The following regulated medical waste management activities are conditionally exempt from permitting provided no open dump, hazard, or public nuisance is created and wastes are managed in accordance with the requirements promulgated by other applicable state or federal regulations, or the conditions provided in 9VAC20-121-300.E

• Sharps Drop Boxes: Household sharps collected in public sharps drop boxes as a convenience to the public, provided the following requirements are met:
  • Sharps drop boxes shall only receive household sharps from individual home generators who choose to transport household sharps to the drop box. Sharps drop boxes shall not receive waste from collection vehicles or other entities that have collected waste from more than one real property owner;
  • All owners and operators of sharps drop boxes 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; and
  • Collected sharps shall be treated or disposed of as regulated medical waste. Untreated sharps shall not be recycled or disposed of in a solid waste landfill or other solid waste management facility. Collected sharps that are shipped offsite as part of a mail-back program shall be transported in accordance with the requirements of 39 CFR 111 and 9VAC20-121-150.K
• Facilities that employ a treatment method to treat regulated medical waste onsite but subsequently package, label, and transport the waste offsite to be further managed as regulated medical waste are exempt from permitting but are subject to all other standards outlined in Part III of the RMW Regulations.
• Treatment systems (such as an effluent decontamination system) used to treat industrial or domestic sewage discharges in compliance with federal, state, or local pretreatment requirements as applicable. If the treatment unit separates solids from liquids prior to discharge, the solids shall be managed as regulated medical waste unless it meets an exemption.
• Combustion of up to 10% by weight of regulated medical waste in a Virginia Solid Waste Management Regulations (9VAC20-81) permitted solid waste incinerator, thermal treatment, or waste to energy facility. Regulated medical waste must be an approved supplemental waste or included in an approved material review process in accordance with the State Air Pollution Control Board regulations and management of the regulated medical waste prior to addition to the incinerator, thermal treatment, or waste to energy unit must be in accordance with 9VAC20-121.
• Temporary offsite storage of regulated medical waste generated from an emergency cleanup for up to 72 hours, including in a locked vehicle, prior to transporting directly to a regulated medical waste management facility permitted to receive the waste for treatment, transfer, or disposal, provided that all regulated medical waste is:
  • Generated from an emergency or unplanned sudden or non-sudden spill or release of regulated medical waste requiring immediate response in order to protect human health or the environment, and the regulated medical waste was not generated by a health care professional or nonstationary health care provider;
  • Collected from not more than one individual regulated medical waste generator and is not received from collection vehicles or other entities that have collected waste from more than one real property owner;
  • Managed, stored, and transported in accordance with all requirements of Part III of the RMW Regulations, except for the storage timeframe which shall be no more than 72 hours; and
  • Not a Category A waste, hazardous waste, or radioactive waste.

Unless exempt, the owner or operator of the following regulated medical waste management facilities shall apply for a permit-by-rule:

Regulated medical waste transfer stations, including when a vehicle transporting regulated medical waste will be parked for 24 hours or more during transport;

Facilities treating regulated medical waste employing a treatment method described in 9VAC20-121-240; and

Facilities treating regulated medical waste employing an alternate treatment method.

Permit application requirements are outlined in Part V of the Regulated Medical Waste Management Regulations.  To obtain a Permit-by-Rule the applicant must submit the following information to the appropriate DEQ Regional Office, Land Protection Manager:

1. DEQ Form RMW PBR

2. Notice of Intent in accordance with 9VAC20-121-310.A.2.a

   • Disclosure statement (DEQ Forms DISC-01 and DISC-02)

   • A copy of the certification for at least one operator licensed by the Board for Waste Management Facility Operators as required by § 10.1-1408.2 of the Code of Virginia.

   • Local government certification (DEQ Form CERT-01)

   • Results of public participation effort conducted in accordance with 9VAC20-121-310.A.2.a(4).

3. Certification of facility siting, as applicable;

4. P.E. Certification of facility design and construction in accordance with the design and construction standards, as applicable;

5. Design plans certified by a professional engineer (see section A.2.d);

6. Documentation of the authorization to discharge into an approved sanitary sewer system or publicly or privately owned treatment works;

7. A certification that the facility meets Part III Standards for Management, Part IV Transfer Station and Treatment Facilities, as applicable, and a copy of the regulated medical waste management plan. The certification shall also include a statement that the emergency contingency plan has been provided to the local police and fire departments, local emergency manager, and local emergency health coordinator;

8. Copy of the treatment technology approval for alternate treatment technologies;

9. A treatment plan (see section E) for each treatment unit;

10. For treatment facilities, a Treated Waste Disposal Plan  (see section D);

11. Closure Plan (see section G);

12. Demonstration of legal control over the site for the permit life;

13. State Corporation Commission certification (not applicable to governmental units);

14. Closure cost estimates and proof of financial responsibility as required by the Financial Assurance Regulations for Solid Waste Disposal, Transfer, and Treatment Facilities;

15. Permit fees;

16. Public participation (see section A.3), unless the regulated medical waste treatment units have received a permit from the department based on the regulations promulgated by the State Air Pollution Control Board or State Water Control Board that required facility-specific public participation procedures.

Upon receiving the certifications and other required documents, including the results of the public meeting and the applicant's response to the comments received, the department shall conduct a completeness review and respond within 30 days. 

If the applicant’s submission for a regulated medical waste transfer station is administratively complete the applicant shall be deemed to operate under a permit-by-rule status.

If the applicant's submission for a treatment unit is administratively complete, the applicant shall be deemed to operate under permit-by-rule status and granted authorization to initiate validation testing in accordance with an approved validation protocol and PBR. The facility shall not accept regulated medical waste for treatment until the results of validation testing and operating parameters are submitted and approved by the department.

If the applicant's submission is administratively incomplete, the department will respond with a letter stating that the facility will not be considered to have a permit-by-rule or initiate the validation protocol until the missing certifications or other required documentation is submitted. At the time of the initial receipt or at a later date, the director may require changes in the documents designed to assure compliance with the Regulated Medical Waste Management Regulations. Should such changes not be accomplished by the facility owner or operator, the facility will not be deemed to have a regulated medical waste management facility permit.

Prior to using any treatment system, the facility must conduct validation testing to demonstrate effective treatment of regulated medical waste. A minimum of three separate treatment runs performed on three separate days using three distinct loads should be conducted, with one run being performed in the Department’s presence.  Test runs shall meet the following requirements:

• Operating parameters used during the tests must be consistent with the parameters that will be used during routine operation of the treatment process (e.g., cycle duration, temperature, pressure, chemical concentration, irradiation exposure time, or other treatment parameters as applicable).

• Surrogate waste load composition (e.g., porosity, liquids, solids, moisture content, organic matter, thermal resistance, and type of packaging or containers) and waste load configuration (e.g., packing density and orientation) used during the tests must be consistent with the waste properties and loading process that will be used during routine operation. The surrogate waste load shall represent the most difficult waste anticipated to be treated during routine operation.

• The weight and volume of the surrogate waste loads used during the tests must be consistent with the amount of waste that will be treated during routine operation. Validation testing must be performed at the treatment unit's full capacity unless an alternate load size is approved.

  Testing must employ commercially-prepared biological indicators with a minimum concentration of 6 log₁₀ spores per biological indicator and meeting requirements of 9VAC20-121-260.D.

• The process must employ devices or instrumentation (i.e., thermochemical indicators, thermochemical recording devices, and parametric controls) that demonstrates the treatment unit is achieving critical operating parameters for effective treatment in accordance with 9VAC20-121-260.E.

• Effective treatment of regulated medical waste must achieve a 6 log₁₀ or greater reduction of the viable spore concentrations of the most appropriate bacterial species for the treatment method in accordance with 9VAC20-121-260.F.

The facility shall not accept regulated medical waste for treatment until the results of validation testing and operating parameters are submitted and approved by the department. 

Validation testing shall be repeated when any of the following occurs:

1. Failure of treatment system to achieve operational parameters during validation testing.

2. Failure to achieve microbial inactivation in any biological indicator during validation testing.

3. Failure of the untreated control indicator to show growth of the viable spore concentration;

4. Any modifications to any of the treatment process operational parameters, bioburden, waste mass, chemical type, concentration, irradiation or exposure time, type of waste to be treated, or mechanical or engineering changes to the treatment system from those assessed during the validation testing;

5. A failure identified in subdivision 1, 2, or 3 of this subsection during periodic challenge testing as identified by biological or process monitoring that occurs three or more times in a calendar year or during the first 30 days of actual operation;

6. A treatment device has been operational without a repeat validation for at least five years; or

7. A treatment device has not been used for at least one year.

A permit-by-rule shall not be transferred by the permittee to a new owner or operator. However, when the property transfer takes place without proper closure, the new owner shall notify the department of the sale and fulfill all the requirements contained in 9VAC20-121-310.A.2. Upon presentation of the financial assurance proof required by Financial Assurance Regulations for Solid Waste Disposal, Transfer, and Treatment Facilities by the new owner, the department will release the former owner from the closure and financial responsibilities and acknowledge existence of the new permit-by-rule in the name of the new owner.

The owner or operator of a facility operating under a permit-by-rule may modify its design and operation by furnishing the department a new certificate and applicable permit fees.

For modifications of design, the new certificate shall be prepared by a professional engineer and shall include new documentation required under 9VAC20-121-310.A.2, as applicable, and 9VAC20-121-310.A.3.

For modifications to the operations, the owner or operator shall submit to the department a new certificate and documentation required under 9VAC20-121-310.A.2, as applicable. For treatment units, a new treatment plan and revalidation with department approval to begin operation will be required for design and operation changes that include changing the treatment unit type, changing the treatment unit operating parameters, changes in waste stream, and adding a new treatment unit.

Whenever modifications in the design or operation of the facility affect the provisions of the closure plan, the owner or operator shall revise the closure plan and submit to the department a new certificate and documentation required under 9VAC20-121-310.A.2, as applicable. Should there be an increase in the closure costs, the owner or operator shall submit a new proof of financial responsibility.

An emergency permit may be issued in the event the director finds an imminent and substantial endangerment to human health or the environment.  The director may issue a temporary emergency permit to a facility to allow transfer, treatment, or storage of regulated medical waste as outlined in 9VAC20-121-310.B.1.

Emergency permits may be needed to store regulated medical waste generated during an emergency above regulatory or permit limits (e.g., storage of Ebola-contaminated waste generated during care of a patient), or the treatment of regulated medical waste not allowed in a facility permit (e.g., DEQ-developed additional treatment unit validation and operational protocols for anticipated treatment of Ebola wastes). An emergency permit is not limited to the above scenarios but provided as an example of the types of scenarios that might require a facility to obtain an emergency permit.

Management of regulated medical wastes in response to an emergency will require coordination with DEQ to determine appropriate requirements consistent with the regulated medical waste regulations. Please contact the Solid Waste Permit Coordinator for assistance in determining whether an emergency permit is needed.

Emergency permits can be issued for 90 days and may be renewed not more than three times, if necessary, and with appropriate justification.  Each such renewal shall be for a period of not more than 90 days.

The Regulated Medical Waste Management Regulations provide operational performance standards for autoclaves (steam sterilization), microwaves, dry heat, chemical treatment, alkaline hydrolysis, and incineration.  All other treatment technologies require the applicant to petition DEQ for evaluation of an alternative treatment technology by submitting the following completed form:

Petition for Evaluation and Approval of Regulated Medical Waste Treatment Technology, DEQ Form RMWTP-01