One minor suggestion regarding the definition of "storage" =  >200 gallons of waste. There often seems to be confusion (between inspectors and "storage facilities")  of how to calculate the 200 gallons; also there is some confusion as to whether the calculation is actual waste stored or potential to store waste. Sounds like it should be simple - but this has been a point of contention for a few facilities.

Additionally, typically medical waste is not calculated/tracked, by RMW industry standards, in gallons. It is calculated or tracked  in pounds or tons. Has DEQ considered changing the units of waste to be more inline with industry standards?

Section 810 - Amendment of permits only addresses temporary authorizations; but does not address permanent permit amendments. This regulation should, at least,  reference PBR amendments in 9VAC20-81, in order to provide guidance for amendments submission and approvals.

In order to establish standing, I represent San-I-Pak for Virginia.  San-I-Pak is a manufacturer of medical waste treatment equipment.  We have been in business for over 30 years with over 800 systems in operation.  The core focus of our business is to enable generators of RMW to responsibly manage this material themsleves.  We feel it is the ethically correct action for a hospital to contain RMW as close to the point of generation as possible.  This method of managing RMW has the benefit of lower cost, improved infection control practices, improved emergency preparedness, community protection and reduced carbon emissions.  While we do not expect a mandate for on-site treatment, we would like to see regulations that encourage on-site treatment while ensuring proper safeguards are in place.

Section 180 - Permit by rule

A permit by rule regulation generally enables hospitals to easily manage their medical waste onsite.  Virginia's regulation is unique in that it requires operators of the equipment to go through a state licensing program. No other state in the country has this requirement for onsite medical waste treatment. We have one client who removed their onsite treatment system due to this requirement.  They would get an operator licensed only to have that operator leave the hospital for other employment.  We feel this requirement is a duplication of effort and unnecessary.  First, the training for an "autoclave" license also requires training on an incinerator.  There are no incinerators for medical waste in Virginia. (US EPA HMIWI report, http://www.epa.gov/ttnatw01/129/hmiwi/epa453b10001_hmiwi.pdf)  Second, the training outline lists items that are all monitored by several departments within the hospital for compliance with Joint Commission, OSHA and Department of Health. Finally, proper operation of a specific brand of treatment system will be different.  Most equipment manufacturers offer training as part of the purchase.  I think this portion of the regulation can be replaced with the requirement that the treatment system is operated and maintained to manufacturer recommendations.  The generator is responsible for ensuring that their system meets or exceeds state requirements for efficacy.  This requirement can be verified through the operations records already required to be maintained for 3 years.

The entire Part VII of the regulation can be eliminated.  Based on the Clean Air Act requirements, there are less than 20 hospitals still using incineration.  As of the 2010 update from the EPA, there are none in Virginia.  To address the potential desire to install an incinerator, you can make it the perogative of the Director to approve any installation.  One of the requirements for applying for a permit should be meeting all EPA Clean Air requirements.

Section 600 - Disposal of treated wastes

Any efforts to expand the number of facilities that can receive treated medical waste would be appreciated.  As stated earlier, we would like to encourage generators to manage their RMW onsite.  A significant part of that is the final disposition of the waste.  If the only acceptance facility is several hours away, a generator is less likely to treat onsite, even if it is the right thing to do for their facility.

Thank you

Steve Hilliker, MBA

San-I-Pak, Inc.