Regulatory Open Forum

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  • 1.  Regulations for Shipping Biohazardous Waste

    Posted 07-Feb-2013 20:30
    I have recently been asked about regulations on having our customers return product that has been in use (i.e. often having yeast build up or other biofilm). Im not sure if this qualifies to be labeled in a certain way by the customer or how we should be informing them to send it. We do instruct them to double bag in a ziplock style bag. Does anyone know of any thing else I should be aware of?

    Thank you for any input you may have. 

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    Lauren Gilmore
    Regulatory Affairs Specialist
    United States
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  • 2.  RE:Regulations for Shipping Biohazardous Waste

    Posted 08-Feb-2013 06:01
    Lauren,

    This is a common concern. There are very specific shipping regulations around items that are a potential biohazard - they do vary a bit depending on the method of shipping (air, surface, ship etc).

    We provide a "return kit" to our customers free of charge that has all of the correct barriers (very often a double ziploc does not mee the requirements) and biohazard labeling. It also has clear instructions on what the user needs to do to handle or santize the device, how to package it in the kit etc. You can work with your shipping agents (FedEx, UPS etc) to make sure all of the regulations are met when designing such a kit.

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    Ginger Glaser RAC
    Vice-President, Quality and Regulatory Affairs
    American Medical Systems Inc
    Minnetonka MN
    United States
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  • 3.  RE:Regulations for Shipping Biohazardous Waste

    Posted 08-Feb-2013 14:03
    FYI:

    Guidelines for shipping and receiving biological materials.  

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    Regulatory Doctor, Coach, Mentor, and Consultant
    Riner VA
    United States



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  • 4.  RE:Regulations for Shipping Biohazardous Waste

    Posted 08-Feb-2013 08:26
    Transportation and shipping of hazardous waste is regulated by the Department of Transportation at the Federal Level.
    http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&sid=dfec99df9f21ef29b59a8565433a56cd&rgn=div6&view=text&node=49:2.1.1.3.8.2&idno=49
    Addtional state requirements regarding recordkeeping may apply depending on what state the hazardous waste generator is located in and therefore is shipping from. For example here is an information page for NH.
    http://des.nh.gov/organization/divisions/waste/swmb/rims/faq_manifest.htm
    Hazardous waste of any kind must be properly packaged and labeled depending on the classification, and documentation must be maintained in the form of a "manifest."

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    Jean Bigoney PHD
    Managing Member
    Nu Device Consulting LLC
    Newport NH
    United States
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  • 5.  RE:Regulations for Shipping Biohazardous Waste

    Posted 08-Feb-2013 09:02
    Hi Lauren,
    Transportation of potentially infectious materials is addressed in 49CFR Part 173, Subpart D.  IATA and the WHO offer guidance documents on transportation of Infectious Substances. 
    If the return items will be imported into the USA, you should also verify that you do not require an Etiologic Agent Import Permit (EAIP) from the US CDC.  Check out FAQs regarding the EAIP at www.cdc.gov/od/eaipp/faq.htm.  It is possible that you are exempt from the permit requirements if the material is known to be non-infectious, but you may need to have the shipper state this with the import documentation.

    Best of luck-
    Carole

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    Carole Harris RAC
    International Regulatory Program Manager
    Asuragen, Inc
    Austin TX
    United States
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    Original Message


  • 6.  RE:Regulations for Shipping Biohazardous Waste

    Posted 08-Feb-2013 11:42
    Determine whether it is likely that the returned product when handled is capable of transmitting a known infectious organism, a pathogen that causes disease. If so, it should be labeled as a biohazard. Does the product come into contact with human biological fluids, and do universal precautions apply? Does the product have any aspect that is sharp and can puncture skin? Is it possible for the customer to sanitize the product before it is returned, at least on the outside so that it is safe to touch? This would be a courtesy. If the product is only dirty with accumulation of the growth of environmental bacterial film or yeast that is not known to be infectious, then it is not necessarily a biohazard. If someone could be confused about its safety by looking at it, then label it appropriately to avoid confusion. If you just do not know, take the precaution to label it as a biohazard and package it so that it can be handled safely. Train employees that handle returned product and establish consistent procedures to ensure the safe handling of returned product.

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    Kenneth Kasper PHD
    Executive Director, QA/RA
    ARK Diagnostics, Inc.
    Fremont CA
    United States
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