What is FSVP?

What is FSVP? - The Short Version

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The Foreign Supplier Verification Program or FSVP is a US food safety law concerning food and beverage produce being imported into the United States.

 

FSVP came into force May 30, 2017, under the Food Safety modernisation Act (FSMA). After a seemingly endless amount of recalls, listeria outbreaks and general food safety issues, the decision was made to overhaul the way the US enforces food safety.

 

FSVP is concerned with foreign suppliers (food and beverage businesses that export produce to the US) and how they manage the food safety of their products. FSVP was put in place to make sure that any food produce imported to the US is produced to the same standard that American food companies are held to.

 

The Long Version

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FSVP is mandated by the FDA Food Safety Modernization Act (FSMA). A major point of the law is that the same preventive food safety standards apply to food consumed in the U.S., regardless of where the food is produced.

 

FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards. More specifically, FSVP requires that importers verify their suppliers are producing food using processes and procedures that offer the same level of public health protection as the preventive controls (PC) requirements in the preventive controls and current good manufacturing practices rules for human food and animal food and produce safety FSMA rules, and that the food is not adulterated and properly labelled with respect to US regulation.

 

When Did FSVP Come into Force?

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FSVP came into force May 30, 2017, with multiple different dates depending on the type of business. It is important to note the compliance dates for FSVP are not based on the size of the importer. Instead, the compliance dates are staggered based on the size of the foreign supplier and the regulations that apply to the foreign supplier. The first compliance date was eighteen months after the FSVP final rule was published in the Federal Register. This date gave importers sufficient time to understand the rule and develop their FSVPs.

 

FSVP compliance dates were linked to other FSMA rules as the FDA wanted to minimize the likelihood that an importer would be required to comply with the FSVP regulation before its supplier is required to comply with other FSMA food safety regulations.

 

Who Has to be in Compliance With FSVP?

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U.S. importers subject to this first compliance date have foreign suppliers that fall into one of three categories:

 

• Foreign suppliers that will not be covered by the PC or produce safety rules ;

• Foreign suppliers subject to the PC for Human Food rule and are not “small businesses,” “qualified facilities” (certain very small businesses) or subject to the Pasteurized Milk Ordinance; or

• Foreign suppliers subject to the current good manufacturing practices (CGMP) requirements in the PC for Animal Food rule, and are not “small businesses” or “qualified facilities”.

 

If you are still unsure where you fit into this picture, the FDA released a chart to help clarify who needs to do what, the "Am I Subject to FSVP?" is for importers to refer to if they are unsure which the rule applies to them and their specific product.

 

What Do Importers Have to Verify Under FSVP?

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Importers covered by the FSVP rule have to verify that their suppliers meet applicable FDA food safety requirements, including that the food is not adulterated or mis-branded with respect to allergens.

 

Importers do have some flexibility with respect to the preventative controls (PC) and produce safety rules. Importers need to have a program that allows them to demonstrate that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the PC or produce rules.

 

However, importers will have additional time to develop and implement FSVPs for foods from smaller suppliers that are considered qualified facilities or small businesses under the PC rules, as well for food subject to the produce safety rule.

 

Has the FSVP Changed the Admission Process?

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Yes.

 

When food is offered for entry into the United States, the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will require the filer to enter at least one additional code as part of the required data elements. An FSVP importer subject to the May 30 compliance date should use the entity role code “FSV,” indicating the entry is subject to the FSVP regulation. This will then prompt the ACE system to ask for the importer’s name, email address, and unique facility identifier (UFI) recognized as acceptable by FDA. The FDA issued guidance formally recognizing the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP. This tends to be the most widely used and accepted UFI for importing to the US,

 

Conversely, if the food entry line is exempt from the requirements of FSVP, or not subject to the rule because it has a later compliance date, the filer should use one of two Affirmation of Compliance codes, either “FSX” (designating that the food is exempt from FSVP or that compliance with FSVP is not yet required) or “RNE” (designating, more specifically, that the food is exempt from FSVP because it will be used for research or evaluation in accordance with 21 CFR 1.501(c) of the FSVP regulation). If one of these codes is not transmitted for an imported food product under FDA jurisdiction, the entry line will be rejected. It is important to note that while importers will be required to provide their importer identification disclaimer on information through the ACE system.

 

The FDA wont enforce overall compliance with this rule on a shipment-by-shipment basis at the port of entry, the general approach to enforcing compliance will be to inspect U.S. importers and review their records to make sure they are in compliance.

 

What to expect from an FSVP Inspection?

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Remember that, unlike traditional facility inspections, FSVP inspections are based on the review of records, rather than observations of food production. While most of the FSVP inspections will be at the importer’s place of business, the FDA may also request that some importers provide FSVP records to FDA electronically, or through other means that deliver the information quickly.

 

In either case, the investigator will ask to view the importer’s FSVP records to determine if there are deficiencies. In most cases, if any deficiencies are found, the importer will be provided an opportunity to correct them. the focus right now is on supporting compliance, except for problems that pose a danger to health or reflect intentional disregard for legal responsibilities.

 

Importers should expect an approach that is interactive, the investigators will be asking questions about what they see and there will be the opportunity for a real dialogue. it is encouraged that importers try to keep the lines of communication open with FDA if problems are found, allowing for the correct action to be taken. If a corrective action is needed, the importer should communicate clearly what actions will be taken and by what date the corrections will be completed.

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I already audit my supplier. Can I use that audit as a verification activity?

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There are many different types of verification activities that can be used to meet the requirements of FSVP. The rule mentions review of the supplier’s relevant food safety records, sampling and testing, and onsite auditing as examples of verification activities that may be appropriate, either individually or in combination.

 

Which activity importers choose should be based on their evaluation of the risk of the food and their supplier’s performance. If importers determine that an audit is the appropriate verification activity, they must make sure the audit meets the requirements in the rule, namely that the audit considers the FDA food safety requirements that apply, and that the auditor is qualified to perform the audit (e.g., education, training, experience).

 

Which activity importers choose should be based on their evaluation of the risk of the food and their supplier’s performance. If importers determine that an audit is the appropriate verification activity, they must make sure the audit meets the requirements in the rule, namely that the audit considers the FDA food safety requirements that apply, and that the auditor is qualified to perform the audit (e.g., education, training, experience).

 

The FDA encourages all importers to ensure the scope of the audits they currently use consider all applicable FDA food safety regulations, including the PC and produce safety rules if they apply to their supplier. In addition, they should ensure that the auditors performing the audits are qualified auditors in accordance with the FSVP rule.

 

The Purpose of an FSVP

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FSVP was put in place to protect the US Food & Beverage market. FSVP allows the FDA to hold importers accountable for ensuring the products they bring into the United States are held to the same safety standards as domestically produced food.

 

While its a significant change to US food safety, its overall aim is to increase the quality and safety of all produce within the US. FSVP provides a way to get information about foreign suppliers to help ensure that they are meeting U.S. safety requirements and, thus, keeping food safe for U.S. consumers.

 

How we can help

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We specialise in FSVP and FSMA. we have helped hundreds of foreign food suppliers get fully FDA and US compliant so that their business can prosper within the United States.

 

Contact us Today

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We will help you get compliant with FDA from start to finish. We can cater specifically to your business regardless of if you already have some compliance measures in place or none at all.

 

We offer every service you need to be compliant and legal for the US Market, at a very reasonable cost, including :

 

• FDA Registration

• FSVP Assessment / Plans

• US Label Reviews & Designs

• FSVP Import Agent Services

• Tariff & HTS Code Advice

• Prior Notice and Importer of Record Services

 

We will always advise our clients on the best possible route to get fully compliant as fast as possible and at the lowest possible cost. We also offer additional food safety services such as HACCP Plan reviews, Amazon FSVP and Trade show FSVP plans. Please check out our full service page if you would like to learn more.