Oncology Supply Company — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration JUN 1 7 2009 1200 New Jersey Ave, S.E. Washington, D.C. 20590 Mr. Brad King Regulatory Compliance Manager Oncology Supply Company 2801 Horace Shepard Drive Dothan, A1 36303 Ref. No.: 09-0071 Dear Mr. King: This responds to your e-mail letter regarding the requirements for training under the Hazardous Materials Regulations (HMR; 49 CFR Parts 17 1 - 180). Specifically, you ask about training requirements for employees preparing materials for transportation in accordance with a special permit. In accordance with § 172.702 of the HMR, a hazmat employer must ensure that each of its h m a t employees is trained. This training must include general awareness, function- specific, safety, and security awareness training as specified in § 172.704(a). Note that function-specific training includes training concerning the requirements of special permits that are specifically applicable to the .functions the employee performs. See 9 172.704(a)(2)(i)). Training conducted to comply with the hazard communication programs required by the Occupational Safety and Health Administration (29 CFR 19 10.120) or the Environmental Protection Agency (40 CFR 3 1 1.1) or training that complies with security training programs required by other Federal or international agencies may be used to satisfy the training requirements set forth in § 172.704 to the extent that such training addressed the training components specified in $ 172.704(a). Under the HMR, each hazmat employer must certify that each of its hazmat employees has been trained and tested, as required. A record of current training must be created and retained by each hazmat employer as specified in 4 172.704(d). I hope this satisfies your inquiry. If we can be of further assistance, please contact us. Sincerely, Charles E. Betts ce of Hazardous Materials Standards hhief, Standards Development#

Page 2Page 1 of 1 Drakeford, Carolyn cPHMSA> " *---- - . - --- -- *-m*--*- --- --- ---- -- -* --*-- - From: INFOCNTR <PHMSA> Sent: Tuesday, March 24, 2009 3:29 PlVl To: Drakeford, Carolyn <PHMSA> Subject: FW: Letter of Interpretation Please Importance: High Attachments: SP9275-2006080006.pdf Gensia-Teva.pdf From: King, Brad [mailto:brad.king@oncologysupply.com] Sent: Tuesday, March 24, 2009 10:45 AM To: INFOCNTR <PHMSA> Cc: Koogler, Tim; Cox, Steve Subject: Letter of Interpretation Please Importance: High Under this special permit attached that excludes us from normal DOT shipping requirements for flammable liquids dealing with ethyl alcohol it refers to required training under number 11 paragraph 2 which states: Each "Hazmat employee" as defined in 171.8 who performs a function subject to this special permit must receive training on the requirements and conditions of this special permit in addition to the training required by 49CFR 172.00 through 172.704. If we keep our associates trained on compliance with provisions of this permit along with the HM126F training, Chemical Specefic, and Hazwoper that is given in orientation, is this sufficient to meet the training requirements in this special permit due to the fact that under the permit we are able to ship flammables up to 16oz without additional surcharges and Haz MaterialIShippers declaration paperwork requirements? Thanks, Brad King Regulatory Compliance Manager Oncology Supply Company Brad King@oncologysupply com 334.984.2542 Phone 334.983.4460 Fax 888.877.8430 ext 2542 Toll Free 2801 Horace Shepard Drive Dothan, AL 36303 CONFIDENTIALITY NOTICE. This electronic mail transmission may contain privileged an information and is intended only for the review of the party to whom it is addressed received this transmission in error, please immediately return it to the sender, del it without reading it. Unintended transmission shall not constitute the waiver of t or any other privilege.#

Page 3February 12, 2009 U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration East Building, PHH - 30 1200 New Jersey Avenue. Southeast Washington, D.C. 20590 DOT-SP 9275 (TWELFTH REVISION) (FOR RENEWAL, SEE 49 CFR 5 107.109) 1. GRANTEE: (See individual authorization letter) 2. PURPOSE AND LIMITATION: a. This special permit authorizes the transportation in commerce of certain limited quantities of liquids and solids containing ethyl alcohol and exempts these shipments from the provisions of 49 CFR except as provided herein. The most recent revision supersedes all previous revisions. b. The safety analyses performed in development of this special permit only considered the hazards and risks associated with transportation in commerce. c. Unless otherwise stated herein, this special permit consists of the special permit authorization letter issued to the grantee together with this document. 3. REGULATORY SYSTEM AFFECTED: 49 CFR Parts 106, 107 and 171- 180. 4. REGULATIONS FROM WHICH EXEMPTED: 49 CFR Parts 171-180, except as specified in this special permit. 5. BASIS: This special permit is based on the Pipeline and Hazardous Materials Safety Administration's (PHMSA) editorial review under 5 107.121 initiated on February 11, 2009.#

Page 4Continuation DOT-SP 9275 (12th Rev.) Page 2 February 12, 2009 6. HAZARDOUS MATERIALS (49 CFR S 172.101): Proper Shipping Name Hazardous Materials Description Hazard Class/ Division N/A Identi- f ication Number N/A Packing Group No DOT Shipping name required (Beverages, foods, cosmetics and medicines, medical screening solutions, and concentrates used therein containing ethyl alcohol classed as a flammable liquid or as solids containing a flammable liquid. ) N /A 7. PACKAGING AND SAFETY CONTROL MEASURES: Packagings prescribed are strong, outer packagings which meet the requirements of 5 173.24. In addition, the special permit grantee must ensure that the inner packagings of combination packagings are packed, secured, and cushioned to prevent breakage, leakage and movement during conditions normally incident to transportation. Cushioning material must not be capable of reacting dangerously with the contents of the inner packagings or having its protective properties significantly weakening in the event of the leakage. The following restrictions apply: a. Liquids containing not more than 70% by volume ethyl alcohol may be packaged in non-glass inner packagings not exceeding one gallon capacity. Solids containing not more than 70% by weight ethyl alcohol may be packaged in non-glass inner packagings not exceeding 8 pounds capacity. Glass inner packagings not exceeding 16 fluid ounces for flammable liquids or one pound for solids containing flammable liquids are also authorized. b. Liquids containing more than 70% ethyl alcohol by volume may be packaged in inner packagings not exceeding 8 fluid ounces. Solids containing more than 70% ethyl alcohol by weight may not be packaged in inner packagings exceeding % pound in weight.#

Page 5Continuation DOT-SP 9275 (12th Rev.) Page 3 February 12, 2009 c. The net liquid contents of all inner packagings in any single outer packaging may not exceed 192 fluid ounces. The net solid contents of all inner packagings in any single outer packaging may not exceed 32 pounds. The gross weight of any single outer package shipped under this special permit may not exceed 65 pounds. SPECIAL PROVISIONS: a. A person who is not a holder of this special permit who receives a package covered by this special permit may reoffer it for transportation provided.no modifications or changes are made to the package and it is reoffered for transportation in conformance with this Special Permit and the HMR. b. A current copy of this special permit must be maintained at each facility where the package is offered or reoffered for transportation. c. An ethyl alcohol solution shipped under this special permit may contain other hazardous materials provided the solution, absent the ethyl alcohol, is not subject to 49 CFR. d. This special permit does not apply to flammable liquids or solids containing flammable liquids carried in personal baggage aboard aircraft, ( § 175.85(a)). MODES OF TRANSPORTATION AUTHORIZED: Motor vehicle, rail freight, cargo vessel, cargo only aircraft, and passenger- carrying aircraft. MODAL REOUIREMENTS: a. Copies of this special permit or special permit authorization letter is not required to accompany the package or shipment. b. For transportation by passenger and cargo aircraft, no outer package may be transported under the terms of this special permit which contains an inner packaging exceeding: (1) 16 fluid ounces of flammable liquid, or (2) 1 pound of solids containing flammable liquid.#

Page 6Continuation DOT-SP 9275 (12th Rev.) Page 4 February 12, 2009 11. COMPLIANCE: Failure by a person to comply with any of the following may result in suspension or revocation of this special permit and penalties prescribed by the Federal hazardous materials transportation law, 49 U.S.C. 5101 - et seq: - o All terms and conditions prescribed in this Special Permit and the Hazardous Materials Regulations, 49 CFR Parts 171-180. o Persons operating under the terms of this special permit must comply with the security plan requirement in Subpart I of Part 172 of the HMR, when applicable. o Registration required by § 107.601 et seq., when applicable. Each "Hazmat employee", as defined in § 171.8, who performs a function subject to this special permit must receive training on the requirements and conditions of this special permit in addition to the training required by §§ 172.700 through 172.704. No person may use or apply this special permit, including display of its number, when the special permit has expired or is otherwise no longer in effect. Under Title VII .of the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) - 'The Hazardous Materials Safety and Security Reauthorization Act of 2005' (Pub. L. 109-59), 119 Stat. 1144 (August 10, 2005), amended the Federal hazardous materials transportation law by changing the term "exemption" to "special permit" and authorizes a special permit to be granted up to two years for new special permits and up to four years for renewals. 12. REPORTING REQUIREMENTS: Shipments or operations conducted under this special permit are subject to the Hazardous Materials Incident Reporting requirements specified in 49 CFR §§ 171.15 - Immediate notice of certain hazardous materials incidents, and 171.16 - Detailed hazardous materials incident reports. In addition, the grantee(s) of this special permit must notify the Associate Administrator#

Page 7Continuation DOT-SP 9275 (12th Rev.) Page 5 February 12, 2009 for Hazardous Materials Safety, in writing, of any incident involving a package, shipment or operation conducted under terms of this special permit. Issued in Washington, D.C.: c:. --- iJE,.&i for Theodore L. Willke Associate Administrator for Hazardous Materials Safety Address all inquiries to: Associate Administrator for Hazardous Materials Safety, Pipeline and Hazardous Material Safety. Administration, U.S. Department of Transportation, East Building PHH-30, 1200 New Jersey Avenue, Southeast, Washington, D.C. 20590. Copies of this special permit may be obtained by accessing the Hazardous Materials Safety Homepage at http://hazmat.dot.gov/sp app/special permits/spec perm index.htm Photo reproductions and legible reductions of this special permit are permitted. Any alteration of this special permit is prohibited. PO: sln#