[Pharmwaste] New DOT requirement for authorized collectors

Vivian Futran Fuhrman vivian at productstewardship.us
Mon Jul 11 12:18:07 EDT 2016


Hi Jeanie and All,

At PSI we have been in touch with Stericyle and with the DOT about the new requirements. In order to help provide information to the public, PSI is planning a free webinar in conjunction with the DOT with a presentation on the new requirements by a DOT representative, and time to ask him questions. The TENTATIVE date for this call is Wednesday, July 27th, and I will be sending more information on this once we have confirmed with the DOT.

The requirement apparently arose in response to DOT's interpretation that collectors/reverse distributors dealing with material collected through a take-back program do not know what is in the waste generated, and so they cannot make a hazard determination.  In response, it seems that Stericyle requested an Emergency Special Permit from the DOT, and requested that it be as generic as possible so that others could use it as well. I have attached a email from the DOJ which contains a very helpful sample party status application. This can be used by authorized collectors who prepare collected materials for shipping (SHIPPER) and by reverse distributors (CARRIER).

Best,
Vivian
______________________________
Vivian Fuhrman, Ph.D.
Associate for Policy and Programs
Product Stewardship Institute, Inc.
29 Stanhope St., 3rd Floor, Boston, MA 02116
P: (617) 236-4771 F: (617) 236-4766
www.productstewardship.us<http://www.productstewardship.us/>
vivian at productstewardship.us<mailto:vivian at productstewardship.us>
The Product Stewardship Institute, Inc. is an equal opportunity provider and employer.


From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Jaramillo, Jeanie
Sent: Monday, July 11, 2016 12:16 PM
To: Catherine Zimmer; pharmwaste at lists.dep.state.fl.us
Subject: Re: [Pharmwaste] New DOT requirement for authorized collectors

The wastes are pharmaceuticals from households. We actually can't characterize them because the DEA prohibits going through these items.

Thank you for your information. I'll do some more digging.

Jeanie Jaramillo-Stametz, PharmD
Managing Director, Texas Panhandle Poison Center
Asst. Professor, Texas Tech UHSC School of Pharmacy
Director, Medication Cleanout
1300 S. Coulter St., Suite 105
Amarillo, TX 79106
(voicemail): (806)414-9299
(poison center office): (806)414-9402; 9404
(mobile): (806)376-0039

From: Catherine Zimmer [mailto:zenllc at usfamily.net]
Sent: Monday, July 11, 2016 11:13 AM
To: Jaramillo, Jeanie; pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: RE: [Pharmwaste] New DOT requirement for authorized collectors

Hi Jeanie and all,
I just did a regulatory review for a client re: transport of waste pharmaceuticals.  There may be some exemptions for your facility under Materials of Trade or even under consumer commodity, but without knowing more about the waste, I can't say.

Yes, employee training may or may not be free.  There are training modules on the DOT's PHMSA website.

Very truly yours,

Catherine Zimmer, MS, BSMT
Reducing and managing healthcare related waste and costs for fifteen years.
Executive director, HEARRT Midwest
www.hearrtmidwest.wildapricot.org<http://www.hearrtmidwest.wildapricot.org>
Principal, Zimmer Environmental Improvement, LLC
St. Paul, MN
Ph:  651.645.7509
zenllc at usfamily.net<mailto:zenllc at usfamily.net>

From: Pharmwaste [mailto:pharmwaste-bounces at lists.dep.state.fl.us] On Behalf Of Jaramillo, Jeanie
Sent: Monday, July 11, 2016 10:55 AM
To: pharmwaste at lists.dep.state.fl.us<mailto:pharmwaste at lists.dep.state.fl.us>
Subject: [Pharmwaste] New DOT requirement for authorized collectors

Hello All,

We have a permanent medication disposal receptacle at the pharmacy located on our University campus. I assist with its management (and finding funding for it!) We were recently notified that we are now required to obtain a DOT permit in order to ship these med-containing boxes. I'm attaching a letter from the DOT for your review and I'm hopeful that some of you are more knowledgeable on this and can help.

While the DOT permit has no related fee, the underlying theme seems to be that the meds are considered "hazardous" and there is a statement that "Each "Hazmat employee", as defined in § 171.8, who performs a function subject to this special permit must receive training on the requirements and conditions of this special permit in addition to the training required by §§ 172.700 through 172.704". My guess is the training won't be free.

>From the DOT letter, it appears that this action has resulted from a request by Stericycle. Yet, household generated pharmaceutical waste is exempt from RCRA, so I'm at a loss. It also seems a conflict of interest that a medical waste vendor has pushed for this. These are the same meds that mail order companies are shipping to patients nationwide.

This is yet another barrier to participation as "authorized collectors".

Any thoughts?

Jeanie Jaramillo-Stametz, PharmD
Managing Director, Texas Panhandle Poison Center
Asst. Professor, Texas Tech UHSC School of Pharmacy
Director, Medication Cleanout
1300 S. Coulter St., Suite 105
Amarillo, TX 79106
(voicemail): (806)414-9299
(poison center office): (806)414-9402; 9404
(mobile): (806)376-0039

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