(A) Each generator of less than fifty pounds
of infectious waste in any one month (small generator) shall:
(1) Identify and separate infectious from
non-infectious waste at the point of generation for the purposes of determining
whether the generator must comply with paragraph (B) of this rule;
(2) Place
all of
the following
sharp infectious wastes in
a "sharps" container
, as defined in paragraph (B) of
rule 3745-27-34 oftheAdministrativeCode:
.
(a) Sharp infectious wastes as
defined in rule 3745-27-01 oftheAdministrativeCode and paragraph (C)(1) of this
rule; and
(b) All unused discarded hypodermic
needles, syringes, and scalpel blades; and
(c) All discarded hypodermic
needles, syringes, and scalpel blades used by the generator that are not
infectious wastes as defined in rule 3745-27-01
oftheAdministrativeCode.
(3)
(a)
Either treat all specimen cultures and cultures of viable infectious agents on
the premises where they are generated to render them noninfectious by any of
the methods, techniques, or practices prescribed by paragraph (B) of rule
3745-27-32 of the Administrative
Code before they are transported off that premises for disposal; or
(b) Ensure that such wastes are treated to
render them noninfectious at a treatment facility off that premises that is
owned or operated by the generator, a treatment facility that holds a license
issued under division (B) of section
3734.05 of the Revised Code, a
treatment facility that is authorized by rule
3745-27-32 of the Administrative
Code, prior to disposal of the wastes, or a facility in another state operating
in compliance with state and federal regulations.
(4) Not be considered a treatment facility as
"treatment" and "facility" are defined in section
3734.01 of the Revised Code when
the generator treats specimen cultures and cultures of viable infectious agents
on the premises where they are generated. Such treated cultures may be
transported and disposed of in the same manner as solid wastes and need not
comply with the
shipping
disposal paper
system as described in
paragraph (C) of rule
3745-27-33 of the Administrative
Code;
(5) Quantify the waste
generation rate and keep records recorded in pounds. This generation rate and
record shall pertain to the aggregate quantity of waste generated on the
premise owned or operated by the generator on a calendar month basis. Upon
request of the board of health or its authorized representative, or the
director or his authorized representative, the generator shall provide
information regarding the infectious waste generation rate, the generator shall
quantify and record the monthly generation rate
utilizing one of the following:
. A monthly generation rate log shall display the month and
the weight of all the infectious waste generated on the premises during that
calendar month.
(a) A monthly generation rate log
which shall display the month and the weight of all the infectious waste
generated on the premises during that calendar month; or
(b) Treatment shipping papers that
have the weight of all the infectious waste that is generated and sent for
treatment documented in pounds for a calendar month; or
(c) A combination of a monthly
generation rate log and treatment shipping papers to document the monthly
generation rate if the generator does not send all infectious wastes generated
on the premises for treatment. A generator shall indicate on the monthly
generation rate log when this combination is being used. The treatment shipping
papers shall be affixed to the corresponding generation rate log page for the
indicated month. The mathematical calculation from the log page and the
treatment shipping papers shall be clearly indicated on the log
page.
(6)
Determine by monthly records, required by paragraph (A)(5) of this rule, if
fifty pounds or more of infectious waste is generated. If fifty pounds or more
of infectious waste is generated in any one month the generator shall register
with the
director
Ohio environmental protection agency as a generator of
infectious waste on the forms prescribed by the director and as outlined in
paragraph (A) of rule
3745-27-36 of the Administrative
Code. Generator registration certificates shall apply to premises and shall not
include emergency vehicles or public safety vehicles; and
(7) Comply with paragraph (C) of this rule.
A generator who complies with paragraph (A)(2) of this rule and
who generates less than fifty pounds of infectious wastes each month and does
not hold a certificate of registration as a generator of infectious wastes may
transport and dispose of infectious wastes
in the same manner as solid wastes.
(B) Each generator of infectious wastes
holding a certificate of registration under paragraph (A) of rule
3745-27-36 of the Administrative
Code, and any other person who generates fifty pounds or more of infectious
wastes in any one month (large generator), shall:
(1) Segregate infectious wastes from other
wastes at the point of generation. At a minimum, infectious wastes shall be
placed in separate containers,
in accordance with
rule 3745-27-34 oftheAdministrativeCode, from other wastes until
rendered non-infectious;
(2) Place infectious wastes other
than "sharps" in red or conspicuously labeled plastic bags labeled with the
international biohazard symbol in accordance with paragraph (A) of rule
3745-27-34 oftheAdministrativeCode;
(3)
(2)
Place
all of the
following
sharp infectious wastes in a
"sharps" container
, as defined in paragraph (B) of
rule 3745-27-34 oftheAdministrativeCode:
;
(a) Sharp infectious wastes as
defined in rule 3745-27-01 oftheAdministrativeCode and paragraph (C)(1) of this
rule; and
(b) All unused discarded hypodermic
needles, syringes, and scalpel blades; and
(c) All discarded hypodermic
needles, syringes, and scalpel blades used by the generator that are not
infectious wastes as defined in rule 3745-27-01
oftheAdministrativeCode.
(4)
(3)
Not grind any sharp infectious wastes, not
compact any such wastes until after the wastes have been treated in accordance
with rule
3745-27-32 of the Administrative
Code and not compact or grind any other type of infectious wastes until after
the wastes have been treated in accordance with rule
3745-27-32 of the Administrative
Code;
(5)
(4)
Dispose of the
infectious wastes at a solid waste disposal facility holding a license issued
under division (A) of section
3734.05 of the Revised Code,
after being treated to render them non infectious by either:
(a) Treating the infectious waste that is
generated at a facility owned or operated by the generator by any of the
methods, techniques, or practices prescribed by paragraph
(B)
(A) of
rule
3745-27-32 of the Administrative
Code to render them non-infectious; or
(b) Designating the wastes for treatment off
that premises at an infectious waste treatment facility holding a license
issued under division (B) of section
3734.05 of the Revised Code, or
to a facility that holds a license issued under section
4717.17, 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 prior
to disposal of the wastes, or a facility in another state operating in
compliance with state and federal regulations.
(6) Employ only transporters who are
registered with the director under section 3734.022 of the Revised Code to
transport untreated infectious wastes off the premises where they were
generated. A generator who meets the requirements of paragraph (B) of this rule
and exclusively transports infectious wastes generated at premises owned or
operated by the generator is exempt from the payment of the registration fee,
but not from registration as a transporter;
(7) Cause all infectious wastes that
have not been treated to render them noninfectious in accordance with rule
3745-27-32 oftheAdministrativeCode to be transported in shipments consisting
only of untreated infectious wastes;
(8)
(5)
Provide information on the major components of
his
the
infectious wastes, any method of treatment of the wastes to render them
non-infectious, and the generator's system for distinguishing between waste
packages
containers that contain treated and untreated wastes
to persons with whom the generator has entered into
a contract or agreement
an
arrangement to
transport,
treat
, or dispose of the wastes upon
receiving a written request from those persons;
(9)
(6)
Ensure that all
treated infectious wastes
,
whether treated or untreated, that are transported off the premises
where they are generated are accompanied by a
shipping
disposal
paper that meets the requirements of rule
3745-27-33 of the Administrative
Code
;
.
(10) Develop a spill containment and
clean-up procedure. A copy of the procedure shall be posted or readily
available on the premises to persons likely to handle infectious waste,
including janitorial services. The name, address, and telephone number of the
infection control manager or infectious waste control manager and their
back-up, along with the location of all spill containment and clean-up
materials/kits at this facility, shall be listed at the top of the spill
containment and clean-up procedure. Copies of the procedure shall be provided
at the request of the board of health with jurisdiction or the director of the
Ohio EPA or their authorized representatives;
[Comment: These procedures can be
the same procedures that were developed in response to OSHA's bloodborne
pathogen regulations.]
(11) Ensure that clean-up
materials/kits are available in those areas designated in the spill containment
and clean-up procedures. Materials utilized in the clean-up of a spill of
infectious wastes shall include, but are not limited to:
(a) Materials designed to absorb
spilled liquids;
(b) An U.S. EPA registered hospital
disinfectant that is also tuberculocidal, for a contact time as specified by
the manufacturer, a unexpired dated stablized bleach product that is an U.S.
EPA registered hospital disinfectant that is also tuberculocidal, for a contact
time as specified by the manufacturer, or materials necessary to prepare a
minimum ten per cent sodium hypochlorite solution prepared immediately prior to
use with a minimum of thirty minutes of contact time with the
waste;
[Comment: Household bleach depending
upon brand is three to five per cent sodium hypochlorite by volume. A 1:10
dilution of household bleach (one part household bleach to nine parts of water)
contains a minimum ten cent volume/volume sodium hypochlorite solution and will
produce a solution with 3000-5000 parts per million of free available
chlorine.
To make a ten per cent household
bleach solution for disinfection, add approximately 6.4 ounces of household
bleach to 57.6 ounces of tap water. This yields 1/2 gallon of
solution.]
(c) Red or biohazard labeled bag(s)
as specified in paragraph (A) of rule 3745-27-34
oftheAdministrativeCode;
(d) Latex gloves, or equivalent type
of glove, and any other personal protective equipment necessary to implement
the spill containment and clean-up procedure; and
(e) A first aid kit, unless
emergency medical care is available on the premises, boundary tape, and other
appropriate safety equipment.
(12) Implement the spill clean-up
procedure that has been developed in accordance with paragraph (B)(10) of this
rule using materials stated in paragraph (B)(11) of this rule, to clean up all
spills of infectious wastes; and
(13) Comply with paragraph (C) of
this rule.
(C) All generators of infectious wastes shall
comply with the following provisions:
(1) A
generator of infectious wastes, who also generates wastes consisting of any
instrument designed to pierce or lacerate used in the body adornment of human
beings, that have 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 pierce or lacerate, shall manage such
instruments in the same manner as sharp infectious wastes;
(2) Nothing in this rule prohibits a
generator of infectious wastes from designating and managing wastes, in
addition to those defined as infectious
wastes under paragraph (B)(15) of rule 3745-27-01
oftheAdministrativeCode, as infectious wastes when, in the judgment of
the generator, those other wastes should be managed as infectious wastes
because they are, or are likely to be, contaminated with infectious agents.
After designating any such other wastes as infectious, the generator shall
manage those wastes in compliance with the requirements of this rule;
(3) Generators of infectious wastes may
discharge untreated liquid or semiliquid infectious wastes consisting of blood,
blood products, body fluids, and excreta into a disposal system, as defined in
section 6111.01 of the Revised Code,
unless the discharge of those wastes into a disposal system is inconsistent
with the terms and conditions of any permit for the system issued under Chapter
6111. of the Revised Code;
(4) A
generator holding a license issued under section
4717.17 of the Revised Code
shall not consider the weight of blood, blood products, other body fluids, or
embalming fluids that are discharged on the site of their generation into a
disposal system, as defined in section
6111.01 of the Revised Code,
when determining the quantity of infectious wastes produced by that generator
or the monthly generation rate;
(5)
A generator of infectious wastes may transport or cause to be transported
infectious wastes that have been treated to render them noninfectious in
accordance with paragraph (B) of rule
3745-27-32 of the Administrative
Code in the same manner as noninfectious wastes are transported;
(6) No wastes consisting of dead animals or
parts thereof shall be considered when determining the quantity of infectious
wastes produced by any generator if the dead animals or parts meet all of the
following:
(a) Were not intentionally exposed
to infectious agents during research, production of biologicals, or testing of
pharmaceutical;
(b) Were produced
by a veterinarian holding a license issued under Chapter 4741. of the Revised
Code; or
(c) Were treated or
disposed of by a person holding a license issued under Chapter 953. of the
Revised Code.
(7) Any
infectious waste or infectious waste mixture that meets the definition of
hazardous waste as specified in rule
3745-51-03 of the Administrative
Code shall be managed as a hazardous waste in accordance with Chapters 3745-50
to 3745-69 of the Administrative Code. No generator of infectious waste shall
transport, or cause to be transported, wastes deemed hazardous in accordance
with rule
3745-51-03 of the Administrative
Code to an infectious waste treatment facility licensed in accordance with
section
3734.05 of the Revised
Code;
(8) A generator of infectious
waste who produces infectious waste that is also radioactive waste shall:
(a) Manage the waste in accordance with
applicable Ohio department of health and U.S. nuclear regulatory commission
regulations; and
(b) Use a
monitoring instrument, calibrated at least annually, to verify that infectious
waste that is also radioactive is no longer required to be managed in
accordance with Ohio department of health and U.S. nuclear regulatory
commission regulations; and
(c) Not
transport, or cause to be transported, any infectious waste that is also
radioactive to an infectious waste treatment facility licensed under section
3734.05 of the Revised Code
unless the monitoring instrument indicates that the levels of radioactivity do
not exceed Ohio department of health and U.S. nuclear regulatory commission
regulations for managing as a non-regulated material or waste.
[Comment: The purpose of this paragraph is to clarify the
interaction between this rule and the statutory requirements of the Ohio
department of health, Chapter 3748. of the Revised Code and rules promulgated
thereunder, and the U.S. nuclear regulatory commission when materials are both
infectious waste and radioactive waste.]
(d) Infectious waste that is also radioactive
but no longer required to be managed in accordance with Ohio department of
health or U.S. nuclear regulatory commission regulations shall be handled in
accordance with
rules 3745-27-34 and
rule 3745-27-35 of the Administrative Code.
[Comment: The intent of this regulation is to have the
generator of the wastes verify that the contents have decayed to a sufficient
level that the wastes are no longer regulated as radioactive wastes or
materials.]
(9)
A generator, that is a hospital as defined in section
3727.01 of the Revised Code, may
accept for treatment or storage prior to
treatment
transportation to
a treatment facility licensed in accordance with section 3734.05 of the Revised
Code the following wastes:
(a) Sharp
infectious wastes and all unused discarded hypodermic needles, syringes, and
scalpel blades that are
packaged in accordance with
paragraph (B) of rule 3745-27-34 oftheAdministrativeCode
in containers securely closed to prevent leaks or
punctures that are generated by a generator of less than fifty pounds in
any one month and who has staff privileges at the hospital;
(b) Infectious wastes generated by an
individual for purposes of
his/her
their own care or treatment; and
(c) Infectious wastes generated in providing
care to a patient by an emergency medical services organization as defined in
section 4765.01 of the Revised
Code.
(10) An emergency
medical services organization, as defined in section
4765.01 of the Revised Code,
shall not be required to quantify the infectious waste that is accepted by a
generator that is a hospital as defined in section
3727.01 of the Revised
Code;
(11) A generator shall handle
all infectious wastes in accordance with rule
3745-27-35 of the Administrative
Code.
