(A) This rule sets
forth the procedures and criteria for approval of an alternative infectious
waste treatment technology. An alternative infectious waste treatment
technology is any combination of methods, techniques, practices, designs,
constructions, operations, process, or equipment, intended to treat infectious
waste that is not specified in rule
3745-27-32
of the Administrative Code. Nothing in this rule relieves the owner or operator
seeking such approval from the requirement to obtain any applicable permits or
licenses including those pursuant to sections
3734.02 and
3734.05 of the Revised
Code.
(B) The applicant may request
either a statewide approval or a site-specific approval, in accordance with
paragraphs (C), (D), and (E) of this rule. An alternative treatment technology
with statewide approval may be used at any facility throughout the state of
Ohio without the operator first performing initial validation testing. An
alternative treatment technology with site-specific approval shall have initial
validation testing performed by the operator prior to use. The following
demonstrations shall accompany any such approval request:
[Comment: Validation testing is performed prior to use to
ensure that the alternative treatment technology will be able to achieve the
performance standard for treatment. Quality assurance testing is an on-going
monitor of the treatment technology's ability to attain the performance
standard for treatment.]
(1)
Statewide approval performance standard. The achievement of a minimum four
log10 reduction of bacterial spores and a minimum five log10 reduction of
mycobacteria as specified in table 1 of paragraph (E)(1) of this rule
immediately upon exit of the wastes from the treatment unit.
(2) Site-specific approval performance
standard. The achievement of a minimum four log10 reduction of bacterial spores
specified in table 2 of paragraph (E)(1) of this rule immediately upon exit of
the wastes from the treatment unit.
(C) The applicant shall ensure that sound and
accepted scientific microbial techniques were used to develop all data
submitted during the approval process including but not limited to the
following:
(1) Enumeration of all stock
suspensions or a representative sampling of carriers.
(2) Placement of all samples and controls
into buffered diluent.
(3)
Performance of three test runs for each microorganism and control.
(4) Collection of all samples and controls
upon exiting the treatment unit.
(5) Neutralization of the collected samples
and applicable controls immediately upon exiting the treatment unit, if the
technology utilizes chemical treatment.
(6) Homogenation of each dilution immediately
prior to withdrawing an aliquot for plating or continued dilution.
(7) Inoculation of the growth media
immediately with the dilutions of processed waste samples and applicable
controls. If immediate inoculation is not possible, then the samples shall be
placed in ice for a period of time not to exceed sixty minutes, unless an
alternative timeframe for holding the samples has been approved by the
director.
If there is documentation to support the use of longer time
periods for holding the samples prior to plating, or prior to placing inoculant
into growth media, 3745-27-38 2 or further handling for dilution of a
particular technology that does not comply with this rule, Ohio EPA may accept
the use of longer time periods prior to plating, or to placing into growth
media, or further handling for dilution that demonstrates achievement of the
performance standard for the treatment technology. The applicant shall
demonstrate to Ohio EPA's satisfaction through the use of sound scientific
microbial technique and peer-reviewed journal reference, or equivalent
documentation, that an alternate time period is appropriate. The applicant
shall submit the documentation for approval by Ohio EPA prior to use in
testing.
(8) Plating of
dilutions in triplicate.
(9)
Utilization of those microbial plates that contain between thirty and
three-hundred colonies.
(10)
Utilization of only those plate counts that demonstrate a margin of error no
greater than five per cent difference between the replicate plates and no
greater than a ten per cent difference in individual test runs. If one of the
three replicate plates has a quantitative difference of greater than five per
cent, then that replicate plate shall not be utilized and the calculation shall
be formulated utilizing two replicate plates.
(11) Performance of subsequent test runs. If
all three of the plate counts have a quantitative difference of greater than
five per cent between them, the test run is considered invalid and another test
load for that particular microorganism or spore shall be prepared and processed
through the unit.
(12) Performance
of subsequent test loads. If any one of the three test run plate dilution
series has a quantitative difference of greater than ten per centbetween them,
the test run shall be considered invalid and another test load for that
particular series shall be prepared and processed through the unit.
[Comment: "Samples" as used in this paragraph refers to either
portions of previously inoculated wastes or inoculated carriers.
(D) The applicant shall
submit to Ohio EPA the following items:
(1) A
written request for approval of the infectious waste treatment technology. The
request shall specify whether the applicant is seeking a statewide or site
specific approval.
(2) A completed
"Evaluation Of An Infectious Waste Treatment Technology Information Request
Form" as prescribed by Ohio EPA.
[Comment: Upon receipt of the written request and evaluation
form, Ohio EPA will public notice the receipt of the application in the weekly
review.]
(3) An operating
manual or other treatment unit program logic which describes in detail the
operations of the unit and the critical factors influencing the treatment
capability of the equipment. This description shall include, but is not limited
to, the waste feed rate, maximum hourly capacity, residence time, pH,
temperature reading, treatment chemical concentration, and sequence of
treatment events.
(4) The microbial
testing protocol designed and used to evaluate the capability of the
alternative infectious waste treatment unit to achieve the performance standard
as specified in paragraph (B) of this rule.
(5) A microbial testing report containing the
microbial testing results using an appropriate protocol. The microbial testing
results shall comply with paragraphs (C) and (E) of this rule and demonstrate
the achievement of the performance standard upon exiting the treatment unit, as
follows:
(a) For statewide approval, the
request shall demonstrate the achievement of a minimum four log10 reduction of
bacterial spores and a minimum five log10 reduction of mycobacteria as
specified in table 1 in this rule.
(b) For site-specific approval, the request
shall demonstrate the achievement of a minimum four log10 reduction of
bacterial spores specified in table 2 in this rule.
(E) The applicant shall ensure
that the microbial testing and protocol are designed to evaluate the capability
of the treatment unit to achieve the performance standard and comply with the
following requirements. For the purposes of this rule, "samples" means either a
representative portion of previously inoculated waste or an inoculated carrier:
[Comment: It is strongly recommended that the applicant submit
the proposed microbial testing protocol to Ohio EPA prior to testing. Upon
request, Ohio EPA will review and provide written comment on the protocol. This
service is offered to provide guidance intended to help the applicant's efforts
in documenting effective treatment of infectious wastes.]
(1) Selection of challenge microorganisms.
The applicant shall use the appropriate microorganisms to test the
effectiveness of a particular treatment technology in accordance with the
following:
(a) Those applicants who request
statewide approval shall select microorganisms from table 1 as follows:
(i) Use a mycobacteria species which is the
most resistant to any aspect of the treatment technology.
(ii) Use a bacterial spore species which is
the most resistant to any aspect of the treatment technology.
[Comment: Particular mycobacteria and bacterial spores are more
resistant to various treatment conditions that each technology presents;
therefore, the selection of the appropriate species is a valuable test for
challenging that alternative treatment technology. The applicant should
consider the "D" value when selecting the appropriate species.]
Table 1
Mycobacteria
-- Mycobacterium terrae
-- Mycobacterium phlei
-- Mycobacterium bovis
Bacterial spores
-- Geobacillus stearothermophilus
-- Bacillus subtilis
(b) Those applicants who request
site-specific approval shall select one microorganism from the bacterial spore
species which is the most resistant to all aspects of the treatment technology,
listed in table 2.
[Comment: Particular bacterial spores are more resistant to
various treatment conditions that each technology presents; therefore, the
selection of the appropriate bacterial spores is a valuable test for
challenging that alternative treatment technology. The applicant should
consider the "D" value when selecting the appropriate species.]
Table 2
Bacterial spores
-- Geobacillus stearothermophilus
-- Bacillus subtilis
(c) Applicants for either type of approval
may select and use other microorganism not listed in either table 1 or table 2,
provided the applicant demonstrates to the satisfaction of the director that
the alternative microorganism is of equal resistance as the listed indicator
microorganism of that particular category.
(d) Applicants for either type of approval
shall select the most resistant microorganisms to their treatment technology
for use in the testing process.
[Comment: All microorganisms used during testing for either
type of request shall be reduced in number to the levels stated in paragraph
(D)(5) of this rule.]
(2) Sufficient number of challenge
microorganisms. The applicant shall use and be able to retrieve a sufficient
number of challenge microorganisms to quantify the results for each test waste
load, and for each type of inoculation. Prior to log10 reduction efficacy
testing of the treatment unit, the applicant shall determine the number of
recoverable microorganisms. The recoverable number of microorganisms will
determine the number of challenge microorganisms sufficient to start with for
all subsequent testing for log10 reductions. The applicant shall perform one of
the following:
[Comment: The percent number of recoverable microorganisms (%R)
is in the appendix to this rule.]
(a)
Applicants may directly inoculate the waste load using the appropriate
microbial suspension to implement the following:
(i) Inoculation with enough liquid suspension
of the appropriate mycobacteria to give an adjusted theoretical challenge, as
defined in the appendix to this rule, of at least 1.0 X 10\6\ microorganisms
per gram of waste, or per milliliter of waste if the technology is designed to
treat liquid infectious wastes, for the mycobacteria specified in table 1 of
paragraph (E)(1) of this rule.
(ii)
Inoculation with enough liquid suspension to give an adjusted theoretical
challenge, as defined in the appendix to this rule, of at least 1.0 X 10\5\
bacterial spores per gram of waste, or per milliliter of waste if the
technology is designed to treat liquid infectious waste.
(b) Applicants may choose to use a carrier
system. Each individual carrier shall maintain a sufficient recoverable
inoculum to allow the applicant to inoculate, retrieve, and calculate the
adjusted theoretical challenge population. The applicant shall implement the
following:
(i) Inoculation with enough
recoverable carriers of the appropriate mycobacteria to give an adjusted
theoretical challenge, as defined in the appendix to this rule, of at least 1.0
X 10\6\ microorganisms.
(ii)
Inoculation with enough recoverable carriers, such as bacterial spore strips,
of the appropriate bacterial spores to give an adjusted theoretical challenge,
as defined in the appendix to this rule, of at least 1.0 X 10\5\ bacterial
spores.
(3)
Selection of test waste loads. The applicant shall use test waste loads that
are representative of the waste stream that the treatment technology is
designed to treat. The amount of waste used to comprise an individual test run
shall be sufficient to simulate operation of the unit at full capacity. The
applicant shall utilize test waste loads that pose the greatest challenge to
the treatment technology being tested in accordance with the following:
(a) Determine which categories of infectious
wastes, as defined in rule
3745-27-01 of the
Administrative Code, the treatment technology will and will not be capable of
treating.
(b) Use full-scale
production units for all testing.
(c) Select infectious waste test loads using
one of the following criteria:
(i) For those
treatment technologies that are designed to treat any and all categories of
infectious wastes, as defined in rule
3745-27-01 of the
Administrative Code, the applicant shall use test waste loads comprised, at a
minimum, of the following:
(a) Thirty per
cent organic materials such as blood or other products derived from blood, and
culture media.
(b) Forty per cent
absorbent material.
(c) Thirty per
cent non-absorbent material.
[Comment: Waste loads used for testing should contain at least
thirty per cent organic material to simulate the possibility of processing
laboratory waste. Absorbent material means those waste items such as surgical
drapes and sponges and patient gowns that will readily absorb liquids.
Non-absorbent material means waste items such as exam gloves, tubing, and
plastic containers that do not readily absorb liquids.]
(ii) For those treatment
technologies that are designed to treat a specific category of infectious
waste, as defined in rule
3745-27-01 of the
Administrative Code, the applicant shall use test waste loads composed of one
hundred per cent of the specific infectious waste category that the treatment
technology is designed to treat.
(iii) For those treatment technologies that
are designed to treat any category of infectious wastes as defined in rule
3745-27-01 of the
Administrative Code, but are sensitive to particular combinations or individual
items contained in a waste stream, the applicant shall use test waste loads
composed of one hundred per cent of the combination or individual item of that
specific infectious waste category, as defined in rule
3745-27-01 of the
Administrative Code, which poses the greatest challenge to that treatment
technology.
[Comment: An example of a treatment technology that would have
to use a test waste load as outlined in paragraph (E)(3)(c)(iii) of this rule
would be a chemical treatment technology whose active ingredient is a chemical
that is "bound" or "consumed" by large quantities of organics that may be
present in a waste load. Therefore, the treatment technology would be required
to use test waste loads composed of one hundred per cent of organics. This
testing would challenge the treatment technology in a "worse case" scenario.]
(iv) For those treatment
technologies that are designed to treat any category of infectious wastes, as
defined in rule
3745-27-01 of the
Administrative Code, but the applicant intends to request approval for treating
only specific waste loads at specific volumes, the applicant may use test waste
loads comprised of combinations other than those listed in paragraph (E)(3) of
this rule. The director's approval letter will reflect these specific
conditions.
[Comment: An example of a treatment technology that may elect
to use a test waste load as outlined in paragraph (E)(3)(c)(iv) of this rule
would be a chemical treatment technology whose active ingredient is a chemical
that is "bound" or "consumed" by large quantities of organics that may be
present in a waste load. Therefore, the applicant may use test waste loads
composed of combinations or volumes other than those listed above. The
director's approval letter will reflect the applicants selection of test waste
load for use during actual infectious waste treatment activities.]
(v) For those treatment
technologies that are designed to treat any and all categories of infectious
wastes as defined in rule
3745-27-01 of the
Administrative Code, the applicant may use alternative test waste loads
comprised of materials or volumes other than those outlined in paragraph
(E)(3)(c)(i) of this rule, provided that the applicant demonstrates to Ohio
EPA's satisfaction that an alternative test waste load provides a greater
challenge to the technology.
(4) Preparation of the test waste loads. The
applicant shall prepare and inoculate test waste loads, selected in accordance
with paragraph (E)(3) of this rule, in the following manner:
(a) Prepare the test waste load by doing any
of the following:
(i) Autoclaving infectious
wastes to achieve sterility and then cooling the treated infectious wastes
prior to inoculation with the challenge microbial suspensions or carrier.
(ii) Preparing test waste loads
using new/unused representative materials.
[Comment: An applicant who chooses to use test waste loads of
noninfectious materials may do so either by using infectious wastes that have
been autoclaved or materials that contain clean, unused, new, and/or previously
packaged materials. It is the applicant's responsibility to ensure that the
test waste load materials are representative of the waste stream.]
(b) Inoculate the test
waste loads ensuring that all preparations are accomplished in a manner that
will distribute the inoculum evenly throughout the waste load. The ratio of the
volume of inoculum to the amount of waste shall not be less than one to twenty
(not less than five per cent). Inoculation shall be accomplished by doing any
of the following:
(i) Using a microbial
suspension, seed the test waste load with a sufficient number of challenge
microorganisms as specified in paragraph (E)(2) of this rule.
(ii) Using a carrier system, introduce one
carrier with the appropriate inoculum for each ten pounds of waste in the test
load. If the test load consists of less than ten pounds of waste, then a
minimum of three carriers shall be used in each test load. The carriers shall
be evenly distributed throughout the waste load.
(5) Enumeration of the original
inoculum. The applicant shall perform the enumeration of either the initial
inoculum in the stock suspension or a representative sampling of carriers as
follows:
(a) For a stock suspension, do the
following:
(i) Enumerate all initial stock
suspensions of microorganisms and control immediately prior to introduction
into the test waste load used.
(ii)
Inoculate the test waste load immediately prior to introduction into the
treatment unit.
(iii) Use the stock
suspension number obtained above to determine the theoretical challenge (TC)
and subsequently the adjusted theoretical challenge (ATC) for each test run as
described in the appendix to this rule.
(b) For a carrier system, do the following:
(i) Verify through prior enumeration the
inoculum contained on a representative sampling of carriers.
(ii) Determine the theoretical challenge (TC)
for each microorganism and subsequently the adjusted theoretical challenge
(ATC) for each test run as described in the appendix to this rule.
(6) Performing the
treatment test runs. The applicant shall evaluate the treatment unit utilizing
microorganisms or carriers in accordance with the following:
(a) Use full-scale production units for all
testing;.
(b) Conduct a recovery
test run, using sound and accepted scientific microbial techniques, as
specified in paragraph (C) of this rule, for each microorganism to determine
the percentage of microorganisms that can be recovered from the waste loads
used for testing, as specified in the appendix of this rule. The applicant
shall perform at least one recovery test run absent of the aspect of the
treatment technology that is responsible for the microbial kill.
[Comment: One recovery test run must be performed for each
Mycobacterium spp., Geobacillus stearothermophilus or Bacillus subtilis spore.
The recovery test run is necessary to determine the amount of loss of
microorganisms or spores that is due to the physical aspects of the treatment
unit and therefore to determine the ability to retrieve the microorganisms or
spores from the waste or carrier.]
(c) Utilize a minimum of three treatment test
runs per microorganism or spore.
(d) Demonstrate the attainment of the
applicable performance standard as specified in paragraph (B) of this rule at
the completion of all three test runs.
(7) Recording data during testing. The
applicant shall produce a permanent record of the following observations or
recordings:
(a) The date of testing.
(b) The time of day that each test
load is placed into the treatment unit.
(c) The time of day that each sample is
retrieved from the treatment unit.
(d) The applicable observed or recorded
operational parameters at which the treatment unit was operated.
[Comment: The applicant is expected to record the operational
parameters for the treatment unit which any operator would use to ensure that
the treatment unit was operating properly. Such operational parameters would
include any preset or permanent settings or parameters that would affect the
function of the unit.]
(8) Determining the sample number. The
applicant shall ensure that a sufficient number of samples are collected in
order to demonstrate compliance with the applicable performance standard as
specified in paragraph (B) of this rule by evaluating the following factors:
(a) The total treatment capacity.
(b) The throughput process, such as a batch
or continuous treatment process.
(c) The physical state of the processed
waste, such as loose or conglomerated.
(d) The categories of infectious waste as
defined in rule
3745-27-01 of the
Administrative Code that the technology is designed to treat.
[Comment: More processed waste samples should be collected from
larger test loads to ensure that samples are representative. As a general
guideline, Ohio EPA would recommend that at least nine samples be collected.
The nine collected samples may be used to make three composite samples.]
(9) Collection
of test samples. The applicant shall use a sufficient number of samples
collected from each test run as the waste exits the treatment unit or shall
collect all carriers as they exit the treatment unit to determine the number of
surviving microorganisms or spores in accordance with the following:
(a) Neutralize, if applicable, all controls
and samples immediately upon exiting the treatment unit using a documented or
prior tested neutralizer that will not affect the viable number of
microorganisms being tested.
(b)
Cool all samples and controls to room/ambient temperature upon exiting the
treatment unit and prior to preparation of the dilutions.
[Comment: The use of a buffered diluent to place all samples
and controls into will satisfy the requirement of cooling and preparation of
the dilutions. This requirement need not be a two step process.]
(c) Prepare dilutions from each
collected sample or composite sample.
(10) Plating of test samples and calculation
of test results. The applicant shall ensure that samples are plated and the
results shall be calculated as follows:
(a)
The dilutions that are chosen for plating must be plated in triplicate.
(b) Utilize only those microbial
plates that contain between thirty and three hundred colonies or plaques for
the demonstration of the attainment of the performance standard as specified in
paragraph (B) of this rule.
(c) Do
not use any plate count if one of the three replicate plates has a quantitative
difference of greater than five per cent. That replicate plate shall not be
used and the calculation shall be formulated utilizing two replicate plates. If
all three of the plate counts have a quantitative difference of greater than
five per cent between them, the test run is considered invalid and another test
load for that particular microorganism or spore shall be prepared and processed
through the unit.
(d) Do not use
any dilution series from a test run if any one of the three test run plate
dilution series has a quantitative difference of greater than ten per cent with
either of the other two. The test run shall be considered invalid and another
test load for that particular series shall be prepared and processed through
the unit.
(11) Preparing
the microbial testing report. The microbial testing report shall be prepared by
the test manager responsible for conducting the microbial testing and shall
present the raw data and results gathered in accordance with the protocol, as
specified in paragraph (E) of this rule. The report shall contain, at a
minimum, the following information:
(a)
Testing parameters and results based upon a protocol which follows the
standards specified in paragraph (E) of this rule.
(b) Enough detailed information so that the
reported results and procedures could be reproduced by an independent
laboratory.
(c) An introduction
describing the intent of the testing. The introduction shall also contain the
name, address, and telephone number of the laboratory and the name of the test
manager.
(d) A separate section
describing all materials and methods used to perform the testing and subsequent
incubation of dilution of samples.
(e) A results section which contains, but is
not limited to, the following:
(i) All raw
data including all individual microbial counts.
(ii) Log reduction levels achieved for each
test microorganism or spore obtained from the microbial testing of the three
test loads that achieved the performance standard.
(iii) At least one example of each
calculation used to determine the log10 reduction levels through the
utilization of the formulas found in the appendix to this rule.
(f) A conclusion section
documenting the ability of the treatment technology to achieve the applicable
performance standard as specified in paragraph (B) of this rule.
(12) When, in the judgement of the
Ohio EPA, the protocol or testing method of a particular technology can not be
designed in accordance with this rule, the director may accept an alternate
protocol or testing method that does demonstrate achievement of the performance
standard for the treatment technology. The applicant shall demonstrate to the
director's satisfaction through the use of sound scientific microbial technique
and peer-reviewed journal reference or equivalent documentation that an
alternate is of equal or greater challenge.
[Comment: Ohio EPA anticipates requests for approval of
technologies that will not have enough residual material available for
microbial testing.]
(F) Approval criteria. The director shall not
approve an application for an alternative infectious waste treatment technology
unless the director determines all of the following:
(1) The use of the technology will be
protective of human health and the environment.
(2) The application conforms with the
applicable requirements of paragraphs (B), (C), (D) and (E) of this rule.
(3) The treatment technology is,
at a minimum, capable of attaining the following performance standards in
accordance with paragraph (B) of this rule:
(4) The testing performed as a part of the
application was performed on full-scale production units.
(5) For a site-specific approval, the
applicant shall produce published, scientific, peer reviewed literature which
indicates that results included in the application are repeatable and will be
able to attain the performance standard as specified in paragraph (B) of this
rule.
(6) In determining whether an
alternative technology will be capable of attaining the applicable performance
standard, the director may consider the actual performance history of a
technology that has been used or approved for use outside of Ohio.
(G) Contents of the director's
authorization. Those alternative infectious waste treatment technologies that
are approved by the director shall receive an authorization which at a minimum,
shall contain the following:
(1) A
description of the technology.
(2)
The parameters at which the technology shall be operated during the treatment
of infectious wastes.
(3) A
condition that the applicant include a copy of the approval letter in the front
of each operating manual distributed with the treatment units.
(4) The operational procedures to be followed
during the use of the alternative technology including any prohibitions of
specific categories of infectious wastes.
(5) A quality assurance testing program to
ensure that the treatment technology is achieving a minimum four log10
reduction in bacterial spores. When determining the frequency of biological
quality assurance testing, the director may consider the use of reliable
parametric monitoring that is available with that technology at the time of
approval.
(6) Quality assurance
record keeping requirements.
(7)
The measures the operator shall take to manage infectious wastes in the event
that the treatment technology fails to achieve the applicable performance
standard.
(8) For those
technologies that receive a site specific approval, a condition that infectious
wastes may not be treated using that treatment technology until the owner or
operator demonstrates through validation testing as specified in the director's
approval letter that the treatment unit is capable of achieving the performance
standard specified in paragraph (B) of this rule.
(9) Any other conditions or requirements that
the director deems appropriate in order to ensure that the approved alternative
technology will be capable of achieving the performance standard specified in
paragraph (B) of this rule and that the technology will be capable of being
operated in a manner that is protective of human health and the environment.
(10) The director's authorization
for the treatment technology shall reflect the types and volumes of waste
streams that the treatment technology has been tested against.
(H) The director may deny an
application for an alternative infectious waste treatment technology if, within
one hundred and eighty days of receipt of notification, the application is
incomplete or, the applicant has not corrected noted deficiencies and
resubmitted the application, or has not notified Ohio EPA that the application
is being withdrawn.
(I) Changes to
an authorized alternative treatment technology. Changes to an authorized
alternative treatment technology shall be submitted in writing to Ohio EPA for
the director's authorization and shall include the information required by this
rule.
(J) Revocation. The director
may revoke any approval of an alternative infectious waste treatment technology
when any of the following has occurred:
(1)
Any applicable laws have been or are likely to be violated.
(2) The application contained false or
incorrect information such that the application would not have been approved if
the correct information had been submitted.
(3) Under actual operation, the technology
consistently fails to attain the applicableperformance standard as specified in
paragraph (B) of this rule.
(4) The
use of the technology causes or threatens to cause harm to human health or the
environment.
APPENDIX
CALCULATING LOG REDUCTIONS FOR INFECTIOUS WASTE TREATMENT
TECHNOLOGIES
See Appendix at
http://www.registerofohio.state.oh.us/pdfs/3745/0/27/3745-27-38_PH_FF_A_APP2_20070625_1032.pdf