{"operation":"document","citation":"01-0101","title":"BD Preanalytical Solutions — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2001-08-20","effective_on":null,"summary":"01-0101 response to BD Preanalytical Solutions concerning 173.4.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0101.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0101.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-01-0101","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2001/010101.pdf","body":"<<<PAGE 1>>>\n\n* ..\nof Transportation\nU.S.Department\n400 Seventh Street, S.W.\nWashington, D.C. 20590\nResearch and\nAUG 2 0 2001\nAdministration\nSpecial Programs\n•\nMs. M. Wendy Bosshardt\nRegulatory Affairs Specialist\nRef. No. 01-0101\nBD Preanalytical Solutions\n1 Becton Drive\nFranklin Lakes, NJ\n07417\nDear Ms. Bosshardt:\nThis is in response to your April 24, 2001, letter and subsequent\ntelephone conversation with a member of my staff, requesting\nclarification on the small quantity exception under the Hazardous\nMaterials Regulations (HMR; 49 CER Parts 171-180). Specifically,\nyou ask if a vacuum (i.e., negative pressure) in each receptacle\nand shrink wrap around the tray and stoppered tubes meet the\nrequirement for a positive closure as specified in § 173.4 (a) (3)\nof the HMR. You sent in a sample packaging for our review.\nTo qualify for the small quantity exception, each inner\nreceptacle with a removable closure must have the closure held\nsecurely in place with wire, tape, or other positive means.\npositive means of closure.\n[S 173.4 (a) (3)] Negative pressure in a receptacle is not a\nwhich securely holds each tube's closure in place may be used to\nHowever, shrink wrap around the tray\nsatisiy the requirement of § 173.4 (a) (3) •\nBased on the sample\nwhich you submitted we note that the shrink wrap is placed\nloosely over the test tubes and may not ensure that test tubes in\nthe center of the tray have their closures held in place by\npositive means. This could easily be corrected by placing a\npiece of fiberboard or other such material over the test tubes\nbefore the shrink wrap is affixed or by placing the shrink wrap\ntightly around the test tubes.\nI hope this satisfies your request.\nSincerely,\nTransportation Regulations Specialist\nOffice of Hazardous Materials Standards\n\n<<<PAGE 2>>>\n\n:\n- * m Becton Drive\nBD Preanalytical Solutions\n+ BAH.\ntel: 201.847.4500\nFranklin Lakes, New Jersey 07417\nwww.bd.com\nSmall Quantity Exceptions\n01-0101\n•\nBD\nIndispensable to\nhuman health\nApril 24, 2001\nMr. Edward T. Mazzullo\nDirector, Office of Hazardous Materials Standards (DHM-10)\nResearch and Special Programs Administration ('RSPA\")\n400 7* Street, SW\nU.S. Department of Transportation\nWashington, DC 20590-0001\nFacsimile (202) 366-3012\nDear Mr. Mazzullo:\nEnclosed are plastic blood collection tubes for Demonstration Purposes Only with an\nvisual purposes only. The plastic tubes are to demonstrate our belief that our product has\nexplanation letter. We have provided plastic, unlabeled empty blood collection tubes for\na positive means of closure that will support BD's certification in accordance with HMR\n§ 173.4(a)(10).\nlach blood collection tube is sealed with a rubber stopper, the negative pressure of th\nvacuated tube provides positive means of closure and the use of plastic shrink wrappins\nof the seal tubes within the polystyrene tray provide further positive means of closure.\nThank you for your assistance and we look forward to hearing from you. If you need any\nfurther information regarding our products please do not hesitate to contact me at (201)\n847-6280.\nRegards,\nwendy sasharat\nM. Wendy Bosshardt\nRegulatory Affairs Specialist\nBecton, Dickinson and Company","truncated":false,"body_characters":3184}