Interpretation Response #09-0259 ([Revance Therapeutics, Inc.] [Mr. Philip Perotti])
Below is the interpretation response detail and a list of regulations sections applicable to this response.
Interpretation Response Details
Response Publish Date:
Company Name: Revance Therapeutics, Inc.
Individual Name: Mr. Philip Perotti
Location State: CA Country: US
View the Interpretation Document
Response text:
December 11, 2009
Mr. Philip Perotti
QA Sr. Manager
Revance Therapeutics, Inc.
7555 Gateway Blvd
Newark, CA 94560
Ref. No. 09-0259
Dear Mr. Perotti:
This responds to your letter requesting clarification of the packaging requirements for toxic substances under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask whether any regulatory exceptions apply to shipments of Botulinum Toxin A, a Division 6.1 Packing Group I hazardous material, in quantities of 0.5 mg per shipment. Your questions are paraphrased and answered as follows:
Q1. Do the HMR provide any packaging exceptions for hazardous materials described as "UN3462, Toxins, extracted from living sources, solid, n.o.s., 6.1, PG I"?
A1. No. Packaging exceptions for a hazardous material are specified, if any, in a section or sections identified in Column (8A) of the § 172.101 Hazardous Materials Table (HMT). There is no section referenced in Column (8A) of the HMT entry for "UN3462, Toxins, extracted from living sources, solid, n.o.s., 6.1, PG I."
Q2. Special provision 141 is referenced in Column (7) of the HMT entry for UN3462. How does this special provision impact the proper description or packaging of Botulinum Toxin A?
A2. Under § 172.102(c)(1) Special provision 141, if your material also meets the criteria for a Division 6.2 infectious substance, it must be described as UN2900 or UN2814, as appropriate, and packaged in accordance with requirements in § 173.196.
Q3. If Botulinum Toxin A does not meet the definition of an infectious substance, is it eligible for the small quantity exceptions under § 173.4?
A3. Yes, if all the conditions specified in § 173.4 are met.
I trust this satisfies your inquiry. Please contact us if we can be of further assistance.
Sincerely,
Hattie L. Mitchell
Chief, Regulatory Review and Reinvention
Office of Hazardous Materials Standards
172.101, 172.102, SP 141, 173.4, 173.196