Current through August 26, 2024
(1) NOTIFICATION AND WITHDRAWAL FROM THIS
SUBCHAPTER FOR HEALTHCARE FACILITIES MANAGING HAZARDOUS WASTE PHARMACEUTICALS.
(a)
Notification. A
healthcare facility shall notify the department, using the site identification
form, EPA form 8700 -12, that it is a healthcare facility operating under this
subchapter. A healthcare facility is not required to fill out box 10.B., waste
codes for federal ly regulated hazardous waste, of the site identification form
with respect to its hazardous waste pharmaceuticals. A healthcare facility
shall submit a separate notification, using a site identification form, for
each site or EPA identification number.
1. A
healthcare facility that already has an EPA identification number shall notify
the department, using the site identification form EPA 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
calendar days of September 1, 2020, or within 60 calendar days of becoming
subject to this subchapter.
2. A
healthcare facility that does not have an EPA identification number shall
obtain one by notifying the department, using the site identification form EPA
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 calendar days of September 1, 2020, or within 60 calendar
days of becoming subject to this subchapter.
3. A healthcare facility shall keep a copy of
its notification on file for as long as the healthcare facility is subject to
this subchapter.
(b)
Withdrawal. A healthcare facility that operated under this
subchapter but is no longer subject to this subchapter, because it is a very
small quantity generator under s. NR 662.014, and elects to withdraw from this
subchapter, shall notify the department using the site identification form EPA
form 8700 -12 that it is no longer operating under this subchapter. 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 shall
submit a separate notification, using a site identification form, for each EPA
identification number.
1. A healthcare
facility shall submit the site identification form notifying that it is
withdrawing from this subchapter before it begins operating under the
conditional exemption under s. NR 662.014.
2. A healthcare facility shall keep a copy of
its withdrawal on file for 3 years from the date of signature on the
notification of its withdrawal.
(2) 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 thorough ly familiar with proper waste
handling and emergency procedures relevant to their responsibilities during
normal facility operations and emergencies.
(3) HAZARDOUS WASTE DETERMINATION FOR
NON-CREDITABLE PHARMACEUTICALS. A healthcare facility that generates a solid
waste that is a non -creditable pharmaceutical shall determine whether that
pharmaceutical is a hazardous waste pharmaceutical, because it exhibits a
characteristic identified in ch. NR 661 subchapter C or is listed in ch. NR 661
subchapter D, in order to determine whether the waste is subject to this
subchapter. A healthcare facility may choose to manage its non -hazardous waste
pharmaceuticals as non-creditable hazardous waste pharmaceuticals under this
subchapter.
(4) STANDARDS FOR
CONTAINERS USED TO ACCUMULATE NON-CREDITABLE HAZARDOUS WASTE PHARMACEUTICALS AT
HEALTHCARE FACILITIES.
(a) A healthcare
facility shall 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
reasonab ly foreseeable conditions.
(b) 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 it does not have the potential to do any of
the following:
1. Generate extreme heat or
pressure, fire or explosion, or violent reaction.
2. Produce uncontrolled toxic mists, fumes,
dusts, or gases in sufficient quantities to threaten human health.
3. Produce uncontrolled flammable fumes or
gases in sufficient quantities to pose a risk of fire or explosions.
4. Damage the structural integri ty of the
container of non -creditable hazardous waste pharmaceuticals.
5. Threaten human health or the environment
through other like means.
(c) A healthcare facility shall keep
containers of non-creditable hazardous waste pharmaceuticals closed and secured
in a manner that prevents unauthorized access to its contents.
(d) 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 under s.
NR 668.03(3) shall be accumulated in
separate containers and labeled with all applicable hazardous waste numbers, or
hazardous waste codes.
(5) 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."
(6) MAXIMUM
ACCUMULATION TIME FOR NON-CREDITABLE HAZARDOUS WASTE PHARMACEUTICALS AT
HEALTHCARE FACILITIES.
(a) A healthcare
facility may accumulate non -creditable hazardous waste pharmaceuticals on-site
for one year or less without a license or having interim status.
(b) 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 pharmaceuticals first become a
waste. A healthcare facility may make this demonstration by any of the
following methods:
1. Marking or labeling the
container of non -creditable hazardous waste pharmaceuticals with the date that
the non-creditable hazardous waste pharmaceuticals became a waste.
2. Maintaining an inventory system that
identifies the date the non -creditable hazardous waste pharmaceuticals being
accumulated first became a waste.
3. 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.
(7) 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 under ch. NR 668. A
healthcare facility that generates non-creditable hazardous waste
pharmaceuticals shall comply with the land disposal restrictions in accordance
with s.
NR 668.07(1) requirements, except that
it is not required to identify the hazardous waste numbers or hazardous waste
codes on the land disposal restrictions notification.
(8) 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 under s.
NR 664.0072 or 665.0072 may accumulate the returned non
-creditable hazardous waste pharmaceuticals on-site for up to an additional 90
calendar days provided the rejected or returned shipment is managed in
accordance with subs. (4) and (5). Upon receipt of the returned shipment, the
healthcare facility shall do all of the following:
(a) Sign one of the following:
1. Item 18c of the original manifest, if the
original manifest was used for the returned shipment.
2. Item 20 of the new manifest, if a new
manifest was used for the returned shipment.
(b) Provide the transporter a copy of the
manifest.
(c) Within 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.
(d) Within 90 calendar
days of receipt of the rejected shipment, transport or offer for transport the
returned shipment in accordance with the shipping standards under s. NR 666.508(1).
(9) REPORTING
BY HEALTHCARE FACILITIES FOR NON-CREDITABLE HAZARDOUS WASTE PHARMACEUTICALS.
(a)
Annual reporting by healthcare
facilities. A healthcare facility is not subject to annual reporting
requirements under s.
NR 662.041 with respect to non -creditable hazardous
waste pharmaceuticals managed under this subchapter.
(b)
Exception reporting by healthcare
facilities for a missing copy of the manifest.
1. `Shipments from a healthcare facility to a
designated facility.' For shipments from a healthcare facility to a designated
facility, all of the following exception reporting requirements apply:
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 60 calendar days of the date the non-creditable
hazardous waste pharmaceuticals were accepted by the initial transporter, the
healthcare facility shall submit all of the following to the department:
1) A legible copy of the original manifest,
indicating that the healthcare facility has not received confirmation of
deliver y.
2) A handwritten or
typed note on the original 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.
2. `Shipments rejected by the designated
facility and shipped to an alternate facility.' For shipments rejected by the
designated facility and shipped to an alternate facility, all of the following
exception reporting requirements apply:
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 60 calendar 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 shall submit all of the
following to the department:
1) A legible
copy of the original manifest, indicating that the healthcare facility has not
received confirmation of delivery.
2) A handwritten or typed note on the
original 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.
(c)
Additional reports. The
department may require healthcare facilities to furnish additional reports
concerning the quantities and disposition of non-creditable hazardous waste
pharmaceuticals.
(10)
RECORDKEEPING BY HEALTHCARE FACILITIES FOR NON-CREDITABLE HAZARDOUS WASTE
PHARMACEUTICALS.
(a) A healthcare facility
shall keep a copy of each manifest signed in accordance with s.
NR 662.023(1) for 3 years or until it receives a signed co
py from the designated facility that received the non -creditable hazardous
waste pharmaceuticals. This signed copy shall be retained as a record for at
least 3 years from the date the waste was accepted by the initial
transporter.
(b) A healthcare
facility shall keep a copy of each exception report for a period of at least 3
years from the date of the report.
(c) A healthcare facility shall keep records
of a ny test results, waste analyses, or other determinations made to support
its hazardous waste determination consistent with s.
NR 662.011(6), for at least 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.
(d) The periods of
retention referred to in this section are extended automatically during the
course of a ny unresolved enforcement action regarding the regulated activity,
or as requested by the department.
(e) All records shall be readily available
upon request by the department.
(11) 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 the requirements
of this subchapter.
(12) 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 s. NR 662.014, without a license or without having interim status, provided the
receiving healthcare facility meets all of the following:
(a) Is under the control of the same person,
as defined in s.
NR 660.10(90), 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 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 s.
NR 660.10 may not be deemed to "control" such healthcare
facilities.
(b) Is operating under
this subchapter for the management of its non-creditable hazardous waste
pharmaceuticals.
(c) Manages the
non -creditable hazardous waste pharmaceuticals that it receives from off-site
in compliance with this subchapter.
(d) Keeps records of the non-creditable
hazardous waste pharmaceuticals shipments it receives from off-site for 3 years
from the date that the shipment is received.
