Law Offices of James Kean — Hazardous Materials Safety Interpretation

Page 1U.S. Department 1200 New Jersey Avenue SE of Transportation Wasllingloll, DC 20590 Pipeline and Hazardous Materials Safety Administration DEC 2 1 2011 Mr. James Campbell Kean, JD, LLM Master of Laws, Environment and Energy Law Law Offices of James Kean 2 Hilshire Oaks Court Houston, TX 77055 Ref. No. 11-0204 Dear Mr. Kean: This responds to your August 17,2011 request for clarification of the Hazardous Materials Regulation' s (HMR~ 49 CPR Parts 171-180) exception for biological products or medical preparations in § 173.306(b)(3). In your letter, you present your specific interpretations of conditions specified in the exception applicable to a particular scenario. You ask that we comment on the accuracy of each of your interpretations. Your interpretations of § 173.306(b)(3) and PHMSA's responses are as follows: (1) Scenario: Division 2.1 (Flammable gas) medicinal aerosols and inhalers (each of which meet the exception criteria) are covered under this provision, even though the metal aerosols and inhalers may contain flammable gases. Response: Your understanding is correct, provided the medicinal aerosols and inhalers otherwise meet all of the conditions as described in the exception in § 173.306(b)(3). Division 2.1 (Flammable gas) materials may not be transported in plastic containers under this exception. (2) Scenario: The capacity limitation (not to exceed 35 cubic inches (19.3 fluid ounces» applies separately to each individual container. There is no limit to the number of separate containers that may be placed together inside one outer container. In other words, multiple individual Division 2.1 medicinal aerosols and/or inhalers (each of which meet the exception criteria) may be placed within one outer container. Response: Your understanding that the capacity limitation applies separately to each individual container is correct. Your understanding that there is no limit to the number of separate containers that may be placed together inside one outer packaging is incorrect. The introductory paragraph to § 173.306(b) states that for trans portation by aircraft the net quantity per package may not exceed the quantity specified in column (9A) of the Hazardous Materials Table in § 172.10 l. Further, the gross weight of the#

Page 2completed package must not exceed 30 kg (66 pounds) for any mode of transportation (§ 173.306(a». (3) Scenario:·Where the exception criteria specify "strong outside packaging," any outer container that meets the, general packaging requirements of 49 CFR 173.24 will suffice. Response: Your understanding is incorrect. "Strong outer packaging," synonymous with "strong outside packaging," is defined in § 171.8 as the outermost enclosure that provides protection against the unintentional release of its contents. It is a packaging that is sturdy, durable, and constructed so that it will retain its contents under normal conditions of transportation. In addition, a strong outer packaging must meet the general requirements of subpart B of part 173. For transportation by aircraft, a strong outer packaging is subject to § 173.27. (4) Scenario: Other than the reference to "strong outside packaging" there are no special labeling or packaging requirements that apply to Division 2.1 (Flammable gas) medicinal aerosols and inhalers (each of which meet the exclusion criteria). Response: Your understanding is incorrect. When transporting materials in accordance with the exception in § 173.306(b)(3) by aircraft, the package must be labeled as specified in Part 172, Subpart E. The package must be marked in accordance with § 172.315. For packaging requirements, please see the Response to Scenario 3 provided above. I hope this answers your inquiry. If you need additional assistance, please contact this office at (202) 366-8553. BenSupko Acting Chief, Standards Development Standards and Rulemaking Division#

Page 3James Kean, ID, LLM Maslcl· of lAws EIlVirolllll('tlt., E:nerglj allll Natllrtll ROSOllrCi!S 8/17111 Mr. T. Glenn Foster Chief, Regulatory Review and Reinvention Branch Standards and Rulemaking Division US Department of Transportation Pipeline and Hazardous Materials Safety Administration East Building, 2nd Floor 1200 New Jersey Avenue, SE Washington, DC 20590 Re: Request for a Formal Letter of Interpretation 49 CFR Section 173.306(b)(3) Dear Mr. Foster~ This is a request for a fomlai letter of interpretation regarding the exclusion of certain limited quantities of compressed gases from certain labeling and packaging requirements. 49 173.306(b)(3) states: "Nonrefillable metal or plastic containers charged with a Division 6.1 Packing Group III or nonflammable solution containing biological products or a medical preparation which could be deteriorate by heat, and compressed gas or gases. Plastic containers must only contain 2.2 nonflammable soluble or emulsified compressed gas. The capacity of each container may not exceed 35 cubic inches (19.3 fluid ounces). The pressure in the container may not exceed 140 psig at 130 [deg]F, and the liquid content of the product and gas must not completely till the containers at 130 [deg]F. One completed container out of each lot of 500 or less. filled for shipmen~ must be heated, until the pressure in the container is equivalent to equilibrium pressure of the contents at 130 [deg]F. There must be no evidence of leakage, distortion, or other defect. The container must be packed in strong outside packagings." For clarity's sake, we request written interpretation on each ofthe following points: 1. Class 2.1 medicinal aerosols and inhalers (each of which meet the exclusion criteria) are covered under this provision, even though the metal aerosols and inhalers may contain flammable gases.#

Page 42. The capacity limitation (not to exceed 35 cubic inches (19.3 fluid ounces)) applies separately to each individual container. There is no limit to the number of separate containers that may be placed together inside one outer container. In other words, multiple individual Class 2.1 medicinal aerosols and/or inhalers (each of which meet the exclusion criteria) may be placed within one outer container. 3. Where the exclusion criteria specifY "strong outside packaging", any outer container that meets the general packaging requirements at 49 CFR 173.24 wiH suffice. 4. Other than the reference to "strong outside packaging" there are no special labeling or packaging requirements that apply to Class 2.1 medicinal aerosols and inhalers (each ofwhich meet the exclusion criteria). Please feel free to contact me if you have any questions, concems or are in need of further clarifications.#