| (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.
(D) A reverse distributor must keep a copy of each
exception report for at least three years from the submission of the
report.
(E) A reverse distributor must keep records to document
personnel training, in accordance with 40 CFR §262.17(a)(7)(iv)
as adopted under §335.53 of this title.
(F) All records must be readily available upon request
by an inspector. 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 by the executive
director.
(d) When a reverse distributor must have a permit.
A reverse distributor is an operator of a hazardous waste treatment,
storage, or disposal facility and is subject to the permitting and
other requirements of this chapter if the reverse distributor:
(1) does not meet the conditions of this section;
(2) accepts manifested hazardous waste from off-site;
or
(3) treats or disposes of hazardous waste pharmaceuticals
on-site.
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