Interpretation Response #16-0028
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
June 06, 2016
Mr. Corey J. Bennett
Assistant BioSafety Officer, ARO
Wadsworth Center Laboratories
New York State Department of Health
5668 State Farm Road
Guilderland, NY 12084
Reference No. 16-0028
Dear Mr. Bennett:
This letter is in response to your February 17, 2016, email requesting clarification of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to state governments and the transportation of infectious substances. We have paraphrased your questions and answered them in the order you provided.
Q1. It is our understanding that § 171.1(d)(5) excepts from the HMR a state entity that transports hazardous materials by state employees in state-owned vehicles solely for noncommercial, state government purposes. Is this correct?
A1. The answer is yes. As provided in § 171.1(d)(5), the HMR do not apply to transportation of a hazardous material in a motor vehicle, aircraft, or vessel operated by a Federal, state, or local government employee solely for noncommercial Federal, state, or local government purposes. Therefore, when the New York State Department of Health transports hazardous materials for its own use, using its own personnel, and in its own vehicles, it is not engaged in transportation in commerce and not subject to the HMR.
Q2. It is our understanding that an infectious substance that does not meet the definition under § 173.134(a)(1)(i) for a Category A infectious substance may appropriately be classified as a Category B infectious substance as described under § 173.134(a)(1)(ii). Is this correct?
A2. The answer is yes. If a material meets the definition of an infectious substance (Division 6.2)—a material known or reasonably expected to contain a pathogen—under § 173.134(a)(1) and does not meet the definition of a Category A infectious substance under § 173.134(a)(1)(i), it meets the definition of a Category B infectious substance under § 173.134(a)(1)(ii). Category A is an infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs, whereas Category B is an infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals.
Q3. Do the HMR require that infectious materials regulated as select agents under 42 CFR Part 73 be classified as Category A infectious substances?
A3. The answer is no. The HMR require shippers and carriers of select agents and toxins that are listed in 42 CFR Part 73 and 9 CFR Part 121 to develop and adhere to in-depth security plans for transporting these materials and to use these plans to train their employees (see § 172.800(b)(13)). The HMR also except from regulation as a Division 6.2 material infectious substances forensic material known or suspected to contain a Category A infectious substance or an infectious substance listed as a select agent in 42 CFR Part 73 when: 1) transported on behalf of a U.S. government, state, local, or Indian tribal government agency; 2) placed in secondary packagings marked with a “BIOHAZARD” symbol that conforms to specifications in 29 CFR 1910.1030(g)(1)(i); 3) containing an itemized list of the packaging’s contents between the secondary and outer packaging; and 4) placed in completed packagings capable of meeting the performance test standards for infectious substance packagings
prescribed in 49 CFR 178.609 (see § 173.134(b)(15)).
I hope this information is helpful. Please contact us if we can be of further assistance.
T. Glenn Foster
Chief, Regulatory Review and Reinvention
Standards and Rulemaking Division
171.1(d)(5), 173.134(a)(1)(i), 173.134(a)(1)(ii), 173.134(a)(1), 172.800(b)(13), 1910.1030(g)(1)(i), 173.134(b)(15)
|§ 173.134||Class 6, Division 6.2-Definitions and exceptions|