Administrative Code

Virginia Administrative Code
9/25/2022

Part XI. Variances and Other Procedures

Article 1
Petition for Variance

9VAC20-120-840. General.

Article 1
Petition for Variance

Any person directly affected by this chapter may petition the director to grant a variance from any requirement of this chapter, subject to the provisions of this part. Any petition submitted to the director is also subject to the provisions of the Virginia Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

The director will not accept any petition relating to:

1. Equivalent testing or analytical methods contained in EPA Publication SW-846;

2. Definitions of regulated medical waste contained in Part III (9VAC20-120-80 et seq.) of this chapter; and

3. A change in the regulatory requirements that the petitioner is currently violating until such time as the violation has been resolved through the enforcement process.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.1, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

Article 2
Variances to Requirements

9VAC20-120-850. Application and conditions.

Article 2
Variances to Requirements

The director may grant a variance from any regulation contained in Parts IV through X to a petitioner if the petitioner demonstrates to the satisfaction of the director that:

1. a. Strict application of the regulation to the facility will result in undue hardship that is caused by the petitioner's particular situation, or

b. Technical conditions exist that make a strict application of the regulation difficult to achieve, and

c. The alternate design or operation will result in a facility that is equally protective of the human health and the environment as that provided for in the regulations; and

2. Granting the variance will not result in an unreasonable risk to the public health or the environment.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.2, eff. June 29, 1994.

9VAC20-120-860. Effects of the decisions.

A. When the director renders a decision under this section in accordance with the procedures contained here, he may:

1. Deny the petition;

2. Grant the variance as requested; or

3. Grant a modified or partial variance.

B. When a modified variance is granted, the director may:

1. Specify the termination date of the variance;

2. Include a schedule for:

a. Compliance, including increments of progress, by the facility with each requirement of the variance; and

b. Implementation by the facility of such control measures as the director finds necessary in order that the variance may be granted.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.3, eff. June 29, 1994.

9VAC20-120-870. Submission of petition.

A. All petitions submitted to the director shall include:

1. The petitioner's name and address;

2. A statement of petitioner's interest in the proposed action;

3. A description of desired action and a citation to the regulation from which a variance is requested;

4. A description of need and justification for the proposed action;

5. The duration of the variance, if applicable;

6. The potential impact of the variance on public health or the environment;

7. Other information believed by the petitioner to be pertinent; and

8. The following statements signed by the petitioner or his authorized representative:

"I certify that I have personally examined and am familiar with the information submitted in this petition and all attached documents, and that, based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment."

B. In addition to the general information required of all petitioners under this article:

1. To be successful the petitioner shall address the applicable standards and criteria.

2. The petitioner shall provide an explanation of the petitioner's particular situation that prevents the facility from achieving compliance with the cited regulation.

3. The petitioner shall provide other information as may be required by the department.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.4, eff. June 29, 1994.

9VAC20-120-880. Petition processing.

A. After receiving a petition that includes the information required in 9VAC20-120-870, the director will determine whether the information received is sufficient to render the decision. If the information is deemed to be insufficient, the director will specify additional information needed and request that it be furnished.

B. The petitioner may submit the additional information requested, or may attempt to show that no reasonable basis exists for the request for additional information. If the director agrees that no reasonable basis exists for the request for additional information, he will act in accordance with subsection C of this section. If the director continues to believe that a reasonable basis exists to require the submission of such information, he will proceed with the denial action in accordance with the Virginia Administrative Process Act (VAPA).

C. After the petition is deemed complete:

1. The director will make a tentative decision to grant or deny the petition.

2. In case that petition may be tentatively denied, the director will offer the petitioner the opportunity to withdraw the petition, submit additional information, or request the director to proceed with the evaluation.

3. Unless the petition is withdrawn, the director will issue a draft notice tentatively granting or denying the application. Notification of this tentative decision will be provided by newspaper advertisement in the locality where the petitioner is located. The director will accept comment on the tentative decision for 30 calendar days.

4. Upon a written request of any interested person, the director may, at his discretion, hold an informal fact finding meeting described in § 2.2-4011 of the Virginia Administrative Process Act. A person requesting a meeting shall state the issues to be raised and explain why written comments would not suffice to communicate the person's views. The director may in any case decide on his own motion to hold such a meeting.

5. After evaluating all public comments the director will, within 15 calendar days after the expiration of the comment period:

a. Notify the petitioner of the final decision; and

b. Notify all persons who commented on the tentative decision or publish it in a newspaper having circulation in the locality.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.5, eff. June 29, 1994; amended, Virginia Register Volume 18, Issue 18, eff. June 19, 2002.

9VAC20-120-890. Petition resolution.

A. In the case of a denial, the petitioner has a right to request a formal hearing to challenge the rejection.

B. If the director grants a variance request, the notice to the petitioner shall provide that the variance may be terminated upon a finding by the director that the petitioner has failed to comply with any variance requirements.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.6, eff. June 29, 1994.

Article 3
Innovative Treatment Technology Review

9VAC20-120-900. General.

Article 3
Innovative Treatment Technology Review

The requirements for alternate treatment methods contained in Part IX allow, at subdivision 2 d of 9VAC20-120-640, that new or innovative treatment technologies can be approved for permitting if the director reviews the process and determines that it provides treatment in keeping with this chapter and protects public health and the environment, and if the director establishes appropriate conditions for their siting, design, and operation. This article establishes the criteria, protocols, procedures, and processes to be used to petition the director for review and to demonstrate the suitability of the proposed process for the treatment of regulated medical waste.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.7, eff. June 29, 1994.

9VAC20-120-910. Criteria for microbial inactivation.

A. Inactivation is required to be demonstrated of vegetative bacteria, fungi, all viruses, parasites, and mycobacteria at a 6 Log10 reduction or greater; a 6 Log10 reduction is defined as a 6 decade reduction or a one millionth (0.000001) survival probability in a microbial population (i.e., a 99.9999% reduction).

B. Inactivation is required to be demonstrated of B. stearothermophilus spores or B. subtilis spores at a 4 Log10 reduction or greater; a 4 Log10 reduction is defined as a 4 decade reduction or a 0.0001 survival probability in a microbial population (i.e., a 99.99% reduction).

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.8, eff. June 29, 1994.

9VAC20-120-920. Representative of biological indicators.

A. One or more representative microorganisms from each microbial group shall be used in treatment efficacy evaluation.

1. Vegetative Bacteria.

- Staphylococcus aureus (ATCC 6538)

- Pseudomonas aeruginosa (ATCC 15442)

2. Fungi.

- Candida albicans (ATCC 18804)

- Penicillium chrysogenum (ATCC 24791)

- Aspergillus niger

3. Viruses.

- Polio 2 or Polio 3

- MS-2 Bacteriophage (ATCC 15597-B1)

4. Parasites.

- Cryptosporidium spp. oocysts

- Giardia spp. cysts

5. Mycobacteria.

- Mycobacterium terrae

- Mycobacterium phlei

- Mycobacterium bovis (BCG) (ATCC 35743)

B. Spores from one of the following bacterial species shall be used for efficacy evaluation of chemical, thermal, and irradiation treatment systems.

1. B. stearothermophilus (ATCC 7953)

2. B. subtilis (ATCC 19659)

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.9, eff. June 29, 1994.

9VAC20-120-930. Quantification of microbial inactivation.

A. Microbial inactivation ("kill") efficacy is equated to "Log10 Kill," which is defined as the difference between the logarithms of number of viable test microorganisms before and after treatment. This definition is equated as:

Log10 Kill = Log10 I(cfu/g) %68 Log10 R(cfu/g) where:

Log10Kill is equivalent to the term Log10 reduction.

"I" is the number of viable test microorganisms introduced into the treatment unit.

"R" is the number of viable test microorganisms recovered after treatment.

"cfu/g" are colony forming units per gram of waste solids.

B. For those treatment processes that can maintain the integrity of the biological indicator carrier (i.e., ampules, plastic strips) of the desired microbiological test strain, biological indicators of the required strain and concentration can be used to demonstrate treatment efficacy. Quantification is evaluated by growth or no growth of the cultured biological indicator.

C. For those treatment mechanisms that cannot ensure or provide integrity of the biological indicator (i.e., chemical inactivation/grinding), quantitative measurement of treatment efficacy requires a two step approach: Step 1, "Control"; Step 2, "Test." The purpose of Step 1 is to account for the reduction of test microorganisms due to loss by dilution or physical entrapment.

1. Step 1.

a. Use microbial cultures of a predetermined concentration necessary to ensure a sufficient microbial recovery at the end of this step.

b. Add suspension to a standardized medical waste load that is to be processed under normal operating conditions without the addition of the microbial inactivation agent (i.e., heat, chemicals).

c. Collect and wash waste samples after processing to recover the biological indicator organisms in the sample.

d. Plate recovered microorganism suspensions to quantify microbial recovery. (The number of viable microorganisms recovered serves as a baseline quantity for comparison to the number of recovered microorganisms from wastes processed with the microbial inactivation agent).

e. The required number of recovered viable indicator microorganisms from Step 1 must be equal to or greater than the number of microorganisms required to demonstrate the prescribed Log reduction as specified in 9VAC20-120-910 (i.e., a 6 Log10 reduction for vegetative microorganisms or a 4 Log10 reduction for bacterial spores). This can be defined by the following equation:

Log10RC = Log10IC %68 Log10NR

where: Log10RC is greater than or equal to 6 for vegetative microorganisms and is greater than or equal to 4 for bacterial spores and where:

Log10RC is the number of viable "Control" microorganisms (in colony forming units per gram of waste solids) recovered in the nontreated processed waste residue.

Log10IC is the number of viable "Control' microorganisms (in colony forming units per gram of waste solids) introduced into the treatment unit.

Log10NR is the number of "Control" microorganisms (in colony forming units per gram of waste solids) that were not recovered after processing. Log10NR represents an accountability fad-or for microbial loss.

2. Step 2.

a. Use microbial cultures of the same concentration as in Step 1.

b. Add suspension to the standardized medical waste load that is to be processed under normal operating conditions with the addition of the microbial inactivation agent.

c. Collect and wash waste samples after processing to recover the biological indicator organisms in the sample.

d. Plate recovered microorganism suspensions to quantify microbial recovery.

e. From data collected from Step 1 and Step 2, the level of microbial inactivation (i.e., "Log10 Kill") is calculated by employing the following equation:

Log10Kill = Log10IT %68 Log10NR %68 Log10RT, where:

Log10Kill is equivalent to the term Log10 reduction.

Log10IT is the number of viable "Test" microorganisms-(in colony forming units per gram of waste solids) introduced into the treatment unit. Log10IT = Log10IC.

Log10NR is the number of "Control microorganisms (in colony forming units per gram of waste solids) that were not recovered after processing.

Log10RT is the number of viable "Test" microorganisms (in colony forming units per gram of waste solids) recovered in treated processed waste residue.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.10, eff. June 29, 1994.

9VAC20-120-940. Efficacy testing protocols.

A. Methodology employed to determine treatment efficacy of the technology will need to assure required microbial inactivation and assure the protocols are congruent with the treatment method. Protocols developed for efficacy testing shall incorporate, as applicable, recognized standard procedures such as those found in Test Methods for Evaluating Solid Waste, Physical/Chemical Methods and Standard Methods for the Examination of Water and Waste Water.

B. The department shall prescribe those types and compositions of medical wastes that present the most challenge to treatment effectiveness under normal operating conditions of the equipment reviewed.

C. Dependent on the treatment process and treatment efficacy mechanisms utilized, protocols evaluating medical waste treatment systems shall specifically delineate or incorporate, as applicable:

1. Waste compositions that typify actual waste to be processed;

2. Waste types that provide a challenge to the treatment process;

3. Comparable conditions to actual use (i.e., process time, temperature, chemical concentration, pH, humidity, load density, load volume);

4. Assurances that biological indicators (i.e., ampules, strips) are not artificially affected by the treatment process;

5. Assurances of inoculum traceability, purity, viability and concentration;

6. Dilution and neutralization methods that do not affect microorganism viability;

7. Microorganism recovery methodologies that are statistically correct (i.e., sample collection, number of samples/test, number of colony forming units/plate); and

8. Appropriate microbial culturing methods (i.e., avoidance of microbial competition, the selection of proper growth media and incubation times).

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.11, eff. June 29, 1994.

9VAC20-120-950. Technology approval process.

A. To initiate the technology review process the petitioner shall complete and submit the "Petition For Evaluation and Approval of Regulated Medical Waste Treatment Technology Part A: General Information" to the department. The petitioner shall:

1. Provide a detailed description of the medical waste treatment equipment to be tested including manufacturer's instructions and equipment specifications, operating procedures and conditions including, as applicable, treatment times, pressure, temperatures, chemical concentrations, irradiation doses, feed rates, and waste load composition;

2. Provide documentation demonstrating the treatment method meets microbial inactivation criteria and required testing protocols including a detailed description of the test procedures and calculations used in fulfilling required performance standards verifying treatment efficacy, of user verification methodology, and of microbial culturing protocols that ensure traceability, purity and concentration;

3. Provide information on available parametric controls, verifying treatment efficacy and ensuring operator non-interference;

4. Provide documentation of applicable emission controls for suspected emissions;

5. Provide information relating to waste residues including their potential hazards/toxicities and their specific mode of disposal or recycling;

6. Provide documentation providing occupational safety and health assurance; and

7. Provide information on energy efficiency and other potential benefits the treatment technology has to offer to the environment.

B. The petitioner shall demonstrate that all required surrogate pathogens and resistant bacterial endospores are inactivated to criteria specified in 9VAC20-120-910 and 9VAC20-120-930 under the representative challenge waste load compositions.

C. The petitioner shall develop and demonstrate that site approval and user verification testing protocols are workable and valid.

D. The petitioner shall demonstrate where technically practical, the treatment efficacy relationship between biological indicator data and data procured from real-time parametric treatment monitoring equipment.

E. The petitioner shall demonstrate evidence of U.S. EPA pesticide registration for those treatment processes that employ a chemical agent to inactivate microorganisms.

F. Upon completion of items contained in 9VAC20-120-910 through 9VAC20-120-950, the technology approval that results is granted only under the conditions specified in the manufacturer's instructions and equipment specifications, operating procedures and conditions including, as applicable, treatment times, temperatures, pressure, chemical concentrations, irradiation doses, feed rates, and waste load composition. Any significant revisions to these equipment and operating conditions, as warranted relevant to the department, will require reapplication for approval to the department.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.12, eff. June 29, 1994.

9VAC20-120-960. Site approval process.

A. To fulfill treatment efficacy and information requirements for site approval, the equipment user shall:

1. Demonstrate that the equipment cited is the same equipment and process approved by the department as specified in 9VAC20-120-950.

2. Demonstrate that required resistant bacterial endospores are inactivated as specified in 9VAC20-120-910 B criteria under typical waste load and department specified challenge compositions;

3. Verify that user verification protocols adequately demonstrate treatment effectiveness; and

4. Verify the treatment efficacy relationship between biological indicator data and data procured from real-time parametric treatment monitoring equipment.

B. The site facility shall provide a written operations plan that includes:

1. The names or positions of the equipment operators;

2. The waste types or categories to be treated;

3. Waste segregation procedures required;

4. Wastes types prohibited for treatment;

5. Equipment operation parameters;

6. Treatment efficacy monitoring procedures;

7. Personal protective equipment requirements;

8. Emergency response plans; and

9. Operator training requirements.

C. The site facility shall submit to the department for their review:

1. Equipment model number and serial number;

2. Equipment specification and operations manual;

3. A copy of the facility's written plan; and

4. Certification documentation of operator training.

D. As a condition of site approval, the department shall have a right to inspect the facility and the right to revoke site approval if health and safety violations are discovered, if permit conditions are not being fulfilled, or if the facility is not adhering to its written plan.

E. Any modifications to the medical waste treatment unit may require re-approval by the director and may involve further efficacy testing.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.13, eff. June 29, 1994.

9VAC20-120-970. User verification.

A. To verify that the medical waste treatment unit is functioning properly and that performance standards are achieved, the petitioner shall:

1. Demonstrate that required resistant bacterial endospores are inactivated to criteria as specified in 9VAC20-120-910 B under standard operating procedures using protocols that have previously been approved by the department as specified under 9VAC20-120-950 and 9VAC20-120-960;

2. Establish a frequency of biological monitoring; and

3. Document and record all biological indicator and parametric monitoring data.

B. To document treatment efficacy for steam sterilizers and autoclaves, the equipment operator shall:

1. Adopt standard written operating procedures that denote:

a. Sterilization cycle time, temperature, pressure

b. Types of waste acceptable

c. Types of containers and closures acceptable

d. Loading patterns or quantity limitations;

2. Document times/temperatures for each complete sterilization cycle;

3. Use time-temperature sensitive indicators to visually denote the waste has been decontaminated;

4. Use biological indicators placed in the waste load (or simulated load) periodically to verify conditions meet microbial inactivation requirements as specified in 9VAC20-120-910 B; and

5. Maintain all records of procedure documentation, time-temperature profiles, and biological indicator results.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.14, eff. June 29, 1994.

9VAC20-120-980. Small medical waste treatment devices.

A. All small medical waste treatment devices shall fulfill the requirements necessary for technology approval and shall meet the treatment efficacy requirements as defined in 9VAC20-120-910.

B. Technology and siting approval are the responsibility of the petitioner. The petitioner shall provide to the department:

1. All information required for technology approval as defined in 9VAC20-120-950;

2. All information required of site approval for a typical site for which the equipment is designed as defined in 9VAC20-120-960; and

3. All materials and documents required of the user to ensure proper use, safety, and effective treatment. These materials and documents would include:

a. An operations and maintenance manual;

b. Information on proper use and potential misuse;

c. Treatment efficacy testing instructions;

d. Training/education manual; and

e. Available service agreements/programs.

C. The manufacturer (vendor) shall furnish the user of the treatment device:

1. An operations and maintenance manual;

2. Information on proper use and potential misuse;

3. Treatment efficacy testing instructions;

4. Training/education manual; and

5. Available service agreements/programs.

D. Upon the installation of the treatment device, the manufacturer shall compile a record of the buyer, the location, and the results of onsite challenge testing at time of purchase. This information shall be submitted annually to the department by the petitioner as the notification record of site registrations of equipment installed that previous year.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.15, eff. June 29, 1994.

9VAC20-120-990. Waste residue disposal.

A. Information on the characteristics of all waste residues (liquids and solids), and the mechanisms and models of their disposal shall be provided by the petitioner on the "Evaluation of Medical Waste Treatment Technology: Information Request Form." This information will include:

1. Description of residues (i.e., liquid, solid, shredded, hazardous constituents);

2. Waste designation (i.e. hazardous, special, general);

3. Disposal mechanism (i.e. landfilling, incineration, recycling); and

4. Recycling efforts, if anticipated, (i.e., waste types, amounts, percentages, name and location of recycling effort).

B. Information on waste residue disposal shall be provided by the user facility as required under site approval (9VAC20-120-960). This information shall include:

1. All information requested in 9VAC20-120-1000 A;

2. The site of disposal (name and address);

3. The mechanism of disposal (i.e. landfilling or incineration); and

4. The amounts of residues anticipated to be disposed (e.g., volume and weight per week).

C. If residues are to be recycled the following information shall be provided by the user facility as required under site approval (9VAC20-120-960). This information shall include:

1. The types of waste residue to be recycled;

2. The amounts of waste residue to be recycled;

3. The percentage of the total waste and waste residue to be recycled;

4. The recycling mechanism used; and

5. The name and location of the recycler.

D. Previously untreated medical wastes used in the development and testing of prototypical equipment shall be considered potentially infectious and will be required to be disposed as untreated medical waste.

E. Prototypical equipment testing using non-infectious or previously treated medical waste (i.e., treated by an approved process such as steam sterilization) that has been inoculated with recommended surrogate pathogens can be disposed as general solid wastes after verification of treatment effectiveness.

F. All liquid and solid waste residues will be disposed of in accordance with applicable state and local regulations.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.16, eff. June 29, 1994.

9VAC20-120-1000. Operator training.

A. To assure proper operation of the treatment process, the manufacturer (vendor) shall provide to the user as part of the treatment equipment purchase an operator training program that will include:

1. A description of all mechanical equipment, instrumentation, and power controls;

2. A description of system's operations including waste types acceptable, loading parameters, process monitors, treatment conditions, and disposal;

3. A description of all parametric controls, their appropriate settings as correlated with biological indicators, and calibration requirements;

4. A description of proper responses, including identification of system upsets (i.e., power failure, jamming, inadequate treatment conditions) and emergency conditions (i.e., fire, explosion, release of chemical or biohazardous materials);

5. A description of personal protective equipment requirements for routine, abnormal, and emergency operations; and

6. A description of all potential occupational safety and health risks posed by the equipment and its use.

B. The facility shall additionally develop a written treatment equipment operations plan that will include:

1. Responsibility delegation for safe and effective equipment operation to operating personnel;

2. A description of operating parameters that must be monitored to ensure effective treatment;

3. A description of all process monitoring instrumentation and established ranges for all operating parameters;

4. A description of the methods required to ensure process monitoring instrumentation is operating properly; and

5. A description of methods and schedules for periodic calibration of process monitoring instrumentation.

C. The facility shall document and keep on record copies of all training for at least three years.

Statutory Authority

Chapter 14 (§ 10.1-1400 et seq.) of Title 10.1 of the Code of Virginia.

Historical Notes

Derived from VR672-40-01:1 § 11.17, eff. June 29, 1994.

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