STAATT III

Executive Summary
and Daily Discussions
Orlando, Florida
December, 2005
 STAATT III CONFERENCE
DECEMBER 5-7, 2005
PREFACE

A meeting was held in Orlando in December, 2005, to discuss the new developments
which had occurred since the 1998 publication of the STAATT II Guidance Report on the
processing of medical waste. Participants included local, state and federal regulators,
as well as representatives of companies that manufacture and/or operate treatment
technologies.

The Executive Summary of the STAATT III Meeting describes the most important issues
on which consensus were achieved by those in attendance. In addition, more detailed
summaries of the conference discussions are included to provide a more complete
understanding of the wide range of topics and issues considered by the participants,
including the recommendation to require the same efficacy data for autoclaves as for
any other type of treatment technology. The areas of consensus and recommendations
which emerged from this meeting will form the basis for the complete revision of
previous STAATT reports. The forthcoming STAATT III Guidance Report, which will be
available by the end of 2007 in electronic and hard copy formats, will provide all involved
in the medical waste industry with updated information on the most complex and
continuing issues concerning this special waste stream. In addition, the report will offer
clear guidance to both regulators and vendors on areas ranging from applications for
approval of treatment technologies to “Z” values of bacterial spore biological indicators.

If after reading the summaries you have questions, comments or recommendations,

please direct them to Ira F. Salkin (irasalkin@aol.com), Edward Krisiunas
(ekrisiunas@aol.com) or Joe Delloiacovo (delloiac@optonline.net).
 STAATT III CONFERENCE
DECEMBER 5-7, 2005
EXECUTIVE SUMMARY

Meetings were held in Orlando, FL from December 5 – 7, 2005 to review and revise the
information contained in the STAATT I (April, 1994) and STAATT II (December, 1998)
guidance documents. The following are the more significant recommendations reached
at the meetings:

Introduction

Conference participants were recognized experts in the evaluation and testing of

medical waste treatment technologies from state and federal agencies, as well as
representatives of governmental organizations within the United Kingdom and
technology vendors (see attached list of participants). Several key issues were reviewed
and discussed including new information on potential treatment limitations of steam
autoclaves, detailed presentation on the requirements of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), guidelines for evaluating air emission
generated by various types of treatment technologies, and additional recommendations
on approving treatment systems based on more realistic conditions likely to be
encountered in their actual operation at healthcare, research and commercial facilities.

Though several of the participants hold official positions in state and federal
agencies, this document does not necessarily represent the policies or
recommendations of any of the state/federal agencies or commercial concerns that the
participants represent.

STAATT guidelines have become widely recognized as an industry source of

scientific knowledge and experience and used as an important tool by regulators
throughout the US and around the world. This document should be used as a guide to
the methods and procedures that may be employed in the evaluation and approval of
treatment technologies.

Treatment Technologies

Autoclaves

During the STAATT I and II conferences autoclaves were not considered

“emerging” or “alternative” technologies. However, the current consensus is that
autoclaves be included under the broad umbrella of medical waste treatment
technologies. As such, they must meet the same standards in efficacy/validation testing
as any other treatment systems, especially if used for the treatment of suction canisters,
human pathological waste, animal carcasses, and/or other thermally resistant waste
materials, e.g. items within sharps containers or material wrapped in tyvek plastic.
Operational parameters should continue to be determined through discussions between
vendors (or on rare occasions, the operator) and regulators, but the parameters should
never be below those established in efficacy testing by vendors/operators of treatment
systems.

However, in the majority of states, the operating standards are based on the
century old practices employed in the sterilization of medical devices, i.e., those that are
employed within the sterile environment of the human body. It was the general
consensus that effective treatment of medical waste creates a different set of challenges
 STAATT III CONFERENCE
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EXECUTIVE SUMMARY

for autoclaves than do medical devices. Presentations by several participants of their

own investigations indicated that the efficacy of autoclaves was dependent upon many
variables including, but not limited to, the composition, density, liquid content, weight,
and types of containers of the loads as they all affect the physics of heat transfer and
steam penetration. In certain instances, the efficacy of autoclaves was found to be less
than the minimum standards recommended by STAATT. In addition, types of biological
indicators, e.g., genus and species of bacterial spores, their “D” values, the placement of
the indicators in the load, as well as the methods used to determine the temperatures
both within the autoclave and the test loads could affect the selection of the operating
parameters by the vendors and operators. These observations raise questions as to the
“standard” operating parameters used by autoclaves in the treatment of medical waste
and suggest that vendors and users conduct efficacy studies that incorporate the
multiple variables that present significant challenges to the autoclave’s capability to
effect treatment.

In-Situ Chemicals – Suction Canisters

The attendees recommended that the federal Environmental Protection Agency

adopt the same efficacy requirements as employed in the evaluation of any type of
treatment technology for those chemicals used in the in situ treatment of the contents of
suction canisters. If the vendors of products that chemically encapsulate components of
the medical waste stream, i.e., sharps, body fluids, etc., make claims that such
encapsulation treats these items, then it was the general consensus that the treatment
capabilities of these products be held to the same standards as any other system.

Furthermore, it was noted that suction canisters and similar items in the medical
waste stream present a unique challenge to the capabilities of any technology that does
not preshred the containers. A presentation made during the conference on
independent testing indicated that those systems that ruptured rigid containers, e.g.,
suction canisters, were effective in the treatment of contents of the containers.
However, if rigid containers were not broken by the technologies and their liquid contents
were not integrated into the waste loads, inconsistent or unsuccessful treatment of the
liquids was found. Based upon these and other findings discussed, the attendees
recommended further exploration of the issues created by suction canisters in their
treatment by thermal and chemical based systems.

Chemical Treatment System

A representative of the EPA’s antimicrobials group presented the following key

points regarding the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA):

If a technology is an instrument or contrivance that inactivates microorganisms

on medical waste, then the technology is considered a device and FIFRA
registration is not required;

If the technology employs a chemical or substance that inactivates
microorganisms on medical waste, then the chemical in the technology is
considered a pesticide and FIFRA registration is required;

A pesticide device is not required to be registered under FIFRA;

However, that same device is regulated under FIFRA; and
 STAATT III CONFERENCE
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EXECUTIVE SUMMARY

It is against the law for anyone to sell or distribute chemical pesticides without
EPA labeling. To obtain FIFRA registration, chemical vendors must present data
from efficacy tests that demonstrate a 4 Log10 inactivation of bacterial spores and
a 6 Log10 inactivation of mycobacteria vegetative cells.

High Heat Technologies

Discussions also focused on the evaluation of plasma arc and pyrolysis

technologies. Both are high heat systems that do not involve direct exposure of the
waste to a flame (which sets them apart from incineration according to US EPA
regulations). Plasma arc reduces waste to molten slag, while pyrolysis breaks down
waste at high heat in the absence of oxygen. No sample can be recovered from
plasma arc treatment, and coupled with the high temperatures that climb into the
thousands of degrees, it was concluded that plasma arc units could be excepted from
efficacy testing. However, since pyrolysis involves relatively lower temperature and,
since there are reports of potential sample recovery from this technology, it was
concluded that no similar exception be made for pyrolysis.

All Treatment Technologies

The STAATT guidance document currently recommends that the efficacy of

treatment technologies be determined by subtracting the average colony forming units
(CFUs) found after treatment from the average CFUs recovered from untreated control
samples. These calculations were generally based upon three untreated and nine or
more treated samples employed in the testing. However, it was suggested that this
method may contribute to misleading results and may not allow the assessment of
outliers found during studies. It was therefore suggested the application of 95%
confidence interval in the calculations might provide a more accurate method for
assessing the results from efficacy/validation/challenge tests. In theory, such a
statistical analysis would eliminate the problems created by outliers and provide more
accurate assessment of treatment technologies. However, since the numbers of
samples required to calculate 95% confidence intervals and the methods to be used in
these calculations could not be provided during the discussions, it was decided to
postpone any attempt of reaching a consensus on the inclusion of this approach for a
future meeting.

Building on the discussions during the STAATT II conference, the attendees

recommended the application of parametric monitoring as a method for meeting the
quality control regulatory requirements. However, it was stipulated that the parametric
monitoring criteria be validated through efficacy testing. In addition, the criteria or set-
points should be revalidated at regular intervals employing in most instances, biological
indicators. Finally, the monitoring devices should provide permanent records from real
time collection of the operating conditions.

There was consensus that regulators consider as part of their review and
evaluation of treatment technologies the following environmental matters:

Aerobiology studies of areas adjacent to Biological and chemical testing of the liquid
the treatment equipment/system discharges from the equipment
Balance of air handling through the QC of environmental factors and
 STAATT III CONFERENCE
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EXECUTIVE SUMMARY
technology and/or within the area where equipment use to minimize potential
the equipment is located negative environmental impacts from using
the treatment equipment
Negative pressure within the system Fixed portal radiation monitors
Application of HEPA and charcoal filters

Microbial Inactivation and Test Indicators

There was consensus for maintaining bacterial spores and mycobacterial cells as
the biological indicators in efficacy studies of all medical waste treatment technologies.
In addition, it was agreed that all treatment systems must demonstrate a 4 log10
inactivation of bacterial spores and a 6 log10 reduction of mycobacteria viable cells. It
was acknowledged that a small number of regulatory jurisdiction require by either
statute or regulation a 6 log10 inactivation of bacterial spores. In addition, there are
regulatory agencies that require in efficacy and/or validation tests the inclusion of
additional types of biological indicators, e.g., fungi, protozoan parasites. However,
evidence accumulated since the publication of STAATT II guidance report indicates
that neither the inclusion of additional test organisms nor a 6 log10 inactivation of
spores are needed to demonstrate the capabilities of any system to effectively treat
medical waste. This consensus view is supported by many current reference texts, as
for example, the Manual of Clinical Microbiology, 8th ed., published by the American
Society for Microbiology in 2003.

There was some discussion of the lesser resistance of mycobacteria cells as

compared to bacterial spores and whether or not the former indicator should be
included in efficacy/validation tests. However, it was noted that mycobacteria are
associated with infections of concern to users and policy makers and as such
represent a real world demonstration of a technology’s ability to destroy pathogens.
While they are less resistant than spores, they are still more resistant than other
vegetative microorganisms and remain a challenge to the efficacy of treatment
systems. Furthermore, there are no reports known to attendees of treatment
technologies that could effectively inactivate these two indicators but not other
vegetative microorganisms. Therefore, it was recommended to include inactivation of
mycobacteria as part of the proposed STAATT III report.

Since the last STAATT meeting, experience has demonstrated that spores
produced by the same bacterial species with the same ATCC accession code but
obtained from two different vendors may not be similar in their resistance/susceptibility
to heat treatment. This and other differences in the nature of bacterial spores are now
known to be due, in part, to differences in their D-values. The latter is defined as the
exposure time required, under specified sets of conditions, to cause a one log10 or 90%
reduction in the initial concentration of the biological indicator. It is an indication of
relative resistance of the spores to heat or thermal treatment. Organisms of the same
species and/or ATCC strain can have their D-values altered to either enhance or
diminish their resistance to treatment. Some manufacturers of biological indicators
provide the D-values of the spores in their products and in many instances this
information is included with each spore shipment. It was the consensus that D-values
should be considered as a factor in the selection of bacterial spores required in
efficacy/validation testing of heat treatment technologies and that this topic be
considered in future meetings.
 STAATT III CONFERENCE
DECEMBER 5-7, 2005
EXECUTIVE SUMMARY

However, since there are no comparable D-values for use with chemical
treatment systems, it was proposed to use random samples from up to three separate
lots of spores from each of three vendors in efficacy studies. Multiple
strips/suspensions could be used as part of a single run. While this could provide an
interim measure without a significant increase in cost, the attendees considered that
they did not have enough information to reach a definitive conclusion on chemical D-
values, or an alternative to thermal D-values.

One question brought out in the discussions was whether there were bacterial
spore formers other than Bacillus atrophaeus (B. subitis var. niger) and Geobacillus
(Bacillus) stearothermophilus that could be employed in efficacy/validation tests. It
was noted that while the use of a bacterial strain suggested by the Association of
Official Analytical Chemists (AOAC) was included in the STAATT I guidance
document, those present at the conference decided not to take any final action as to
recommending its use in the proposed STAATT III guidance document.

Since none of the attendees knew of any reports that indicated significant
differences in the resistance/susceptibility of Bacillus atrophaeus and Geobacillus
stearothermophilus spores to heat or chemical treatment, either could be employed in
evaluations of treatment technologies. However, the former is more commonly
employed in studies involving dry heat technologies while the latter in tests of systems
that use moist heat, e.g., autoclaves.

Approving Medical Waste Treatment Technologies

There was no consensus as to a “benchmark” local, county, state or federal

regulatory program whereby meeting the requirements of that jurisdiction translates to
across-the-board acceptance in other jurisdictions. This presents challenges in terms of
time and capital expenditures to vendors as they attempt to satisfy the requirements of
each regulatory jurisdiction. In addition, the development of standard efficacy/validation
test protocols remains a continuing objective due to variations in the components of the
medical waste stream from state to state or even facility to facility, as well as inherent
differences in medial waste treatment technologies and their respective treatment
claims.

It was recommended that vendors of all treatment technologies submit their

protocols to obtain approval of regulatory agencies prior to the initiation of the testing.
Efficacy (to demonstrate vendor claims) and validation studies (once the system is sited)
should be conducted for all medical waste treatment systems. Challenge testing or
quality control can be conducted through the use of either parametric monitoring or

biological indicators provided that parametric monitors have been validated with
indicators through efficacy testing and are revalidated at regular intervals as determined
through discussions between regulators and vendors.

In the rare instances in which the technologies were designed and employed for
purposes other than the treatment of medical waste and the manufacturers make no
claims as to the capabilities of their systems to treat this waste, it becomes the
operators’ responsibility to support efficacy and validation testing.
 STAATT III CONFERENCE
DECEMBER 5-7, 2005
EXECUTIVE SUMMARY

Waste loads that typify actual waste to be processed, in terms of its components,
volume, and density would provide the optimum test of treatment technologies.
However, specifying a waste load or a handful of technology-specific waste loads could
create false impressions as to the capabilities of treatment technologies and their use at
specific facilities. In addition, the composition of waste loads vary from facility to facility,
state to state and even country to country relative to the presence of fibers (natural and
synthetic), plastics, paper, organic load, etc., as reported from within and outside of the
United States. Therefore, it is hoped that in subsequent meetings that a description of a
standard test load can be provided, but for the present, determining such a load remains
a collaborative effort between the vendor (or in rare instances, the operator) and
regulator.

It was the consensus of those attending that untreated controls be used

whenever possible as the benchmark in efficacy and validation studies. The levels of
biological indicators obtained through these controls are reflective of any losses caused
by sampling methods, shipment of test materials and laboratory procedures. Therefore,
these controls provide more accurate indications of initial concentrations of bacterial
spores and mycobacterial vegetative cells in efficacy/validation studies than those
assessed in the laboratories of the biological indicator vendors.

The attendees recommended that laboratories conducting any form of efficacy or

validation tests of medical waste treatment technologies be independent of the
vendors/operators of these systems. In addition, the laboratory is responsible for the
chain of custody, the preparation of samples, their shipment to the test site, their
collection upon completion of testing and their shipment to the laboratory for the analysis
of the samples. The review of the test protocols and data generated from the tests are
the responsibility of the regulatory agencies.

Future directions

Those attending the conference suggested in order to further the exchange of

information and provide assistance to regulators and vendors, that a professional
scientific educational organization be established. To this end, the International Society
on Analytical Analysis of Treatment Technologies (IStAATT) was founded at the
conclusion of the conference with the following Mission statement:

IStAATT will promote and enhance broader understanding of the collection, transport
and treatment of the medical waste stream through the exchange of information by its
members and with the members of other relevant professional organizations. The
Society’s interest will include, but not be limited to; appropriate methods for packaging

solid and liquid medical waste, on and off-site transport, appropriate biological indicators
for evaluating the efficacy of treatment technologies, efficacy test protocols and
procedures, methods to periodically monitor the continuing operation of treatment
systems, consistent treatment standards, and related matters. The Society will sponsor
education conferences on medical waste and workshop programs related the collection,
transport and treatment of this waste stream. The Society will review published medical
waste regulations, recommendations and guidelines, attempt to influence the contents of
such documents, support appropriate standards and criteria for all phases of processing
 STAATT III CONFERENCE
DECEMBER 5-7, 2005
EXECUTIVE SUMMARY
this waste stream and act as an international focal point for the consolidation of views on
these issues. The STAATT documents and format will be the foundation upon which
future guidance will be issued by the Society. Through these efforts, IStAATT seeks to
promote the safety of those exposed to medical waste as a result of their occupation and
ensure the protection of public health and the environment from the hazards inherent in
the medical waste stream.

IStAATT has as of November, 2006 been incorporated in New York State, has
received its Employee Identification Number for the federal Internal Revenue Service in
December, 2006 (needed to establish a separate bank account) and will soon be filling
to obtain “not-for-profit – tax exempt” status. Those interested in becoming members of
this fledgling organization may contact Ira F. Salkin (irasalkin@aol.com), Edward
Krisiunas (ekrisiunas@aol.com) or Joe Delloiacovo (delloiac@optonline.net).
 STAATT III CONFERENCE
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DAY 1 SUMMARY – DECEMBER 5, 2005

TYPES OF TESTS

It is recommended that vendors of technologies who make claims as to the capabilities

of the systems to treat medical waste obtain prior approval of their efficacy test protocols
from the regulatory agency from which a permit or license is being sought. Initial
efficacy testing must be conducted with biological indicators for all alternative treatment
technologies and autoclaves (known hereafter as medical waste treatment
technologies). Validation testing to evaluate the capabilities of the system’s operator
and the operation of the technology once the system is sited, should be conducted for all
medical waste treatment technologies. Challenge testing or QC can be conducted
through the use of either parametric monitoring or biological indicators provided that
parametric monitors have been validated with indicators through efficacy testing and are
revalidated at regular intervals as determined through discussions between regulators
and vendors. In the rare instances in which the technologies were employed for
purposes other than the treatment of medical waste and the vendors make no claims as
to the capabilities of their systems to treat this waste, it would be the operators’
responsibility to support efficacy and validation testing.

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

Initial efficacy, on-site validation, and quality control monitoring should remain integral to
the STAATT guidance document.

Is it acceptable to manually document data associated with parametric monitoring? This

can be acceptable, but how these data are recorded and maintained are at the discretion
of the regulator. While the majority of technologies available today allows for the easy
collection and recording of parametric control references, it was suggested that in the
event a recording device is inoperative, manually logging the data should be allowed
until such time as the device is repaired or replaced. This too would be at the discretion
of the regulators. It was recommended that data, if collected manually, be correlated with
digitally-obtained parametric monitoring whenever practical.

Each of the STAATT documents has and will continue to be published as guidance
documents. STAATT represents the consensus of a group of state regulators and other
experts on the subject of medical waste treatment. The documents generated serve as
a source of uniformity for draft regulations, but there is no mandate that each state use
all or any part of the guidelines set forth.

Each state is responsible for setting its own regulations, and each is responsible for
determining which medical waste treatment technologies may operate within its
jurisdiction. There is no consensus as to a “benchmark” jurisdiction whereby meeting
the requirements of that jurisdiction translates to across-the-board acceptance in other
jurisdictions. This presents challenges to the vendors to satisfy the requirements of
jurisdictions one by one in the form of time and capital. In addition, the development of
standard efficacy/validation test protocols remains a challenge due to variations in the
components of the medical waste stream from state to state or even facility to facility, as
well as inherent differences in medial waste treatment technologies and their respective
treatment claims.
 STAATT III CONFERENCE
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DAY 1 SUMMARY – DECEMBER 5, 2005
From these discussions, it was recommended that:

1. Further effort be made to work with various jurisdictions to standardize

requirements from one to the next;
2. Where practical for meeting part or all of a jurisdiction’s regulations, efficacy
testing for another regulatory agency should be able to be used and accepted by
the former agency. As expressed:

“Microbiological efficacy testing, if conducted in accord with, and meeting

the requirements of STAATT Guidelines, need only be conducted once.
If waste composition and densities are comparable, and the proposed
operating parameters are identical, the results may be submitted for
license application in other states or countries.”

3. However, it should be noted that autoclaves tested at or new sea level will
operate at higher pressures to attain the same temperatures when used at higher
latitudes. Therefore, one parameter (temperature) would be consistent under
both conditions, but another (pressure) would have to be different at the two
altitudes.

WORST CASE TESTING SCENARIOS FOR HEAT AND CHEMICAL TREATMENTS

There was consensus for maintaining a 4 Log10 inactivation of bacterial spores and a 6
Log10 reduction of viable mycobacterial cells as the criteria for assessing the efficacy of
all medical waste treatment technologies. However, no consensus was achieved as to
the criteria to be used in the treatment of prion-contaminated and bioterrorism-generated
waste.

One question brought out in the discussions was whether there were other biological
indicators that could be used in efficacy/validation/challenge testing. Bacillus
atrophaeus (B. subitis var. niger) is more resistant to dry heat, while Geobacillus
(Bacillus) stearothermophilus is more resistant to moist heat. However, it was noted that
even a dry heat treatment system, in the presence of a wet waste, becomes moist heat
technology.

Another question considered was whether a 95% confidence interval should be

employed in a statistical evaluation of efficacy/validation testing data, i.e., the ability of
the technologies to meet the 4 Log10 and 6 Log10 inactivation criteria. The use of such
confidence intervals would diminish the possible subjectivity of microbiological methods
and assist in interpreting the random failures that may be encountered with all treatment
technologies. In other words, as expressed during the discussions, what do occasional
outliers mean in perspective to the broad assessment of the systems? If a 3.8 Log10
reduction in bacterial spores is encountered, can the technologies still meet the
efficacy/validation test requirements? Alternatively, do two results indicating only a 2.5
Log10 inactivation infer that the systems cannot meet approval standards? The
consensus of those attending the meeting was that the 95% confidence interval must be
interpreted on the basis of the number and severity of the failures to achieve the
consensus standards.
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DAY 1 SUMMARY – DECEMBER 5, 2005

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

The worst case scenario parameters covered here, i.e., 4 Log10 inactivation of bacterial
spores and 6 Log10 reduction of mycobacteria viable cells should apply to all
technologies. There was a brief discussion on the lesser resistance of mycobacteria and
whether or not this biological indicator should be excluded from the test parameters.
However, it was iterated that mycobateria are associated with certain infections of
concern, such as tuberculosis, that carry weight with users and policy makers as a real
world demonstration of a technology’s ability to destroy pathogens. While they are less
resistant than spores, they are still more resistant than other vegetative microorganisms
and remain a challenge to the efficacy of treatment systems. As such, inactivation of
mycobacteria will remain a component of the proposed STAATT III report.

BIOLOGICAL INDICATORS

The following items discussed earlier were reiterated and expanded upon as follows:

 The number and type of indicators from STAATT II should be carried forth in
the future STAATT III guidance report. There were additional comments
regarding materials generated through bioterrorism incidents and the use of a
4 Log10 reduction of bacterial spores as a treatment criterion, but no
consensus was achieved;
 There were no treatment systems known to those attending the meeting that
could effectively inactivate bacterial spores and mycobacteria but not other
vegetative microorganisms, such as fungi and viruses;
 There were no reports known to those attending of significant variation in the
resistance/susceptibility between Bacillus atrophaeus and Geobacillus
stearothermophilus spores to either heat or chemical treatment;
 Chemicals used in the in situ treatment of the contents of suction canisters
should meet the same standards as other medical waste technologies (i.e., 6
Log10 reduction of mycobacteria and 4 Log10 inactivation of bacterial spores).
 Use AOAC recommended strain of bacteria species for chemical
technologies noted in the STAATT I guidance report was considered, but no
final action was taken as to recommending its use in the proposed STAATT
III guidance document.

Exceptions to the 6 Log10 /4 Log10 test criteria were discussed for plasma arc and
pyrolysis technologies. Both are high heat technologies without direct exposure of the
waste to a flame (which sets it apart from incineration according to US EPA regulations).
Plasma arc reduces waste to molten slag, while pyrolysis breaks down waste at high
heat in the absence of oxygen. No sample can be recovered from plasma arc treatment,
and coupled with the high temperatures that climb into the thousands of degrees, it was
concluded that plasma arc units could be excepted from efficacy testing. Because of the
lower temperature and reports of potential sample recovery from pyrolysis technologies,
it was concluded that no similar exception be made for pyrolysis.
 STAATT III CONFERENCE
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DAY 1 SUMMARY – DECEMBER 5, 2005

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

Remarks and recommendations:

 While cast iron pipe with spore strips sealed inside can yield a charred but
recoverable sample for analysis of high heat systems, stainless steel strips
seeded with bacterial spores can be used as they too provide recoverable
samples;
 Where references to the use of spore strips or suspensions are common in
previous guidance document, it was recommended to use the term spores
rather than strips or suspensions in future reports;
 While some states, such as New Jersey, recommend a 6 Log10 reduction of
bacterial spores be achieved in efficacy/validation testing, it was agreed that
the recommendations of the STAATT I committee of a 4 Log10 inactivation of
bacterial spores be maintained in the STAATT III report. As part of the
original discussions that concluded with the first STAATT guidance
document, the group looked at several levels of inactivation (I through IV –
see STAATT I) with increasing requirements in the level of treatment. Some
wanted Level II, others III, and others IV. Level III was attainable by all
alternative technologies at the time, while Level IV was unattainable. With
consideration given to the disposition of the treatment waste, Level III offered
sufficient kill and a safety factor to ensure protection of the public and health
care workers. Level III has stood the test of time, and there have been no
reported incidents of infectious disease transmission from equipment meeting
Level III inactivation of microorganisms. A heightened level of treatment (i.e.,
Level IV) is not something that the private sector, such as landfills, is
currently recommending.
 Spore strips currently available for purchase are generally not standardized
for use in the evaluation of medical waste treatment equipment.
Furthermore, in some states, the use of spore strips is not allowed. However,
since the spore strips have been successfully used over the last 10 years,
states are encouraged to allow their use when such use is practical (e.g.,
when spore strips can be recovered or the technologies allow for their use).

TEST LOAD COMPOSITION

Waste loads that typify actual waste to be processed, in terms of its components,
volume, and density would provide the optimum test of treatment technologies. This
leads to the question as to how regulators can establish a standard load considering the
variability of waste generated at different facilities and differences in the capabilities of
treatment technologies. Opinions differed on the typical test loads and even as to
whether those that regulate medical waste should be involved in determining the
composition of standard loads.

While participants from the United Kingdom have assessed waste created at healthcare
facilities and identified items that would be difficult to treat, similar information is not
available in the United States. Discussions continued on waste load composition
 STAATT III CONFERENCE
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DAY 1 SUMMARY – DECEMBER 5, 2005

including specifying its organic content and particle size. Suggestions were made that
testing be conducted with actual waste as generated at the site at which the equipment
will be used. In subsequent meetings, it is hoped that a description of a standard test
load can be provided, but for the present, determining such a load remains a
collaborative effort between the vendor (or in rare instances, the operator) and regulator.
A revision to STAATT II, section 3.2, paragraph 3, will include suction canisters to the list
of examples, signifying them as a unique challenge.

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

The composition of waste loads vary from facility to facility, state to state and even
country to country relative to the presence of fibers (natural and synthetic), plastics,
paper, organic load, etc., as reported from within and outside of the United States.
Specifying a waste load or a handful of technology-specific waste loads could create
false impressions as to the capabilities of treatment technologies and their ability to be
used at specific facilities. For example, a technology which is to be used with mostly
hollow plastic items may fare poorly when the actual waste stream is laden with
absorbent fabric and encapsulated liquid volumes. Furthermore, claims are made as to
the capabilities of a technology that may be beyond the typical parameters of that
equipment’s standard protocols, e.g., treatment of pathologic waste. In such
circumstances, it would be necessary to incorporate all waste components claimed by a
vendor (or in rare instances as described, the operator) as within the capabilities of the
technology in their efficacy test protocols..

Aside from identifying a few difficult to treat items in the guidance document to be
generated from this meeting, the consensus of those attending was not to recommend a
standard waste load, with the expectation that medical waste generated at a facility
could be used to assess treatment technologies as part of on-site validation of the
equipment.

APPROPRIATE BACTERIAL CONTROLS

Since the last STAATT meeting, experience has demonstrated that spores produced by
the same bacterial species with the same ATCC accession code but obtained from two
different vendors may not be similar in their resistance/susceptibility to heat treatment.
This and other differences in the nature of bacterial spores are now known to be due, in
large part, to differences in their D-values.

The D-value is defined as the exposure time required, under specified sets of conditions,
to cause a one log10 or 90% reduction in the initial concentration of the biological
indicator. It is an indication of relative resistance of the spores to heat or thermal
treatment. Organisms of the same species and/or ATCC strain can have their D-values
altered to either enhance or diminish their resistance to treatment. Some manufacturers
of spore strips can provide the D-values for their products and in many instances, this
information is included with each spore shipment.

A range of D-values is established by the United States Pharmacopoeia (USP) for

systems using steam, dry heat and Ethylene Oxide to treat medical instruments.
Commercial spore manufacturers must comply with USP and FDA regulations on the
 STAATT III CONFERENCE
DECEMBER 5-7, 2005
DAY 1 SUMMARY – DECEMBER 5, 2005

labeling of spores products and their D-values. It is the consensus that D-values should
be considered as a factor in the selection of bacterial spores required in
efficacy/validation testing and this topic be considered in future meetings.

However, since there are no comparable D-values for use with chemical treatment
systems, it was proposed to use random samples from up to three separate lots of
spores from each of three vendors in efficacy studies. Multiple strips/suspensions could
be used as part of a single run. While this could provide an interim measure without a
significant increase in cost, it was determined that the group did not have enough
information to reach a definitive conclusion on chemical D-values, or an alternative to
thermal D-values.

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

While the inclusion of the D-value of spores may assist to standardize efficacy testing,
the concept is still new for the evaluation of medical waste treatment technologies and
could create confusion for both regulators and vendors. The group did not choose to
include D-values in STAATT III guidance document to emerge from the meeting, but
would be willing to consider a definite proposal on how D-values would be used and how
D-values would factor into efficacy/validation testing at some future date to ensure that
all technologies are held to the same test standards.

AUTOCLAVES

Autoclaves during the STAATT I and II conferences were not considered “emerging” or
“alternative” technologies. However, the current consensus is that autoclaves be
included under the broad umbrella of medical waste treatment technologies, unless
otherwise specifically excluded from the STAATT III guidance report. As such,
autoclaves must meet the same standards in efficacy/validation testing as any other
treatment systems, especially if used for the treatment of suction canisters, human
pathological waste, animal carcasses, and/or other thermally resistant materials.
Operational parameters should continue to be determined through discussions between
vendors (or on rare occasions, the operator) and regulators, but they should never be
operated at parameters below those established in efficacy testing by vendors who claim
the use of their technologies in the treatment of medical waste.

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

In STAATT’s I and II, autoclaves were exempt from efficacy testing based on their long-
standing reputation as a means of disinfection and sterilization of medical devices.
However, based upon evidence presented at the meeting, the consensus of attendee’s
was that autoclaves be required to meet the same efficacy/validation criteria as all other
medical waste treatment systems. It was noted that the long standing history of
autoclaves was not in question but rather that they be subjected to the same sort of
evaluations as any other technology.
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

95% CONFIDENCE INTERVAL

The STAATT guidance document currently recommends that the efficacy of treatment
technologies be determined by subtracting the average colony forming units (CFUs)
found after treatment from the average CFUs recovered from untreated control samples.
These calculations were generally based upon three untreated and nine or more treated
samples employed in the testing. However, it was suggested that this method may
contribute to misleading results and may not allow the assessment of outliers found
during studies. For example, what is the significance of one of the nine test samples
being outside the average range and is it more significant if this outlier is one or three
logs greater than the average CFUs recovered from samples? The use of a 95%
confidence interval in the calculations might provide a more accurate method for
assessing the results from efficacy/validation/challenge tests. In theory, such a
statistical analysis would eliminate the problems created by outliers and provide more
accurate assessment of treatment technologies. However, since the numbers of
samples required to calculate 95% confidence intervals and the methods to be used in
these calculations could not be provided during the discussions, it was decided to
postpone any attempt of reaching a consensus on the inclusion of this approach until
this information is obtained and circulated among participants (Please note that methods
for calculating a 95% confidence interval have been received and are included at the
end of this summary).

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

Additional remarks concerning a 95% confidence interval (CI):

 If CI is accepted and recommended, it should apply to testing of all

technologies;
 If CI is used, it should be employed in efficacy, validation and challenge (QC)
studies. For example, over a period of a year, one QC failure may be of little
concern, but additional incidents in the same or shorter periods of time may
indicate a systemic problem with the technology and CI may assist in
determining the cause of the failures;
 While some suggested that CI calculations could require as many as 20 or
more samples, it was noted during discussions that CIs could be obtained
with fewer samples, if one factors in the necessary number of standard
deviations;
 There were a number of attendees either in favor of or intrigued by this
proposal, but several considered that requiring the use of 95% CI calculation
would be excessive given the nature of the waste stream to be treated.

SUCTION CANISTERS AND AUTOCLAVE EFFICACY

Based on surveys in California, 1.6% of suction canisters are solidified, with or without
sterilants in the solidifying agent and are sent to landfills. However, an overwhelming
82.7% are treated either on-site or at commercial facilities through the use of autoclaves.
A variety of suction canisters, solidifiers, and autoclaves were evaluated in order to
determine if this type of technology was effective as a means of treating this unique
component of the waste stream. The objective of the tests was to assess if autoclaves
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

could heat the contents to 250oF and maintain this temperature for 30 minutes to
achieve a 4 Log10 reduction of Geobacillus stearothermophilus or Bacillus atrophaeus
spores. Spore strips in glassine envelopes were stapled to tongue depressors and the
latter were positioned in the center of suction canisters prior to the addition of the
solidifying agent. In addition, thermocouples were positioned to take readings at the
center of the mass before the canisters were sealed. It was found in qualitative studies
that test strips removed from 8 of 20 suction canisters treated at off-site facilities were
positive after routine autoclave cycles. In addition, thermocouple data from 96% of the
suction canisters indicated that they did not achieve, in the center of the solidified
contents, sufficiently high temperatures to inactivate bacterial spores. Finally, 15 of 16
spore strips recovered from suction canisters after treatment in 5 autoclaves at 3
different medical centers were positive, i.e., spore growth was found when strips were
cultured in appropriate media.

As part of a parallel study, similar test samples attached to tongue depressors were
placed into suction canisters and the latter distributed at the bottom, middle, and top of
test loads contained in the carts of two different large commercial autoclaves. When
subjected to routine autoclave operating parameters, 0.7 to 3.9 Log10 reduction of
Geobacillus stearothermophilus and/or Bacillus atrophaeus spores was achieved.
Canisters at the bottom of the carts proved to be the most difficult to treat effectively.

Based upon the presentation of these results, attendees recommended further

exploration of modifying the configuration of the waste load, as well as examining the
thermodynamics of the test cycle as opposed to altering the effects of steam penetration.
In addition, there is a need to conduct reproducible investigations of the treatment of
suction canisters with and without solidifying agents.

A presentation was made concerning studies conducted in the UK involving the

assessment of different types of treatment technologies. It was found that systems that
operated most efficiently involved the rupturing of containers holding large liquid
volumes, such as chest drains and suction canisters. Rigid containers that did not
rupture and integrate their liquid volume into the waste load resulted in inconsistent or
unsuccessful treatment of the liquids. Officials there are working to assist industry in the
UK to meet existing standards.

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

Several attendees on this day voiced the opinion that autoclaves were being singled out
while other types of treatment technologies had not been included in these
investigations. It was noted that at the time of the STAATT I and II guidance documents,
autoclaves were considered to be accepted technologies and little attention was paid to
their inclusion in recommendations contained in these two reports. Furthermore, the use
of autoclaves in the treatment of medical waste was increasing as the application of
incinerators was decreasing throughout the US. Finally, the composition of the waste
stream has been changing, the use of suction canisters increasing and few
investigations have ever been conducted as to the efficacy of autoclaves in treating
these and other elements of the changing medical waste stream. Therefore, these
studies represent the initial attempts to explore the application of autoclaves to treat
medical waste, rather than the singling out of these systems.
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

Several of the attendees requested additional studies be conducted, e.g., what types of
autoclaves were tested (static, gravity-fed, rotational tumbling action, what pressures,
what temperatures, etc.), prior to reaching any consensus on the use of autoclaves or
providing any recommendations in future STAATT guidance documents. However,
others felt that there were sufficient data available, preliminary or not, upon which to
reach a consensus rather than waiting for additional studies which might take years to
complete.

Some of those attending these discussions inquired if the concern were really regulatory
in nature as opposed to evaluating the risks involved in employing autoclaves in the
treatment of medical waste. For example, while suction canisters may represent the
highest concentration of organic matter in the waste stream, none of those attending the
conference were aware of any incident in which even one of the estimated 60 million
canisters generated and treated per year around the world was linked to infection.
However, very few epidemiologic studies have been conducted involving medical waste
as a reservoir of infectious agents.

FIFRA

A representative of the EPA’s antimicrobials group presented the following key points
regarding the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA):

 If a technology is an instrument or contrivance that inactivates

microorganisms on medical waste, then the technology is considered a
device and FIFRA registration is not required;
 If the technology employs a chemical or substance that inactivates
microorganisms on medical waste, then the chemical in the technology is
considered a pesticide and FIFRA registration is required;
 A pesticidal device is not required to be registered under FIFRA;
 However, that same device is regulated under FIFRA
 For clarification on any of these items, please contact Ms.Campbell-
McFarlane as indicated below.

It is against the law for anyone to sell or distribute chemical pesticides without EPA
labeling. To obtain FIFRA registration, chemical vendors must present data from
efficacy tests involving the two types of biological indicators and these data must
demonstrate a 4 Log10 inactivation of bacterial spores and a 6 Log10 inactivation of
mycobacteria.

The US EPA’s Antimicrobials Division is considering expanding its technical

requirements to the sterilants used in suction canisters for the treatment of their organic
contents. The attendees recommended that the EPA adopt the same efficacy
requirements for these chemicals as for the chemicals used in treating medical waste in
any technology, i.e., a 4 Log10 inactivation of bacterial spores and a 6 Log10 inactivation
of mycobacteria, with a load consisting of 100% organic material within the canisters.
The group is also considering specifying a 95% confidence interval. It was agreed that
attendees, individually or in association with others in STAATT would assist the EPA, if
requested, on this matter.
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005
The attendees also discussed encapsulation devices, i.e., products that encapsulate
components of the medical waste stream, i.e., sharps, body fluids, etc. It was the
general consensus that treatment capabilities of such products be held to the same
standards as any other technology, i.e., a 4 Log10 inactivation of bacterial spores and a 6
Log10 inactivation of mycobacteria. In addition, if the treatment is achieved through the
use of a chemical, e.g., a sterilent or disinfectant, that FIFRA registration of the chemical
must be obtained by the manufacturer.

For more information on FIFRA, including registration, the group is requested to contact
Jacqueline Campbell-McFarlane of the United States Environmental Protection Agency
(EPA), Antimicrobials Division, at (703) 308-6416 or Campbell-
McFarlane.Jacqueline@epa.gov.

UNTREATED CONTROLS

As noted earlier in the discussions, it was the consensus of the group that the results for
studies involving untreated controls be used to obtain a baseline in efficacy tests of all
treatment technologies and further, that this recommendation be incorporated any
guidance document to emerge from the meeting.

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

Those that participated in the conference on this additional day also endorsed the use of
data from untreated control studies in evaluating the efficacy of all treatment
technologies.

One of the participants suggested that shredders used in some technologies to preshred
the waste prior to thermal or chemical treatment could in themselves create logarithmic
reductions in the concentration of biological indicators. If in fact this was the case, then
such pre-treatment shredding systems would have to employ higher initial
concentrations of the biological indicators to account for losses due to the shredding
process.

Shredding is not recognized as medical waste treatment method and there are no
studies available which would support the use of shredders as a form of treatment. The
population reduction which may be observed would more likely be the result of
dispersion of the waste during shredding or other non-treatment factors. The use of
shredding before, during or after treatment of medical waste remains an area of concern
to those attending these discussions.

The group discussed the use of the term pre-shredding and suggested that it not be
used collectively to represent all options. Rather it was recommended that “internal or
external destructive technologies” employed prior to the treatment of the waste replace
the term. This is an area that merits further discussion and research rather internal or
external destructive technologies should be used. This is an area that merits further
discussion and research
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

PARAMETRIC MONITORING

The consensus of the attendees was again that challenge and regular quality control
testing could be conducted through either parametric monitoring or through the use of
biological indicators provided that parametric monitors have been validated through
efficacy testing. In addition, these criteria should be revalidated at regular intervals as
determined through discussions between regulators and vendors or in the rare instances
that the vendors make no claims as to the capabilities of their systems to treat medical
waste, the operators of the technology. The group also recommended that the
parameters being monitored by the devices should be permanently recorded from real
time collection.

SUPPLEMENT FROM DISCUSSIONS ON DAY 3 – DECEMBER 7, 2005

With respect to the word “permanent” and how it pertained to keeping records, it was
suggested and agreed that the data would need to be in a format that could be reviewed
and that the medium of the record should be determined by the appropriate regulatory
agency.

The responsible regulatory authority determines, in accord with its regulations, the
frequency of QC studies. While some states require QC testing as often as every 40
hours of operation, some attendees suggested that QC tests be performed with
biological indicators on an annual basis with parametric monitoring to provide confidence
in the interim. Alternatively others present expressed the opinion that such yearly QC
tests assign too much validity to what some thought were possible variables involved in
parametric monitoring. Consequently, no recommendation was made for revalidation
intervals for parametric monitors to be included in a STAATTT III guidance report.

Several representatives of regulatory agencies noted that they have neither the
personnel nor financial resources to regularly review parametric or biological indicator
QC data. Some suggested that as the data are generated electronically, it might be
possible to upload the parametric data to transmit it to the regulatory agencies for their
review. However, it was noted that the recording and potential uploading would involve
proprietary software and/or be site-specific. As such, distant review of electronic data is
not currently feasible.
BIOLOGICAL AEROSOLS AND CHEMICAL EFFLUENT

There was consensus that regulators consider as part of their review and evaluation of
treatment technologies the following environmental matters:
Environmental Issues

Aerobiology studies of areas adjacent to Biological and chemical testing of the liquid
the treatment equipment/system discharges from the equipment
Balance of air handling through the QC of environmental factors and
technology and/or within the area where equipment use to minimize potential
the equipment is located negative environmental impacts from using
the treatment equipment
Negative pressure within the system Fixed portal radiation monitors
Application of HEPA and charcoal filters
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

TEST LABORATORIES

It was the consensus of those attending the conference that laboratories conducting any
form of efficacy or validation tests of medical waste treatment technologies be
independent of the vendors of these technologies. In addition, the laboratory is
responsible for the chain of custody –the preparation of samples, their shipment to the
test site, their collection upon completion of testing and their shipment to the laboratory
for the analysis of the samples. The review of the test protocols and data generated from
the tests are the responsibility of the regulatory agencies.

As a means of minimizing delay and potential rejection of data, it was recommended that
laboratories and consultants inform regulators prior to the initiation of testing as to the
test protocols and nature of the data that may be generated through the tests. Such
involvement of the regulatory agencies could eliminate the need to retest the equipment
due to regulatory issues.

EMERGING TREATMENT ISSUES/CONCPETS FOR FURTHER DISCUSSION

BIODEFENSE

Biodefense plans and the disposal of waste generated by bioterrorism events, e.g., 23
reported cases of anthrax spore exposure, are being linked to the use of medical waste
technologies. However, these systems were not designed for nor are they intended for
use in the treatment of building decontamination residue (BDR) from these sorts of
incidents. Given the design of many of these devices and the heat or chemical medium
used for treatment, medical waste treatment systems are currently not suitable for use in
biodefense. While no recommendations were made, the attendees agreed to reexplore
their application at a future date.

TREATMENT OF CHEMOTHERAPEUTICS AND PHARMACEUTICALS

Chemotherapeutics and pharmaceuticals are commonly found in health care facilities

and while chemotherapy waste in other than trace amounts is regulated by the EPA
through the Resource Conservation and Recovery Act, there is not a similar regulatory
body or set of regulations that are concerned with pharmaceuticals entering the waste
stream. Since there is concern about the presence of pharmaceuticals appearing in
wastewater and other environmental reservoirs, several states already limit or ban the
commingling of drug with medical waste.

While some high heat technologies can be expected to deactivate pharmaceuticals, the
group did not make any recommendations for the use of alternative treatment
technologies in the treatment or disposal of pharmaceuticals. The attendees would
welcome additional research and data covering the environmental ramifications of
pharmaceuticals in the medical waste stream.
PRIONS
While the most resistant infectious agent to thermal and chemical treatment, the
incidents of these forms for disease in humans in the United States is at the most, one
per million in the population. Other prion contaminated materials such as waste
generated in research with prions, animal carcasses, their body parts or bedding may
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

present a challenge to facilities attempting to inactivate prion proteins. The attendees

did not provide recommendations for the inclusion of these agents in the STAATT III
guidance document.
OUTLIERS
As noted earlier in this summary, the STAATT guidance document currently
recommends that the efficacy of treatment technologies be determined by subtracting
the average colony forming units (CFU) found after treatment from the average CFU
recovered from untreated control samples. However, it was suggested that this method
may contribute to misleading results and may not allow the assessment of outliers found
during studies. To deal with this situation within present procedures for quantitatively
assessing results from efficacy studies, it was proposed to set minimum log reduction
values in addition to the target average log reductions. For example, the guidance
document could present the following goals:
Bacterial spores – required average reduction of 4 log10 AND a minimum log reduction of
any single test sample of 2 log10
Mycobacterial vegetative cells – required average reduction of 6 log10 AND a minimum
log reduction of any single test ample of 3 log10
While this approach is similar to that currently in use in the Environmental Protection
Agency’s Guide Standard for Testing Microbiological Water Purifiers, its application in
the evaluation of medical waste treatment technologies is not sanctioned by any federal
or state regulatory agency. Therefore, this concept, including the minimum log reduction
values, needs to be further discussed and evaluated.
NON-MEDICAL WASTE ITEMS
While the STAATT guidance documents address issues related to items commonly
defined as medical waste, they fail to consider non-medical waste items that may enter
this waste stream. Therefore, future STAATT reports could possibly include responses
to one or more of the following questions:
• What common non-medical waste items do generators include in this waste
stream?
• Would the inclusion of these items be in violation of state and federal
regulations?
• Can these items be effectively processed by medical waste treatment
technologies, without creating worker safety issues or damage to the
technologies?
• What methods or procedures can be employed to restrict the inclusion of non-
medical waste items into the waste stream?
•
It should be note that some states, e.g., California, have amended their medical waste
regulations to include definitions and specific handling requirements for items not
presently included in the definitions of medical waste. In California, non-RCRA
pharmaceutical wastes can be included in the medical waste stream to be incinerated or
treated with high heat technologies. General responses to these questions which could
be of use to federal and state regulatory agencies will be addressed at subsequent
medical waste conferences.
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

95% CONFIDENCE INTERVAL CALCULATIONS

The following methods were provided by Mr. Robert McIntrye of the Environment
Agency of the United Kingdom:

95% Confidence Intervals for Validation Spore Results

(1) The Control Run

The Control Run utilises either

• A number of spore strips, or
• Sub-samples of waste containing a spore suspension

In both cases the spores samples must be analysed using the methodology that is
identical to the test run for the recovery of spores.

The following must be determined

• The mean (XC) number of spores recovered

• The Log10 of (XC)

For example - From six spores strips the following results are achieved (adjusted to
account for analytical dilutions) for number of spores recovered

1.6 x 106
1.3 x 106
1.1 x 106
1.5 x 106
1.2 x 106
1.4 x 106

mean (XC) = ΣxC = 8.1 x 106 = 1.35 x 106

NC 6

Log10 (XC) = 6.13

Where
• ΣxC Is the sum of the individual results for each spore strips or control samples
• NC Is the number of spore strips or control samples analysed

(2) D-Value Correction

The D-value is the time taken, in minutes, for a 1 Log10 reduction, in the number of
spores.

Each batch of spores will have a certified D-value.

 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

Not all batches of spores will have the same D-value. It is accepted that this D-value
may vary by up to 100% for commercially available spores of the same type, and that
variance beyond this range is available on request.

The choice of spore strip may therefore increase or reduce the number of spores
recovered by a factor of 10 and can predictably alter the reported reduction by 2 log10.
STAATT considers that in principle 4 log reduction should be demonstrable for any
commercially available spore batch.

The level III criteria require the use of spores where the certified D-value is ≥ 2 minutes
• at 121°C wet heat (Geobacillus stearothermophilus)
• at 160°C dry heat (Bacillus atrophaeus)

Where certified D-value is < 2 minutes, or determined at parameters other than those
identified above, the level III criteria are invalid.

Required Test Reduction

The required Log10 reduction can be used to calculate the target test Log10 result

Log10 (Test) = Log10 (XC) - 4

Using the examples above

Log10 (Test) = 6.13 – 4 = 2.13.

Test B: Confidence Intervals for Log Reduction

The test run spores samples must be analysed using the methodology that is identical to
the control run for the recovery of spores.

The following must be determined

• The mean (XT) number of spores recovered

• The standard deviation (σ) of spores recovered
• The Log10 of (XT)
• The Upper 95% confidence interval of (XT)
• The Log10 of the Upper 95% confidence interval of XT

For example - From six spores strips the following results are achieved (adjusted to
account for analytical dilutions) for number of spores recovered

0
167
12
0
15
62
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005
55
231
0
35

mean (XT) = ΣxT = 641 = 64.1

NT 10

Standard Deviation = 81.2

Log mean (XT) = 1.81

Upper 95% confidence limit (Lu) = mean + (1.96 x Stdev) = 223

The Log of the Upper 95% confidence interval (Log10Lu)= 2.35

STAATT Level III CRITERIA

The required log reduction must be achieved with 95% confidence.

(Log10Lu) must be less than Log10 (Test)

2.35 is more than 2.13….the required log reduction has not been achieved with 95%
confidence

The 95% confidence level of treatment is 6.13 - 2.35 = 3.78

(The mean log inactivation achieved is 6.13 – 1.81 = 4.32)

Routine Monitoring.

Routine Challenge testing may be conducted qualitatively or quantitatively.

Qualitative testing involves the detection of growth/no growth of spores following

treatment. The weakness of this method is that the number of spores surviving cannot
be determined, and that the frequency of growth occurring is dependent on the input
dose, the D-value and the efficacy of the process. This method is recommended for
smaller processes, and for processes where the efficacy makes spore growth extremely
improbable. Qualitative testing should not be used where growth is expected or has
previously occurred.

Quantitative testing involves the enumeration of spores that survive treatment. The
advantage is that this allows the efficacy of treatment to be determined. This method is
recommended for larger capacity processes and those processes where survival of
small number of spores may be a previous of predictable occurrence.

The Assessment of qualitative spore data

Qualitative testing does not permit enumeration of spores. Where growth occurs it is not
possible to determine if one, some or all spores survived. All positive results are
therefore significant and should be investigated. An individual result may be accepted
where parametric monitoring of all critical parameters is in place, is working effectively,
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

and indicates that the process achieved the required treatment criteria. Where several
positive results occur over a period of time this is more significant.

The following criteria are considered to be the minimum standard and best practice
should substantially exceed these.

• 95 % of the individual spores strips, with a population of >1 x 104, in the first 6
months of operation , and each calendar year, should demonstrate no growth., AND
• For thermal processes thermal indicator strips should accompany each spore strip
and indicate that the minimum time and temperatures have been achieved for 99%
of spore strips.
• The number and type of spore/thermal indicator strips used, and the frequency of
spore testing throughout the calendar year is uniform.
• For each calendar year a summary report should be prepared that indicates the
results obtained and any failures.
• Where >1% (or 1, whichever is greater) of spore strips exhibit growth in any calendar
year quantitative testing should be used in future of qualitative.

These criteria must include all test strips recovered from the plant to be valid. The 5%
criteria have been provided to allow for both potential contamination and the uncertainty
of microbial data.

The Assessment of Quantitative spore criteria

Quantitative testing does permit the enumeration of spores even where growth occurs.
The significance of a single positive result can therefore be determined; however
consideration should be given to the issues of microbial uncertainty and potential
contamination. An individual adverse result may be accepted where parametric
monitoring of all critical parameters is in place, is working effectively, and indicates that
the process achieved the required treatment criteria. Where several adverse results
occur over a period of time this is more significant.

The following criteria are considered to be the minimum standard and best practice
should substantially exceed these.

• 95 % of the individual spores strips, with a population of >1 x 106, in the first 6
months of operation , and each calendar year, should demonstrate 4 log10
inactivation or higher., AND
• For thermal processes thermal indicator strips should accompany each spore strip
and indicate that the minimum time and temperatures have been achieved for 99%
of spore strips.
• The number and type of spore/thermal indicator strips used, and the frequency of
spore testing throughout the calendar year is uniform.
• For each calendar year a summary report should be prepared that indicates the
results obtained and any failures. The data should be referenced to the validation
report to demonstrate that predicted treatment efficacy, rather than minimum
standards, are being achieved. 90% of spore results should demonstrate a level of
inactivation ≥ the 95% confidence level of treatment determined during validation.
 STAATT III MEETING
DECEMBER 5-7, 2005
DAY 2 SUMMARY DECEMBER 6, 2005

These criteria must include all test strips recovered from the plant to be valid. The %
criteria have been provided to allow for both potential contamination and the uncertainty
of microbial data.
 STAATT III MEETING
DECEMBER 5-7, 2005
ATTENDEES

DECEMBER 5-6, 2005

Amalendu Bagchi Francine Joyal

Wisconsin Dept. of Natural Resources FL Dept of Environmental Protection
P.O. Box 7921 Solid Waste Section, MS 4565
101 South Webster St. 2600 Blair Stone Rd
Madison, WI 53707 Tallahassee, FL 32399-2400
Phone: (608) 267-7576 Phone: (850) 245-8747
amalendu.bagchi@dnr.state.wi.us Francine.joyal@dep.state.fl.us

Eric Beller Ed Krisiunas

Texas Commission of Environmental Quality WN WN International
MC-124, P.O. Box 13087 P.O. Box 1164
Austin, TX 78711-3087 Burlington, CT 06013
Phone: (512) 239-1177 Phone: (860) 675-1217
ebeller@tceq.state.tx.us Fax: (860) 675-1311
Mobile: (860) 944-2373
ekrisiunas@aol.com
Sue Berry
Health Protection Agency
South Yorkshire Health Protection Unit Stephen T. Kubo
Unit C Department of Health Services, State of California
Meadow Court Medical Waste Management Program
Hayland Street, Off Amos Rd P.O. Box 997413, MS 7405
Sheffield Sacramento, CA 95899-7413
UK S91 BY Phone: (916) 449-5684
Phone: 0114 242 8858 Fax: (916) 449-5665
Sue.berry@hpa.org.uk skubo@dhs.ca.gov

Barbara Bickford Jacquie McFarlane

WI Department of Natural Resources, WA/3 EPA (7510C)
PO Box 7921 1200 Pennsylvania Ave
101 S. Webster St Washington, DC 20460
Madison, WI 53707-7921 Phone: (703) 308-6416
Phone: (608) 267-3548 Campbell-mcfarlane.Jacqueline@epa.gov
Fax: (608) 267-2768
Barbara.bickford@dnr.state.wi.us
Medical.waste@dnr.state.wi.us
Jack McGurk
3
Systems Improvement Initiators, Inc (Si )
7506 Westover Ct
Jonathan Brania Fair Oaks, CA 95628
Underwriters laboratories Inc. Phone: (916) 947-0884
12 Laboratory Drive jackmcgurk@aol.com
Research Triangle Park, NC 27709-3995
Phone: (919) 549-1768
Fax: (919) 547-6262
Bob McIntyre
Jonathan.brania@us.ul.com Environment Agency
Manley House
Kestrel Way
Edith Coulter Sowton Industrial Estate
FL Department of Health Exeter
4052 Bald Cypress Way Devon
Bin A08 EX2 7LQ
Tallahassee, FL 32399-1710
Phone: (850) 245-4277
Edith_coulter@doh.state.fl.us
 STAATT III MEETING
DECEMBER 5-7, 2005
ATTENDEES

Joe Cronin Phillip Morris, CPM

KS Department of Health and Environment Terra Verda
1000 SW Jackson , Ste 320 140A Amicks Ferry Rd 328
Topeka, KS 66612-1366 Chapin, SC 29036
(785) 296-1667 Phone: (803) 920-2418
jcronin@kdhe.state.ks.us infection@yahoo.com

John Demaree Lindsay Mothershed

Texas Commission on Environmental Quality AL Department of Environmental Management
MC-124, P.O. Box 13087 P.O. Box 301463
Austin, TX 78711-3087 Montgomery, AL 36130-1463
Phone: (512) 239-1268 Phone: (334) 271-7741
jdemaree@tceq.state.tx.us glm@adem.state.al.us

Shawn Doyle Ron Pilorin

Sterilator Company California Department of Health Services
30 Water St Medical Waste Management Program
Cuba, NY 14727 1616 Capitol Avenue, MS-7405
Phone: (585) 968-2377 P.O. Box 997413
sdoyle@sterilator.com Sacramento, CA 95899-7413
Phone: (916) 449-5689
Fax: (916) 449-5665
John N. Gohlke rpilorin@dhs.ca.gov
Medical Waste Regulatory Program
Michigan Department of Environmental Quality
525 West Allegan St Ira F. Salkin, Ph.D., F(AAM)
P.O. Box 30241 Information From Science, LLC
Lansing, MI 48909-7741 P.O. Box 408
Phone: (517) 241-1320 West Sand Lake, NY 12196
Fax: (517) 373-4797 Phone/Fax: (518) 674-1713
gohlkej@michigan.gov irasalkin@aol.com

Ed Golding Lynne Sehulster, Ph.D.

Florida Department of Health, Division of Centers for Disease Control and Prevention
Environmental Health Division of Healthcare Quality Promotion
Bureau of Community Environmental Health Epidemiology and Laboratory Branch
4052 Bald Cypress Way, Bin A08 1600 Clifton Road
Tallahassee, FL 32399-1712 Mailstop A-35
Phone: (850) 245-4277 Atlanta, GA 30333
Fax: (850) 487-0864 Phone: (404) 639-2314
Edward_golding@doh.state.fl.us Fax: (404) 639-2647
Los0@cdc.gov
John Gu
Alison Shockley
FDI Inc Ohio EPA
1512 Catalina P.O. Box 1049
Ann Arbor, MI 48103
Columbus, OH 43216-1049
Phone: (734) 730-0623
Phone: (614) 728-5335
nzzha@comcast.net Fax: (614) 728-5315
Alison.Shockley@epa.state.oh.us
 STAATT III MEETING
DECEMBER 5-7, 2005
ATTENDEES

Malcolm Holliday, Ph.D. Wayne Turnberg, Ph.D.

Microbiology Department Washington Department of Health
th
Newcastle Hospitals Trust 1610 NE 150 St, MS: K17-9
Freeman Hospital Shoreline, WA 98155
Newcastle Upon Tyne Phone: (206) 418-5559
NE7 7DN Fax: (206) 418-5515
UK Wayne.turnberg@doh.wa.gov
Phone: 0191 213 7292
Malcolm.holliday@nwth.nhs.uk
Malcolm.holliday@tgh.nwth.northy.hns.uk
Paul Warden
Analytical Services, Inc
130 Allen Brook Ln
Barbara Howard, PE P.O. Box 515
GA EPD, Solid Waste Management Program Williston, VT 05495
4244 International Pkwy, Suite 104 Phone: (800) 723-4432, x15
Atlanta, GA 30354 pwarden@analyticalservices.com
Phone: (404) 362-2572
Fax: (404) 362-2693 Alan G. Woodard, Ph.D.
Barbara_howard@dnr.state.ga.us Bureau of Solid Waste, Reduction and Recycling
Division of Solid and Hazardous Materials
Steven F. Hughes 625 Broadway
Albany, NY 12233-7253
Community Sanitation Program
Phone: (518) 402-8706
Massachusetts Department of Public Health
Fax: (518) 402-8681
250 Washington St, 7th Floor
agwoodar@gw.dec.state.ny.us
Boston, MA
Phone: (617) 624-5757
Fax: (617) 624-5777
Steven.Hughes@state.ma.us
 STAATT III MEETING
DECEMBER 5-7, 2005
ATTENDEES

VENDORS – DECEMBER 7, 2005

Angel Aguiar Selin Hoboy

Bondtech Corp Stericycle, Inc
2400 N Hwy 27 28161 N Keith Dr
Somerset, KY 42503 Lake Forest, IL 60046
Phone: (800) 414-4231 Phone: (847) 607-2080
Direct: 305-668-8650 Fax: (847) 456-8889
Mob: 305-798-3967 shoboy@stericycle.com
aaguiar@aol.com
Alice Jacobsohn
Steve Birch National Solid Wastes Management Association
Aduromed Medical Waste Institute
3 Trowbridge Dr 4301 Connecticut Ave, NW – Ste. 300
Bethel, CT 06801 Washington, DC 20008
Phone: (203) 798-1080 Phone: (202) 364-3724
Fax: (202) 364-3792
alicej@envasns.org
Lee Boyland
Honna Technologies Inc Gordon Kaye, Ph.D.
704 Kenwood Circle WR2
Melbourne, FL 32940 2910-D Fortune Circle W
Phone: (321) 255-3995 Indianapolis, IN 46421
leeboyland@att.net Mobile: (518) 369-6399
Fax: (518) 271-2040
Joe Delloiacovo Wr2kaye@aol.com
gkaye@wr2.net
WR2
2910-D Fortune Circle W
Indianapolis, IN 46421 Elliott Koppel
Phone: (973) 989-2680 MCM Environmental Technologies Inc
Mob: 001- 201-230-2913 One Parker Plaza
Fax: (973) 989-2681 Fort Lee, NJ 07024
jdelloiacovo@wr2.net Phone: (201) 242-1222
delloiac@optonline.net ekoppel@mcmetech.com

Mike Fields Max D. Lechtman, Ph.D.

Vestara
Enserv/MedShred
15411 Redhill Ave, Suite F
6575 W Loop South, Ste 145
Tustin, CA 92780
Bellaire, TX 77401
Phone: (714) 258-7218
Phone: (713) 349-0063
mfields@enserv.com Fax: (714) 897-7759
bythemax@socal.rr.com

Russell Firestone Rick Long

Sanitec Industries Bondtech Corp
th
1250 24 St NW, Ste 350 2400 N Hwy 27
Washington, DC 20037 Somerset, KY 42553
rick@bondtech.net
Phone: (202) 263-3648
Fax: (202) 263-3622
rfirestone@sanitecind.com Arthur McCoy
San-I-Pak
Tracy, CA
Phone: (209) 836-2310
arthurmccoy@sanipak.com
 STAATT III MEETING
DECEMBER 5-7, 2005
ATTENDEES

Dr. Sandy Glazer Mark Miller

Red Bag Solutions P.O. Box 6706
3431 Benson Ave, Ste 100 Boise, ID 83707
Baltimore, MD 21227 mark@larsonmiller.com
Phone:443-524-4245
Mob: 301-254-2234
Fax:443-5244250 Gary Mostow
sglazer@redbag.com Dornoch Medical
5724 N Pulaski Rd
Terry Grimmond Chicago, IL 60646
Phone: (312) 493-4000
3 Tarbett Rd gmostow@dornoch.com
Hillcrest, Hamilton
New Zealand
Phone NZ +64 7 8564042 Michael Schott
tgrimmond@danielsinternational.com 52 Bianco Ct
El Dorado Hills, CA 95762
Phone: (916) 939-1681
James Harkess m.schott@sbcglobal.net
Sanitec Industries
9065 Norris Ave
Sun Valley, CA 91352 Tim Spencer
Phone: (818) 504-0343 Positive Impact Waste Solutions
sanitecjh@sbcglobal.net 601 S Pagewood
Odessa, TX 79761
Raymond Hart Phone: (432) 580-5885
Mobile: (432) 352-5286
Med-Shred Inc tspen@piwsinc.com
6575 W Loop South, Suite 145
Bellaire, TX 77401
Phone: (713) 349-0063
rhart@medshred.com

Tim Hertwick
Aduromed
3 Trowbridge Dr
Bethel, CT 06801
Phone: (203) 798-1080