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

Fauquier County Environmental Services will be negatively impacted by proposed changes to the Regulated Medical Waste Management chapter of the Virginia Administrative Code, specifically proposed additions contained in 9VAC20-121-10 “Definitions,” 9VAC20-121-90 “Identification of regulated medical waste” and 9VAC20-121-300 “Applicability.”

In September 2018, Fauquier County Environmental Services began implementation of a home sharps collection program, with approval from DEQ Northern Region staff and the local office of the Virginia Department of Health. This program was conceived due to repeated sharps injuries within County staff, particularly recycling sorting staff, caused by improperly disposed home sharps in recycling material at the County’s residential recycling facility.

The program is designed to provide a convenient and accessible way for Fauquier County residents to dispose of home sharps in a safe manner, and keep them out of the larger waste and recycling stream. In order for the program to be affordable to the County, and to prevent an increased financial burden to County taxpayers, the resulting home sharps were allowed by DEQ to be disposed of directly into the working face of Fauquier County’s sanitary MSW landfill, PN 575.

The collection and disposal of home sharps is carried out in an organized and safe fashion, with program specifics previously approved by DEQ.  Fauquier County Environmental Services has also developed and implemented a department-specific Exposure Control Plan in consultation with Katherine West, BSN, MSEd, CIC.  We are only collecting home sharps directly from only Fauquier County residents at our facilities, and in-person screening of each deposit (required by the program) allows us to be certain we are not accepting sharps from business entities. After implementation of the sharps collection program in late 2018, sharps injuries among Environmental Services staff dropped by 50% in 2019, and to zero in 2020. In 2021, Environmental Services had only one possible sharps-related injury, the specific source of injury being undetermined, and there have been zero sharps-related injuries in 2022 to date. There have been no reported hazards to staff or the public related to disposal of collected home sharps in the sanitary landfill’s working face.

Under the proposed additions to the regulations, there is a newly defined “sharps drop box” in the proposed 9VAC20-121-10 “Definitions”, which is “a secure, tamper-proof sharps container for the temporary storage of only household sharps provided for the convenience of individual home generators who choose to transport their own household sharps to the collection point and where collected sharps are packaged, labeled, and managed as regulated medical waste.” Under this definition, the residential collection points operated by Fauquier County Environmental Services would be defined as sharps drop boxes. We have no objection to this definition, save for the last line “where collected sharps are packaged, labeled and managed as regulated medical waste.” This line of the proposed regulation would negatively impact our program, as it would trigger all other requirements of the regulated medical waste regulations in regard to our collection, transport and disposal of home sharps.

The proposed draft of 9VAC20-121-90 “Identification of regulated medical waste” also negatively impacts our program. Previously, home sharps were largely exempt from regulation.  Under this draft of 9VAC20-121-90, both subsection B.2.d. (“This also includes sharps generated through veterinary practice, acupuncture needles, and household sharps collected in a sharps drop box”) and D.2. (“Household sharps centrally collected in a sharps drop box shall be managed as regulated medical waste in accordance with 9VAC20-121-300 E 1”)  home sharps collected in a sharps drop box are specifically designated as regulated medical waste, triggering the requirements outlined in the proposed 9VAC20-121-300 “Applicability.”

The proposed draft of 9VAC20-121-300 “Applicability” also negatively impacts our program. Under 9VAC20-121-300 E.1.a-c, we may collect home sharps in a sharps drop box at our residential collection facilities, but “must comply with the general handling, packaging and labeling, storage, reusable container, spill cleanup, transportation, and Category A waste management requirements for regulated medical waste outlined in Part III (9VAC20-121-100 et seq.) of this chapter,” with the further restriction in that same subsection that “Collected sharps shall be treated or disposed of as regulated medical waste in accordance with this chapter. Untreated sharps shall not be recycled or disposed of in a solid waste landfill or other solid waste management facility.”

The proposed regulations as outlined above will effectively eliminate Fauquier County Environmental Services’ ability to continue operating our home sharps collection program. It will no longer be financially viable, and will place an undue burden on the County’s taxpayers as it would require a significant budget increase to comply with the new requirements. This program has been highly successful in providing a needed resource for residents in a largely rural area with few options for safe home sharps disposal. It has been very effective in reducing sharps injuries amongst our staff.

We believe that our system as currently operating is no less protective of human health and the environment than residents legally disposing of individual or packaged home sharps mixed in household solid wastes. In actuality, we feel that our system is more protective, as we ensure that home sharps are directly disposed of in our landfill’s working face using specific safety procedures, rather than having household sharps interspersed in waste that is collected by widely varying methods, dumped on our MSW transfer station tipping floor, and shipped out to another landfill via public roads. In the view of Fauquier County Environmental Services, this regulatory change will only serve to increase health and safety risks to our staff and others, as unmanaged home sharps are highly likely to be improperly and unsafely disposed.

We would propose several options for changes to the draft regulations in question:

1. Create a separate category for a permitted solid waste facility that would allow it to directly operate sharps drop boxes at such facilities, with the caveat that only home sharps would be disposed of in the associated permitted facility. This should include a permitted sanitary landfill, but could be expanded to include a permitted MSW transfer station should DEQ agree. Our program would not be affected by this expansion, but we can see the potential utility of this for other localities.
2. Eliminate or modify the last line of 9VAC20-121-300 E.1.c. that states “Untreated sharps shall not be recycled or disposed of in a solid waste landfill or other solid waste management facility,” to allow for disposal of home sharps as outlined in the previous bullet point.
3. Provide for a process to apply for an exemption or variance to the proposed regulation that would allow Fauquier County Environmental services or other localities to obtain said exemption/variance, if we are able to show a significant benefit to public health and access to needed services, combined with little to no risk to health or the environment.

Please see comments below from NWRA Healthcare Waste Institute.

Best,

Anne.

1550 Cry

  CommentID: 121805