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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

Regulation Sections

Section Subject
172.101 Purpose and use of hazardous materials table
173.196 Category A infectious substances
173.4 Small quantities for highway and rail