{"operation":"document","citation":"23-0087","title":"North Carolina Department of Health and Human Services — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2024-01-22","effective_on":null,"summary":"23-0087 response to North Carolina Department of Health and Human Services concerning 171.8, 173.199.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0087.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0087.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-23-0087","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/docs/standards-rulemaking/hazmat/interpretations/78141/230087.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous\nMaterials Safety\nAdministration\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nJanuary 22, 2024\nKristi Jenkins\nNorth Carolina Department of Health and Human Services\nState Laboratory of Public Health\n4312 District Drive\nRaleigh, NC 27607\nReference No. 23-0087\nDear Ms. Jenkins:\nThis letter is in response to your September 29, 2023, email, and subsequent emails requesting\nclarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable\nto the reuse of a rigid outer packaging when shipping a Category B infectious substance. You\nstate that facilities are shipping Category B infectious substances in a “triple packaging”\n—\nconsisting of a new primary receptacle, a new secondary packaging, and a reused rigid outer\npackaging—and that the completed packaging is appropriately marked and labeled as required. It\nis your understanding that the reused rigid outer packaging is permitted for Category B infectious\nsubstances provided it is not contaminated or damaged in any way; however, you seek\nclarification and ask questions regarding the drop test and recordkeeping requirements for reused\npackagings.\nWe have paraphrased and answered your questions as follows:\nQ1. As required by § 173.199(a)(4), you ask how the 1.2 meter (3.9-ft.) drop test is verified\nwhen a rigid outer packaging is reused for a Category B infectious substance package.\nA1. The HMR requires a Category B infectious substance to be packaged in a triple\npackaging consisting of a primary receptacle, a secondary packaging, and a rigid outer\npackaging. Although Category B infectious substances are not subject to any other\nrequirements in the HMR when following § 173.199, we note that as defined in § 171.8\nan outer packaging means the outermost enclosure of a composite or combination\npackaging together with any absorbent materials, cushioning and any other components\nnecessary to contain and protect inner receptacles or inner packagings. Further, a “rigid\npackaging”1 is a packaging that is sufficiently stiff and unyielding as to always retain its\noriginal shape and dimensions under all conditions of transportation. A person can verify\ndrop test capability from the manufacturer or distributor of the packaging or perhaps a\nprevious shipper (consignor) of a Category B infectious substance package. Note, if a\n\n<<<PAGE 2>>>\n\nperson is unable to verify drop test capability of a Category B infectious substance\npackaging such that there is uncertainty in complying with performance standards of\n§ 173.199, it is recommended that a person should not reuse the rigid outer packaging for\nCategory B shipments.\nQ2. You ask how a person can verify the 1.2 meter (3.9-ft.) drop test capability when reusing\nan outer “brown box” as the rigid outer packaging of a Category B infectious substance\npackage. You state that the “brown box” was previously used to transport reagents or\nother materials.\nA2. Capability may be demonstrated by testing, assessment, or experience. This may be\nsatisfied using a number of methods, including actual previous handling and\ntransportation experience, design, construction, filling, and closure instruction\ninformation, or absent such methods, through the performance of a drop test. It is the\nshipper’s responsibility to ensure that the “brown box” rigid outer packaging—in\ncombination with the other packaging components—meet the performance standards of\n§ 173.199. Based on the photograph you provided as a reference, the “brown box” must\nbe a “rigid outer packaging” in accordance with § 173.199(a)(1).\nQ3. You ask whether a person reusing a “brown box” rigid outer packaging and marking it as\na Category B infectious substance for transportation is permitted to do so without\nobtaining proof that the “brown box” rigid outer packaging has passed the 1.2 meter\n(3.9ft.) drop test as required in § 173.199(a)(4).\nA3. The HMR do not define a specific method for validating package capability, however the\nperson filling and marking the package as a Category B infectious substance assumes\nresponsibility for the package capability. Please note examples of verification\nmethods in answer “A2.”\nQ4. You ask how a shipper complies with the record retention requirements—i.e., keeping a\ncopy of the packaging instructions for one year—if a person reuses a “brown box” rigid\nouter packaging as part of a Category B infectious substance package.\nA4. If a shipper uses a completed Category B infectious substance package, they should be\nprovided clear instructions on filling and closing a packaging from the manufacturer and\nsubsequent distributor in accordance with § 173.199(a)(10). If a shipper is reusing a\n“brown box” as a rigid outer packaging as part of a Category B infectious substance\npackage where the (re)shipper has not been provided filling and closure instructions by\nthe original shipper (consignor), a downstream shipper would then assume the role as the\n“manufacturer” subject to the requirements of § 173.199 and would be responsible for\ncreating their own filling and closure instructions—to include complying with record\nretention requirements. Note, a shipper must perform due diligence to obtain instructions\non filling and closing of a packaging from the manufacturer or subsequent distributor if\nunable to obtain these instructions from a previous shipper.\n\n<<<PAGE 3>>>\n\nQ5. You ask whether a person who prepares the completed Category B infectious substance\npackage—i.e., not the packaging manufacturer or subsequent distributors of the\npackagings—is excepted from the record retention requirements for filling and closure\ninstructions as prescribed in § 173.199(a)(10).\nA5. See answer A4.\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 4>>>\n\nBaker\n23-0087\nFrom: Baker, Yul (PHMSA)\nTo: Dodd, Alice (PHMSA)\nCc: Jones, Jessie Jane CTR (PHMSA); DerKinderen, Dirk (PHMSA)\nSubject: FW: Category B regulations interpretation\nDate: Tuesday, October 3, 2023 11:42:59 AM\nImportance: High\nMorning Alice,\nCan you please upload the following e-mail below into our interp database as a request for interpretation\nand assign the request to me?\nThank you,\nMr. Yul Brenner Baker Jr.\nTransportation Regulations Specialist, Standards Development\nUSDOT, PHMSA\nPipeline and Hazardous Materials Safety Administration\n1200 New Jersey Ave, SE, Washington, DC, 20590\nOffice number: 717-688-9977\nFrom: Jenkins, Kristi W <kristi.jenkins@dhhs.nc.gov>\nSent: Friday, September 29, 2023 2:36 PM\nTo: Baker, Yul (PHMSA) <yul.baker@dot.gov>\nSubject: FW: Category B regulations interpretation\nImportance: High\nCAUTION: This email originated from outside of the Department of Transportation (DOT). Do\nnot click on links or open attachments unless you recognize the sender and know the content\nis safe.\nGood afternoon, Yul. I have not been able to get my email request below to go through; it has been\nrejected since I’m not a member of the group. So I was provided your email and am hoping you can\nhelp answer my questions or direct me to someone who can provide an interpretation of the\nregulations in regards to my questions below.\nThank you so much!\nKristi Jenkins, MT(ASCP)\nLaboratory Improvement Consultant, Bioterrorism & Emerging Pathogens Unit\nDivision of Public Health, NC State Laboratory of Public Health\nNC Department of Health and Human Services\n828-772-9372 mobile\n919-807-8600 24/7 Duty Phone\nkristi.jenkins@dhhs.nc.gov\n\n<<<PAGE 5>>>\n\nSTATE LABORATORY OF PUBLIC HEALTH\n4312 District Drive\nRaleigh, NC 27607\nNC DHHS provides essential services to improve the health, safety and well-being of all North\nCarolinians. Learn more about NCDHHS initiatives and priorities.\nFrom: Jenkins, Kristi W\nSent: Friday, September 29, 2023 11:58 AM\nTo: hazmatinterps@dot.gov\nCc: Martin, Luke (PHMSA) <luke.martin@dot.gov>; Hatfield, Clayton (PHMSA)\n<clayton.hatfield@dot.gov>\nSubject: Category B regulations interpretation\nImportance: High\nTo Whom it May Concern:\nI provide the packaging and shipping training for infectious substances here in North Carolina and\nhave a few questions that I need some interpretation for to ensure I am training staff correctly. Any\nguidance you could provide would be greatly appreciated!\nDue to limited funding, facilities are re-using boxes instead of using a new Category B box each time\nthey have a shipment. They are triple packing as required and relabeling the outside of the box with\nappropriate Category B markings and labels. My understanding has always been that this is\nappropriate as long as the box is not contaminated or damaged in any way. However, this has raised\nsome questions that I can’t seem to reconcile with the regulations.\n1. How is the 4 ft drop test requirement verified when packing material is being re-used? If\nsomething happens to a Cat B package in transit, how would staff verify this requirement if\njust using a brown box from a previous shipment and triple packing it? Is it safe to assume\nthat all packages received, passed that requirement at the manufacturer’s end, or is that only\na requirement for Category B packing material?\n2. How do shippers comply with the record retention requirement of keeping a copy of the\npacking instructions for 1 year if they are re-using boxes that did not come with packing\ninstructions? I recently discovered that 173.199(a)(10) says a copy of the instructions must be\nkept by the manufacturer and subsequent distributors for at least one year from the date of\nissuance. Does this mean that shippers are exempt from this requirement?\nThank you for your assistance!\n\n<<<PAGE 6>>>\n\nKristi Jenkins, MT(ASCP)\nLaboratory Improvement Consultant, Bioterrorism & Emerging Pathogens Unit\nDivision of Public Health, NC State Laboratory of Public Health\nNC Department of Health and Human Services\n828-772-9372 mobile\n919-807-8600 24/7 Duty Phone\nkristi.jenkins@dhhs.nc.gov\nSTATE LABORATORY OF PUBLIC HEALTH\n4312 District Drive\nRaleigh, NC 27607\nNC DHHS provides essential services to improve the health, safety and well-being of all North\nCarolinians. Learn more about NCDHHS initiatives and priorities.\nEmail correspondence to and from this address is subject to the North Carolina Public Records Law and may be disclosed to third parties\nby an authorized State official. Unauthorized disclosure of juvenile, health, legally privileged, or otherwise confidential information,\nincluding confidential information relating to an ongoing State procurement effort, is prohibited by law. If you have received this email in\nerror, please notify the sender immediately and delete all records of this email.","truncated":false,"body_characters":10739}