35 Ill. Adm. Code 726.602
Standards for Non-Creditable Hazardous Waste Pharmaceuticals
Section 726.602Â Standards for Non-Creditable Hazardous
Waste Pharmaceuticals
a)Â Â Â Â Â Â Â Â Notification
and Withdrawal from Subpart P for Healthcare Facilities Managing Hazardous
Waste Pharmaceuticals
1)Â Â Â Â Â Â Â Â Notification.Â
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 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)Â Â Â Â Â Â Â 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 Subpart P.
B)Â Â Â Â Â Â Â 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 Subpart P.
C)Â Â Â Â Â Â Â A
healthcare facility must keep a copy of its notification on file for as long as
the healthcare facility is subject to Subpart P.
BOARD NOTE:Â 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 meet
this mandate.
2)Â Â Â Â Â Â Â Â Withdrawal.Â
A healthcare facility that operated under Subpart P but is no longer subject to
Subpart P, because it is a VSQG under 35 Ill. Adm. Code 722.114, and that
elects to withdraw from Subpart P, must notify the appropriate agency using
USEPA Form 8700-12 that it is no longer operating under 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)Â Â Â Â Â Â Â A
healthcare facility must submit USEPA Form 8700-12 notifying that it is
withdrawing from Subpart P before it begins operating under the conditional
exemption of 35 Ill. Adm. Code 722.114.
B)Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â 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) to determine if
the waste is subject to Subpart P. A healthcare facility may choose to manage
its non-hazardous waste pharmaceuticals as non-creditable hazardous waste
pharmaceuticals under Subpart P.
d)Â Â Â Â Â Â Â Â Standards
for Containers Used to Accumulate Non-Creditable Hazardous Waste
Pharmaceuticals at Healthcare Facilities
1)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Generate
extreme heat or pressure, fire or explosion, or violent reaction;
B)Â Â Â Â Â Â Â Produce
uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to
threaten human health;
C)Â Â Â Â Â Â Â Produce
uncontrolled flammable fumes or gases in sufficient quantities to pose a risk
of fire or explosions;
D)Â Â Â Â Â Â Â Damage
the structural integrity of the container of non-creditable hazardous waste
pharmaceuticals; or
E)Â Â Â Â Â Â Â Through
other like means threaten human health or the environment.
3)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â A
healthcare facility may accumulate non-creditable hazardous waste pharmaceuticals
and nonhazardous non-creditable waste pharmaceuticals in the same container,
except that the non-creditable hazardous waste pharmaceuticals prohibited from
being combusted because of the dilution prohibition of 35 Ill. Adm. Code
728.103(c) (i.e., metal-bearing waste codes listed in 35 Ill. Adm. Code
728.Appendix K, unless one or more of the criteria in 35 Ill. Adm. code
728.103(c)(1) through (c)(6) are met), or because it is prohibited from being
lab packed due to
35 Ill. Adm. Code 728.Table C
)
must be accumulated in separate containers, and labeled with all applicable
USEPA hazardous waste numbers.
e)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â Maximum
Accumulation Time for Non-Creditable Hazardous Waste Pharmaceuticals at
Healthcare Facilities
1)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Maintaining
an inventory system that identifies the date when the
accumulated
non-creditable hazardous waste pharmaceuticals first became
a waste;
C)Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â 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 35 Ill. Adm.
Code 728.107(a), except that it is not required to identify the USEPA hazardous
waste numbers on the land disposal restrictions notification.
h)Â Â Â Â Â Â Â Â 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 compliance with the
manifest discrepancy provisions of 35 Ill. Adm. Code 724.172 or 725.172, may
accumulate the rejected non-creditable hazardous waste pharmaceuticals on-site
for up to an additional 90 days if the rejected or returned shipment is managed
in compliance with subsections (d) and (e). Upon receipt of the returned
shipment, the healthcare facility must:
1)Â Â Â Â Â Â Â Â Sign
the applicable of the following:
A)Â Â Â Â Â Â Â Item
18c
(Signature of Alternate Facility (or Generator))
of the original manifest, if the original manifest was used for the returned
shipment; or
B)Â Â Â Â Â Â Â Item
20
(Designated Facility Owner or Operator.Â
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)Â Â Â Â Â Â Â Â Provide
the transporter a copy of the manifest;
3)Â Â Â Â Â Â Â Â Within
30 days after receiving the rejected shipment, send a copy of the manifest to
the designated facility that returned the shipment to the healthcare facility;
and
4)Â Â Â Â Â Â Â Â Within
90 days after receipt of the rejected shipment, transport or offer for
transport the returned shipment in compliance with the shipping standards of
Section 726.608(a).
i)Â Â Â Â Â Â Â Â Â Reporting
by Healthcare Facilities for Non-Creditable Hazardous Waste Pharmaceuticals
1)Â Â Â Â Â Â Â Â 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 Subpart P.
2)Â Â Â Â Â Â Â Â Exception
Reporting by Healthcare Facilities for a Missing Copy of the Manifest
A)Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â Â A
legible copy of the original manifest to the Agency, indicating that the
healthcare facility has not received confirmation of delivery; and
ii)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â 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 forwarded 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)Â Â Â Â Â Â Â Â Â A
legible copy of the original manifest to the Agency, indicating that the healthcare
facility has not received confirmation of delivery; and
ii)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â Â Recordkeeping
by Healthcare Facilities for Non-Creditable Hazardous Waste Pharmaceuticals
1)Â Â Â Â Â Â Â Â A
healthcare facility must keep a copy of each manifest signed in compliance 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)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â 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)Â Â Â Â Â Â Â Â The periods
of retention referred to in this Section are extended automatically during any
unresolved enforcement action regarding the regulated activity or as requested
in writing by the Agency.
5)Â Â Â Â Â Â Â Â A
healthcare facility must make all records readily available upon request by a
USEPA or Agency inspector.
k)Â Â Â Â Â Â Â Â 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 compliance with
the requirements of Subpart P.
l)Â Â Â Â Â Â Â Â Â 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, if the receiving healthcare facility meets the following
conditions:
1)Â Â Â Â Â Â Â Â 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 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)Â Â Â Â Â Â Â Â The
receiving healthcare facility is operating under Subpart P for the management
of its non-creditable hazardous waste pharmaceuticals;
3)Â Â Â Â Â Â Â Â The
receiving healthcare facility manages the non-creditable hazardous waste
pharmaceuticals that it receives from off site in compliance with Subpart P;
and
4)Â Â Â Â Â Â Â Â 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.