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Interpretation Response #06-0181 ([Laboratory Medicine Consultants] [Ms. Jane Swerdlow])

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

Interpretation Response Details

Response Publish Date:

Company Name: Laboratory Medicine Consultants

Individual Name: Ms. Jane Swerdlow

Location State: NV Country: US

View the Interpretation Document

Response text:

Aug 22, 2006

 

Ms. Jane Swerdlow                 Reference No. 06-0181
Chief Operating Officer
Laboratory Medicine Consultants
3059 South Maryland Parkway
Las Vegas, NV 89109-6209

Dear Ms. Swerdlow:

This is in response to your July 28, 2006 letter, requesting clarification of the diagnostic specimen requirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask if your couriers may use the Materials of Trade (MOTS) exception in § 173.6 to pick up and deliver diagnostic specimens (e.g., biopsies in 10% formalin, pap smears, and body fluids) for testing.

Under current FIMR requirements, the MOTS exception may be used to transport Division 6.2 material, other than a Risk Group 4 material, that is a diagnostic specimen, biological product, or regulated medical waste. A diagnostic specimen is any human or animal material, including excreta, secreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected humans or animals. Provided the biopsies, pap smears, and body fluids are being transported by your employees in support of your business and do not contain a Risk Group 4 infectious substance you may take full advantage of the MOTS exception.

In addition to the MOTS exception, you may also utilize the exception in § 173.134(b)(6) to transport diagnostic specimens. In accordance with this paragraph, diagnostic specimens are excepted from all requirements in the HMR provided they are transported by private or contract carrier in a motor vehicle used exclusively to transport diagnostic specimens or biological products.

On June 2, 2006 we published a final rule under Docket RM-226A (71 FR 32244) entitled, “Hazardous Materials: Infectious Substances; Harmonization with the United Nations Recommendations.” The rule, which becomes effective on October 1, 2006, will align the FIIVIR with international regulations applicable to the transportation of Division 6.2 materials. The most significant change is the adoption of a two-tiered classification system for Division 6.2 materials comprised of Category A and Category B materials in place of the current four-tiered risk group system. The final rule will not change the applicability of the MOTS or private/contract carrier exceptions to your operation. However, we suggest you review the changes prior to October 1, 2006. The final rule is available at the following URL:

http://hazmat.dot.gov/regs/rules/final/71fr/docs/71fr-32243.pdf

I hope this information is helpful. Please contact us if you require additional assistance. Sincerely,

 

John A. Gale
Chief, Standards Development
Office of Hazardous Materials Standards

173.6, 173.134(b)(6)

Regulation Sections

Section Subject
173.134 Class 6, Division 6.2-Definitions and exceptions
173.6 Materials of trade exceptions