{"operation":"document","citation":"06-0267","title":"Healthcare Support Services — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2007-01-23","effective_on":null,"summary":"06-0267 response to Healthcare Support Services concerning 173.24a.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0267.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0267.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-06-0267","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2006/060267.pdf","body":"<<<PAGE 1>>>\n\nof Transportation\nU.S. Department\nWashington, D.C. 20590\n400 Seventh Street, S.W.\nPipeline and\nHazardous Matericils Safety\nAdministration\nLisa Hardesty, MA, CHCC, HEM\nReference No. 06-0267\nHealthcare Support Services\n:4593 North Barton Lake Drive\nVicksburg, MI 49097\nDear Ms. Hardesty:\nwith a member of my staff asking how to transport Division 6.2 (infectious) and non-\nThis is in response to your November 17, 2006 e-mail and recent telephone conversations\ninfectious patholog cal wastes preserved in a 10% buffered formalin solution under the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You state different\nHospitals around the United States offer these wastes for transport mixed with formalin\ncontaining various concentrations of formaldehyde up to but not exceeding 10%,\ndescribed herein as \"10% buffered formalin.\" You also state the wastes exhibi: corrosive\nand toxic characteristics and are subject to the hazardous waste manifest requirements of\nthe U.S. Environmental Protection Agency (EPA). I have paraphrased your questions and\nanswered them in the order provided.\nQ1.\nIs a 10% bu fered formalin solution considered a hazardous material under the\nHMR? If sc, does § 173.24a(c)(2)(iii) apply to a formalin solution placed in an\nregulated medical waste?\ninner packaging with a Division 6.2 material that meets the definition for a\nAl.\nAs provided in § 173.22 of the HMR, it is the shipper's responsibility to properly\nclass a hazardous material. This Office does not perform that function. However,\npackaging with non-hazardous material meets the definition for a Class 9\nit is our opirion that formalin containing 10% formaldehyde placed in an inner\n(miscellanecus) material and should be described as \"UN 3334, Aviation regulated\nliquid, n.o.s. (formaldehyde), 9\" for transportation by aircraft, or \"NA 3082, Other\nregulated substances, liquid, n.o.s. (formaldehyde), 9, PG III\" for domestic\ntransportation in all modes. See § 172.202(b). Formalin containing less that 10%\nformaldehyde does not meet the definition for a hazardous material under the\nHMR\nor stabilizing material under the provisions of § 173.24a(c)(2)(iii) must conform to\nClass 9 formalin packaged with regulated medical waste (RMW) as a preservative\nthe requirements in § 173.197 and the material must be described as \"U.V 3291,\nRegulated medical waste, n.o.s, 6.2, PG II.\" Section 173.24a(c) permits the\ntransportation of more than one hazardous material in a non-bulk outer packaging\n173-24a (X2)(ii)\n060267\n\n<<<PAGE 2>>>\n\nparagraph (c)(2), a packaging containing inner packagings of Division 6.2 material\nmay also contain refrigerants, anticoagulants used to stabilize blood or plasma, or\nsmall quantities of Class 3, 8, 9 or other materials used to stabilize or prevent\ndegradation of the sample provided the quantity of such materials does not exceed\n30 mL or 30 g for each inner packaging and 4 L or 4 kg for each outer packaging.\n02.\nIs a formalin solution that is subject to the EPA hazardous waste manifest\nrequirements considered a hazardous material under the HMR?\nA2.\nYes. For purposes of the HMR, a hazardous waste is a material that is subject to\nthe EPA hazardous waste manifest requirements in 40 CFR Part 262. Provided the\nmaterial does not meet the definition for any other hazard class, a waste formalin\n(formaldehyde), 9\" for transportation by aircraft, or \"NA 3082, Waste other\nsolution may be described as \"UN 3334, Waste aviation regulated liquid, n.o.s.\nregulated si bstances, liquid, n.o.s. (formaldehyde), 9, PG III\" for domestic\ntransportation in all modes.\nFor a formalin solution meeting the definition for a hazardous waste under the\nconform to he requirements in § 173.197 and the material must be described as\nHMR that is contained in the same inner packaging as RMW, the packaging must\n\"UN 3291, Regulated medical waste, n.o.s., 6.2, PG II.\" If the shipper determines\nthat enough formalin is placed in the package such that 100 pounds of\nits contents also meets the definition of a hazardous substance and musi: be\nformaldehyde is present at a concentration by weight of 0.2 percent or 2000 ppm,\nPG II.\"\ndescribed as \"RQ, UN 3291, Regulated medical waste, n.o.s, (formaldehyde), 6.2,\nQ3.\ninfectious substances?\nDoes the 30 mL limit for formalin in § 173.24a(c)(2)(iii) apply to RMW or all\nA3.\nincluding RIMW. See answer Al above.\nYes. The 30 mL limit in § 173.24a(c)(2)(iii) applies to all infectious substances,\nQ4.\n02-0292) you state the appropriate proper shipping name for biological samples\nIn a letter of interpretation your agency issued on April 10, 2003, (Reference No.\npreserved with a 10% buffered formalin solution transported by aircraft is \"NA\n3082, Other regulated substances, n.o.s. (formaldehyde), 9, PG III.\" Does the same\nproper shipping description apply to ground transportation?\nA4.\nYes, provided the biological samples or pathological materials packagerd with the\nformalin solution do not meet the definition for a Division 6.2 material and the\nmaterial is transported domestically. However, please note that on October 1,\n1999, we added the proper shipping description \"UN 3334, Aviation regulated\nliquid, n.o.s. (formaldehyde), 9\" to the Hazardous Materials Table to align the\nHMR with international requirements for transporting hazardous materials (Docket\n2\n\n<<<PAGE 3>>>\n\nNo. HM-215C; 64 FR 10741 and 64 FR 44426). As stated in our July 13, 2001\nletter of interpretation (Reference No. 01-0120), this is the preferred proper\nshipping name for 10% buffered formalin solutions that meet no other hazard class\nanswer Al above.\nand are offered for domestic and international transportation by aircraft. See\nI hope this information is helpful.\nSincerely.,\nHattie L. Mitchell, Chief\nRegulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 4>>>\n\nEdmonson\nNovember 17, 2006\n8173.24a(c)(2) Gi\nApplicability\nEileen Edmonson\nPHH-10\n06-0267\n400 7th St., S.W.\nWashington, DC 20590-0001\nDear Ms. Edmonson,\nI am writing to request an interpretation of 49 CFR 173.24a(c)(2)(iii) regarding the\ntransport of pathological materials preserved in 10% buffered formalin.\nI consult with a company that transports regulated medical waste and pathological waste\nthat requires formalin to be decanted prior to shipment. I have heard that there are some\nentities that accept for shipment containers where the inner packagings exceed the 30 ml\nexception for a preservative material in hazard Classes 3, 8, 9. My questions are:\n1. Is 10% burfered formalin considered a hazardous material as stated ir.\n§173.24a(c)(2)(i1)?\n2. Would the shipment of pathological materials in 10% buffered formalin in\namounts greater than 30ml in each inner package constitute a hazardous waste\nsubstances?\nshipment? Does the 30ml apply to regulated medical waste or only infectious\n3. And finally, in a letter of interpretation dated April 10, 2003 the proper shipping\ndescription (for air transport) of biological samples preserved with a 10%\nbuffered formalin solution was given as \"Other Regulated Substances, n.o.s., 9,\nNA 3082, PGIII\". Would the same proper shipping description apply for ground\ntransportation of 10% buffered formalin solution used to preserve pathological\ntissues that have now become a waste?\nsolution may exhibit the characteristics of corrosivity, and toxicity and would\nBased upon my knowledge of DO1 and EPA regulations, a 10% buffered formalin\ntypically be classified in this instance as a hazardous waste. I appreciate your\nattention to this matter on my behalf and await your direction.\nShould you have any additional questions, please contact me at (269)-649-1623\nSincerely,\nLisa Hardesty, MA, CHCC, HEM\nHealthcare Support Services\n\n<<<PAGE 5>>>\n\nPage 1 of 1\nEdmonson, Eileen <PHMSA>\nFrom:\nLisa Hardesty [lisahardesty@comcast.net]\nSent:\nSaturday, November 18, 2006 9:49 PM\nTo:\nEdmonson, Eileen <PHMSA>\nSubject:\nRequest for interpretation\nAttachments: Formalin Interp_11_17_06.doc\nname and e-mail information as a contact for USDOT interpretations. I've been struggling for a number of years\nMy name is Lisa Hardesty and I'm a healthcare compliance consultant based in the Midwest. I was given your\nopinions regarding the transportation of pathological waste immersed in a 10% formalin preservative. Some\nover proper shipment of 10% buffered formalin. Regulated medical waste vendors seem to have conflicting\nhaulers require the hospital to decant the formalin before shipping the pathological waste as regulated medical\nwaste: while other haulers encourage the hospitals not to decant the formalin. Please review my questions as\noutlined in the attached letter. I sincerely appreciate any direction you can offer.\nBest regards,\nHealthcare Support Services\nLisa Hardesty, MA, CHCC, HEM\n269-649-4076 fax\n269-649-1623 phone\n11/21/2006","truncated":false,"body_characters":8817}