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Rule 3745-570-01 | Infectious waste - applicability.
(A) Except as otherwise provided in
paragraph (E) of this rule, this chapter is applicable to any person who does
any of the following: (1) Generates infectious
waste. (2) Stores infectious
waste. (3) Treats infectious
waste. (4) Establishes, owns, or
operates an infectious waste treatment facility. (5) Disposes of
infectious waste. (B) In addition to the multi-program rules made applicable
by reference in this chapter, the following multi-program rules apply to this
chapter: (1) Rule 3745-500-01 of
the Administrative Code, which pertains to the applicability of Chapter
3745-500 of the Administrative Code. (2) Rule 3745-500-35 of the
Administrative Code, which pertains to relationships among authorizing
documents, rules, and the authority of the director and board of
health. (3) Rule 3745-500-120 of
the Administrative Code, which pertains to procedures for issuing, denying,
modifying, transferring, and revoking licenses and permits to
install. (4) Rule 3745-500-130 of
the Administrative Code, which pertains to procedures for approved boards of
health and Ohio EPA regarding the retention and distribution of authorizing
documents. (5) Rule 3745-500-150 of
the Administrative Code, which pertains to alterations to a permit to
install. (6) Rule 3745-500-210 of
the Administrative Code, which pertains to variances. (7) Rule 3745-500-220 of
the Administrative Code, which pertains to exemptions. (8) Rule 3745-500-330 of the
Administrative Code, which pertains to termination of a permit to install
issued under Chapter 3734. of the Revised Code. (9) Rule 3745-500-350 of the
Administrative Code, which pertains to causes for revoking a permit to install
issued under Chapter 3734. of the Revised Code. (10) Rule 3745-500-360 of the
Administrative Code, which pertains to an administrative change to a permit to
install. (C) Any person may apply for a variance
from any provision of this chapter. (D) An owner or operator that applies for or maintains a
solid waste license with an infectious waste notation in accordance with
section 3734.05 of the Revised Code is subject to the applicable provisions of
Chapter 3745-550 of the Administrative Code. (E) This chapter is not applicable to the
following: (1) Infectious wastes
generated on the premises of a single-family residence when the generation is
not the result of a commercial enterprise. (2) Infectious wastes
generated by individuals for purposes of their own care or treatment that are
disposed of with solid wastes from the individual's
residence. (3) Treatment or disposal
of wastes as described in division (C) of section 3734.021 of the Revised
Code. (4) Activities the
regulation of which is preempted by 49 U.S.C. 5125. (5) Controlled substances
handled in accordance with Chapters 4729. and 3719. of the Revised Code or
materials that have been ordered destroyed by a court of law that are destroyed
at facilities licensed for the treatment of infectious waste.
Last updated April 7, 2025 at 8:02 AM
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Rule 3745-570-02 | Definitions.
If a term used in this chapter is defined in rule
3745-500-02 of the Administrative Code, the definition of the term used in rule
3745-500-02 of the Administrative Code is applicable to this chapter unless the
term is defined in this rule. As used in this chapter: (A) "Alternative infectious waste
treatment technology" or "alternative treatment technology"
means any combination of methods, techniques, practices, designs,
constructions, operations, processes, parameters, or equipment designed to
treat infectious waste that is not specified in paragraphs (A) to (D) of rule
3745-570-201 of the Administrative Code. (B) (1) "Biological
challenge testing" means periodic monitoring or testing of an infectious
waste treatment unit or technology that employs the use of biological
indicators to demonstrate achievement of the performance standard for treatment
by the treatment unit or technology. (2) "Biological
indicator" means a specific microorganism used to evaluate the capability
of a process to decontaminate or treat infectious waste. For the purposes of
this definition, biological indicators include bacterial spores inoculated on
carriers, suspensions, and self-contained indicators. (C) [Reserved.] (D) [Reserved.] (E) "Efficacy testing" means
testing of an autoclave, incinerator, or alternative infectious waste treatment
technology conducted by a laboratory, independent of the system manufacturer,
in conformance with generally recognized scientific principles and practices,
including microbiologic examinations and other pertinent assessments of waste
material to establish operating parameters for effective treatment of
infectious waste. (F) [Reserved.] (G) [Reserved.] (H) [Reserved.] (I) (1) "Infectious agent" has the
same meaning as in section 3734.01 of the Revised Code. (2) "Infectious waste storage
area" or "storage area" means any portion of the infectious
waste handling area used to collect, accumulate, or store any infectious wastes
prior to treatment. (3) "Infectious waste treatment
unit" or "treatment unit" means the apparatus responsible for
the attainment of the performance standard for treatment and for the reduction
in microorganisms that is part of the treatment process. A free standing
shredder or grinder is not considered a treatment unit. [Comment: If the treatment process is completed
within a single enclosed piece of equipment, then the treatment unit and
treatment process are considered one and the same.] (J) [Reserved.] (K) [Reserved.] (L) "Large generator of infectious
waste" or "large generator" means the following: (1) Any person who
generates fifty pounds or more of infectious waste in any one month at any
premises owned or operated by the person. (2) Any person holding a
registration certificate issued in accordance with rules adopted under Chapter
3734. of the Revised Code, including all generators listed on the infectious
waste registration certificate. (3) Any person who, as
part of their business activities, engages in the designation and segregation
of infectious waste at places including but not limited to crime or accident
scenes and who generates fifty pounds or more of infectious waste per
month. (M) "Modify" or "modification" means an
infectious waste treatment facility undergoing any of the
following: (1) A substantial change in waste
handling at the infectious waste treatment facility including but not limited
to any change to the following: (a) Type of waste received. (b) Any change in the infectious waste treatment
facility's treatment technology or process. (2) An increase in the
treatment capacity. For the purposes of this definition, "treatment
capacity" means the maximum amount of waste permitted by Ohio EPA to be
loaded into the treatment unit per hour, or the engineered throughput capacity
per hour if no such permitted capacity is authorized. (3) Any other substantial
change that may endanger human health or the environment. (N) [Reserved.] (O) [Reserved.] (P) (1) "Performance standard for
treatment" means the following: (a) For purposes of autoclaving and treatment by ozone, a
six log10 reduction of Geobacillus
stearothermophilus spores. (b) For
purposes of incineration, a six log10
reduction of Bacillus subtilis spores. (c) For purposes of
alternative infectious waste treatment technologies, a six log10 reduction in the appropriate bacterial
spores. (2) "Primary
container" means the inner packaging or containment system that is in
direct contact with, holding, and securing infectious waste. A primary
container includes but is not limited to a red bag or sharps
container. (Q) [Reserved.] (R) [Reserved.] (S) (1) "Sample"
means portions of previously inoculated wastes or portions of previously
inoculated carriers. (2) "Secondary container" means
the non-bulk outer packaging or containment system used to hold and secure a
primary container. A secondary container is a disposable or reusable rigid
pail, carton, drum or portable bin that is, under normal conditions of use,
leak-resistant, strong enough to prevent tearing or bursting, puncture
resistant, impervious to moisture, has leak-proof sides and bottom, has a
tight-fitting cover or is otherwise closeable, and is in good
repair. (3) "Select
agent" means an infectious agent, zoonotic agent, or toxin determined to
have the potential to pose a severe threat to public health or safety or the
environment as specified in 42 C.F.R. Part 73, 7 C.F.R. part 331, or 9 C.F.R.
part 121, as amended through July 2023. (4) "Sharp infectious waste" or
"sharps" means any instrument designed to cut, pierce, or lacerate
that was or is likely to have been exposed to or contaminated with, or is
likely to transmit, an infectious waste or zoonotic agent or has come in
contact with blood or other body fluids including but not limited to needles,
syringes with an attached needle, or any other type of instrument designed for
the purpose to cut, pierce, or lacerate. (5) "Small generator of infectious
waste" or "small generator" means any person who generates less
than fifty pounds of infectious waste in any one month at each premises owned
or operated by the person. (T) (1) "Treat" or
"treatment" means any method, technique, or process that renders the
wastes noninfectious including but not limited to steam sterilization and
incineration. Treat or treatment of wastes identified in division (R)(7) of
section 3734.01 of the Revised Code includes methods, techniques, or processes
to substantially reduce or eliminate the potential for the wastes to cause
lacerations or puncture wounds. (2) "Treatment
cycle" means the timeframe from when the treatment unit attains the
approved treatment parameters until achievement of the performance standard for
treatment that has been demonstrated through the use of a biological indicator
or parametric monitoring.
Last updated April 7, 2025 at 8:02 AM
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Rule 3745-570-31 | Handling and storage of infectious waste.
(A) Any person handling infectious waste
or containers utilized for the handling or storage of infectious waste shall
manage the waste and containers in a manner that ensures the
following: (1) The integrity of all
containers is maintained. (2) Infectious waste
neither escapes nor is expelled from the container. (3) Infectious waste is
maintained in a nonputrescent state, using refrigeration or freezing when
necessary. (4) Infectious waste that becomes
putrescent is immediately refrigerated or frozen and is treated and disposed of
as soon as possible regardless of any storage timeframe. (5) Neither the infectious waste nor the
containers provide a breeding place or a food source for birds, insects,
rodents, or other vectors. (B) No person shall store infectious
waste in rental self-storage units. (C) Any person storing infectious waste
shall manage infectious waste handling areas in a manner that ensures the
following: (1) Indoor storage has
visible signage posted at all points of access displaying the international
biohazard symbol. (2) All points of access
for outside storage, including trucks or trailers, are locked to prevent
unauthorized access and have visible signage displaying the international
biohazard symbol. (3) If a truck or trailer
is used for storage of infectious waste, the truck or trailer is equipped in
such a manner as to prevent the spillage of infectious waste and
liquids. (4) For a large generator, infectious
waste is stored only at locations listed on the registration
certificate. (5) For an infectious waste treatment
facility, infectious waste is stored only at the licensed
facility. (D) Any person intending to reuse a
primary or secondary container shall ensure the container is as
follows: (1) Constructed of
non-porous material. (2) Empty of infectious
waste. (3) Thoroughly cleaned
with a detergent and sufficient agitation or pressure to remove visible
contamination from surfaces and then disinfected after each use with one of the
following: (a) A U.S. EPA registered hospital disinfectant that is
also tuberculocidal for a contact time as specified by the
manufacturer. (b) Water at a temperature of at least one hundred eighty
degrees Fahrenheit for a minimum contact time of fifteen seconds. (E) Any person intending to recycle
secondary containers consisting of corrugated cardboard or other recyclable
material shall ensure that the containers have not been exposed to untreated
infectious waste and display no staining or other signs of spillage of
untreated infectious waste. (F) Additional requirements for
infectious waste treatment facilities. In addition to the requirements
contained in paragraphs (A) to (D) of this rule, the owner or operator of an
infectious waste treatment facility shall do the following: (1) Store untreated
infectious waste as follows: (a) For no more than fourteen days. (b) In quantities that do not exceed seven times the
infectious waste treatment facility's total maximum daily throughput
capacity. (2) If at any time the
owner or operator does not meet paragraph (F)(1)(a) or (F)(1)(b) of this rule,
immediately implement the contingency plan specified in rule 3745-570-200 of
the Administrative Code and notify on the same or next business day the
appropriate health district and Ohio EPA district office of the implementation
of the contingency plan.
Last updated April 7, 2025 at 8:02 AM
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Rule 3745-570-100 | Infectious waste generators - general obligations.
(A) A generator shall manage infectious
waste and mixtures of infectious waste with another waste as
follows: (1) For infectious waste that is also a
hazardous waste, in accordance with Chapters 3745-50 to 3745-69 of the
Administrative Code. No generator of infectious waste may transport or cause
the transportation of hazardous waste to an infectious waste treatment
facility. (2) For infectious waste that is also
radioactive waste, in accordance with the following: (a) Manage the waste in accordance with applicable Ohio
department of health and U.S. nuclear regulatory commission
regulations. (b) Use a monitoring instrument, calibrated at least
annually, to verify that infectious waste that is also radioactive no longer
needs to be managed in accordance with Ohio department of health and U.S.
nuclear regulatory commission regulations. (c) In a manner that prevents transportation of the waste
to an infectious waste treatment facility until monitoring in accordance with
paragraph (A)(2)(b) of this rule demonstrates that the waste no longer needs to
be managed in accordance with Ohio department of health and U.S. nuclear
regulatory commission regulations. (d) Manage the waste in accordance with rule 3745-570-110
or 3745-570-120 of the Administrative Code, as applicable, if monitoring in
accordance with paragraph (A)(2)(b) of this rule demonstrates that the waste no
longer needs to be managed in accordance with Ohio department of health or U.S.
nuclear regulatory commission regulations. (B) A generator that is a hospital as defined in section
3727.01 of the Revised Code may accept the following waste for treatment or
storage prior to treatment: (1) Infectious waste from
a generator that has staff privileges at the hospital and generates less than
fifty pounds of infectious waste in any one month. (2) Infectious waste
generated by an individual for purposes of the individual's own care or
treatment. (3) Infectious waste
generated in providing care to a patient at the scene of an emergency or during
the transportation of the patient to the hospital by an emergency medical
service organization as defined in section 4765.01 of the Revised
Code. (C) Not later than sixty days after
containers of infectious waste are closed and no longer considered in use by a
generator, the generator shall ensure that containers of infectious waste are
either received by an infectious waste treatment facility or lawfully disposed
as solid waste in accordance with paragraph (B) of rule 3745-570-110 of the
Administrative Code. (D) The following shall not be considered when determining
the quantity or monthly generation rate of infectious waste produced by a
generator: (1) The weight of blood, blood products,
other body fluids, or embalming fluids that are discharged on the site of
generation into a disposal system as defined in section 6111.01 of the Revised
Code if the generator holds a license issued under Chapter 4717. of the Revised
Code. (2) For an emergency medical service
organization as defined in section 4765.01 of the Revised Code, infectious
waste accepted by a generator that is a hospital as defined in section 3727.01
of the Revised Code. (E) A generator may discharge untreated
liquid or semiliquid infectious waste consisting of exclusively blood, blood
products, body fluids, and excreta into a disposal system as defined in section
6111.01 of the Revised Code unless otherwise specified in a permit for the
system issued under Chapter 6111. of the Revised Code. (F) Except as provided in paragraphs
(A)(1) and (A)(2) of this rule, nothing in this chapter prohibits a generator
of infectious waste from designating and managing waste, in addition to
infectious waste, as infectious waste when, in the judgment of the generator,
the other waste should be managed as infectious waste because the waste is, or
is likely to be, contaminated with infectious agents. After designating any
such other waste as infectious, the generator shall manage the waste in
compliance with this chapter.
Last updated April 7, 2025 at 8:02 AM
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Rule 3745-570-110 | Requirements for small generators of infectious waste.
(A) A small generator of infectious waste
shall comply with the following: (1) Handle and store
infectious waste in accordance with rule 3745-570-31 of the Administrative
Code. (2) Identify and separate
infectious waste from other waste at the point of generation. (3) Place sharp
infectious waste in a container labeled with the biohazard symbol and designed
to contain sharp infectious waste. (4) Quantify and record
the amount, in pounds, of infectious waste generated on a calendar month basis
for each premises owned or operated by the generator and provide the
information to Ohio EPA or the approved health district upon
request. (5) Submit an application
and obtain a registration certificate in accordance with rule 3745-570-125 of
the Administrative Code if fifty pounds or more of infectious waste is
generated in any one month using the records created in accordance with
paragraph (A)(4) of this rule. (6) Ensure the treatment
of all specimen cultures and cultures of viable infectious agents is in
accordance with either of the following: (a) On the premises where generated using any of the
methods, techniques, or practices prescribed in rule 3745-570-201 of the
Administrative Code. Treatment in accordance with this paragraph does not
constitute a treatment facility; treated cultures may be managed in the same
manner as solid waste and are not subject to the disposal paper requirements
contained in rule 3745-570-130 of the Administrative Code. (b) Off the premises where generated at any of the
following: (i) A treatment facility
holding a license issued under division (B) of section 3734.05 of the Revised
Code. (ii) A facility in
another state operating in compliance with applicable state and federal
laws. (iii) A facility that
holds a license or renewal of a license to operate a crematory facility issued
under Chapter 4717. of the Revised Code and a permit issued under Chapter 3704.
of the Revised Code to the extent that the treatment of those wastes is
consistent with that permit and its terms and conditions. [Comment: A small generator is subject to the
applicable packaging requirements contained in 49 C.F.R. Part 173 to 49 C.F.R.
Part 178.] (B) With the exception of cultures
specified in paragraph (A)(6) of this rule, a small generator that meets the
requirements of this rule may dispose of infectious waste in the same manner as
solid waste.
Last updated April 7, 2025 at 8:03 AM
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Rule 3745-570-120 | Requirements for large generators of infectious waste.
(A) A large generator of infectious waste
shall comply with the following: (1) Apply for and maintain a valid
registration certificate in accordance with rule 3745-570-125 of the
Administrative Code. (2) Handle and store
infectious waste in accordance with rule 3745-570-31 of the Administrative
Code. (3) Segregate infectious waste from other
waste at the point of generation and at a minimum place the infectious waste in
containers labeled with the biohazard symbol until rendered
non-infectious. (4) Place sharp infectious waste in a
container labeled with the biohazard symbol and designed to contain
sharps. (5) Not compact or grind infectious waste
until after the waste has been treated in accordance with rule 3745-570-201 of
the Administrative Code. (6) Ensure that all infectious waste is
treated to render the infectious waste non-infectious prior to disposal in
accordance with either of the following: (a) At a treatment facility owned or operated by the
generator using any of the methods, techniques, or practices prescribed in rule
3745-570-201 of the Administrative Code. (b) Off the premises where generated at any of the
following facilities: (i) An infectious waste
treatment facility licensed in accordance with division (B) of section 3734.05
of the Revised Code. (ii) A facility in another state operating in compliance
with applicable state and federal laws. (c) At a facility that holds a license or renewal of a
license to operate a crematory facility issued under Chapter 4717. of the
Revised Code and a permit issued under Chapter 3704. of the Revised Code to the
extent that the treatment of those wastes is consistent with that permit and
its terms and conditions. (7) Ensure that all infectious waste
treated on site that is transported off the premises where generated is
accompanied by a disposal paper in accordance with rule 3745-570-130 of the
Administrative Code. (8) Retain copies of all disposal papers
for a minimum of five years, or longer if requested in writing by Ohio
EPA. [Comment: A large generator is subject to the
applicable packaging requirements contained in 29 C.F.R. Part 1910.1030, 49
C.F.R. Part 173, and 49 C.F.R. Part 178.] (B) Upon written request, a large
generator shall provide information regarding the following to persons with
whom the generator has entered into an arrangement to treat the infectious
waste or dispose of the treated infectious waste: (1) The major components
of the infectious waste. (2) Any method of
treatment employed by the generator to render the infectious waste
non-infectious. (3) The generator's
system for distinguishing between waste containers that contain treated and
untreated infectious waste.
Last updated April 7, 2025 at 8:03 AM
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Rule 3745-570-125 | Registration certificate for large generators of infectious waste.
(A) Not later than thirty days after the
last day of the month in which fifty pounds or more of infectious waste was
generated, a large generator shall submit an application for a registration
certificate to Ohio EPA on forms prescribed by the director that at a minimum
includes the following and is accompanied by a nonrefundable application fee of
one hundred forty dollars: (1) The address and contact information
for each premises owned or operated by the generator where infectious waste is
generated that generates fifty pounds or more of infectious waste in any one
month or treats infectious waste. (2) A signature in accordance with rule
3745-500-50 of the Administrative Code. (B) The applicant shall correct noted
deficiencies and resubmit the application not later than fifteen days after
receipt of a written notification that an application is deficient. Failure to
submit a corrected application will not extend a registration
cycle. (C) Issuance. (1) A registration
certificate is valid for three years, unless revoked. (2) A registration
certificate is not transferable. (D) If changes are necessary to update current registrant
information, premises information, or treatment methods, the large generator
shall submit an application for an amended registration certificate to Ohio EPA
on forms prescribed by the director. An amended registration certificate does
not alter the expiration date of the original registration
certificate. [Comment: There is no fee to amend a registration
certificate.] (E) Not later than thirty days prior to expiration of a
registration certificate, a large generator that intends to continue to
generate infectious waste shall submit one of the following to Ohio
EPA: (1) An application for a
registration certificate in accordance with paragraph (A) of this
rule. (2) If less than fifty
pounds of infectious waste is generated by the generator monthly at all
premises owned or operated by the generator, an application to revert to a
small generator together with documentation that no more than fifty pounds of
infectious waste was generated in any one month, including the weight of any
untreated liquid infectious waste that is disposed of on the premises, during
the six months prior to expiration of the registration
certificate.
Last updated April 7, 2025 at 8:03 AM
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Rule 3745-570-130 | Disposal paper.
(A) The owner or operator of a treatment
facility shall ensure that all treated infectious waste leaving the premises is
accompanied by a disposal paper legibly completed on forms prescribed by the
director, or an alternative form that conforms to this rule, that contains the
following: (1) The name of the
treatment facility where the infectious waste was treated, the name of the
owner and operator of the treatment facility, and the address and telephone
number for the treatment facility. (2) A signed and dated certification by
the owner or operator that the infectious waste has been treated by methods,
techniques, and practices in accordance with this chapter. (3) A signature in
accordance with rule 3745-500-50 of the Administrative Code. (B) A disposal paper shall accompany the
treated infectious waste to the solid waste disposal facility and not be kept
by a transfer facility.
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Rule 3745-570-200 | General requirements for infectious waste treatment facilities.
(A) The owner or operator shall conduct
all construction and operations at the infectious waste treatment facility in
compliance with all applicable authorizing documents. (B) Facility management plan. Unless
sodium hypochlorite is exclusively utilized for the treatment of cultures in
compliance with rule 3745-570-204 of the Administrative Code, prior to
acceptance of infectious waste the owner or operator shall develop, maintain,
and implement a facility management plan that complies with the
following: (1) The plan includes
copies of the following: (a) Applicable authorizing documents for the infectious
waste treatment facility. (b) The manufacturer's equipment specifications,
owner's manual, and maintenance schedule for each treatment
unit. (c) The schedule for the monitoring and recording device
calibration or replacement. (d) The maintenance and repair log for each treatment
unit. (e) Infectious waste spill containment and clean-up
procedures. (f) The facility contingency plan that at a minimum
contains the following: (i) A table of
contents. (ii) The name, address,
and telephone number of the facility to which the plan applies. (iii) A purpose
statement. (iv) Designation of an
emergency coordinator and alternate emergency coordinator, their contact
information, and a description of their responsibilities. (v) Designation of
alternative infectious waste treatment facilities and, if the alternative
infectious waste treatment facilities are owned or operated by another owner or
operator, documentation that infectious wastes from the treatment facility will
be accepted by the alternative treatment facility. (vi) A description of
storage, handling, refrigeration, and freezing procedures, including the
procedures the owner or operator will implement to send the untreated
infectious waste to an alternative infectious waste treatment facility
designated in accordance with paragraph (B)(1)(f)(v) of this rule in the event
of a violation of paragraph (F)(1)(a) or (F)(1)(b) of rule 3745-570-31 of the
Administrative Code. (vii) A proposed schedule
for responding to an emergency. (g) Emergency telephone numbers for the
following: (i) The emergency
coordinator and an alternate coordinator. (ii) The local fire
department. (iii) The local emergency
management office, if applicable. (iv) The local health
department. (v) The local police
department. (vi) The local Ohio EPA
district office. (h) A section for recording the results of biological
challenge testing and applicable validation testing. (i) Start-up, loading, operating, shut down, and equipment
malfunction procedures for each treatment unit. (j) A section for daily logs as specified in paragraph (C)
of this rule. (k) All strip charts, graphs, spreadsheets, and treatment
parameter records, with each record dated. (l) The disposal papers for the treated infectious waste
completed in accordance with rule 3745-570-130 of the Administrative
Code. (m) Copies of contingency plan paperwork showing where
infectious waste went if not treated at the infectious waste treatment
facility. (n) A training certification statement for each employee
who operates the infectious waste treatment unit or loads infectious waste into
the infectious waste treatment unit that the employee received annual training
in accordance with paragraph (B)(3) of this rule that is maintained for the
duration of employment. (2) The plan is
maintained in accordance with the following: (a) By calendar year, at a minimum including the current
calendar year and the two previous calendar years. (b) The plan for the current calendar year is maintained in
a designated area on the premises of the infectious waste treatment
unit. (c) The facility management plans for the two previous
calendar years may be located and maintained in other accessible areas so long
as a notation is made in the current year's facility management plan
identifying the location of the past facility management plans. (d) Such that the facility management plans are accessible
to employees during working hours. (3) The plan includes an annual training
schedule that at a minimum provides for instruction on the contents of the
facility management plan to each employee who will operate the infectious waste
treatment unit or load the infectious waste treatment unit. A written training
certification statement attesting that the employee received training shall be
signed and dated by each employee upon completing the training and the owner or
operator. (C) Daily log of operations. (1) Unless sodium
hypochlorite is exclusively utilized for the treatment of cultures in
compliance with rule 3745-570-204 of the Administrative Code, the owner or
operator shall use and maintain a daily log of operations on forms prescribed
by the director, or an alternative form that contains all of the specified
information, for each treatment unit that at a minimum includes the
following: (a) The name of the person operating each treatment
unit. (b) An indication of whether the load was for validation,
biological challenge testing, or treatment. (c) The date and time each load of infectious waste was
charged into each treatment unit. (d) The date and time each treatment cycle started and
ended. (e) The date and time the treatment unit was
unloaded. (f) Any documentation associated with the monitoring of
infectious waste treatment parameters required by each approved infectious
waste treatment method. (2) Information produced
by the treatment unit may substitute for the daily log provided all the
information specified in paragraphs (C)(1)(a) to (C)(1)(f) of this rule is
readily available to Ohio EPA and the approved health district. (D) Annual report. Not later than February first of each
year, the owner or operator of a licensed infectious waste treatment facility
shall submit an annual report to Ohio EPA and the approved health district that
at a minimum includes the following: (1) The name, address,
and telephone number of the infectious waste treatment facility. (2) The name, email
address, and telephone number of the contact person for the infectious waste
treatment facility. (3) The hours of operation for the
infectious waste treatment facility. (4) The total quantity of infectious
waste treated at the infectious waste treatment facility monthly for each state
and country of origin. (5) All biological challenge testing
results that do not demonstrate achievement of the performance standard for
treatment, documentation of how infectious waste from the treatment unit that
failed to demonstrate achievement of the performance standard for treatment was
managed, and actions taken by the owner or operator to ensure that the
treatment unit attains the performance standard for treatment. (E) Record keeping. The owner or operator shall retain and
provide records as follows: (1) Except as otherwise
provided in this paragraph, retain all records for a period of not less than
five years, with that period beginning on the date of recording, sample, or
measurement. Retention periods are extended during the course of any unresolved
litigation or when requested by Ohio EPA. (2) Provide Ohio EPA and
the approved health district access to, and copies of, all records upon
request. (F) Construction. The owner or operator shall construct and
maintain the treatment facility in a manner that ensures the
following: (1) All-weather access
roads withstand the anticipated degree of use and allow passage of vehicles
with minimum erosion and dust generation. (2) The infectious waste handling areas
are equipped with non-absorbent floors that are not overlaid with an absorbent
covering. (3) Proper slopes and drainage are
established and maintained to prevent the ponding of liquids in the infectious
waste handling areas. (G) General operational requirements. The
owner or operator shall ensure operations are conducted in accordance with the
following: (1) Handle and store
infectious waste in accordance with rule 3745-570-31 of the Administrative
Code. (2) Ensure no hazardous
waste is accepted. (3) Refrain from treating waste in a
manner that is prohibited by the Ohio department of health or the U.S. nuclear
regulatory commission. (4) Locate and maintain a copy of the
operating and loading procedures for each infectious waste treatment unit in
the immediate area of that infectious waste treatment unit and make a copy of
those procedures readily available to the personnel operating the infectious
waste treatment unit. (5) Ensure that all
personnel operating the infectious waste treatment unit are trained on the
contents of the facility management plan in accordance with paragraph (B)(3) of
this rule prior to operating the infectious waste treatment unit. (6) Restrict access to infectious waste
handling areas to authorized personnel using signs or a locking
mechanism. (7) Perform validation testing for each
new treatment unit to demonstrate the ability of the treatment unit to achieve
the performance standard using the approved treatment method prior to using the
treatment unit to treat infectious waste or introducing a new waste type to an
existing treatment unit. (8) Perform validation testing for each
treatment unit intended for use in the treatment of select agents, ensuring
that the test loads are packaged in the same manner as wastes contaminated with
a select agent. (9) Perform biological challenge testing
on each load of waste containing select agents and hold the waste on-site until
challenge testing confirms the achievement of the performance standard for
treatment. (10) Perform validation testing to
demonstrate the ability of the infectious waste treatment unit to achieve the
performance standard if the infectious waste treatment unit has not been used
for the treatment of infectious waste for more than three hundred sixty-five
days. (11) Load infectious waste into the
treatment unit in such a manner as not to compact, puncture, or otherwise
damage the containers. (12) Manage sharps and re-usable sharps
containers in a manner that eliminates the potential of the sharps to cause
lacerations or puncture wounds during treatment, handling, storage, and
disposal and in accordance with the following: (a) Open sharps containers specifically designed for re-use
using only mechanical means. (b) Mechanically dump contents of re-usable sharps
containers into a secondary container immediately prior to loading into a
treatment unit. (c) Manage the empty, re-usable sharps container in
accordance with rule 3745-570-31 of the Administrative Code. (13) Ensure infectious waste is not loaded
into the treatment unit during periods of precipitation unless the infectious
waste and the waste loading operations are protected from the
precipitation. (14) Manage all waste contained within the
treatment unit as infectious waste in accordance with rule 3745-570-31 of the
Administrative Code if any of the following occur: (a) Treatment of the infectious waste does not conform to
the approved treatment method as specified in rule 3745-570-201 of the
Administrative Code. (b) A malfunction of the treatment unit. (15) Ensure that wastewater resulting from
a spill of infectious waste is not disposed into a storm sewer and handled in
accordance with either of the following: (a) Discharged into a disposal system permitted in
accordance with Chapter 6111. of the Revised Code provided the discharge is not
inconsistent with that permit. (b) Absorbed and handled as infectious waste. (16) Ensure infectious waste intended for
recycling is managed in accordance with the following: (a) Infectious waste is treated using an autoclave in
accordance with rule 3745-570-203 of the Administrative Code. (b) Biological challenge testing is conducted for each load
of infectious waste treated before recycling. (c) Treated infectious waste that is intended for recycling
is stored at the treatment facility until the results of the biological
challenge testing have been obtained. The owner or operator shall re-treat the
infectious waste and repeat the biological challenge testing when results
indicate that the biological challenge testing failed. (17) Comply with rules
3745-570-125 and 3745-570-222 of the Administrative Code when any infectious
waste treatment facility intends to discontinue treating infectious waste at
any facility or premises. [Comment: The owner or operator is subject to the
applicable packaging requirements contained in 29 C.F.R. Part 1910.1030, 49
C.F.R. Part 173, and 49 C.F.R. Part 178, as amended through July 2023.] (H) The owner or operator shall ensure that infectious
waste that has been treated in accordance with this rule is managed as
follows: (1) Disposed at a
licensed solid waste disposal facility or in such a facility in another state
operating in compliance with state and federal regulations, unless the treated
wastes have been managed in accordance with paragraph (G)(15) of this
rule. (2) Accompanied with
disposal papers as specified in rule 3745-570-130 of the Administrative
Code.
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Rule 3745-570-201 | Approved infectious waste treatment methods.
The owner or operator shall treat infectious waste
utilizing only the following approved infectious waste treatment
methods: (A) Incineration in accordance with rule
3745-570-202 of the Administrative Code. (B) Autoclaving in accordance with rule
3745-570-203 of the Administrative Code. (C) Chemical treatment utilizing a sodium
hypochlorite solution for cultures in accordance with rule 3745-570-204 of the
Administrative Code. (D) Ozone exposure treatment in
accordance with rule 3745-570-205 of the Administrative Code. (E) An effective alternative treatment
technology approved by the director in accordance with rule 3745-570-211 of the
Administrative Code. (F) An effective alternative treatment technology approved
by the director prior to the effective date of this rule.
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Rule 3745-570-202 | Incineration.
(A) Methodology. The owner or operator using incineration shall
conduct treatment of infectious waste in accordance with the following
methodologies: (1) Using a multi-chamber incinerator that
provides complete combustion of all wastes, excluding metal, glass, and ceramic
items. (2) Maintaining 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. [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.] (B) Operational criteria. The owner or operator shall operate the
incinerator as follows: (1) Continuously record the primary and secondary
chamber temperatures using a temperature recording device with a real-time
display that is permanently connected to the incinerator and is capable of
producing an instant paper or electronic record. (2) If the temperature recording device becomes
inoperable, do the following until repairs are made: (a) Manually record the
chamber temperatures immediately after each charge of infectious waste and
again for a minimum of once every ten minutes thereafter until the burn down
cycle is initiated. (b) Provide proof that
repair parts have been ordered if requested by Ohio EPA or the approved health
district. (c) Discontinue use of the
incinerator if the incinerator becomes inoperable due to a failure in the
thermocouple or thermocouple wiring. (3) Use an independent company to calibrate, repair, or replace
primary and secondary chamber temperature recording devices or temperature
measuring devices in accordance with either of the following: (a) The manufacturer's
maintenance schedule, specifications, or recommendations. (b) If the
manufacturer's maintenance schedule, specifications, or recommendations
are not available, a calibration schedule as determined by the owner or
operator that at a minimum includes annual calibrations. (4) Ensure the incinerator is equipped with a mechanical process
to prevent the charging of infectious waste into the incinerator until the
minimum temperatures specified in paragraph (A)(2) of this rule are
achieved. (5) Ensure the incinerator has automatic auxiliary burners
capable of independently maintaining the secondary chamber temperature at the
minimum temperature specified in paragraph (A)(2) of this rule, excluding the
heat content of the infectious waste. (6) Ensure the incinerator is not charged beyond 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 Ohio EPA, division of air pollution control, or if no such permit has
been issued, the design capacity as determined by the
manufacturer. (7) Re-incinerate or otherwise treat wastes not combusted to ash
except for the materials specified in paragraph (A)(1) of this
rule. (C) Upon written notification from Ohio EPA, the owner or
operator shall sample and test the stack gas and the resulting bottom ash after
the addition of Bacillus species spores to a load of infectious waste in
accordance with the protocol provided by Ohio EPA and submit the results within
the time frame specified in the notice. (D) The owner or operator
shall manage ash from the incineration of infectious waste in accordance with
the following: (1) Store all ash from the incinerator in a leak
proof closed container and ensure the ash is free of liquids prior to
disposal. (2) Characterize ash resulting from the treatment of infectious
waste quarterly, or more frequently if specified by Ohio EPA, as
follows: (a) Separately test the fly
ash and bottom ash. (b) Obtain representative
samples of the fly ash and bottom ash using the "Simple Random Sampling
Method" described in the "U.S. EPA Test Methods for Evaluating Solid
Waste, third edition (SW846)," chapter nine. (c) Use an independent
analytical laboratory to test samples of the fly ash and bottom ash for metals
in accordance with the U.S. EPA Test Methods for Evaluating Solid Waste, third
edition (SW846)," method 1311, "Toxicity Characteristic Leaching
Procedure." (3) The applicable solid waste or hazardous waste requirements in
Chapter 3734. of the Revised Code and the rules adopted
thereunder. (4) Manage any ash spilled outside of the
treatment unit as treated infectious wastes unless the owner or operator has
reason to manage the ash as hazardous waste. (E) The owner or operator
shall maintain the dated 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, and
the results of fly and bottom ash testing for a minimum of five
years.
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Rule 3745-570-203 | Autoclaving.
(A) For the purposes of this rule, the
following definitions apply: (1) "Treatment
cycle" means the combination of the minimum time, temperature, and
pressure necessary to achieve the performance standard for treatment. Treatment
cycle does not include the time needed to bring the autoclave up to the
operating temperature or pressure or the time it takes for the autoclave to
exhaust and allow opening of the chamber. (2) "Total treatable
volume" means the total volume of infectious waste that can be treated per
treatment cycle. The total treatable volume of infectious waste is calculated
using one of the following: (a) The manufacturer's specification for the total
volume of the autoclave. (b) An estimate that is less than, but based upon, the
manufacturer's specification for the total volume of the
autoclave. (c) The total treatable volume at each validation or
biological challenge test calculated by listing the number of bags, boxes,
bins, and sharps containers of infectious waste used during the testing and
adding the volumes of those containers, provided the total treatable volume
does not exceed the manufacturer's specifications. (B) Methodology. The owner or operator
shall operate an autoclave in such a manner that every load achieves the
performance standard for treatment and in accordance with the
following: (1) Maintain a minimum
gauge pressure of fifteen pounds per square inch and a minimum temperature of
either one hundred twenty-one degrees Centigrade or two hundred fifty degrees
Fahrenheit for a minimum of sixty minutes during a treatment cycle, provided
the performance standard for treatment is achieved. (2) Maintain a different combination of
time, temperature, and pressure for the duration of the treatment cycle for
which the owner or operator has demonstrated achievement of the performance
standard for treatment through validation testing in accordance with paragraph
(D) of this rule prior to use for the treatment of infectious
waste. (C) Operational criteria. The owner or operator shall
operate an autoclave treating infectious waste in accordance with the
following: (1) Continuously record
the temperatures, pressures, and time using recording devices with a real-time
display that are permanently connected to the autoclave and produces an instant
paper or electronic record. (2) If the autoclave
temperature and pressure readings are below what is specified in the gauge
pressure versus temperature of saturated steam table in the appendix to this
rule, or are not within two degrees over or two pounds per square inch over the
corresponding reading specified in the gauge pressure versus temperature of
saturated steam table in the appendix to this rule, do one of the
following: (a) Discontinue use of the autoclave until the autoclave is
repaired or calibrated in accordance with paragraph (C)(4) of this
rule. (b) Perform biological challenge testing at a minimum
weekly in accordance with paragraph (E) of this rule. If at any time biological
challenge testing fails, the owner or operator shall discontinue use of the
autoclave until the autoclave is repaired or calibrated in accordance with
paragraph (C)(4) of this rule. (3) If a recording device becomes
inoperable, provide proof that repair parts have been ordered if requested by
Ohio EPA or the approved health district and do either of the following until
repairs are made: (a) Manually record the data no longer available from the
recording device at intervals that do not exceed five minutes until the exhaust
cycle is initiated. (b) Discontinue use of the autoclave until repaired if
failure or malfunction occurs in any recording device. (4) Use an independent person to
calibrate, repair, or replace temperature recording devices or temperature
measuring devices in accordance with either of the following: (a) The manufacturer's maintenance schedule,
specifications, or recommendations. (b) If the manufacturer's maintenance schedule,
specifications, or recommendations are not available, a calibration schedule as
determined by the owner or operator that at a minimum includes annual
calibrations. (5) Evacuate the air from the autoclave
chamber before each treatment cycle is started. (6) Ensure that the autoclave is not
loaded beyond the total treatable volume. (7) Ensure that pathological waste is
treated only after receipt of written concurrence from Ohio EPA in accordance
with paragraph (D)(3)(c) of this rule. (D) Validation testing. The owner or
operator shall perform validation testing in accordance with paragraph (G) of
rule 3745-570-200 of the Administrative Code and the following: (1) Except as provided in
paragraph (D)(3) of this rule, demonstrate the capability of the autoclave to
achieve the performance standard for treatment as follows: (a) Use a challenge population of spores as spore strips
with a population of at least 1.0 x 106 Geobacillus stearothermophilus spores,
ampules containing at least 1.0 x 106 Geobacillus stearothermophilus spores per
milliliter, or commercially available steam packs that contain a population of
at least 1.0 x 106 Geobacillus
stearothermophilus spores. (b) Ensure that the Geobacillus stearothermophilus spore
testing methodology does not result in the denaturation of the proteins within
the inoculating media. (c) Compose the validation testing waste load in a manner
that stimulates the most challenging waste load for the autoclave. (d) Place the challenge population of spores into three
test containers composed of material such as treated infectious waste,
newspaper, plastic backed absorbent pads, or general refuse that has been
placed into either boxes, bags, or sharps containers. (e) Place the challenge population of spores into three
test containers composed of material such as already treated infectious waste,
newspaper, plastic backed absorbent pads, or general refuse that has been
placed into either boxes, bags, or sharps containers in the center of each
waste load. (f) Place the test containers with the challenge population
of spores in the location that poses the greatest challenge to the technology.
If the autoclave will not hold three containers of waste, then each test
container shall contain a spore strip or ampule. Commercially available steam
packs may be placed into the three test containers instead of treated
infectious waste, newspaper, plastic backed absorbent pads, or general
refuse. (g) Treat the waste load containing the challenge
population of spores in a manner consistent with the daily operation of the
autoclave for the treatment of infectious waste. (h) Record the following information: (i) The autoclave
pressure, temperature, and treatment cycle time that the owner or operator is
attempting to validate for the treatment of infectious waste. (ii) The date and time
the treatment cycle started. (iii) The date and time the treatment cycle
ended. (iv) The name of the person who loaded the autoclave and the
name of the person performing laboratory analysis of the challenge population
of spores. (v) A diagram depicting the pattern of infectious waste
loading and location of the challenge population of spores during the
validation testing. Those units that have rotating treatment chambers do not
need to be diagrammed. (vi) The total treatable volume of infectious waste used
during the validation testing. Once a total treatable volume of infectious
waste 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. (vii) The autoclave chamber temperature and pressure during
the treatment cycle, as recorded by the permanently connected recording
devices. (viii) The daily results of spore growth during an incubation
period not less than the time specified by the manufacturer of the spore strip
or ampule, 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. (i) Remove and incubate the challenge population of spores
used in validation testing for not less than the period of time specified by
the manufacturer of the spore strip or ampule. (j) Upon request by Ohio EPA or the approved health
district, perform validation testing in the presence of Ohio EPA or the
approved health district to verify that the written operating procedures in the
facility management plan are sufficient to meet the performance standard for
treatment. (k) If directed by Ohio EPA or the approved health
district, perform validation testing using twice as many spore strips or
ampules in the same locations in the autoclave and allow Ohio EPA or the
approved health district to remove and separately incubate one-half of the
spore strips or ampules. (2) If any of the
challenge population of spores used to perform the testing are positive for
growth at any time during the incubation period, do the following: (a) Conclude that the autoclave has failed to achieve the
performance standard for treatment. (b) Manage the infectious waste placed within the autoclave
during and after the failed validation testing as infectious
waste. (c) Not use the autoclave to treat infectious waste until a
successful validation test has been performed. (3) Demonstrate the
capability of the autoclave to achieve the performance standard for treatment
of pathological waste as defined in this chapter as follows: (a) Submit a protocol to Ohio EPA for validation testing
that is consistent with this rule and specifically addresses the density of
pathological waste. (b) Conduct the validation testing in accordance with the
approved protocol only after receipt of written approval of the protocol from
Ohio EPA. (c) Submit results of the validation testing to Ohio EPA
for concurrence. (4) Repeat validation
testing if there is a change to the physical structure of the treatment
unit. (E) Biological challenge testing. The owner or operator
shall perform biological challenge testing on an autoclave treating infectious
waste at a minimum monthly in accordance with the following: (1) As follows to
determine the capability of the autoclave to achieve the performance standard
for treatment: (a) Using a challenge population of spores as spore strips
with a population of at least 1.0 x 106 Geobacillus stearothermophilus spores,
ampules containing at least 1.0 x 106 Geobacillus stearothermophilus spores per
milliliter, or commercially available steam packs that contain a population of
at least 1.0 x 106 Geobacillus
stearothermophilus spores. (b) Ensure that the Geobacillus stearothermophilus spore
testing methodology does not result in the denaturation of the proteins within
the inoculating media. (c) Place the challenge population of spores into the
center of each of three test containers composed of material such as treated
infectious waste, newspaper, plastic backed absorbent pads, or general refuse
that has been placed into either boxes, bags, or sharps containers
representative of the normal or anticipated use for that autoclave
unit. (d) Place the test containers with the challenge population
of spores in the location that poses the greatest challenge to the technology.
If the autoclave will not hold three containers of waste, then each test
container shall contain a spore strip or ampule. Commercially available steam
packs may be placed into the three test containers instead of newspaper,
plastic backed absorbent pads, or general refuse. (e) Treat the waste load containing the challenge
population of spores in a manner consistent with the daily operation of the
autoclave for the treatment of infectious waste including the same temperature,
pressure, time, and total treatable volume. (f) Perform the biological challenge testing at the same
combinations of temperature, pressure, and time, as the validation
testing. (g) Record the following information for each treatment
cycle: (i) The date and time the treatment style
started. (ii) The date and time the treatment cycle
ended. (iii) The temperature and pressure recorded during the
treatment cycle. (iv) The name of the person who loaded the autoclave and the
name of the person performing laboratory analysis of the challenge population
of spores. (v) A diagram depicting the pattern of infectious waste
loading and location of the challenge population of spores during the testing.
Those units that have rotating treatment chambers do not need to be
diagrammed. (vi) The total treatable volume. (vii) The duration, in days, and temperature used for the
incubation of the challenge population of spores, in accordance with the
manufacturer's recommendation for optimal growth. (viii) The results of spore growth during an incubation period
not less than the time specified by the manufacturer of the spore strip or
ampule, 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. (h) Remove and incubate the challenge population of spores
used in the biological challenge testing for not less than the period of time
specified by the manufacturer of the spore strip or ampule. (i) Upon request by Ohio EPA or the approved health
district, perform biological challenge testing in the presence of Ohio EPA or
the approved health district to verify that the written operating procedures in
the facility management plan are sufficient to meet the performance standard
for treatment. (j) If directed by Ohio EPA or the approved health
district, perform biological challenge testing using twice as many spore strips
or ampules in the same locations in the autoclave and allow Ohio EPA or the
approved health district to remove and separately incubate one-half of the
spore strips or ampules. (2) If any of the
challenge population of spores used to perform the testing are positive for
growth at any time during the incubation period, do the following: (a) Conclude that the autoclave has failed to achieve the
performance standard for treatment. (b) Manage the infectious waste placed within the autoclave
during and after the failed biological challenge testing as infectious
waste. (c) Not use the autoclave to treat infectious waste until a
successful biological challenge test has been performed.
View Appendix
Last updated April 7, 2025 at 8:05 AM
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Rule 3745-570-204 | Chemical treatment of cultures with sodium hypochlorite solution.
(A) Methodology. An owner or operator,
small generator, or large generator treating cultures consisting of liquid
culture media or of solid agar media with only surface growth using a sodium
hypochlorite solution shall employ the following methods, techniques, and
practices when using the solution: (1) Use a fifteen per
cent sodium hypochlorite solution volume per volume. [Comment: 2.4 cups of household bleach and 13.6
cups of water makes one gallon of treatment solution.] (2) Submerge or flood the
cultures for a minimum of thirty minutes in the chemical treatment
solution. (3) Mix the treatment solution
immediately prior to use. (4) Decant or absorb excess treatment
solution from the cultures prior to disposal of the culture. (5) Discard the treatment solution after
use. (B) An owner or operator, small
generator, or large generator treating cultures of infectious agents that are
recommended by the centers for disease control and prevention to be handled in
accordance with biosafety level three or level four practices shall not treat
the cultures using this method.
Last updated April 7, 2025 at 8:05 AM
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Rule 3745-570-205 | Ozone exposure treatment.
(A) For the purposes of this rule,
"treatment cycle" means the combination of the minimum time and
minimum ozone concentration necessary for the ozone treatment unit to achieve
the performance standard for treatment. Treatment cycle does not include the
time needed to bring the unit up to the minimum ozone concentration necessary
to achieve the performance standard for treatment. (B) Methodology. The owner or operator
shall operate an ozone treatment unit such that every load achieves the
performance standard for treatment and as follows: (1) Maintain a minimum
concentration of ozone of one thousand five hundred parts per million for sixty
minutes during a treatment cycle. (2) Maintain a different
combination of minimum concentration of ozone and time for which the owner or
operator has demonstrated achievement of the performance standard for treatment
through validation testing performed in accordance with paragraph (D) of this
rule prior to use for the treatment of infectious wastes. (C) The owner or operator shall operate
an ozone treatment unit in accordance with the following: (1) Continuously record
the ozone concentration and time throughout the treatment unit using ozone
recording devices that are capable of producing an instant paper or electronic
record with a real-time display permanently connected to the ozone treatment
unit that continuously displays the ozone concentration and time for visual
monitoring. The owner or operator shall continuously record the temperatures,
pressures, and time using recording devices with a real-time display that are
permanently connected to the autoclave and produces an instant paper or
electronic record. (2) If a recording device
become inoperable, provide proof that repair parts have been ordered if
requested by Ohio EPA or the approved health district and do either of the
following until repairs are made: (a) Manually record the ozone concentration at intervals
that do not exceed five minutes. (b) Discontinue use of the ozone treatment unit for the
treatment of infectious waste until repaired if failure or malfunction occurs
in any ozone recording device. (3) Use an independent
person to calibrate, repair, or replace ozone recording devices in accordance
with either of the following: (a) The manufacturer's maintenance schedule,
specifications, or recommendations. (b) If the manufacturer's maintenance schedule,
specifications, or recommendations are not available, a calibration schedule as
determined by the owner or operator that at a minimum includes annual
calibrations. (4) Ensure that
pathological waste is treated only after receipt of written concurrence from
Ohio EPA in accordance with paragraph (D)(3)(c) of this rule. (D) Validation testing. The owner or
operator shall perform validation testing of an ozone treatment unit in
accordance with paragraph (G) of rule 3745-570-200 of the Administrative Code
and the following: (1) Except as provided in
paragraph (D)(3) of this rule, demonstrate the capability of the ozone
treatment unit to achieve the performance standard for treatment as
follows: (a) Use a challenge population of spores as spore strips
with a population of at least 1.0 x 106 Geobacillus stearothermophilus
spores. (b) Compose the validation testing waste load in a manner
that simulates the most challenging waste load for the ozone treatment
unit. (c) Treat the waste load containing the challenge
population of spores in a manner consistent with the daily operation for the
ozone treatment unit for the treatment of infectious wastes. (d) Record the following information for each treatment
cycle: (i) The ozone
concentration and treatment cycle time that the owner or operator is attempting
to validate for the treatment of infectious wastes. (ii) The date and time
the treatment cycle started. (iii) The date and time
the treatment cycle ended. (iv) The name of the
person who loaded the ozone treatment unit and the name of the person
performing laboratory analysis of the challenge population of
spores. (v) The ozone
concentration during the treatment cycle, as recorded by the permanently
connected ozone recording device. (vi) The duration, in
days, and temperature used for the incubation of the challenge population of
spores, in accordance with the manufacturer's recommendation for optimal
growth. (vii) The results of
spore growth during an incubation period not less than the time specified by
the manufacturer of the spore strip, 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. (e) Remove and incubate the challenge population of spores
used in the validation testing for not less than the period of time specified
by the manufacturer of the spore strip. (f) Upon request by Ohio EPA or the approved health
district, perform validation testing in the presence of Ohio EPA or the
approved health district to verify that the written operating procedures in the
facility management plan are sufficient to meet the performance standard for
treatment. (g) If directed by Ohio EPA or the approved health
district, perform validation testing using twice as many spore strips and allow
Ohio EPA or the approved health district to remove and separately incubate
one-half of the spore strips. (2) If any of the
challenge population of spores used to perform the testing are positive for
growth at any time during the incubation period, do the following: (a) Conclude that the ozone treatment unit has failed to
achieve the performance standard for treatment. (b) Manage the infectious waste placed in the ozone
treatment unit during and after the failed validation testing as infectious
waste. (c) Not use the ozone treatment unit to treat infectious
waste until a successful validation test has been performed. (3) Demonstrate the
capability of the ozone treatment unit to achieve the performance standard for
treatment of pathological waste as defined in this chapter as
follows: (a) Submit a protocol to Ohio EPA for validation testing
that is consistent with this rule and specifically addresses the density of
pathological waste. (b) Conduct the validation testing in accordance with the
approved protocol only after receipt of written approval of the protocol from
Ohio EPA. (c) Submit results of the validation testing to Ohio EPA
for concurrence. (4) Repeat validation
testing if there is a change to the physical structure of the ozone treatment
unit. (E) Biological challenge testing. The
owner or operator shall perform biological challenge testing on an ozone
treatment unit treating infectious waste at a minimum weekly in accordance with
the following: (1) As follows to
demonstrate the capability of the ozone treatment unit to achieve the
performance standard for treatment: (a) Using a challenge population of spores as spore strips
with a population of at least 1.0 x 106 Geobacillus stearothermophilus
spores. (b) Treat the waste load containing the challenge
population of spores in a manner consistent with the daily operation of the
ozone treatment unit for the treatment of infectious wastes at the same
combinations of ozone concentration and time as the validation
testing. (c) Record the following information for each treatment
cycle: (i) The date and time the
treatment cycle started. (ii) The date and time
the treatment cycle ended. (iii) The ozone
concentration recorded during the treatment cycle. (iv) The name of the
person who loaded the ozone treatment unit and the name of the person
performing laboratory analysis of the challenge population of
spores. (v) The duration, in
days, and temperature used for the incubation of the challenge population of
spores, in accordance with the manufacturer's recommendation for optimal
growth. (vi) The results of spore
growth during an incubation period not less than the time specified by the
manufacturer of the spore strip, 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. (d) Remove and incubate the challenge population of spores
used in the biological challenge testing for not less than the period of time
specified by the manufacturer of the spore strip. (e) Upon request by Ohio EPA or the approved health
district, perform biological challenge testing in the presence of Ohio EPA or
the approved health district to verify that the written operating procedures in
the facility management plan are sufficient to meet the performance standard
for treatment. (f) If directed by Ohio EPA or the approved health
district, perform biological challenge testing using twice as many spore strips
in the same locations in the ozone treatment unit and allow Ohio EPA or the
approved health district to remove and separately incubate one-half of the
spore strips. (2) If any of the
challenge population of spores used to perform the testing are positive for
growth at any time during the incubation period, do the following: (a) Conclude that the ozone treatment unit has failed to
achieve the performance standard for treatment. (b) Manage infectious waste placed within the ozone
treatment unit during and after the failed biological challenge testing as
infectious waste. (c) Not use the ozone treatment unit to treat infectious
wastes until a successful biological challenge test has been
performed.
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Rule 3745-570-210 | Alternative infectious waste treatment technology request.
(A) An applicant requesting approval of
an alternative infectious waste treatment technology shall submit the following
to Ohio EPA prior to using the alternative treatment technology to treat
infectious waste: (1) A complete
application describing the alternative infectious waste treatment technology on
forms prescribed by the director that at a minimum includes the
following: (a) Name and address of the company that built the
alternative infectious waste treatment technology. (b) Name, email address, and telephone number of the
applicant. (c) Name, model number, method of treatment, and the
capacity of the treatment unit. (d) A characterization of the alternative infectious waste
treatment technology, including the identification of the element of the
alternative infectious waste treatment technology designed to kill infectious
agents. (e) Any other information the director requests to
demonstrate compliance with this chapter and Chapter 3734. of the Revised
Code. (2) An operating manual
or other treatment technology program logic that describes in detail the
operations of the alternative treatment technology and the critical factors
influencing the treatment capability of the alternative treatment technology,
including but not limited to the waste feed rate, maximum hourly capacity,
residence time, pH, temperature, treatment chemical concentration, and sequence
of treatment events. (3) A copy of the
efficacy testing protocol designed in accordance with rule 3745-570-212 of the
Administrative Code and used to evaluate the capability of the alternative
infectious waste treatment technology to achieve the performance standard for
treatment specified in paragraph (A)(5) of this rule. (4) An efficacy testing
report that complies with paragraph (B) of rule 3745-570-212 of the
Administrative Code and contains the efficacy testing results obtained using
the protocol specified in paragraph (A)(3) of this rule. (5) Documentation demonstrating the
alternative treatment technology achieves a performance standard for treatment
of six log10 reduction of bacterial
spores. (B) Compliance with this rule does not relieve a person of
any obligation to obtain permits or licenses including those specified in
sections 3734.02 and 3734.05 of the Revised Code.
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Rule 3745-570-211 | Approval criteria for issuance of an alternative infectious waste treatment technology approval.
(A) Approval criteria. The director may
approve an application for an alternative infectious waste treatment technology
only if the director determines the following: (1) The applicant
complies with paragraph (A) of rule 3745-570-210 of the Administrative
Code. (2) The use of the alternative treatment
technology is protective of human health, safety, and the
environment. (3) The applicant has
demonstrated that the alternative treatment technology is capable of attaining
the performance standard for treatment specified in rule 3745-570-210 of the
Administrative Code. (B) Alternate infectious waste treatment
approval. At a minimum, an approval for an alternative infectious waste
treatment technology shall include the following: (1) A description of the
alternative treatment technology and its design and a notice that any changes
to the design render the approval inapplicable. (2) The treatment
parameters for operating the treatment unit during the treatment of infectious
waste and the requirements for continuous monitoring of those treatment
parameters. (3) A requirement that
the applicant include an operating manual with each distributed treatment unit
that includes a copy of the approval letter. (4) The operational
procedures to be followed by the owner and operator during the use of the
alternative treatment technology including any prohibitions of specific
categories of infectious wastes. (5) A biological
challenge testing and validation testing obligation to ensure that the
alternative treatment technology is achieving the applicable performance
standard for treatment. (6) Record keeping
requirements, which may include but are not limited to treatment parameters,
monitoring documentation, and biological challenge testing
results. (7) Measures to be
utilized to manage infectious waste in the event that the alternative treatment
technology fails to achieve the performance standard for treatment specified in
rule 3745-570-210 of the Administrative Code. (8) Any other conditions or requirements
that the director deems appropriate in order to ensure that the approved
alternative treatment technology will be capable of achieving the performance
standard for treatment specified in rule 3745-570-210 of the Administrative
Code and that the treatment technology will be capable of being operated in a
manner that is protective of human health, safety, and the
environment. (9) A statement that the approval
authorizes the use of the alternative treatment technology only when both of
the following are satisfied: (a) The alternative treatment technology is designed as set
forth in the approval. (b) The alternative treatment technology is used to treat
only the types and volumes of waste streams that were tested in accordance with
rule 3745-570-212 of the Administrative Code and for which testing results were
provided as part of the application. (10) A description of the
types and volumes of waste streams for which the alternative infectious waste
treatment technology has been tested against in accordance with rule
3745-570-212 of the Administrative Code. (C) The director may deny an application
for an alternative infectious waste treatment technology if any of the
following occur: (1) Not later than one
hundred eighty days after being notified of deficiencies, the applicant has not
corrected noted deficiencies and resubmitted the application. (2) The applicant has
notified Ohio EPA that the application is being withdrawn. (3) Any of the approval
criteria set forth in paragraph (A) of this rule have not been
satisfied. (4) The applicant has not
demonstrated sufficient reliability, expertise, and competency to operate an
infectious waste treatment technology in a manner that is protective of human
health, safety, and the environment. (D) Revocation. The director may revoke any alternative
infectious waste treatment technology approval when any of the following has
occurred or is likely to occur: (1) The use or operation
of the alternative infectious waste treatment technology has resulted or is
likely to result in a violation of any applicable law. (2) The application
contained false or incorrect information. (3) Under actual
operation, the technology consistently fails to attain the performance standard
for treatment as specified in rule 3745-570-210 of the Administrative
Code. (4) The applicant has
changed the design of the approved technology such that the equipment no longer
meets the originally submitted specifications. (5) The use of the
technology causes or threatens to adversely affect, or has adversely affected
human health, safety, or the environment. (6) The applicant does
not exhibit sufficient reliability, expertise, and competency to operate the
infectious waste treatment technology in a manner that is protective of human
health, safety, and the environment. (7) The applicant failed
to timely submit an analysis required by rule 3745-570-213 of the
Administrative Code. (8) The analysis
submitted pursuant to rule 3745-570-213 of the Administrative Code demonstrates
that the alternative infectious waste treatment technology no longer meets the
performance standard for treatment under this chapter. (E) Notwithstanding any other provision
of this chapter, when issuing, denying, or revoking an alternative infectious
waste treatment technology approval, the director may consider the actual
performance history of a technology that has been used or approved for use
outside of Ohio.
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Rule 3745-570-212 | Alternative infectious waste treatment technology efficacy testing.
(A) An applicant for an alternative
infectious waste treatment technology approval shall ensure that the efficacy
testing protocol is designed to evaluate whether the alternative treatment
technology used by the treatment unit is capable of achieving the performance
standard for treatment set forth in rule 3745-570-210 of the Administrative
Code, complies with the appendix to this rule, and includes the
following: [Comment: It is strongly recommended that the
applicant submit the proposed efficacy testing protocol to Ohio EPA prior to
testing. Upon request, Ohio EPA will review and provide comments on the
protocol.] (1) Using sound
scientific microbial techniques that at a minimum include the
following: (a) Enumeration of all stock suspensions. (b) Enumeration of a representative sampling of
carriers. (c) Placement of all samples and controls into buffered
diluent. (d) Performance of a minimum of three test runs with a
minimum of three samples for each microorganism and control. (e) Collection of all samples and controls immediately upon
completion of the treatment cycle. (f) Neutralization of the collected samples and applicable
controls immediately upon collection from the treatment unit, if the treatment
technology utilizes chemical treatment. (g) Homogenization of each dilution immediately prior to
withdrawing an aliquot for plating or continued dilution. (h) Inoculation of the growth media immediately with the
dilutions of processed waste samples and applicable controls, unless immediate
inoculation is not possible. (i) If immediate inoculation is not possible, place the
samples 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, and then immediately inoculate in accordance with paragraph (A)(1)(h)
of this rule. (j) Plating of dilutions in triplicate. (k) Utilization of only microbial plates that contain
between thirty and three-hundred colonies. (l) 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. (m) If the difference between the plate counts of the
replicate plates in a single run has a quantitative difference of greater than
five per cent between them, test another waste load for that particular
bacterial spore. 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. (n) If any of the three test runs has a quantitative
difference of greater than ten per cent between them, test another waste load
for that series. If any one of the three test run plate dilution series has a
quantitative difference of greater than ten per cent between them, the test run
is considered invalid. (2) Using a bacterial
spore species selected from Table 1 of this rule that is the most resistant to
the treatment technology as the challenge microorganism, subject to concurrence
by Ohio EPA, using the "D" value as appropriate. | Geobacillusstearothermophilus. | | Bacillus subtilis. | | Bacillus atrophaeus. | | Any other bacterial spore species that isdetermined to be resistant to all aspects of the treatmenttechnology. |
(3) Conducting a recovery
test run prior to efficacy testing to determine the amount of bacterial spore
loss as a result of the physical aspects of the treatment unit and the ability
of the treatment unit to retrieve the bacterial spores from the waste or
carrier. The applicant shall use a sufficient number of challenge
microorganisms in the recovery test run such that the challenge microorganisms
can be retrieved using one of the following methods to quantify the results for
each test waste load: [Comment: The percent number of recoverable
microorganisms (%R) calculations are contained in the appendix to this
rule.] (a) Direct inoculation technique. Directly inoculate the
infectious waste with enough liquid suspension containing the appropriate
bacterial spores to give an adjusted theoretical challenge, calculated in
accordance with the appendix to this rule, of at least 1.0 x 107 bacterial spores per gram of waste, or per
milliliter of waste if the technology is designed to treat liquid infectious
waste. (b) Carrier system technique. Inoculate the infectious
waste with enough recoverable carriers, such as bacterial spore strips,
containing the appropriate bacterial spores to give an adjusted theoretical
challenge, calculated in accordance with the appendix to this rule, of at least
1.0 x 107 bacterial spores per
gram of waste. (4) Testing only waste
loads that satisfy the following: (a) Are representative of the waste stream that the
alternative treatment technology is designed to treat. (b) Are of sufficient volume to simulate operation of the
treatment unit at full capacity. (c) Are composed such that the test waste load poses the
greatest challenge to the alternative treatment technology. (d) For those alternative treatment technologies that are
designed to treat a specific category of infectious waste, are composed
entirely of the specific infectious waste category that the alternative
treatment technology is designed to treat. (e) For those alternative treatment technologies that are
designed to treat every category of infectious waste but are sensitive to
particular combinations or individual items contained in a waste stream, are
composed entirely of the combination or individual item of that specific
infectious waste category that poses the greatest challenge to that alternative
treatment technology. [Comment: An example of an alternative
treatment technology that would use a test waste load as outlined in this
paragraph 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 need to use test waste loads composed of one hundred per cent
organics. This testing would challenge the treatment technology in a
"worst-case" scenario.] (f) Are comprised entirely of new or unused representative
materials or of infectious waste sterilized by autoclaving and cooled to
ambient temperature prior to inoculation. (5) Inoculation
procedures to ensure the applicant prepares each test waste load in accordance
with paragraph (A)(4) of this rule and the following: (a) Distributes the inoculum evenly throughout the test
waste load such that the ratio of the volume of inoculum to the amount of waste
is not less than one to twenty, or five per cent. (b) Introduces the appropriate challenge microorganisms or
inoculum as follows: (i) Using a microbial
suspension to seed the test waste load with the sufficient number of challenge
microorganisms determined in accordance with paragraph (A)(3) of this
rule. (ii) Using a carrier
system to introduce one carrier with the appropriate inoculum for each ten
pounds of infectious waste in the test waste load with a minimum of three
carriers in each test waste load, with all carriers distributed evenly
throughout the waste load. (6) Enumeration
procedures to ensure the applicant enumerates either the initial inoculum in
the stock suspension or a representative sample of carriers as
follows: (a) For the stock suspension, the following: (i) Enumerate all initial
stock suspensions of bacterial spores and control suspensions immediately prior
to introduction into the test waste load. (ii) Inoculate the test
waste load immediately prior to introduction into the treatment
unit. (iii) Use the stock
suspension number obtained from enumerating the stock suspensions in accordance
with paragraph (A)(3) of this rule to determine the theoretical challenge and
the adjusted theoretical challenge for each test run in accordance with the
appendix to this rule. (b) For a carrier system, the following: (i) Verify the inoculum
contained on a representative sample of carriers using the manufacturer's
lot enumeration. (ii) Determine the
theoretical challenge for each microorganism and the adjusted theoretical
challenge for each test run in accordance with the appendix to this
rule. (7) Procedures to ensure
the applicant performs treatment test runs in accordance with the appendix to
this rule to evaluate the treatment unit using bacterial spore suspensions or
spore carriers that do the following: (a) Use full-scale production units for all
testing. (b) Use a sufficient number of representative samples in
each treatment test run by evaluating the following factors: (i) The total treatment
capacity. (ii) Whether the
alternative treatment technology is a batch or continuous treatment
process. (iii) The physical state
of the processed infectious waste, such as loose or conglomerated. (iv) The results of the
recovery test run performed in accordance with paragraph (A)(3) of this
rule. [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.] (c) Use a minimum of three treatment test
runs. (d) Meet the performance standard for treatment specified
in rule 3745-570-210 of the Administrative Code at the completion of all three
test runs. (8) A permanent record of
the following observations or recordings: (a) The date and time that each test waste load is placed
into the treatment unit. (b) The date and time that each sample is retrieved from
the treatment unit. (c) The applicable observed or recorded operational
parameters at which the treatment unit was operated. (9) Procedures to ensure
the applicant manages the samples collected from each test run upon exit of the
treatment unit in accordance with the following: (a) Neutralizes, if applicable, all controls and samples
immediately upon exiting the treatment unit using a documented or previously
tested neutralizer that will not affect the viable number of bacterial spores
being tested. (b) Cools all samples and controls to ambient temperature
upon exiting the treatment unit and prior to preparation of the
dilutions. [Comment: The use of a buffered diluent will
satisfy the requirement of cooling and preparation of the dilutions. This
requirement need not be a two-step process.] (c) Prepares dilutions from each collected
sample. (B) Efficacy testing report. The
applicant shall ensure the test manager responsible for conducting the efficacy
testing prepares an efficacy testing report that presents the raw data and
results gathered in accordance with the protocol as specified in paragraph (A)
of this rule and at a minimum contains the following: (1) An introduction
describing the intent of the efficacy testing including the name, address, and
telephone number of the laboratory and the name of the test
manager. (2) Testing parameters
and all results based upon a protocol that complies with paragraph (A) of this
rule. (3) Sufficient
information so that the reported results and procedures can be reproduced by an
independent laboratory. (4) A description of all
materials and methods used to perform the efficacy testing, subsequent dilution
of samples, and incubation of samples. (5) All raw data
including all individual microbial counts. (6) Log10 reduction levels achieved for the bacterial
spores obtained from the efficacy testing of the three test waste loads that
achieved the performance standard for treatment specified in rule 3745-570-210
of the Administrative Code. (7) An example of each
calculation used to determine the log10 reduction levels using the formulas found in
the appendix to this rule. (8) Documentation of the
ability of the treatment technology to achieve the performance standard for
treatment as specified in rule 3745-570-210 of the Administrative
Code. (9) A statement, signed
and certified in accordance with rule 3745-500-50 of the Administrative Code,
documenting that the efficacy testing was conducted in compliance with an
efficacy testing protocol that complies with this rule.
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Rule 3745-570-213 | Alternative infectious waste treatment technology ten year update.
(A) Any person with an approval for an
alternative infectious waste treatment technology that was issued prior to the
effective date of this rule who wishes to continue to treat infectious waste as
authorized by that approval shall submit to Ohio EPA, not later than one
hundred eighty days after the effective date of this rule, an analysis
comparing the efficacy of the alternative infectious waste treatment technology
to the performance standard for treatment under this chapter. (B) Beginning on the effective date of
this rule, any person with an effective alternative infectious waste treatment
technology approval shall submit to Ohio EPA an analysis comparing the efficacy
of the alternative infectious waste treatment technology to the performance
standard for treatment in the chapter as follows: (1) For an alternative
infectious waste treatment technology issued prior to the effective date of
this rule, on each tenth anniversary of the date that the analysis was
submitted in accordance with paragraph (A) of this rule or the date that is one
hundred eighty days after the effective date of this rule, whichever is
sooner. (2) For an alternative
infectious waste treatment technology issued pursuant to this chapter, on each
tenth anniversary of the date the initial approval was issued. (C) If, based on an analysis submitted pursuant to this
rule, the director determines that the alternative infectious waste treatment
technology no longer achieves the performance standard for treatment under this
chapter, the director may require the person to make the necessary changes to
bring the alternative infectious waste treatment technology into compliance
with the standards in the current version of rule 3745-570-210 of the
Administrative Code and submit the alternative infectious waste treatment
technology for approval in accordance with this chapter.
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Rule 3745-570-219 | Infectious waste treatment facilities - permit and license provisions.
(A) No person shall establish a new infectious waste
treatment facility or modify an existing infectious waste treatment facility
without first obtaining both a permit to install from the director in
accordance with this chapter and a license issued by the licensing authority in
accordance with Chapter 3745-501 of the Administrative Code that includes a
notation to treat infectious waste, as applicable. (B) An owner or operator shall obtain, maintain, and comply
with all effective permits to install, licenses, orders, and other
authorizations issued in accordance with Chapter 3734. of the Revised Code and
the rules adopted thereunder. (C) An owner or operator shall obtain, maintain, and comply
with all applicable authorizations as specified in Chapters 3704., 3734., and
6111. of the Revised Code. (D) Paragraphs (A) and (E) of this rule do not apply to an
owner or operator who meets any of the following: (1) An owner or operator
who is the generator of the infectious waste and exclusively treats infectious
waste that is generated at any premises owned or operated by that generator
utilizing methods, techniques, and practices established by rules adopted under
this chapter. (2) A hospital, as
defined in section 3727.01 of the Revised Code, that exclusively accepts
infectious wastes for treatment that are generated by any of the following and
treats those wastes utilizing methods, techniques, and practices established by
rules adopted under this chapter: (a) 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 the hospital. (b) An emergency medical service organization, as defined
in section 4765.01 of the Revised Code, providing care to a
patient. (c) An individual for purposes of the individual's own
care or treatment. (3) A crematory facility
licensed under Chapter 4717. of the Revised Code and permitted under Chapter
3704. of the Revised Code. (4) A unit of a hazardous
waste facility for which a hazardous waste facility installation and operation
permit is required by Chapter 3734. of the Revised Code. (E) Ten year design demonstration. The owner or operator
shall submit to Ohio EPA, upon every tenth anniversary of the effective date of
the permit to install that approved initial construction of the facility, an
analysis comparing the infectious waste treatment facility to the regulatory
requirements under this chapter. If the director determines the analysis
demonstrates that the infectious waste treatment facility is no longer
consistent with regulatory requirements under this chapter, then the director
may require the owner or operator to obtain the appropriate authorization from
Ohio EPA to make the necessary changes to bring the infectious waste treatment
facility into compliance with the standards in the current version of this
chapter. If these changes will result in deviations from what is contained in
the current authorizing document, the owner or operator shall obtain the
appropriate authorization from the director prior to making the changes. If a
permit to install application is necessary, the director shall not apply the
siting criteria outlined in paragraphs (C)(3) and (C)(4) of rule 3745-570-221
of the Administrative Code.
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Rule 3745-570-220 | Infectious waste treatment facility permit to install application.
(A) A person proposing to establish or
modify an infectious waste treatment facility, including a solid waste
incinerator that also treats infectious waste, shall submit a permit to install
application and any subsequent revisions to the director and the approved
health district where the facility is or will be located that contains at a
minimum the following: (1) The plan sheets and
narratives as specified in paragraphs (C) and (D) of this rule that are
sufficiently detailed to allow clear understanding and technical review of the
permit application, provide assurance that the facility is designed and will be
operated in accordance with this chapter, and are readily understandable by
operating personnel at the infectious waste treatment facility. (2) A written statement
from each person who holds title to the land on which the infectious waste
treatment facility is or will be located that each titleholder acknowledges
that the applicant is submitting a permit to install application and may use
the land for the purpose of establishing or operating an infectious waste
treatment facility. (3) Copies of the letters of intent and
mail receipts as specified in paragraph (E)(3) of this rule. (4) A certification statement and
signature in accordance with rule 3745-500-50 of the Administrative
Code. [Comment: Section 3734.05 of the Revised Code
provides information regarding timeframes and fees associated with permit to
install applications.] (B) The applicant shall be the owner or
operator of the infectious waste treatment facility. (C) Detail engineering plans, specifications, and
information shall be shown on plan sheets by means of drawings and narrative
descriptions where appropriate and be signed and sealed by a professional
engineer. An individual plan drawing may contain information specified in more
than one individual subheading. At a minimum, the detail engineering plans,
specifications, and information shall be on plan drawings with minimum
dimensions of twenty-four inches by thirty-six inches and include the
following: (1) A cover sheet,
numbered sheet 1, that contains the following information: (a) The name of the infectious waste treatment
facility. (b) The precise geographical location and boundaries of the
infectious waste treatment facility and the one-thousand-foot radius around the
property line, shown on a road map. (c) The name, address, and telephone number of both the
applicant and the operator of the infectious waste treatment
facility. (d) The name and address of each owner of the land to be
used for the infectious waste treatment facility. (e) The name and address of the person who prepared the
plans. (f) An index of the plan sheets. (2) Plan sheets, numbered
consecutively as sheets 2A, 2B, 2C, etc. that contain plan drawings with
information specified in an individual subheading on the same plan drawing and
a scale of one inch equals no greater than two hundred feet. The plan drawings
shall show the following items located within one thousand feet of the limits
of the infectious waste treatment handling area: (a) The property lines of all land owned or leased for the
infectious waste treatment facility as determined by a property survey
conducted by a professional surveyor registered in Ohio as evidenced by the
signature and seal of the professional surveyor. (b) All public roads and railroads. (c) All existing land uses, zoning classifications,
property owners, political subdivisions, and communities. (d) Existing topography showing vegetation and surface
waters of the state with a contour interval no greater than five
feet. (e) All existing occupied dwellings. (f) The north arrow. (3) Plan sheets, numbered
consecutively as sheets 3A, 3B, 3C, etc. that contain plan drawings with the
following items specified in an individual subheading on the same plan drawing
and a scale of one inch equals no greater than fifty feet: (a) The location of all existing or proposed infectious
waste treatment buildings, storage facilities, and occupied
structures. (b) The location of existing or proposed utilities
including water, sewerage and sewage treatment, electricity, gas, and telephone
or other utility company easements on or bordering the facility. (c) The location of all fencing, gates, natural screening,
and other screening on the site. (d) The location of the infectious waste handling
areas. (e) The location of the treatment units. (f) The location of container wash systems. (g) The location of treated infectious waste
storage. (h) The location of the drainage structures. (i) The location of spill containment and clean-up
kits. (j) The location of fire extinguishers and other fire
response equipment. (4) Plan sheets, numbered
consecutively as sheets 4A, 4B, 4C, etc. showing the plan view, front view, and
profile view of each treatment unit with sufficient detail to provide full
understanding of the design and operation of each treatment unit. (5) For an incinerator
subject paragraph (C)(4) of rule 3745-570-221 of the Administrative Code, plan
drawings that clearly delineate all infectious waste handling areas showing
both of the following: (a) The distance between the infectious waste handling
areas and the property line of the premises on which the infectious waste
treatment facility will be located. (b) All domiciles, schools, jails, and prisons located
within one thousand feet of the infectious waste handling areas. (D) The following information shall be presented in
narrative form and signed and sealed by a professional engineer: (1) A summary of how the
infectious waste treatment facility will meet the standards and requirements in
this chapter, including the treatment methodology, validation and biological
challenge testing, and any other waste management issues specified in this
chapter. (2) A discussion of the
following information: (a) The treatment method, operational criteria, and how the
treatment parameters, validation testing, and biological challenge testing
demonstrate the achievement of the performance standard for
treatment. (b) The identification and utilization of all existing or
proposed treatment buildings, storage facilities, and occupied
structures. (c) The utilization of all fencing, gates, natural
screening, and other screening at the infectious waste treatment
facility. (d) The utilization of infectious waste handling areas
including but not limited to how the owner or operator will comply with rule
3745-570-31 of the Administrative Code. (e) The utilization and drainage of the decontamination
area. (f) The infectious waste treatment facility operating
hours. (g) The functions, qualifications, training, and
certification of staff handling infectious waste. (h) The format and use of the daily log including
identifying all operational and maintenance procedures performed and the
sources of related service and parts. (i) The design and function of the collection system for
ash or other byproducts of the treatment process. (j) The handling and disposal of particulates captured by
the air pollution control system. (k) The method used to distinguish hazardous waste as
defined in rule 3745-50-10 of the Administrative Code. (l) The method used to distinguish infectious waste that is
also radioactive waste regulated by the Ohio department of health or the U. S.
nuclear regulatory commission. (m) The names and addresses of all third parties contracted
to implement validation or biological challenge testing
activities. (n) The accident or spill containment and clean-up
procedures. (o) The facility contingency plan specified in rule
3745-570-200 of the Administrative Code. (p) The coordination with the local fire department,
emergency management officials, and police department in the event of an
emergency. (E) Concurrent to submitting the permit
application, the applicant shall also do the following: (1) If the infectious
waste treatment facility is an off-site facility as defined in section 3734.41
of the Revised Code, submit a disclosure statement to the attorney
general's office as specified in rules 109:6-1-01 to 109:6-1-04 of the
Administrative Code. (2) Submit a license
application to the licensing authority in accordance with Chapter 3745-501 of
the Administrative Code. (3) Mail letters of intent via certified
mail or any other form of mail accompanied by a receipt that describe the
intended establishment or modification of an infectious waste treatment
facility and include a description of property and infectious waste treatment
facility boundaries to the following entities: (a) The governments of the general purpose political
subdivisions where the infectious waste treatment facility is located including
but not limited to county commissioners, the legislative authority of a
municipal corporation, or the board of township trustees. (b) The single or joint county solid waste management
district or regional solid waste management authority where the infectious
waste treatment facility is located or that is served by the infectious waste
treatment facility. (c) The owner or lessee of any easement or right of way
bordering or within the proposed infectious waste treatment facility boundaries
that may be affected by the infectious waste treatment facility. (d) The local zoning authority having
jurisdiction. (4) Submit to the
director the nonrefundable application fee as established in Chapter 3734. of
the Revised Code. (F) If the director determines that
additional information is necessary, including additional and identically
complete copies of the permit to install application, the applicant shall
supply such information as a precondition to further consideration of the
permit to install application.
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Rule 3745-570-221 | Permit to install issuance.
(A) When acting on a permit to install,
the director shall follow the appropriate procedures set forth in rule
3745-500-120 of the Administrative Code. (B) Notwithstanding any deficiency, an
application for a permit to install may be considered and acted upon if
sufficient information is contained in the detail engineering plans,
specifications, and information for the director to determine whether the
criteria set forth in this rule are satisfied. (C) The director shall not approve any
permit to install application unless the director determines the
following: (1) Establishment or
modification and operation of the infectious waste treatment facility will not
violate Chapter 3704., 3714., 3734. or 6111. of the Revised Code. (2) The owner or operator is capable of
operating the infectious waste treatment facility in compliance with Chapters
3704., 3714., 3734., 3745., and 6111. of the Revised Code. (3) The owner or operator is capable of
constructing, operating, and closing the infectious waste treatment facility in
accordance with the terms and conditions of the permit to install and this
chapter. (4) The location of the infectious waste
treatment facility is not located within any of the following: (a) The boundaries of a regulatory floodplain. (b) The boundaries of a floodplain as determined by the
applicant based upon a design storm equal to the 100-year 24-hour rainfall
event, defined in "Rainfall Frequency Atlas of the United States" and
using standard methodologies set forth in "Urban Hydrology for Small
Watersheds" and section four of the "National Engineering Hydrology
Handbook" when no regulatory floodplain designation exists. (5) A permit to install application for
the installation of a new incinerator demonstrates that infectious waste
handling areas are not located within any of the following: (a) Three hundred feet of the property line. (b) One thousand feet of an occupied dwelling, school,
jail, or prison in existence on the date the application for the permit to
install is submitted. (6) The owner and operator of the
infectious waste treatment facility are in substantial compliance with, or on a
legally enforceable schedule through issuance of an administrative order or
judicial order to attain compliance with, Chapters 3704., 3714., 3734., 3745.,
and 6111. of the Revised Code at solid waste facilities, infectious waste
treatment facilities, construction and demolition debris facilities, and
construction and demolition debris processing facilities they own or operate,
and are in substantial compliance with all applicable orders issued by the
director, the environmental review appeals commission, or courts having
jurisdiction in accordance with Chapter 3746-13 of the Administrative
Code. (7) The applicant meets the requirements
of sections 3734.40 to 3734.47 of the Revised Code and the rules adopted
thereunder. (D) The director may consider at a
minimum the following when determining whether or not to approve a permit to
install application for an infectious waste treatment facility: (1) The social and
economic impact of the air contaminants, water pollutants, or other adverse
environmental impact that may be a consequence of issuance of the permit to
install. (2) The impact the
proposed or modified infectious waste treatment facility may have on corrective
actions that have been taken, are presently being taken, or are proposed to be
taken in the immediate area. (E) The permit to install shall remain in
effect until the director has received, and concurred with in writing,
certification that all closure activities have been completed, unless the
permit has been terminated in accordance with rule 3745-500-330 of the
Administrative Code or revoked in accordance with rule 3745-500-350 of the
Administrative Code or for other lawful grounds. (F) Incorporation by reference. The text of the
incorporated materials is not included in this rule and is hereby made a part
of this rule. Only the specific version specified in this rule is incorporated.
Any amendment or revision to a referenced document is not incorporated until
this rule has been amended to specify the new version. The availability of
these documents is provided below; however, many of the documents are also
available for inspection and copying at most public libraries and "The
State Library of Ohio." As used in this rule: (1) "National Hydrology Engineering Handbook,"
included in the United States department of agriculture, natural resources
conservation service publication, "National Engineering Handbook,"
updated March 2020. The full text is available in electronic format at:
https://directives.sc.egov.usda.gov/viewerfs.aspx?hid=21422. (2) National oceanic and atmospheric administration,
national weather service publication, "Rainfall Frequency Atlas of the
United States," updated 2006. The full text is available in electronic
format at:
https://www.weather.gov/media/owp/hdsc_documents/Atlas14_Volume2.pdf. (3) United States department of agriculture, natural
resources conservation service technical release number 55, "Urban
Hydrology for Small Watersheds," updated June 1986. The full text is
available in electronic format at:
https://www.nrc.gov/docs/ML1421/ML14219A437.pdf.
Last updated April 7, 2025 at 8:07 AM
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Rule 3745-570-222 | Closure of an infectious waste treatment facility.
(A) The owner or operator shall comply
with this rule as follows: (1) For an owner or
operator that is excepted from obtaining a permit and license pursuant to this
chapter and Chapter 3745-501 of the Administrative Code, paragraphs (C)(1),
(C)(4), (C)(5), and (D) of this rule. (2) For an owner or
operator that is subject to the license requirements contained in Chapter
3745-501 of the Administrative Code, paragraphs (B) to (D) of this
rule. (3) For an owner or
operator that maintains a solid waste license with an infectious waste notation
in accordance with section 3734.05 of the Revised Code, paragraphs (B) to (D)
of this rule for the infectious waste operations. (B) Closure of an infectious waste treatment facility is
mandatory when one or more of the following apply: (1) The owner or operator
declares in writing to Ohio EPA or the approved health district that the
infectious waste treatment facility will permanently cease treating infectious
waste. (2) The infectious waste
treatment facility ceases to treat infectious waste for a period of three
hundred sixty-five days. (3) The owner or operator physically
removes the infectious waste treatment unit, unless the owner or operator has
multiple infectious waste treatment units and still treats infectious waste
with the remaining infectious waste treatment units. (4) The issued infectious waste treatment
facility license has expired and the owner or operator has not applied for a
renewal license in accordance with Chapter 3745-501 of the Administrative
Code. (5) The issued infectious waste treatment
facility license has expired and another license has been applied for and
denied as a final action of the licensing authority. (6) The issued infectious waste treatment
facility license has been revoked as a final action of the licensing
authority. (C) The owner or operator shall perform closure as
follows: (1) For an owner or
operator described in paragraph (A)(1) of this rule, comply paragraph (D) of
rule 3745-570-125 of the Administrative Code. (2) If closure is triggered in accordance
with paragraph (B)(1), (B)(2), or (B)(3) of this rule, submit a written notice
by certified mail or any other form of mail accompanied by a receipt not later
than thirty days prior to the date the facility will cease infectious waste
treatment to the following: (a) The appropriate Ohio EPA district office. (b) The approved health district. (c) All generators and transporters who have used the
infectious waste treatment facility in the past six months. (3) If closure is triggered in accordance
with paragraph (B)(4), (B)(5), or (B)(6) of this rule, send written notice by
certified mail or any other form of mail accompanied by a receipt not later
than seven days after the final action to all generators and transporters who
have used the facility in the past six months. (4) Not later than fourteen days after
the facility has ceased to accept infectious waste, remove all untreated
infectious wastes from the facility and transport the infectious waste to a
treatment facility that is in compliance with applicable state and federal
laws. (5) Not later than thirty days after the
facility has ceased to accept infectious waste, thoroughly clean the infectious
waste treatment facility by completing at a minimum the following: (a) Washing all areas of the facility including but not
limited to containers, equipment, machines, floors, and facility surfaces that
were in contact with untreated infectious wastes at any time during the
operation of the facility using one of the following
disinfectants: (i) An unexpired
tuberculocidal hospital disinfectant registered with the United States
environmental protection agency, for a contact time specified by the
manufacturer. (ii) A minimum ten per cent sodium/potassium hypochlorite
solution prepared immediately prior to use for a minimum contact time of thirty
minutes. (b) Remove and properly dispose of any quench pit or water
tank residue and liquids remaining at the facility. (c) Submit the most recent facility management plan to Ohio
EPA. (d) Post signs, in a manner as to be easily visible at all
access points into the infectious waste treatment facility, stating in letters
not less than three inches high that the infectious waste treatment facility is
closed and ensure that the signs are maintained in legible condition for not
less than six months and read as follows: "This facility is closed for all
infectious waste treatment activities." (D) Not later than thirty days after completing closure in
accordance with this rule and before the closed infectious waste treatment
facility may be converted to other uses, the owner or operator shall submit
written certification that includes a statement and signature in accordance
with rule 3745-500-50 of the Administrative Code, stating the infectious waste
treatment facility has been closed in accordance with this rule to the
appropriate Ohio EPA district office and to the approved health
district. (E) Closure of the infectious waste
treatment facility shall be deemed complete when the owner or operator receives
written concurrence with the closure certification from Ohio EPA.
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