1

University of Colorado at Colorado SpringsUniversity of Colorado at Colorado Springs

Shipping Biological Shipping Biological Materials Certification CourseMaterials Certification Course

Department of Environmental Health and Safetywww.uccs.edu/~pusafety/environmental/index.shtml

2

Introduction

The purpose of this training module is to familiarize The purpose of this training module is to familiarize the Principal Investigator and lab personnel with the Principal Investigator and lab personnel with the regulations, different shipping categories; and the regulations, different shipping categories; and proper labeling and packaging of biological proper labeling and packaging of biological materials. The information in the slides will provide materials. The information in the slides will provide just an overview. The links in the slides and the just an overview. The links in the slides and the support resources and packing instructions at support resources and packing instructions at www.uccs.edu/~pusafety/environmental/index.shtwww.uccs.edu/~pusafety/environmental/index.shtmlmlwill provide the necessary shipping details.

3

IntroductionIntroductionPacking & Shipping Infectious SubstancesPacking & Shipping Infectious Substances

● Roles, Responsibilities, & RegulationsRoles, Responsibilities, & Regulations● Training RequirementsTraining Requirements● DefinitionsDefinitions● Classifications & Identification of Infectious SubstancesClassifications & Identification of Infectious Substances● Packing Instructions, Materials, & LabelsPacking Instructions, Materials, & Labels● Shipper’s Declaration for Dangerous GoodsShipper’s Declaration for Dangerous Goods

International AspectsInternational AspectsCertification QuizCertification Quiz

Outline of CourseOutline of Course

Please contact EH&S at 255-3201 if you have questions or Please contact EH&S at 255-3201 if you have questions or need assistance in completing this course.need assistance in completing this course.

4

Requirements and regulations change Requirements and regulations change frequently and are subject to interpretation.frequently and are subject to interpretation.

This training is required every two years unless This training is required every two years unless requirements or regulations significantly change requirements or regulations significantly change within this time frame.within this time frame.

EH&S will notify you when training is due. EH&S will notify you when training is due. Please make sure to keep your training records Please make sure to keep your training records available.available.

5

safety reasonssafety reasons legal reasonslegal reasons financial reasonsfinancial reasons

Authorities may examineAuthorities may examine laboratorieslaboratories documentationdocumentation normal packages normal packages all “leakers”all “leakers”

Why Should We Follow Regulations?Why Should We Follow Regulations?

6

Canada Canada TDGRTDGR

US US CCFR 49FR 49

Other Other RegsRegsCountriesCountries

Sources of RegulationsSources of Regulations

IATA IATA DGR DGR

Intl Civil Av Org (ICAO)Intl Civil Av Org (ICAO)Technical InstructionsTechnical Instructions

United Nations (UN) COETDGUnited Nations (UN) COETDG(~30 countries)(~30 countries)

Model RegulationsModel Regulations

7

The United StatesThe United States

Department of Transportation Department of Transportation - DOT - DOT writeswrites regulations. regulations.

Federal Aviation Administration Federal Aviation Administration - FAA - FAA enforcesenforces regulations. regulations.

8

DOTDOT

An infectious substance is regulated as a hazardous material under the U.S. Department of Transportation’s (DOT’s) Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). The HMR apply to any material DOT determines is capable of posing an unreasonable risk to health, safety, and property when transported in commerce. An infectious substance must conform to all applicable HMR requirements when offered for transportation or transported by air, highway, rail, or water. Regulations are now consistent with international standards - IATA, UN, WHO

9

IATA IATA DangerousDangerousGoods RegulationsGoods Regulationscurrent edition (annual)current edition (annual)

an airline trade publicationan airline trade publication developed directly from ICAO developed directly from ICAO a guide recognized by the world’s airlines a guide recognized by the world’s airlines govern shipping regulated materials by air, govern shipping regulated materials by air,

nationally and internationallynationally and internationally no legal authorityno legal authority

Sources Sources of Informationof Information

10

Guidance on Regulations for the Transport of Infectious Substances (2009-2010)

Applicable from 1 January 2009WHO/HSE/EPR/2008.10

http://whqlibdoc.who.int/hq/2008/WHO_HSE_EPR_2008.10.pdf

Sources Sources of Informationof Information

11

Federal RegisterFederal Register U.S. LawsU.S. Laws legal authoritylegal authority if in doubt, followif in doubt, follow IATAIATA

Final Rule June 2, 2006

Sources Sources of Informationof Information

12

Sentinel Laboratory Guidelines Sentinel Laboratory Guidelines for Suspected Agents of Bioterrorismfor Suspected Agents of Bioterrorism

Packing and Shipping Infectious SubstancesPacking and Shipping Infectious SubstancesRevised January 1, 2008Revised January 1, 2008

http://www.asm.org/images/pdf/PackingandShipping1-08.pdfhttp://www.asm.org/images/pdf/PackingandShipping1-08.pdf

Sources Sources of Informationof Information

13

WHO Laboratory Biosafety Manual, WHO Laboratory Biosafety Manual, 33rdrd Edition - 2004 Edition - 2004

Sources Sources of Informationof Information

http://whqlibdoc.who.int/publications/2004/9241546506.pdfhttp://whqlibdoc.who.int/publications/2004/9241546506.pdf

14

These regulations work, These regulations work, and workers are protected !and workers are protected !

WHO, 2005 In 2003, 4,920,000 packages of infect subs were shipped worldwide. Only 106 (0.002%) of the packages were reported damaged. All of the packages contained absorbent material which contained the leaking material. NONE of the secondary or outer containers was damaged WHO, 2007to date, NO reported cases of illness due to the release of infectious substance during transport

15

These regulations applyThese regulations applyto anyone who…to anyone who…

packs,packs, ships,ships, handles, orhandles, or carriescarries

dangerous goods.dangerous goods.

16

USA: Regulations DO NOT apply USA: Regulations DO NOT apply to Category B substances and patient to Category B substances and patient specimens transported by specimens transported by private or private or contract carriercontract carrier in motor vehicles used in motor vehicles used onlyonly for transporting same. for transporting same.

Transport by CourierTransport by Courier

City Lab Service

17

• OSHA regulations applyOSHA regulations apply• biohazard labelsbiohazard labels• double containersdouble containers• stabilized containersstabilized containers• no passengers no passengers • taxis OKtaxis OK

Transport by CourierTransport by Courier

18

More Stringent Regulations: Passengers and crew members are prohibited from transporting infectious

substances as or in carry-on baggage, checked baggage or on their person.

State VariationsEach country or “state” may adopt

more stringent regulationsOperator Variations

Every airline is allowed to adopt more rigid regulations in place

Transport by AirlinesTransport by Airlines

19

Who Is a Shipper?Who Is a Shipper?

A shipper can be anyone who A shipper can be anyone who offers dangerous goods for transport offers dangerous goods for transport to a commercial carrier (DHL, FedEX, to a commercial carrier (DHL, FedEX, Delta, British Air, etc.) Delta, British Air, etc.) oror signs a signs a Shipper’s Declaration Shipper’s Declaration for Dangerous Goodsfor Dangerous Goods..

could be could be youyou

could be could be couriercourier

20

Shippers of Category A infectious substances must:Shippers of Category A infectious substances must: be trainedbe trained

-- general: functions, regulationsgeneral: functions, regulations-- function-specific: packing, handlingfunction-specific: packing, handling

- - safety: hazards presented by infectious safety: hazards presented by infectious substances, safe handling, and emergency substances, safe handling, and emergency response proceduresresponse procedures - - security: if shipping Category A, or select agents, security: if shipping Category A, or select agents, or otherwise appropriateor otherwise appropriate be testedbe tested (documentation of passing)(documentation of passing) receive a certificatereceive a certificate with details of training with details of training be certifiedbe certified by the employer (EH&S)by the employer (EH&S)

Training RequirementsTraining Requirements

21

Retraining is required.Retraining is required.

IATA DOT (USA)IATA DOT (USA) every every 2* 2* years every years every 3*3* yearsyears

*Required sooner if requirements or regulations change within this time frame.

Training RequirementsTraining Requirements

22

When you pack and ship you must …When you pack and ship you must …

DECIDEDECIDE if Substance Is a DG and Subject to Regulations if Substance Is a DG and Subject to Regulations

CLASSIFYCLASSIFY the Substance the Substance

IDENTIFYIDENTIFY the Substance the Substance

SELECTSELECT Packing Instructions and Packaging Packing Instructions and Packaging

PACKPACK the Substance Correctly the Substance Correctly

MARKMARK and and LABELLABEL the Package the Package

DOCUMENTDOCUMENT the Shipment if Category A the Shipment if Category A