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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**  **p harmaceuticals**  April 16, 2012 Participants: Phil Retallick, Sr. VP of Regulatory Affairs, Clean Harbors (CH) J ohn Kelsey , VP, C H 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 man y examples, f rom June 2010

– June 2011 , Clean Harbors worked with Novant in Winston
- Salem, North Carolina and brought their seven facilities (with 1800 beds) into compliance. C H estimates 80
- 85% of hospitals are currentl y non compliant with RCRA in their management of hazardous pharmaceutical waste
. The non
compliance rate among phy sician ’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 complianc e vary within a hospital ? A: Ingeneral, hospitals lack a comprehensive pharmaceutical waste management program implemented uniformly across the entire facility
. Floor waste in the OR/ER/NI CU 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. T h ere are two containers (one black for hazardous waste streams, the other blue, for non
- hazardous waste streams). Onl y f

ive to eight percent of the pharmaceutical waste on the hospital floor is hazardous , but half of the waste is put in the hazardous contai ner. Clean Harbors will incinerate it all, hazardous and non
- hazardous waste together. The median amount of pharmaceutical waste generated b y a hospital is 50 lbs./bed/y ear, with a ty pical range of between 45 and 60 pounds. If a facility is generating outside of that range, or quality

control identifies areas that are not properl y s egregating out solid and medical waste from the pharmaceutical waste stream , Clean Harbors will recommend re - training staff.2

3. Q: I s the cost of incinerating pharmaceutical wast e similar to incinerating the ty pical 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 chemo therap y drug . Every thing else can be incinerated. Most pharmaceutical waste falls under one or two waste codes, with a high volume, and low concentration. As long as y ou sort out the arsenic trioxide, you can just incinerate every thing, 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

largel y 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 sy stem. 6. Q: What is the break
- down of facilities, in terms of hazardous waste generating quantit y? A: L ess 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 L QG’s for various reasons. Two drugs of concern with respect to generator status are nicotine patches and warfarin . Because both are P
- liste d wastes , they would shift a hospital to L QG status if a facility generated more than 1 kilogram per month. Warfarin is a blood thinner and nicotine patches are given primaril y to patients who are experiencing bed stay s and thus cannot smoke, or if they ar e trying to stop smoking as part of a treatment. 7. Q: What is your incinerating capacit y? A: 700,000 tons a y ear of high temperature incineration capacity . We are using about 90% of our capacit y. 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 any thing. HM 181 and 40 CFR 173 packing regulations apply to the transportation of these materi als. 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.