{"operation":"document","citation":"99-0192","title":"Bio-Safe America, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"1999-12-16","effective_on":null,"summary":"99-0192 response to Bio-Safe America, Inc. concerning 173.134.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0192.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0192.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-99-0192","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/1999/990192.pdf","body":"<<<PAGE 1>>>\n\nUS.Department\n400 Seventh Street, S.W.\nof Transportation\nWashington, D.C\n20590\nResearch and\nSpecial Programs\nAdministration\nDEC | 6 1999\nMs. Samantha Burdick\nRef. No. 99-0192\nOffice Manager\nBio-Safe America, Inc.\n4301 32nd Street West, Suite C-16\nBradenton, Florida 34205\nDear Ms. Burdick:\nThis is in response to your letter dated July 12, 1999, requesting clarification of the packaging\nexceptions in 49 CFR 173.134(b)(3) for \"Regulated Medical Waste, 6.2, UN 3291, PG I'\" in the\nHazardous Materials Regulations (HMR; 49 CFR Parts 171-180).\nYour understanding of the exceptions in § 173.134(b)(3) is correct. As provided by § 173.134(b)(3),\na regulated medical waste that is transported by a private or contract carrier is excepted from: (1) the\n\"INFECTIOUS SUBSTANCE\" label, if the-outer packaging is marked with a \"BIOHAZARD\"\nmarking conforming to 29 CFR 1910.1030, and (2) for other than a waste culture or stock of an\ninfectious substance, the specific packaging requirements in § 173.197, if packaged in a rigid, non-bulk\npackage conforming to §§ 173.24 and 173.24a, and 29 CFR 1910.1030.\nI hope this satisfies your request.\nSincerely,\nDelmer F. Billings\nChief, Standards Development\nOffice of Hazardous Materials Standards\n173.13\n990192\n\n<<<PAGE 2>>>\n\nBoothe\nJuly 12,1999\n§173.134\nMr. Edward Mazzullo, Director\n99-0192\nUS DOT/RSPA\n400 7% Street S.W.\nWashington, D.C. 20590\nDear Mr. Mazzullo:\nI am wating in reference to the US DOT regulations pertaining to containers manufacture\nor the transportation of regulated medical waste. I was referred to you by Mr. Arthu\nPollack in the standards division in regard to obtaining a letter from your office regatding\ncertain exceptions to the packaging requirements.\nCFR 49 Parts 100-185 set forth the regulations for transportation of all hazardous materials,\nincluding regulated medical waste. Bio-Safe America, Inc. is a medical waste transporter and,\npackaging and marking requirements for various types of carriers and different types of\ntheretore, must comply with these regulations. However, there are exceptions to the\nsubstances being transported.\nPart 173.197 sets forth the packaging regulations for regulated medical waste. In this section,\nminimum construction standards are established, testing and certification procedures are\ndiscussed (specific testing procedures are located in parts 173.24 and 173.242), and UN\nStandard Packaging (UN markings, numbers) is defined. However, part 173.134 sets forth\nEXCEPTIONS to the packaging requirements for regulated medical waste in part 173.197.\nBased on our interpretation of the regulations, we believe that our boxes do not require\ntesting or certification based on several of these exceptions. I have indicated below those\nthat apply to Bio-Safc Amrica, Inc. directly. The specific exceptions are as follows:\n173.134 Packaging Exceptions\nA Regulated Medical Waste that is transported by a private or contract carrier (Bio-Safe\nAmerica is a contract carrier) is excepted from:\n1. Infectious Substance label, if the outer packaging is marked with a \"biohazard\" marking\n(Bio-Safe America's boxes have always been printed with the international biohazard\nsymbol and the word \"biohazard\").\nrequirements that Bio-Safe America's containers comply with.\nBIO-SAFE AMERICA, INC.\n4301 32ND STREET WEST, SUITE C-16\nBRADENTON, FL 34205\n\n<<<PAGE 3>>>\n\n-2-\nJuly 12,1999\nParts 173.24 and 173.24a set forth General Non-Specification and Specification Packaging\nRequirments for hazardous materials:\n1. There will be no identifiable leakage.\n2. The effectiveness of the package will not be substantially reduced due to temperature\nchanges or weather conditions.\n3. Inner packaging (bags) must be secured to prevent leakage.\nUnder normal use and conditions, Bio-Safe America's boxes meet all of the above\nspecifications.\nBased on this information, it is our understanding that our containers are not subject to UN\nStandard Packaging requirements, including testing and certification, UN markings, and\nidentification numbers.\nindividuals in your department, including Ms. Helen Engrum and Mr. Arthur Pollack, both\nAs part of my research in this matter, I have had several telephone conversations with\nregulatory specialists. I also spoke with Mr. Phil Olsen at the office of the Associate\nAdministrator, Mr. Alan Roberts. After I had explained our situation to them, each of these\nindividuals verbally agreed with our interpretation of the exceptions in the regulations. I am\nnow, however, in need of written clarification of this information from your office.\nPlease call me at 941-755-1921 with any questions or comments regarding this matter. If\npossible, please fax your response to this inquiry to my attention at 941-753-1416.\nThank you for your time and attention in this matter.\nSincerely,\nSinteth\nSamantha Burdick\nOffice Manager","truncated":false,"body_characters":4839}