Current through 2024-13, March 27, 2024
A.
Packaging
Biomedical waste must be properly packaged to assure
effective containment throughout the handling, storage, transport, and
treatment processes.
(1) Biomedical
wastes, other than sharps and bulk liquids, must be packaged in bags which are
impervious to moisture and have a strength sufficient to resist ripping,
tearing or bursting under normal conditions of usage and handling.
(2) All bags containing biomedical waste must
be red in color and imprinted with the international biohazard symbol and the
words "biomedical waste" or "infectious waste." Waste in red bags will be
considered biomedical waste and must be managed as biomedical waste.
(3) Bags must be sealed by forming a secure
closure which results in a leak-resistant seal.
(4) Discarded sharps must be segregated from
other biomedical waste at the point of generation. Discarded sharps will be
placed directly into leak-resistant, rigid, puncture-resistant containers
without clipping or breaking. When full or in preparation to be sent for
treatment, these containers will be taped closed or tightly lidded to preclude
loss or leakage of contents. After proper packaging, sharps containers may be
placed in biomedical waste bags referred to in Section 12(A)(1) of these rules.
NOTE: An example of an acceptable container for storing
discarded sharps at home is an empty rigid plastic bottle.
(5) Discarded bulk blood and other liquids
which is to be transported off-site will be packaged in tightly stoppered,
unbreakable flasks or bottles or other appropriate containers.
(6) All biomedical waste bagged in accordance
with Section 12(A)(3), sharps containerized in accordance with Section
12(A)(4), and bulk liquids containerized in accordance with Section l2(A)(5)
which are to be transported off-site must also be packaged for storage or
handling by placement in disposable corrugated fiberboard boxes or equivalent
rigid containers such as reusable pails, cartons, drums, or portable bins. The
box or container must be leak-resistant or lined with a bag which is impervious
to moisture and has a 200-pound burst strength as measured by the industry's
Mullen test.
(7) Reusable
containers used for the handling of biomedical waste must be thoroughly washed
and disinfected each time they are emptied unless the surfaces of the
containers have been effectively protected from contamination by disposable
liners, bags or other devices which are removed and disposed of with the waste.
A red bag may not be enclosed in a bag of another color.
(8) Reusable containers used for the handling
of biomedical waste must not be used for containment of waste to be disposed of
as non-biomedical waste or for any other purpose except after being
disinfected.
B.
Labeling
Biomedical waste to be transported off-site must be labeled
immediately after packaging in accordance with Section 12(A)(6). The label must
be securely attached to the outer layer of packaging and be clearly legible.
Indelible ink will be used to complete the information on the label, and the
label will be at least three inches by five inches in size. The following
information must be included on the label:
(1) The name, address, business telephone
number, and registration number of the generator;
(2) "Biomedical Waste" or "Infectious Waste"
in large print;
(3) "Refrigeration
Required" in large print if pathological waste, cultures, or animal carcasses
or body parts are included in the contents;
(4) The name, address, business telephone
number, and registration number of the person or persons to whose control the
biomedical waste is to be transferred;
(5) The international biohazard symbol;
and
(6) The date upon which the
biomedical waste was packaged in accordance with Section12(A)(6).
C.
Handling
(1) Packages of biomedical waste must be
handled in a manner that does not impair the integrity of the
packaging.
(2) Trash chutes will
not be used to transfer biomedical waste between locations where it is
contained.
(3) Compactors must not
be used in the handling of biomedical waste. Biomedical waste in bags or other
containers must not be subjected to compaction by any compacting device and
must not be placed for storage or transport in a portable or mobile trash
compactor.
D.
Storage
(1) Biomedical waste must be
segregated from other wastes.
(2)
All on-site storage of containers of biomedical waste must be in a designated
area away from general traffic flow patterns and, where possible, in a room
reserved for this purpose. The manner of storage must prevent access to or
contact with such waste by unauthorized persons.
(3) Biomedical waste must be stored in a
manner that preserves the integrity of the container and is not conducive to
rapid microbial growth and/or putrefaction. Pathological waste, cultures, and
discarded animal carcasses and body parts stored for more than 24 hours after
packaging in accordance with Section 12(A)(3) must be refrigerated at a
temperature of 45[DEGREE] F or below in a refrigerator or refrigerated space
used only for biomedical waste.
(4)
All areas used for the storage of biomedical waste must be capable of being
readily maintained in a sanitary condition.
(5) All biomedical waste containers must be
stored in a manner that allows access for inspection.
(6) Biohazard signs must be posted wherever
biomedical waste is stored or contained, including on storage rooms doors,
refrigerators, bins and other containers.
E.
Manifests and Record Keeping
Requirements
(1) Except as provided for
in Section 4, the generator of biomedical waste that is to be transported
off-site for treatment or disposal shall initiate a biomedical waste 4-part
manifest available from the Department. Copy 4 of the biomedical waste manifest
is to be retained by the generator; Copy 3, by the transporter; Copy 2, by the
transfer or treatment facility; and Copy 1 is to be returned to the
generator.
(2) If the generator
does not receive the completed manifest from the treatment facility within 35
days after the date the waste was accepted by the transporter, the generator
shall report this fact to the Department.
(3) Retention of Records. Manifests must be
retained by the generator for a period of not less than 3 years. The period of
retention of records is extended automatically during the course of any
unresolved enforcement action regarding the regulated activity or as requested
by the Commissioner. These records must be made available for inspection by the
Department upon request.
(4) The
Department may approve electronic manifesting systems upon demonstration to the
Department that the system meets EPA electronic manifest standards and provides
an equal degree of regulatory oversight as the existing system. A paper copy
must be provided to a generator upon request.