1. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. Shipment of Hazardous Materials Regulatory Update John Gramza, CHMM Manager, Quality and Regulatory Affairs Cardinal Health COCHMM Meeting September 15, 2009 © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.

2. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 2 PHMSA Rulemaking Activities Final Rules

3. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 3 Battery Safety/International Harmonization Docket Numbers: [HM-215J]/[HM-224D] Final rule issued: December 30, 2008 Final rule published: January 14, 2009 Effective date: February 13, 2009 Voluntary compliance date: January 1, 2009 Mandatory compliance date: January 1, 2010 –Or as otherwise stated

4. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 4 Batteries and battery-powered devices must be prepared and packaged to prevent short circuits, unintentional activation, and damage to terminals “Non-spillable” battery definition New requirements for –“Wet” batteries –Batteries containing Sodium –Batteries containing Potassium Hydroxide –Lithium batteries –Battery powered vehicles and equipment Incidents involving shipments of batteries and battery-powered devices must be reported (DOT 5800.1) Air waybill or other documentation accompanying the shipment or marked on the package must indicate that batteries and battery- powered devices meet conditions for transport Battery Safety [HM-215J]/[HM-224D]

5. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 5 Hazardous Materials Table Updates Fuel Cells –New Proper Shipping Names and packaging requirements Adopted the UN and ICAO excepted quantity provisions for air and vessel shipments Re-draft of Small Quantity Exception [§173.4] –§173.4 Small quantities for highway and rail –§173.4a Excepted quantities –§173.4b De minimis exceptions Marine pollutants –Current list maintained as basis for regulating substances hazardous to the environment; shippers may use new IMDG criteria –New mark for marine pollutants consistent with IMDG Code International Harmonization [HM-215J]/[HM-224D]

6. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 6 Organic Peroxides table “Cargo Aircraft Only” label Additional exceptions to limited quantity exceptions for compressed gases [49 CFR 173.306(a)(5)] Shipping paper descriptions –Subsidiary hazard classes International Harmonization [HM-215J]/[HM-224D]

7. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 7 Rail Safety and Security (HM-232E and HM-246) HM-232E requires railroads to select safest, most secure routes for transportation of explosive, Radioactive, and PIH materials based on analysis of all available alternatives. –Interim Final Rule published 4/16/08; effective date 6/1/08 –Final rule published 11/26/08; effective date 12/26/08 HM-246 establishes enhanced safety measures for rail transportation of PIH materials, including interim design standards for railroad tank cars. –Final rule published 1/13/09; effective date 3/16/09

8. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 8 PHMSA Rulemaking Activities Proposed Rules

9. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 9 Air Packaging [HM-231A] Enhance safety of non-bulk packagings used in air transport –ANPRM published 7/7/2008 –NPRM planned for Summer 2009 Mandate testing of all combination packaging for liquids aboard aircraft

10. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 10 Security Plans (HM-232F) Purpose: –Propose a “risk-based” model –Modify list of materials for which security plans are required to include only those that pose a security threat in transportation NPRM published 9/9/2008. Final rule planned for Fall 2009

11. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 11 Registration Fees (HM-208G) Purpose: –Revise registration fee to enable funding of enforcement programs NPRM published 5/5/08. Proposed fee increase on large businesses from $1,000 to $2,500 NPRM withdrawn (June 22, 2009) [74 FR 29456 – NPRM]

12. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 12 Loading/Unloading (HM-247) Purpose: –Develop measures to enhance the safety of loading and unloading operations for bulk packagings Notice published 1/4/08 ANPRM/NPRM planned for Summer/Fall 2009

13. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 13 Enforcement Authority (PHM-7) Purpose: Develop procedures for implementing enhanced enforcement authority provided in 2005 hazmat reauthorization NPRM published 10/2/2008. Proposed procedures for: –Opening packages to identify undeclared or non- compliant shipments –Temporary detention and inspection of suspicious packages –Issuance of emergency orders (restrictions, prohibitions, recalls, and out-of-service orders) to address unsafe conditions or imminent hazard Final rule planned for Spring 2010

14. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 14 Additional Works in Progress  HM-218E (Cargo tank/cylinder petitions)  Final rule planned for Spring 2009  HM-206F (ER Telephone numbers)  Final rule planned for Spring 2009  HM-233A (Special Permits)  NPRM planned for Summer 2009

15. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 15 New Initiatives Combustible liquids Nurse tanks Reverse logistics Part 174 (Rail) review Part 176 (Vessel) review Lithium batteries (the sequel…)

16. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 16 Shipments of Batteries

17. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 17 What is a Battery? “Layman” terms: A device used to convert stored chemical energy into usable electrical energy Technical terms: –A “battery” is a series of connected “cells” –A cell” is the device that converts the chemical energy into electrical energy Comprised of a anode, cathode and electrolyte Hazards –All batteries can give off heat or sparks due to short circuits Lithium batteries are difficult to extinguish Corrosive batteries (lead-acid) can leak or spill

18. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 18 Where Regulated by DOT… Forbidden materials –[49 CFR 173.21(c)] –“…electrical devices which are likely to create sparks or generate a dangerous quantity of heat, unless packages in a manner which precludes such an occurrence…” Dry, sealed batteries (e.g., alkaline) –Minimal regulation (special provision 130) Wet batteries, filled with acid or alkali or “non-spillable” –Exceptions apply [49 CFR 173.159] Lithium Batteries –Highly regulated [49 CFR 173.185; S.P 29, 188, 189]

19. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 19 Shipments of Lithium Batteries Two types of Lithium batteries –Lithium metal (non-rechargeable) Known as “Primary” lithium batteries –Lithium-ion (rechargeable; although typically only when they're installed in the device they're powering, or in a special charging unit Known as “Secondary” lithium batteries

20. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 20 Lithium Batteries Sizes “Small” – Exceptions apply “Medium” – Exceptions apply (DOT only) “Large” or “normal” – fully regulated BATTERY “SIZE” Primary Cell/Battery Max. Lithium Content Secondary Cell (Lithium Ion) Equivalent Lithium Content Small1.0 grams / 2.0 grams1.5 grams / 8.0 grams Medium5.0 grams / 25 grams Large>5.0 grams / >25 grams

21. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 21 Lithium Batteries (49 CFR 172.101) Lithium batteries, contained in equipment 9UN3091II9 29, 188, 189, 190, A54, A55, A101, A104 185 None See A101, A104. 35 kgA Lithium batteries packed with equipment 9UN3091II9 29, 188, 189, 190, A54, A55, A101, A103 185 None See A101, A103. 35 kg gross A Lithium battery 9UN3090II9 29, 188, 189, 190, A54, A55, A100. 185 None See A100 35 kg gross A

22. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 22 Primary Lithium Batteries –Almost always prohibited on passenger aircraft –Non-Rechargeable –Cannot be reclassified to a “Consumer Commodity, ORM-D” –Requires marking stating “PRIMARY LITHIUM BATTERIES – FORBIDDEN FOR TRANSPORT ABOARD PASSENGER AIRCRAFT” Note type-size requirements based upon package weight

23. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 23 Primary Lithium Batteries - Exceptions Exceptions for “small” Lithium batteries [SP 188] –Must pass UN test requirements –No UN specification packaging required Separated to prevent short circuits Strong outer packaging or in equipment –No marking required for batteries in or packed with equipment and weight of batteries is <5kg –Additional requirements for packages containing >24 cells or 24 batteries Exceptions for “medium” Lithium batteries [SP 189] –Highway or rail only –Must pass UN test requirements –No UN specification packaging required Separated to prevent short circuits Strong outer packaging or in equipment –No marking required for batteries in or packed with equipment and weight of batteries is <5kg –Additional requirements for packages containing >24 cells or 24 batteries

24. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 24 Primary Lithium Batteries - Exceptions Primary Lithium batteries may not be shipped on passenger aircraft, except when the following conditions are met: –Packed “with” or “in” equipment –Each cell ≤5g Lithium –Each battery ≤25g Lithium –Net weight ≤5kg (11 lbs.) –[SP A101] –NOTE: Additional IATA requirements may apply

25. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 25 Lithium Batteries – Disposal/Recycling Lithium batteries for disposal/recycling –[49 CFR 173.185(d)] –Motor vehicle only –Excepted from UN specification packaging Packed in strong outer packaging Protected against short circuits

26. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 26 Lithium Batteries – Fully Regulated Must meet UN testing requirements Be equipped to prevent –Reverse current flow –Short circuits –Violent rupture Use a PG II combination package Pack as to prevent movement Certain discharged batteries may only be shipped for disposal

27. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 27 Future Changes in Lithium Battery Regulations Lithium-ion classification (secondary) –New UN/ID Numbers for Lithium-ion batteries and Lithium metal batteries (UN3481 vs UN3090) –New UN/ID Numbers for batteries packed or contained in equipment (UN3481 (Li-ion) and UN3091 (Li-metal) Because lithium batteries are relatively new technology, the regulations are subject to change in the future. Other batteries are being reviewed for possible new regulation. –Nickel Metal Hydride

28. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 28 More Information…

29. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 29 Hazardous Materials Information Center Operated by PHMSA (800) HMR-4922 or (202) 366-4488 Hours: 9 AM to 5 PM EST Purpose: –Obtain answers to HMR questions –Request copies of documents –Report HMR violations –Fax on demand –Training materials E-mail: infocntr@dot.gov

30. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 30 Additional Resources Websites: –Department of Transportation http://www.dot.gov/new/index.htm –Pipeline and Hazardous Materials Administration (PHMSA) http://www.phmsa.dot.gov/ –Regulations.gov http://www.regulations.gov/search/Regs/home.html#home –Transportation Security Administration (TSA) www.tsa.gov

31. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 31 Additional Resources Trade Organizations –Association of Hazmat Shippers (AHS) –Dangerous Goods Advisory Council (DGAC) –Council on Safe Transportation of Hazardous Articles (COSTHA)

32. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 32 Questions John Gramza, CHMM Manager, Quality and Regulatory Affairs Cardinal Health 7000 Cardinal Place Dublin, OH 43017 P: (614) 553-4654 F: (614) 652-8782 E: john.gramza@cardinalhealth.comjohn.gramza@cardinalhealth.com

33. © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved. Pyxis® and Alaris® are registered trademarks of Cardinal Health, Inc. or one of its subsidiaries. All other trademarks are the property of their respective owners. 33 Thank you! © 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.