Guidance on Reporting Cumulative
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.