NR 666.510(1)(f)4.
4. If the reverse distributor alrea
dy
meets the security
requirements of this paragraph because of other regulatory requirements, such as drug enforcement administration or state board of pharmacy
regulations, the facility
is not required to provide separate securi
ty
measures pursuant to this section.
NR 666.510(1)(g)
(g)
Contingency plan and emergency procedures at a reverse distributor. A reverse distributor that accepts potentially
creditable hazardous waste pharmaceuticals from off
-site shall prepare a contingency
plan and comp
ly
with the other requirements under subch.
M of ch. NR 662.
NR 666.510(1)(h)
(h)
Closure of a reverse distributor. When closing an area where a reverse distributor accumulates potential
ly
creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, the reverse distributor shall comply
with s.
NR 662.017 (1) (h) 2. and
3. NR 666.510(1)(i)1.1. `Unauthorized waste report.' A reverse distributor shall submit an unauthorized waste report if the reverse distributor receives waste from off-site that it is not authorized to receive, such as non-pharmaceutical hazardous waste, or regulated medical waste. The reverse distributor shall prepare and submit an unauthorized waste report to the department within 45 calendar da
ys after the unauthorized waste arrives at the reverse distributor and shall send a copy
of the unauthorized waste report to the healthcare facility
or other entit
y that sent the unauthorized waste. The reverse distributor shall manage the unauthorized waste in accordance with all applicable regulations. The unauthorized waste report shall be signed by
the owner or operator of the reverse distributor, or its authorized representative, and contain all of the following information:
NR 666.510(1)(i)1.a.
a. The EPA identification number, name, and address of the reverse distributor
.
NR 666.510(1)(i)1.c.
c. The EPA identification number, name, and address of the healthcare facility
that shipped the unauthorized waste, if available.
NR 666.510(1)(i)1.d.
d. A description and the quantity
of each unauthorized waste the reverse distributor received.
NR 666.510(1)(i)2.
2. `Additional reports.' The department may require reverse distributors to furnish additional reports concerning the quantities and disposition of potentially
creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals.
NR 666.510(1)(j)
(j)
Recordkeeping by reverse distributors. The periods of retention referred to in this section are extended automatically
during the course of a
ny unresolved enforcement action regarding the regulated activit
y, or as requested by
the department. A reverse distributor shall keep all of the following records, paper or electronic, readily available upon request
by
an inspector:
NR 666.510(1)(j)1.
1. A co
py
of its notification on file for as long as the facility
is subject to this subchapter.
NR 666.510(1)(j)2.
2. A co
py
of the delivery confirmation and the shipping papers for each shipment of potentially
creditable hazardous waste pharmaceuticals that it receives, and a co
py
of each unauthorized waste report, for at least 3
years from the date the shipment arrives at the reverse distributor
.
NR 666.510(1)(j)3.
3. A co
py
of its current inventory for as long as the facili
ty
is subject to this subchapter.
NR 666.510(2)
(2)
Additional standards for reverse distributors managing potentially creditable hazardous waste pharmaceuticals destined for another reverse distributor. A reverse distributor that does not have a license or interim status shall comply
with all of the following conditions, in addition to the requirements specified in sub.
(1), for the management of potentially creditable hazardous waste pharmaceuticals that are destined for another reverse distributor for further evaluation or verification of manufacturer credit:
NR 666.510(2)(a)
(a) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from a healthcare facility
shall send those potentially
creditable hazardous waste pharmaceuticals to another reverse distributor within 180 calendar days after the potentially creditable hazardous waste pharmaceuticals have been evaluated or follow sub.
(3) for evaluated hazardous waste pharmaceuticals.
NR 666.510(2)(b)
(b) A reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from another reverse distributor shall send those potentially
creditable hazardous waste pharmaceuticals to a reverse distributor that is a pharmaceutical manufacturer within 180 calendar days after the potentially
creditable hazardous waste pharmaceuticals have been evaluated or follow sub.
(3) for evaluated hazardous waste pharmaceuticals.
NR 666.510(2)(c)
(c) A reverse distributor shall ship potentially
creditable hazardous waste pharmaceuticals destined for another reverse distributor in accordance with s.
NR 666.509.
NR 666.510(2)(d)
(d) The periods of retention referred to in this paragraph are extended automatical
ly
during the course of a
ny
unresolved enforcement action regarding the regulated activit
y, or as requested by
the department. A reverse distributor shall keep all of the following records, paper or electronic, readily available upon request
by
an inspector for each shipment of potentially
creditable hazardous waste pharmaceuticals that it initiates to another reverse distributor, for at least 3
years from the date of shipment:
NR 666.510(3)
(3)
Additional standards for reverse distributors managing evaluated hazardous waste pharmaceuticals. A reverse distributor that does not have a license or interim status shall comply with all of the following conditions, in addition to the requirements of sub.
(1), for the management of evaluated hazardous waste pharmaceuticals:
NR 666.510(3)(a)
(a)
Accumulation area at the reverse distributor. A reverse distributor shall designate an on
-site accumulation area where it will accumulate evaluated hazardous waste pharmaceuticals.
NR 666.510(3)(b)
(b)
Inspections of on-site accumulation area. A reverse distributor shall inspect its on
-site accumulation area at least once every
7 calendar da
ys, looking at containers for leaks and for deterioration caused
by
corrosion or other factors, as well as for signs of diversion.
NR 666.510(3)(c)
(c)
Personnel training at a reverse distributor. Personnel at a reverse distributor who handle evaluated hazardous waste pharmaceuticals are subject to the training requirements under s.
NR 662.017 (1) (g).
NR 666.510(3)(d)
(d)
Labeling and management of containers at on-site accumulation areas. A reverse distributor accumulating evaluated hazardous waste pharmaceuticals in containers in an on
-site accumulation area shall do all of the following:
NR 666.510(3)(d)1.
1. Label the containers with the words, “hazardous waste pharmaceuticals."
NR 666.510(3)(d)2.
2. Ensure the containers are in good condition and managed to prevent leaks.
NR 666.510(3)(d)3.
3. Use containers that are made of or lined with materials that will not react with, and are otherwise compatible with, the evaluated hazardous waste pharmaceuticals, so that the ability of the container to contain the waste is not impaired.
NR 666.510(3)(d)4.
4. Keep containers closed, if the container is holding liquid or gel evaluated hazardous waste pharmaceuticals. If the liquid or gel evaluated hazardous waste pharmaceuticals are in their original, intact, sealed packaging or repackaged in intact, sealed packaging, they are considered to meet the closed container standard.
NR 666.510(3)(d)5.
5. Manage a
ny
container of ignitable or reactive evaluated hazardous waste pharmaceuticals, or a
ny container of commingled incompatible evaluated hazardous waste pharmaceuticals so that the container does not have the potential to do any of the following:
NR 666.510(3)(d)5.b.
b. Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health.
NR 666.510(3)(d)5.c.
c. Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions.
NR 666.510(3)(d)5.d.
d. Damage the structural integri
ty
of the container of hazardous waste pharmaceuticals.
NR 666.510(3)(d)6.
6. Accumulate evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition under s.
NR 668.03 (3), for example arsenic trioxide (P012), in separate containers from other evaluated hazardous waste pharmaceuticals at the reverse distributor
.
NR 666.510(3)(e)
(e)
Hazardous waste numbers. Prior to shipping evaluated hazardous waste pharmaceuticals off-site
, all containers shall be marked with the applicable hazardous waste numbers, or hazardous waste codes. A nationally recognized electronic s
ystem, such as bar coding or radio frequency identification, may
be used to identify
the EPA hazardous waste numbers.
NR 666.510(3)(f)
(f)
Shipments. A reverse distributor shall ship evaluated hazardous waste pharmaceuticals that are destined for a permitted or interim status treatment, storage, or disposal facility
in accordance with the applicable shipping standards specified in s.
NR 666.508 (1) or
(2).
NR 666.510(3)(g)
(g)
Procedures for a reverse distributor for managing rejected shipments. A reverse distributor that sends a shipment of evaluated 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 evaluated hazardous waste pharmaceuticals on-site for up to an additional 90 calendar days in the on
-site accumulation area provided the rejected or returned shipment is managed in accordance with sub.
(1) and this subsection
. Upon receipt of the returned shipment, the reverse distributor shall do all of the following:
NR 666.510(3)(g)1.a.
a. Item 18c of the original manifest, if the original manifest was used for the returned shipment.
NR 666.510(3)(g)1.b.
b. Item 20 of the new manifest, if a new manifest was used for the returned shipment.
NR 666.510(3)(g)3.
3. Within 30 calendar days of receipt of the rejected shipment of the evaluated hazardous waste pharmaceuticals, send a copy
of the manifest to the designated facility
that returned the shipment to the reverse distributor
.
NR 666.510(3)(g)4.
4. Within 90 calendar days of receipt of the rejected shipment, transport or offer for transport the returned shipment of evaluated hazardous waste pharmaceuticals in accordance with the applicable shipping standards under s.
NR 666.508 (1) or
(2).
NR 666.510(3)(h)
(h)
Land disposal restrictions. Evaluated hazardous waste pharmaceuticals are subject to the land disposal restrictions under ch.
NR 668. A reverse distributor that accepts potentially creditable hazardous waste pharmaceuticals from off
-site shall comply
with the land disposal restrictions in accordance with s.
NR 668.07 (1) requirements.
NR 666.510(3)(i)
(i)
Reporting by a reverse distributor for evaluated hazardous waste pharmaceuticals. NR 666.510(3)(i)1.
1. `Annual reporting by a reverse distributor.' A reverse distributor that ships evaluated hazardous waste pharmaceuticals off
-site shall prepare and submit a single copy
of an annual report to the department by
March 1 of each
year in accordance with s.
NR 662.041.
NR 666.510(3)(i)2.
2. `Exception reporting by a reverse distributor for a missing copy of the manifest - shipments from a reverse distributor to a designated facility.' NR 666.510(3)(i)2.a.a. A reverse distributor who does not receive a co
py of the manifest with the signature of the owner or operator of the designated facility
within 35 calendar da
ys of the date the evaluated hazardous waste pharmaceuticals were accepted by the initial transporter, shall contact the transporter or the owner or operator of the designated facility
to determine the status of the evaluated hazardous waste pharmaceuticals.
NR 666.510(3)(i)2.b.
b. A reverse distributor shall submit an exception report to the department if it has not received a copy
of the manifest with the signature of the owner or operator of the designated facility
within 45 calendar days of the date the evaluated hazardous waste pharmaceutical was accepted by
the initial transporter. The exception report shall include all of the following:
1) A legible copy of the manifest for which the reverse distributor does not have confirmation of delivery.
2) A cover letter signed by the reverse distributor, or its authorized representative, explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the results of those efforts.
NR 666.510(3)(i)3.
3. `Exception reporting by a reverse distributor for a missing copy of the manifest - shipments rejected by the designated facility and shipped to an alternate facility.' NR 666.510(3)(i)3.a.a. A reverse distributor that does not receive a copy
of the manifest with the signature of the owner or operator of the alternate facili
ty
within 35 calendar days of the date the evaluated hazardous waste pharmaceuticals were accepted
by
the initial transporter shall contact the transporter or the owner or operator of the alternate facility
to determine the status of the hazardous waste. The 35-day
time frame begins the date the evaluated hazardous waste pharmaceuticals are accepted
by the transporter forwarding the hazardous waste shipment from the designated facility
to the alternate facilit
y.
NR 666.510(3)(i)3.b.
b. A reverse distributor shall submit an exception report to the department if it has not received a copy
of the manifest with the signature of the owner or operator of the alternate facility
within 45 calendar days of the date the evaluated hazardous waste pharmaceuticals were accepted by
the initial transporter. The 45
-day
timeframe begins the date the evaluated hazardous waste pharmaceuticals are accepted by
the transporter forwarding the hazardous waste pharmaceutical shipment from the designated facility
to the alternate facilit
y. The exception report shall include all of the following:
1) A legible copy of the manifest for which the generator does not have confirmation of delivery.
2) A cover letter signed by the reverse distributor, or its authorized representative, explaining the efforts taken to locate the evaluated hazardous waste pharmaceuticals and the results of those efforts.
NR 666.510(3)(j)
(j)
Recordkeeping by a reverse distributor for evaluated hazardous waste pharmaceuticals. NR 666.510(3)(j)1.
1. A reverse distributor shall keep a log, written or electronic, of the inspections of the on
-site accumulation area, as required under
par
. (b). This log shall be retained as a record for at least 3
years from the date of the inspection.
NR 666.510(3)(j)2.
2. A reverse distributor shall keep a co
py
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 evaluated hazardous waste pharmaceutical. This signed co
py shall be retained as a record for at least 3 years from the date the evaluated hazardous waste pharmaceutical was accepted
by
the initial transporter.
NR 666.510(3)(j)3.
3. A reverse distributor shall keep a co
py
of each annual report for at least 3
years from the due date of the report.
NR 666.510(3)(j)4.
4. A reverse distributor shall keep a co
py
of each exception report for at least 3
years from the submission of the report.
NR 666.510(3)(j)6.
6. All records shall be readily available upon request by
an inspector. The periods of retention referred to in this section are extended automatically
during the course of a
ny unresolved enforcement action regarding the regulated activit
y, or as requested by
the department.
NR 666.510(4)
(4)
When a reverse distributor is required to have a license. A reverse distributor is an operator of a hazardous waste treatment, storage, or disposal facility
and is subject to the requirements under chs.
NR 664,
665, and
667 and the license requirements under ch.
NR 670, if the reverse distributor does any of the following:
NR 666.510(4)(c)
(c) Treats or disposes of hazardous waste pharmaceuticals on-site.
NR 666.510 History
History: CR 19-082: cr.
Register August 2020 No. 776, eff. 9-1-20; correction in (1) (e) 2., (2) (c), (3) (g) (intro.) made under s.
35.17, Stats.,
Register August 2020 No. 776.
subch. HH of ch. NR 666
Subchapter HH — Household and Very Small Quantity Generator Hazardous Waste Collection Facilities
NR 666.900
NR 666.900 Applicability. This subchapter establishes minimum design and operating standards for owners or operators of collection facilities that collect or store household hazardous waste or very small quantity generator waste, or both. The owner or operator of a collection facility is exempt from the hazardous waste storage facility standards and licensing requirements in chs.
NR 664,
665 and
670 if the owner or operator complies with all applicable requirements of this subchapter.
NR 666.900 History
History: CR 05-032: cr.
Register July 2006 No. 607, eff. 8-1-06.
NR 666.901
NR 666.901 Definitions. The following definitions apply to this subchapter:
NR 666.901(1)
(1) “Affected municipality" means a town, city, village or county in which a collection facility is located, or is proposed to be located.
NR 666.901(2)
(2) “Collection facility" means a facility established to collect or store household hazardous waste or very small quantity generator waste, or both.
NR 666.901(3)
(3) “Elementary neutralization unit” means a container or tank used for neutralizing wastes that are hazardous only because they exhibit the corrosivity characteristic defined in s.
NR 661.0022, or they are listed in subch.
D of ch. NR 661 only for corrosivity.
NR 666.901(4)
(4) “Household hazardous waste" means a household waste that exhibits a characteristic of hazardous waste or is listed in ch.
NR 661.
NR 666.901(5)
(5) “Permanent collection facility" means a collection facility where household hazardous waste or very small quantity generator waste, or both, is collected or stored for more than 5 consecutive days.
NR 666.901(6)
(6) “Temporary collection facility" means a collection facility where household hazardous waste or very small quantity generator waste, or both, is collected or stored for no more than 5 consecutive days.
NR 666.901 History
History: CR 05-032: cr.
Register July 2006 No. 607, eff. 8-1-06;
CR 19-082: am. (3)
Register August 2020 No. 776, eff. 9-1-20.
NR 666.902
NR 666.902 Standards for design of permanent collection facilities. The owner or operator of a permanent collection facility shall construct and maintain the facility according to all of the following minimum design criteria:
NR 666.902(1)
(1) A collection facility may not be located in any of the following:
