Michael: We all have heard that the food industry is facing increasing domestic and international pressure from governmental regulatory agencies. Within the past several months, I have received many questions concerning the FDA's newly enacted Foreign Supplier Verification Program, "FSVP" for short. Clients primarily wanted to know how to comply with FSVP, including what it takes to be a “Qualified Individual” (QI) as required by the law. (Each import establishment needs to have a QI to create their FSVP plan).
While I have the ability to provide a relatively clear overview of FSVP, I am by no means an expert on the issue - but we know plenty of people who are!
Introducing Claudio Innocenti, an FDA-certified FSVP regulatory expert and principal consultant with United Safety Agents (USA). I first met Claudio at an Association of Foods Industry meeting in Newark, NJ where his expertise on this topic was apparent.
Claudio recently visited Foa & Son’s NYC office, and I, along with my colleague Sal Fazzolari, had the opportunity to learn more about these regulations and their impact on the industry. He explained what importers need to know, what options they have, and what’s ahead for the industry and this new set of food safety laws.
Michael: Let’s start at the beginning, as this topic may be quite foreign to some. What is FSVP, and why should importers be paying attention?
Claudio: FSVP is a new 12,000-word law that will fundamentally change the way food importers conduct business. Put simply, the FSVP is a set of FDA food-safety regulations that require all importers bound by this law to verify that the food and food-related products they import are being produced in a manner that provides the same level of public health protection as those produced domestically.
Importers need to pay attention because compliance with FSVP is mandatory. Those that fail to meet the new requirements can face penalties ranging from a warning to imprisonment. The FDA is currently conducting regulatory audits and has made this new initiative their priority. Fortunately, there is still time to put a compliance plan in place.
Michael: You mentioned that FSVP is targeted to food importers. Are all food importers subject to FSVP?
Claudio: All importers and imports of food and food-related products are subject to FSVP, with some exceptions.
Imports intended for food research purposes or personal consumption are exempt. Imports of juice and some of juice's raw ingredients are exempt. Imports of certain meat, poultry, and egg products are exempt. Imports of alcoholic beverages and some of the raw ingredients intended for use in alcoholic beverages are exempt. And imports of seafood are exempt.
It is important to mention that although the framers of this law have allowed for specific exceptions, there are many caveats to those exceptions. I strongly recommend that each importer conduct a thorough review of FSVP's applicability with respect to their individual circumstances.
Michael: When does FSVP come into effect?
Claudio: It depends. The FDA has been rolling out FSVP compliance dates since May of 2017. The next mandatory deadline is March 19, 2018, with the following being March 18, 2019. Factors such as the importer's annual sales, number of people the importer employs, the size of the foreign suppliers they utilize, and the type of food they import are all used to determine the appropriate compliance date. Again, I would urge importers to read the law and determine their regulatory burden based on their individual situation.
Michael: What are some of the requirements of FSVP? How does all of this work?
Claudio: There is quite a bit of information to cover, but to start, for every food and every foreign supplier of that food, the regulation requires importers to develop, maintain, and follow an appropriate Foreign Supplier Verification Program. The program must be developed and maintained by a “qualified individual” (QI) and provide for the treatment and control of all foreseeable hazards and their subsequent corrective contingencies. The QI will need to reach out to each foreign supplier that the importer uses to obtain a Hazard Analysis and Critical Control Point plan (HACCP plan) - along with other relevant food-safety documentation - for each of the food or food-related products sourced from that foreign supplier. Depending on the product, its related hazards, and the structure of the importer's supply-chain, the QI may then need to reach out to the foreign suppliers' suppliers, and so on. Once all the HACCP plans have been received and analyzed by a QI that can read and understand them in their original language, the real work of building an FSVP plan can commence.
Depending upon each food's hazard profile, the QI will determine the appropriate fail-safes for all biological, chemical, physical, and economically motivated hazards. The QI must then spell out the method and manner in which the importer will ensure that all hazards are controlled and specify a plan for reassessing the various hazards that have been identified. After all verification activates have been performed - and a reliable FSVP plan has been put in place - the importer will need to provide their name, electronic mail address, and unique FDA-acceptable facility identifier number for each line entry of food product offered for importation into the United States. Additionally, the FDA mandates that an accurate and readily accessible record of this process be kept for each and every verification step.
In practice, developing a Foreign Supplier Verification Program compliance plan can be a complex and costly procedure that involves substantial liability - but the FDA believes that the end goal of safeguarding the nation's food supply is well worth the effort.
Michael: You mentioned Qualified Individual multiple times. I’ve received a number of questions about QI’s, with many of those questions coming from importers who may not have a QI on staff. What are their options? Do they need a full time QI, or can this be outsourced?
Claudio: Importers have several options with regard to their FSVP “Qualified Individual” requirement. The new regulations do allow for importers to outsource their FSVP compliance. 21 CFR, §1.500 states that a “...[qualified individual] is not required to be, an employee of the importer...”. This means that for those importers who either do not have a QI on staff, or choose not to burden their QI with this convoluted task, the requirements of FSVP can be undertaken by a third-party.
However, I would strongly caution those importers that are interested in this option to consider the QI’s credentials and FSVP-related experience before moving forward. The FSVP is a new and markedly different law that contains many nuanced stipulations. The likes of which may be overlooked by a QI with less than adequate experience; potentially resulting in the importer’s product being rejected at its port of entry, or worse.
United Safety Agents works with a diverse set of domestic and international food brokers, importers, distributors, and manufacturers to minimize risk, ensure business continuity, and gain a competitive advantage in the marketplace by guaranteeing our client's FSVP compliance. Our FDA-certified agents function as Qualified Individuals and work one-on-one with each client (regardless of their size, or location) to achieve and maintain compliance with this new law.
Michael: Where can importers go to learn more about FSVP, its implications, and potential outsourcing options?
Claudio: There are many great informational resources available to the industry. I would invite those interested in learning more about the Foreign Supplier Verification Program and its application to visit www.UnitedSafetyAgents.com. Once there, they will have access to a wide range of helpful resources and links. Additionally, as a courtesy to FOA & Son's food industry clients, I am personally available to answer any questions and discuss potential compliance strategies.
Michael Lieberman is the Food & Beverage Practice Leader at Foa & Son Corporation.
Foa & Son, founded in 1861, is an international insurance broker based in New York City.
Telephone: +1 (646) 435-7719
To learn more about Foa & Son's Food & Beverage Practice, please visit www.foason.com/foodindustry.
A special thanks to Claudio Innocenti of United Safety Agents.
Claudio can be reached at +1 (888) 551-7403 or by email at firstname.lastname@example.org.