Current through Register Vol. 48, No. 9, September 27, 2024
(a)
Notification and withdrawal from this subpart for healthcare facilities
managing hazardous waste pharmaceuticals-
(1)
Notification. A healthcare facility must notify the Department, using the Site
Identification Form (EPA Form 8700-12), that it is a healthcare facility
operating under this subpart. A healthcare facility is not required to fill out
Box 10.B. (Waste Codes for Federally Regulated Hazardous Waste) of the Site
Identification Form with respect to its hazardous waste pharmaceuticals. A
healthcare facility must submit a separate notification (Site Identification
Form) for each site or EPA identification number.
(i) A healthcare facility that already has an
EPA identification number must notify the Department using the Site
Identification Form (EPA Form 8700-12) that it is a healthcare facility. A
large quantity generator must notify the Department in its next quarterly
report per section 262.41. A small quantity generator must notify the
Department in its annual declaration per section 262.44.
(ii) A healthcare facility that does not have
an EPA identification number must obtain one by notifying the Department using
the Site Identification Form (EPA Form 8700-12) that it is a healthcare
facility within thirty (30) calendar days of the effective date of this subpart
or within thirty (30) calendar days of becoming subject to this
subpart.
(iii) A healthcare
facility must keep a copy of its notification on file for as long as the
healthcare facility is subject to this subpart.
(2) Withdrawal . A healthcare facility that
operated under this subpart but is no longer subject to this subpart, because
it is a very small quantity generator under section 262.14, and elects to
withdraw from this subpart, must notify the Department using the Site
Identification Form (EPA Form 8700-12) that it is no longer operating under
this subpart. A healthcare facility is not required to fill out Box 10.B.
(Waste Codes for Federally Regulated Hazardous Waste) of the Site
Identification Form with respect to its hazardous waste pharmaceuticals.
A healthcare facility must submit a separate notification
(Site Identification Form) for each EPA identification number.
(i) A healthcare facility must submit the
Site Identification Form notifying that it is withdrawing from this subpart
before it begins operating under the conditional exemption of section
262.14.
(ii) A healthcare facility
must keep a copy of its withdrawal on file for three years from the date of
signature on the notification of its withdrawal.
(b) Training of personnel managing
non-creditable hazardous waste pharmaceuticals at healthcare facilities. A
healthcare facility must ensure that all personnel that manage non-creditable
hazardous waste pharmaceuticals are thoroughly familiar with proper waste
handling and emergency procedures relevant to their responsibilities during
normal facility operations and emergencies.
(c) Hazardous waste determination for
non-creditable pharmaceuticals. A healthcare facility that generates a solid
waste that is a non-creditable pharmaceutical must determine whether that
pharmaceutical is a hazardous waste pharmaceutical (i.e., it exhibits a
characteristic identified in part 261, subpart C or is listed in part 261,
subpart D) in order to determine whether the waste is subject to this subpart.
A healthcare facility may choose to manage its non-hazardous waste
pharmaceuticals as non-creditable hazardous waste pharmaceuticals under this
subpart.
(d) Standards for
containers used to accumulate non-creditable hazardous waste pharmaceuticals at
healthcare facilities.
(1) A healthcare
facility must place non-creditable hazardous waste pharmaceuticals in a
container that is structurally sound, compatible with its 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
must manage the container so that it does not have the potential to:
(i) Generate extreme heat or pressure, fire
or explosion, or violent reaction;
(ii) Produce uncontrolled toxic mists, fumes,
dusts, or gases in sufficient quantities to threaten human health;
(iii) Produce uncontrolled flammable fumes or
gases in sufficient quantities to pose a risk of fire or explosions;
(iv) Damage the structural integrity of the
container of non-creditable hazardous waste pharmaceuticals; or
(v) Through other like means threaten human
health or the environment.
(3) A healthcare facility must keep
containers of non-creditable hazardous waste pharmaceuticals closed and secured
in a manner that prevents unauthorized access to its 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 section 268.3(c) must be accumulated in separate
containers and labeled with all applicable hazardous waste numbers (i.e.,
hazardous waste codes).
(e) Labeling containers used to accumulate
non-creditable hazardous waste pharmaceuticals at healthcare facilities. A
healthcare facility must 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 (1) year or less without a permit or having interim status.
(2) A healthcare facility that accumulates
non-creditable hazardous waste pharmaceuticals on-site must demonstrate the
length of time that the non-creditable hazardous waste pharmaceuticals have
been accumulating, starting from the date it first becomes a waste. A
healthcare facility may make this demonstration by any of the following
methods:
(i) Marking or labeling the container
of non-creditable hazardous waste pharmaceuticals with the date that the
non-creditable hazardous waste pharmaceuticals became a waste;
(ii) Maintaining an inventory system that
identifies the date the non-creditable hazardous waste pharmaceuticals being
accumulated first became a waste; or
(iii) 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 part 268. A
healthcare facility that generates non-creditable hazardous waste
pharmaceuticals must comply with the land disposal restrictions in accordance
with section 268.7(a) requirements, except that it is not required to identify
the hazardous waste numbers (i.e., hazardous waste codes) 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 section
264.72 or section 265.72 of this chapter may accumulate the returned
non-creditable hazardous waste pharmaceuticals on-site for up to an additional
ninety (90) calendar days provided the rejected or returned shipment is managed
in accordance with paragraphs (d) and (e) of this section . Upon receipt of the
returned shipment, the healthcare facility must:
(1) Sign either:
(i) Item 18c of the original manifest, if the
original manifest was used for the returned shipment; or
(ii) 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 (30)
calendar days of receipt of the rejected shipment, send a copy of the manifest
to the designated facility that returned the shipment to the healthcare
facility; and
(4) Within ninety
(90) calendar days of receipt of the rejected shipment, transport or offer for
transport the returned shipment in accordance with the shipping standards of
section 266.508(a).
(i)
Reporting by healthcare facilities for non-creditable hazardous waste
pharmaceuticals.
(1) Reporting by healthcare
facilities. Healthcare facilities are not subject to reporting requirements
under section 262.41 or section 262.44 with respect to non-creditable hazardous
waste pharmaceuticals managed under this subpart.
(2) Exception reporting by healthcare
facilities for a missing copy of the manifest.
(i) For shipments from a healthcare facility
to a designated facility:
(A) 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 (60) days of the date
the non-creditable hazardous waste pharmaceuticals were accepted by the initial
transporter, the healthcare facility must submit:
(1) A legible copy of the original manifest,
indicating that the healthcare facility has not received confirmation of
delivery, to the Department for the Region in which the healthcare facility is
located, and
(2) A handwritten or
typed note on the manifest itself, 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)
[Reserved]
(ii) For
shipments rejected by the designated facility and shipped to an alternate
facility.
(A) 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 (60) days of 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 must submit:
(1) A legible copy of the original manifest,
indicating that the healthcare facility has not received confirmation of
delivery, to the Department for the state in which the healthcare facility is
located; and
(2) A handwritten or
typed note on the manifest itself, 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)
[Reserved]
(3) Additional reports. The Department 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 must keep a copy of each manifest signed in accordance with
section 262.23(a) for three (3) years or until it receives a signed copy from
the designated facility that received the non-creditable hazardous waste
pharmaceuticals. This signed copy must be retained as a record for at least
three (3) years from the date the waste was accepted by the initial
transporter.
(2) A healthcare
facility must keep a copy of each exception report for a period of at least
three (3) years from the date of the report.
(3) A healthcare facility must keep records
of any test results, waste analyses, or other determinations made to support
its hazardous waste determination(s) consistent with section 262.11(f), for at
least three (3) years from the date the waste was last sent to on-site or
off-site treatment, storage, or disposal. A healthcare facility that manages
all of its 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 section are extended automatically
during the course of any unresolved enforcement action regarding the regulated
activity, or as requested by the Department.
(5) All records must be readily available
upon request by an inspector.
(k) Response to spills of non-creditable
hazardous waste pharmaceuticals at healthcare facilities. A healthcare facility
must 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 the requirements of this
subpart.
(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 under section
262.14, without a permit or without having interim status, provided the
receiving healthcare facility:
(1) Is under
the control of the same person (as defined in section 260.10) as the very small
quantity generator healthcare facility that is sending the non-creditable
hazardous waste pharmaceuticals off-site ("control," for the purposes of this
section , 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 section 260.10 of this chapter shall not be deemed to "control"
such healthcare facilities) or has a contractual or other documented business
relationship whereby the receiving healthcare facility supplies pharmaceuticals
to the very small quantity generator healthcare facility;
(2) Is operating under this subpart for the
management of its non-creditable hazardous waste pharmaceuticals;
(3) Manages the non-creditable hazardous
waste pharmaceuticals that it receives from off site in compliance with this
subpart; and
(4) Keeps records of
the non-creditable hazardous waste pharmaceuticals shipments it receives from
off site for three years from the date that the shipment is received.
