Function and Purpose of FDA's FSVP

Authored by Selina Mata, Supervisory Consumer Safety Officer, Office of Enforcement and Import Operations, Office of Regulatory Affairs, FDA

The U.S. Food and Drug Administration's (FDA's) Foreign Supplier Verification Programs (FSVP) are approaching their seventh year of implementation. The FSVP require importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards. More specifically, FSVP require importers to verify that their suppliers are producing food using processes and procedures that offer the same level of public health protection as the preventive controls requirements in current Good Manufacturing Practices (cGMPs), the Preventive Controls for Human Food and Preventive Controls for Animal Food rules, and the Produce Safety Rule; and that the food is not adulterated and is properly labeled with respect to allergens. As the program progresses, FDA remains committed to fulfilling its public health mission. Through continuous monitoring, FDA targets high-risk products and supply chains to ensure the efficient use of resources and the most impactful FSVP inspections.

Since the implementation of the FSVP, FDA has improved the accuracy of entry data transmitted through the Automated Commercial Environment (ACE) system and developed processes to improve identification of FSVP importers for inspection. For example, under 21 CFR (Code of Federal Regulations) 1.509, the FSVP regulation requires that, at the time of entry, all FSVP importers provide their name, email address, and a unique facility identifier (UFI) recognized as acceptable by FDA (limited to the DUNS, or Dun and Bradstreet's Data Universal Numbering System).

In March 2018, FDA issued a temporary policy, Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation,¹ which permitted importers to direct their entry filers and brokers to transmit "UNK" (to represent "unknown") under circumstances for which the importer was temporarily unable to obtain a DUNS number. On July 24, 2022, this temporary policy was rescinded,¹ and all FSVP importers must comply with 21 CFR 1.509 of the FSVP regulation and provide a UFI recognized as acceptable by FDA (currently the DUNS number). The removal of this temporary policy greatly improved the accuracy of FSVP entry data and the inventory of FSVP importers.

The FSVP inventory is vast and requires a significant number of resources to conduct inspections, review responses, and provide outreach and education to industry and FDA staff. As of August 2023, FDA's Office of Regulatory Affairs' (ORA's) Office of Import Operations (OIO) staff have covered approximately 4,500 FSVP importers and the corresponding supply chain of over 8,800 foreign suppliers. The FSVP regulation enables FDA to improve oversight of increasingly global food supply chains, which allows for an additional level of confidence for the safety of foods being imported into the U.S.

In 2019, FDA began taking enforcement action against FSVP importers that did not take appropriate corrective actions after being notified of significant violations identified during an FSVP inspection. Most cases submitted for review have been for FSVP importers that did not develop an FSVP for foods imported from their foreign suppliers. As a result, over 200 warning letters have been issued and nearly 60 FSVP importers have been placed on the red list of the FSVP Import Alert (IA) 99-41, "Detention Without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the Foreign Supplier Verification Programs (FSVP) Regulation."

Association of Food Industries (AFI) Perspective

Authored by Bob Bauer, President, AFI

Although the first implementation date of the FSVP regulation for some companies was more than six years ago, the FSVP regulation may still be new to importers, their customers, and even to some staff at FDA. However, that is not to say that any of those sectors were not concerned with food safety; rather, the FSVP regulation within the Food Safety Modernization Act (FSMA) created mandates that did not exist up to that point. It gave FDA much-needed, new, and updated tools to achieve an integral part of its mission—monitoring the safety of food consumed by Americans.

Progressive importers have always conducted food safety surveillance, although perhaps not at the level or frequency required by the FSVP regulation. Many importers had supplier approval procedures in place, although not many that would meet the requirements outlined by the FSVP.

Prior to the implementation of the FSVP regulation, progressive importers typically were the most successful because they had fewer FDA issues and worked with suppliers who were better able to provide safe, quality product on an ongoing basis. Those importers also had an easier transition to FSVP compliance because they had a head start on their competitors.

These importers were also among the first to attend the Food Safety Preventive Controls Alliance (FSPCA) FSVP training course. In addition, many have also had staff members attend the FSPCA's Preventive Controls for Human Food course for two reasons:

1. The course was offered prior to the FSPCA FSVP training course
2. They wanted to get an in-depth look at what was required of their suppliers.

Instructors of the FSPCA FSVP training course have seen a shift in the individuals attending the course to include a mix of new employees of some of the early adapters and employees at companies that were not aware of the FSVP regulation.

The early adapters already had a culture of compliance and were looking to build on it; they wanted to be out front. Owners and managers at these firms saw early compliance as a way to enhance the competitive advantage they already had—and it worked!

The key to effective FSVP compliance is creating a culture of food safety within an importing firm. It is not a one-person job; it is the job of everyone at the company to understand the need for and basic requirements of compliance with the FSVP. Management must buy into the concept and must give those carrying out FSVP compliance tasks within the organization the platform to get that message across to the entire company workforce. Having said that, there is no need go into great detail with those at the firm who are not involved in FSVP compliance; an overview will suffice. However, that overview should send a clear message to everyone that food safety is a top priority.

The FSPCA's FSVP training course is the best way to obtain an understanding of the FSVP requirements and how they can be met. In case one employee leaves or is not available when FDA arrives to conduct an inspection, importers should always have at least two people on staff who have taken the course. Similarly, it is best if a company always has at least two people on staff who are involved in and are familiar with the day-to-day FSVP compliance work. This can be an issue for small firms (many importing firms are small entities), but even if one staffer does the bulk of the compliance work, someone else should know enough about what is going on to be able to do things such as respond to FDA requests.

Additional resources and tools that are available to assist industry and other stakeholders with learning more about the FSVP regulation requirements and FSVP compliance are located on the FDA's website. Some examples include, but are not limited to, the following:

1. The FSMA Technical Assistance Network (TAN) can be used by members of industry for the submission of inquiries related to FSMA rules, programs, and implementation strategies.² FDA Information Specialists or Subject Matter Experts will respond to inquiries received as soon as possible. However, response times may vary, due to the complexity of the questions and the volume of inquiries received. For FSPCA training and scientific or technical questions, the FSPCA Technical Assistance Network is accessible through the FSPCA website.³
2. The FDA Data Dashboard is designed to support the understanding and analysis of FDA data accessible to the public. Housed within the FDA Data Dashboard, the Firm/Supplier Evaluation Resource⁴ was put in place to assist FSVP importers to verify that their foreign suppliers are meeting applicable U.S. food safety standards. Among other FSVP requirements, FSVP importers are required to evaluate the applicable FDA food safety regulations and information relevant to their foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety, prior to approving their foreign suppliers.
3. FDA's Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals⁵ was developed to provide guidance to members of industry on the FSVP regulation requirements in 21 CFR part 1, subpart L. This guidance does not establish legally enforceable responsibilities; rather, it describes the agency's current thinking and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited.

“Through continuous monitoring, FDA targets high-risk products and supply chains to ensure the efficient use of resources and the most impactful FSVP inspections.”

AFI's Best Practices

Some steps importers have taken to facilitate FSVP compliance are outlined below.

Training. As mentioned, the FSPCA's FSVP training course is extremely helpful, as is attending industry events where FDA personnel and others present updates on FSVP compliance. These events provide up-to-date information on where importers are falling short when it comes to FSVP compliance.

Some importers are strongly suggesting (perhaps even requiring) their suppliers to have at least two people attend the FSPCA's Preventive Controls for Human Food course. As with the FSPCA's FSVP training course, this course is a great way to understand what it takes to achieve compliance with the regulation and can assist suppliers with understanding the importer's needs.

Standard Operating Procedures (SOPs). Creating a food safety culture starts with educating everyone at the company about why food safety is so important. A standard operating procedure (SOP) document that outlines the requirements and lists those responsible for compliance with the FSVP regulation, etc., is a great first step. That SOP should be presented to all employees when initially created and periodically thereafter, so that food safety remains top of mind.

Communication. Communication cannot be stressed enough. The companies doing the best job of FSVP compliance are doing so in large part because of their communication efforts. They are communicating clearly with their own teams and all of their partners about what is needed, and about any compliance issues.

Progressive importers have always had an advantage over their competitors and have always been among the more successful companies in the import sector. By embracing that need for a culture of food safety, they have enhanced that competitive advantage and further strengthened their relationships with suppliers, customers, and others in the supply chain. FDA is dedicated to working alongside industry to ensure the safety and security of FDA-regulated products entering U.S. commerce.

References

1. U.S. Food and Drug Administration (FDA). Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation. April 2022. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-compliance-providing-acceptable-unique-facility-identifier-foreign-supplier.
2. FDA. "FSMA Technical Assistance Network (TAN)." Current as of September 9, 2022. https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-technical-assistance-network-tan.
3. FSPCA. "FSPCA Technical Assistance Network (TAN)." https://fspca.my.site.com/FSPCA/s/?language=en_US.
4. FDA. "Data Dashboard: Firm/Supplier Evaluation Resources." https://datadashboard.fda.gov/ora/fd/fser.htm.
5. FDA. "Guidance for Industry: Foreign Supplier Verification Programs for Importers of Food for Humans and Animals." January 2023. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-foreign-supplier-verification-programs-importers-food-humans-and-animals.