Originally published by the Journal of Commerce in May 2017.
When the Food Safety Modernization Act took effect in January 2011, there were many parts of it which would take time to figure out. FDA made a point of trying to work with the importing community so that when it rolled out the various regulations which would inevitably result, they would be as reasonable as possible for the trade to implement. Now comes one of the most challenging of those regulations – the Foreign Supplier Verification Program (FSVP).
The FSVP is that part of the Act which puts the onus on the importer to work with his suppliers to make sure the food he imports is safe. FDA has had in place for many years the HACCP or Hazard Analysis Critical Control Points procedure for juices and seafood, and a similar food safety protocol for low acid canned food. In its simplest terms, as Wikipedia says: “… HACCP … is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe, and designs measurements to reduce these risks to a safe level”. While aiming to accomplish that same food safety goal in a different manner, the FSVP adds much challenge and complexity in getting there. The FSVP takes effect on May 30, 2017. Are you ready?
Importer of Record: CBP v. FDA
To be clear, the May 30, 2017 deadline anticipates importers will report the name, email address and DUNS number of the FSVP importer at time of entry, and this is where much of the confusion lies. Many think the FSVP importer and the CBP importer of record are the same –they are not! The CBP importer of record is the party who owns (or at least has a financial interest) in the imported goods. The FSVP importer does need to have a financial interest in the imported goods, but he is also expected to have knowledge about the food safety practices of the supplier and control over the supply chain. FDA has defined the FSVP importer to be a U.S. person who at time of entry either owns the product, has purchased the food product or has agreed to purchase the food product. If no such person exists, somebody in the U.S. still has to be the FSVP importer and that requires the foreign supplier to appoint a U.S. agent. That U.S. agent must give written consent to take on the role of FSVP importer of record or at least act on the foreign supplier’s behalf to fulfill the supplier’s obligations.
The Agent’s Role:
It is possible to be the U.S. agent and not be the FSVP supplier’s agent. One frustrating situation is the U.S. agent for food facility registration purposes can be appointed without his knowledge or consent, but not so the U.S. agent for FSVP purposes. Because the role of the U.S. agent for FSVP purposes carries with it significant responsibility, no service provider is likely going to be willing to take on that role.
To be clear, the role of the FSVP agent, as it is with the FSVP importer, is to evaluate and verify the necessary food safety measures are in place by the foreign supplier. Further, that evaluation and verification must be carried out by a “qualified individual”, meaning that individual must know how to identify and mitigate potential food hazards throughout the supply chain, which includes audits, lab testing, food safety processes and recordkeeping. In short, the qualified individual makes sure the foreign supplier has implemented appropriate preventive controls, that they are working, and if not, he cannot and should not certify the foreign supplier is compliant or that the food offered for import is safe.
Some foods are exempt:
– Suppliers and food otherwise covered by the HACCP regulations;
– Foodstuff subject to USDA regulations – meat, poultry and eggs;
– Alcoholic beverages;
– Food imported for research or evaluation provided not for retail sale (and properly labelled as such);
– Food transshipped through the U.S. for export, even if first processed in the U.S; and
– Other foods, including raw fruits and vegetables, low acid canned foods, dietary supplements, which are subject to modified requirements.
Acknowledging the current state of confusion, FDA on May 4, 2017 announced by way of CBP’s CSMS (Cargo System Messaging Service) 17-000255, it will temporarily allow “UNK” (unknown) for the DUNS number of the FSVP importer during the “onboarding” period which starts on May 30th. CBP also stated that UNK should only be used if the 9 digit site specific DUNS number is not available at time of import. So if you have it, use it! The CSMS provides a portal address where DUNS numbers can be looked up or obtained – www.fdadunslookup.com. CBP also states it will send another CSMS when the grace period expires.
The standard applied in terms of the foreign supplier’s food safety protocols mandates the requirements be equivalent to the U.S. regulations. What this will likely mean is that U.S. importers will not be able to validate the food offered for import by their foreign suppliers is safe without much more documentation in advance of shipment and likely also prior to an order being confirmed. What documents are needed? What is sufficient? How will red flags be handled? Will there be third party audits? If so, who conducts them? Who pays for them? There are also staggered implementation deadlines (reaching out to July 2020, and also factor in the Produce Safety Rule) which add to the confusion. There are still lots of open question. Perhaps the biggest one from the FDA’s side is how will it enforce the new requirements?
It is generally thought FDA realizes how much of a change the FSVP program will bring to the importing community. If we consider the current method of enforcing HACCP, that is not generally done at time of arrival. Of course, if a supplier is found to be deficient, it would be reasonable to expect imported shipments will be stopped. Otherwise, FDA may spot check shipments, and ask for and evaluated copies of HACCP plans, and then take action accordingly.
The general sense (or hope at least) is that FDA will spend some time after May 30th educating the importing public. However, that does not mean importers should ignore the requirements. Failing to comply equates to failing the attitude test, and that never works!
The final regulations were published in the Federal Register on November 27, 2015! If you are a food importer and have not heard of the FSVP requirements, where have you been? If you really don’t know about the FSVP, you should immediately check the FDA website and figure out how you are impacted: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm. If you are not ready yet, you better get up to speed very quickly since it will be up to the importer to tell the customs broker who to report as the FSVP importer. It is your role to figure out the requirements and revise your supply chain accordingly and there is precious little time left!