The Council on Safe Transportation of Hazardous Articles, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation 1200 New Jersey Avenue, SE Washington, D.C. 20590 Materials Safety Administration Pipeline and Hazardous JUN 7 2007 Administrator Mr. John V. Currie Reference No. 07-0087 The Council on Safe Transportation 7803 Hill House Court of Hazardous Articles, Inc. Fairfax Station, VA 22039 Dear Mr. Currie: This is in response to your February 20, 2007 letter to Mr. Bob Richard, Deputy Associate Administrator for Hazardous Materials Safety, Pipeline and Hazardous Materials Safety Administration, concerning how to transport packages that contain blood and urine samples that do not meet the definition for a hazardous material under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You state these samples are placed in packages that are pre-printed with the words "Diagnostic Specimen." Your letter was forwarded to the Office of Hazardous Materials Standards for reply. We paraphrased and answered your questions below. Q1. To ensure continued compliance with the HMR, must a carrier ask the offeror if infectious substance to learn whether or not it contains this material? If carriers every package displaying the marking "DIAGNOSTIC SPECIMEN" contains an do not ask the offerors this question, are they at risk of committing a probable violation of the HMR based on their potential knowledge of the contents? Al. The answer to both questions is no. Effective October 1, 2006, under Docket No. PHMSA-2004-16895 (HM-226A; 6/2/06), we replaced the proper shipping name and marking "Diagnostic specimen" with "Biological substances, Category B" and a diamond-shaped mark containing the letters and numbers "UN 3373" printed at least 6 mm (0.24 inches) high. See § 173.199(a)(5). Although the HMR do not prohibit the words "Diagnostic specimen" from being marked on a package, on and after October 1, 2006, these words may no longer be used to denote a Division 6.2 (infectious) material. Note, however, in accordance with continue in use until depleted or for one year after the October 1, 2006 effective § 172.101(I), stocks of preprinted shipping papers or package markings may date, whichever is less. A carrier is not required to question the offeror on Division 6.2 material; however, it may be in the carrier's best interest to do so to whether or not a package marked "DIAGNOSTIC SPECIMEN" contains a ensure he or she is not inadvertently transporting an item meeting the definition of a hazardous material. 172.101 173.199 (a) 6) 070087#

Page 2Q2. Do the HMR prohibit shippers from displaying the words "DIAGNOSTIC SPECIMEN" on all packages? Are we correct in assuming it is not a prohibited marking? A2. The HMR do not prohibit display of the words "DIAGNOSTIC SPECIMEN" on a package. Q3. May a shipper offering patient specimens exempt from regulation under the HMR transporting these materials in the United States? to an international transport carrier call them diagnostic specimens when A3. Yes. I hope this satisfies your request. Sincerely, Hattie L. Mitchell, Chief Office of Hazardous Materials Standards Regulatory Review and Reinvention#

Page 3Edmonson §113.134 $172.303 §173.199 COSTHA Diagnostic Speumen Marking 07-0087 February 20, 2007 William Duff President Dr. Robert A. Richard US DOT PHMSA Deputy Associate Administrator bill_duff@toyota.com Toyota Motor Sales First Vice President 400 7° St. SW. Suite 8421-D Novartis Pharmaceuticals Robert Heinrich PHH-70 Room 8431 Robert.Heinrich@pharma.novartis.com Washington, DC 20590-0001 aristopher Palabrica, CPM, CHM! cond Vice President/ Ireasur chrisp@mayschem.com Mays Chemical Co. Dear Dr. Richard: Jeanne Zmich Secretary JEANNEZ@alc-net.com Labelmaster The recent amendments to the HMR pertaining to infectious Executive Committee Member substances have raised some questions that continue to cause Eli Lilly and Company Kachard climer request a written clarification that could be disseminated to effected confusion between shippers and carriers. COSTHA would respectfully R.Lattimer@lilly.com Board of Directors persons in the industry. donald.bossow@johnsondiversey.com JohnsonDiversey, Inc. There are numerous pre-printed packages currently in transportation UPS Freight Larry Cross that continue to display the previously required "Diagnostic Specimen" lwcross@overnite.com shipments do not meet the definition of a "Biological Substance, marking. There is a very high probability that these specimen Mary Kay Inc. John D'Aloia Category B", much less the definition of an infectious substance. The john.d'aloia@mkcorp.com majority of these shipments are offered for transportation from clinics, Procter & Gamble Steven Dishion from otherwise healthy individuals. hospitals, and doctor's offices and are typically blood or urine samples dishion.sl@pg.com Purolator Courier Ltd. David Evans devans2@purolator.com COSTHA's question remains, what must the carrier do to ensure Sun Chemical Corporation Amy Fischesser continued compliance with the HMR? Must the carrier question every amy. fischesser@nasunchem.com single package displaying the marking "DIAGNOSTIC SPECIMEN"? Janet Kolodziey-Nykolyn This would require expenditure of resources of immense proportions Janet_L. Kolodziey-Nykolyn@roche.com Roche and will undoubtedly continue for some time to come. In reality, the ord Motor Company Claudia Meeks term Diagnostic Specimen is no longer a regulatory term. But if the meeks@ford.com they at risk of possible regulatory scrutiny based on potential carriers continue the transportation of these packages so marked, are Richard Schweitzer, PLLC General Counsel "constructive knowledge" of the contents? display of the term "Diagnostic Specimen" on all packages? Since the Do the HMR now require that shippers must immediately discontinue term is no longer used to describe a regulated hazardous material and The Council on Safe Transportation of Hazardous Articles, Inc. 7803 Hill House Court Fairfax Stacion, A 22039 Phone: 7030451-4031 Fax: 7031451-4207 www.costha.com#

Page 4not a prohibited marking? Would you concur that a shipper offering what would be thus the term is no longer recognized by the regulations, are we correct in assuming it is considered patient exempt specimens to a carrier in international transport, could alsc call them diagnostic specimens for transport within the US? This has been identified as a significant issue in the foreseeable future and we ask that PHMSA provide an expeditious response in order that COSTHA may assist in distribution of a guidance document to enhance safe and efficient transportation. Thank you in advance for your prompt consideration of this issue. Sincerely yours, Staune COSTHA Administrator 7803 Hill House Court The Council on Safe Transportation of Hazardous Articles, Inc Fairfax Station, VA 22039 mail@costha.com www.costha.com Phone: 703/451-4031 Fax: 703/451-4201#