© 2009 cardinal health, inc. or one of its subsidiaries. all rights reserved. pyxis® and alaris®...

© 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 MaterialsRegulatory Update

John Gramza, CHMMManager, Quality and Regulatory AffairsCardinal HealthCOCHMM Meeting

September 15, 2009

© 2009 Cardinal Health, Inc. or one of its subsidiaries. All rights reserved.

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PHMSA Rulemaking ActivitiesFinal Rules

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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

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• 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]

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• 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]

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• 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]

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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

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PHMSA Rulemaking ActivitiesProposed Rules

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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

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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

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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]

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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

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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

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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

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New Initiatives

• Combustible liquids

• Nurse tanks

• Reverse logistics

• Part 174 (Rail) review

• Part 176 (Vessel) review

• Lithium batteries (the sequel…)

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Shipments of Batteries

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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

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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]

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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

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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

Small 1.0 grams / 2.0 grams 1.5 grams / 8.0 grams

Medium 5.0 grams / 25 grams 5.0 grams / 25 grams

Large >5.0 grams / >25 grams >5.0 grams / >25 grams

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Lithium Batteries (49 CFR 172.101)

Lithium batteries, contained in equipment

9 UN3091 II 9

29, 188, 189, 190, A54, A55,

A101, A104

185 185 NoneSee

A101, A104.

35 kg A

Lithium batteries packed with equipment

9 UN3091 II 9

29, 188, 189, 190, A54, A55,

A101, A103

185 185 NoneSee

A101, A103.

35 kg gross

A

Lithium battery

9 UN3090 II 9

29, 188, 189, 190, A54, A55,

A100.

185 185 NoneSee

A10035 kg gross

A

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Primary Lithium Batteries

• 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

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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

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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

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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

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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

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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

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More Information…

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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: [email protected]

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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

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Additional Resources

• Trade Organizations– Association of Hazmat Shippers (AHS)– Dangerous Goods Advisory Council (DGAC)– Council on Safe Transportation of Hazardous Articles

(COSTHA)

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Questions

John Gramza, CHMMManager, Quality and Regulatory AffairsCardinal Health7000 Cardinal PlaceDublin, OH 43017P: (614) 553-4654F: (614) 652-8782E: [email protected]

© 2009 cardinal health, inc. or one of its subsidiaries. all rights reserved. pyxis® and alaris®...

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