Interpretation Response #11-0204 ([Law Offices of James Kean] [Mr. James Campbell Kean])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Law Offices of James Kean
Individual Name: Mr. James Campbell Kean
Location State: TX Country: US
View the Interpretation Document
Response text:
December 21, 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 CFR 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 transportation by aircraft the net quantity per package may not exceed the quantity specified in column (9A) of the Hazardous Materials Table in § 172.101. Further, the gross weight of the completed 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.
Sincerely,
Ben Supko
Acting Chief, Standards Development
Standards and Rulemaking Division
172.306, 172.315, 173.27