Section 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.

Historical Notes

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

Statutory Authority

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