Virginia Law

A. In accordance with 9VAC20-121-240 I, chemical treatment and other alternate treatment technologies may be approved for permitting if the department reviews the process and determines that the technology provides treatment in accordance with this chapter and protects public health and the environment, and if the department establishes appropriate conditions for their siting, design, and operation. This section establishes the criteria, protocols, procedures, and processes to be used to petition the director for review and to demonstrate the suitability of the proposed technology for the treatment of regulated medical waste.

B. Alternate treatment technologies are subject to the general treatment standards of 9VAC20-121-240 and the additional requirements of this section. To ensure effectiveness of the proposed chemical or alternate treatment technology, the applicant must demonstrate effective microbial and bacterial inactivation at a 6 log₁₀ or greater reduction for the microorganisms and spores listed in subsections C and D of this section through validation testing that meets the requirements of 9VAC20-121-260.

C. Microbial inactivation shall be demonstrated using one or more representative microorganisms from each microbial group:

1. For vegetative bacteria: either Staphylococcus aureus (ATCC 6538) or Pseudomonas aeruginosa (ATCC 15442).

2. For fungi: either Candida albicans (ATCC 18804), Penicillium chrysogenum (ATCC 24791), or Aspergillus niger.

3. For viruses: either Polio 2 or Polio 3, or MS-2 Bacteriophage (ATCC 15597-B1).

4. For parasites: either Cryptosporidium spp. oocysts or Giardia spp. Cysts.

5. For Mycobacteria: either Mycobacterium terrae, Mycobacterium phlei, Mycobacterium bovis (BCG) (ATCC 35743).

D. Bacterial inactivation shall be demonstrated for chemical, thermal, and irradiation treatment systems using spores from either B. stearothermophilus (ATCC 7953) or B. subtilis (ATCC 19659).

E. 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 shall be used to demonstrate effective treatment. Effective treatment is demonstrated by no growth in all treated biological indicators and growth in all untreated biological indicators during validation and periodic challenge testing.

F. For those treatment mechanisms that cannot ensure or provide integrity of the biological indicator (i.e., chemical inactivation or grinding), quantitative measurement of effective treatment 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 is:

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 a 6 log₁₀ or greater reduction.

2. Step 2 is:

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.

3. From data collected from Step 1 and Step 2, the level of microbial and bacterial inactivation shall be calculated based on the:

a. Number of viable "Test" microorganisms (in colony forming units per gram of waste solids) introduced into the treatment unit,

b. Number of "Control" microorganisms (in colony forming units per gram of waste solids) that were not recovered after processing, and

c. Number of viable "Test" microorganisms (in colony forming units per gram of waste solids) recovered in treated processed waste residue.

G. To initiate the technology review process the applicant shall complete and submit DEQ Form RMWTP-01, Application for Evaluation and Approval of Regulated Medical Waste Treatment Technology to the department. The application shall be accompanied by:

1. A detailed description of the chemical or alternate treatment technology. The description must include:

a. A discussion of operating procedures and conditions, including, as applicable, treatment times, pressure, temperatures, chemical concentrations, irradiation doses, feed rates, and waste load composition;

b. A discussion of parametric controls, verifying effective treatment, and ensuring operator noninterference; and

c. A discussion of waste residues and by-products generated and methods of disposal or recycling.

d. The description shall be accompanied by the manufacturer's operations manual or equipment usage instructions, equipment specifications, and maintenance manual.

2. Documentation demonstrating the chemical or alternate treatment technology meets microbial and bacterial inactivation criteria specified under subsections B through F of this section. The documentation must include a description of the test procedures and calculations used in fulfilling required performance standards verifying effective treatment, of user verification methodology, and of microbial culturing protocols that ensure traceability, purity and concentration, and copy of all test results.

3. A chemical management plan describing all chemicals to be stored on site and include copies of Safety Data Sheets for all chemicals used for regulated medical waste treatment and EPA pesticide registration, if applicable.

4. Documentation providing occupational safety and health assurance.

H. The applicant shall demonstrate that all required surrogate pathogens and resistant bacterial endospores are inactivated to criteria specified in subsections B through F of this section under the representative surrogate waste load compositions.

I. The applicant shall demonstrate where the relationship between effective treatment, biological indicator data, and data procured from real-time parametric monitoring devices for the treatment unit.

J. The review of the application will occur in accordance with this subsection.

1. After receiving an application that includes the information and demonstrations required in subsections A through I of this section, the department will perform an administrative review and determine whether the information received is sufficient to approve the proposed chemical or alternate treatment technology. If the information is deemed to be insufficient, the department will request that additional information be furnished.

2. The applicant may submit the additional information requested or may demonstrate that the additional information should not be required. If the department agrees that the additional information is not required, the department will determine if the application is complete.

3. After the application is deemed complete, the director may then issue a treatment technology approval. The approval shall be issued under the conditions specified in the manufacturer's instructions and equipment specifications, operating procedures, and conditions as outlined in the application, including, as applicable, treatment times, temperatures, pressure, chemical concentrations, irradiation doses, feed rates, and waste load composition. Any significant revision to these conditions will require reapplication for approval in accordance with this section.

4. Following technology approval, any facility wishing to use the approved technology to treat regulated medical waste shall apply for and obtain the necessary permits in accordance with Part V (9VAC20-121-300 et seq.).