III. Process for Approving Medical Waste Treatment Technologies

This report recommends that both state and site approval be attained for the use of any medical
waste treatment technology. Specific recommendations are provided for:

. State approval requirements of the technology to ensure that the
technology is effective in safely inactivating microorganisms to specified
criteria;

. Site approval requirements to verify that the sited equipment meets

approved specifications and microbial inactivation requirements under
actual operating conditions; and

. USEPA pesticide registration requirements, as applicable, for those medical
waste treatment technologies that use chemicals as the microbial

inactivator.

Additionally, the report recommends that parametric monitoring of the treatment process can
substitute or replace biological indicator monitoring provided certain verification and monitoring
parameters are achieved.

IV. Permitting and Site Authorization Issues

Several permitting and state authorization issues relating to alternate medical waste treatment

technology approval are identified and discussed. Recommendations are provided for the
following issues:

: User verification for microbial inactivation monitoring
° Commercial versus on-site facilities

. Previously approved technologies

° Small medical waste treatment devices

. Waste residue disposal

. Operator training
. Equipment operations plan

° Emergency and contingency response plan

iv



EXECUTIVE SUMMARY

I. Introduction

The purpose of this report is to establish a framework or guideline that defines medical waste
treatment technology efficacy criteria and delineates the components required to establish an
effective state medical waste treatment technology approval process. The recommendations made
in this report 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, the guidelines developed should serve

only to provide guidance to the states in the development of an approval process for medical
waste treatment technologies.

The establishment of qualitative and quantitative parameters that ensure effective and safe
medical waste treatment are required in defining treatment technology efficacy criteria and
delineating the components necessary to establish an effective state medical waste treatment
technology approval process. Recommendations are provided in this report for the following:

. Medical Waste Treatment Technology Efficacy Assessment

° Medical Waste Treatment Technology Approval Process
. Permitting and Site Authorization Issues
. Research and Development

I. Medical Waste Treatment Technology Efficacy Assessment Criteria

This report recommends that all medical waste treatment technologies meet the following
microbial inactivation criteria:

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.

In meeting these criteria, selected pathogen surrogates which represent vegetative bacteria, fungi,
parasites, lipophilic/hydrophilic viruses, mycobacteria, and bacterial spores are recommended.
Formulas and methods of calculations are recommended and are based on microbial inactivation
("kill") efficacy as equated to "Log,, Kill", which is defined as the difference between the
logarithms of the number of viable test microorganisms before and after treatment.

iii


V. Research and Development

This report recommends that each state view as optional its participation in experimental medical
waste treatment research and development projects. For those states opting to participate in
medical waste treatment technology research and development projects, issues recommended to
be considered are the following: ia

. Process of establishing research and development variances, including
limitations and allowances;

. Potential environmental emissions and occupational exposures;

. Treatment process residue disposal; and

° Agency funding and staffing.
This report also provides supplementary materials to assist a state in developing guidelines, an
information request form, and microbial inactivation testing protocols. These materials are
located in the Appendices A-C under the following headings:

. State Guideline for Approval of Medical Waste Treatment Technologies;

° Application for Evaluation and Approval of Medical Waste Treatment
Technologies; and

° Example: Treatment Efficacy Testing Protocol for a Grinder/Chemical
Medical Waste Inactivation Process.


2
.

TECHNICAL ASSISPANCE MANUAL: STATE REGULATCRY

OVERSIGHT OF MEDICAL WASTE TREATMENT TECHNOLOGIF*:

April 1994

A Report of the State and Territorial Association
on Alternate Treatment Technologies


GLOSSARY
"AOAC refers to the Association of Official Analytical Chemists.

"ATCC" refers to the American Type Culture Collection.

"Biological Indicator(s)" means those microorganisms that are used as representative microbial
agents in imactivation studies and testing.

"Cfu" refers to colony forming units.

"Challenge Load" means a medical waste load that has been constructed by composition (i.e.,
organic content, density, moisture/liquid content, or other physical or chemical
composition) or amount to provide an appropriate challenge to the treatment process and
microbial inactivating agent.

"Committee" refers to the State and Territorial Association on Alternate Treatment
Technologies.

"FIFRA" refers to the Federal Insecticide, Fungicide, and Rodenticide Act.
"IEPA" refers to the Dlinois Environmental Protection Agency.

"Log,Kill” is defined as the difference between the logarithms of number of viable test
microorganisms before and after treatment.

"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.

"6 Log, Reduction" is defined as a 6 decade reduction or a 0.000001 survival probability in
a microbial population; i.e., a 99.9999% reduction.

"Microbial Inactivation" is defined in Section 2.2 of this document

"Pathogen Surrogate(s)" means those microorganisms that are used as biological indicators in
efficacy studies and testing that represent known microbial pathogens.

"Surrogate Load” means a waste load that has been constructed to represent a typical medical
waste load by composition (i.e., organic content, density, moisture or liquid content, or
other physical or chemical composition) and amount.

"Treatment" is defined as a mechanism (such as treatment, chemical, irradiation, etc.) which
inactivates microbial organisms.

"USEPA" refers to the United States Environmental Protection Agency.

vi


TABLE OF CONTENTS

EXECUTIVE SUMMARY
GLOSSARY
1.0 INTRODUCTION .........0 0... c cece cece eee eee eee eee pe eeeee 1
2.0 MEDICAL WASTE TREATMENT TECHNOLOGY
EFFICACY ASSESSMENT CRITERIA ........ 0. cee eee cece eee eee eens 4
21 Classification of Emerging Medical Waste Treatment Technologies ....... 4
22 Definition of Microbial Inactivation ........... 0.0 e cee eee eee eee 3
Table I - Levels of Microbial Inactivation .... 0.2.0.0... cece ee eee 8
23 Representative Biological Indicators ...........c cece eee eeceeeee 12
Table II - Recommended Biological Indicators .............00000e8 13
Table III - Biological Indicator Selection Criteria ............--.044 14
2.4 Quantification of Microbial Inactivation ............ 00 ec ee ee eee 16
3.0 | PROCESS FOR APPROVING MEDICAL WASTE TREATMENT
TECHNOLOGIES ........ 0. coe ec e cece ce ceccc nett een ee eens 19
3.1 Biological Inactivation Efficacy: Establishing Protocols .............. 19
3.2 Approval of Medical Waste Treatment Technologies ................ 21
3.3. Parametric Monitoring and Controls ............ cece eceeeeeeees 23
3.4 Site Approval for Medical Waste Treatment Technologies ...........- 24
3.5. USEPA Pesticide Use Registration ........ 0.00... eee e ee eee eee 25
4.0 PERMITTING AND STATE AUTHORIZATION ISSUES ..............-- 27
4.1 User Verification: Biological Inactivation Efficacy Monitoring ........ 27
4.2 Commercial Versus On-Site Facilities ©0002... 0... e cece cece eee 27
43 Previously Approved Technologies ........ 00. cee eee e eee cues 28
4.4 Small Medical Waste Treatment Devices ............-.0 eee eeeee 29
4.5 Waste Residue Disposal... 6.0... 0... cece cece eee eee ences 36
4.6 Operator Training... 06... cee ccc eee cee cee teen ee eens 31
4.7 Equipment Operations Plan..... 2. 6... eee eee cee eee eee ene 32
4.8 Emergency and Contingency Response Plan ............00eeeveuee 33
5.0 RESEARCH AND DEVELOPMENT........ ace e cere c ere neeeeeene 35
6.0 RECOMMENDATIONS FOR FUTURE ACTIVITIES ......-.--eeeeeeees 37
7.0 SELECTED BIBLIOGRAPHY ......... . ccc cece cect eee eee eee 38


APPENDIX A - STATE GUIDELINE FOR APPROVAL OF MEDICAL
WASTE TREATMENT TECHNOLOGIES ...............00055

APPENDIX B - APPLICATION FOR EVALUATION AND APPROVAL OF
MEDICAL WASTE TREATMENT TECHNOLOGIES ..... Kee eeee

APPENDIX C - EXAMPLE: MICROBIAL INACTIVATION TESTING PROTOCOL
FOR A GRINDER/CHEMICAL MEDICAL WASTE
INACTIVATION PROCESS

APPENDIX D - LIST OF PARTICIPANTS

ii