The current RMW regulation is out-dated, confusing, and hard to stay in compliance with. The RMW regulation needs to be updated to be more inline with current technologies, economic values, other regulations, and best management practices through clear and concise regulations. Additionally the regulation needs to better address smaller generators and healthcare facilities; as they have different objectives, waste generation processes, and economic status. The updating of this regulation will improve the over State-wide compliance efforts.

The Healthcare Waste Institute (HWI) of the National Waste & Recycling Association (NWRA) represents suppliers and service providers in the healthcare waste industry both in Virginia and on a national basis. We offer the follow with respect to the NOIRA on Virginia's regulated medical waste (RMW) regulations:

1. Regulations governing RMW are necessary to protect the public health, safety and welfare. Appropriate management of RMW ensures that it does not create a public health risk.
2. Should Virginia adopt regulations with reasonable changes, these regulations could  benefit small businesses such as smaller healthcare facilities by providing potential costs savings and reducing compliance risk.
3. The current regulations are outdated, confusing and conflict with other regulations.

Therefore, we support making updates to the rule to make them more clear and easier to understand. Further, we would be interested in participating in the rulemaking process.

Stericycle, Inc. (Stericycle) has submitted comments to Debra Harris earlier today, June 26, 2019.  We were unable to copy our full comments in this space, below provides an excerpt of our comments.  Please contact me at the email address I have listed here for a full copy of comments if needed.  We appreciate the opportunity and hope to be chosen to participate in the regulatory advisory panel.

We would like to address the following discussion points made in the NOIRA to further support the need for changes to the regulations found in 9VAC20-120.

1. is necessary for the protection of public health, safety, and welfare or for the economical performance of important governmental functions;

Stericycle Response:  The regulation is necessary for the protection of public health, safety, and welfare.  Though the collection and management of RMW is not regulated at a federal level, almost all states have regulations to manage this waste stream.  Many of those states have expanded on what is covered under their RMW regulations to include waste streams like pathological wastes, trace chemotherapy wastes, and non-RCRA pharmaceutical waste and we would encourage the Department to do the same. We would also recommend adding sections to the regulation regarding the management of wastes that are considered Category A infectious substances per DOT regulations.  An example would be waste from patients with Ebola. Stericycle was involved in collection and management of Ebola patient waste in 2014 and we encourage all states to consider Category A wastes and potential situations generating these wastes in their regulations.

2. minimizes the economic impact on small businesses in a manner consistent with the stated objectives of applicable law;

Stericycle response: We would disagree that the current regulation minimizes economic impact on small businesses.  Making appropriate modifications to the regulations would however have a potentially minimizing effect on economic impact on small businesses.  Though we are not a small business, we service customers/generators that are and some of the current regulation requirements increase our cost to do business, which can affect even small generators.  Some parts of the regulation that impact us negatively include:

3. 1. 1. The numerous requirements for RMW transfer sites, including the requirement to be permitted if waste is stored on a trailer for more than 24 hours.
      2. The requirement to refrigerate waste after 7 days of storage.
      3. The requirement to shred treated RMW before landfilling. 

4. is designed to achieve its intended objective in the most efficient, cost-effective manner;

Stericycle response: We have stated some of the reasons why we disagree that the current regulation is efficient and cost-effective above in (ii) but would like to include the following points as they have impacts on larger generators such as hospitals:

5. 2. 4. Many generators of large amounts of waste prefer the use of roll-off containers for storage and management of their wastes, however, due to the current storage regulations, these containers must be removed every 7 days, even if they are not full.  This results in additional cost for the healthcare facilities.
      5. The limit on storage of RMW being only 200 gallons of waste; otherwise a permit is needed. This is an unclear requirement and is not a common way that waste storage is identified and managed in regulation.  The 200 gallon limit seems arbitrary as this is not an amount referenced in other regulations. 

6. is clearly written and easily understandable;

Stericycle response: The regulations are similar to other state regulations in that they reference solid waste regulations.  It is understood that there is need to reference some solid waste regulations, but, the Department should consider creating one section for RMW regulations that contains all needed information, avoiding cross-references to solid waste regulations as much as possible, to make the regulations clear and easy to understand and comply with.  We would also encourage limiting cross-referencing within the RMW regulation itself.  We have included an attachment to these comments that lays out a proposed outline for how the regulations could be structured in order to avoid cross-referencing and to promote clarity on what parts apply to each regulated entity. These suggestions will assist the regulated community – generators, transporters, and treatment facilities, in understanding and compliance by providing all needed information in one clear and concise regulation. 

7. overlaps, duplicates, or conflicts with federal or state law or regulation;

Stericycle response: We appreciate that the regulations generally do not conflict with federal or state laws or regulations, especially DOT.  However, we would like to point out two places where some conflict and/or confusion could occur:

8. 3. 6. The definition of “Etiologic Agents” references 42 CFR 72.3.  This section of federal regulation no longer exists.  If the Department wants to include a definition for similar agents, perhaps include 42 CFR Part 73 on Select Agents and Toxins. 
      7. Parts of the regulation seem to pull from the federal Environmental Protection Agency’s (EPA) hazardous waste regulations.  For example, the terms “listed” and “characteristic” are used at times.  These are terms used to define hazardous wastes that are found on lists (U, P, F, and K lists) and/or exhibit hazardous waste characteristics (ignitability, corrosivity, reactivity, toxicity).  We would recommend not using the terms “listed” or “characteristic” in defining RMW.

9. is impacted by changes in technology, economic conditions, or other factors in the area affected by the regulation since the last review.

 Stericycle response: We believe that changes in the industry and advancement of practices and technology merit changes in the regulations.

These regulations are due to be updated.  While reading the draft, most of the obvious proposed changes look reasonable.  However toward the end of the proposal, I do have concerns on the validation series of events, both from the standpoint of cost, efficiency, and wording of that proposed section.