Chemical Program
> Guidance on Reporting Cumulative Threshold Transactions
We have had several questions from the regulated community seeking
additional guidance on reporting cumulative thresholds as required by 21
CFR 1300.02(28)(i) and 1310.04(f).
The following guidance should address these questions:
- Cumulative thresholds are calculated on multiple shipments within a
calendar month.
- For exports the cumulative threshold is
exporter/chemical/customer specific. Exporter A makes multiple
below-threshold shipments of Chemical 1, that eventually meet or
exceed threshold, to Customer B.
- For imports the cumulative threshold is importer/chemical
specific. Importer A imports multiple below-threshold shipments of
Chemical 1, that eventually meet or exceed threshold, from Suppliers
B, D and E.
- For transshipments and international shipments the
cumulative threshold is supplier/chemical/customer specific. Foreign
Supplier A makes multiple below-threshold shipments of Chemical 1,
that eventually meet or exceed threshold, to Foreign Customer B.
- A DEA-486 or transshipment notice will be accepted for processing
under the following two conditions:
- The DEA-486 or transshipment notice is filed at the time the
monthly cumulative threshold is met. In this instance, the DEA-486
or notice must include a statement that the report is filed
because the cumulative threshold has been met. The statement
should include the total quantity shipped and number of shipments
made prior to meeting the threshold. For example: "This
DEA-486 is filed because I have met the monthly cumulative
threshold. I made 4 prior shipments totaling 0.7 kilograms this
month."
- The DEA-486 or transshipment notice is filed in anticipation
of meeting the monthly cumulative threshold. In this instance, the
DEA-486 or transshipment notice must include a statement that the
report is filed because the cumulative threshold will be met
during the current calendar month. For example: "This DEA-486
is filed in anticipation of meeting the cumulative threshold this
month."
- If a report does not meet the above conditions, the company will be
notified that their report is not necessary and the report will not be
processed.
- The DEA-486 or transshipment notice must also meet all pre-shipment
notification requirements which are either: 1) 15-days for a new
customer or importer or, 2) on or before the day of shipment for
existing regular customers or importers. For example, if Company A
makes two, below-threshold shipments of Chemical 1 to Customer B in
the first half of a calendar month, and if DEA has no record of
Customer B, then Company A must give DEA 15-day advance notice before
they make a third shipment to Customer B that will meet or exceed the
monthly cumulative threshold amount.
- In addition to the statements mentioned in item 5 above, any report
filed with DEA because of the cumulative threshold must include the
actual quantity and date shipped in the appropriate places in order to
match other shipping documents presented to the U.S. Customs Service
at time of entry or exit.
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