| (i) generate extreme heat or pressure, fire or explosion,
or violent reaction;
(ii) produce uncontrolled toxic mists, fumes, dusts,
or gases in sufficient quantities to threaten human health;
(iii) produce uncontrolled flammable fumes or gases
in sufficient quantities to pose a risk of fire or explosions;
(iv) damage the structural integrity of the container
of hazardous waste pharmaceuticals; or
(v) through other like means threaten human health
or the environment; and
(F) Accumulate evaluated hazardous waste pharmaceuticals
that are 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) (e.g., arsenic trioxide
(P012)) in separate containers from other evaluated hazardous waste
pharmaceuticals at the reverse distributor.
(5) United States Environmental Protection Agency (EPA)
hazardous waste numbers. Prior to shipping evaluated hazardous waste
pharmaceuticals off-site, all containers must be marked with the applicable
EPA hazardous waste numbers. A nationally recognized electronic system,
such as bar coding or radio frequency identification, may be used
to identify the EPA hazardous waste number(s).
(6) Shipments. A reverse distributor must 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 in §335.767(a) or (b)
of this title (relating to Shipping Non-Creditable Hazardous Waste
Pharmaceuticals from a Healthcare Facility or Evaluated Hazardous
Waste Pharmaceuticals from a Reverse Distributor).
(7) 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 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
evaluated hazardous waste pharmaceuticals on site for up to an additional
90 days in the on-site accumulation area provided the rejected or
returned shipment is managed in accordance with subsection (a) or
(c) of this section. Upon receipt of the returned shipment, the reverse
distributor must:
(A) Sign either:
(i) item 18c of the original manifest, if the original
manifest was used for the returned shipment; or
(ii) 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 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; and
(D) Within 90 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 of §335.767(a) or (b) of this title.
(8) Land disposal restrictions. Evaluated hazardous
waste pharmaceuticals 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 reverse distributor that accepts
potentially creditable hazardous waste pharmaceuticals from off-site
must comply with the land disposal restrictions in accordance with
40 CFR §268.7(a) as adopted under §335.431 of this title
(relating to Purpose, Scope, and Applicability).
(9) Reporting by a reverse distributor for evaluated
hazardous waste pharmaceuticals. Reverse distributors are subject
to the following reporting requirements.
(A) A reverse distributor that ships evaluated hazardous
waste pharmaceuticals off-site must:
(i) comply with the reporting requirements of §335.9
of this title (relating to Recordkeeping and Annual Reporting Procedures
Applicable to Generators), and
(ii) in every even-numbered year, submit supplemental
biennial reporting information for the previous odd-numbered report
year required by 40 CFR §262.41 as adopted by reference under §335.56
of this title (relating to Recordkeeping and Reporting Applicable
to Small and Large Quantity Generators), upon request, in a method
approved by the executive director within the specified timeframe.
Information submitted to the executive director in accordance with
Subchapter A of this chapter (relating to Industrial Solid Waste and
Municipal Hazardous Waste in General), Subchapter C of this chapter
(relating to Standards Applicable to Generators of Hazardous Waste),
and Subchapter R of this chapter (relating to Waste Classification)
is not required to be resubmitted in a biennial report.
(B) If a reverse distributor does not receive a copy
of the manifest with the signature of the owner or operator of the
designated facility within 35 days of the date the evaluated hazardous
waste pharmaceuticals were accepted by the initial transporter, the
reverse distributor must contact the transporter or the owner or operator
of the designated facility to determine the status of the evaluated
hazardous waste pharmaceuticals.
(C) A reverse distributor must submit an exception
report to the executive director if it has not received a copy of
the manifest with the signature of the owner or operator of the designated
facility within 45 days of the date the evaluated hazardous waste
pharmaceutical was accepted by the initial transporter. The exception
report must include:
(i) a legible copy of the manifest for which the reverse
distributor does not have confirmation of delivery; and
(ii) 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.
(D) For shipments rejected by the designated facility
and shipped to an alternate facility, a reverse distributor that does
not receive a copy of the manifest with the signature of the owner
or operator of the alternate facility within 35 days of the date the
evaluated hazardous waste pharmaceuticals were accepted by the initial
transporter must 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
facility.
(E) For shipments rejected by the designated facility
and shipped to an alternate facility, a reverse distributor must submit
an exception report to the executive director if it has not received
a copy of the manifest with the signature of the owner or operator
of the alternate facility within 45 days of the date the evaluated
hazardous waste pharmaceuticals were accepted by the initial transporter.
The 45-day time frame 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 facility. The exception report must include:
(i) A legible copy of the manifest for which the generator
does not have confirmation of delivery; and
(ii) 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.
(10) Recordkeeping by a reverse distributor for evaluated
hazardous waste pharmaceuticals. Reverse distributors are subject
to the following recordkeeping requirements.
(A) A reverse distributor must keep a log (written
or electronic) of the inspections of the on-site accumulation area,
required by subsection (c)(2) of this section. This log must be retained
as a record for at least three years from the date of the inspection.
(B) A reverse distributor must keep a copy of each
manifest signed in accordance with 40 CFR §262.23(a) as adopted
under §335.54 of this title (relating to Hazardous Waste Manifest)
for three years or until it receives a signed copy from the designated
facility that received the evaluated hazardous waste pharmaceutical.
This signed copy must be retained as a record for at least three years
from the date the evaluated hazardous waste pharmaceutical was accepted
by the initial transporter.
(C) A reverse distributor must keep a copy of each
report required by subparagraph (9)(A) of this subsection for at least
three years from the due date of the report.
Cont'd... |
