(a) Notification and withdrawal from this subchapter
for healthcare facilities managing hazardous waste pharmaceuticals.
A healthcare facility must notify the executive director that it is
either subject to this subchapter, or is withdrawing from regulation
under this subchapter, using the following procedures.
(1) Notification. A healthcare facility must notify
the executive director that it is a healthcare facility operating
under this subchapter using a method approved by the executive director
within 60 days of becoming subject to this chapter. The method approved
by the executive director collects the information required by the
United States Environmental Protection Agency (EPA) Site Identification
Form.
(A) A healthcare facility must submit a separate notification
for each site or EPA identification number.
(B) A healthcare facility is not required to submit
EPA hazardous waste numbers with this notification.
(C) A healthcare facility must retain a copy of a notification
as long as the healthcare facility is subject to this subchapter.
(2) Withdrawal. A healthcare facility that elects to
withdraw from this subchapter because it is a very small quantity
generator that meets the conditions for exemption for a very small
quantity generator under 40 Code of Federal Regulations (CFR) §262.14
as adopted under §335.53 of this title (relating to General Standards
Applicable to Generators of Hazardous Waste) must notify the executive
director that it elects to withdraw from this subchapter using a method
approved by the executive director. A healthcare facility is not required
to submit any EPA hazardous waste numbers with this notification.
A healthcare facility must submit a separate notification for each
site or EPA identification number.
(A) A healthcare facility must submit the notification
that it is withdrawing from this subchapter in accordance with this
paragraph before it begins operating under the conditions for exemption
of a very small quantity generator in 40 CFR §262.14 as adopted
under §335.53 of this title.
(B) A healthcare facility must retain a copy of a notification
of withdrawal for three years from the date of the signature on the
notification of 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 by determining
if it exhibits a characteristic identified in 40 CFR Part 261, Subpart
C or is listed in 40 CFR Part 261, Subpart D as adopted under §335.504
of this title (relating to Hazardous Waste Determination) in order
to determine whether the waste is subject to this subchapter. A healthcare
facility may elect to manage its nonhazardous waste pharmaceuticals
as non-creditable hazardous waste pharmaceuticals under this subchapter.
(d) Standards for containers used to accumulate non-creditable
hazardous waste pharmaceuticals at healthcare facilities. A healthcare
facility must store containers containing non-creditable hazardous
waste pharmaceuticals in accordance with the following container management
standards.
(1) Container requirements. 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) Ignitable, reactive, or incompatible wastes. 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:
(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; or
(E) through other like means threaten human health
or the environment.
(3) Container security. 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) Accumulating non-creditable waste pharmaceuticals
in the same container. A healthcare facility may accumulate non-creditable
hazardous waste pharmaceuticals and nonhazardous 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 40 CFR §268.3(c) as adopted under §335.431
of this title (relating to Purpose, Scope, and Applicability) must
be accumulated in separate containers and labeled with all applicable
EPA hazardous waste numbers.
(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. A healthcare facility
must observe the following standards for on-site accumulation time
of non-creditable hazardous waste pharmaceuticals.
(1) Maximum accumulation time. A healthcare facility
may accumulate non-creditable hazardous waste pharmaceuticals on-site
for one year or less without a permit or having interim status.
(2) Accumulation start date. 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:
(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 40 CFR Part 268 as adopted under Subchapter O of this
chapter (relating to Land Disposal Restrictions). A healthcare facility
that generates non-creditable hazardous waste pharmaceuticals must
comply with the land disposal restrictions in accordance with 40 CFR §268.7(a)
requirements as adopted under §335.431 of this title, except
that it is not required to include the EPA 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 40 CFR §264.72 as
adopted under §335.152 of this title (relating to Standards)
or 40 CFR §265.72 as adopted under §335.112 of this title
(relating to Standards) may accumulate the returned non-creditable
hazardous waste pharmaceuticals on-site for up to an additional 90
days provided the rejected or returned shipment is managed in accordance
with subsections (d) and (e) of this section. Upon receipt of the
returned shipment, the healthcare facility must complete the following.
(1) Healthcare facility manifest signature. The healthcare
facility must sign either:
(A) item 18c of the original manifest, if the original
manifest was used for the returned shipment; or
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