{"operation":"document","citation":"03-0038","title":"Statlab Medical Product — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2003-02-28","effective_on":null,"summary":"03-0038 response to Statlab Medical Product concerning 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0038.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0038.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-03-0038","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2003/030038.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nFEB 28 2003\nof Transportation\n400 Seventh St., S.W.\nWashington, D.C. 20590\nMr. John Bickel\nVice President\nRef. No. 03-0038\nStatlab Medical Product\nP.O. Box 1155\nLewisville, TX 75067\nDear Mr. Bickel:\nThis is in response to your January 30, 2003 letter regarding the classification of formaldehyde\nunder the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you\nask whether a solution of 4% formaldehyde mixed with non-hazardous materials shipped in 20\nml, 30 ml, 45 ml, 60 ml, and 120 ml vials by aircraft are subject to the HMR.\nBased on subsequent information you provided to this Office, it is our opinion that your\nproducts are not subject to the requirements of the HMR. Generally, solutions of less than 10%\nformaldehyde 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\nHMR. However, as provided by § 173.22 of the HMR, it is the shipper's responsibility to\nproperly class a hazardous material. Generally, manufacturers have the knowledge to properly\nclass the materials and products they produce. However, in some situations, it may be necessary\nto enlist an outside laboratory to assist in the classification process as testing may have to be\nconducted to see how a product compares to the criteria for the various hazard classes.\nI hope this satisfies your request.\nSincerely,\nHothe smithel\nHattie L. Mitchell\nOffice of Hazardous Materials Standards\nChief, Regulatory Review and Reinvention\n173.22\n030038\n\n<<<PAGE 2>>>\n\n01/30/2003 15:20 FAX 8724361369\nSTATLAB\nBetts\n@002\nStatlab\nmedical produc\n03-0038\nPhone 07-436-1010 X20\nLewisville, TX 75057\nFax 072-435-1389\nEmall jdbickalSntattab.com\n1/30/03\nMr. Edward Mazzulo\nDirector of Office of Hazardous Materials Standards\nDepartment of Transportation\nWashington, DC 2059D\nRoom 8422, 7th. St SW\nby fax: 202-386-3012\nDear Mr. Mazzulo:\nI am requesting a revised letter of interpretation from you office regarding the transportation of small\nquantities of formalin solution. Please reference your letter (01-0184) dated 9/4/01 and the original\nIt is my opinion that Mr. Gale agreed that for the specified material (4% formaldehyde and balance being\nwould not be a regulated material when shipped by air. If this is correct my follow up question deals with\nwater and other non-hazardous materials aka. 10% formalin solution) in unit volumes* of 13mL that these\nIt is my view that 10% formalin in any of the above referenced volumes would not be regulated when\nappreciate your timely response 1o this matter.\nshipped by air.\nCan you please confim this understanding or state your objections? I would very much\nSincerely.\nJohn Bickel, VP\n*all referenced units are packaged in plastic screw top vials which have passed the 95kPa pressure test.\n\n<<<PAGE 3>>>\n\n01/30/2003 15:21 FAX 9724361369\nSTATLAB\n41003\nStotlab\nmedical producto\n106 Hillside Dr.\nPhone 97-436-1010 x20\nLewisville, TX 75057\nEmail Jdbickel@statlab.com\nFax 972-436-1369\n7/16/01\nMr. Edward Mazzulo\nDirector of Office of Hazardous Materials Standards\nRoom 8422, 7th. St SW\nDepartment of Transportation\nWashington, DC 20590\nby fax: 202-366-3012\nDear Mr. Mazzulo:\nI am requesting a revised letter of interpretation from you office regarding the transportation of small\n(6/95 letter 10 J.G. McKay with SAF-T-PAK) but have additional information which may be of interest.\nquantities of formalin solution. I understand this issue has been addressed by your office previously\nformaldehyde with the balance being water and other non-hazardous materials. Formalin solution is\nBy way of clarification formalin solution (aka 10% formalin) typically consists of 3.7-4% of actual\ngenerally packaged in small, screw-top plastic vials of various sizes for diagnostic purposes. These vials\nthat roughly 70 million of these vials are distributed to laboratories in the US, most of which are shipped\nare filled to 1/2 capacity, the smallest of which (and most popular) contains 13mL of formalin. I estimate\nUN2209 or UN1198. It has instead been casually classed as UN3335 which leaves it subject to debate.\nunregulated by air. It is quite clear that formalin solution in this dilution meets neither the definition of\nInsofar as these formalin vials are generally shipped unregulated by laboratories across the country I\nhazardous material and is regarded accordingly. To put another way, if this conclusion were inaccurate\ncan't help but conclude that the collective opinion is that formalin solution does not meet any definition of\nthe economic and administrative impact would be tremendous to these laboratories.\nthe other being the collective opinion across the country which departs from this interpretation. I believe\nSo on the one hand there exists the letter of interpretation from your office suggesting class 9 status and\nthe level of being a substance \"which has narcotic, noxious or other properties such that, in the event of\nthis collective opinion is based on the notion that formalin solution at the 3.7-4% range does not rise to\nas to prevent the correct performance of assigned duties.\"\nleakage or spillage on an aircraft extreme annoyance or discomfort could be caused to crew members so\nThis is particularly so given the very small\ntoan 52 of material contained in these vials. (note: the actual formaldehyde content per 13mL vial is less\nAccordingly, it is my opinion that 10% formalin solution does not meet the definition of a hazard and car\nobjections? I would very much appreciate your timely response to this matter.\nhip unregulated by air as it does by ground. Can you please confim this understanding or state your\nSincerely,\nJonn Bickel, VP\n\n<<<PAGE 4>>>\n\n.. 01/30/2003 15:22 FAX 9724361369\nSTATLAB\n0004\n400 Seventh St., S.W.\nResearch and\nWashington. D.C. 20590\nSome ration s\nSEP - 4 2001\nMr. John Bickel\nVice President\nRef. No. 01-0184\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 Neison\nof my staff regarding the classification of formaldehyde under the Hazardous Materials Regulations\nJ. G. McKay, and ask if a solution of 3.7 to 4% formaldehyde mixed with non-hazardous materials\n(HMR; 49 CFR Parts 171-180). Specifically, you cite a June 6, 1995 letter sent from this Office to\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 requiremants of the HMR. The letter you refer to addresses 10% formaldehyde\nsolutions, which meet the definition of a Class 9 hazardous material. Gencrally, 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 FMR.\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\ncriteria for various hazard classes.\nclassification process, as testing may have to be conducted to see how a product compares to the\nI hope this satisfies your request.\nSincerely,\n• Gale\nTransportation Regulations Specialist\nOffice of Hazardous Materials Standards","truncated":false,"body_characters":7524}