Current through Register Vol. 48, No. 38, September 20, 2024
a) Notification and
Withdrawal from this Subpart P for Healthcare Facilities Managing Hazardous
Waste Pharmaceuticals
1) Notification. A
healthcare facility must notify the Agency, using Notification of RCRA Subtitle
C Activities (Site Identification Form) (USEPA Form 8700-12), that it is a
healthcare facility operating under this Subpart P. 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 (using the Site Identification Form) for each site or USEPA
identification number.
A) A healthcare
facility that already has a USEPA identification number must notify the Agency,
using USEPA Form 8700-12, that it is a healthcare facility as part of its next
annual report, if it is required to submit one; or, if not required to submit
an annual report, within 60 days after becoming subject to this Subpart
P.
B) A healthcare facility that
does not have a USEPA identification number must obtain one by notifying the
Agency, using USEPA Form 8700-12, that it is a healthcare facility as part of
its next annual report, if it is required to submit one; or if not required to
submit an annual report, within 60 days after becoming subject to this Subpart
P.
C) A healthcare facility must
keep a copy of its notification on file for as long as the healthcare facility
is subject to this Subpart P.
BOARD NOTE: Corresponding 40 CFR 266.602(a)(1) requires
biennial reporting. The Board has required annual reporting, since Section
20.1 of the Act
requires the Agency to assemble annual reports, and only annual facility
activity reports will enable the Agency to fulfill this mandate.
2) Withdrawal. A
healthcare facility that operated under this Subpart P but is no longer subject
to this Subpart P, because it is a VSQG under 35 Ill. Adm. Code
722.114,
and that elects to withdraw from this Subpart P, must notify the appropriate
agency using USEPA Form 8700-12 that it is no longer operating under this
Subpart P. A healthcare facility is not required to fill out Box 10.B. (Waste
Codes for Federally Regulated Hazardous Waste) of USEPA Form 8700-12 with
respect to its hazardous waste pharmaceuticals. A healthcare facility must
submit a separate notification (using USEPA Form 8700-12) for each USEPA
identification number.
A) A healthcare
facility must submit USEPA Form 8700-12 notifying that it is withdrawing from
this Subpart P before it begins operating under the conditional exemption of 35
Ill. Adm. Code 722.114.
B) A
healthcare facility must keep a copy of its withdrawal on file for three years
after 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 managing
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 Subpart D of 35 Ill. Adm. Code 721 or is listed in
Subpart D of 35 Ill. Adm. Code 721) in order to determine whether the waste is
subject to this Subpart P. A healthcare facility may choose to manage its
non-hazardous waste pharmaceuticals as non-creditable hazardous waste
pharmaceuticals under this Subpart P.
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 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; or
E) 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 their contents.
4) A healthcare facility may accumulate
non-creditable hazardous waste pharmaceuticals and nonhazardous non-creditable
waste pharmaceuticals in the same container, except that the healthcare
facility must accumulate non-creditable hazardous waste pharmaceuticals
prohibited from being combusted because of the dilution prohibition of 35 Ill.
Adm. Code
728.103(c)
in separate containers and label the containers with all applicable USEPA
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
1) 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) A healthcare facility that accumulates
non-creditable hazardous waste pharmaceuticals on-site must demonstrate the
length of time that the facility has accumulated the non-creditable hazardous
waste pharmaceuticals, 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 when the
non-creditable hazardous waste pharmaceuticals became a waste;
B) Maintaining an inventory system that
identifies the date when the accumulated non-creditable hazardous waste
pharmaceuticals first became a waste;
C) Placing the non-creditable hazardous waste
pharmaceuticals in a specific area and identifying the earliest date when 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 35 Ill. Adm. Code
728. A healthcare facility that generates non-creditable hazardous waste
pharmaceuticals must comply with the land disposal restrictions in accordance
with 35 Ill. Adm. Code
728.107(a)
requirements, except that it is not required to identify the USEPA 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 that later receives
that shipment back as a rejected load in accordance with the manifest
discrepancy provisions of 35 Ill. Adm. Code
724.172 or
725.172,
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). Upon receipt of
the returned shipment, the healthcare facility must do the following:
1) Sign the applicable of the following:
A) Item 18c (Signature of Alternate Facility
(or Generator)) of the original manifest, if the original manifest was used for
the returned shipment; or
B) Item
20 (Designated Facility Owner or Operator. Certification of hazardous materials
covered by the manifest except as noted in Item 18a) 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 30 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; and
4) Within 90 days after receipt of the
rejected shipment, transport or offer for transport the returned shipment in
accordance with the shipping standards of Section 726.608(a).
i) Reporting by Healthcare
Facilities for Non-Creditable Hazardous Waste Pharmaceuticals
1) Biennial Reporting by Healthcare
Facilities. Healthcare facilities are not subject to annual reporting
requirements under 35 Ill. Adm. Code
722.141,
with respect to non-creditable hazardous waste pharmaceuticals managed under
this Subpart P.
2) Exception
Reporting by Healthcare Facilities for a Missing Copy of the Manifest
A) For Shipments from a Healthcare Facility
to a Designated Facility. 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 60 days after the date when the initial transporter accepted
the non-creditable hazardous waste pharmaceuticals, the healthcare facility
must submit the following:
i) A legible copy
of the original manifest to the Agency, indicating that the healthcare facility
has not received confirmation of delivery; and
ii) 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) For Shipments Rejected by the
Designated Facility and Shipped to an Alternate Facility. 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 60 days after the date when the initial transporter forwarding
the shipment of non-creditable hazardous waste pharmaceuticals from the
designated facility to the alternate facility accepted the non-creditable
hazardous waste, the healthcare facility must submit the following:
i) A legible copy of the original manifest to
the Agency, indicating that the healthcare facility has not received
confirmation of delivery; and
ii) 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.
3) Additional Reports. The Agency may, in
writing, require a healthcare facility 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 35 Ill. Adm. Code
722.123(a)
for three years or until it receives a signed copy from the designated facility
that received the non-creditable hazardous waste pharmaceuticals. The
healthcare facility must retain this signed copy as a record for at least three
years after the date when the initial transporter accepted the waste.
2) A healthcare facility must 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 must keep records of any test results, waste analyses, or other
determinations made to support its hazardous waste determinations consistent
with 35 Ill. Adm. Code
722.111(f),
for at least three years after the date the waste was last sent to onsite or
off-site treatment, storage, or disposal. A healthcare facility that manages
all of its non-creditable nonhazardous waste pharmaceuticals as non-creditable
hazardous waste pharmaceuticals is not required to keep documentation of its
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 in writing by the Agency.
5) A healthcare facility must make all
records readily available upon request by a USEPA or Agency
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 P.
l) Accepting Non-Creditable Hazardous Waste
Pharmaceuticals from an Off-Site Healthcare Facility That Is a VSQG. A
healthcare facility may accept non-creditable hazardous waste pharmaceuticals
from an off-site healthcare facility that is a VSQG under 35 Ill. Adm. Code
722.114, without a permit or without having interim status, provided the
receiving healthcare facility fulfills the following conditions:
1) The receiving healthcare facility is under
the control of the same person (as defined in 35 Ill. Adm. Code
720.110) as the
VSQG healthcare facility 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 VSQG healthcare facility. ("Control", for the purposes of this
subsection (l)(1), means the power to direct the policies of the healthcare
facility, whether by the ownership of stock, voting rights, or otherwise. A
contractor that operates a healthcare facility on behalf of a different person,
as defined in 35 Ill. Adm. Code 720.110, does not "control" a healthcare
facility);
2) The receiving
healthcare facility is operating under this Subpart P for the management of its
non-creditable hazardous waste pharmaceuticals;
3) The receiving healthcare facility manages
the non-creditable hazardous waste pharmaceuticals that it receives from off
site in compliance with this Subpart P; and
4) The receiving healthcare facility keeps
records of the non-creditable hazardous waste pharmaceuticals shipments it
receives from off site for three years after the date when it received the
shipment.
