# Laboratory Medicine Consultants — Hazardous Materials Safety Interpretation

- **operation:** document
- **citation:** 06-0181
- **title:** Laboratory Medicine Consultants — Hazardous Materials Safety Interpretation
- **source type:** guidance
- **agency:** Pipeline and Hazardous Materials Safety Administration
- **status:** guidance
- **official:** true
- **published on:** 2006-08-22
- **effective on:** Not available
- **summary:** 06-0181 response to Laboratory Medicine Consultants concerning 173.134, 173.6.
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- **markdown:** https://regulus.evalyn.ai/document/phmsa-interpretation-06-0181.md
- **app url:** https://regulus.evalyn.ai/document/phmsa-interpretation-06-0181
- **source url:** https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2006/060181.pdf
**body:**

<<<PAGE 1>>>

J.S. Department
of Transportatior
Washington, D.C. 20590
400 Seventh Street, S.W.
Pipeline and
Administration
Hazardous Materials Safety
AUG 22 2006
Ms. Jane Swerdlow
Ref. No.: 06-0181
Laboratory Medicine Consultants
Chief Operating Officer
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
exception in § 173.6 to pick up and deliver diagnostic specimens (e.g., biopsies in 10%
171-180). Specifically, you ask if your couriers may use the Materials of Trade (MOTS)
formalin, pap smears, and body fluids) for testing.
Under current HMR requirements, the MOTS exception may be used to transport
biological product, or regulated medical waste. A diagnostic specimen is any human or
Division 6.2 material, other than a Risk Group 4 material, that is a diagnostic specimen,
animal material, including excreta, secreta, blood and its components, tissue, and tissue
infected humans or animals. Provided the biopsies, pap smears, and body flu ds are
fluids being transported for diagnostic or investigational purposes, but excluding live
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 HM-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 HMR 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 charge the
applicability of the MOTS or private/contract carrier exceptions to your operation.
173.6
173.134(616)
060181

<<<PAGE 2>>>

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,
7.i
John À. Gale
i Office of Hazardous Materials Standards
Chief, Standards Development

<<<PAGE 3>>>

Supko
§113.13466)6)
July 28, 2006
5,
173-6
U.S. Department of Transportation
Definitions "Exceptions
Pipeline and Hazardous Materials Safety Administration
06-0181
400 7" St., S.W.-
Office Of Hazardous Materials Safety
Washington, DC 20590
Re: Request for Interpretation
I am requesting an interpretation regarding the regulations governing ground
transportation of medical laboratory specimens. Our laboratory couriers pick up and
deliver medical specimens, primarily biopsies in 10% buffered formalin, pap smears and
body fluids, for diagnostic testing. It is our understanding these specimens meet the
definition of a diagnostic specimen as described in CFR49 173.134 Class 6, Division 6.2
(4) and are an exception from Division 6.2. Therefore these specimens do not need an
UN identification number. They are packaged for shipment according to CFR 173.6 (4).
As an organization we want to make sure our interpretation is correct and they we do not
need any separate DOT designation for transportation of these specimens.
If you have any questions, my direct telephone number is 702-938-9904 or my e-mail
address is swerdlow @Imclabs.com. Thank you for your assistance.
Sincerely,
Jane Swerdlow
Chief Operating Officer
Laboratory Medicine Consultants
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