Responses to frequently asked questions regarding recent changes to FDA/FSVP import shipments

1. This document does not constitute legal advice. It is for informational purposes only.
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FDA FSVP Frequently Asked Questions
Updated: May 30, 2017
General Questions:
1. Why am I being asked for this now?
a. FSVP reporting is being phased in over two years beginning May 30, 2017 as part of the ongoing
implementation of the Food Safety Modernization Act.
2. What is the purpose of the new regulations?
a. FDA is trying to ensure that imported food articles meet US food safety standards.
3. How can I determine if my human or animal food is subject?
a. http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472461.pdf
4. Is all food required to be covered by an FSVP?
a. No, there are several exemptions, which are explained in the PDF at the above-provided link on
FDA’s web site.
5. Where can a company obtain a DUNS number?
a. https://fdadunslookup.com/ (will need to create an account)
6. I see the term modified requirements, what does that mean?
a. FDA has established modified verification standards based on several factors including # of
employees and sales volume of the supplier. However, he reporting data elements remain
identical.
PGA Message Set (entry) Reporting
7. What information is required to be reported in the PGA Message Set?
a. FSVP Importer name and complete street address
b. DUNS number of the FSVP Importer or UNK (UNK may be used temporarily)
c. eMail address of FSVP Importer
8. May I transmit the phone number and/or name of an individual?
a. Yes, although not required.
9. May a foreign (non US) entity be a FSVP Importer party?
a. No, the FSVP Importer must be a US entity.
10. Can UPS be designated as the FSVP Importer party along with our DUNS number?
a. No, UPS currently will not act as the FSVP Importer.
11. What other numbers can be used in lieu of a DUNS number to identify the FSVP Importer?
a. Currently FDA only accept the DUNS number. FDA may announce others in the future. FDA has
approved using UNK temporarily.
12. Is food for research and evaluation covered?
a. No, food for research and evaluation is exempt and a code of RNE is transmitted in the PGA
Message Set to advise FDA of exempt status for the shipment.
13. If you have a consolidation with multiple individuals, not companies, who should be the FSVP Importer?
a. Personal shipments are exempt.
14. In a shipment with multiple consignees, who would be the FSVP?
a. FDA defines the FSVP importer as the owner or consignee of the covered food. If no owner or
consignee exists, a US Agent may be appointed. In a multiple consignee/owner scenario, FDA

2. This document does not constitute legal advice. It is for informational purposes only.
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would consider each owner or consignee the FSVP importer and they should be reported on the
line level.
b. If the consolidated shipment has a foreign importer of record, due to the definition of FSVP
Importer that FDA has established, UPS believes it is appropriate to use the individual U.S.
consignees as the FSVP when reporting the line level data.
15. I am a foreign importer that ships on consignment and need a US agent to act as the FSVP Importer, can
you recommend any companies I can contact?
a. At this time, UPS is unaware of any third party companies that act in this capacity.
16. What are the reporting requirements for Canadian, Australian and New Zealand food manufacturers?
a. FSVP reporting on the entry remains the same as any other country
17. Which location within my company should be reported for the FSVP Importer?
a. FDA suggests that the DUNS number and address should match the location where the FSVP
records are stored.
18. May I report a third party as the FSVP Importer? i.e., a party different than the importer or consignee
company?
a. Yes, if there is no owner of the goods or consignee with a financial interest in the goods (i.e.,
goods are on consignment) a US based Agent may be reported.
19. Can more than one FSVP Importer be used on a transaction?
a. Yes. The FSVP Importer is reported on the line level. This allows for multiple FSVP Importers on
an entry.
Exemptions – Is my shipment exempt from reporting
20. Are personal shipments exempt?
a. Yes, personal shipments are exempt from FSVP reporting
21. My food is subject to HAACP requirements, am I required to report an FSVP Importer upon importation?
a. No, HAACP foods are exempt and will use code FSX to notify FDA of the exemption in the PG
message set.
22. I import seafood which is exempt from reporting. Do I use the FSX exemption code?
a. It depends.
i. If the FDA product code for my commodity starts with 16 or 32 no FSVP Importer
reporting is required
ii. If my commodity is exempt but the correct product code is other than 16 or 32 than I
will need to use the FSX exemption code

3. This document does not constitute legal advice. It is for informational purposes only.
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23. My supplier has fewer than 500 employees. When must I begin reporting?
FSVP Reporting Compliance – May 30, 2017
Food Category Supplier Category
Processed Human Foods Suppliers with 500 or more full
time equivalent employees
Game Meats All suppliers
Finished Dietary Supplements All suppliers
Dietary Ingredients Suppliers with 500 or more full
time equivalent employees
Animal Food/Pet Treats Suppliers with 500 or more full
time equivalent employees subject
to cGMP requirements
Produce not Covered under the
Produce Safety Rule (see produce
chart below)
All suppliers
Table courtesy of FDA Food Imports
Produce Chart: These items are subject to FSVP party reporting beginning May 30.
Table courtesy of FDA Food Imports
24. My supplier is considered a Qualified Facility, when will I be required to conduct the FSVP?

4. This document does not constitute legal advice. It is for informational purposes only.
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Table courtesy of FDA Food Imports
25. What categories of imported food are permanently exempt from FSVP reporting?
• Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis
and Critical Control Point (HACCP) regulations for those products, and certain
ingredients for use in juice and fish and fishery products subject to the HACCP
regulations.
• Food for research or evaluation
• Food for personal consumption
• Alcoholic beverages and certain ingredients for use in alcoholic beverages
• Food that is imported for processing and future export
• Low-acid canned foods (LACF), such as canned vegetables, but only with respect to
microbiological hazards covered by other regulations, as well as certain ingredients for
use in LACF products (but only with respect to microbiological hazards).
• Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture
at the time of importation
Please note there are other exemptions. If you feel another exemption applies to you please advise us.