Welcome to the fourth edition of the FSMA Files column. This month, we’re focusing on questions we’ve received regarding the foreign supplier verification requirements under FSMA. These questions are timely, as the first compliance date for FDA’s Foreign Supplier Verification Programs (FSVP) regulation was May 30. This column is a complement to the discussion of how the supplier verification rules affect the almond industry, which appeared in the April column, so we recommend reviewing that discussion if you have questions on these issues.
Please keep your questions coming! You can send them to Tim Birmingham at tbirmingham@almondboard.com with the subject line “FSMA Files.”
Question: In what circumstances does the FSVP rule apply? How is it likely to affect the California Almond industry?
Straight Talk: The FSVP rule applies only to imported food. Because California Almonds are grown domestically, the industry should only be affected by FSVP for imported ingredients used in value added products.
Explanation: There are two supplier-verification rules under FSMA: FSVP and the supply-chain program under Preventive Controls (sometimes called “Subpart G”). FSVP applies to imported food, regardless of whether the product is a finished food or an ingredient for further processing. Subpart G under Preventive Controls applies to all ingredients that will be used for further processing under a Food Safety Plan. There is overlap in the scope of the two rules; however, the FSVP rule provides that if an imported ingredient will be further processed in a facility in compliance with Preventive Controls, you do not need to conduct supplier verification for that food under FSVP. Thus, FSVP tends to affect imported finished foods, while all other ingredients (regardless of whether they are sourced domestically or internationally) are subject to supplier verification under Preventive Controls.
California Almonds will never be subject to FSVP because they are not imported. However, ingredients used for value-added products made with California Almonds may be subject to supplier verification under FSVP or Preventive Controls. The basic principle underlying FSMA supplier verification is that an ingredient requires verification when you rely on your supplier to control a hazard in the food. For example, if you are using a spice blend to season almonds and apply the seasoning post-lethality, you would need to engage in supplier verification to ensure that the spice blend is safe because you are not subjecting it to a kill step.
Question: I’ve heard that there are changes at the border due to FSVP. Can you explain what’s happening?
Straight Talk: All imported foods now need to make additional declarations at the border to account for FSVP. This is the case even when the importer is deemed in compliance with FSVP, because supplier verification is conducted under Preventive Controls. Imports will be rejected if this new information is not provided at entry. These requirements typically will only affect companies in the almond supply chain if they are directly importing an ingredient that will be used in manufacturing or processing almonds.
Explanation: The FSVP requirements apply to the FSVP importer. This is defined as the entity in the U.S. that owns the food, has purchased the food or has agreed in writing to purchase the food at the time of entry. (If no one in the U.S. meets this definition, then the foreign owner has to identify a U.S. agent to serve as the FSVP importer.) There can be more than one entity in the supply chain that meets the FSVP importer definition, in which case the various parties that qualify need to confer to determine which entity will be identified to CBP at entry. For foods that fall under FSVP, including imported foods for which the importer is conducting supplier verification under the Preventive Controls regulation, the FSVP importer must electronically provide their name, email address and unique facility identifier recognized as acceptable by FDA when filing entry with U.S. Customs and Border Protection (CBP). FDA has affirmed the use of Dun & Bradstreet Data Universal Numbering System (DUNS) numbers as the acceptable unique facility identifiers for this purpose.
When a food product under FDA oversight is offered for entry into the United States, the CBP Automated Commercial Environment (ACE) system will prompt the filer to transmit one of the following codes:
- An entity role code (FSV) which will send a signal to the ACE system indicating the entry line is subject to the FSVP regulation; for these foods, the FSVP importer’s name, email address and DUNS number must be provided; or
- The “affirmation of compliance” code (FSX) which can be used for food exempt from FSVP (e.g., food under juice HACCP) or food for which the FSVP compliance date has not yet occurred; or
- The affirmation of compliance code (RNE) which can be submitted at entry for food for research and evaluation that falls within the corresponding FSVP exemption
In the event that the FSVP importer’s DUNS number is not available, FDA is also temporarily allowing filers to submit the value UNK (unknown) in the unique facility identifier field for the FSVP importer. FDA intends to contact those FSVP importers for whom UNK was transmitted in place of the DUNS number and “will provide additional information to help ensure that FSVP importers understand this FSVP regulation requirement and take the appropriate steps to obtain a UFI.” FDA will provide a communication to importers at a future date when use of the UNK value is discontinued.
Keep in mind that the FSVP importer identified at entry is the entity that FDA will hold responsible for FSVP compliance. Therefore, it is important for all companies that receive imported food (either finished products or ingredients) to determine those circumstances in which they meet the definition of FSVP importer (i.e., they either own, have purchased or have a written agreement to purchase the food at the time of entry). When more than one entity meets the definition of FSVP importer, companies will need to work with their supply chain to determine who will assume FSVP responsibility and therefore be identified as the FSVP importer to FDA through the CBP ACE system. Companies in the almond supply chain that use imported ingredients but do not handle importation of these ingredients may want to contact their suppliers to confirm who will be handling FSVP for these ingredients.
This column was prepared by Elizabeth Fawell and Maile Hermida, who are lawyers with Hogan Lovells US LLP in Washington, D.C. The FSMA Files column is provided for informational purposes only and does not constitute legal advice.
