{"operation":"document","citation":"13-0112","title":"Great Lakes Custom Law — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2013-07-10","effective_on":null,"summary":"13-0112 response to Great Lakes Custom Law concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0112.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0112.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-13-0112","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2013/130112.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\nJUL 1 0 2013\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nMr. Jason P. Wapie1mick\nGreat Lakes Custom Law\n32437 Five Mile Road\nLivonia, Michigan 48154\nReference No. 13-0112\nDear Mr. Wapiennick:\nThis is in response to your request for clarification of the Hazardous Materials Regulations\n(HMR; 49 CFR 171-180) applicable to your client transporting anatomical parts by motor\nvehicle to and from various states, Mexico, and Canada for medical programs. In your\nletter, you state that the anatomical parts are non-infectious, and are often transported with\nmedical and clinical equipment and laboratory products. Specimens, equipment and\nproducts are packaged to prevent any risk of exposure or contamination. At the conclusion\nof the medical program, the anatomical parts will either be cremated or, if their condition\nallows, returned to the client's facility for use in future medical programs.\nYour questions are paraphrased and answered as follows:\nQ1. If the anatomical parts being transported meet the Division 6.2 (Infectious\nsubstance) definition in § 173.134(a)(l ), would § 173 .134(b )(1 0) and/or (b )(14)\nexcept the shipper from the requirements of Parts 171 through 177 of the HMR, or\nonly the requirements of§ 173.134?\nA 1. Provided the anatomical pmis being transported meet the Division 6.2 (Infectious\nsubstance) definition in § 173.134(a)(l ), the shipper would be excepted from only\nthe requirements of§ 173.134.\nQ2. For purposes of your response and as presented above, please assume the\nanatomical parts are excepted from the requirements of either § 173.134 or Parts\n171 through 177 of the HMR, and further that they are erroneously assigned\nidentification number \"UN3373 .\" Is there a violation of§ 171.2(k)? Is there a\nviolation of§ 172.303(a)?\nA2. The answer is yes. Section 171.2(k) specifies that no person may, by marking or\notherwise, represent that a hazardous material is present in a package, container,\nmotor vehicle, rail car, aircraft, or vessel if the hazardous material is not present.\nSection 172.303(a) specifies that no person may offer for transportation or transpmi\n\n<<<PAGE 2>>>\n\nQ3. A3. Q4. a package which is marked with the proper shipping name, the identification\nnumber of a hazardous material or any other markings indicating that the material is\nhazardous unless the package contains the identified hazardous material or its\nresidue. Therefore, ifthe markings are not covered and are visible during\ntransportation, a violation of§ 171.2(k) (marking a package as though a hazardous\nmaterial is present when it is not) and § 172.303(a) (prohibited marking) has\noccurred.\nFor purposes of your response, please assume the anatomical parts are erroneously\nassigned \"UN3373,\" but are loaded and unloaded by the shipper and transported in a\ntrunk or cargo area and are not visible \"without close inspection.\" Is the erroneous\n\"UN3373\" assignment prohibited by§ 172.303(a) or is that section inapplicable\nunder § 172.303(b )(1) or (2)?\nSection 172.303(b) states that the prohibited marking requirements in paragraph (a)\nof§ 172.303 do not apply to transportation of a package in a transport vehicle or\nfreight container if the package is not visible during transportation and is loaded by\nthe shipper and unloaded by the shipper or consignee. In your scenario, although the\npackage is loaded and unloaded by the shipper and transported in a trunk or cargo\narea, the incorrect markings are still visible, and therefore the package is not in\ncompliance with the HMR.\nAgain, for purposes of your response and assuming the same scenario as Q3, is the\nincorrect \"UN3373\" assignment prohibited and does § 172.303(b )(1) or (b )2) apply?\nWould there still be a violation of§ 171.2(k)?\nA4. See A3.\nI hope this information is helpful. Please contact this office should you have additional\nquestions.\nSincerely,\nT. Glem1 Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nJason P. Wapiennik\n32437 Five Mile Road\nLivonia, Michigan 48154\n~~~ln~re.\n§ 11Z. 10 I\nGREAT LAKES CUSTOMS LAWtjJ73·13tj\n~11:l· 303 '\ncusToMs & INTERNATIONAL TRADE LAW befin,'fi()n.s 1 tVbrk1n3\n13-6112\nTel: (734) 855-4999\nFax: (734) 573-6032\njason@greatlakescustomslaw.com\nMay 22,2013\nU.S. DOT\nPHMSA Office ofHazardous Materials Standards\nAttn: PHH-10\nEast Building\n1200 New Jersey Avenue, SE.\nWashington, DC 20590-0001\nINFOCNTR@DOT.GOV\nVIA E-MAIL ONLY\nRE: Request for formal interpretation\nDear Sir/Madam:\nWe request a formal interpretation ofthe applicability of the Federal Hazardous Material\nRegulations (\"FHMR\") to a Client's operations (\"Client\").\nThe Client is a bio-medical skills and research company that utilizes donated human\nanatomical parts for medical programs to advance medical and surgical techniques by providing\ndoctors with valuable hands-on experience, allowing them to learn new procedures and skills\nbefore working with living patients. The medical programs occur at facilities designed for or\nspecially outfitted to accommodate the anatomical parts and the medical program.\nAs part of its mission, the Client frequently travels via motor vehicle to and from various\nStates, and on occasion into Canada and Mexico, with human anatomical parts for use in the\nmedical programs. The anatomical parts are non-infectious, and are often transported with\nmedical/clinical equipment and laboratory products. Both specimens and equipment/products are\npackaged to prevent any risk of exposure or contamination. At the conclusion of the medical\nprogram, anatomical parts will either be cremated or, if their condition allows, returned to\nClient's facility for use in future medical programs.\nIn view of the foregoing, we present the following questions for an interpretation of the\nFHMR:\n1. If the anatomical parts transported by Client should ever meet the defmition of\n173.134(1), would 49 CFR 172.134(b)(10) and/or (14) exempt Client from the\nrequirements of Parts 171 through 177 of the FHMR, or just the requirements of\n173.134?\n\n<<<PAGE 4>>>\n\n2. For purposes of your response, please assume the anatomical parts are exempt\nfrom the requirements of either 173.134 or Parts 171 through 177, as posed above,\nand further that they are erroneously assigned UN 3373. Is there a violation of\n171.2(k)? Is there a violation of 172.303(a)?\n3. For purposes of your response, please assume the anatomical parts are\nerroneously assigned UN 3373, but are loaded and unloaded by Client and\ntransported in a trunk or cargo area and are not visible without close inspection. Is\nthat erroneous UN 3373 assignment prohibited by 172.303(a) or is that section\ninapplicable under 172.303(b )(1) or (2)?\n4. For purposes of your response, please assume the same situation as item 3 above\nand, furthermore, that 172.303(b )( 1) or (2) applies. Can there still be a violation\nof 171.2(k)?\nIf you should require additional information, please do not hesitate to contact me at your earliest\nconvenience by any means indicated above.\nWe appreciate your consideration and look forward to your response.\nVery truly yours,\nBy: Jason P. Wapiennik\nPage 2 of2","truncated":false,"body_characters":7206}