Current through Register Vol. 48, No. 9, September 27, 2024
(1) No person may operate an infectious waste
treatment or disposal facility or generator facility without first obtaining a
permit as required by this regulation except as exempted in section T. A
separate permit shall be required for each site or facility although the
Department may include one or more different types of facilities in a single
permit if the facilities are collocated on the same site.
(2) All treatment facilities must treat the
waste as indicated in Section T.
(3) Infectious waste treatment residue must
not be disposed of until or unless Department approved monitoring methods
confirm effectiveness of the treatment process.
(4) All treatment facilities must develop and
submit to the Department for approval a standard operating procedure manual
which will include at a minimum:
(a)
unloading and handling procedures;
(b) safety procedures;
(c) emergency preparedness and response
plans;
(d) receiving, record
keeping, and reporting procedures;
(e) remedial action plans;
(f) quality assurance plans for treatment
methods;
(g) radiological and
hazardous waste monitoring procedures;
(h) procedures for identifying types and
quantities of infectious waste received;
(i) contingency plans for use of alternate
facilities; and
(j) procedures for
disposition of treatment residues.
(5) Approval for acceptance of infectious
waste at a treatment or disposal facility may be withdrawn by the Department
for noncompliance with the standard operating procedure manual.
(6) When a facility ceases infectious waste
management activities, it shall notify the Department in writing, immediately,
and it shall thoroughly clean and disinfect the facility and all equipment used
in the handling of infectious waste. All untreated waste shall be disposed of
in accordance with the requirements of this regulation.
(7) In the event of an accidental spill of
infectious waste the designated personnel at the facility shall:
(a) contain the spill to the area immediately
affected;
(b) immediately disinfect
the area which is contaminated;
(c)
pick up, repackage as required or otherwise immediately remove the spilled
material into the treatment system;
(d) record the incident in a bound log book,
including the quantity spilled, personnel involved, and the nature and
consequences of the event; and
(e)
It is unlawful for any person to discharge infectious waste or treatment
residue into the environment of this State except as permitted by the
Department. If a release of infectious waste or treatment residue to the
environment is known or suspected, the facility must report to the Department
within twenty-four (24) hours and immediately investigate and confirm all
suspected releases. Action may then be required by local, state, or federal
officials so that the infectious waste or treatment residue discharge no longer
presents an actual or potential hazard to human health or the
environment.
(8) All
individuals involved with handling and management of waste shall receive
thorough training in their responsibilities and duties. A training protocol
shall be submitted to the Department at the time of application for a permit.
Training documentation for individuals shall be submitted to the Department
within thirty (30) days of completion.
(9) Permittees shall notify the Department in
writing within thirty (30) days prior to any changes in ownership, operating
control, name, or location. The Department may upon written request transfer a
permit to a new owner or operator where no other change in the permit is
necessary provided that a written agreement containing a specific date for
transfer of permit responsibility and financial assurance between the current
and new owner has been submitted to the Department.
(10) A facility receiving waste generated in
a hospital or other generator which uses radioactive material must screen
incoming waste for radioactivity as they arrive at the treatment facility. Such
facilities must:
(a) use instrumentation which
is approved by the Department for this purpose;
(b) have the operator properly trained on
such equipment;
(c) have such
equipment calibrated at least once a year by an authorized
calibrator;
(d) maintain a log of
quality assurance testing and calibration of such instrumentation;
and
(e) report any and all
incidents when radioactive materials are detected to the Department for
guidance in dealing with the radioactive materials. The Department may allow a
treatment facility to hold containers of waste containing radioactive material
for radioactive decay after the facility has submitted procedures for
appropriately managing the containers and has received approval from the
Department. However, under no circumstance may a treatment facility solicit the
receipt of radioactive material.
(11) Facilities shall schedule shipments of
waste to prevent a backlog of loaded transportation vehicles at the facility or
offsite. The number of loaded and unloaded transport vehicles stored onsite
will be controlled by permit conditions.
(12) A facility receiving waste generated
offsite must log-in transport vehicles as they arrive at the facility in a
bound log book and note in this book if any shipments are rejected. The
treatment facility must:
(a) disinfect the
cargo-carrying compartment(s) immediately after unloading the waste;
and
(b) clean out visible debris
and immediately put debris into the treatment system.
(13) Incinerators must, in addition to items
(1) through (12) above:
(a) provide complete
combustion of the waste and packaging to carbonized or mineralized
ash;
(b) comply with all applicable
regulations issued by the Department; and
(c) receive authorization for disposal of
treatment residue from the Department prior to disposition into a landfill
located in this state, and said authorization shall be based on relevant
analyses and requirements deemed necessary by the Department. Such
authorization may be incorporated into a landfill permit.
(14) All steam sterilizers must, in addition
to items (1) through (12) above.
(a) use
Department approved indicator organisms in test runs to assure proper treatment
of the waste. Indicator organisms must be used daily at a commercial facility
and monthly at a generator facility in each steam sterilizer;
(b) record the temperature and time during
each complete cycle to ensure the attainment of a temperature of 121 degrees
Centigrade (250 degrees Fahrenheit) for 45 minutes or longer at fifteen (15)
pounds pressure, depending on quantity and density of the load, in order to
achieve sterilization of the entire load; (Thermometers shall be checked for
calibration at least annually.)
(c)
have a gauge which indicates the pressure of each cycle;
(d) use heat sensitive tape or other device
for each container that is processed to indicate that the steam sterilization
temperature has been reached. The waste will not be considered appropriately
treated if the indicator fails;
(e)
use the biological indicator Bacillus stearothermophillus placed at the center
of a load processed under standard operating conditions to confirm the
attainment of adequate sterilization conditions;
(f) maintain records of the procedures
specified in (b), and (e) above for period of not less than three (3) years;
and
(g) assure that treatment
residues are disposed of in accordance with applicable State and Federal
requirements.
