Current through Register Vol. 41, No. 3, September 23, 2024
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.).
Statutory Authority: § 10.1-1402 of the Code of
Virginia; 42 USC §
6941 et seq.; 40 CFR Part
257.
