E. MICROBIOLOGICAL TEST PROCEDURES

} Any proposed treatment method shall be capable of inactivating vegetative bacteria, fungi
{ or yeasts, parasites, lipophilic/hydrophilic viruses, and mycobacteria at a 6 Logy reduction
or greater. Bacterial spores shall be inactivated at a 4 Log,, reduction or greater. A
representative from each of the following microbial groups is required for testing.

El. Listed below are several test organisms which have been used as micfObiological
indicators to determine the effectiveness of a given treatment method. If there are
any data either to support or refute the inactivation of any of the biological
indicators using the proposed treatment process under normal operating conditions,
please check the appropriate space next to the indicator.

NOTE:

If protocols utilized by the applicant to generate
microbial inactivation data are deemed unacceptable by
the Department, the Department reserves the right to
request that the applicant resubmit data generated from
Department-approved protocols. If data has not yet been
procured to support the inactivation of the listed
biological indicators below, please contact the
Department before initiating efficacy testing to ensure
research protocols are in accordance with the
Department’s requirements.

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

Fungi
- Candida albicans (ATCC 18804)

- Penicillium chrysogenum (ATCC 24791)
- Aspergillus niger

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

Parasites
- Cryptosporidium spp. oocysts
- Giardia spp. cysts

B-S


K. QUALITY ASSURANCE AND VERIFICATION OF MICROBIAL INACTIVATION

=

K2. What is the recommended frequency that a microbiological indicator should be used
to confirm effectiveness of the system? Specify. ou

How is the quality assurance of the treatment process addressed? Specify.

K3. Other than the biological indicators listed in Section E, what other indicators,
integrators, or monitoring devices would be used to show that the treatment unit or
process was functioning properly? (Please describe and explain.)

How is it determined that the processed waste has received proper treatment?
(Check the appropriate item.)

Temperature indicator:

visual only___

continuous.

Pressure indicator: visual only continuous,

Time indicator: visual only continuous. both.

Chemical concentration indicator: visual only continuous both

Other: Please specify.

| K5. How have the treatment process monitors been correlated with biological indicators to
ensure effective and accurate monitoring of the treatment process? Specify.

. What is the established process monitor calibration schedule, and what is its
frequency of calibration?

How are the process monitors interfaced to the system’s operations to effect proper
treatment conditions? Explain.

How are the process monitor controls secured to prevent operator over-ride of the
process before treatment is adequately affected? Explain.

. What failure mode and effect analyses have been performed on the treatment system?
Specify and provide.

B-10


G. ENVIRONMENTAL EFFECTS OF THE TREATMENT PROCESS

Are any negative effects on the environment anticipated from the use of the
treatment process and/or disposal of the treated waste from the treatment process?

What environmental, occupational, and/or public health hazards would be associated
* with a malfunction of the treatment process? Specify. *.

.

If the treatment process includes the use of water, steam, or other liquids, how will
this waste discharge be handled (i.e., sewer, recycled, etc.)? Specify.

What are the physical characteristics of the waste residues generated from the
treatment process (i.e., wet, dry, shredded, powdered, etc.)? Specify.

. How will the treated medical waste from this process be disposed of (i.e., landfill,
incineration, recycled, etc.)? Specify.

Are any by-products classified as hazardous waste (40 CFR Part 261)?

Yes__No___- Complete Item A6.

What hazard abatement/reduction strategies will be used in during the operation of

this treatment process (include engineering controls, person protection equipment,
etc.)?

| H3. What training will the operator(s) of the treatment process receive?


Mycobacteria
- Mycobacterium terrae

“+ Mycobacterium phlei
- Mycobacterium bovis (BCG) ATCC 35743)

Bacterial Spores

- B. stearothermophilus (ATCC 7953)
- B. subtilis (ATCC 19659)

Were the results certified by an independent public health or certified testing
laboratory? Yes No.

If yes, indicate the name, address, and telephone number of the certifying laboratory
and attach the test protocol, results and an explanation of any available data not
supporting the reduction factors referenced above.

Please indicate all by-products and discharges (to air, water, or land) which may be
generated as a result of this alternative treatment technology.

Stack Emissions___ Heat__ Slag Vapors or Fumes__

Ash___ Liquid Smoke Aerosols,

Leachate__ Dust, Odor. Steam.

Chemical Residues___

Other, specify

If any of the above by-products or discharges are indicated, how will they be
controlled?

If there are no by-products or discharges indicated, how was this determined?
Are any of these by-products or discharges USEPA-listed hazardous wastes (40 CFR

Part 261), biohazardous, etc.? No__ Yes__. If yes, explain necessary controls,
personal protective equipment, storage, disposal, etc.

B-6


J. CHEMICAL INACTIVATION TREATMENT PROCESSES

Ji. If the treatment process involves the use of chemical inactivation:
a) What is the name of the active ingredient?
b) What concentrations must be used and maintained?

c)

At what pH is the chemical agent active?

d) What is the necessary contact time?

e) If there is any incompatibility with specific materials and surfaces, specify.

f) What is the pH of any end products (i.e., liquid effluents)?

g) List any additional factors or circumstances that may interfere with the
chemical’s inactivation potential.

32. What is the active life of the chemical agent after it has been exposed to air or
contaminated medical waste?

Have studies been conducted relative to the long-term effectiveness of the chemical
agent while in use? If yes, please attach a copy of the study and test results.

34. What health and safety hazards may be associated with the chemical (present and
long-term)? Specify.

MSDS Attached? Yes__ No__

35. Is the chemical agent registered for this specific use with the Environmental
Protection Agency (USEPA) Pesticide Registration Division? Yes__- No__

If yes, provide the USEPA registration number and a copy of the
EPA-approved label instructions for use.

Is the spent chemical agent classified as a hazardous waste by USEPA (40 CFR Part
261) or by other state criteria? Yes__ No___ If yes, specify whether by USEPA
or by which state(s) :

37. 1s an environmental impact study for the chemical agent available? Yes No__
If yes, attach a copy of this information.

B-9

—


APPENDIX B

APPLICATION FOR EVALUATION AND APPROVAL OF
MEDICAL WASTE TREATMENT TECHNOLOGIES

The “Application for Evaluation and Approval of Medical Waste Treatment Technologies” is
provided as a guidance document to assist state agencies in reviewing new medical waste
treatment technologies. The document is intended to serve only as a model for state development
of initial application forms by providing a general format of pertinent technology review
questions. Definitions and terms used in this document may require revision to conform with
specific state legislative and regulatory requirements.


O. CERTIFICATION STATEMENT

APPLICATION FOR EVALUATION AND APPROVAL OF
MEDICAL WASTE TREATMENT TECHNOLOGIES

| a
CERTIFICATION STATEMENT

I certify that the information requested and contained in this document is accurate and complete and that all existing
documentation requested in this application for this system or similar systems is provided. The Vendor, identified below, agrees
to provide [state agency} all results of all studies conducted by or for any state, company, agency or country, or any other person
as defined at (state regulation], which the vendor conducts, or is in any way aware of, to determine the operational performance
of any aspect of the equipment for which authorization to operate in this state is requested on the filing this application. ~
aware that regulated medical waste management systems to be operated in this state for regulated medical waste treatment 0.1
destruction must be identical to the system described in this application for authorization to operate in this state and for wnich
operational data is presented in the application for (state agency] review. Any and all changes in the system and «+ -d
equipment after this application submittal and [state agency] review and authorization to operate must be submitted in wri
[state agency} prior to use. The {state agency’s] permitting conditions or other agency’s authorizations granted to operate
system to treat and/or destroy regulated medical waste will be reviewed by [state agency] periodically to ensure specifically
authorized regulated medical waste technology systems meet currently accepted standards for regulated medical waste
management. [State Agency] may modify system operational or performance requirements for systems that received prior
authorizations to operate, if warranted to protect human health and the environment.

—

I am further aware that on reviewing the completed application and the required attachments, [state agency] may have |
additional questions and require submissions of data and other information deemed necessary regarding this or related medical
waste disposal systems. Failure to provide all existing requested information will result in delays in processing the request ‘or }
|] authorization to operate. Failure to provide all required information as outlined in the application, or willfully withholding
information, may be cause for (state agency] to deny or rescind authorization to operate if [state agency] determines that ‘be |

NAME OF SYSTEM/EQUIPMENT MODEL NUMBER
NAME OF CERTIFYING PERSON (must be a corporate officer) TITLE

|
SIGNATURE OF CERTIFYING PERSON (must be a corporate officer) DATE
NAME OF PERSON COMPLETING APPLICATION TITLE |
NAME OF VENDOR (COMPANY) TELEPHONE
NAME OF DIVISION

ADDRESS

CITY, STATE & ZIP CODE

B-12


L POST-TREATMENT RESIDUE DISPOSAL, RECLAMATION OR RECYCLING

How will the treated medical wastes from this process be disposed of:

Burial in an approved landfill___

Incineration__

Recycled____

If the wastes are to be recycled, provide additional evidence regarding this strategy.

If the wastes are to be recycled, what percentage of the treated waste will be

M. POTENTIAL ENVIRONMENTAL BENEFITS
. Has an energy analysis been conducted on the proposed technology?
Yes___ No___ If yes, specify and provide results of that analysis.
Has an economic analysis been performed on the proposed technology?

Yes___ No___ If yes, specify and provide results of that analysis.

. How does this treatment technology improve on existing medical waste treatment and
disposal methods? Specify.

What is the potential of this proposed technology for waste volume reduction?
Specify.

N. OTHER RELEVANT INFORMATION AND COMMENTS

All approvals or denials received from other states, counties or agencies concerning any

aspect of equipment operation and efficacy; as well as all safety, competency or training
requirements for the users/operators, etc. must also be’ included.

B-11


L CRITICAL FACTORS OF THE TREATMENT PROCESS

What are the critical factors that influence the specific treatment technology?
Specify. -

re

What are the consequences if these factors are not met? Specify.

Explain the ease and/or difficulty of operation of the medical waste treatment
system. Specify.

What type of ongoing maintenance is required in the operation of the treatment
system? Specify.

Maintenance Manual Attached? Yes__ No__

What emergency measures would be required in the event of a malfunction?
Specify.

How are these measures addressed in an emergency plan or in the operations
protocol?

{ 17. What is the maximum amount of waste to be treated by this process per cycle?

|

How long is a cycle?



Contaminated waste from
animals

Sharps

Other

H Please refer to the state medical waste regulations for further definition of the medical
waste categories and prescribed medical waste management requirements.

D7. What waste characteristics present the most challenge to the proposed treat ent
process: .

Organic materials

Liquids

Density/compaction

Other characteristics

D8. Describe by composition (i.e., material and percentage) those medical wastes thit
would pose the most challenge to the proposed technology. Why?

Describe the physical or chemical components of medical wastes that would
interfere, cause mechanical breakdown, or compromise the treatment process or
microbial inactivation efficacy.


B. LEVEL OF TREATMENT

Does the level of microbial inactivation achieved by the treatment process meet the
following definition?

"Inactivation of vegetative bacteria, fungi, lipophilic/hydrophilic viruses, parasites,
and mycobacteria at a 6 Log,, reduction or greater; and inactivation of B.
stearothermophilus spores or B. subtilis spores at a 4 Log,) reduction or-greater.”

Yes__ -No___ If no, specify where the definition is unfulfilled.

Cc CHARACTERIZATION OF PROPOSED SED TREATMENT PROCESS

Please check the appropriate categories that best describe the methods of this

proposed technology. Proposed treatment technologies may incorporate several of
the categories listed below.

Chemical Heat
Mechanical Shredder
Microwave Grinder
Hammermill Irradiation
Plasma Arc Radiowave
Encapsulation

_ Other (specify)

Please identify if the proposed system is compatible or non-compatible with the following
types of waste.

Type of Waste Compatible Non-compatible

Caltures and stocks of
infectious agents and
associated biologicals

Liquid human and animal waste
including blood and blood
products and body fluids

Pathological waste

B-3


APPLICATION FOR EVALUATION AND APPROVAL OF MEDICAL WASTE
TREATMENT TECHNOLOGIES:

Complete the following questionnaire and return it along with the application. Please include any
additional support data which maybe applicable. Use additional paper if necessary, Reference
with the related section and number(s).

A GENERAL

Is the treatment technology best suited for on-site use at the point of generation, or
is it adaptable for use as a commercial or regional treatment process receiving waste
from several generators?

On-site. Commercial/Regional Both,

A2. Is this treatment technology specified for use at small generator facilities such as
physician, dental, or veterinary offices or clinics?

Yes. No.

Has this treatment technology been approved/disapproved in any other state? If so,
please indicate which states have issued a decision and submit copies of
approvals/disapprovals.

z

Has the use of this equipment ever resulted in any environmental or occupational
safety violation (federal, state, or local)?

eB

Has the use of this equipment ever resulted in any injuries, of any kind, or
transmissions of any disease to any person? Describe all such instances.

B

Have you reviewed all applicable state solid and medical waste regulations for
medical waste acceptance, treatment, and disposal?

Have you inquired as to whether any other permits are required? Please enclose
agency response and requirements with your application. List all required permits |

and enclose copies of any permit approvals.
_

>
x

NOTE: Local governments or other agencies may require permits.

B-2