J4.

35.

56.

b) The disposal site (name and address);
c) The mechanism of disposal (i.e. landfilling or incineration); and

d) The amounts of residue(s) anticipated to be disposed of (e.g., volume and
weight per week). -

ra

,

Ef residue(s) are to be recycled, the following information shall be provided by the
user facility as required under site approval (Section F). This information shall
include:

a) The types of waste residue to be recycled;

b) The amounts of waste residue to be recycled;

©) The percentage of the total waste and waste residue to be recycled;

d) The recycling mechanism used; and

e) The name and location of the recycler.

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 of as untreated wedical waste.

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 pathogen surrogates can be disposed of as
general solid waste after verification of microbial inactivation.

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

OPERATOR TRAINING

K1.

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 which shall include:

a) A description of all mechanical equipment, instrumentation, and power
controls;

b) A description of system operations including waste types acceptat'~

A-14


a) Step 1:

1)

2)

3)

4)

5)

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

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

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

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 treatment agent).

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 Section A (i.e., a 6 Log,, reduction for
vegetative microorganisms or a 4 Log,, reduction for bacterial
spores). This can be defined by the following equations:

LogiRC = LogysIC - Log, NR

or
Logy)NR = LogiglC - Log,gRC

where:

LogioRC > 6 for vegetative microorganisms and >
4 for bacterial spores and where:

LogyRC is the number of viable "Control"
microorganisms (in colony forming units per gram
of waste solids) recovered in the non-treated
processed waste residue;

Log,IC is the ‘number of viable “Control”
microorganisms (in colony forming units per gram
of waste solids) introduced into the treatment unit;

Log, NR is the number of "Control" microorganisms

AS


F4,

F5.

cy)
°)
f)
8)
h)
i)

Wastes types prohibited for treatment;
Equipment operation parameters;
Microbial inactivation monitoring procedures;

Shut-down, clean-out and maintenance procedures; -

ny

Personal protective equipment requirements; and

Operator training requirements.

The site facility shall provide a written emergency and contingency response piza
that includes:

a)

b)

°)

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

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

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

The site facility shall submit to the Agency for their review:

a)
b)
°)
qd)
°)
f)

Equipment model number and serial number;

Equipment specification and operations manual;

Certification that equipment is identical to the state authorized system;
A copy of the facility’s operations plan;

A copy of the facility’s emergency and contingency response plan; and

Certification documentation of operator training.

As a condition of site approval, the Agency 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 nut
adhering to its written plans.

A-10

Come]


D. EFFICACY TESTING PROTOCOLS

Di.

D2.

D3.

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 USEPA "Test Methods for Evaluating Solid Waste, Physical/Chemical

Methods" and APHA et al., Standard Methods for the Examination of Water and
Waste Water.

The state agency reviewing medical waste treatment technologies (the "Agency")
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.

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

a) Waste compositions that typify actual waste to be processed;

b) Waste types that provide a challenge to the treatment process;

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

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

e) Assurances of inoculum traceability, purity, viability and concentration;

f) Dilution and neutralization methods that do not affect microorganism
viability;

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

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


b)

Step 2:
1)
2)

)

4)
5)

(in colony forming units per gram of waste solids)
which were not recovered in the non-treated
Processed waste residue. Log,,.NR represents an
accountability factor for microbial loss.

Use microbial cultures of the same concentration as in Step1.

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

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

Plate recovered microorganism suspensions to quantify microbial recovery.

From data collected from Step 1 and Step 2, the level of ‘microbial
inactivation (i.¢., "Log, Kill") is calculated by employing the followviag
equation:

Log, Kill = LogyIT - Log,.NR - Log, RT

where:

Log, Kill is equivalent to the term Log,, reduction;

LogiIT is the number of viable "Test"
microorganisms (in colony forming units per gram
of waste solids) introduced into the treatment unit.
LogylT = LogyIC;

Log,oNR is the number of "Control" microorganisms
(in colony forming units per gram of waste solids)
which were not recovered in the non-treated
processed waste residue;

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

A6


E7.

The manufacturer (vendor) shall develop contingency response plans and protocols
for use in the event of an emergency, accident, or equipment malfunction. The
manufacturer (vendor) shall demonstrate that developed protocols are effective in
providing operator safety from physical, chemical, or biological exposures during
and after the event including decontamination procedures.

The manufacturer (vendor) shall demonstrate evidence of USEPA pesticide
registration for those treatment Processes that employ a chemical agent to
inactivate microorganisms.

Upon demonstration to the Agency’s satisfaction, technology approval 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. Revisions to these
equipment and operating conditions, as warranted relevant to the Agency, will
require re-application for approval to the Agency.

F. SITE APPROVAL PROCESS

Fl.

To fulfill microbial inactivation requirements and information requirements for site
approval, the equipment user shall:

a) Demonstrate that the equipment sited is the same equipment and process
approved by the Agency as specified in Section E.

b) Demonstrate that required resistant bacterial endospores are inactivated as
specified in Section A2 criteria under typical waste load and Agency
specified challenge compositions;

c) Verify that user verification protocols adequately demonstrate microbial
inactivation; and

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

The site facility shall provide a written operations plan that includes:
a) The names or positions of the equipment operators;
b) The waste types or categories to be treated;

c) Waste segregation procedures required;

A9


APPENDIX A

STATE GUIDELINE FOR APPROVAL OF
MEDICAL WASTE TREATMENT TECHNOLOGIES


G3. Medical waste incinerators are to be Operated, maintained, and monitored as
Specified in applicable site and operating permits.

SMALL MEDICAL WASTE TREATMENT DEVICES

Hi. All small medical waste treatment devices shall fulfill the requirements necessary

for technology approval and shall meet the microbial inactivation requirements as
defined in Section A. :

H2. Technology and siting approval are the tesponsibility of the manufacturer or
equipment vendor. The manufacturer (vendor) shall provide to the Agency:

2)
v)

°)

All information required for technology approval as defined in Section E;

All information required of site approval for a typical site for which the
equipment is designed as defined in Section F; and

All materials and documents required of the user to ensure proper use,

safety, and effective treatment. These materials and documents would
include:

1) An operations and maintenance manual;

2) Information on proper use and potential misuse;
3) Microbial inactivation testing instructions;

4) Training/education manual; and

5) Available service agreements/programs.

H3. The manufacturer (vendor) shall furnish the user of the treatment device:

a)
b)
¢)
d)
°)

An operations and maintenance manual;
Information on proper use and potential misuse;
Microbial inactivation testing instructions;
Training/education manual; and ,

Available service agreements/programs.

A-12


F6.

Any modifications to the medical waste treatment unit may require re-approvai oy
the Agency and may involve further efficacy testing.

G. USER VERIFICATION

G1.

G2.

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

a)

b)

°)

Demonstrate that required resistant bacterial endospores are inactivated to
criteria as specified in Section A2 under standard operating procea: “es
using protocols that have previously been approved by the Agency a:
specified under Section E and F;

Demonstrate adherence to the frequency of biological monitoring specified
by the Agency; and

Document and record all biological indicator and parametric monitoring
data.

To document microbial inactivation for steam sterilizers and autoclaves, the
equipment operator shall:

a)

Adopt standard written operating procedures which denote:

1) Sterilization cycle time, temperature, pressure

2) Types of waste acceptable

3) Types of containers and closures acceptable

4) Loading patterns or quantity limitations;

Document times/temperatures for each complete sterilization cycle;

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

Use biological indicators placed .in the waste load (or simulated load)
periodically to verify that conditions meet microbial inactivation
requirements as specified in Section A2; and

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

A-ll

.


E. TECHNOLOGY APPROVAL PROCESS

El.

Fo initiate the technology review process, the manufacturer (vendor) shali
complete and submit the "Evaluation of Medical Waste Treatment Technology:
Information Request Form" to the Agency. The manufacturer (vendor) shall:

a)

b)

°)

8)

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;

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 microbial inactivation,
of user verification methodology, and of microbial culturing protocols
which ensure traceability, purity and concentration;

Provide information on available parametric controls/monitoring devices,
verifying microbial inactivation and ensuring operator non-interference;

Provide documentation of applicable emission controls for suspected
emissions;

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

Provide documentation providing occupational safety and health assurance;
and

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

The manufacturer (vendor) shall demonstrate that all required pathogen surrogates
and resistant bacterial endospores are inactivated to criteria specified in Section
A and Section C under all Agency specified challenge waste load compositions

The manufacturer (vendor) shall develop and demonstrate that site approval anc
user verification testing protocols are workable and valid.

The manufacturer (vendor) shall demonstrate where technically practical, =<
relationship between biological indicator data and data procured from reai-time
parametric treatment monitoring equipment.

AS

ey


- Mycobacterium phlei
- Mycobacterium bovis (BCG) (ATCC 35743).

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

a) B. stearothermophilus (ATCC 7953)
b) _B subtilis (ATOC 19659). -

C. QUANTIFICATION OF MICROBIAL INACTIVATION

Ci.

Microbial inactivation (“kill”) efficacy is equated to "Logi Kill" which is defined
as the difference between the logarithms of the number of viable ies:
microorganisms before and after treatment. This definition is equated as:

Log,cKill = Logy(cfu/g "I") - Log,o(cfu/g "R")

where:

Log, Kill is equivalent to the term Log,, 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; and

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

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 microbial inactivation. Quantification is evaluated by growth or
no growth of the cultured biological indicator.

For those treatment mechanisms that cannot ensure or provide integrity of the
biological indicator (i.e., chemical inactivation/grinding), quantitative measuremer*
of microbial inactivation 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.

A4


°)

4)

8)

loading parameters, process monitors, treatment conditions, and residue
disposal procedures;

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

A description of proper responses, including identification of system upsets
(ie, power failure, jamming, imadequate treatment conditions) and
procedures to be followed during emergency conditions (i.e., fire,
explosion, release of chemical or biohazardous materials);

A description of the procedures for equipment shut-down and clean-out for
maintenance or other purposes;

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

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

The facility shall develop a written equipment operations plan which shall include:

a)

b)

¢)

4)

f)

Delegation of responsibility for safe and effective equipment operation to
operating personnel;

A description of operating parameters that must be monitored to ensure
microbial inactivation;

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

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

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

A description of the procedures for equipment shut-down and clean-out for
maintenance or other purposes. .”

The facility shall develop a written contingency and emergency response plan to
include:

A-15


LS. Granting of an Experimental Permit does not assure future site approval on state
approval of the process.

L6. Facilities with experimental permits cannot accept waste for monetary gain.

A-17


STATE GUIDELINE FOR APPROVAL OF MEDICAL
WASTE TREATMENT TECHNOLOGIES

A. DEFINITION OF MICROBIAL INACTIVATION

Al.

Inactivation is required to be demonstrated of vegetative _ bacteria, fungi,
lipophilic/hydrophilic viruses, parasites, and mycobacteria at a 6 Log,, reduction
or greater, a 6 Log,, 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).

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

B. REPRESENTATIVE BIOLOGICAL INDICATORS

BI.

One or more of the following representative microorganisms from each microbial
group shall be used to determine if microbial inactivation requirements are met:

a) Vegetative Bacteria

- Staphylococcus aureus (ATCC 6538)
- Pseudomonas aeruginosa (ATCC 15442)

b) = Fungi
- Candida albicans (ATCC 18804)
- Penicillium chrysogenum (ATCC 24791)
- Aspergillus niger

c) Viruses
- Polio 2 or Polio 3
- MS-2 Bacteriophage (ATCC 15597-B1)

d) ‘Parasites

- Cryptosporidium spp. oocysts
- Giardia spp. cysts

e)  Mycobacteria
- Mycobacterium terrae

A-3


PREFACE

This guideline summarizes the discussions and results of the State and Territorial Association on
Alternate Treatment Technologies. It should be emphasized that the recommendations provided
by the Association and adopted by the participating states are an attempt to find commonality on
many of the issues and criteria required in the medical waste treatment technology review
process. Recognizing that all states may not totally agree with these recommended criteria or
protocols, this guideline can serve as a foundation or model for the development of siate
guidelines or regulations. It is also recognized that definitions, terms, and :egu.atory
methodologies used within the framework of this guideline may not be compatible wi:a graated
legislative authority or existing regulatory language. As such, this guideline may require revision
to conform with specific state statutes and regulatory requirements.


H4.

Upon the installation of the treatment device, the manufacturer shall compile a
record of the buyer, the location, and the results of on-site challenge testing at
time of purchase. This information shall be submitted annually to the Agency by
the manufacturer (vendor) as the notification record of site registrations of
equipment installed that previous year.

L_ PREVIOUSLY APPROVED TECHNOLOGIES o

It.

Medical waste treatment equipment which is subject to these registration and
technology approval requirements that has been installed and operated before
January 1, 1994, shall comply with current efficacy standards by (date). By
(date), pre-existing medical waste’ tréatnent equipment shall have been moditiec
to meet’ current standards, taken ‘out of service, or replaced by approved
equipment.

Steam sterilizers, autoclaves, and incinerators are not included within the category
of "emerging treatment technologies" and are not subject to these registration and
technology approval requirements. Site and operation permits are still
necessitated, as required, under applicable state regulations.

WASTE RESIDUE DISPOSAL

J.

32.

Information on the characteristic(s) of all waste residues (liquids and solids), and
the mechanism(s) and mode(s) of their disposal shall be provided by the
manufacturer on the "Application for Evaluation and Approval of Medical Waste
Treatment Technologies." This information shall include:

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

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

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

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

Information on waste residue disposal shall be provided by the user facility as
required under site approval (Section F). This information shall include:

a) All information requested in Section J1;

A-13


K4.

a) A description of all potential occupational safety and health risks posed by
- the equipment and its use;

b) A description of proper responses for system upsets and emergency
conditions;

c) A description of personal protective equipment requirements for routine,
abnormal, and emergency operations;

qd) A description of proper medical response if required; and

e) A pre-designated disposal site for untreated or inadequately treated medical
waste if a mechanical failure precludes use of the treatment equipment.

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

RESEARCH AND DEVELOPMENT

Ll.

The Agency may issue an Experimental Permit for medical waste treatment
Processes or techniques that are undergoing research and development if the
applicant can provide evidence that:

a) Environmental impact is minimal; and
b) Occupational exposures are minimal.

The Agency’s "Evaluation of Medical Waste Treatment Technology: Information
Request Form" shall be submitted and shall contain environmental and
occupational safety data in addition to equipment specifications, residue
management and disposal, and any available preliminary microbial inactivation
data and protocols.

All equipment testing shall preferably use non-infectious or previously treated
medical waste (i.¢., treated by an approved process such as steam sterilization) that
has been inoculated with recommended pathogen surrogates listed in Section B.
Waste residues generated can be disposed of as general solid wastes upon
verification of microbial inactivation. Untreated medical wastes used in the
development and testing of prototypical equipment shall be considered potentially
infectious and will be required to be disposed of as untreated medical waste.

All Experimental Permits have a duration not to exceed two years with a one-time
Tenewal.

A-16

a