Abbott Laboratories — Hazardous Materials Safety Interpretation

Page 1Of as oratione 400 Seventh St., S.W. Washington, D.C. 20590 peria Programs FEB - 8 2001 dministratior Ref. No. 00-0358 Mr. Michael P. Monaghan 1401 Sheridan Road Abbott Laboratories North Chicago, IL 60064-4000 Dear Mr. Monaghan: This is in response to your letter and subsequent telephone conversation with a member of my staff concerning transporting your product as "Consumer commodity" under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). Specifically, you ask whether the lack of an informational product label prohibits a product from being transported as "Consumer commodity, ORM-D." The answer is no. The HMR do not require informational narked "Consumer commodity, ORM-D' in accordance witl roduct labels; however, a consumer commodity package must b $ 172.316. I hope this information is helpful. Please do not hesitate to contact us if you need additional information. Sincerely, Natte e mithell Hattie I. Mitchell, Chief Regulatory Review and Reinvention Office of Hazardous Materials Standards ....- 000358#

Page 2ABBOTT MIntuRe 172,11 171.8 Pharmaceutical Products Division 00-8358 ONSUMeR Abbott Laboratories CoMModit 1401 Sheridan Road North Chicago, Illinois 60064-4000 December 19, 2000 Director, Office of Hazardous Material Standards Edward T Massullo USDOT/RSPA (DHM-10) 400 7" Street Southwest Washington, D.C. 20590 Re: Request For Determination of "Consumer Commodity" Applicability Dear Mr. Massullo: Assuming the final, labeled package will be "...suitable for sale through retail sales agencies or Sefeline instrumentalities for consumption by individuals for purposes of personal care or household use.", does a hazardous material packaged in its/unTabeled, final container it one location, but shipped to another location for labeling of the container, meet the 49 CFR 171.8 definition of "Consume NON-DOT commodity" while in transit between the packaging and labeling facilities? Below is a schematic to help clarify the question: iNtor-type LABELS Tanufacturing , ocation A Location B. Packaging Labeling Facility Facility public highway Transported via air or Product public highway Transported via air or Label clinic. etc. for sale To pharmacy, or distributioa mect the "consumer Question: Does the material his leg of the transportation? om modity" definition during Your assistance is greatly appreciated. Please feel free to contact me at (847) 935-7467 if you have any questions. Sincerely, Environmental/Hazardous Material Transportation Manager D-551, Bldg. A3#