{"operation":"document","citation":"21-0019","title":"Burlington Products, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2021-05-26","effective_on":null,"summary":"21-0019 response to Burlington Products, Inc. concerning 173.196, 178.601, 178.609.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0019.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0019.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-21-0019","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/75071/210019.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nMay 26, 2021\nBill Greene\nBurlington Products, Inc.\n70 East Sunrise Highway\nSuite 500\nValley Stream, NY 11581\nReference No. 21-0019\nDear Mr. Greene:\nThis letter is in response to your March 1, 2021, email, and subsequent phone conversation and\nemail, requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-\n180) applicable to the packaging requirements for infectious substances.\nWe have paraphrased and answered your questions as follows:\nQ1. You ask whether a plastic bag used as the primary receptacle or secondary packaging for\nthe packaging of a Category A or B infectious substance is required to have a certified lab\ntest the plastic bag to determine that it meets the capability performance standard of not\nleaking at an internal pressure of 95 kPa (0.95 bar, 14 psi).\nA1. The answer is no. Laboratory certification is not a specific condition of meeting the\ncapability standard associated with the internal pressure requirement for primary or\nsecondary packaging.\nQ2. You ask what a bag manufacturer must do to satisfy the “must be capable of”\nrequirement concerning a plastic bag’s ability to meet a pressure requirement.\nA2. The internal pressure requirement for a primary receptacle or secondary packaging used\nfor Category A or Category B infectious substances is a capability performance standard.\nThe HMR does not specify the manner in which this performance standard must be met.\nThe bag manufacturer should use its expertise and knowledge regarding the design and\nmaterials used in the production of the packaging when making this determination in the\nabsence of choosing to perform tests.\n\n<<<PAGE 2>>>\n\nQ3. You ask what temperature must the plastic bag be conditioned to prior to pressure testing\nthe primary or secondary plastic bag packaging used to ship infectious substances\n(Category A or B) by ground or air.\nA3. The HMR does not specify temperature conditioning requirements associated with the\nperformance of an internal pressure test for these packagings. However, with respect to\nCategory A infectious substance packaging standards, the primary receptacle or\nsecondary packaging must be capable of withstanding, without leakage, temperatures in\nthe range of −40 °C to + 55 °C (−40 °F to + 131 °F) (see § 173.196(a)(7)). Furthermore,\nCategory A infectious substance packaging must meet the test standards of § 178.609 for\nthe completed package and is subject to conditioning requirements (see paragraphs (b)\nand (f)) for performance of certain tests. For Category B infectious substance packages,\nthere is a standard that the effectiveness of the completed package must not be\nsubstantially reduced for minimum and maximum temperatures, normally encountered\nduring transportation, as well as an integrity requirement associated with refrigerated or\nfrozen specimens.\nQ4. You ask whether a pressure-sustaining bag used as a component in a combination\npackaging can be altered per § 178.601(g)(4) without further testing.\nA4. The selective testing and packaging variations of § 178.601(g), including paragraph\n(g)(4), are not applicable. Infectious substance packagings are subject to test\nrequirements in § 178.609, which outlines authorized variations in the primary receptacle\nof a tested package in § 178.609(i).\nQ5. What is the distinction in the regulations between a “leak-tight bag” and a “leakproof\nbag?”\nA5. For the purposes of the HMR, there is a no distinction. The term “leakproof” is\ncommonly used in the HMR in association with a test (i.e., leakproofness test) used to\ndetect leaks in a packaging to ensure a package is free from leakage. “Leaktight” is\nanother term that is used to describe a packaging, including its closures or valves, which\nis free from leakage.\nI hope this information is helpful. Please contact us if we can be of further assistance.\nSincerely,\nDirk Der Kinderen\nChief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nCiccarone\n21-0019\nFrom: INFOCNTR (PHMSA)\nTo: Subject: Date: Dodd, Alice (PHMSA); Hazmat Interps\nFW: Request for Letter of Interpretation\nMonday, March 1, 2021 12:02:17 PM\nHi Alice,\nPlease see below for a letter of interpretation request. When speaking with Breanna this morning,\nhe stated that he would like a three week turnaround on the letter. Please contact our office with\nany questions.\nThank you,\nSarah (HMIC)\nFrom: service@burlingtonproducts.com [mailto:service@burlingtonproducts.com]\nSent: Monday, March 1, 2021 10:23 AM\nTo: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov>\nSubject: RE: Request for Letter of Interpretation\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or\nopen attachments unless you recognize the sender and know the content is safe.\nJonathon -\nThank you for your prompt acknowledgment of receipt.\nThe information you requested:\nWilliam Greene\nBurlington Products\n70 East Sunrise Highway, Suite 500\nValley Stream, NY 11581\n718-797-4940\nBill Greene\nBURLINGTON PRODUCTS, INC.\nUN Standard & Custom Containers for Hazardous Materials\n718.797.4940\nservice@burlingtonproducts.com\nFrom: \"INFOCNTR (PHMSA)\" <INFOCNTR.INFOCNTR@dot.gov>\nSent: 3/1/21 10:14 AM\nTo: \"service@burlingtonproducts.com\" <service@burlingtonproducts.com>\nSubject: RE: Request for Letter of Interpretation\n\n<<<PAGE 4>>>\n\nDear Bill,\nWe have received your request for a written letter of interpretation regarding the hazardous\nmaterials regulations (49 CFR Parts 171-180). The hazardous materials regulations are available\nat the following URL:\nhttps://www.phmsa.dot.gov/phmsa-regulations\nHowever, before we can submit your request for processing, please respond to this email with:\nFull Name\nPhysical Mailing Address\nTelephone Number\nSincerely,\nJonathon, Hazardous Materials Specialist\nAn e-mail response from this office is considered informal guidance. Formal guidance may be\nrequested in accordance with 49 CFR 105.20. https://www.phmsa.dot.gov/standards-\nrulemaking/hazmat/hazardous-materials-information-center\nFrom: service@burlingtonproducts.com [mailto:service@burlingtonproducts.com]\nSent: Monday, March 1, 2021 10:08 AM\nTo: INFOCNTR (PHMSA) <INFOCNTR.INFOCNTR@dot.gov>\nSubject: Request for Letter of Interpretation\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do not click on links or\nopen attachments unless you recognize the sender and know the content is safe.\n\n<<<PAGE 5>>>\n\nI am writing to request a Letter of Interpretation concerning the questions addressed below.\nAt issue is a plastic bag that has been pressure tested to 95kPa so that it can be used as the\nprimary or secondary\npackaging to ship diagnostic specimens, infectious substances and other biohazards (Class A\nand Class B) via ground or air.\n1 Does the insertion of an absorbent pad into the bag thereby disqualify the bag's pressure\ncertification?\n2 Must the bag be tested with the absorbent pad inserted into the bag in order to be properly\nqualified?\n3 If the second question is answered affirmatively, must the bag be tested with each different\ntype or different size\nof absorbent pad or are there permitted substitutions or exceptions?\n4 If the third question is answered affirmatively, what are the permitted substitutions?\n5 If a plastic bag that has been pressure tested to 95kPa to qualify as a primary or secondary\npackaging, does the\nrule expressed in §178.601(g)(4)(i) apply, assuming all other criteria in (4) Variation 4 are met?\nThere is some urgency to these issues and a reply at your earliest convenience would be greatly\nappreciated.\nThank you very much for your help with this matter.\nWilliam Greene\nBurlington Products\nBill Greene\nBURLINGTON PRODUCTS, INC.\nUN Standard & Custom Containers for Hazardous Materials\n718.797.4940\nservice@burlingtonproducts.com","truncated":false,"body_characters":7943}