(A) The owner or
operator of an infectious waste treatment facility shall treat all infectious
wastes in accordance with an approved infectious waste treatment method.
Infectious waste treatment facilities are licensed infectious waste treatment
facilities and all large generators who treat infectious wastes on-site.
Treatment shall occur in accordance with all paragraphs in this rule applicable
to that particular treatment technology and paragraph (I) of this rule. The
following is a list of infectious waste treatment methods approved in the state
of Ohio:
(1) Incineration, as specified in
paragraphs (C) and (I) of this rule;
(2) Autoclaving, as specified in paragraphs
(D) and (I) of this rule;
(3)
Chemical treatment utilizing a sodium hypochlorite solution for cultures, as
specified in paragraphs (E) and (I) of this rule;
(4) Applied heat encapsulation for sharps, as
specified in paragraphs (F) and (I) of this rule;
(5) Chemical treatment utilizing peracetic
acid and grinding, as specified in paragraphs (G) and (I) of this rule;
and
(6) Alternative treatment
technologies approved by the director. The owner or operator of any infectious
waste treatment facility utilizing either a statewide or a site-specific
alternative infectious waste treatment technology approved by the director in
accordance with rule
3745-27-38 of the Administrative
Code shall comply with the director's approval letter for that treatment
technology and paragraph (I) of this rule.
[Comment: incineration, autoclaving
and chemical treatment using a sodium hypochlorite solution for cultures were
designated approved infectious waste treatment methods for statewide use
pursuant to section 3734.02 of the Revised Code. Applied heat encapsulation,
chemical treatment utilizing peracetic acid and grinding and microwaving have
already been approved by the director as accepted alternative infectious waste
treatment technologies. All other statewide or site-specific infectious waste
treatment technologies must first attain approval from the director, prior to
use.]
(C) Incineration. The owner
or operator of any infectious waste treatment facility utilizing incineration
as a treatment technology shall comply with the following:
(1) Methodology. The owner or operator shall
use methods, techniques, and practices for the treatment of infectious wastes
in accordance with the following:
(a) All
incineration shall occur in a multi-chamber incinerator which provides complete
combustion of the wastes, excluding metallic, glass, and ceramic
items;
(b) A minimum temperature of
one thousand two hundred degrees Fahrenheit in the primary chamber and a
minimum of one thousand six hundred degrees Fahrenheit with a minimum one
second residence time in the secondary chamber shall be maintained;
[Comment: Additional temperature, residence time, and
compliance testing requirements may be necessary to achieve appropriate air
emission standards in accordance with Chapter 3704. of the Revised
Code.]
(c) Each incinerator
shall be equipped with a mechanical process(es) to prevent the charging of
infectious wastes into the incinerator until the minimum temperatures required
in paragraph (C)(1)(b) of this rule are achieved;
(d) Incinerators shall have automatic
auxiliary burners that are capable, excluding the heat content of the wastes,
of independently maintaining the secondary chamber temperature at the minimum
of one thousand six hundred degrees Fahrenheit;
(e) Incinerators shall not be charged beyond
either:
(i) The maximum hourly waste
capacity. For the purposes of this rule, the maximum hourly waste capacity is
the same as the hourly capacity as stated in the permit to operate issued by
the Ohio EPA, division of air pollution
control; or
(ii) The design
capacity as determined by the manufacturer, if no permit to operate is issued
by the Ohio EPA, division of air pollution
control.
(f) Wastes not
combusted to ash, except for metallic, glass, and ceramic items, shall be
handled and treated as infectious wastes and may be reincinerated.
(2) Specific operational criteria.
The owner or operator shall design, construct, and operate the equipment for
the treatment of infectious wastes in accordance with the following:
(a) Store all ash from the incinerator in a
leakproof, closed container. The ash shall be free of liquids before
disposal;
(b) Any ash spilled
outside of the treatment unit shall be managed as treated infectious wastes
unless the owner or operator has reason to manage such wastes as hazardous
waste;
(c) The owner or operator
shall:
(i) Characterize the ash resulting
from the treatment of infectious wastes as either a solid waste or a hazardous
waste by:
(a) Separately testing fly ash and
bottom ash for metals, and;
(b)
Obtaining representative samples of bottom and fly ash utilizing the "simple
random sampling method" described in the "U.S. EPA Test Methods for Evaluating
Solid Waste, third edition (SW846),"
Chapter
chapter nine.
The samples shall be collected and tested quarterly, or more frequently as
required by
the Ohio EPA, for the toxicity
characteristic leaching procedure (TCLP) for metals utilizing an independent
analytical laboratory using the methodology specified in the "hazardous waste
rules" as defined in paragraph (A) of 3745-50-10 of the Administrative
Code.
(ii) Manage the
ash in accordance with the applicable solid waste or hazardous waste
requirements in Chapter 3734. of the Revised Code and the rules adopted
thereunder.
[Comment: Pursuant to paragraph (I) of this rule,
the owner or operator of an incinerator
owner or operator must maintain for a three
year period the dated permanent recordings of primary and secondary chamber
temperatures, documentation of calibration or replacement of the temperature
measuring or recording devices, results of Bacillus species spore testing, if
so required, and the results of fly and bottom ash testing.]
(3) Quality assurance.
The owner or operator of the infectious waste treatment technology shall use
the following quality assurance testing requirements to demonstrate that the
treatment unit is capable of attaining the performance standard as specified in
this rule for the treatment of infectious wastes:
(a) Produce and maintain a permanent record
of primary and secondary chamber temperatures utilizing continuous temperature
recorders. Chamber temperatures shall also be displayed for visual monitoring.
In the event of a temperature recorder failure the owner or operator shall:
(i) Manually record the chamber
temperature(s). The chamber temperature(s) shall be manually recorded
immediately after each charge of infectious waste and, at a maximum, once every
ten minutes thereafter until the burn down cycle is initiated. Manual recording
of the temperature(s) shall continue until repair of the recording device. The
operator shall demonstrate proof that repair parts have been ordered if
requested by
the Ohio EPA or approved
health department; and
[Comment: Temperature recordings taken after a charge of
infectious waste that occurred sooner than ten minutes from the previous charge
of infectious waste fulfills the maximum ten minute temperature recording
requirement.]
(ii)
Discontinue use of the incinerator, until repaired, for the treatment of
infectious wastes if failure has occurred in the temperature measuring device,
such as a thermocouple or thermocouple wiring.
(b) Utilize an independent company to
calibrate/repair
calibrate, repair or replace primary and secondary
chamber temperature recording devices
and/or
or temperature
measuring devices in accordance with the following:
(i) The manufacturer's maintenance schedule,
specifications, or recommendations; or
(ii) A calibration schedule as determined by
the facility, with, at a minimum, annual calibrations, if the manufacturer's
specifications are not available.
(c) Sample, upon written notification by
the Ohio EPA, stack gas and the resulting
bottom ash after the addition of Bacillus species spores to a load of
infectious waste. Sampling shall be accomplished in accordance with the
protocol provided by the Ohio
EPA.
(4) Comply with
paragraph (I) of this rule.
(D) Autoclaving. The owner or operator of any
infectious waste treatment facility utilizing autoclaving as a treatment
technology shall comply with the following:
(1) Methodology. The owner or operator shall
use methods, techniques, and practices for the treatment of infectious wastes
in accordance with the following:
(a) All
autoclaves shall operate at a minimum temperature of one hundred twenty-one
degrees Centigrade or two hundred fifty degrees Fahrenheit at a minimum of
fifteen pounds per square inch gauge pressure for a minimum of sixty minutes
during a treatment cycle; or
(b)
The owner or operator of an autoclave who uses combinations during the
treatment cycle, other than the minimum time, temperature, and pressure
requirements, as specified in paragraph (D)(1)(a) of this rule, to treat
infectious wastes may do so provided that achievement of the performance
standard is demonstrated by validation testing, as outlined in paragraph (D)(4)
of this rule, prior to use for the treatment of infectious wastes; and
[Comment: Although autoclaving has been approved for statewide
use pursuant to section
3734.021 of the Revised Code,
the capability of autoclave units to treat infectious wastes is variable. The
variability is due to a number of factors such as: type of wastes treated; the
size and density of the waste load; the packaging of the waste; gravity versus
vacuum displacement of the air in the chamber; and steam quality. Hence, this
rule provides for a process by which autoclaves that are capable of treating
infectious wastes at operating parameters below the specified minimum
parameters may be approved for use at the lower operating parameters.]
(c) For the purposes of this rule,
the treatment cycle is that combination of time, temperature, and pressure
needed to achieve the performance standard of a four log (base ten) reduction
in Bacillus stearothermophilus spores. The treatment cycle does not include the
time needed to bring the chamber up to the operating
temperature/pressure
temperature or pressure nor the time it takes for the
autoclave to exhaust and allow opening of the chamber; and
(d) The total treatable volume of infectious
wastes used in either the validation or quality assurance testing shall be the
total volume of wastes that can be treated per treatment cycle. The total
treatable volume of infectious wastes may be calculated by using any one of the
following:
(i) The manufacturer's
specification for the total volume of the autoclave; or
(ii) A lesser estimate based upon the
manufacturer's specification of the total volume of the autoclave; or
(iii) An actual calculation of the total
treatable volume at each validation or quality assurance test. The total
treatable volume shall be calculated by listing the number of bags, boxes,
and/or
or
sharps containers of infectious wastes used during the testing, and
adding the volumes of those containers.
[Comment: an example to actually calculate the total treatable
volume. The autoclave test load consisted of three bags, four boxes, and six
sharps containers. The volume of each container is: bag = 3 cubic feet, box =
2.5 cubic feet, sharps container = 0.21 cubic feet. Therefore, the total
treatable volume of wastes in the quality assurance test load and hence, the
maximum amount of wastes that can be treated at any one time is [((3)(3))+((4)(
2.5))+((6)( 0.21))] = 20.26 cubic feet.]
(e) Autoclaves shall not be loaded beyond the
total treatable volume of infectious wastes, as defined in paragraph (D)(1)(d)
of this rule; and
(f) Autoclaves
shall not treat pathological wastes, including without limitation, human and
animal tissues, organs, and body parts, that are contaminated with or are
likely to be contaminated with infectious agents, removed or obtained during
surgery or autopsy or for diagnostic evaluation and gross anatomical wastes
such as human or animal limbs and sections containing bone, and animal
carcasses, except small sections of tissue that are only several cells wide
used for microscopic evaluation, utilizing autoclaving unless the owner or
operator:
(i) Submits a protocol to
the Ohio EPA for approval prior to
validation testing to demonstrate that the autoclave unit can effectively
achieve the performance standard of a minimum four
log
10
log
(base ten)
reduction of a challenge population of Bacillus stearothermophilus
spores;
(ii) Demonstrates, through
the use of a protocol acceptable to
the
Ohio EPA, that the autoclave unit can effectively achieve the performance
standard of a minimum four
log10
log (base ten) reduction of a challenge population of
Bacillus stearothermophilus spores within such wastes; and
(iii) Receives approval from
the Ohio EPA to operate the unit to treat
pathological wastes.
(2) Specific operational criteria. The owner
or operator shall design, construct, and operate the equipment for the
treatment of infectious wastes in accordance with the following:
(a) Produce and maintain a permanent record
of the chamber temperature utilizing a temperature recording device permanently
connected to the unit. The device shall permanently record a data point at a
maximum of every two minutes. The temperature shall be displayed for visual
monitoring. In the event of a temperature recording device failure, the owner
or operator shall:
(i) Manually record the
chamber temperature, at a maximum, once every ten minutes until the exhaust
cycle is initiated. The temperature shall be manually recorded for no longer
than the time necessary to repair the mechanical failure. The operator shall
demonstrate proof that repair parts have been ordered if requested by
the Ohio EPA or approved health department;
and
(ii) Discontinue use of the
autoclave for the treatment of infectious wastes until repaired if failure or
malfunction occurs in the temperature measuring device, such as a thermocouple
or thermocouple wiring.
(b) Demonstrate the achievement of the
performance standard by the treatment unit for the treatment of infectious
wastes. The owner or operator shall perform this by checking the daily
operation of the pressure and temperature monitoring devices in the following
manner:
(i) Record into the daily log, as
required in paragraph (I) of this rule, the actual gauge readings of
temperature and pressure and not the manual settings of the treatment unit,
during the treatment cycle of a load of infectious wastes; and
(ii) Use the
pressure/steam
gauge
pressure versus temperature
of saturated
steam table in the appendix
of
to this rule to confirm that the temperature or
pressure readings obtained from the gauges are within either +2 degrees or +2
pounds per square inch (psi) from either the temperature or pressure readings
in the referenced table. If the temperature or pressure monitoring devices are
not within +2 degrees or +2 pounds per square inch (psi) in accordance with the
pressure/steam
gauge
pressure versus temperature
of saturated
steam table located in the appendix
of
to this rule, then
the owner or operator shall select one of the following options. The owner or
operator may continue use of the autoclave until such time that the autoclave
is repaired or calibrated in accordance with paragraph (D)(2)(c) of this rule:
(a) Discontinue use of the autoclave for the
treatment of infectious wastes; or
(b) Perform weekly (every seventh day that
the autoclave is used for treatment) quality assurance testing in accordance
with paragraph (D)(3) of this rule. If the weekly quality assurance testing
fails, discontinue use of the autoclave for the treatment of infectious wastes
until the autoclave is able to operate in accordance with the
pressure/steam
gauge
pressure versus temperature
of saturated
steam table located in the appendix
of
to this rule.
Infectious wastes placed within the unit during and after the failed spore
testing shall not be considered treated and shall be handled as infectious
wastes.
[Comment: Any autoclave that does not operate within the
pressure/steam
gauge
pressure versus temperature of saturated
steam table parameters located in the appendix of
to this rule and
fails the weekly quality assurance testing is to be calibrated. See paragraph
(D)(2)(b) of this rule.]
(c) Utilize an independent company to
calibrate/repair
calibrate or repair the autoclave chamber pressure
gauge, temperature recording device, or temperature measuring device in
accordance with the following:
(i) The
manufacturer's maintenance schedule, specifications, or recommendations;
or
(ii) A calibration schedule as
determined by the facility, with, at a minimum, annually, if the manufacturer's
specifications are not available.
[Comment: A direct relationship exists between the pressure and
temperature of saturated steam. If either the temperature recording or pressure
device begins to give false readings, then the autoclave owner or operator will
be able to note this since the published known values will no longer match the
observed values. However, the owner or operator will not know if the pressure
or temperature value is incorrect and may have to have both instruments
evaluated by an independent company.]
(3) Quality assurance.
The owner or operator shall perform quality assurance testing to demonstrate
the capability of the autoclave to achieve the performance standard of a
minimum four
log
10
log (base ten)
reduction of Bacillus stearothermophilus spores. The quality assurance testing
for autoclaves shall be performed monthly, in accordance with the following
provisions:
(a) Perform monthly quality
assurance testing every calendar month in which the autoclave is used for the
treatment of infectious wastes to ensure the capability of the autoclave to
achieve the performance standard of a minimum four
log
10
log (base ten) reduction of Bacillus
stearothermophilus spores;
(b) Use
a challenge population of spores as either spore strips with a population of at
least 1.0 x 10
4 Bacillus stearothermophilus spores,
ampules containing at least 1.0 x 10
4 Bacillus
stearothermophilus spores per milliliter or a commercially available steam pack
which contains a population of at least 1.0 x 10
4
Bacillus stearothermophilus spores. The owner or operator shall ensure that the
Bacillus stearothermophilus spore testing methodology does not result in the
denaturation of the proteins within the inoculating media;
[Comment: For quality assurance testing,
the Ohio EPA has set the performance
standard for the treatment of infectious wastes by autoclaving to be a four
log
10
log (base ten) reduction of Bacillus
stearothermophilus spores. The quality assurance is designed to be a
qualitative (growth/no
growth or no growth) system. If the owner or operator
uses strips or ampules with a greater spore population, then the treatment unit
must still achieve a complete kill of all spores.]
(c) Compose the waste load of containers of
both infectious wastes and non-infectious wastes. The majority of the waste
load may consist of infectious wastes. However, at least three test containers
shall consist of material such as newspaper, plastic backed absorbent pads, or
general refuse placed into either boxes, bags, or sharps containers
representative of normal or anticipated use for that autoclave unit. A spore
strip or ampule shall be placed in the center of each test container. In the
event that the autoclave will not hold three containers of wastes, then each
test container shall contain a spore strip or ampule. Alternatively,
commercially available steam packs may be placed into the three representative
containers instead of the newspaper, plastic backed absorbent pads, or general
refuse;
(d) Treat the waste load
containing the challenge population of spores in the same manner as the daily
operation of the autoclave for the treatment of infectious wastes. This would
include the same temperature, pressure, time, and total treatable volume. The
quality assurance testing shall be performed at the same combinations of
temperature, pressure, and time, as the validation testing;
(e) Record the following information during
the monthly quality assurance testing:
(i) The
date;
(ii) The time the treatment
cycle started, as specified in paragraph (D)(1) of this rule;
(iii) The time the treatment cycle ended, as
specified in paragraph (D)(1) of this rule;
(iv) The chart or graph of the chamber
temperature produced by the permanently connected temperature recording
device;
(v) The name of the person
who loaded the autoclave and the name of the person performing laboratory
analysis of the challenge population of spores;
(vi) A diagram depicting the pattern of
infectious waste loading and location of the challenge population of spores
during the testing except those units which have rotating treatment chambers
are not required to diagram the pattern of waste loading;
(vii) The total treatable volume of
infectious wastes used during the quality assurance testing as defined in
paragraph (D)(1) of this rule;
(viii) The autoclave chamber pressure, as
displayed by the permanently connected gauge, during the treatment cycle as
specified in paragraph (D)(1) of this rule;
(ix) The incubation temperature and time (in
days) of the challenge population of spores, in accordance with the
manufacturer's recommendation for optimal growth; and
(x) The results of spore growth during
incubation for a period of seven days or for the maximum period of time as
specified by the manufacturer of the spore test. The results of spore growth
shall be recorded as indicated by the development of turbidity in the growth
media. The development of turbidity in the growth media is indicative of growth
of the challenge population of spores present unless other morphological or
metabolic testing indicates that the growth is due to a contaminating
microorganism.
(f)
Remove and incubate the challenge population of spores used in the quality
assurance testing for either seven days or for the maximum period of time as
specified by the manufacturer of the spore test. If any of the challenge
population of spores used to perform the testing are positive for growth at any
time during the incubation period, the unit has failed to achieve the
performance standard required for treatment. Infectious wastes placed within
the unit during and after the spore testing shall not be considered treated and
shall be handled as infectious wastes. The autoclave unit shall not be used for
further treatment of infectious wastes until the problem has been determined
and rectified and another successful quality assurance test performed. The
rectification may require the operator to increase the minimum temperature
and/or
or
pressure requirements or cycle time; and
(g) Perform the quality assurance testing,
upon request by, and in the presence of,
the Ohio EPA or approved health department to
verify that the written operating procedures as located in the facility
management plan are sufficient to meet the performance standard of a four
log
10
log (base ten) reduction in Bacillus
stearothermophilus spores. If so directed, the owner or operator shall use
twice as many spore tests in the same location in the autoclave and permit
the Ohio EPA or approved health department
to remove and separately incubate one-half of the spore tests.
[Comment: autoclave owners or operators treating infectious
wastes in accordance with the specifications in this rule must maintain, for a
three year period, the dated permanent recordings of autoclave chamber
temperatures, documentation of the calibrations of the temperature measuring
devices performed by an independent company, documentation of the monthly
checks on the measuring device, and the results of the monthly quality
assurance testing using a challenge population of spores.]
(4) Validation testing. The owner
or operator shall perform validation testing to demonstrate the capability of
the autoclave to achieve the performance standard of a minimum four
log10
log (base ten) reduction of Bacillus
stearothermophilus spores. The validation testing for autoclaves shall be
performed in accordance with the following provisions:
[Comment: Validation testing is performed prior to use for
treatment by an operator who wishes to use an alternative combination to the
time, temperature, and pressure requirements specified in paragraph (D)(1)(a)
of this rule. Validation testing is a check to ensure that the alternate
combination will result in the achievement of the performance standard for
treatment. Quality assurance testing is an on-going monitor, performed monthly,
of the autoclave's continuing ability to attain the performance standard for
treatment.]
(a) Perform validation
testing to ensure that the autoclave, using combinations of temperature,
pressure, and time other than the minimums specified in paragraph (D)(1)(a) of
this rule, is capable of achieving the performance standard of a minimum four
log10
log (base ten) reduction of Bacillus
stearothermophilus spores;
(b) Use
a challenge population of spores as either spore strips with a population of at
least 1.0 x 10
4 Bacillus stearothermophilus spores,
ampules containing at least 1.0 x 10
4 Bacillus
stearothermophilus spores per milliliter or a commercially available steam pack
which contains a population of at least 1.0 x 10
4
Bacillus stearothermophillus spores. The owner or operator shall ensure that
the Bacillus stearothermophilus spore testing methodology does not result in
the denaturation of the proteins within the inoculating media;
[Comment: For validation testing, the Ohio EPA has set the performance standard for
the treatment of infectious wastes by autoclaving to be a four
log10
log (base ten) reduction of Bacillus
stearothermophilus spores. The validation testing is designed to be a
qualitative (growth/no
growth or no growth) system. If the owner or operator
uses strips or ampules with a greater spore population, then the treatment unit
must still achieve a complete kill of all spores.]
(c) Compose the validation testing waste load
of containers of non-infectious wastes. The waste load for testing shall
consist of materials other than infectious wastes, such as newspaper, plastic
backed absorbent pads, or general refuse placed into boxes, bags, or sharps
containers which are representative of the normal or anticipated use for that
autoclave unit. A challenge population of spores shall be placed in the center
of each test container;
(d) Treat
the waste load containing the challenge population of spores in the same manner
as the autoclave will be used during daily operations for the treatment of
infectious wastes. This would include the same temperature, pressure, time, and
total treatable volume;
(e) Record
the following information during the validation testing:
(i) A written statement indicating the
autoclave pressure, temperature, and treatment cycle time that the facility
owner or operator is attempting to validate for the treatment of infectious
wastes;
(ii) The date;
(iii) The time the treatment cycle started,
as specified in paragraph (D)(1) of this rule;
(iv) The time the treatment cycle ended, as
specified in paragraph (D)(1) of this rule;
(v) The chart or graph of the chamber
temperature produced by the permanently connected temperature recording
device;
(vi) The name of the person
who loaded the autoclave and the name of the person performing laboratory
analysis of the challenge population of spores;
(vii) A diagram depicting the pattern of
infectious waste loading and location of the challenge population of spores
during the validation testing. Those units which have rotating treatment
chambers are not required to diagram the pattern of waste loading;
(viii) The total treatable volume of
infectious wastes used during the validation testing as defined in paragraph
(D)(1) of this rule. Once a total treatable volume of infectious wastes that an
autoclave has been validated to treat has been established, infectious waste
loads of lesser than the established total treatable volume may be treated
without further validation;
(ix)
The autoclave chamber pressure, as recorded by the permanently connected gauge,
during the treatment cycle as specified in paragraph (D)(1) of this
rule;
(x) The challenge population
of spores shall be incubated in accordance with the manufacturer's
recommendation for optimal growth; and
(xi) The results of spore growth during
incubation shall be recorded daily, for a period of seven days or for the
maximum period of time as specified by the manufacturer of the spore test. The
results of spore growth shall be recorded as indicated by the development of
turbidity in the growth media. The development of turbidity in the growth media
is indicative of growth of the challenge population of spores unless other
morphological or metabolic testing indicates that the growth is due to a
contaminating microorganism.
(f) Remove and incubate the challenge
population of spores used in the validation testing for either seven days or
for the maximum period of time as specified by the manufacturer of the spore
test. If any of the challenge population of spores used to perform the testing
are positive for growth at any time during the incubation period, the unit has
failed to achieve the performance standard required for treatment of infectious
wastes. In order to utilize the autoclave for the treatment of infectious
wastes using combinations of temperature, pressure and time other than the
minimums specified in paragraph (D)(1) of this rule, the operator shall either:
(i) Change the treatment cycle temperature,
pressure,
and/or
or time requirements and again perform the validation
testing until the performance standard is achieved. Rectification may require
the operator to increase the minimum treatment cycle temperature, pressure
and/or
or time
requirements; or
(ii) Operate the
autoclave at the minimum operation parameters of one hundred twenty-one degrees
Centigrade or two hundred fifty degrees Fahrenheit, fifteen pounds per square
inch gauge pressure for sixty minutes.
(g) Perform validation testing, upon request
by, and in the presence of,
the Ohio EPA or
approved health department to verify that the written operating procedures as
located in the facility management plan are sufficient to meet the performance
standard of a four
log10
log (base ten) reduction in Bacillus
stearothermophilus spores. If so directed, the owner or operator shall use
twice as many spore tests in the same location in the autoclave and permit
the Ohio EPA or approved health department
to remove and separately incubate one-half of the spore tests.
[Comment: Autoclave owners or operators treating infectious
wastes in accordance with the specifications in this rule must maintain, for a
three year period, the dated permanent recordings of autoclave chamber
temperatures, documentation of the calibrations of the temperature measuring
devices performed by an independent company, documentation of the monthly
checks on the measuring device, and the results of the validation testing using
a challenge population of spores.]
(5) Comply with paragraph (I) of this
rule.
(F) Applied heat
encapsulation for sharps. The owner or operator of any infectious waste
treatment facility utilizing applied heat encapsulation for sharps shall comply
with the following:
(1) Methodology. The owner
or operator shall use methods, techniques, and practices for the treatment of
infectious wastes in accordance with the following:
(a) Process only waste loads of sharps that
consist of at least seventy per cent by weight of plastic material;
(b) Process only waste loads of sharps in a
heating chamber within the treatment unit for a minimum treatment time of
thirty minutes at a minimum temperature of three hundred thirty degrees
Fahrenheit;
(c) Process sharps that
are not totally encapsulated within a solid plastic mass as sharp infectious
wastes;
(d) Treat only sharps as
defined in rule
3745-27-01 of the Administrative
Code and as specified in division (A)(1)(a) of section
3734.021 of the Revised Code. No
other infectious wastes shall be treated using this treatment technology;
and
(e) Treat only sharps that
contain no more than "residual liquid". "Residual liquid", for the purposes of
this rule, is defined as that liquid which remains in the
wastes
waste
item after being emptied or in the case of a syringe after the plunger has been
fully depressed.
(2)
Specific operational criteria. The owner or operator shall design, construct,
and operate the equipment for the treatment of infectious wastes in accordance
with the following:
(a) Maintain the
following documentation for a period of three years for each treatment unit:
(i) A quality assurance log as specified in
this rule;
(ii) A daily operating
log which permanently maintains a record of the following:
(a) The date of each treatment
cycle;
(b) The time of day each
treatment cycle was started and ended; and
(c) The name of the person operating the
treatment unit for each treatment cycle.
(b) If the treatment of sharps is interrupted
as a result of a malfunction of the treatment unit due to such occurrences as
jamming, overloading, electrical, or mechanical reasons, all sharps contained
within the unit shall be managed as infectious wastes. Infectious wastes may be
maintained within the unit until the problem is corrected unless the wastes
become putrescent or become a food source or breeding place for insects or
rodents; and
(c) Treat only sharps
that are not contaminated with chemicals that volatilize or are contaminated
with antineoplastic agents.
(3) Quality assurance. The owner or operator
shall perform quality assurance testing to demonstrate the capability of the
applied heat encapsulation system to achieve the performance standard of a
minimum four
log10
log (base ten) reduction of Bacillus subtilis
spores. The owner or operator of the applied heat encapsulation system shall
perform quality assurance testing in accordance with the following provisions:
(a) Perform quality assurance testing
semi-annually or after every fifty cycles whichever comes first to ensure that
the applied heat encapsulation system is capable of achieving the performance
standard of a minimum four
log10
log (base ten) reduction of Bacillus subtilis
spores;
(b) Prepare a challenge
population of spores using a spore strip, still within the glassine envelope,
containing at least a minimum population of 1.0 x
10
4 Bacillus subtilis spores by:
(i) Wrapping the spore strip in aluminum foil
and placing it at the bottom of the heating chamber, prior to adding sharps and
initiation of the treatment cycle, so that the folded seams are placed on the
outside of the resulting solid mass; or
(ii) Placing the aluminum foil wrapped spore
strip directly into the heating chamber without the addition of any waste, for
technologies that utilize a system where the foil wrapped strip would become
part of the encapsulated material.
[Comment: For quality assurance testing,
the Ohio EPA has set the performance
standard for the treatment of infectious wastes to be a four
log10
log (base ten) reduction of Bacillus subtilis
spores. The quality assurance is designed to be a qualitative (growth/no
growth or no
growth) system. If the treatment unit owner or operator uses strips with a
greater spore population, then the treatment unit must still achieve a complete
kill of all spores.]
(c) Compose the waste load of sharp
infectious wastes;
(d) Treat the
sharp waste load containing the challenge population of spores in the same
manner as the daily operation of the applied heat encapsulation system for the
treatment of sharps as specified in paragraph (F) of this rule;
(e) Aseptically remove the spore strip from
the wrapped foil and glassine envelope, upon completion of the treatment
cycle;
(f) Incubate the challenge
population of spores used in the quality assurance testing for either seven
days or for the maximum period of time as specified by the manufacturer of the
spore strip. If any of the challenge population of spores used to perform the
testing are positive for growth at any time during the incubation period, the
unit has failed to achieve the performance standard required for treatment.
Infectious wastes placed within the unit during and after the spore testing
shall not be considered treated and shall be handled as infectious wastes. The
applied heat encapsulation system shall not be used for further treatment of
infectious wastes until the problem has been determined and rectified and
another successful quality assurance test performed;
(g) Maintain a quality assurance log that
provides a written record of the results of the quality assurance testing
performed. Record the following information during the quality assurance
testing:
(i) The date;
(ii) The time the treatment cycle started, as
specified in paragraph (F) of this rule;
(iii) The time the treatment cycle ended, as
specified in paragraph (F) of this rule;
(iv) The heating chamber
temperature;
(v) The name of the
person who loaded the heating chamber and the name of the person performing
laboratory analysis of the challenge population of spores;
(vi) The challenge population of spores shall
be incubated in accordance with the manufacturer's recommendation for optimal
growth; and
(vii) The results of
spore growth during incubation for a period of seven days or for the maximum
period of time as specified by the manufacturer of the spore test. The results
of spore growth shall be recorded as indicated by the development of turbidity
in the growth media. The development of turbidity in the growth media is
indicative of growth of the challenge population of spores present unless other
morphological or metabolic testing indicates that the growth is due to a
contaminating microorganism.
(h) Perform the quality assurance testing,
upon request by, and in the presence of,
the Ohio EPA or approved health department to
verify that the written operating procedures as located in the facility
management plan are sufficient to meet the performance standard of a four
log10
log (base ten) reduction in Bacillus subtilis
spores. If so directed, the owner or operator shall use twice as many spore
strips in the same location in the heating chamber and permit
the Ohio EPA or approved health department
to remove and separately incubate one-half of the spore strips.
(4) Comply with paragraph (I) of
this rule.
(G) Chemical
treatment with peracetic acid and grinding. The owner or operator of any
infectious waste treatment facility utilizing chemical treatment with peracetic
acid and grinding shall comply with the following:
(1) Methodology. The owner or operator shall
use methods, techniques, and practices for the treatment of infectious wastes
in accordance with the following:
(a) Process
each waste load using the appropriate concentration of peracetic acid, as
specified in paragraph
(G)(1)(g)
(G)(1)(f) of this rule;
(b) Operate all treatment units at a minimum
of ten minutes per treatment cycle using the following parameters: the grinding
cycle shall operate for a minimum of three minutes at the beginning of the
treatment cycle. The chemical soak portion of the treatment cycle shall operate
for a minimum of seven minutes;
(c)
Mark the canister to indicate the volume of blood present. The person(s)
filling the canister with infectious wastes shall mark the canister to indicate
that the canister contains less than
100
one hundred
milliliters of blood or that the canister contains at least
100
one
hundred milliliters but less than
1000
one thousand
milliliters of blood. The generator shall also separately indicate the
approximate volume of blood contained within the canister on the daily
operating log as prescribed by
the Ohio
EPA;
(d) Not process waste loads
containing volumes of blood greater than
1000
one thousand
milliliters or
1
one liter;
(e) Not process wastes contaminated with
non-incidental quantities of chemicals, body parts containing bone, organs,
whole carcasses, quantities of gauze or rubber or latex that may become
entangled around the rotors or blades, or heavy metal items;
(f) Package all sharps not
sufficiently ground to minimize the puncture or laceration potential in the
same manner as sharp infectious wastes;
(g)
(f)
Use a minimum of 17.1 milliliters of
35%
thirty-five per
cent peracetic acid when the infectious waste load contains less than or
equal to
100
one
hundred milliliters of blood. Use a minimum of 79.8 milliliters of
35%
thirty-five per
cent peracetic acid when the infectious waste load contains greater than
100
one
hundred milliliters but less than or equal to
1000
one thousand
milliliters (
1
one liter) of blood;
(h)
(g)
Examine the specifically designed indicator disk
upon completion of the treatment cycle and before the waste is dewatered and
bagged. The entire indicator on the disk shall have a visible color change as
an indication that peracetic acid was used during the process; and
(i)
(h)
If there is not a complete color change, then
the wastes are not considered treated and shall be treated again with either a
new charge of the appropriate concentration of peracetic acid and a new
indicator disk or using another approved treatment method in accordance with
this rule.
(2) Specific
operational criteria. The owner or operator shall design, construct, and
operate the equipment for the treatment of infectious wastes in accordance with
the following:
(a) Use rotating blades
contained within the specialized canister to grind the infectious
wastes;
(b) Operate all treatment
units using a specially designed canister that sets down inside the machine
cabinetry and contains internal grinding blades;
(c) Record the peracetic acid dosage used for
each treatment cycle in a daily operating log. The unit operator shall complete
the operating log as prescribed by the Ohio
EPA;
(d) Keep the cap on the
canister when the canister is in use as an infectious waste receptacle. The cap
shall not be removed prior to arrival at the treatment area. The collection cap
is to be removed before treatment;
(e) Disinfect the canister cap after each use
using any one of the following disinfectants:
(i) An U.S. EPA registered hospital
disinfectant that is also tuberculocidal, for a contact time as specified by
the manufacturer; or
(ii) A
unexpired dated stabilized bleach product that is an U.S. EPA registered
hospital disinfectant that is also tuberculocidal, for a contact time as
specified by the manufacturer; or
(iii) A minimum ten per cent sodium
hypochlorite solution prepared immediately prior to use with a minimum of
thirty minutes of contact time.
(f) If treatment occurs outside the
parameters as outlined in this rule, as a result of a malfunction of the unit
due to such occurrences as jamming, overloading, electrical, or mechanical
reasons, all wastes contained within the unit shall be managed as infectious
wastes. Infectious wastes may be temporarily maintained within the unit unless
the wastes becomes putrescent or becomes a food source or breeding ground for
insects or rodents.
(3)
Quality assurance. The owner or operator shall perform quality assurance
testing to demonstrate the capability of the chemical treatment with peracetic
acid and grinding unit to achieve the performance standard of a minimum
3745-27-32 22 four log
10 reduction of Bacillus subtilis
spores. The quality assurance testing for the chemical treatment with peracetic
acid and grinding unit for the treatment of infectious wastes is specified as
follows:
(a) Produce and maintain for a
period of three years a permanent record of the daily operational and
maintenance activities for the infectious waste treatment technology in the
facility management plan as follows:
(i)
Utilize a daily operating log form, as prescribed by the Ohio EPA for each unit for each day that
infectious wastes are treated in the unit. All daily operating logs for a
treatment unit shall be grouped together and arranged by date within the
grouping; and
(ii) Conduct
preventative maintenance checks and services as stated in the operating
manual.
(b) Repair the
treatment unit in the event of a malfunction of the chemical treatment using
peracetic acid and grinding. The unit shall not be used for the treatment of
infectious wastes until repaired; and
(c) Perform quality assurance testing, upon
request of
the Ohio EPA, for each unit.
This testing shall demonstrate the unit's capability to achieve a minimum four
log10
log (base ten) reduction of Bacillus subtilis
spores.
(4) Comply with
paragraph (I) of this rule; and
(5)
Comply with requirements as specified in the director's approval letter issued
in accordance with rule
3745-27-38 of the Administrative
Code.
(I)
General facility requirements. All owners and operators of a infectious waste
treatment facility shall comply with the following:
(1) Retain all records for three years.
Retention periods are extended during the course of any unresolved litigation,
or when requested by the Ohio EPA. The
three-year period for records retention shall start from the date of recording,
sample, or measurement and is applicable to all records included in the
facility management plan;
(2)
Develop and maintain in one area on the premises of the infectious waste
treatment unit a facility management plan, excluding generators who utilize
chemical treatment of cultures or applied heat encapsulation for sharps, in
accordance with this rule:
[Comment: The facility management plan may be composed of
several volumes, binders, or computer disks.]
(a) The facility management plan shall
contain copies of the following information and documentation:
(i) Applicable environmental regulations
regarding infectious wastes, solid wastes, surface water, and air pollution
control;
(ii) Applicable infectious
wastes, solid wastes, surface water, and air authorizing documents (such as
licenses, registrations,
and/or
or permits) for the treatment facility;
(iii) Manufacturer's equipment
specifications, owner's manual for the treatment unit, and maintenance
schedule;
(iv) Monitor and
recording device calibration or replacement schedule;
(v) Maintenance and repair log for each
treatment unit;
(vi) Infectious wastes spill
containment and clean-up procedures;
(vii)
(vi)
Facility
contingency plan;
(viii)
(vii)
Results of
quality assurance and applicable validation testing requirements;
(ix)
(viii)
Procedures for
treatment unit start-up, loading, operating, shut down, and equipment
malfunction;
(x)
(ix)
Emergency
telephone numbers including, at a minimum: the facility emergency coordinator,
the fire department, any existing local emergency management office, the local
health department, the police department, and
the Ohio EPA district office;
(xi)
(x)
The permanently recorded daily logs as specified
in paragraph (I)(3) of this rule. A daily log shall be maintained for each
treatment unit for a period of three years;
(xii)
(xi)
All strip charts, graphs,
and/or
or
manually produced temperature records. Each chart, graph, or record shall be
dated and maintained for a period of three years;
(xiii)
(xii)
Disposal
and
treatment shipping papers for the infectious wastes
generated and/or treated; and
(xiv)
(xiii)
A training
certification statement, as required in paragraph (I)(3) of this rule, shall be
maintained for each employee who operates the infectious waste treatment unit
and/or
or
loads infectious wastes into the infectious wastes treatment unit. Each
training certification statement shall be maintained for the duration of such
employment.
[Comment: The training certificate statement is not required to
be maintained for an employee who no longer works for the organization or whose
job responsibilities no longer include and will not include operating or
loading the infectious waste treatment unit.]
(b) All of the current calendar year's
information is to be located in this same area such as an office or work area.
The two previous calendar year's information may be maintained in other
accessible areas or multiple rooms depending on the amount of available space
at the facility. A notation shall be made in the current year's facility
management plan regarding the location of any past calendar year's information;
and
(c) Documents and information
contained in paragraph (I)(2)(a) of this rule of the facility management plan
shall be accessible to employees during working hours.
[Comment: Nothing in this rule prohibits the facility
management plan or parts thereof from being copied and located in other areas
of the facility for the purpose of easy access for employees. However, there
shall be only one official facility management plan that shall be located in
one general area and accessible during working hours.]
(3) Provide training on the
contents of the facility management plan for each employee who will operate the
infectious waste treatment unit
and/or
or load the infectious waste treatment unit before
he
the
employee is responsible for operating or loading the infectious waste
treatment unit. A written certification statement attesting that the employee
received the specified training shall be signed and dated by each employee and
the owner or operator of the facility;
(4) Use a daily log of operation to record
charging of the infectious waste treatment unit. A printout produced by the
treatment unit may substitute for the daily log provided all the information
required is present on the printout. Unless already required to keep a charging
log in accordance with rule
3745-75-04 of the Administrative
Code, permanently record in a daily log of operation the following, as
applicable:
(a) The date;
(b) The time the first load or batch of
infectious wastes was charged into each treatment unit;
(c) The time the last load or batch of
infectious wastes were charged into each treatment unit for the day;
(d) Name(s) of the person(s) operating each
infectious waste treatment unit and the time of day the operator started the
unit;
(e) The time the treatment
unit was unloaded;
(f) Whether the
load was for validation, quality assurance or usual treatment; and
(g) The actual daily autoclave pressure and
temperature reading.
[Comment: A printout containing partial information may be used
when attached to a daily log containing the remaining required
information.]
(5) Provide, in the immediate area of the
infectious waste treatment unit and readily available to the personnel
operating the treatment unit, the operating and loading procedures for the
treatment unit;
(6) If the
treatment of infectious wastes occurs outside the treatment parameters
established in each methodology paragraph of this rule specific to the type of
treatment technology in use and as a result of a malfunction of the unit due to
such occurrences as jamming, overloading, electrical, or mechanical reasons,
then all wastes contained within the unit shall be managed as infectious
wastes. The infectious wastes may be maintained within the treatment unit until
the problem is corrected unless the wastes become putrescent or become a food
source or breeding place for insects or rodents;
(7) Conduct all construction and operations
at the facility in strict compliance with the applicable authorizing
document(s), including permit(s) to install issued under Chapter 3745-27 of the
Administrative Code, plan approval(s), and alteration(s) concurred with in
writing by Ohio EPA; the license issued under Chapter 3745-37 of the
Administrative Code; court orders; and findings and orders issued by the
director;
(8) Construct and
maintain all-weather access roads in such a manner as will withstand the
anticipated degree of use and allow passage of vehicles with minimum erosion
and dust generation;
(9) Construct
and maintain non-absorbent floors in all infectious waste handling areas. Such
areas shall not be overlaid with an absorbent covering;
[Comment: Nothing in this paragraph prohibits the overlaying of
the concrete or asphalt floors with a cleanable non-absorbent covering.]
(10) Conduct loading operations
into any treatment unit in such a manner as not to compact or puncture the
containers of infectious wastes;
(11) Do not charge infectious wastes into the
treatment unit during periods of precipitation unless the wastes to be loaded
and the waste loading operations are protected from the elements of
weather;
(12) Discharge into a
disposal system in accordance with Chapter 6111. of the Revised Code or absorb
and handle as infectious wastes, any wastewater resulting from a spill of
infectious wastes or the cleanup of a spill of infectious wastes from all
infectious waste handling areas. Such wastewater shall not be disposed into a
storm sewer;
(13) Construct and
maintain proper slopes and drainage to prevent the ponding of liquids in
infectious waste handling areas;
[Comment: Methods of drainage are not limited to systems
consisting of underground pipes.]
(14) Restrict infectious waste handling areas
to authorized personnel, utilizing signs or a locking mechanism;
(15) Shall not treat wastes for which such
treatment or disposal is prohibited by the Ohio department of health or the
U.S. nuclear regulatory commission;
(16) Shall not accept wastes for which such
storage, treatment or disposal is prohibited in the "hazardous wastes rules" as
defined in paragraph (A) of rule
3745-50-10 of the Administrative
Code;
[Comment: The "hazardous wastes rules" as defined in paragraph
(A) of rule
3745-50-10 of the Administrative
Code contain the regulations for the proper handling of hazardous wastes. For
technical information regarding the designation, handling, treatment, and
disposal of hazardous waste, please contact the division of hazardous waste
management at the appropriate Ohio EPA district office.]
(17) The owner or operator of a licensed
infectious waste treatment facility shall submit an annual report to
the Ohio EPA central office and the
approved health district no later than february first of each year. The annual
report shall consist, at a minimum, of the following:
(a) The name, address, telephone number, and
contact person for the facility;
(b) Hours of operation for the
facility;
(c) Monthly total of
infectious wastes treated at the facility for each state
and/or
or
country of origin; and
(d) Any
quality assurance results that do not demonstrate achievement of the
performance standard.
(18) The owner or operator of an
infectious waste treatment facility shall maintain spill containment and
clean-up kit(s). The location of the kit(s) shall be noted at the top of the
infectious wastes spill procedures. The kit shall consist of at least the
following items:
(a) Materials designed to absorb
spilled liquids;
(b) A U.S. EPA registered hospital
disinfectant that is also tuberculocidal, for a contact time as specified by
the manufacturer, an unexpired dated stabilized bleach product that is an U.S.
EPA registered hospital disinfectant that is also tuberculocidal, for a contact
time as specified by the manufacturer, or materials necessary to prepare a
minimum ten per cent sodium hypochlorite solution prepared immediately prior to
use with a minimum of thirty minutes of contact time with the
wastes;
[Comment: The specific solutions
stated in the rule are percent solutions of household bleach not percent
solutions of the active ingredient, sodium hypochlorite. Household bleach
depending upon brand is three to five per cent sodium hypochlorite by volume. A
1:10 dilution of household bleach (one part household bleach to nine parts of
water) contains a minimum ten cent volume/volume sodium hypochlorite solution
and will produce a solution with 3000-5000 parts per million of free available
chlorine. To make a ten per cent household bleach solution for disinfection,
add approximately 6.4 ounces of household bleach to 57.6 ounces of tap water.
This yields 1/2 gallon of solution.]
(c) Red or biohazard labeled bag(s)
as specified in paragraph (A) of rule 3745-27-34
oftheAdministrativeCode;
(d) Latex gloves, or equivalent type
of glove, and any other personal protective equipment necessary to implement
the spill containment and clean-up procedure; and
(e) A first aid kit, unless
emergency medical care is available on the premises, boundary tape, and other
appropriate safety equipment.
(19) The owner or operator of an
infectious waste treatment facility shall, at a minimum, implement the
following procedures subsequent to a spill of infectious wastes or its
discovery:
(a) Use appropriate protective
equipment during the spill clean-up operation;
(b) Limit access to the spill area
only to authorized personnel;
(c) Place broken containers and
spillage inside overpack bags in the kit, minimizing exposure;
(d) Use absorbent materials to
collect any liquids spilled in the area. After use, the absorbent materials
shall be considered infectious wastes;
(e) Clean the contaminated area,
after the spilled materials have been contained, liquids absorbed and solids
removed;
(f) Decontaminate, after cleaning
the area, the cleaned area by adequately applying a disinfectant specified in
this rule;
(g) Clean and disinfect
nondisposable items;
(h) Manage disposable items as
infectious wastes;
(i) Take necessary steps to
replenish containment and clean-up kit; and
(j) Call for emergency assistance,
as needed.
(20)
(18)
Infectious wastes that have been treated in
accordance with the provisions of this rule shall be handled in the same manner
as solid wastes. Such treated infectious wastes shall be disposed in a licensed
solid waste disposal facility, or a facility in another state operating in
compliance with state and federal regulations. Shipments of treated infectious
wastes shall be accompanied by disposal
shipping papers as required by rule
3745-27-33 of the Administrative
Code;
[Comment: Small generators of infectious wastes who treat the
infectious wastes that they generate are not required to comply with the
disposal shipping paper requirements of rule
3745-27-33 of the Administrative
Code.]
(21)
(19)
All "sharps" shall
be managed in a manner to eliminate the potential of those wastes to cause
lacerations or puncture wounds during handling
,
transportation, and disposal;
(22)
(20)
Perform quality assurance testing to demonstrate
the ability of the treatment unit to achieve the performance standard if the
unit has not been used for the treatment of infectious wastes for more than one
year;
(23)
(21)
Any large
generator who treats infectious wastes on-site and any infectious waste
treatment facility licensed to treat infectious wastes, who intends to
discontinue treating infectious wastes at any facility or premise, shall comply
with rules
3745-27-36 and
3745-27-39 of the Administrative
Code;
(24)
(22)
Apply for and
obtain an operating license from the board of health of the health district
where the facility will be located, or from the director if the director has
assumed the licensing function, unless the facility currently holds an
operating license; and
(25)
(23)
The following infectious waste treatment
facilities are exempt from the permitting and licensing requirements stated in
division (C) of section
3734.02 and division (B) of
section
3734.05 of the Revised Code:
(a) An infectious waste treatment facility
that is owned or operated by the generator of the wastes and exclusively treats
wastes that are produced by that generator at any premises owned or operated by
that generator, by methods established under this rule; and
(b) Hospitals as defined in section
3727.01 of the Revised Code,
that accept for treatment infectious wastes generated by any of the following:
(i) Generators who produce fewer than fifty
pounds of infectious wastes during any one month and who are not listed on a
registration certificate as a generator of infectious wastes and who have staff
privileges at that hospital; or
(ii) An emergency medical service
organization, as defined in section
4765.01 of the Revised Code,
regardless of whether the wastes were generated in providing care to the
patient at the scene of an emergency or during the transportation of the
patient to the hospital; or
