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Interpretation Response #03-0113 ([New York State Department of Health] [Ellis Jacobs, Ph.D., DABCC])

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

Interpretation Response Details

Response Publish Date:

Company Name: New York State Department of Health

Individual Name: Ellis Jacobs, Ph.D., DABCC

Location State: NY Country: US

View the Interpretation Document

Response text:

Aug 30, 2004

 

Ellis Jacobs, Ph.D., DABCC                Reference No. 03-0113
Director, Clinical Laboratory
Evaluation Program
Wadsworth Center
New York State Department of Health
P.O. Box 509
Albany, NY 12201-0509

Dear Dr. Jacobs:

This is in response to your letter asking if whole blood samples offered for transportation by your program to administer various proficiency tests for the purpose of licensing laboratories in the State of New York are subject to the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). From telephone conversations with Ms. Kathi Wagner of your staff, we understand the whole blood has been tested and determined to not meet the definition of a hazardous material, but before being offered for commercial transportation to the laboratories for analysis, various chemicals, parasites, or microbiological agents may be added. We apologize for the delay in responding and any inconvenience this may have caused.

You are correct that blood collected for transfusion and biological products subject to approval by the Food and Drug Administration or the U.S. Department of Agriculture are not subject to the HMR (see § 173.134(b)). However, the samples you use for your various test programs may be subject to the HMR if you add chemicals or other materials to the samples.

Blood and other biological samples that do not meet the definition of a Division 6.2 (infectious) material in § 173.134(a) or the definition of another class of hazardous material in Part 173 are not subject to the HMR. Thus, the blood samples you transport for your engraftment monitoring, immunohematology proficiency test, and parentage/identity testing programs are not regulated under the HMR. Similarly, if the serum samples you transport for your clinical chemistry, cytokines, diagnostic immunology, endocrinology, hematology, oncology, parasitology, therapeutic substance monitoring, and clinical and toxicology proficiency test programs are not infectious and do not meet the definition of another hazard class, they are not subject to the HMR.

Sincerely,

 

Hattie L. Mitchell, Chief
Regulatory Review and Reinvention
Office of Hazardous Materials Standards

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions