{"operation":"document","citation":"12-0243","title":"New York State Department of Environmental Conservation — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2013-03-08","effective_on":null,"summary":"12-0243 response to New York State Department of Environmental Conservation concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0243.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0243.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-12-0243","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2012/120243.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\nMAR 0 8 2013\nAlan G. Woodard, Ph.D.\nBureau of Permitting and Planning\nDivision of Materials Management\nNew York State Department ofEnvironmental Conservation\n625 Broadway\nAlbany, NY 12233-7258\nReference No. 12-0243\nDear Mr. Woodard:\nThis is in response to your October 26, 2012 e-mail, and October 4 and 26, 2012 telephone\nconversations with a member of my staff requesting clarification of the Hazardous Materials\nRegulations (HMR; 49 CPR Parts 171-180) applicable to the transportation of waste\n\"agricultural clearance material\" (e.g., food, table and galley refuse, packaging, passenger\nwaste, etc.), as this term is defined and regulated by the U.S. Department of Agriculture's\nAnimal Plant Health Inspection Service (APHIS).\nIn your letter, you state these wastes typically are not contaminated with an infectious\nsubstance but some have been found to contain botulism, bacillus anthracis, and foreign\nbiological agents. You also state APHIS requires these materials to be removed from any\nmeans of conveyance during interstate or international transportation and destroyed in the\nsame manner as \"UN 3271, Regulated medical waste, n.o.s., 6.2 (infectious), PG II\"\n(RMW), to minimize introducing plant pests and animal diseases in the United States. You\nasked in your telephone conversation if agricultural clearance material may be excepted\nfrom regulation as a Division 6.2 material in conformance with§ 173.134(b)(l6), when it is\ndescribed as \"agricultural products\" and/or \"food,\" and offered, transported, and treated for\ndisposal in the same manner as RMW.\nThe answer is yes provided the agricultural clearance materials 1) are \"agricultural\nproducts\" or \"food\" as these terms are generally defined by the Food and Drug\nAdministration under the Federal Food, Drug, and Cosmetics Act (FFDCA; 21 U.S.C. 301\net. seq.), or 2) comply with an exception PHMSA added in 2011 under 49 CPR\n173.134(c)(2). Section 173.134(b)(16) states material known or suspected ofbeing\ncontaminated with a Division 6.2 material that also meets the definitions in 21 U.S.C. § 332\net. seq. of the FFDCA for either \"agricultural products\" or \"food\" is excepted from\nregulation under the HMR. By excepting agricultural products and food contaminated with\nDivision 6.2 material from regulation under the HMR, this Office intended to avoid\nunnecessary duplication of existing Department ofHealth and Human Services' Food and\nDrug Administration (FDA) regulations for managing and transporting these materials (see\nDocket No. PHMSA-2004-16895 (HM-226A); 70 FR 29170 and 71 FR 32244). The\n\n<<<PAGE 2>>>\n\nPipeline and Hazardous Materials Safety Administration (PHMSA) recently learned that the\nFederal Food, Drug, and Cosmetics Act (FFDCA; 21 U.S.C. 301 et. seq.) does not define\n\"agricultural products\" or \"food\" in 21 U.S.C. 332; therefore, the reference in\n§ 173 .134(b )(16) to these FFDCA terms is in error (this section refers to injunction\nproceedings only). PHMSA will make necessary corrections in a future rulemaking.\nThe exception prescribed in § 173 .134( c )(2) permits the following materials to be offered\nfor transportation and transported as RMW when packaged in a rigid non-bulk packaging\nconforming to the general packaging requirements of§§ 173.24 and 173.24a and packaging\nrequirements specified in 29 CFR 1910.1030, and transported by a private or contract carrier\nin a vehicle used exclusively to transport RMW:\n1) waste stock or culture of a Category B infectious substance;\n2) plant and animal waste regulated by the APHIS;\n3) waste pharmaceutical materials;\n4) laboratory and recyclable wastes;\n5) infectious substances that have been treated to eliminate or neutralize pathogens;\n6) forensic materials being transported for final destruction;\n7) rejected or recalled health care products;\n8) documents intended for destruction in accordance with the Health Insurance\nPortability and Accountability Act of 1996 (HIP AA) requirements; and\n9) medical or clinical equipment and laboratory products provided they are properly\npackaged and secured against exposure or contamination (see Docket No.\nPHMSA-2009-0151 (HM-218F), July 20,2011 (76 FR 43530)).\nIf APHIS considers \"agricultural clearance material\" to be included in its definitions for\nplant and animal waste, the shippers transporting this material may wish to use the\n§ 173 .134( c )(2) exception. This exception also requires sharps containers to be securely\nclosed to prevent leaks or punctures. In addition, § 172.202( e) permits a non-hazardous\nmaterial to be described on a shipping paper with a proper shipping name from the\nHazardous Materials Table(§ 172.101 Table) provided the hazard class number and\nidentification number are not included. If none of these exceptions are satisfactory, the\n· HMR prescribes that only materials known or suspected of being contaminated with a\nCategory B, Division 6.2 material may be described and transported in commerce as\n\"Regulated medical waste\" (see § 171.2(k)).\nI hope this satisfies your request.\nSincerely,\nT. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\n2\n\n<<<PAGE 3>>>\n\nDrakeford, Carolyn (PHMSA)\nFrom:\nSent:\nTo:\nCc:\nSubject:\nEdmonson, Eileen (PHMSA)\nFriday, October26, 20121:05 PM\nDrakeford, Carolyn (PHMSA)\nFoster, Glenn (PHMSA)\nFW: Agricultural Clearance Material/Regulated Garbage\nI /lLl.n 12-()G?<-f\\.J\nHi Carolyn,\nCan you please log this letter in the system.\nThanks,\nEileen Edmonson\nUSDOT/PHMSA\n(202) 366-4481 (w)\n(202) 366-7041 (f)\neileen.edmonson@dot.gov (e-mail)\nhttp://www. phmsa.dot.gov/hazmat (website)\ninfocntr@dot.gov (Hazmat Info Center E-mail)\nFrom: Alan Woodard [mailto:agwoodar@gw.dec.state.ny.us]\nSent: Friday, October 26, 2012 1:02PM\nTo: Edmonson, Eileen (PHMSA)\nSubject: Re: Agricultural Clearance Material/Regulated Garbage\nHello Eileen:\nStill working on the pharmaceutical waste issue which eventually we will discuss with you. Another nuance has\nsurfaced. APHIS requires \"Agricultural Clearance Material\" removed from any means of conveyance during international\nor interstate movements that is comprised of food, table refuse, galley refuse, packaging, passenger waste, etc., to be\nplaced in specific packaging, labeled as regulated garbage, and transported and treated before disposal as though it is a\nmedical waste. Although there have been incidents of garbage containing food contaminated with botulism or foreign\nbiological agents, animal skins contaminated with B. anthracis, etc., typically the material is not contaminated. APHIS\nrequires that it be removed in this manner to prevent the introduction and spread of exotic plant pests and\ndiseases. Regulated medical waste (RMW) handlers/transporters collect this material for processing. Stericycle obtains\nquantities of the material in New York State and ships it with RMW to their commercial autoclaves for treatment and\neventual disposal. My understanding is it is being shipped in this manner in other locations throughout the U.S. USDOT\nregulations except agricultural products and food contaminated with infectious substances but does not address APHIS\nregulated garbage specifically. Does this exception apply to regulated garbage? We believe that since this type of\ngarbage being transported for treatment as though it were potentially infectious or capable of causing public health or\nenvironmental harm, it should be packaged and labeled as RMW. Does PHMSA agree? If not, what is your opinion on\nhow it should be regulated/excepted under the HMR? Thanks\nAlan\nAlan G. Woodard, Ph.D.\nNew York State Department of Environmental Conservation\nDivision of Materials Management\nBureau of Permitting & Planning\n625 Broadway\nAlbany, New York 12233-7258\n1\n\n<<<PAGE 4>>>\n\nOffice: (518) 402-8706\nFax: (518) 402-8681\nE-Mail :agwoodar@gw .dec.state.ny. us\n2","truncated":false,"body_characters":7953}