Dear Valued Customer,
As your global transportation and related services provider, UPS would like to review some important developments as mandated in the U.S. Public Health Security and Bioterrorism Preparedness and Response Act of 2002 for certain food shipments importing into and transiting through the United States. These changes became effective December 12, 2003.
New U.S. Food and Drug Administration (FDA) regulations require more information in order for shipments to clear the Bureau of Customs and Border Protection (CBP) and FDA. In order to avoid delays in shipment clearance and delivery, as well as other potential penalties, customers may be required to take important steps to comply.
Here is a brief summary of the changes required by these rules:
U.S. domestic and foreign facilities that manufacture and process, pack, or hold food for human or animal consumption in the United States must register with the FDA, unless the facility qualifies for an exemption under the FDA regulations.
Foreign food facilities covered by these regulations must designate a U.S. agent. As of December 12, 2003, the FDA must be electronically notified in advance of any shipments of human food and animal food imported into, or transiting the U.S., unless the food is excluded from Prior Notice.
Prior Notice is not required for home-made non-commercial food shipments shipped by an individual, to an individual, as gifts for personal use. Furthermore, current FDA policy is not to require Prior Notice when food purchased at a commercial establishment is exported or offered for export by a non-commercial shipper for a non-commercial purpose (i.e., from an individual, to an individual, as a gift or as a household good for personal use). In addition, certain food shipments that are re-exported, and shipments containing meat, poultry, and egg products falling under exclusive USDA jurisdiction, are exempt. Additional exclusion criteria can be found at the FDA web site www.access.fda.gov
FDA Registration
Food exporters, suppliers, affiliates, etc., outside the United States who ship regulated food products, will be required to register with the FDA, unless they qualify for an exemption from Registration under the FDA regulations. Also, U.S. food importers may be required to register if they operate a food facility covered by these regulations.
It is likely that International/intercontinental food shipments may transit the US. Given that fact, it will be necessary for such food shippers to register with the FDA as well - even if the ultimate destination is not the US.
There is no charge to register. Individuals or companies can complete the FDA Registration process online 24 hours a day, 7 days a week, from any location in the world by going to www.fda.gov/furls. Upon completion, the FDA sends immediate confirmation and a Registration Number.
Alternatively, Registration can be completed by filling out FDA Form 3537 (available online or by request to 301-575-0156 or 800-216-7331). The form can be returned by fax to 301-210-0247 or mailed to: U.S. Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857.
U.S. Agent Requirement for Foreign Facilities
The new U.S. FDA regulations require that foreign food facilities covered by these regulations designate an agent residing or maintaining a place of business in the United States. The U.S. agent will act only as a communications link between the FDA and the foreign facility, and the foreign food facility must provide the U.S. agent's contact information in the registration.
Prior Notice
Unless excepted, Prior Notice of imported food must be filed two to eight hours before arrival (i.e., the port where the food first arrives in the United States), depending on the mode of transport. (Two hours by land via road, four hours by air or land via rail, or eight hours by water). Prior Notice may be submitted electronically to either U.S. Bureau of Customs and Border Protection (CBP) or the FDA, depending on the type of transaction and article of food.
UPS may submit the Prior Notice to the FDA on the shipper's behalf. In that case, UPS will need to submit a separate electronic filing of Prior Notice for each food item, unless an exemption applies. For the international transportation of small packages via "UPS Express Plus ", "UPS Express" and "UPS Expedited", UPS will include the Prior Notice service in the fee for FDA clearance. This $20 brokerage fee for FDA filing could be a new fee for certain food shipments that prior to this regulation did not require an FDA filing.
Effect of Rules on Shipping Procedures
Within UPS WorldShip v7.0, shippers will have the option to check a box indicating that the shipment contains food. Once the shipment has been processed, the shipper will be directed to a page on UPS.com where they can input information required by the FDA for clearance.
For customers not using WorldShip, select the Export Documentation page in the Support section of UPS.com.
Preparing the Commercial Invoice
Customer-Generated Commercial Invoice: UPS recommends that shippers who generate their own commercial invoice should include the following data for each commodity on their commercial invoice (e.g., this information should appear on each commercial invoice line item):
Manufacturer’s Name and Address
Manufacturer’s FDA Registration Number
Shipper’s FDA Registration Number (if different from manufacturer)
Prior Notice Confirmation Number
Harmonized Tariff Schedule (HTS) Number
UPS Shipping System Commercial Invoice: UPS recommends that a shipper who uses the commercial invoice feature of various UPS shipping systems (e.g. UPS WorldShipTM, UPS Internet Shipping, UPS CampusShip, etc.), should enter the above information in the Product Description Field on the Invoice Processing interface. This will ensure the data appears on their commercial invoice in the appropriate place. This data will also be electronically communicated to UPS to streamline customs clearance.
Since the Product Description field is limited to 105 characters, UPS encourages you to enter the information as follows (this will leave 54 characters for their actual product description):
Manufacturer FDA # = MFGFDA#12345678901
Exporter FDA # (if different) = EXPFDA#12345678901
Prior Notice # = PN#123456789012
Shipper Compliance Is Critical
As noted above, both food importers and exporters may be required to register with the FDA, and if required, should register as soon as possible.
Failure to register and to include FDA Prior Notice data on the shipping documentation (e.g., commercial invoice) is likely to cause delays, including return of the shipment. At the foreign port of origin, UPS may refuse incompletely documented shipments. In the United States, imported food articles from a foreign facility may be held at the port of arrival until Registration is complete. Moreover, civil or criminal sanctions may result from failure to comply with the FDA Registration and Prior Notice regulations.
This letter is for informational purposes only. It does not constitute legal advice and should not be used as such. For further information on any aspect of the new FDA regulations, including information on whether you may be exempt from the Registration requirements, you should access the FDA website at www.cfsan.fda.gov/~dms/fsbtac13.html
Please feel free to communicate these FDA regulation changes to affiliates, suppliers and vendors both outside and within the U.S. If you have any questions pertaining to UPS Worldwide services, please call the UPS International Customer Service (in the U.S.) at 1-800-782-7892. Outside the US, please check www.ups.com for Customer Service contact information worldwide.
We value the business our customers entrust to us and look forward to working closely with you on these regulation changes.
Sincerely,
Dale Hayes
Vice President
Grady Hopper
Vice President
