December 13, 2007, Introduced by Rep. Miller and referred to the Committee on Regulatory Reform.
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending sections 13805, 13807, 13809, 13810, 13811, 13813,
13815, 13817, 13819, 13821, 13823, 13825, 13827, 13829, 13830, and
13831 (MCL 333.13805, 333.13807, 333.13809, 333.13810, 333.13811,
333.13813, 333.13815, 333.13817, 333.13819, 333.13821, 333.13823,
333.13825, 333.13827, 333.13829, 333.13830, and 333.13831),
sections 13805, 13807, 13809, 13810, 13811, and 13815 as added by
1990 PA 21, sections 13813, 13817, 13819, 13823, 13825, 13827,
13829, 13830, and 13831 as added by 1990 PA 18, and section 13821
as amended by 1996 PA 67, and by adding sections 13812, 13820,
13832, and 13833.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec.
13805. (1) "Advisory council" means the interdepartmental
medical
waste advisory council created in section 13827.
(1) "Alternative treatment technology" means a method for the
decontamination of medical waste other than incineration.
(2)
"Autoclave" means to sterilize using a vessel used to
decontaminate medical waste by superheated steam under pressure.
(3) "Biohazard symbol" means the symbol depicted in 29 CFR
1910.1030.
(4) "Body art facility" means a facility that practices
physical human body adornment by an operator utilizing body
piercing, tattooing, branding, or permanent cosmetics.
(5) "Body piercing" means the perforation of human tissue,
other than an ear, for a nonmedical purpose.
(6) "Branding" means a permanent mark made on human tissue by
burning with a hot iron or other instrument.
(7)
(3) "Decontamination" means rendering the process of
reducing potential pathogens in medical waste to render it safe for
routine handling as solid waste.
(8) "Department" means the department of environmental quality
or its authorized representative.
(9) (4)
"Fund" means the medical
waste emergency response fund
created in section 13829.
(10) (5)
"Health facility or
agency" means that term as
defined in section 20106.
(11) (6)
"Household" means a
single detached dwelling unit or
a single unit of a multiple dwelling.
(12) (7)
"Infectious agent" means
a pathogen that is
sufficiently
virulent so that if exposure
of a susceptible host is
exposed
to the pathogen in an adequate
concentration and through a
portal
of entry , the result could be result in
transmission of
disease to a human.
(13) "Laboratory" means any of the following that generates
medical waste:
(a) A research facility.
(b) An analytical facility.
(c) A clinical facility that performs analysis or research.
(14) "Landfill" means a municipal solid waste landfill as
defined by R 299.4104 of the Michigan administrative code.
(15) (8)
"Medical waste" means any
of the following: that are
not
generated from a household, a farm operation or other
agricultural
business, a home for the aged, or a home health care
agency:
(a) Cultures and stocks of infectious agents and associated
biologicals
toxins, including,
but not limited to, laboratory
waste, biological production wastes, discarded live and attenuated
vaccines, culture dishes, and related devices.
(b) Liquid human and animal waste, including blood and blood
products and body fluids, but not including urine or materials
stained with blood or body fluids.
(c) Pathological waste.
(d) Sharps.
(e)
Contaminated wastes Wastes
from animals used in research
that
have been exposed to agents infectious to humans, these being
primarily
research animals including,
but not limited to,
carcasses, body parts, blood, body fluids other than urine, and
feces or bedding visibly contaminated with blood or body fluids.
(f) Trauma waste.
Sec.
13807. (1) "Pathogen" means a microorganism an agent that
produces
causes disease
in humans.
(2) "Pathological waste" means human organs, tissues, body
parts other than teeth, products of conception, and fluids removed
by
trauma or during surgery, or
autopsy, or other medical
procedure, and not fixed in formaldehyde or other fixative agent. A
specific organ, body part, or tissue removed by trauma or during
surgery, autopsy, or other medical procedure that is not known to
be or is not highly likely to be contaminated with an infectious
agent and that is requested by an individual to be returned for
religious, ethnic, or personal reasons is not pathological waste.
(3) "Person" means an individual, partnership, corporation,
association, governmental entity, or other legal entity.
(4) (3)
"Point of generation"
means the point at which medical
waste leaves the producing facility site.
(5) (4)
"Producing facility", subject to subsection (6), means
a facility that generates, stores, removes, decontaminates, or
incinerates
transports medical waste, . including, but not limited
to, all of the following:
(a) A transfer station where medical waste is stored.
(b) A home health care agency where medical waste is stored
that was generated during delivery of home health care services and
returned to the home health care agency by its employees.
(c) A trauma waste management practitioner.
(6) "Producing facility" does not include the following:
(a) A funeral home that does not practice embalming and does
not generate medical waste.
(b) A residence.
(c) A farm operation or other agricultural business.
(d) A facility licensed by the department of human services
that provides residential care services, such as adult and child
foster family and group homes, child day care centers, child care
institutions, child or adult foster care camps, and homes for the
aged.
(7) "Public sharps collection program" means a program
operated by a public authority or nonprofit organization designed
to assist the home user in the safe disposal of discarded sharps
only.
(8) (5)
"Release" means any
spilling, leaking, pumping,
pouring, emitting, emptying, discharging, injecting, escaping,
leaching, dumping, or disposing of medical waste into the
environment in violation of this part.
(9) (6)
"Response activity" means
an activity necessary to
protect the public health, safety, welfare, and the environment,
and includes, but is not limited to, evaluation, cleanup, removal,
containment, isolation, treatment, monitoring, maintenance,
replacement of water supplies, and temporary relocation of people.
(10) (7)
"Sharps" means needles,
syringes, scalpels, and
intravenous
tubing with needles any object
that is able to cut or
penetrate the skin or packaging material. This includes, but is not
limited to, a needle, a syringe with an attached needle, a scalpel,
a lancet, a broken vaccine vial, a culture slide or dish, a
capillary tube, and intravenous tubing with a needle attached.
(11) (8)
"Storage" means the
containment of medical waste in a
manner that does not constitute disposal of the medical waste.
(12) "Tattooing" means 1 or more of the following:
(a) Making an indelible mark upon the human body by the
insertion of a pigment under the skin.
(b) Making an indelible design upon the human body by
production of scars other than by branding.
(13) (9)
"Transport" means the
movement of medical waste from
the point of generation or from a trauma scene to any intermediate
point and finally to the point of treatment or disposal. Transport
does not include the movement of medical waste from a health
facility or agency to another health facility or agency for the
purposes of testing and research.
(14) "Trauma" means either of the following:
(a) Illness or death other than in a hospital, clinic, or
other medical setting.
(b) Bodily injury.
(15) "Trauma scene" means a site contaminated with trauma
waste. The site may be, but is not limited to, a fixed physical
structure or a mobile physical structure, such as a mobile home,
recreational vehicle, motor vehicle, aircraft, watercraft, or
vessel.
(16) "Trauma waste" means human organs, tissues, body parts
other than teeth, products of conception, and fluids removed by
trauma, and not fixed in formaldehyde or other fixative agent. A
specific organ, body part, or tissue removed by trauma that is not
known to be or is not highly likely to be contaminated with an
infectious agent and that is requested by an individual to be
returned for religious, ethnic, or personal reasons is not trauma
waste.
(17) "Trauma waste management practitioner" or "practitioner"
means a person who undertakes as a commercial activity the cleanup,
handling, and transport of trauma waste from a trauma scene in this
state.
(18) "USDOT" means the United States department of
transportation.
Sec.
13809. A producing facility that does not incinerate
decontaminate
medical waste on site shall do ensure that all of the
following are done to contain medical waste:
(a) Package, contain, and locate medical waste in a manner
that protects and prevents the medical waste from release at the
producing facility or at any time before ultimate disposal.
(b)
Separate the categories of At
the point of origin, sort
and
separate medical waste at the point
of origin by type as listed
in
section 13805(15) into appropriate
containers. that are labelled
as
required under subdivision (c).
(c) Label or mark the containers required under subdivision
(b)
with a biohazard symbol or the words "medical waste" or
"pathological
waste" in letters not less than 1 inch high before
transport in accordance with USDOT regulations as specified in 49
CFR part 172, subparts D and E.
(d)
Not compact or mix medical waste with other waste
materials
before decontamination, incineration, and disposal.
(e)
If decontaminated medical waste is mixed with other solid
waste,
clearly label the container to indicate that it contains
decontaminated
medical waste.
(d) Segregate medical waste that is being packaged for final
decontamination or disposal from other waste materials.
(e) (f)
Store medical waste in such a
manner that prevents
putrefaction and also prevents infectious agents from coming in
contact with the air or with individuals.
(f) (g)
If medical waste is stored outside
of the producing
facility or at the business location of a trauma waste management
practitioner, store the medical waste in a secured area or locked
in a container that weighs more than 500 pounds and prevent access
to the area or container by vermin or unauthorized individuals.
(g) (h)
Not store medical waste on the
premises of the
producing facility for more than 90 days. The storage period begins
when the use of the storage container is initiated. However, if a
producing facility generates only sharps as medical waste and
generates 1 liter or less of sharps waste in a 90-day period, the
90-day storage period begins when the sharps container becomes
full, except that a partially full sharps container shall be
disposed of within 1 year after sharps are first placed in the
container. If a producing facility generates only sharps as medical
waste, the producing facility shall record on the sharps waste
container the following dates, when those dates occur:
(i) The date when sharps waste is first placed in the storage
container.
(ii) The date when the container becomes full.
(h) Not store transfer station storage containers for more
than 7 days or as otherwise approved by the department.
(i) Store trauma waste being transported in a vehicle so it is
physically separated by partition or compartments and does not
present a cross-contamination hazard to the decontamination
equipment and supplies stored and transported in the same vehicle.
(j) Transport medical waste in accordance with USDOT shipping
regulations.
(k) Retain USDOT medical waste shipping paper records for a
minimum of 3 years.
Sec.
13810. A producing facility that incinerates
decontaminates
medical waste on site shall do ensure that all of
the following are done to contain medical waste:
(a)
Package, contain, and locate medical waste in a matter
manner that protects and prevents the medical waste from release at
the producing facility or at any time before ultimate disposal.
(b) Sort and separate medical waste by type as listed in
section 13805(15) into appropriate containers that are labeled in
accordance with subdivision (d).
(c) (b)
Separate and dispose of sharps in
the manner described
in
section 13811(d) 13811(1)(d).
(d) (c)
Label the containers required under
subdivision (a) or
(b) with a biohazard symbol or the words "medical waste" or
"pathological waste" in letters not less than 1 inch high.
(e) (d)
Not store medical waste on premises
of the producing
facility for more than 90 days.
Sec.
13811. (1) A producing facility shall store,
decontaminate,
and dispose of ensure that medical waste is
decontaminated and disposed of pursuant to all of the following
requirements:
(a) Cultures and stocks of material contaminated with an
infectious agent shall be stored in closed, puncture-resistant
containers,
decontaminated by autoclaving or incineration use of an
autoclave
or incinerator, and disposed of in a sanitary
landfill,
or shall be subjected to a decontamination and disposal process
approved by the department.
(b)
Blood, and blood products, and
body fluids shall be
disposed of by 1 or more of the following methods:
(i) Flushing Flushed
down a sanitary sewer.
(ii) Decontaminating by autoclaving or incineration.
(iii) Solidifying.
(iv) If not in liquid form, transferring to a sanitary
landfill.
(ii) Decontaminated by use of an autoclave or incinerator and
disposed of in a landfill.
(iii) Solidified then decontaminated by use of an autoclave or
incinerator and disposed of in a landfill.
(iv) (v) A decontamination and disposal process approved by the
department.
(c) Pathological waste and trauma waste shall be disposed of
by 1 or more of the following methods:
(i) Incineration or cremation.
(i) Incinerated and disposed of in a landfill.
(ii) Cremated.
(iii) (ii) Grinding and flushing Ground and flushed into a
sanitary sewer.
(iv) (iii) Burial Buried in a cemetery , if packaged
and
transported
in leakproof containers of sufficient integrity to
prevent
rupture accordance with USDOT
requirements.
(iv) Grinding until rendered unrecognizable, stored in
closed,
puncture-resistant,
properly labeled containers, and, if not in
liquid
form, disposed of in a sanitary landfill.
(v) A decontamination and disposal process approved by the
department.
(d) Sharps shall be disposed of by 1 of the following methods:
(i) Placement in rigid, puncture-resistant containers
that are
appropriately
labeled and transported to a sanitary landfill in a
manner
that retains the integrity of the container.
(ii) Incineration or decontamination and grinding that
renders
the
objects unrecognizable. Ground sharps shall be placed in a
sealed,
rupture-resistant container and transported to a sanitary
landfill.
(i) Disposed of in a landfill if packaged and transported in
accordance with USDOT requirements.
(ii) Decontaminated by use of an autoclave or incinerator and
disposed of in a landfill.
(iii) A decontamination and disposal process approved by the
department.
(e)
Animal waste contaminated with organisms infectious to
humans
a pathogen shall be disposed of by incineration or by burial
in
a sanitary landfill in properly labeled, double containers that
are
leakproof and puncture-resistant and are tightly sealed to
prevent
escape of fluids or material. Contaminated animal organs
disposed
of separately shall be rendered unrecognizable. 1 of the
following methods:
(i) Decontaminated by use of an autoclave or incinerator and
disposed of in a landfill.
(ii) Disposed of in a landfill if packaged and transported in
accordance with USDOT requirements.
(iii) A decontamination and disposal process approved by the
department.
(2) A medical waste treatment technology shall attain during
operation a minimum level of decontamination to protect human
health, safety, welfare, and the environment as established by
rules promulgated by the department.
Sec. 13812. (1) A medical waste treatment technology shall not
be installed or used unless the technology has been reviewed and
approved by the department. The department shall review the
technology for compliance with this act and rules promulgated under
this act.
(2) An application for evaluation and review of the medical
waste treatment technology shall be submitted to the department,
with supportive documentation, on a form provided by the
department. The department shall review the application and
supportive documentation and shall approve or deny the application.
If the application is denied, the department shall specify the
reasons for the denial issued and what additional information is
needed to approve an application.
(3) An evaluation fee of $500.00 shall be submitted with each
application under this section. The collected fee shall be
forwarded to the state treasury and deposited in the fund.
(4) The manufacturer shall provide to the department the name
and address of each producing facility where installation of the
approved technology is to occur. The equipment shall not be used
until on-site efficacy and validation testing are successfully
completed. Approval of a treatment technology by the department
under this part is for the use of the technology as a medical waste
treatment method only. The producing facility is responsible for
securing any other permits or required approvals needed for the
technology from other agencies or department programs.
Sec.
13813. (1) Each A producing facility shall register with
the
department on a form prescribed by the department. A producing
facility
shall have a written medical waste management plan that
contains
information required in section 13817 on file on the
premises
within 90 days after registration.
(2) A producing facility shall submit the following
registration fee with the registration form:
(a)
For a producing facility that is a private practice office
with fewer than 4 licensees under article 15 who are physicians,
physician assistants, dentists, podiatrists, certified nurse
practitioners, certified nurse midwives, acupuncturists, or
veterinarians employed by, under contract to, or working at the
producing facility, a registration fee of $50.00 before October 1,
2009 or $80.00 on or after October 1, 2009.
(b) For a producing facility that is a private practice office
with 4 or more licensees under article 15 who are physicians,
physician assistants, dentists, podiatrists, certified nurse
practitioners, certified nurse midwives, acupuncturists, or
veterinarians employed by, under contract to, or working at the
producing
facility, a registration fee of $20.00 for each licensee,
up
to a maximum total registration fee
of $80.00 before October 1,
2009 or $100.00 on or after October 1, 2009.
(c) For a producing facility that is a health facility or
agency, including a hospital with fewer than 150 beds and a home
health care agency, a registration fee of $75.00 before October 1,
2009 or $100.00 on or after October 1, 2009.
(d) For a producing facility that is a health facility or
agency that is a hospital with 150 or more licensed beds or a
laboratory, a registration fee of $150.00.
(e) For a producing facility that is not a health facility or
agency, including, but not limited to, a body art facility, blood
draw station, blood or blood product collection facility, funeral
home, animal control shelter, pharmacy, school district, nursing
home, hospice, and ambulance operation, a registration fee of
$75.00 before October 1, 2009 or $80.00 on or after October 1,
2009.
(f) For a producing facility that is a trauma waste management
practitioner, a medical waste treatment facility, or a medical
waste collection and transport company, a registration fee of
$150.00.
(3) A mobile health care unit, such as a bloodmobile, that is
owned and operated by a registered producing facility in a fixed
location shall be included under the registration of the registered
facility.
(4) (3)
Upon receipt of a complete
registration form and
registration
fee under this section, or section 13815, the
department shall issue a certificate of registration to the
producing facility unless the department determines that the
producing facility is not in compliance with this part or the rules
promulgated under this part. A certificate of registration issued
under this section is valid for 3 years from its date of issuance.
The
department shall investigate each complaint received and may
inspect
a producing facility registered under this section pursuant
to
the receipt of a complaint.
(5) (4)
Registration fees collected
pursuant to this section
and section 13815 shall be forwarded to the state treasury and
deposited
pursuant to section 13829 in
the fund.
(6) A public sharps collection program shall register as a
medical waste producing facility but is exempt from payment of any
registration fee under this section.
(7) Notwithstanding section 13807(6), all funeral homes shall
manage used body bags as medical waste pursuant to this part.
Sec.
13815. A producing facility shall submit the following
registration
fee with the registration form required under section
13813:
(a)
For a producing facility that is a health facility or
agency
other than a hospital described in subdivision (b) and for a
producing
facility that is not a health facility or agency, a
registration
fee of $75.00.
(b)
For a producing facility that is a health facility or
agency
that is a hospital with 150 or more licensed beds or a
clinical
laboratory, a registration fee of $150.00.
(1) Subject to subsection (2), a person shall not engage in
the cleanup, handling, and transport of trauma waste from a trauma
scene in this state unless the person is registered and has been
issued a trauma waste transport permit under this section. Except
as otherwise provided in this subsection, before a person engages
in the cleanup, handling, and transport of trauma waste from a
trauma scene in this state, the person shall apply for registration
and to receive a trauma waste transport permit on forms and in the
manner prescribed by the department.
(2) A person who engaged in the cleanup, handling, and
transport of trauma waste from a trauma scene in this state on the
day before the effective date of the amendatory act that added this
subsection may continue to engage in the cleanup, handling, and
transport of trauma waste from a trauma scene on and after that
date, subject to the following:
(a) Within 30 days of the effective date of the amendatory act
that added this subsection, the person shall notify the department
that the person is engaging in the cleanup, handling, and transport
of trauma waste from a trauma scene and that the person intends to
continue to engage in that activity.
(b) On or before the date and in the manner prescribed by the
department, the person shall submit an application for registration
and to receive a trauma waste transport permit.
(c) Upon receipt of the application under subdivision (b), the
department shall proceed in the manner prescribed in subsection (4)
for acting upon a new application and either issue a certificate of
registration and a trauma waste transport permit or notify the
person that its application for registration and issuance of a
trauma waste transport permit has been denied under this section
and include the reasons for the denial. The person shall
immediately cease operation as a trauma waste management
practitioner upon receipt of a notice that its application for
registration and issuance of a trauma waste transport permit has
been denied under this section. A person who receives a notice that
its application for registration and issuance of a trauma waste
transport permit has been denied under this subdivision may reapply
as prescribed in subsection (3), and the department shall proceed
in the manner prescribed in subsection (4) on the application as if
it were a new application.
(3) A person that submits an application for registration and
to receive a trauma waste transport permit under this section shall
submit all of the following with the application:
(a) A registration fee of $150.00.
(b) A written trauma waste management plan that meets the
requirements of subsection (7).
(c) Proof of financial responsibility for bodily injury,
property damage, or environmental damage to third parties caused by
accidental occurrences arising from the trauma waste cleanup and
transport activities of the trauma waste management practitioner.
(d) Subject to subsection (5), a fee prescribed by the
department to cover the expense of the background check required
under subsection (4).
(4) Upon receipt of a complete application for registration
form under this section and subject to subsection (5), the
department shall cause to be conducted a background check of all
individuals listed in the application as being the owners,
officers, directors, partners, or other key employees of the trauma
waste management practitioner. The department shall determine
whether any information received as a result of the background
check makes the practitioner ineligible to be registered and issued
a trauma waste transport permit under this section and, if so,
shall not register or issue a permit to the person. The department
shall notify the person that its application for registration and
issuance of a trauma waste transport permit has been denied under
this section and include the reasons for the denial. A person who
receives a notice that its application for registration and a
trauma waste transport permit has been denied under this subsection
may reapply in the manner prescribed in subsection (3), and the
department shall proceed in the manner prescribed in this
subsection on the application as if it were a new application. If
the department determines that the applicant is able to engage in
the cleanup, handling, and transport of trauma waste in a manner
that will protect the public health, safety, welfare, and the
environment, the department shall issue a certification of
registration and a trauma waste transport permit to the applicant
under this section. If any of the information or documentation
required under subsection (3) is not yet available at the time of
application, the department may issue a permit on a conditional
basis, subject to receipt of that information or documentation as
soon as practical after issuance of the conditional permit. The
applicant shall comply with all deadlines and requirements for the
submission of the information or documentation in order to receive
an unconditional trauma waste transport permit under this section.
(5) A certificate of registration and trauma waste transport
permit issued under this section is valid for 1 year from the date
of issuance. A trauma waste management practitioner shall comply
with subsection (2) and any rules or other guidance issued by the
department to obtain a renewal permit under this section. The
department shall act on a renewal application in the same manner as
a new application under subsection (4). However, the department is
not required to conduct a background check annually, but shall
conduct a background check of a trauma waste management
practitioner for a renewal application at least once every 3 years.
(6) Within 90 days of the effective date of the amendatory act
that added this subsection and on a continuing basis, the
department, in consultation with the trauma waste management
industry and the health care industry, shall establish the
following standards:
(a) Documentation of personal protection required to be
provided for and used by employees of trauma waste management
practitioners.
(b) Technologies and chemicals appropriate to the task of
cleaning, handling, and disinfecting a trauma scene.
(c) Other standards as necessary.
(7) A trauma waste management practitioner shall develop a
trauma waste management plan that contains information relating to
the cleanup, handling, and transport of all trauma waste removed,
stored, transported, and disposed of by the practitioner. The
trauma waste management plan shall describe all of the following:
(a) The personal protection to be provided to employees of the
practitioner to minimize exposure to infectious agents throughout
the process of handling and transporting trauma waste.
(b) The technologies, chemicals, and procedures to be used in
the task of cleaning, handling, and disinfecting the trauma scene.
(c) Any other information that the department determines is
necessary under subsection (6).
(8) A trauma waste management practitioner shall update its
trauma waste management plan every year or within 30 days of a
change in any of the following:
(a) A person or site named in the plan.
(b) The types of trauma waste handled or the methods of
handling trauma waste.
(9) Upon request, a trauma waste management practitioner shall
produce its current trauma waste management plan for an employee of
the department pursuant to a routine or unannounced inspection or
the investigation of a complaint. A practitioner shall maintain a
current version of its trauma management plan on file on the
premises at all times. Upon revision of any portion of its trauma
waste management plan, a practitioner shall promptly file the
revised plan with the department and shall comply with all
requirements of the department under section 13819.
(10) A trauma waste management practitioner shall comply with
its trauma waste management plan and shall transport trauma waste
to a producing facility that decontaminates or incinerates medical
waste for treatment or disposal. A trauma waste management
practitioner shall not store trauma waste on its premises for more
than 14 days. A trauma waste management practitioner shall package
medical waste in the manner prescribed in section 13821 and as
otherwise prescribed by the department.
(11) The department may inspect a trauma waste management
practitioner in either a routine or unannounced manner in order to
determine whether the practitioner should be registered and a new
or renewal permit should be issued to the practitioner under this
section or to investigate a complaint. The department may deny,
suspend, or revoke registration and the issuance of a permit if the
department determines that the practitioner is not able to engage
in the cleanup, handling, and transport of trauma waste in a manner
that will protect the public health, safety, and welfare and the
environment. A trauma waste management practitioner is entitled to
notice and a hearing in the manner prescribed in section 92 of the
administrative procedures act of 1969, 1969 PA 306, MCL 24.292, if
the department determines that it must suspend or revoke
registration and the issuance of a permit under this subsection.
(12) The department shall develop, maintain, and post on its
website a current list of registered trauma waste management
practitioners. The department shall periodically submit a current
list of registered trauma waste management practitioners to local
health agencies, local health officers, local environmental health
administrators, and county sheriffs. Upon request, the department
shall submit a current list of registered trauma waste management
practitioners to other public agencies and to the general public.
Sec. 13817. (1) Subject to subsection (7), a producing
facility shall have a written medical waste management plan on file
on the premises within 90 days after registration as a producing
facility.
The medical waste management plan required
in section
13813
shall contain information relating
to the handling of all
medical
waste generated, stored, or decontaminated , or incinerated
at
each the producing facility or transported from the producing
facility
for handling by another facility for storage , or
decontamination ,
incineration, or for disposal in a sanitary
landfill,
cemetery, or other disposal site. A professional
corporation
person may identify and prepare a common medical
waste
management plan for all producing facilities owned and operated by
the
corporation person. A
copy of the common medical waste
management plan shall be kept available at each producing facility
site for inspection by the department.
(2)
The A medical
waste management plan shall comply
with this
act and describe each of the following, to the extent the
information is applicable to the producing facility:
(a) The types of medical waste handled.
(b) The segregation, packaging, labeling, and collection
procedures used.
(c) The use and methods of on-site or off-site storage.
(d) The use and methods of on-site or off-site
decontamination.
(e) The use of on-site or off-site incineration.
(f) The corporate or other legally recognized business name,
of
solid waste haulers who transport address,
and telephone number
of medical waste disposal service companies that transport or treat
medical waste for the producing facility.
(g)
The use name and address of sanitary landfills,
cemeteries, and other disposal sites to which medical waste is
directly taken by the producing facility.
(h) The measures to minimize exposure of the producing
facility's employees to infectious agents throughout the process of
handling and disposing of the medical waste, including, where
applicable, the use of protocols, procedures and training, personal
protective devices and clothing, physical containment or isolation
devices or systems, and prevention or control of aerosols.
(i) The name of the individual responsible for the management
of the medical waste.
(j) Cleanup methods and procedures to be used in response to
spills of medical waste.
(2)
A medical waste management plan shall comply with the
requirements
of this act.
(3)
A producing facility shall update a its medical waste
management
plan each time there is every
3 years or within 30 days
of
a change in either any of
the following: , within 30 days after
the
change occurs:
(a) A person or site named in the plan.
(b) The types of medical waste handled or the methods of
handling medical waste at the facility.
(4) Upon request, a producing facility shall make its medical
waste management plan available to the department pursuant to a
routine or unannounced inspection or the investigation of a
complaint.
(5) Upon receipt of 24 hours' advance notice, a producing
facility shall make its medical waste management plan available to
an employee of the producing facility for inspection on the
premises or provide a copy of the medical waste management plan to
the employee.
(6) A producing facility shall comply with its medical waste
management plan.
(7) This section does not apply to a trauma waste management
practitioner.
Sec. 13819. (1) Upon review of a medical waste management plan
under
section 13817(4) 13817 or
a trauma waste management plan
under section 13815, the department may require a producing
facility
or trauma waste management
practitioner to modify the
medical
waste management its plan at any time the department
determines that the plan is not adequate to protect the public
health, safety, and welfare and the environment or is inconsistent
with
state or federal law. Upon determining that the plan is
inadequate
or inconsistent under this section making
such a
determination, the department shall notify the producing facility
or
the trauma waste management practitioner in
writing of its the
determination and the specific modifications necessary for
compliance. The producing facility or trauma waste management
practitioner
shall modify the plan accordingly within 10 days after
receipt
of the notice from the time
period specified by the
department in its notice.
(2) The department may issue a warning to a producing facility
or trauma waste management practitioner that fails to modify a plan
within the 10-day period.
Sec. 13820. The department may enter at any reasonable time
upon private or public property upon which medical waste is
reasonably believed to be located to determine compliance with this
part or a rule promulgated under this part.
Sec. 13821. (1) A producing facility that transports medical
waste or has medical waste transported off the premises of the
producing facility or a trauma scene shall package and transport
the
medical waste in the following manner: accordance with the
applicable USDOT hazardous materials regulations specified under 49
CFR parts 171 to 180.
(a)
Sharps that are not ground or incinerated as described in
section
13811(d) shall be contained for disposal in individual
leakproof,
rigid, puncture-resistant containers that are secured to
preclude
loss of the contents. In addition, a container used to
store
or transport a number of individual sharps containers shall
be
leakproof. These containers shall be conspicuously labeled with
the
word "sharps". Sharps that are contained pursuant to this
subdivision
may be disposed of as solid waste pursuant to part 115
(solid
waste management) of the natural resources and environmental
protection
act, Act No. 451 of the Public Acts of 1994, being
sections
324.11501 to 324.11549 of the Michigan Compiled Laws.
However,
sharps shall not be compacted or handled during transport
in
a manner that will result in breakage of a sharps container.
(b)
Medical waste other than sharps shall be contained in bags
other
than body pouches or other containers that are impervious to
moisture
and have a strength sufficient to resist ripping, tearing,
breaking,
or bursting under normal conditions of usage or handling.
The
bags or containers shall be secured so as to prevent leakage
during
storage, handling, or transport.
(2) Medical waste that is decontaminated and packaged in
accordance with sections 13809, 13810, and 13811, as applicable,
may be disposed of as solid waste pursuant to part 115 of the
natural resources and environmental protection act, 1994 PA 451,
MCL 324.11501 to 324.11550.
(3) Hazardous waste, as defined in part 111 of the natural
resources and environmental protection act, 1994 PA 451, MCL
324.11101 to 324.11153, shall not be disposed of as medical waste.
Sec.
13823. (1) If A person who
discovers suspected medical
waste
is discovered on any land or water in the this state
and
reported
to the department of natural resources, the department of
public
health, a local health department, the department of state
police,
or any other state or local governmental agency, the agency
or
department receiving the report shall promptly investigate to
confirm
the existence of medical waste. If the existence of medical
waste
is confirmed by a department or agency other than the
department
of natural resources, a report shall be transmitted
immediately
to the department of natural resources. shall report
the
medical waste to the department. The
department of natural
resources
may if appropriate take measures to
contain the medical
waste, to close off the area, to remove the medical waste from the
environment, and to do all things necessary to protect the public
health,
safety, and welfare and the environment. The department of
natural
resources may if appropriate conduct
an investigation to
determine the source of the medical waste.
(2)
The department of natural resources may consult with the
department
of public health, the appropriate local health
department,
the department of state police, and the department of
attorney
general on the actions taken by the department of natural
resources
under this section.
(3)
After the department of natural resources confirms the
existence
of medical waste under this section, the department of
natural
resources shall inform the legislature, the governor, the
advisory
council, and the public on the results of any
investigation
conducted within 30 days after the investigation is
completed.
Sec.
13825. (1) If there is a suspected violation of this part
on
the premises of a health facility or agency or on the premises
of
an incinerator owned and operated by a health facility or agency
producing
facility, the department of public
health shall promptly
conduct
an investigation to confirm the violation. If the suspected
violation
is reported to the department of natural resources, a
local
health department, the department of state police, or any
other
state or local governmental agency, the report immediately
shall
be transmitted to the department of public health. If the
investigation confirms the existence of a violation of this part,
the
department of public health may if appropriate take measures to
correct
the violation and to do all things necessary to protect the
public health, safety, and welfare and the environment.
(2)
The department of public health may consult with the
department
of natural resources, the appropriate local health
department,
the department of state police, and the department of
attorney
general on the actions taken by the department of public
health
under this section. If the suspected violation of this part
is
at an incinerator owned and operated by a health facility or
agency,
the department of public health immediately shall notify
the
department of natural resources and request the assistance of
the
department of natural resources in conducting the
investigation.
(3)
If the department of public health confirms the existence
of
a violation under this section, the department of public health
shall
inform the legislature, the governor, the advisory council,
and
the public on the results of the investigation conducted within
30
days after the investigation is completed.
Sec.
13827. (1) The interdepartmental medical waste advisory
council
is created in the department. The council shall consist of
the
following members appointed as follows:
(a)
One individual appointed by the director of public health
representing
the department.
(b)
One individual appointed by the director of the department
of
natural resources representing the department of natural
resources.
(c)
One individual appointed by the director of the department
of
state police representing the department of state police.
(d)
One individual appointed by the director of commerce
representing
the department of commerce, who has knowledge of
tourism
in the state.
(e)
One individual appointed by the attorney general
representing
the department of the attorney general.
(2)
The representative of the department shall serve as
chairperson.
(3)
The advisory council The
department shall do all of the
following:
(a) Collect data pertaining to medical waste reports and
investigations under this part.
(b)
Annually report to the governor , and
the standing
committees in the senate and house of representatives with
jurisdiction
over public health matters , the department of public
health,
and the department of natural resources on all of the
following:
(i) The number of medical waste reports received and
investigations conducted under this part.
(ii) The implementation and effectiveness of this part.
(iii) Changes in the overall regulatory scheme pertaining to
medical waste, including, but not limited to, the enactment of
pertinent federal law.
(iv) Recommendations, if any, that the advisory
council
department has for changes to this part or any other state statute
or rule that pertains to medical waste.
(v) Coordinate reports and investigations under this
part
between
the department of public health and the department of
natural
resources.
Sec. 13829. (1) The medical waste emergency response fund is
created in the state treasury.
(2)
The state treasurer shall deposit in the fund all money
fees
received pursuant to this act part, revenue under section
13831(3), and all money received by the fund as otherwise provided
by law.
(3) The state treasurer shall direct the investment of the
fund. Interest and earnings of the fund shall be credited to the
fund. Money in the fund at the close of the fiscal year shall
remain in the fund and shall not revert to the general fund.
(4) The department shall be the administrator of the fund for
auditing purposes.
(5) (4)
Not The department shall
expend money from the fund,
upon appropriation, only for the following purposes:
(a)
Not more than 80% of the total amount
in the fund shall be
used
by the department of public health for
administrative expenses
related
to the implementation of this part.
, and the balance may
be
used by the department of natural resources for
(b)
For response activities necessitated
by addressing the
release of medical waste into the environment.
(c) For programs relating to medical waste reduction,
management, and education.
Sec.
13830. (1) The department shall promulgate rules to
prescribe
training standards for both medical and nonmedical
personnel
who handle medical waste in producing facilities
implement this part.
(2)
Each producing facility shall train its personnel who
handle
medical waste pursuant to the rules promulgated under
subsection
(1).
Sec.
13831. (1) Except as provided in subsection (2), a person
who
violates this part or a rule promulgated under this part is
subject
to an administrative fine of not more than $2,500.00 for
each
violation and an additional fine of not more than $1,000.00
for
each day during which the violation continues. For a first
offense,
the department of public health or the department of
natural
resources may postpone the levying of a fine under this
subsection
for not more than 45 days or until the violation is
corrected,
whichever occurs first.
(2)
A person who fails to register with the department or have
a
medical waste management plan available for inspection in
compliance
with sections 13813 and 13817 is subject to an
administrative
fine of $500.00.
(3)
A person who violates this act may be enjoined by a court
of
competent jurisdiction from continuing the violation.
(1) The department may request that the attorney general bring
an action in the name of the people of this state for any
appropriate relief, including injunctive relief, for a violation of
this part or rules promulgated under this part.
(2) In addition to any other relief provided under this
section, the court may impose on any person in violation of this
part or rules promulgated under this part a civil fine as follows:
(a) Except as provided in subdivision (b), a civil fine of not
more than $2,500.00 for each violation and an additional civil fine
of not more than $1,000.00 for each day during which the violation
continues.
(b) A civil fine of $500.00 for failure to register with the
department under section 13813 or 13815 or to make a trauma waste
management plan or a medical waste management plan available to the
department under section 13815 or 13817, respectively.
(3) In addition to any other relief provided by this section,
the court may order a person who violates this part or rules
promulgated under this part to pay to this state an amount equal to
all of the following:
(a) The cost of containing and removing medical waste and
taking action necessary to protect public health, safety, and
welfare, and the environment.
(b) The full value of damage done to the natural resources of
this state.
(c) The costs of surveillance and enforcement incurred by this
state as a result of the violation.
(4) Revenue collected under subsection (2) or (3) shall be
deposited in the fund.
Sec. 13832. The department may issue a cease and desist order
to correct a violation of this part or a rule promulgated under
this part to a person who conducts, manages, maintains, or operates
a producing facility if the violation is causing an imminent public
health hazard or threat to the environment.
Sec. 13833. (1) A person who violates this part, a rule
promulgated under this part, or a final order pursuant to this part
is guilty of a misdemeanor punishable by imprisonment for not more
than 6 months or a fine of not more than $1,000.00, or both, plus
any payment ordered under section 13831(3). Each day upon which a
violation described in this section occurs is a separate offense.
(2) A payment ordered under section 13831(3) recovered in a
prosecution under this section shall be deposited in the fund.
However, if a law enforcement agency of a local unit of government
was primarily responsible for the enforcement of this part, the
payment shall instead be forwarded to that local unit of
government.