{"operation":"document","citation":"11-0204","title":"Law Offices of James Kean — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-12-21","effective_on":null,"summary":"11-0204 response to Law Offices of James Kean concerning 172.315, 173.27.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0204.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0204.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0204","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110204.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department 1200 New Jersey Avenue SE\nof Transportation Wasllingloll, DC 20590\nPipeline and Hazardous\nMaterials Safety\nAdministration\nDEC 2 1 2011\nMr. James Campbell Kean, JD, LLM\nMaster of Laws, Environment and Energy Law\nLaw Offices of James Kean\n2 Hilshire Oaks Court\nHouston, TX 77055\nRef. No. 11-0204\nDear Mr. Kean:\nThis responds to your August 17,2011 request for clarification of the Hazardous Materials\nRegulation' s (HMR~ 49 CPR Parts 171-180) exception for biological products or medical\npreparations in § 173.306(b)(3). In your letter, you present your specific interpretations of\nconditions specified in the exception applicable to a particular scenario. You ask that we\ncomment on the accuracy of each of your interpretations. Your interpretations of\n§ 173.306(b)(3) and PHMSA's responses are as follows:\n(1) Scenario: Division 2.1 (Flammable gas) medicinal aerosols and inhalers (each of\nwhich meet the exception criteria) are covered under this provision, even though the\nmetal aerosols and inhalers may contain flammable gases.\nResponse: Your understanding is correct, provided the medicinal aerosols and inhalers\notherwise meet all of the conditions as described in the exception in § 173.306(b)(3).\nDivision 2.1 (Flammable gas) materials may not be transported in plastic containers\nunder this exception.\n(2) Scenario: The capacity limitation (not to exceed 35 cubic inches (19.3 fluid ounces»\napplies separately to each individual container. There is no limit to the number of\nseparate containers that may be placed together inside one outer container. In other\nwords, multiple individual Division 2.1 medicinal aerosols and/or inhalers (each of\nwhich meet the exception criteria) may be placed within one outer container.\nResponse: Your understanding that the capacity limitation applies separately to each\nindividual container is correct. Your understanding that there is no limit to the number\nof separate containers that may be placed together inside one outer packaging is\nincorrect. The introductory paragraph to § 173.306(b) states that for trans portation by\naircraft the net quantity per package may not exceed the quantity specified in column\n(9A) of the Hazardous Materials Table in § 172.10 l. Further, the gross weight of the\n\n<<<PAGE 2>>>\n\ncompleted package must not exceed 30 kg (66 pounds) for any mode of transportation\n(§ 173.306(a».\n(3) Scenario:·Where the exception criteria specify \"strong outside packaging,\" any outer\ncontainer that meets the, general packaging requirements of 49 CFR 173.24 will\nsuffice.\nResponse: Your understanding is incorrect. \"Strong outer packaging,\" synonymous\nwith \"strong outside packaging,\" is defined in § 171.8 as the outermost enclosure that\nprovides protection against the unintentional release of its contents. It is a packaging\nthat is sturdy, durable, and constructed so that it will retain its contents under normal\nconditions of transportation. In addition, a strong outer packaging must meet the\ngeneral requirements of subpart B of part 173. For transportation by aircraft, a strong\nouter packaging is subject to § 173.27.\n(4) Scenario: Other than the reference to \"strong outside packaging\" there are no special\nlabeling or packaging requirements that apply to Division 2.1 (Flammable gas)\nmedicinal aerosols and inhalers (each of which meet the exclusion criteria).\nResponse: Your understanding is incorrect. When transporting materials in\naccordance with the exception in § 173.306(b)(3) by aircraft, the package must be\nlabeled as specified in Part 172, Subpart E. The package must be marked in\naccordance with § 172.315. For packaging requirements, please see the Response to\nScenario 3 provided above.\nI hope this answers your inquiry. If you need additional assistance, please contact this office\nat (202) 366-8553.\nBenSupko\nActing Chief, Standards Development\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nJames Kean, ID, LLM\nMaslcl· of lAws\nEIlVirolllll('tlt., E:nerglj allll\nNatllrtll ROSOllrCi!S\n8/17111\nMr. T. Glenn Foster\nChief, Regulatory Review and Reinvention Branch\nStandards and Rulemaking Division\nUS Department of Transportation\nPipeline and Hazardous Materials Safety Administration\nEast Building, 2nd Floor\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nRe: Request for a Formal Letter of Interpretation 49 CFR Section 173.306(b)(3)\nDear Mr. Foster~\nThis is a request for a fomlai letter of interpretation regarding the exclusion of certain\nlimited quantities of compressed gases from certain labeling and packaging requirements.\n49 173.306(b)(3) states:\n\"Nonrefillable metal or plastic containers charged with a Division 6.1 Packing\nGroup III or nonflammable solution containing biological products or a medical\npreparation which could be deteriorate by heat, and compressed gas or gases.\nPlastic containers must only contain 2.2 nonflammable soluble or emulsified\ncompressed gas. The capacity of each container may not exceed 35 cubic inches\n(19.3 fluid ounces). The pressure in the container may not exceed 140 psig at 130\n[deg]F, and the liquid content of the product and gas must not completely till the\ncontainers at 130 [deg]F. One completed container out of each lot of 500 or less.\nfilled for shipmen~ must be heated, until the pressure in the container is\nequivalent to equilibrium pressure of the contents at 130 [deg]F. There must be\nno evidence of leakage, distortion, or other defect. The container must be packed\nin strong outside packagings.\"\nFor clarity's sake, we request written interpretation on each ofthe following points:\n1. Class 2.1 medicinal aerosols and inhalers (each of which meet the exclusion\ncriteria) are covered under this provision, even though the metal aerosols and\ninhalers may contain flammable gases.\n\n<<<PAGE 4>>>\n\n2. The capacity limitation (not to exceed 35 cubic inches (19.3 fluid ounces)) applies\nseparately to each individual container. There is no limit to the number of\nseparate containers that may be placed together inside one outer container. In\nother words, multiple individual Class 2.1 medicinal aerosols and/or inhalers\n(each of which meet the exclusion criteria) may be placed within one outer\ncontainer.\n3. Where the exclusion criteria specifY \"strong outside packaging\", any outer\ncontainer that meets the general packaging requirements at 49 CFR 173.24\nwiH suffice.\n4. Other than the reference to \"strong outside packaging\" there are no special\nlabeling or packaging requirements that apply to Class 2.1 medicinal aerosols\nand inhalers (each ofwhich meet the exclusion criteria).\nPlease feel free to contact me if you have any questions, concems or are in need of\nfurther clarifications.","truncated":false,"body_characters":6672}