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What importers need to know about FSVP regulations for Food Safety

Imported food plays a crucial role in the global food supply system. However, ensuring food safety poses a significant challenge for importers. Food safety regulations are becoming increasingly complex, and compliance with these regulations is necessary to protect consumers and your business. The Foreign Supplier Verification Program (FSVP) by the United States Food and Drug Administration (FDA) is a vital tool to ensure the safety of imported food. FSVP requires food importers for both human and animal consumption into the United States to take steps to verify that their foreign suppliers are implementing adequate control measures to minimize food safety hazards.

This article by GOL will provide you with an overview of FSVP regulations for Food Safety and Compliance and what importers need to do to comply.

Introduce about FSVP rules

FSVP stands for the Foreign Supplier Verification Program, which designates the US Importer as the entity or individual accountable for the safety of the food being imported.

Under this regulation, every importer subject to its provisions must establish and maintain FSVPs, through which they evaluate and approve each of their food and beverage suppliers.

Furthermore, the rule mandates that these importers conduct supplier verification activities to ensure that the food is safe and complies with applicable FDA food safety requirements.

Foreign Supplier Verification Program

Regulations that FSVP importers need to comply

The FSVP regulation necessitates importers to conduct risk-based supplier verification activities to ensure that:

  • Food is manufactured in a manner that provides a level of public health protection similar to that outlined in sections 418 (related to hazard analysis and risk-based preventive controls) or 419 (related to safe production and harvesting standards for certain types of raw agricultural commodities (RAC)) of the FD&C Act (21 USC 350g and 350h), if applicable;
  • Food is not adulterated as defined in section 402 of the FD&C Act (21 USC 342); and
  • Food intended for human consumption is not misbranded as per section 403(w) of the FD&C Act (21 USC 343(w)) (pertaining to labeling of food allergens).

You can find more detailed information on: FDA Import Holds and Detentions

Who needs to comply with FSVP?

The Foreign Supplier Verification Program mandates that American importers must assess and authorize suppliers while carrying out verification tasks.

An importer, in this context, refers to the American entity or individual who possesses or has arranged to obtain the food upon its entry into the United States. This encompasses those who:

  • Possess the food
  • Have purchased it
  • Have committed in writing to its purchase at the time of entry into the US

In cases where there is no American entity or individual at the time of importation, such as with commercial electronic shipments, fulfilling FSVP obligations may prove challenging. 

The FSVP Agent solution is designed to assist e-commerce sellers such as Amazon, eBay in complying with FSVP regulations. The FSVP Agent provides comprehensive services including:

  • Supplier assessment and verification: The FSVP Agent will assess and verify your foreign suppliers to ensure they meet US food safety standards.
  • Maintenance of FSVP records: The FSVP Agent will help you create and maintain accurate and complete FSVP records.
  • Support for corrective actions: In case of any issues with your suppliers or shipments, the FSVP Agent will support you in taking necessary corrective actions.

An FSVP importer must be based in the United States and conduct business there, requiring physical presence of personnel.

In essence, if there exists a documented agreement, paid invoice, or purchase order for food intended for a specific American entity at the time of US entry, then that entity meets the criteria of ownership and is consequently accountable for and bound by FSVP regulations.

The FDA focuses on the consignee, owner, or designated US Agent for FSVP purposes, rather than intermediaries.

Who needs to comply with FSVP?

Read more: Why is food safety important to the Food Business?

FSVP Adjusted Requirements & FSVP Exemptions

Similar to any regulatory framework, there are specific exemptions and adjustments to consider when assessing how FSVP impacts your operations:

FSVP Adjusted Requirements

There are various circumstances under which FSVP adjusted requirements may come into play. These could hinge on factors such as the nature of imported foods, the location of foreign suppliers, financial considerations for both importer and supplier, or the intended utilization of the food. For instance:

  • Importing dietary supplements necessitates FSVP evaluation of compliance with Current Good Manufacturing Practices (CGMPs) specific to dietary supplements, as delineated in 21 CFR 111, rather than FSMA rules like Preventive Controls or Produce Safety.
  • Importing food from a nation with a food safety system recognition agreement (FSSRA) with the FDA requires documentation affirming that the food falls within the agreement’s scope, was processed or grown in that country, and the supplier adheres to — and maintains good compliance with — that food safety system.
  • If the hazards in imported food are controlled by a US-based food processing facility, verification requirements can be satisfied by written assurances from that facility regarding hazard control.
  • Very small importers or suppliers qualify for simplified FSVP verification activities, which primarily involve obtaining written assurances and basic information from the supplier.

According to the FDA, very small businesses are those with an average annual sales and market value of food they’ve imported, manufactured, processed, packed, or held (including subsidiaries and affiliates) over the past 3 years, totaling less than $1 million for human food or less than $2.5 million for animal food.

While the list is not exhaustive, it provides an overview of the varied types of adjusted requirements that imported food may encounter under FSVP. Some adjustments streamline approval and verification processes, whereas others necessitate a more intricate approach, including evaluation of other relevant food safety regulations.

Read more: How do I get a food import license in the USA?

FSVP Exemptions

FSVP exemptions are applicable based on existing regulations, oversight by other jurisdictions regarding product safety, or due to specific intended uses or destinations, such as:

  • Juice and seafood are subject to FDA’s Hazard Analysis Critical Control Points (HACCP) regulations.
  • Meat and poultry fall under USDA regulations upon import.
  • Alcoholic beverages remain under the jurisdiction of the Alcohol and Tobacco Tax and Trade Bureau (TTB).
  • Foods intended solely for research or evaluation purposes.
  • Foods intended for individual consumption.
  • Foods imported for processing and subsequent overseas shipment.
  • Transshipped foods.

Some frequently asked questions for FSVP importers

What is the difference between FSMA and FSVP?

The Food Safety Modernization Act (FSMA) aims to prevent foodborne illnesses within the US. On the other hand, the Foreign Supplier Verification Program (FSVP), part of the FDA’s FSMA initiative, focuses on ensuring that foreign food suppliers adhere to standards comparable to those of domestic companies in the US.

Is an FSVP Agent the same as a US Agent for a foreign food facility?

No, an FSVP Agent is not the same as a US Agent for a foreign food facility. While both serve as points of contact with the FDA, their roles differ:

  • US Agent for a foreign food facility: This agent acts as the intermediary between the foreign food facility and the FDA. They facilitate communication and represent the foreign facility in dealings with the FDA, but their responsibilities are broader and extend beyond FSVP compliance.
  • FSVP Agent: This agent is specifically required for FSVP compliance when there is no US owner or consignee at the time of goods entry into the US. The FSVP Agent is accountable for meeting all FSVP requirements on behalf of the importer. They must be formally designated in writing, with signed consent, by both the importer and the FSVP Agent.

FSVP importers

Does FSVP provide an exemption for “small quantities”?

Under FSVP, food imported in small quantities is exempt if it’s intended for research purposes or personal consumption, as long as it’s not intended for retail sale and not sold or distributed to the public

Is a DUNS Number Necessary?

According to regulations, the Importer of Record must identify the FSVP Importer when declaring the entry. As part of this declaration, the FSVP Importer must be identified using a “unique facility identifier recognized as acceptable by FDA” (21 C.F.R. 1.509(a)). Currently, the sole FDA-recognized acceptable identifier is a DUNS number.

Where can I find out more About the Hazard Analysis And Risk-Based Preventive Controls (“HARPC”) requirements?

For further information on Hazard Analysis and Risk-Based Preventive Controls (HARPC) requirements, you can explore the comprehensive HARPC website developed by FDAImports.com. This website not only provides details about the Preventive Controls rules but also offers insights into regulatory solutions tailored to assist importers and producers in achieving compliance with every facet of HARPC, and consequently, FSVP. It emphasizes the seamless integration of both provisions at the border, emphasizing the necessity of considering both when crafting a food safety compliance program.

Do FSVP Regulations Apply to Restaurants?

Yes, restaurants are subject to FSVP requirements. According to the guidance, while not every restaurant location is required to store FSVP records, anyone meeting the definition of a U.S. owner, excluding consumers, must adhere to FSVP requirements. The individual or entity serving as the owner at the time of U.S. entry is responsible for FSVP compliance. However, if there are multiple importing offices or facilities, FSVP documents can be centralized at a headquarters location, provided there is documentation clearly identifying who is responsible for FSVP compliance at each importing location.

Do FSVP Regulations Apply to Restaurants?

What Actions Can Importers Take When Incorrectly Designated as an FSVP Importer?

Often, the FDA may conduct inspections of importers and request FSVPs for foods that the company has never actually imported. To rectify such situations, companies can determine if they’ve been mistakenly listed as an FSVP importer by submitting a request to the FDA through the Freedom of Information Act. Additionally, the FDA offers guidance suggesting that contacting the customs broker specified in the line entry can help identify who entered the incorrect information, ensuring that the company is not associated with foods for which it is not the U.S. owner.

Misidentification of FSVP importers can also occur due to misunderstandings regarding the role of a U.S. Agent. Some companies may incorrectly assume that a U.S. Agent under the Bioterrorism Act serves the same function as a U.S. Agent under FSVP regulations. However, these are distinct requirements with different responsibilities. A U.S. Agent under the Bioterrorism Act facilitates communication between the FDA and a foreign facility, whereas a U.S. Agent for FSVP purposes represents the foreign owner and assumes responsibility for the safety of imported food. The latter must provide a signed statement of consent to act as the U.S. Agent to be recognized by the FDA as the responsible party for FSVP compliance.

Additionally, issues can arise when foods are inaccurately identified at entry. It is crucial for companies to ensure the correct identification of the FSVP importer and use accurate product codes when submitting product information for Prior Notice submissions and to customs. Maintaining accuracy throughout the entire process is paramount.

Is Animal Food Regulated by HACCP or FSVP?

There is a common misconception among companies that seafood products are automatically subject to HACCP regulations. However, this is not the case if the food is intended for animals.

The FDA has clarified that fish and fishery products intended for animal food fall under FSVP regulations. While seafood intended for human consumption is governed by HACCP regulations, animal food products are subject to the Preventive Controls (PC) for Animal Food. Similarly, meat and poultry products intended for animals are subject to PC for Animal Food regulations, rather than USDA regulations.

When is Hazard Control Necessary?

Hazard control is deemed necessary if it’s determined that there’s a known or reasonably foreseeable hazard that could lead to severe health consequences or death in humans or animals. According to FDA expectations, a control should be assigned to such hazards. The specific control measures required depend on the hazard assessment and the measures deemed effective in managing that hazard. Generally, if a hazard is identified, there must be a corresponding control implemented somewhere in the supply chain.

Are Dietary Supplements for Animals Required to Follow CGMPs?

The FDA has updated guidance regarding dietary supplements for animals to provide clarity on applicable regulations. Current Good Manufacturing Practices (CGMPs) for dietary supplements apply specifically to supplements intended for human consumption. There is no distinct regulation recognized by the FDA for supplements intended for animals. Instead, such supplements fall under the purview of Preventive Controls (PC) for Animal Food regulations.

The guidance emphasizes that if a dietary supplement is marketed for animals, it is not subject to the modified requirements under FSVP. Instead, it must adhere to the standard PC requirements outlined for animal food products.

Do I Require an FSVP for Dietary Supplement Ingredients?

According to FDA clarification, if you are importing an ingredient for a dietary supplement, it falls under the Preventive Controls (PC) rule rather than being categorized as a dietary supplement, as it is considered a dietary ingredient at that stage.

The regulatory requirements vary based on the importer’s activities with the ingredients:

  • Importers distributing ingredients not intended for manufacturing dietary supplements: In this scenario, importers must have a standard FSVP for each imported ingredient if they are distributing them to another entity.
  • Dietary supplement manufacturers importing dietary ingredients: Importers engaged in manufacturing supplements must designate themselves as the FSVP importer for these ingredients. However, they are not required to maintain FSVPs for the ingredients themselves. Instead, such manufacturers are subject to dietary supplement Current Good Manufacturing Practices (CGMPs), which already impose stringent requirements regarding the components utilized in dietary supplement production.

Do I Require an FSVP for Dietary Supplement Ingredients?

What to Expect During an FSVP Review by Investigators?

Importers should note that FSVP inspections differ from traditional facility inspections as they primarily involve reviewing records rather than observing food production. While most FSVP inspections occur at the importer’s business premises, the FDA may also request that some importers provide FSVP records electronically or through other expedited means as part of a pilot program. In either case, investigators will request access to the importer’s FSVP records to assess for any deficiencies. In the event of deficiencies, importers are typically given an opportunity to address them. Currently, the FDA’s focus is primarily on assisting with compliance, except in cases where issues pose health risks or demonstrate intentional disregard for legal obligations.

It’s worth highlighting that the FDA is heavily investing resources in training personnel to conduct these inspections effectively. Importers can anticipate an interactive approach during inspections, where investigators will engage in dialogue and ask questions about their observations. Importers are encouraged to maintain open communication with the FDA if any issues are identified. If corrective actions are necessary, importers should clearly communicate their plans and timelines for implementing the corrections. If challenges arise in meeting deadlines, importers should promptly inform the FDA

GOL – A reputable FDA registration service provider

Compliance with FSVP is a crucial responsibility for food importers. However, ensuring compliance with FSVP regulations can be complex and time-consuming, involving understanding FSVP requirements, developing FSVP plans, implementing control measures, etc. Therefore, many importers opt to use FSVP consulting services to assist them in compliance.

GOL provides comprehensive FSVP Consulting and FSVP Agent service to help food importers effectively comply with regulations and save time. With our experienced and knowledgeable team of experts in FSVP, GOL will help you:

  • Save time and costs
  • Minimize the risk of regulatory violations
  • Enhance operational efficiency
  • Protect consumers and your business

Contact GOL today for a free consultation on FSVP services or FDA Food Facility Registration Service!

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