{"operation":"document","citation":"10-0153","title":"Public Health, Seattle and King County — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2010-12-08","effective_on":null,"summary":"10-0153 response to Public Health, Seattle and King County concerning 171.8, 172.101, 173.21.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0153.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0153.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-10-0153","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2010/100153.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department of Transportation 1200 New Jersey Ave. SE\nWashington, D.C. 20590\nPipeline and Hazardous Materials\nSafety Administration\nr:: 0 820m\nMr. William Perry\nHealth and Environmental Investigator II\nPublic Health, Seattle and King County\n401 Fifth Avenue, Suite 1100\nSeattle, WA 98104\nReference No. 10-0153\nDear Mr. Perry:\nThis is in response to your telephone conversation with a member of my staff, and your\nsubsequent e-mail and attachments requesting clarification of the Hazardous Materials\nRegulations (HMR; 49 CFR Parts 171-180) applicable to waste pharmaceuticals. Specifically,\nyou present two transportation plans pertaining to a pilot program the City of Seattle and King\nCounty, Washington, would like to begin in these communities to collect waste pharmaceuticals\nfrom consumers and transport them for disposal by common carriers using motor vehicles. You\ndescribed the plans for collecting these materials and conditions common to both, and ask if a\nspecial permit or competent authority approval is needed to transport these materials on a onetime\nor long-term operational basis. You also ask how long it would take to obtain this type of\npermission. We have paraphrased your questions and answered them in the order you provided.\nYou state conditions common to the pharmaceuticals in both scenarios are these materials are:\n1) Drug Enforcement Administration Schedule 2-5 controlled substances; 2) household\nhazardous waste exempt under the Environmental Protection Agency's Resource Conservation\nand Recovery Act and Washington State Dangerous Waste Regulations; and 3) unwanted\nmedications delivered by residents to approved drop-off locations or collected by law\nenforcement offices in Snohomish County, W A.\nBefore packing, you state: 1) all the materials collected will be reviewed by a pharmacist\nexperienced at screening returned medicines and sorted by this pharmacist into controlled and\nnon-controlled categories; 2) unacceptable items under the program's criteria will be removed\n(e.g., sharps, liquid mercury, aerosol cans, etc.); 3) non-controlled medicines will be packaged by\na permitted hazardous waste disposal vendor; and 4) controlled medicines will be packaged in a\n4 milliliter thick plastic drum liner that is closed with a zip-tie and placed in a 10 or 15 gallon,\nUN 1 G standard fiber drum. You also state full packages will be sealed with tamper-evident\ntape, tracked and shipped by a common carrier from the Bothell, W A, Police Department to the\nSauget, IL, Police Department, and disposed of using an approved method, such as incineration.\n\n<<<PAGE 2>>>\n\nYou provided one photograph of typical medicines collected, one photograph of a completed\npackage, and two website links that contain examples of the fiber drum packaging.\nScenario A\nMedicines will be left in their original consumer packagings. As items containing liquids are\npacked, the integrity and tightness of their lids will be checked and corrected as needed. Liquid\ncontainers will be packed upright and pill vial packagings will be used to separate the liquid\ncontainers from each other and the sides ofthe fiber drum. By weight, an estimate of the\ncontents, based on inventories of materials collected from another pilot program (PH:ARM), is\n66 percent will be medications and 34 percent will be packaging materials and containers, and 70\npercent ofthe medicines will be solids and 30 percent will be liquids. The materials packed\naccording to Scenario A will be marked and labeled as \"Consumer commodity, ORM-D.\" This\ncompleted package will weigh 66 pounds or less.\nScenario B\nSolid medicines will be removed from their original packagings and transferred into an approved\nouter packaging. Liquids and ointments will remain in their original consumer packagings. As\nitems containing liquids are packed, the integrity and tightness of their lids will be checked and\ncorrected as needed. Liquid containers will be packed upright and loose pills will be used to\nseparate the liquid containers from each other and the sides of the fiber drum. Additional\ncommercial absorbent (e.g., kitty litter) will be used as needed to provide protective cushioning\nand absorb any leaked liquid contents. By weight, an estimate ofthe contents, based on\ninventories of materials collected from another pilot program (PH:ARM), is 90 percent of the\ncontents will be solids, and 10 percent will be liquids or ointments and their containers. The\nmaterials packed according to this scenario will be marked, labeled, and described as \"UN 3249,\nMedicine, solid, toxic, n.o.s., 6.1 (poisonous), Packing Group (PG) II\" or \"UN 1851, Medicine,\nliquid, toxic, n.o.s., 6.1, Packing Group (PG) II.\" This completed package will weigh\napproximately 60 pounds.\nBased on the information you submitted, the materials packaged as described in both scenarios\nare permitted in transportation under the HMR provided these materials are compatible with the\npackaging materials and do not react dangerously with each other (see §§ 173.21, 173.24,\n173.24a, and 173.153). Completed packages that contain liquids must be marked with\ndirectional arrows to indicate the correct (upright) orientation ofthese inner packagings and their\nclosures within the outer packaging (see § 172.312(a)(2)). Also, please note materials prepared\nin conformance with Scenario B must have the technical name entered in parentheses as a part of\nthe proper shipping description on a shipping paper either after the proper shipping name or at\nthe end ofthe basic description (see § 172.203(k)). As defined in § 171.8 of the HMR,\n\"technical name\" means a recognized chemical name or microbiological name currently used in\nscientific and technical handbooks, journals, and texts. A generic description may be used as a\ntechnical name for a Division 6.1 material provided it readily identifies the general chemical\ngroup.\n\n<<<PAGE 3>>>\n\nIf the packaging and accompanying materials do not meet the criteria prescribed in the HMR, the\npackaging will have to be approved under the terms of a special permit. The application process\nis described in 49 CFR Part 107, Subpart B. Processing times for the issuance of a special permit\nvary based on the complexity and completeness of the application, but this agency requests that\nthe application be submitted at least 120 days before the requested date the applicant want the\nspecial permit becomes effective. For a special permit to be issued, the Pipeline and Hazardous\nMaterials Safety Administration must find that the procedure the applicant has requested\nmaintains a level of safety at least equal to the level required under the HMR.\nI hope this satisfies your request.\nSincerely,\n---/(~\n~~\n~x~~~a15l-r-~~-,-------\nT. Glenn Foster\nChief, Regulatory Review and Reinvention\nStandards and Rulemaking Division\n\n<<<PAGE 4>>>\n\nEdmonson\n§ 17Z~ ;0/\nEdmonson. Eileen (PHMSA)\nFrom: Perry, William [William.Perry@kingcounty.gov]\nSent: Monday, June 14, 20106:04 PM\nTo: Edmonson, Eileen (PHMSA)\nCc: Grasso, Cheri\nSubject: Details of Shipment of Waste Medicines - WA State Pilot\nAttachments: Packaging Description_WP _06142010.doc\nGreetings, Eileen I'm\nfollowing up on our conversation of a couple of weeks ago regarding the shipment of pharmaceutical materials via\ncommon carrier. I've attached a description of the pilot project that we've cooked up here, now with two scenarios.\n«Packaging Description_WP_06142010.doc»\nFrom our conversation, it sounds like our procedures and packaging generally meet DOT's criteria for safe shipment of\nthis material. My questions to you now would be For\nthis one time demonstration, are their any speCial approvals from DOT that would be required?\nIf this were being done on an operational basis, would it require a special permit? If so, how long would that take.?\nThanks for your help with this issue - the complexity of the DOT regulations and website make it especially nice to\ncommunicate with a real person Tata-\nWill\nWill Perry\nHealth & Environmental Investigator II\nPublic Health I Seattle & King County\n401 Fifth Ave, Suite 1100\nSeattle, W A 98104\n206-263-8477 william.perry@kingconnty.gov\n1\n\n<<<PAGE 5>>>\n\nOUTLINE FOR THE SHIPMENT OF CONTROLLED SUBSTANCES TO\nHAZARDOUS WASTE INCINERATION Will Perry 6·14-2010\nPOINTS COMMON TO SCENARIO A OR B\nMaterial used in this pilot will be unwanted medications from residents, collected by the law\nenforcement offices in Snohomish County, Washington.\nAll materials will be HHW exempt by RCRA and WA State Dangerous Waste Regulations\ncriteria.\nContents will be Controlled Substances listed as Schedule 2 5 drugs by the Drug Enforcement\nAdministration.\nBefore packing, all materials will be screened by a pharmacist that is experienced at screening\nreturned medicines. This screening will remove sharps, liquid mercury, aerosol cans or any\nother materials that are not acceptable under the program criteria. The pharmacist will sort the\ncollected medicines into controlled and non-controlled categories. Non-controlled medicines\nwill be packed for pickup by a permitted hazardous waste disposal vendor.\nThe controlled substance medications identified by the pharmacist will be packaged for shipment\nvia common carrier. Outer packaging will be a 10 or 15 gallon 10 fiber drums. Exampleshttp://www.ulinc.comlProductlDetail/S·l\n07 56/Drums-And-Pails/l a-Gallon -Fiber-Drum\nhttp://www.graingcr.comiGrai nger/items/2PYK 7? Pid=scarcll\nA 4-mil plastic drum liner will be used, and closed with a zip-tie before the fiber drum is closed.\nFull packages will be sealed using tamper-evident tape, and then shipped by common carrier\n(UPS or FedEx) from the Bothell, W A Police Department to the Sauget, IL Police Department.\nThroughout the shipment, the custody and location of the package will be tracked and\ndocumented using the carrier's procedures.\nSCENARIO A\nMedicines will be left in their original consumer packaging. As liquid containers are packed, the\nintegrity & tightness of the lids will be checked and corrected as needed. Liquid containers will\nbe packed upright, with pill vials providing separation from other liquid containers and the sides\nof the fiber drum.\nBy weight, an estimated 66% of the contents will be medications - and estimated 34 % will be\npackaging and containers.\nBy weight, an estimated 70% of the medicines will be solids (e. g., pills, patches)\nBy weight, an estimated 30% of the medicines will be liquids (e. g., narcotic cough syrups)\nEstimates are based on inventories of collected material from the PH:ARM pilot.\nThe drum will be shipped and labeled as aRM-D.\n\n<<<PAGE 6>>>\n\nSCENARIOB\nSolid medicines will be removed from their original packaging and poured into an approved\nouter package. Liquids & ointments will be left in their original consumer packaging. As liquid\ncontainers are packed, the integrity & tightness of the lids will be checked and corrected as\nneeded. Liquid containers will be packed upright, with the loose pills providing separation from\nother containers and the sides of the fiber drum. Additional commercial absorbent (\"kitty litter\")\nwill be used as needed to provide protective cushioning.\nBy weight, an estimated 90% of the contents will be solids (e. g., pills, patches)\nBy weight, an estimated 10% of the contents will be liquids or ointments (e. g., narcotic cough\nsyrups) and their containers\nEstimates are based on inventories of collected material from the PH:ARM pilot.\nThe drum will be shipped and labeled as Medicine, solid, toxic, n.o.s.; Packing Group II. and\nMedicine, liquid, toxic, n.o.s., Packing Group II.\nIn the interest of convenient handling, the sealed package will weigh around 60 pounds.\nIf there are questions or items for discussion, please contact Will\nPerry\nHealth & Environmental Investigator II\nPublic Health / Seattle & King County\n401 Fifth Ave, Suite 1100\nSeattle, WA 98104\n206-263-8477 william.perry@kingcounty.gov","truncated":false,"body_characters":11883}