{"operation":"document","citation":"01-0184","title":"Statlab Medical Product — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2001-09-04","effective_on":null,"summary":"01-0184 response to Statlab Medical Product concerning 173.4.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0184.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0184.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0184","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2001/010184.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\n400 Seventh St., SW\nWashington, D.C. 20590\nSpecial Programs\nResearch and\nAdministration\nSEP - 4 2001\nMr. John Bickel\nRef. No. 01-0184\nVice President\nStatlab Medical Product\nP.O. Box 1155\nLewisville, TX 75067\nDear Mr. Bickel:\nThis is in response to your July 16, 2001 letter and subsequent telephone conversation with Eric Nelson\nof my staff regarding the classification of formaldehyde under the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180). Specifically, you cite a June 6, 1995 letter sent from this Office to\nJ. G. McKay, and ask if a solution of 3.7 to 4% formaldehyde mixed with non-hazardous materials\nshipped in 13 ml vials by aircraft are subject to the HMR.\nBased on subsequent information you provided to this Office, it is our opinion that your products are\nnot subject to the requirements of the HMR. The letter you refer to addresses 10% formaldehyde\nsolutions, which meet the definition of a Class 9 hazardous material. Generally, solutions of less than\n10% formaldehyde mixed with non-hazardous materials do not meet the definition of a Class 9\nhazardous material and, provided they do not meet any other hazard class, are not subject to the HMR.\nHowever, as provided by § 173.22 of the HMR, it is the shipper's responsibility to properly class a\nhazardous material. Generally, manufacturers have the knowledge to properly class the materials and\nproducts they produce, although it may be necessary to enlist an outside laboratory to assist in\nclassification process, as testing may have to be conducted to see how a product compares to the\ncriteria for various hazard classes.\nI hope this satisfies your request.\nSincerely,\nGale\nTransportation Regulations Specialist\nOffice of Hazardous Materials Standards\n173.4\n010184\n\n<<<PAGE 2>>>\n\n07/16/2001 10:46 FAX 9724361369\nSTATLAB\nStatlab\nmedical producio\nLawlaville, TX 76057\n106 Hillsido Dr.\nPhone 87-438-1010 x20\nEmall jablckel@oratlab.com\nFax 972-436-1369\nNelson\n7/16/01\n$173.4\nMr. Edward Mazzulo\nDirector of Office of Hazardous Materials Standards\nRoom 8422, 7th. St SW\nDepartment of Transportation\nsmallquanitity\nWashington, DC 20590\n01-0184\nby fax: 202-366-3012\nDear Mr. Mazzulo:\nsmall quantities of formalin solution. I understand this issue has been addressed by your office\nI am requesting a revised letter of interpretation from you office regarding the transportation of\npreviously (6/95 letter to J.G. McKay with SAF-T-PAK) but have additional information which may\nbe of interest.\nformaldehyde with the balance being water and other non-hazardous materials.\nBy way of clarification formalin solution (aka 10% formalin) typically consists of 3.7-4% of actual\nis generally packaged in small, screw-top plastic vials of various sizes for diagnostic purposes.\nformalin. I estimate that roughly 70 million of these vials are distributed to laboratories in the US,\nThese vials are filled to 1/2 capacity, the smaliest of which fand most popular) contains 13mL of\nAEC/str-i,2most of which are shipped unrequlated by air. is quite clear that formaln solution in This dilurian\nmeets neither the definition of UN2209 or UN1198. It has instead been casually classed as\n8/22/011 UN3335 which leaves in subject to debate. Insotar as these formalin vials are generally shipped\nis that formalin solution does not meet any definition of hazardous material and is regarded\nunregulated by laboratories across the country i can't help but conclude that the collective opinion\naccordingly.\nTo put another way, if this conclusion were inaccurate the economic and\nadministrative impact would be tremendous to these laboratories.\nstatus and the other being the collective opinion across the country which departs from this\nSo on the one hand there exists the latter of interpretation from your office suggesting class 9\ninterpretation. I believe this collective opinion is based on the notion that formalin solution at the\n3.7-4% range does not rise to the level of being a substance \"which has narcotic, noxious or other\nroperties such that, in the event of leakage or spillaga on an aircraftextreme annoyance o\niscomfort could be caused to crew members so as to prevent the correct performance of assignec\n(note: the actual formaldehyde content per 13mL vial is less than .52mLl\n\"This is particularly so given the very small volumes of materia! contained in these vials.\nand can ship unregulated by air as it does by ground. Can you please confirm this understanding or\nAccordingly, it is my opinion that 10% formalin solution does not meat the definition of a hazard\nstate your objections? I would very much appreciate your timely response to this matter.\nSincerely,\nJohn Bickel, VP","truncated":false,"body_characters":4699}