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Conference Call with Phil Retallick and John Kelsey of Clean Harbors

Re: Non-Compliance in the Healthcare Industry regarding the EPA’s proposed Universal 

Waste Rule for pharmaceuticals

April 16, 2012

Participants:

Phil Retallick, Sr. VP of Regulatory Affairs, Clean Harbors (CH)

John Kelsey, VP, CH

Jason Price, Industrial Economics (IEc)

Tripp Burwell, IEc

Questions from IEc for Clean Harbors

1. Q: What have you observed in terms of non-compliance in the healthcare industry?

A: Significant non-compliance observed in the field. Hospitals nationwide have 

demonstrated increasing compliance since John began working on the issue in the fall of 

2009. As one of many examples, from June 2010 – June 2011, Clean Harbors worked 

with Novant in Winston-Salem, North Carolina and brought their seven facilities (with 

1800 beds) into compliance. CH estimates 80-85% of hospitals are currently noncompliant with RCRA in their management of hazardous pharmaceutical waste. The noncompliance rate among physician’s offices, dentists, etc. is likely to be even higher. Even 

if a compliance program such as Clean Harbors were to increase compliance by 5-10 

hospitals every week, it would take quite some time for the compliance rate to approach 

100%. 

2. Q: Does compliance vary within a hospital?

A: In general, hospitals lack a comprehensive pharmaceutical waste management 

program implemented uniformly across the entire facility. Floor waste in the 

OR/ER/NICU comprises a large part of the hazardous waste non-compliance. Pharmacies 

are much more compliant. Nurses are required to make the call of what is hazardous 

waste and what is not and they default to hazardous when uncertain. There are two 

containers (one black for hazardous waste streams, the other blue, for non-hazardous 

waste streams). Only five to eight percent of the pharmaceutical waste on the hospital 

floor is hazardous, but half of the waste is put in the hazardous container. Clean Harbors 

will incinerate it all, hazardous and non-hazardous waste together. 

The median amount of pharmaceutical waste generated by a hospital is 50 lbs./bed/year, 

with a typical range of between 45 and 60 pounds. If a facility is generating outside of 

that range, or quality control identifies areas that are not properly segregating out solid 

and medical waste from the pharmaceutical waste stream, Clean Harbors will recommend 

re-training staff.
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3. Q: Is the cost of incinerating pharmaceutical waste similar to incinerating the typical 

hazardous waste?

A: Yes. 

4. Q:Would you please address the treatment standards for hazardous pharmaceutical 

wastes?

A: You can incinerate all FDA approved drugs, with one exception, arsenic trioxide, 

which is a last-resort chemotherapy drug. Everything else can be incinerated. Most 

pharmaceutical waste falls under one or two waste codes, with a high volume, and low 

concentration. As long as you sort out the arsenic trioxide, you can just incinerate 

everything, so the cost of treatment is uniform across hazardous waste pharmaceuticals.

5. Q: What are your testing practices with respect to hazardous pharmaceutical waste?

A: We rely largely on generator knowledge regarding the composition of the waste 

streams we receive. For pharmaceuticals, getting detailed information is fairly

straightforward because most, if not all, drugs are in the chemical abstract system.

6. Q: What is the break-down of facilities, in terms of hazardous waste generating quantity?

A: Less than 5% of all hospitals are LQG’s, 75-80% are SQG’s, 15-20% are CESQG’s. 

None of the hospitals want to be LQG’s for various reasons. Two drugs of concern with 

respect to generator status are nicotine patches and warfarin. Because both are P-listed 

wastes, they would shift a hospital to LQG status if a facility generated more than 1 

kilogram per month. Warfarin is a blood thinner and nicotine patches are given primarily 

to patients who are experiencing bed stays and thus cannot smoke, or if they are trying to 

stop smoking as part of a treatment.

7. Q: What is your incinerating capacity?

A: 700,000 tons a year of high temperature incineration capacity. We are using about 

90% of our capacity.

8. Q: Can you tell us a little bit about the transportation of hazardous waste from the 

facilities to the incinerators?

A: Inhalers present the vast majority of transportation issues. They are marked as a return 

to pharmacy item and have their own separate hazardous class: 2.2. Class 6.1 is toxics, 8 

is corrosive, 3 is flammable. There are exemptions for co-mingling, for instance 3 and 6.1 

can be co-mingled, but inhalers cannot be mixed with anything. HM 181 and 40 CFR 173 

packing regulations apply to the transportation of these materials. Excluding manifest 

costs, the transportation costs for hazardous pharmaceuticals would not have material 

changed under the 2008 proposal to add hazardous pharmaceutical waste to the Universal 

Waste Rule.