Interpretation Response #14-0248 ([R&S Compliance group, LLC.] [Mr. David Rivers])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: R&S Compliance group, LLC.
Individual Name: Mr. David Rivers
Location State: FL Country: US
View the Interpretation Document
Response text:
June 18, 2015
Mr. David Rivers
R&S Compliance Group, LLC.
2707 W. Price Ave.
Tampa, FL 33611
Reference No. 14-0248
Dear Mr. Rivers:
This is in response to your December 30, 2014 letter requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to new explosives. You state your company receives a nitroglycerin and lactose mixture classified as "UN 3319, Nitroglycerin Mixture, Desensitized, Solid, N.O.S., 4.1" transported under approval EX2000120151. You further state that this raw material is used in the production of a pharmaceutical product. Various machines that come in contact with the raw material are cleaned and the cleaning process results in effluent waste material containing a methanol and water mixture with contaminate of nitroglycerin. You present in-house test data from tests run on several lots of effluent waste showing trace concentrations of nitroglycerin between 0.00616- 0.01220 mg/ml. You ask several questions regarding the need for classification of both effluent waste material and tablet nitroglycerin. Your questions are paraphrased and answered as follows:
Q1. In order for § 173.56 to apply, does the resulting effluent material resulting from the alteration process (testing and cleaning) of the originally classified explosive mixture need to meet the definition of a Class 1 material in § 173.50(a) first. Or does § 173.56 apply first because the original ingredient that was altered was subject to § 173.56 and therefore all products or by-products of the initial classified explosive, regardless of the characteristics, or if the product meets the definition of Class 1 per § 173.50(a), require formal testing, classification and approval per § 107.705?
A1. Per § 173.56(a) a new explosive is an explosive produced by a person who has not previously produced that explosive, or has previously produced that explosive but has made a change in the formulation, design, or process so as to alter any of the properties of the explosive. Any product containing an energetic ingredient (e.g., Nitroglycerin) is therefore subject to the requirements of § 173.56, and any modification of such product previously approved is also subject to the same requirements to determine if the modifications meet the definition of a new explosive. However, if the modification results in a new material that may be classified in a hazard class or division other than Class 1 under a proper shipping name specifically listed in the Hazardous Materials Table (HMT) in § 172.101 (e.g. UN1204), the modified material would not be subject to the provisions of §173.56 unless the proper shipping name has a special provision requiring approval under § 173.56.
Q2. If the latter is true, does the final pharmaceutical product, nitroglycerin tablets, require the same approval to transport to pharmacies as the tablet is a result of an alteration of an initially classified explosive?
A2. The nitroglycerin tablets would require approval in accordance with § 173.56(b).
Q3. Would the resulting effluent material, containing residual amounts of what would be a classified explosive in other forms or concentrations, be properly described for transportation by other characteristics. In this case UN1204 Nitroglycerin solution in alcohol.
A3. In accordance with § 173.22, it is the shipper's responsibility to properly classify a hazardous material. This Office generally does not perform this function. However, if the effluent waste can be appropriately described by an existing HMT entry for a hazard class or division other than Class 1 it may be offered for transport under that entry. In your scenario, if the nitroglycerin solution in alcohol and water contains not more than 1 percent nitroglycerin in alcohol with no other energetic ingredients, the effluent would most appropriately be offered as UN1204.
I trust this information is helpful. If you have further questions, please do not hesitate to contact this office.
Sincerely,
Duane A. Pfund
International Standards Coordinator
Standards and Rulemaking Division
173.56, 173.50(a), 107.705, 172.101, 173.56(b), 173.22