Current through all regulations passed and filed through December 16, 2024
(A)
Notification and
withdrawal from rules
3745-266-500 to
3745-266-510 of the
Administrative Code for healthcare facilities managing hazardous waste
pharmaceuticals.
(1)
Notification. A healthcare facility shall notify Ohio
EPA, using Ohio EPA form EPA 9029, that the facility is a healthcare facility
operating in accordance with rules
3745-266-500 to
3745-266-510 of the
Administrative Code. A healthcare facility is not required to fill out waste
codes for federally regulated hazardous waste on the form with respect to the
healthcare facility's hazardous waste pharmaceuticals. A healthcare facility
shall submit a separate notification for each site or EPA identification
number.
(a)
A
healthcare facility that already has an EPA identification number shall notify
Ohio EPA, using Ohio EPA form EPA 9029, that the facility is a healthcare
facility as part of the healthcare facility's next biennial report, if the
healthcare facility is required to submit a biennial report; or if not required
to submit a biennial report, within sixty days after the first effective date
of rules
3745-266-500 to
3745-266-510 of the
Administrative Code, or within sixty days after becoming subject to rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(b)
A healthcare facility that does not have an EPA
identification number shall obtain one by notifying Ohio EPA, using Ohio EPA
form EPA 9029, that the facility is a healthcare facility as part of the
healthcare facility's next biennial report, if the healthcare facility is
required to submit a biennial report; or if not required to submit a biennial
report, within sixty days after the first effective date of rules
3745-266-500 to
3745-266-510 of the
Administrative Code, or within sixty days after becoming subject to rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(c)
A healthcare facility shall keep a copy of the
healthcare facility's notification on file for as long as the healthcare
facility is subject to rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(2)
Withdrawal. A
healthcare facility that operated under rules
3745-266-500 to
3745-266-510 of the
Administrative Code but is no longer subject to rules
3745-266-500 to
3745-266-510 of the
Administrative Code, because the healthcare facility is a very small quantity
generator under rule
3745-52-14 of the Administrative
Code, and elects to withdraw from rules
3745-266-500 to
3745-266-510 of the
Administrative Code, shall notify Ohio EPA, using Ohio EPA form EPA 9029, that
the healthcare facility is no longer operating under rules
3745-266-500 to
3745-266-510 of the
Administrative Code. A healthcare facility is not required to fill out the
waste codes for federally regulated hazardous waste portion of Ohio EPA form
EPA 9029 with respect to the healthcare facility's hazardous waste
pharmaceuticals. A healthcare facility shall submit a separate Ohio EPA form
EPA 9029 for each EPA identification number.
(a)
A healthcare
facility shall submit Ohio EPA form EPA 9029 notifying that the healthcare
facility is withdrawing from rules
3745-266-500 to
3745-266-510 of the
Administrative Code before the healthcare facility begins operating under the
conditional exemption of rule
3745-52-14 of the Administrative
Code.
(b)
A healthcare facility shall keep a copy of the
healthcare facility's withdrawal on file for three years after the date of
signature on the notification of the healthcare facility's withdrawal.
(B)
Training of personnel managing non-creditable hazardous
waste pharmaceuticals at healthcare facilities. A healthcare facility shall
ensure that all personnel that manage non-creditable hazardous waste
pharmaceuticals are thoroughly familiar with proper waste handling and
emergency procedures relevant to the personnel's responsibilities during normal
facility operations and emergencies.
(C)
Hazardous waste
determination for non-creditable pharmaceuticals. A healthcare facility that
generates a waste that is a non-creditable pharmaceutical shall determine
whether that pharmaceutical is a hazardous waste pharmaceutical (i.e., the
waste exhibits a characteristic identified in rules
3745-51-20 to
3745-51-24 of the Administrative
Code or is listed in rules
3745-51-30 to
3745-51-35 of the Administrative
Code) in order to determine whether the waste is subject to rules
3745-266-500 to
3745-266-510 of the
Administrative Code. A healthcare facility may choose to manage non-hazardous
waste pharmaceuticals as non-creditable hazardous waste pharmaceuticals under
rules 3745-266-500 to
3745-266-510 of the
Administrative Code.
(D)
Standards for containers used to accumulate
non-creditable hazardous waste pharmaceuticals at healthcare facilities.
(1)
A healthcare
facility shall place non-creditable hazardous waste pharmaceuticals in a
container that is structurally sound, compatible with the contents, and that
lacks evidence of leakage, spillage, or damage that could cause leakage under
reasonably foreseeable conditions.
(2)
A healthcare
facility that manages ignitable or reactive non-creditable hazardous waste
pharmaceuticals, or that mixes or commingles incompatible non-creditable
hazardous waste pharmaceuticals shall manage the container so that the
container does not have the potential to do any of the following:
(a)
Generate extreme
heat or pressure, fire or explosion, or violent reaction.
(b)
Produce
uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to
threaten human health.
(c)
Produce uncontrolled flammable fumes or gases in
sufficient quantities to pose a risk of fire or explosions.
(d)
Damage the
structural integrity of the container of non-creditable hazardous waste
pharmaceuticals.
(e)
Through other like means threaten human health or the
environment.
(3)
A healthcare facility shall keep containers of
non-creditable hazardous waste pharmaceuticals closed and secured in a manner
that prevents unauthorized access to the contents.
(4)
A healthcare
facility may accumulate non-creditable hazardous waste pharmaceuticals and
non-hazardous non-creditable waste pharmaceuticals in the same container,
except that non-creditable hazardous waste pharmaceuticals prohibited from
being combusted because of the dilution prohibition of paragraph (C) of rule
3745-270-03 of the
Administrative Code shall be accumulated in separate containers and labeled
with all applicable hazardous waste numbers.
(E)
Labeling
containers used to accumulate non-creditable hazardous waste pharmaceuticals at
healthcare facilities. A healthcare facility shall label or clearly mark each
container of non-creditable hazardous waste pharmaceuticals with the phrase
"Hazardous Waste Pharmaceuticals."
(F)
Maximum
accumulation time for non-creditable hazardous waste pharmaceuticals at
healthcare facilities.
(1)
A healthcare facility may accumulate non-creditable
hazardous waste pharmaceuticals on-site for one year or less without an Ohio
hazardous waste permit or a permit by rule.
(2)
A healthcare
facility that accumulates non-creditable hazardous waste pharmaceuticals
on-site shall demonstrate the length of time that the non-creditable hazardous
waste pharmaceuticals have been accumulating, starting from the date the
non-creditable hazardous waste pharmaceutical first becomes a waste. A
healthcare facility may make this demonstration by any of the following
methods:
(a)
Marking or labeling the container of non-creditable
hazardous waste pharmaceuticals with the date that the non-creditable hazardous
waste pharmaceuticals became a waste.
(b)
Maintaining an
inventory system that identifies the date the non-creditable hazardous waste
pharmaceuticals being accumulated first became a waste.
(c)
Placing the
non-creditable hazardous waste pharmaceuticals in a specific area and
identifying the earliest date that any of the non-creditable hazardous waste
pharmaceuticals in the area became a waste.
(G)
Land
disposal restrictions for non-creditable hazardous waste pharmaceuticals. The
non-creditable hazardous waste pharmaceuticals generated by a healthcare
facility are subject to the land disposal restrictions of Chapter 3745-270 of
the Administrative Code. A healthcare facility that generates non-creditable
hazardous waste pharmaceuticals shall comply with the land disposal
restrictions in accordance with paragraph (A) of rule
3745-270-07 of the
Administrative Code, except that the healthcare facility is not required to
identify the hazardous waste numbers on the land disposal restrictions
notification.
(H)
Procedures for healthcare facilities for managing
rejected shipments of non-creditable hazardous waste pharmaceuticals. A
healthcare facility that sends a shipment of non-creditable hazardous waste
pharmaceuticals to a designated facility with the understanding that the
designated facility can accept and manage the waste, and later receives that
shipment back as a rejected load in accordance with the manifest discrepancy
provisions of rule
3745-54-72 or
3745-65-72 of the Administrative
Code, may accumulate the returned non-creditable hazardous waste
pharmaceuticals on-site for up to an additional ninety days, provided the
rejected or returned shipment is managed in accordance with paragraphs (D) and
(E) of this rule. Upon receipt of the returned shipment, the healthcare
facility shall do all of the following:
(1)
Sign either of
the following:
(a)
Item 18c of the original manifest, if the original
manifest was used for the returned shipment.
(b)
Item 20 of the
new manifest, if a new manifest was used for the returned
shipment.
(2)
Provide the transporter a copy of the
manifest.
(3)
Within thirty days after receipt of the rejected
shipment, send a copy of the manifest to the designated facility that returned
the shipment to the healthcare facility.
(4)
Within ninety
days after receipt of the rejected shipment, transport or offer for transport
the returned shipment in accordance with the shipping standards of paragraph
(A) of rule
3745-266-508 of the
Administrative Code.
(I)
Reporting by
healthcare facilities for non-creditable hazardous waste pharmaceuticals.
(1)
Biennial
reporting by healthcare facilities. Healthcare facilities are not subject to
biennial reporting requirements in accordance with rule
3745-52-41 of the Administrative
Code, with respect to non-creditable hazardous waste pharmaceuticals managed in
accordance with rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(2)
Exception reporting by healthcare facilities for a
missing copy of the manifest.
(a)
For shipments from a healthcare facility to a
designated facility:
(i)
If a healthcare facility does not receive a copy of the
manifest with the signature of the owner or operator of the designated facility
within sixty days after the date the non-creditable hazardous waste
pharmaceuticals were accepted by the initial transporter, the healthcare
facility shall submit all of the following:
(a)
A legible copy of
the original manifest, indicating that the healthcare facility has not received
confirmation of delivery, to the director.
(b)
A handwritten or
typed note on the manifest or on an attached sheet of paper, stating that the
return copy was not received and explaining the efforts taken to locate the
non-creditable hazardous waste pharmaceuticals, and the results of those
efforts.
(b)
For shipments
rejected by the designated facility and shipped to an alternate facility.
(i)
If a healthcare
facility does not receive a copy of the manifest for a rejected shipment of the
non-creditable hazardous waste pharmaceuticals that is forwarded by the
designated facility to an alternate facility (using appropriate manifest
procedures), with the signature of the owner or operator of the alternate
facility, within sixty days after the date the non-creditable hazardous waste
was accepted by the initial transporter forwarding the shipment of
non-creditable hazardous waste pharmaceuticals from the designated facility to
the alternate facility, the healthcare facility shall submit all of the
following:
(a)
A
legible copy of the original manifest, indicating that the healthcare facility
has not received confirmation of delivery, to the director.
(b)
A handwritten or
typed note on the manifest or on an attached sheet of paper, stating that the
return copy was not received and explaining the efforts taken to locate the
non-creditable hazardous waste pharmaceuticals, and the results of those
efforts.
(3)
Additional
reports. The director may require healthcare facilities to furnish additional
reports concerning the quantities and disposition of non-creditable hazardous
waste pharmaceuticals.
(J)
Recordkeeping by
healthcare facilities for non-creditable hazardous waste pharmaceuticals.
(1)
A healthcare
facility shall keep a copy of each manifest signed in accordance with paragraph
(A) of rule
3745-52-23 of the Administrative
Code for three years or until the healthcare facility receives a signed copy
from the designated facility which received the non-creditable hazardous waste
pharmaceuticals. This signed copy shall be retained as a record for at least
three years after the date the waste was accepted by the initial
transporter.
(2)
A healthcare facility shall keep a copy of each
exception report for a period of at least three years after the date of the
report.
(3)
A healthcare facility shall keep records of any test
results, waste analyses, or other determinations made to support the healthcare
facility's hazardous waste determinations consistent with paragraph (F) of rule
3745-52-11 of the Administrative
Code, for at least three years after the date the waste was last sent to
on-site or off-site treatment, storage or disposal. A healthcare facility that
manages all of the non-creditable non-hazardous waste pharmaceuticals as
non-creditable hazardous waste pharmaceuticals is not required to keep
documentation of hazardous waste determinations.
(4)
The periods of
retention referred to in this rule are extended automatically during the course
of any unresolved enforcement action regarding the regulated activity, or as
requested by the director.
(5)
All records shall
be readily available upon request by an inspector.
(K)
Response to
spills of non-creditable hazardous waste pharmaceuticals at healthcare
facilities. A healthcare facility shall immediately contain all spills of
non-creditable hazardous waste pharmaceuticals and manage the spill clean-up
materials as non-creditable hazardous waste pharmaceuticals in accordance with
rules 3745-266-500 to
3745-266-510 of the
Administrative Code.
(L)
Accepting non-creditable hazardous waste
pharmaceuticals from an off-site healthcare facility that is a very small
quantity generator. A healthcare facility may accept non-creditable hazardous
waste pharmaceuticals from an off-site healthcare facility that is a very small
quantity generator in accordance with rule
3745-52-14 of the Administrative
Code, without an Ohio hazardous waste permit or without having a permit by
rule, provided the receiving healthcare facility meets all of the
following:
(1)
Is under the control of the same "person," as defined in
rule 3745-50-10 of the Administrative
Code, as the very small quantity generator healthcare facility that is sending
the non-creditable hazardous waste pharmaceuticals off-site or has a
contractual or other documented business relationship whereby the receiving
healthcare facility supplies pharmaceuticals to the very small quantity
generator healthcare facility. ("Control," for the purposes of this rule, means
the power to direct the policies of the healthcare facility, whether by the
ownership of stock, voting rights, or otherwise, except that contractors who
operate healthcare facilities on behalf of a different "person," as defined in
rule 3745-50-10 of the Administrative
Code, shall not be deemed to "control" such healthcare
facilities.)
(2)
Is operating under rules
3745-266-500 to
3745-266-510 of the
Administrative Code for the management of the healthcare facility's
non-creditable hazardous waste pharmaceuticals.
(3)
Manages the
non-creditable hazardous waste pharmaceuticals that the healthcare facility
receives from off-site in compliance with rules
3745-266-500 to
3745-266-510 of the
Administrative Code.
(4)
Keeps records of the non-creditable hazardous waste
pharmaceuticals shipments the healthcare facility receives from off-site for
three years after the date that the shipment is received.
[Comment: For dates of non-regulatory
government publications, publications of recognized organizations and
associations, federal rules, and federal statutory provisions referenced in
this rule, see rule
3745-50-11 of the Administrative
Code titled "Incorporated by reference."]
