of January 2005, a 2 inch diagonal symbol containing "UN 3373" is required.
Packaging and Shipping Category A Infectious Substances (Room Temperature Only)
1. Do not send culture plates. Subculture to a slant or broth.
2. Category A infectious substances can not be sent via the US Postal Service.
3. United Parecel Service does not accept packages containing Category A infectious substances.
4. Do not "mix and match" products. For example, do not use the OSPHL double can system manufactured by Med-Pak, with a Saf-T-Pak outer box. The regulations require that products must "match" for the package to qualify as certified packaging.
5. When shipping Category A infectious substances via shipping companies, follow these directions for using certified infectious packing materials such as the Saf-TPak STP-130, but use their required shipping documents.
6. All specimens must be triple packaged. The following instructions are given as an example using Saf-T-Pak STP-130:
a. Secure the top of a screwtop primary receptacle with adhesive tape.
b. Wrap the primary receptacle in bubble wrap.
c. Place the wrapped primary receptacle into the leakproof, biohazard labeled poly bag along with enough absorbent material.
d. Place the appropriate completed OSPHL forms (see Request Forms) in the pouch of the biohazard-labeled poly bag.
e. Place the poly bag and paperwork in the Tyvek envelope and seal the envelope.
7. Following the directions that come with the STP-130, and place the sealed Tyvek envelope along with cushioning material adequate to fill up the space and prevent breakage in the inner box.
8. Place the inner (brown cardboard) box into the outer box.
9. Label the outer box with the follow- ing information:
a. Name, address and phone number of the sender. This must include the specific name of a responsible person who has knowledge of the shipment, not just the name of the facility sending the shipment.
b. Name, address and phone number of the receiver (consignee).
c. Infectious substances, affecting humans.
d. UN2814 label.
e. Orientation labels and the "Infectious Biohazard Label" with CDC contact information on the STP- 130.
f. Marking of the net or gross quantity.
g. If > 50 ml, Cargo Only label.
11. Fill out the Shippers Declaration. Note: the Emergency Contact number placed on this declaration must be the phone number of a person who is either knowledgeable of the hazardous material being shipped, and has comprehensive emergency response knowledge or a person who has immediate access to a person who possesses such knowledge and information. This phone number must be answered 24/7 by a live person. Paging numbers and answering service numbers are not acceptable. DOT inspectors do randomly call the numbers on these forms. There are companies who provide this service either as a one time service or on an annual contract basis. One of these companies is ChemTrek. They may be reached at 1-800-262-8200 or http://www.chemtrec.com.
The OSPHL does not endorse any product or business service referenced in this manual.
Useful Internet Addresses
Centers for Disease Control (CDC) Emergency Preparedness and Response http://www.bt.cdc.gov/
Oregon State Public Health Laboratory (OSPHL)https://public.health.oregon.gov/LaboratoryServices/CommunicableDiseaseTesting
OSPHL-Laboratory Response Network https://public.health.oregon.gov/LaboratoryServices/LaboratoryResponseNetwork
Packaging and Shipping Updates https://lrn.hr.state.or.us/login/login.cfm
4User name: dhs Password: ps
Transporting Infectious Substances Safely: DOT Brochure October 2006 http://hazmat.dot.gov/training/Transporting_Infectious_Substances_Safely.pdf
Department of Transportation (DOT) Hazardous Materials Regulations (49 CFR 171-179)http://hazmat.dot.gov/regs/rules.htm
Select agent regulation 42 CFR 73 l http://www.cdc.gov/od/sap/faq.htm
For Security Awareness Training required for all labs that package and ship class 6.2 infectious substances. Click on security Awareness Training Module: http://phmsa.dot.gov/staticfiles/PHMSA/Hazmat/digipak/menu.html
United State Postal Service (USPS) (Instructions for mailing Infectious substances 10.17; Instructions for Packaging Diagnostic specimens 10.17.6) http://pe.usps.gov/text/dmm300/601.htm#wp1065087
International Civil Aviation Organization 2005-2006 Technical Instructions Addendum Document http://www.icao.int/icaonet/dcs/9284/guidance_doc_infectious_substances.pdf
International Air Transport Association (IATA) Dangerous Goods Information iata.org/ps/publications/dgr/Pages/index.aspx
World Health Organization (WHO) Guidance on Regulations for the Transport of Infectious Substances-2009-2010 who.int/csr/resources/publications/biosafety/WHO_HSE_EPR_2008_10/en/
Canada Public Health Infectious Substances Material Safety Data Sheets (MSDS) http://www.phac-aspc.gc.ca/msds-ftss/index.html
Oregon DOT-Haz Mat Assistance: Federal DOT transportation regulations are interpreted and enforced by Oregon DOT Haz Mat specialists at 503-258-6995. Commercial Information:
Saf-T-Pak Packaging Materials http://www.saftpak.com
FedEx Dangerous Goods Job Aid & Packaging and Shipping of Dangerous Goods http://images.fedex.com/us/services/pdf/DG_Job_Aid_2011.pdf