Interpretation Response #09-0011 ([Association of Clinical Research Professionals] [Mr. David Vulcano])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 07/08/2009

Company Name: Association of Clinical Research Professionals

Individual Name: Mr. David Vulcano

Location State: VA Country: US

View the Interpretation Document

Response text:

July 8, 2009

Mr. David Vulcano

Chair, ACRP Board of Trustees

Association of Clinical Research Professionals

500 Montgomery Street, Suite 800

Alexandria, VA 22314

Reference No. 09-0011

Dear Mr. Vulcano:

This is in response to your January 7, 2009 letter concerning the training requirements for hazmat employees who prepare and package only Category B infectious substances (Division 6.2) in conformance with § 173.199 of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). You ask if the HMR excepts these employees from all other training requirements under the HMR if they are trained to carry out the provisions of this section.

The answer is yes. Employees trained to know and carry out the requirements prescribed in § 173.199 for Category B infectious substances are excepted from all other training requirements under the HMR when preparing and offering these materials for transportation in commerce. See § 173.199(a) and (e).

You also ask if the learning objectives and methods your association is considering (i.e., a paper-based self-training module, a post test, recurring 3-year training, and a record keeping system) to satisfy the training requirements in § 173.199 are sufficient and/or correct. It is the opinion of this Office that the training scenario you present is sufficient as long as all of the provisions of §173.199 are covered. Section 173.199 stipulates that persons who offer and transport these packages in commerce must be knowledgeable about the requirements of this section. See § 173.199(e).

I hope this information satisfies your request.

Sincerely,

Hattie L. Mitchell

Chief, Regulatory Review and Reinvention

Office of Hazardous Materials Standards

173.199(e)

Regulation Sections