The Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) regulation brought waves of changes for U.S. food importers. For some, it meant making relatively minor adjustments to adapt to the changing currents. For others, it was more like being hit by a tidal wave. For all, it meant creating a FSVP.
In inspecting U.S. importers by reviewing their FSVPs, FDA essentially is able to greatly widen its inspection footprint because through its inspections of importers, FDA is getting a de facto look at the importers’ suppliers.
The FSVP regulation places on the U.S. importer the responsibility for verifying the food it’s importing meets the same food safety standards required of food produced in the U.S. A company’s FSVP consists of all the records/documentation that demonstrate the firm’s compliance with the regulation and is the basis for FDA’s FSVP inspections. With 1,400 FSVP inspections planned for FY2020, every importer must take its FSVP requirements seriously.
Before one begins to develop or review a FSVP, there are key points to consider—the most important being the nature of an FSVP inspection. The FDA inspector will need to see some documents that apply to overall FSVP compliance and will request additional documents that pertain to one or more specific entries. Other important considerations include:
• FSVP inspections are entirely records-based. If it’s not written down, it didn’t happen. That means importers must take the time to understand what records are required and take steps to ensure they have those required records.
• It’s not enough simply to possess the records. Anything that’s received from another party must be reviewed by someone at the firm qualified to review and understand those documents. A system needs to be developed to demonstrate who read the record and when.
• Unless a company is importing only one product from only one supplier, a FSVP actually consists of several FSVPs because the importer must have documentation for each food product/foreign supplier/foreign facility
With limited exceptions, importers need all the following records in their FSVP:
• Hazard analysis
• Evaluation of foreign supplier performance and risk posed by the food
• Procedures for approving foreign suppliers*
• Documentation of foreign supplier approval
• Procedures to ensure use of only approved foreign suppliers*
• Determination of verification activities and frequency
• Performance of verification activities
• Discussion of any needed corrective actions
• Reevaluation of the FSVP, either routinely every three years or for cause
Packaging These Records
The two items in the list with the asterisks (*) are among the documents that relate of overall FSVP compliance. Another set of documents that applies to overall FSVP compliance relate to the qualifications of the person/people who create or review the required FSVP documentation. If one envisions a series of folders, these documents can be kept in one folder. Expect them to be among the first things the inspector reviews. One reason is the failure to have these records is among the most-cited deficiencies in FVSP inspections to date. This is most likely due to the fact that these types of records weren’t needed in the past, so importers unfamiliar with the regulation don’t know they’re required.
The rest of these items would go in folders specific to the foreign supplier. Whether the records are hard copies or electronic copies, the documentation needs to be specific to the manufacturer, food product and facility, so there could be several folders for any given foreign supplier. It’s best to separate things as much as possible (ex: by product), so the importer is showing the inspector only what the inspector came to see. If an importer packages all records for a supplier together, it’s likely increasing the scope of its inspection
In looking at the list of required records, it becomes evident FSVP compliance is an ongoing task. Remember, FSVP inspections relate to specific entries. While a company importing Product 1 from Company A needs to have a hazard analysis (which includes an evaluation of the risk posed by the food) for that product from that company’s facility, that’s not enough. Who at the importing company approved the supplier and when? Who determined the verification activities and their frequency? Then it gets down to specifics about the entry the inspector is reviewing. Does the importer possess documentation to demonstrate the food was produced in a manner that meets U.S. requirements and follows the producer’s preventive control plan—including the verification activities?
The FSVP regulation is new territory for the industry—and FDA. Even many importers that previously requested lots of food safety information from their suppliers probably didn’t have all of what’s required now and/or didn’t have the policies/documents in place for something such as supplier approval. It’s new territory for FDA as well. FSVP inspections are different than other types of FDA inspections; there’s a learning curve for industry and the agency. The agency adopted an “educate while we regulate” philosophy to help all parties. However, that approach is gradually shifting toward enforcement, so importers should take note. Some tips:
• Make certain all company personnel understand what documents are needed, perhaps through a standard operating procedure document that explains how the records fit together.
• Work with all suppliers to get the required information as soon as possible. Make certain they understand the information is needed for all facilities/products.
• Understand the difference between the definition of an Importer of Record with regard to Customs and Border Protection and FSVP Importer for FDA/FSMA. The FSVP Importer must be a U.S. entity and there are many instances in which more than one entity meets the definition. Importers should make certain key company personnel, customs brokers, suppliers and customers understand when the company is to be listed as the FSVP importer and when it’s not.
• Take advantage of training offered through the Food Safety Preventive Controls Alliance (FSPCA), a public-private partnership through which FDA-recognized curriculum was developed regarding FSMA. The FSPCA offers a course on the FSVP regulation (as well as courses on other FSMA rules).
• Have more than one person at the company trained or well versed in the requirements and the actual records. If only one person is qualified and leaves, the firm no longer has a qualified individual and could have some trouble during an inspection.
• Put your company’s best foot forward. There’s no requirement as to how a firm must maintain its records, but it makes a much better impression to be able to produce detailed and organized records in a timely fashion.
• Act transparently with FDA personnel. Follow any deadlines given. If issues are cited, take the steps needed to address them properly.
• Assume that because your company has been in business for many years and never had an FDA issue that it’s in compliance with FSVP regulations.
• Accept documents in another language without having at least two options to quickly get those documents translated if requested by FDA. Of course, if the qualified individual at your company reviewing those documents can’t read and understand them, they’re of no use anyway.
• Make any exceptions for suppliers who have trouble producing the required documentation. The FSVP regulation was put in place to make someone in the U.S. responsible for the safety of the imported food. Making an exception puts the importer at risk.
Much of this is new territory and requires putting to paper and/or formalizing things already in place. Doing it right requires more than reading one article. Doing it right means taking the training and/or thoroughly reviewing the FSVP (and other FSMA) material on FDA’s website and other information sources. Doing it right also means a better result for importers and consumers alike.