Current through Register Vol. 54, No. 44, November 2, 2024
(a) The following processing facilities for
regulated medical and chemotherapeutic waste will be deemed to have a municipal
waste processing permit under this article if the following requirements in
this subsection and subsection (c) are met:
(1) A processing facility with an autoclave
if the following requirements are met:
(i)
The facility processes at least 50% of its own regulated medical waste. The
facility may not accept more than 50% of regulated medical waste for
disinfection from small quantity generators that generate less than 220 pounds
per month.
(ii) The facility does
not process pathological waste or chemotherapeutic waste.
(iii) The facility may additionally process
regulated medical waste to render the waste unrecognizable by processes such as
thermal treatment, melting, encapsulation, shredding, grinding, tearing or
breaking.
(iv) The processed waste
is disposed of or processed in a landfill or incinerator authorized to accept
the waste.
(v) The operator of the
facility provides notice to the Department that includes the following:
(A) An intention to operate under
permit-by-rule.
(B) The name and
address of the facility.
(C) A
description of the processing activity.
(D) The names and telephone numbers of the
individuals responsible for operation of the processing facility.
(2) A processing
facility with an incinerator if the following requirements are met:
(i) The facility processes at least 50% of
its own regulated medical or chemotherapeutic waste. The facility may not
accept more than 50% of regulated medical or chemotherapeutic waste for
disinfection from small quantity generators that generate less than 220 pounds
per month.
(ii) The facility may
process other municipal waste generated onsite if the resulting ash is managed
as processed regulated medical or chemotherapeutic waste.
(iii) The processed waste is disposed of or
processed in a landfill or incinerator authorized to accept the
waste.
(iv) The operator of the
facility provides notice to the Department that includes the following:
(A) An intention to operate under
permit-by-rule.
(B) The name and
address of the facility.
(C) A
description of the processing activity.
(D) The names and telephone numbers of the
individuals responsible for operation of the processing facility.
(3) A processing
facility with steam and superheated water disinfection if the following
requirements are met:
(i) The facility
processes at least 50% of its own regulated medical waste. The facility may not
accept more than 50% of regulated medical waste for disinfection from small
quantity generators that generate less than 220 pounds per month.
(ii) The facility does not process
pathological waste or chemotherapeutic waste.
(iii) The facility may additionally process
regulated medical waste to render the waste unrecognizable by processes such as
thermal treatment, melting, encapsulation, shredding, grinding, tearing or
breaking.
(iv) The processed waste
is disposed of or processed in a landfill or incinerator authorized to accept
the waste.
(v) The operator of the
facility provides notice to the Department that includes the following:
(A) An intention to operate under
permit-by-rule.
(B) The name and
address of the facility.
(C) A
description of the processing activity.
(D) The names and telephone numbers of the
individuals responsible for operation of the processing facility.
(4) Onsite processing of
liquid blood and body fluids using a glutaraldehyde-based or hypochlorite-based
product that encapsulates or converts liquid blood or body fluids into solids
or gels so that no free liquids remain. The Department may approve the use of
other disinfectant-based products under these provisions if their efficacy can
be demonstrated. The processed liquid blood and body fluids may be disposed of
at a municipal waste landfill provided:
(i)
No free liquids remain in the processed waste.
(ii) The landfill has received written
approval from the Department authorizing disposal of the processed liquid blood
and body fluids.
(iii) The facility
does not process chemotherapeutic waste.
(5) Transfer facilities that temporarily
store regulated medical or chemotherapeutic waste for less than 72 hours
provided the stored waste remains in its original packaging, is not putrescent
and does not attract vectors.
(b) Generators that process and disinfect
less than 220 pounds per month of regulated medical waste onsite and render the
waste unrecognizable will be deemed to have a municipal waste processing permit
under this article if the requirements under subsection (c) are met. Generators
that process and disinfect less than 220 pounds per month of regulated medical
waste onsite without rendering the waste unrecognizable will be deemed to have
a municipal waste processing permit under this article if the following
requirements under this subsection and subsection (c) are met:
(1) The generator shall dispose of the
processed waste in a landfill or have the waste incinerated in a facility that
has written approval from the Department to accept this type of
waste.
(2) The generator shall
comply with the log and shipping paper requirements in § 284.701(b)(5)
(relating to scope).
(c)
The following requirements shall be met by facilities identified in subsections
(a)(1)-(4) and (b) to operate under a permit-by-rule:
(1) The facility complies with Subchapters E
and F (relating to segregation and storage; and collection and transportation)
and Chapter 285 (relating to storage, collection and transportation of
municipal waste).
(2) The facility
has necessary permits under the environmental protection acts, and is operating
in accordance with the environmental protection acts and the regulations
promulgated thereunder, the terms and conditions of permits and orders of the
Department.
(3) The operator
maintains at the facility in a readily accessible place the following
information:
(i) For a processing facility
identified in subsection (a), a written plan for managing regulated medical
waste generated at the facility, including waste handling, equipment operation
and maintenance, processing method, disinfection monitoring procedures
including quality assurance procedures, frequency of calibration and a
description of how noninfectious waste is managed to prevent
commingling.
(ii) For processing
facilities subject to a permit-by-rule, daily records of the weight or volume
of the waste that is processed, the method and location of disposal facilities
for wastes from the processing facility, and waste handling problems and
emergencies.
(4)
Processing does not have an adverse effect on public health, safety, welfare or
the environment.
(5) The waste is
disinfected in accordance with §
284.321 (relating to regulated
medical waste monitoring requirements).
(6) Disinfection occurs before or during
processing of the waste.
(7) A log
is maintained for each disinfection unit and is made available to the
Department upon request. The log shall record the following:
(i) The date, time and operator for each
use.
(ii) The dates and results of
calibration.
(iii) The
postdisinfection color reading of temperature sensitive tape and the results of
biological indicator spore testing, in accordance with §
284.321 for steam disinfection
facilities.
(iv) Results of ash
testing which utilizes a methodology approved by the Department, for
incineration facilities.
(8) Remaining waste is managed in accordance
with the act and the regulations promulgated thereunder. For onsite autoclave
facilities that do not render the waste unrecognizable, the treated or
processed regulated medical waste shall be transported in accordance with
Subchapter H (relating to tracking of regulated medical and chemotherapeutic
waste).
(9) For incineration
facilities, an air quality permit shall be obtained as required under the Air
Pollution Control Act (35 P. S. §§ 4001-4015).
(d) Chapter 271, Subchapter E (relating to
civil penalties and enforcement) is applicable to facilities subject to
permit-by-rule.
(e) Notwithstanding
a provision in this section to the contrary, a facility will not be deemed to
have a permit-by-rule if it causes or allows violations of the environmental
protection acts, the regulations promulgated thereunder, the terms or
conditions of a permit issued by the Department, or an order issued by the
Department, or causes a public nuisance. A facility that is subject to
permit-by-rule is not required to apply for a permit under this article, if
that facility operates in accordance with this section.
(f) The requirements under Chapter 271,
Subchapter D (relating to financial assurances requirements) that relate to
bonding and insurance are waived for facilities that are deemed to have a
permit under this section.
This section cited in 25 Pa. Code §
284.411 (relating to
segregation).
