I’m writing with a personal concern regarding revised Virginia Regulated Medical Waste regulations that were recently released for public comment by the Virginia Board of Waste Management [https://townhall.virginia.gov/L/ViewXML.cfm?textid=16685 and https://townhall.virginia.gov/L/GetFile.cfm?File=119%5C5069%5C8858%5CAgencyStatement_DEQ_8858_v3.pdf]. I am a current Virginia resident, and and employed in the medical waste treatment industry. 

My concern after reviewing the revised regulations is that the regulations were revised by a Regulatory Advisory Panel (RAP) that may have been encompassed of individuals that may gain personal benefit from the regulations as written (potentially in violation of § 2.2-3103. Prohibited conduct). This panel, if it is the same as the one listed at https://www.dpor.virginia.gov/Boards/WMFO/, seems to be designed to have a perception of a Conflict of Interest. Though I believe that the Board of Waste Management meant to just get advice from select members of the community, they may be getting advice from individuals that may receive direct or indirect compensation for the prevalence of off-site treatment and transportation of waste and/or direct or indirect compensation for providing training to local businesses for the Waste Management Facility Operator license.

§ 54.1-2210. Board for Waste Management Facility Operators; membership; terms.

The Board for Waste Management Facility Operators shall consist of seven members appointed by the Governor as follows: a representative from the Department of Environmental Quality, a representative from a local government that owns a sanitary landfill, a representative from a local government that owns a waste management facility other than a sanitary landfill, a representative of a private owner of a sanitary landfill, a representative of a private owner of a waste management facility other than a sanitary landfill, and two citizen members, one of whom shall be a representative of a commercial waste generator. No owner shall be represented by more than one representative or employee. The terms of Board members shall be four years, except that vacancies shall be filled for the unexpired term. No member shall serve more than two consecutive four-year terms.

I hope that after reading the below, the Board of Waste Management makes the appropriate amendments to the revised regulations to ensure that the regulations make sense, and that any Board decisions do not advance the perception of a conflict of interest.

The new regulations seem arbitrary and capricious, and are above and beyond industry standard. I would like to see certain regulations changed to ensure that any and all infectious waste is treated at its source, per industry best practice, to prevent its dangerous reintroduction back into our communities. I would think that the average citizen of Virginia would prefer the same.

Numerous Federal agencies have defined or tried to define regulated medical waste. The EPA states, “Medical waste is a subset of wastes generated at health care facilities, such as hospitals, physicians' offices, dental practices, blood banks, and veterinary hospitals/clinics, as well as medical research facilities and laboratories. Generally, medical waste is healthcare waste that that may be contaminated by blood, body fluids or other potentially infectious materials and is often referred to as regulated medical waste.” The CDC states that certain medical waste should be targeted for proper waste disposal processes - “Health-care facility medical wastes targeted for handling and disposal precautions include microbiology laboratory waste (e.g., microbiologic cultures and stocks of microorganisms), pathology and anatomy waste, blood specimens from clinics and laboratories, blood products, and other body-fluid specimens.2 Moreover, the risk of either injury or infection from certain sharp items (e.g., needles and scalpel blades) contaminated with blood also must be considered.” Medical waste is primarily regulated by state environmental and health departments. EPA has not had authority, specifically for medical waste, since the Medical Waste Tracking Act (MWTA) of 1988 expired in 1991. As such, the state of Virginia’s Waste Management Board is trying to revise its regulations to try to provide a safe environment for its populace.

Best practices guidelines state that on-site treatment is preferred¹. On-site treatment decreases the chance that infectious waste gets re-introduced into the community. On-site treatment, generally performed and supervised by the industry experts – medical professionals – that are already mandated to comply with Federal OSHA Blood Born Pathogen Standards (29 CFR 1910.1030) and the Federal DOT regulations (49 CFR § 173.197) governing such wastes – do not need additional state regulations that try to prevent hospitals from completing their missions - to participate in activities to protect and promote the health of the public.

The regulations, as currently written, heavily deter onsite treatment. Not only do the regulations require hospitals to get a license to operate an on-site waste treatment system, they include an odd, never before seen, triple stage pre-vacuum requirement for steam sterilization. I fear that certain parts of these regulations may have been written in this fashion with malicious intent. By deterring on-site treatment, facilities will be required to transport their waste off site, and be forced to pay 3 to 5 times more for waste disposal. Municipal solid waste usually costs a facility less than $0.10 per pound to dispose. Regulated medical waste that requires off site treatment and transport can be charged as much as $0.80 per pound. The average cost of on-site RMW treatment system averages $0.07 to $0.11 per pound, saving the facilities from $0.22 to $0.60 per pound. These cost savings only increase the longer the on-site treatment system is used and the more waste that is treated. At a facility where the RMW poundage can be 2,826,560 lbs per year the facility will need to spend approximately $490,000 per year for off-site waste disposal versus $87,000 per year for an on-site waste treatment system. This is an added $403,000 per year that a hospital in a pandemic should not be forced to pay!

Virginia is the ONLY state in the U.S. that requires hospitals to have a license to run a commercial incinerator or autoclave (Class III), per 9VAC20-121-300. This license is expensive, very hard to attain, requires education in equipment that the hospital will not be using (incinerators), and it requires the employees to leave the hospital facility during a pandemic to try to attain this “privilege”. The Board of Waste Management excluded certain treatment systems from this license requirement, but seemed to fail to take into consideration all available treatment systems and the ramifications of requiring certain industries and easily operated systems in the licensing requirement.

The definition of a commercial incinerator or autoclave cannot be found by the average person because the Department of Professional and Occupational Regulation isn’t capable of even keeping its website updated. The link found at https://candidate.psiexams.com/bulletin/display_bulletin.jsp?ro=yes&actionname=83&bulletinid=570&bulletinurl=.pdf to the “training materials’

is not available.

[https://www.dpor.virginia.gov/uploadedFiles/MainSite/Content/Boards/WMFO/A438REGS_WMFO.pdf]

Some of the listed entities that the Board claims are to provide training are no longer in business or no longer offer the training. There is only one company still claiming to provide such training.

Hospitals cannot afford to lose one employee during a pandemic, much less lose an employee for days on training for easily attained information. Manufacturers of needed equipment will come on sight to ensure that operators know how to operate their systems and will provide industry standard training.

The Class III license also includes training for incinerators. Not only is there not a single incinerator in operation at a hospital in the state of Virginia, but why should a hospital know how to operate a system that they aren’t using? These superfluous requirements do not seem justified or reasonable.

The revised regulations added a new definition just for generators that treat their own waste on site - captive regulated medical waste management facilities; and as such, can easily exempt these specially defined facilities. The revised regulations have already proven that certain treatment systems can be exempted – the RAP board exempted treatment systems used to treat industrial or domestic sewage discharges, and permitted solid waste incinerators, thermal treatments, or waste to energy facilities with combustion of up to 10% by weight of regulated medical waste under 9VAC20-121-300(E.). By exempting these systems, the Board has proven that some systems can and should be exempted from this permit process. The Attorney General also verified that the Board has the authority to amend its regulations (per Christopher E. Bergin, Jr.’s letter dated December 19, 2019). The Board can ensure that these same facilities are still safely treating on-site be re-instituting 9VAC20-120-1000 - Operator Training.

9VAC20-121-240 (C.)(3.) requires a vacuum autoclave to fully evacuate the air three times. Why does a pre-vacuum sterilizer require a minimum of three cycles? This isn’t found in any other regulation or description in the U.S. What scientific reason was used to include a three-cycle pre-vacuum stage? Some autoclaves, such as a Tuttnauer, state that they have pulses of vacuum², but I’ve never seen a 3-cycle vacuum stage. This regulation needs to be amended, as it seems to refer to a type of sterilization system that does not exist.

9VAC20-121-240 (C.)(3.) For vacuum autoclaves, pre-vacuum cycles shall be conducted such that all system air is fully evacuated a minimum of three times at the beginning of each treatment cycle and held with all air evacuated to ensure adequate steam exposure throughout the waste.

Easy solutions exist to correct these regulation errors – the Board can delete the minimum 3 times for the pre-vacuum cycle from 9VAC20-121-240 (C.)(3.), exempt captive regulated medical waste management facilities or on-site regulated medical waste treatment systems that treat less than 500 pounds per load from a license requirement under 9VAC20-121-300, and remove individuals from the Board or RAP that create a perception of a conflict of interest.

My final “fear” is that the regulations could be considered so capricious and expensive that healthcare professionals could bypass the regulations all together by claiming that none of their waste is capable of producing an infectious disease in humans. As 9VAC20-121-90 gives them the legal means to do this – by allowing them to make the ultimate decision as to what they “suspect” might produce an infectious disease – they could in essence decrease their expenses by claiming that 100% of their waste is non-infectious and just municipal waste.

Thank you for taking my comments into consideration. Should you have additional questions or comments, please feel free to contact me.

Best regards,

Bryce Lindley

540-255-3822

1011 Baylor St.

Staunton VA, 24401