{"operation":"document","citation":"04-0279","title":"Daniels Sharpsmart, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2005-06-29","effective_on":null,"summary":"04-0279 response to Daniels Sharpsmart, Inc. concerning 173.197.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0279.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0279.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-04-0279","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2004/040279.pdf","body":"<<<PAGE 1>>>\n\nf Transportatio\nS. Departmel\n400 Seventh Street, S.W.\nWashington, D.C. 20590\nPipeline and\nAdministration\nHazardous Materials Safety\nJUN 29 2005\nMr. Terry Grimmond\nClinical Director\nReference No. 04-0279\n3 Tarbett Road Hillcrest\nDaniels Sharpsmart, Inc.\nHamilton 2001, New Zealand\nDear Mr. Grimmond:\nThis is in response to your letter and electronic mail concerning how to classify and transport\nchemotherapeutic and pharmaceutical wastes under the Hazardous Materials Regulations\n(HMR; 49 CFR Parts 171-180). We paraphrased your questions and answered them in the\norder provided. We apologize for the delay in responding and any inconvenience this may\nhave caused.\nQuestion 1. What hazard classes are chemotherapeutic and pharmaceutical wastes?\nAnswer 1. The hazard class assigned to a material is based on its chemical composition,\nconcentration of ingredients, and hazard characteristics. Under § 173.22 of the HMR, the\nshipper is responsible for determining if a material meets the definition of a hazard class,\nassigning the material an appropriate proper shipping name, and selecting the appropriate\npackage, markings, and labels. Sometimes, more than one proper shipping name from the\nHazardous Materials Table (HMT; § 172.101) may describe the same material. For example,\nn.o.s., 6.1, UN 3249, PG II,\" or \"Waste Toxic solids, organic, n.o.s., 6.1, UN 2811, PG II,\" or,\nif applicable, assign it a proper shipping description based on a specific chemical name.\nFor your reference, § 171.8 defines a hazardous waste to mean a waste material that is subject\nto the Uniform Hazardous Waste Manifest (UHWM) requirements of the U.S. Environmental\nProtection Agency specified in 40 CFR Part 262. A waste that does not require completion of\na UHWM is not considered a \"hazardous waste\" for purposes of the HMR and is not subject\nto the HMR unless it meets the definition of a hazardous material under the HMR. Further,\nwhen a shipper chooses a proper shipping name, the accompanying information for that entry\non the HMT must be used in its entirety and may not be interchanged with that of any other\nentry. If a material does not meet the definition of a HMR hazard class, and it is not a\nhazardous waste, hazardous substance, or marine pollutant, it is not regulated as a hazardous\nmaterial under the HMR.\n173-197 (a)Xvi)\n040279\n\n<<<PAGE 2>>>\n\nQuestion 2. What UN numbers apply to chemotherapeutic ard pharmaceutical wastes?\nNeither term is assigned a UN number in Column 4 of the HMT. Does this mean these\nmaterials are not hazardous under the Department of Transportation's regulations? The UN\nnumbers on the HMT do mention \"Medicine liquid, toxic, n.o.s., 6.1, UN 1851, PG II or III\"\nand \"Medicine, solid, toxic, n.o.s., 6.1, UN 3249, PG II or III.\"\nAnswer 2. The same answer as in Al.\nQuestion 3. If chemotherapeutic and/or pharmaceutical wastes are mixed with Division 6.2\n(infectious) sharps, does the Division 6.2 hazard class take precedence? In discussions with\nMs. Eileen Edmonson of your staff, she said Division 6.2 takes precedence over\nchemotherapeutic and pharmaceutical waste and referred to § 173.197(d)(3)(vi).\nAnswer 3. Section 173.2a specifies how to classify a material having more than one hazard\nunder the HMR. Under § 173.2a(c)(3), a material that meets the definition of a Division 6.2\nhazard class and another hazard class, which may include a limited quantity Class 7 material\nbut no other type of Class 7 material, must be classed as Division 6.2.\nQuestion 4. If chemotherapeutic and/or pharmaceutical wastes are mixed with Division 6.2\nsharps, are neither Division 6.1 or Division 6.2 labels required if a BIOHAZARD marking is\npresent on the sharps container?\nAnswer 4. Sections 172.400 and 172.402(a) require the outside of each package containing a\nhazardous material to be labeled as specified for the material in the HMT, including those for\nthe subsidiary hazard class if applicable. The HMR include an exception from labeling in\n§173.134(c)(1) for \"Regulated medical waste, 6.2 (infectious, UN 3291, PG II\" (RMW)\ntransported by a private or contract carrier in a non-specification, rigid, non-bulk package\nconforming to §§ 173.24 and 173.24a, and 29 CFR 1910.1030. If a package of RMW meets\nthe requirements of the exception, a shipper may place the BIOHAZARD marking\nconforming to 29 CFR 1910.1030, and shown in § 172.323, on the outside of the package in\nplace of the INFECTIOUS SUBSTANCE label shown in § 173.432. To qualify for this\nexception, § 173.134(c)(1)(ii) requires that the package not contain a waste culture or stock of\na Division 6.2 material. Further, § 173.134(d) requires that a Division 6.2 material listed in\nthe exceptions under §§ 173.134(b) and (c) that also meets the definition of another hazard\nclass, or that is a hazardous substance, hazardous waste, or marine pollutant comply with the\napplicable requirements of the HMR for each hazard class it contains, which include, if\napplicable, placing the Division 6.1 label on the outside of the package.\nI hope this information is helpful.\nSincerely,\nHotte z. MAtal\nHattie L. Mitchell, Chief\nRegulatory Review and Reinvention\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nPage 1 of 2\nDrakeford, Carolyn\nFrom:\nEdmonson, Eileen\nEdmonson\nSent:\nMonday, December 13, 2004 3:23 PM\nTo:\nDrakeford, Carolyn\n$/73.197 (1)g) (vi)\nSubject: FW: Chemo and Pharma waste\nRegulated Medica\nCarolyn - Can you please log this in as the new Terry Grimmond letter and assign it to me? He withdrew the one\n04-6279\nhe submitted under reference no. 04-0127.\nThanks,\nEileen\nFrom: Terry Grimmond [mailto:terry.grimmond@sharpsmart.com]\n-----Original Message----\nTo: eileen.edmonson@rspa.dot.gov\nSent: Thursday, December 09, 2004 7:27 PM\nSubject: Chemo and Pharma waste\nI'm back in NZ for a while and going over discussions we had during my Nov visit. May I seek clarification on\nI hope your Thanksgiving was excellent and Christmas preparations are not too hectic.\nChemotherapeutic and Pharmaceutical waste.\nWhen either of these terms is used to search CFR49, very little comes up. They are not included in definitions.\nQ1. What Hazard Class are Chemo and Pharma wastes?\nunderstanding of Class 7 is that it is exclusively for Radioactive items). Pharmaceutical waste is not mentioned at\nThere is a hint in CFR49 §173.197(d)(1)(vi) that Chemo may be in either Class 6.1 or 7 (my\nall.\nNeither term is mentioned in UN List - does this mean they are not hazardous under DOT regulations? The UN\nQ2. What UN number do Chemo and Pharma waste attract?\nList does mention UN 1851 (Medicine Liquid, Toxic, NOS) and UN3249 (Medicine Solid, Toxic, NOS)\nn our discussions you said 6.2 takes precedence over Chemo and Pharma waste, and referred to para 173.19'\n23. If Chemo and/or Pharma waste is mixed with Class 6.2 sharps, does 6.2 take precendence'\nd)3)vi. When I read this para I cannot see a \"precedence\" ruling. (perhaps | wrote wrong para reference).\ninfectious substances containing Risk Group 2 or 3 pathogenic organisms, unabsorbed liquids, and\n173.197 d)3)(vi) Division 6.1 or Class 7 chemotherapeutic waste, untreated cultures and stocks of\nsharps may be transported in a BOP only if separated and secured as provided by paragraph (d)(3)(v) of\nthis section.\nQ4. If Chemo and/or Pharma waste is mixed with Class 6.2 sharps, neither Class 6.1 nor Class 6.2 labels\nKind regards,\nTerry\nTerry Grimmond\n12/14/2004\n\n<<<PAGE 4>>>\n\nPage 2 of 2\nDaniels Sharpsmart Inc\nClinical Director\n12/14/2004","truncated":false,"body_characters":7486}