{"operation":"document","citation":"12-0028","title":"Waste and Compliance Management, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2012-04-02","effective_on":null,"summary":"12-0028 response to Waste and Compliance Management, Inc. concerning 173.134, 173.199, 173.22.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0028.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0028.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0028","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2012/120028.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, D.C. 20590\nAPR 0 2 2012\nMr. Eric Smith\nVice President of Operations\nWaste and Compliance Management, Inc.\n6054 Corte del Cedro\nCarlsbad, CA 92011\nReference No. 12-0028\nDear Mr. Smith:\nThis is in response to your January 17, 2012letter concerning how to describe and transport\ndisposal and recycling products, including sharps, used by medical facilities to treat human\nand animal patients under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-\n180). You state your company obtains these materials from clinics, dental offices,\nveterinary practices, occupational medicine providers, long-term care facilities, and other\ncommercial and government entities. We have paraphrased your questions and answered\nthem as follows.\nQl. Is it permissible to ship sharps that have been used to administer medicine and/or\nother wastes by a commercial motor carrier, such as United Parcel Service (UPS), if\nthey are classified as \"Used healthcare products\" under the HMR?\nAl. The answer is no. Products, including sharps, used by medical facilities to treat\nhumans and animals that are suspected of being contaminated with a Category B,\nDivision 6.2 (infectious substance) material and intended to be transported for\ndisposal or recycling meet the definition provided in§ 173.134(a)(5) for a \"UN\n3291, Regulated medical waste, n.o.s., 6.2, PG II.\" If these products are suspected of\nbeing contaminated with a Category A, Division 6.2 material, that product must be\nclassed and described as either \"UN 2814, Infectious substances, affecting humans,\n6.2\" or \"UN 2900, Infectious substances, affecting animals, 6.2,\" as applicable. The\nHMR defines a used health care product as a medical, diagnostic, or research device\nor piece of equipment, or a personal care product that is used by consumers, medical\nprofessionals, or pharmaceutical providers, and is removed from its original\npackaging, contaminated with potentially infectious body fluids or materials, and not\ndecontaminated or disinfected to remove or mitigate the infectious hazard prior to\n.transportation. Further, it does not meet the definition of a patient specimen,\nbiological product, or regulated medical waste (see§ 173.134(a)(8)). The HMR\nexcepts used health products from regulation if they are being returned to the\n\n<<<PAGE 2>>>\n\nmanufacturer or the manufacturer's designee and: 1) conform to the Department of\nLabor, Occupational Sa(ety and Health Administration's (OSHA's) regulations for\nbloodborne pathogens under 29 CPR 1910.1030, or 2) are packaged and transported\nas prescribed in§ 173.134(b)(12)(ii). If used health care products intended for\ntransportation do not conform to the OSHA standard or the exception in\n§ 173.134(b)(12)(ii), they must comply with regulations prescribed in§ 173.199.\n02. If the answer to question 01 is yes, please specify which HMR section(s) must we\nfollow?\nA2. The answer is no. See answer Al.\n03. A3. 04. A4. If the answer to question 01 is no, what are the consequences under the HMR for\nimproperly classifying and shipping hazardous materials?\nEach person who offers a hazardous material for transportation or transports a\nhazardous material in commerce is responsible for compliance with the requirements\nof the HMR, or a special permit, approval, or registration issued under the HMR,\nwith respect to any regulated function that the person performs or is required to\nperform. Under 49 CPR Part 107, Subpart D, the civil penalty for knowingly\nviolating the Federal hazardous materials transportation law (49 U.S.C. 5101, et.\nseq.) or the HMR can range from $275 to $55,000 per violation per day, or up to\n$110,000 if the violation results in death, serious illness, severe injury to any person,\nor substantial destruction of property. A minimum fine of $495 applies to violations\nrelating to training. See §§ 107.329 and 107.333. Criminal penalties may include\nfines and imprisonment from 5 to 10 years based on the severity of the crime.\nPenalties for violations of the HMR are assessed on a case-by-case basis and depend\non a number of factors, including the nature, circumstances, extent, and gravity of\nthe violation.\nWhich office or department within your organization is the final authority on how to\nclassify hazardous materials and any challenges to a product's classification that can\nbe made?\nUnder § 173.22, it is the shipper's responsibility to properly classify a hazardous\nmaterial before it is offered for or transported in commerce. The Associate\nAdministrator for Hazardous Materials Safety, Pipeline and Hazardous Materials\nSafety Administration (PHMSA), is the competent authority responsible for the\ncontrol and regulation of the transportation of hazardous materials in the United\nStates (see§ 171.8, \"Competent authority\" definition). However, disputes\nconcerning the classification of a hazardous material are typically deferred to the\nappropriate staff in PHMSA's Sciences Branch, Engineering and Research Division,\ntelephone number (202) 366-4545.\n2\n\n<<<PAGE 3>>>\n\nFinally, in your letter, you also mention these materials are sometimes shipped by\ngovernmental agencies. The HMR applies to the transportation of hazardous\nmaterials in commerce. The HMR does not apply to the transportation of a\nhazardous material in a motor vehicle, aircraft, or vessel operated by a Federal, state,\nor local government employee solely for noncommercial governmental purposes\nbecause such transportation is not considered to be \"in commerce\" (see\n§ 171.l(d)(5)). Thus, if a government agency's employees prepare and transport a\nhazardous material for transportation, that material is not subject to the HMR.\nHowever, if a government agency contracts with a third party to class, package,\nprepare shipping documentation, load, or transport hazardous waste on its behalf, the\ncontractor must comply with all applicable HMR requirements.\nI hope this satisfies your request.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n3\n\n<<<PAGE 4>>>\n\nJanuary 17, 2012\nMr. John Gale, Director\nPHMSA\n1200 New Jersey Avenue SE\nWashington, DC 20590\n·JAN2 3 Z01Z\nPROPER CLASSIFICATION OF USED, POTENTIALLY INFECTIOUS SHARPS\nMr. Gale,\nWe manufacture disposal and recycling products used by medical clinics, dental\noffices, veterinary practices, occupational medicine providers, long-term care\nfacilities and other commercial and government entities. Several of our products\nare used by generators to dispose of 'sharps,' including needles and syringes, which\nhave been used in the treatment of human or animal patients and may be\ninfectious.\nOur Isolyser®/SMS®m products are approved by the United States Postal Service\n(Domestic Mail Manual, Reference 601.10.17.5 for shipment of UN3291 Sharps and\nN3291 Regulated Medical Waste) for mailing these materials from generator\n~·locations to our facility.\nFor several reasons, we would like the option to ship these packages using the\nUnited Parcel Service (UPS) network from the generator to our facility. However,\nbecause UPS has not adopted the Domestic Mail Manual, they do not allow the\nshipment of Regulated Medical Waste through their network, regardless of United\nStates Postal Service approval status.\nIt has come to our attention that one of our competitors has classified a product\nwith the exact same characteristics, use and purpose as our sharps mail-back\nproduct as 'Used Healthcare Products.' By using the classification of \"Used\nHealthcare Products,\" their customers are shipping used sharps and other\npotentially infectious waste via UPS.\nBecause UPS regulations prohibit shipping Regulated Medical Waste, we believe the\ncompetitor simply classified their packages as \"Used Healthcare Products,\" for the\npurpose of shipping packages via UPS without scrutiny.\nWCM Waste & Compliance Management Inc.\n6054 Corte del Cedro,\nCarlsbad, California 92011\n866-436-9264 (WCMI) • www.wastewise.com\n\n<<<PAGE 5>>>\n\nTheir product is marketed to generators of used needles, syringes, and other\nhealthcare materials from human and animal patients.\nWith that background information in mind, please provide direction concerning the\nfollowing questions:\nIs it legal to ship sharps, which have been used to administer medicine and/or\nother waste via motor carrier such as UPS, simply by classifying that material as\n\"Used Healthcare Products?\"\nIf yes, please specify which rule section(s) we must follow?\nIf the answer is no, what is the consequence for improperly classifying and shipping\nitems?\nFurther, which organization or department within your organization is the final\nauthority regarding classification and challenges that may be made?\nric Smith\nVP of Operations\n'c WCM, Inc.\nWCM Waste & Compliance Management Inc.\n6054 Corte del Cedro,\nCarlsbad, California 92011\n866-436-9264 (WCMI) • www.wastewise.com","truncated":false,"body_characters":8954}