{"operation":"document","citation":"07-0087","title":"The Council on Safe Transportation of Hazardous Articles, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2007-06-07","effective_on":null,"summary":"07-0087 response to The Council on Safe Transportation of Hazardous Articles, Inc. concerning 172.101, 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0087.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0087.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-07-0087","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2007/070087.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMaterials Safety Administration\nPipeline and Hazardous\nJUN\n7 2007\nAdministrator\nMr. John V. Currie\nReference No. 07-0087\nThe Council on Safe Transportation\n7803 Hill House Court\nof Hazardous Articles, Inc.\nFairfax Station, VA 22039\nDear Mr. Currie:\nThis is in response to your February 20, 2007 letter to Mr. Bob Richard, Deputy\nAssociate Administrator for Hazardous Materials Safety, Pipeline and Hazardous\nMaterials Safety Administration, concerning how to transport packages that contain\nblood and urine samples that do not meet the definition for a hazardous material under\nthe Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You state these\nsamples are placed in packages that are pre-printed with the words \"Diagnostic\nSpecimen.\" Your letter was forwarded to the Office of Hazardous Materials Standards\nfor reply. We paraphrased and answered your questions below.\nQ1. To ensure continued compliance with the HMR, must a carrier ask the offeror if\ninfectious substance to learn whether or not it contains this material? If carriers\nevery package displaying the marking \"DIAGNOSTIC SPECIMEN\" contains an\ndo not ask the offerors this question, are they at risk of committing a probable\nviolation of the HMR based on their potential knowledge of the contents?\nAl.\nThe answer to both questions is no. Effective October 1, 2006, under Docket No.\nPHMSA-2004-16895 (HM-226A; 6/2/06), we replaced the proper shipping name\nand marking \"Diagnostic specimen\" with \"Biological substances, Category B\"\nand a diamond-shaped mark containing the letters and numbers \"UN 3373\"\nprinted at least 6 mm (0.24 inches) high. See § 173.199(a)(5). Although the\nHMR do not prohibit the words \"Diagnostic specimen\" from being marked on a\npackage, on and after October 1, 2006, these words may no longer be used to\ndenote a Division 6.2 (infectious) material. Note, however, in accordance with\ncontinue in use until depleted or for one year after the October 1, 2006 effective\n§ 172.101(I), stocks of preprinted shipping papers or package markings may\ndate, whichever is less. A carrier is not required to question the offeror on\nDivision 6.2 material; however, it may be in the carrier's best interest to do so to\nwhether or not a package marked \"DIAGNOSTIC SPECIMEN\" contains a\nensure he or she is not inadvertently transporting an item meeting the definition of\na hazardous material.\n172.101\n173.199 (a) 6)\n070087\n\n<<<PAGE 2>>>\n\nQ2. Do the HMR prohibit shippers from displaying the words \"DIAGNOSTIC\nSPECIMEN\" on all packages? Are we correct in assuming it is not a prohibited\nmarking?\nA2.\nThe HMR do not prohibit display of the words \"DIAGNOSTIC SPECIMEN\" on\na package.\nQ3. May a shipper offering patient specimens exempt from regulation under the HMR\ntransporting these materials in the United States?\nto an international transport carrier call them diagnostic specimens when\nA3. Yes.\nI hope this satisfies your request.\nSincerely,\nHattie L. Mitchell, Chief\nOffice of Hazardous Materials Standards\nRegulatory Review and Reinvention\n\n<<<PAGE 3>>>\n\nEdmonson\n§113.134\n$172.303\n§173.199\nCOSTHA\nDiagnostic Speumen Marking\n07-0087\nFebruary 20, 2007\nWilliam Duff\nPresident\nDr. Robert A. Richard\nUS DOT PHMSA\nDeputy Associate Administrator\nbill_duff@toyota.com\nToyota Motor Sales\nFirst Vice President\n400 7° St. SW. Suite 8421-D\nNovartis Pharmaceuticals\nRobert Heinrich\nPHH-70 Room 8431\nRobert.Heinrich@pharma.novartis.com\nWashington, DC 20590-0001\naristopher Palabrica, CPM, CHM!\ncond Vice President/ Ireasur\nchrisp@mayschem.com\nMays Chemical Co.\nDear Dr. Richard:\nJeanne Zmich\nSecretary\nJEANNEZ@alc-net.com\nLabelmaster\nThe recent amendments to the HMR pertaining to infectious\nExecutive Committee Member\nsubstances have raised some questions that continue to cause\nEli Lilly and Company\nKachard climer\nrequest a written clarification that could be disseminated to effected\nconfusion between shippers and carriers. COSTHA would respectfully\nR.Lattimer@lilly.com\nBoard of Directors\npersons in the industry.\ndonald.bossow@johnsondiversey.com\nJohnsonDiversey, Inc.\nThere are numerous pre-printed packages currently in transportation\nUPS Freight\nLarry Cross\nthat continue to display the previously required \"Diagnostic Specimen\"\nlwcross@overnite.com\nshipments do not meet the definition of a \"Biological Substance,\nmarking. There is a very high probability that these specimen\nMary Kay Inc.\nJohn D'Aloia\nCategory B\", much less the definition of an infectious substance. The\njohn.d'aloia@mkcorp.com\nmajority of these shipments are offered for transportation from clinics,\nProcter & Gamble\nSteven Dishion\nfrom otherwise healthy individuals.\nhospitals, and doctor's offices and are typically blood or urine samples\ndishion.sl@pg.com\nPurolator Courier Ltd.\nDavid Evans\ndevans2@purolator.com\nCOSTHA's question remains, what must the carrier do to ensure\nSun Chemical Corporation\nAmy Fischesser\ncontinued compliance with the HMR? Must the carrier question every\namy. fischesser@nasunchem.com\nsingle package displaying the marking \"DIAGNOSTIC SPECIMEN\"?\nJanet Kolodziey-Nykolyn\nThis would require expenditure of resources of immense proportions\nJanet_L. Kolodziey-Nykolyn@roche.com\nRoche\nand will undoubtedly continue for some time to come. In reality, the\nord Motor Company\nClaudia Meeks\nterm Diagnostic Specimen is no longer a regulatory term. But if the\nmeeks@ford.com\nthey at risk of possible regulatory scrutiny based on potential\ncarriers continue the transportation of these packages so marked, are\nRichard Schweitzer, PLLC\nGeneral Counsel\n\"constructive knowledge\" of the contents?\ndisplay of the term \"Diagnostic Specimen\" on all packages? Since the\nDo the HMR now require that shippers must immediately discontinue\nterm is no longer used to describe a regulated hazardous material and\nThe Council on Safe Transportation of Hazardous Articles, Inc.\n7803 Hill House Court Fairfax Stacion, A 22039 Phone: 7030451-4031 Fax: 7031451-4207\nwww.costha.com\n\n<<<PAGE 4>>>\n\nnot a prohibited marking? Would you concur that a shipper offering what would be\nthus the term is no longer recognized by the regulations, are we correct in assuming it is\nconsidered patient exempt specimens to a carrier in international transport, could alsc\ncall them diagnostic specimens for transport within the US?\nThis has been identified as a significant issue in the foreseeable future and we ask that\nPHMSA provide an expeditious response in order that COSTHA may assist in\ndistribution of a guidance document to enhance safe and efficient transportation.\nThank you in advance for your prompt consideration of this issue.\nSincerely yours,\nStaune\nCOSTHA Administrator\n7803 Hill House Court\nThe Council on Safe Transportation of Hazardous Articles, Inc\nFairfax Station, VA 22039\nmail@costha.com\nwww.costha.com\nPhone: 703/451-4031 Fax: 703/451-4201","truncated":false,"body_characters":6901}