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Guide to Developing a Foreign Supplier Verification Program (FSVP)

To learn more about Foreign Supplier Verification Programs overall, see our introduction article

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How Do I Develop a Foreign Supplier Verification Program?

If you import products for consumption into the US, you likely are required to develop a foreign supplier verification program (FSVP).


Below is a step by step guide to developing and implementing an FSVP.


1. Determine your Qualified Individual

First, The FSVP must be prepared by a "qualified individual" who has the education, training or experience necessary to perform the activity. If this person is a 3rd party or consultant, that's fine. However, note that supplier verification is an ongoing process and it must always be completed by a qualified individual. For most companies, the easiest solution is to have someone on staff undergo a 2 day training course on developing a Foreign Supplier Verification Program.

Source 21 CFR 1.503


2. Decide How Your Program Works

Before you begin approving suppliers, you must establish the procedures you will use to approve suppliers. The goal is to provide assurance that hazards in the food you import are being prevented.

You can rely on a 3rd party to conduct your supplier verification if you review and assess the documentation yourself and document your review and assessment of the materials.

Examples of appropriate verification activities:

  • Onsite audit by a qualified individual

  • Sampling & testing

  • Review of foreign suppliers food safety records

  • Other appropriate supplier verification activities


3. Conduct Your Verification Activities

This step is the bulk of the process: collecting information from your suppliers, reviewing it, and documenting your review process.

You may rely on a 3rd party to conduct supplier verification activities (i.e. a 3rd party audit) if you assess their documentation with appropriate frequency. You must document your review and assessment of the activities and document that the activities were performed by a qualified individual.

The following are common verification methods for approving suppliers:

Hazard Analysis

You are required to review a hazard analysis for each type of food you import. Hopefully, each of your foreign suppliers has completed one and can provide this to you. If not, then you must conduct a hazard analysis to determine whether there are any hazards requiring a control. This hazard analysis must be written and contain an evaluation of environmental hazards.

Some key points about the hazard analysis:

  • You must either conduct a hazard analysis for each type of food you import OR use a supplier hazard analysis.

  • If you are importing Raw Agricultural Commodities (RACs) then no biological hazards need be considered in the Hazard analysis.

  • If you are reviewing a hazard analysis supplied by the supplier or a 3rd party, then you must document your review of the hazard analysis and confirm that it was conducted by a qualified individual.

  • If no hazards are identified which require a preventive control, then no verification is required for those products. Still you must have a hazard analysis on file to show that this has been determined. This provision does not apply to produce.

Subpart L  - FSVP for Food Importers

Onsite Audit

Certain importers may wish to independently conduct onsite audits of the foreign supplier. Or, they may simply review the audit results conducted by a reputable 3rd party auditor.

An audit is required as part of the supplier verification process when there is "reasonable probability that exposure to the hazard will result in serious adverse health consequences or death" you must conduct or obtain documentation of an onsite audit at least annually. (1.506 (d) (ii) (2)

In this case, an audit may be replaced by written inspection results by the FDA, USDA, or a food safety authority of a country whose food safety system is equivalent to that of the US.

Sampling & Testing of Food

If you choose to use product testing and sampling as part of your verification, you must retain documentation of the following:

  • The number and type of samples tested

  • identification of the food tested (lot numbers)

  • tests conducted and the methods of the testing

  • Any corrective action taken into detection of hazards

  • Information identifying the lab

  • Documentation that the tests were performed by a qualified individual.

Review of Foreign Supplier's Food Safety Records

The most common method of supplier verification is the review of a foreign supplier's food safety records.

If you choose to use your foreign supplier's food safety records as part of your verification, you must retain the following information:

  • The records reviewed

  • Dates of review

  • General nature of the records reviewed

  • Conclusions of review

  • Any corrective actions taken in response to significant deficiencies identified.

  • Documentation that the review was conducted by a qualified individual.

You may not allow on the foreign supplier to conduct supplier verification activities for their own business.

Final Considerations:

Hazards Not Controlled by the Foreign Supplier

Does a 3rd party control one of the hazards on behalf of your supplier (i.e. your overseas milk supplier has their pasteurization completed offsite by another company.) If so, you must collect this verification data from the 3rd party or have your supplier send it to you.

Supplier Performance & History

It is perfectly acceptable to take into consideration your supplier's history, procedures, practices, storage, transportation, etc as part of your verification activities.

Document Your Verification Activities

Remember, it's not enough to simply collect these documents from your foreign suppliers -- you have to assess them and document that assessment.

For example, let's say I'm an importer of Ned's Italian Tomato Sauce and they send me their most recent audit result. Beyond having that audit result on file, I need to record that I reviewed that audit, that it showed me they controlling the hazards in their process, and that my review occurred on such-and-such date.

The Whole Picture

For fear of stating the obvious, you must approve your foreign suppliers on the basis of your evaluation. In other words, you must consider all the information you gather in your approval process and cannot discount any piece of information simply because it is contrary to the result that you're looking for.

This doesn't mean that one failed audit in your supplier's history means you cannot approve them. However, you must acknowledge this information if it is revealed in your verification activities or outside of them.

Source 21 CFR -- 1.504


4. Approve your Suppliers and Maintain the Program

Once you have completed your verification activities, you may add the relevant supplier's to your approved supplier list and begin sourcing product from them. At that point, the program should require only occasional ongoing maintenance

Keeping Records of Your Foreign Supplier Verification Program (FSVP)

Your records should comply with the following provisions:

  • They must be originals, photocopies or digital records

  • You must keep them for 2 years unless otherwise specified

  • They must be available for review by the FDA

  • You do not need to have a specific copy of each record for the FDA (e.g. you can have one copy of a record to satisfy both a state requirement and a federal requirement)

Source 21 CFR §1.510

There are several exemptions to Foreign Supplier Verification Requirements. This section applies to:

Taking Corrective Actions

You must take corrective actions if you determine that the food you are receiving is not meeting the requirements of the FDA regulations. Simply put, if the food you receive could cause harm to a consumer or is unsafe, then you must take some type of corrective action. This determination could be based on customer complaints or verification activities that you conduct (i.e. records review or viewing an inspection result.)

The appropriate corrective action to take could include discontinuing your use of that supplier until the hazards have been addressed.

If this determination occurs outside of the scope of your supplier verification activities, then it may reveal that your verification activities are not comprehensive. Simply put -- you didn't catch the mistake in your normal supplier verification practices therefore something is inherently wrong with your process. In this case you are obligated to update your plan so that you are able to adequately verify your suppliers.

Source 21 CFR §1.508

Re-evaluating Suppliers

You must re-evaluate your foreign suppliers (and document it),

  • Every 3 years, at minimum

  • When you learn anything new or when anything has changed that would warrant a re-evaluation.

You may use a 3rd party foreign supplier review as your re-evaluation, insofar as you document your assessment of that evaluation. The evaluation must be performed by a qualified individual.

Source 21 CFR -- 1.504

 
Intro to Foreign Supplier Verification Program

For step-by-step instructions, see Guide to Developing an FSVP

Supplier Verification Post Image.jpg

What You Need to Know about FSVP

  • Nearly all food imported into the US must be produced in alignment FDA Regulations

  • Foreign Supplier Verification Program (FSVP) is a major component of FSMA which requires US businesses to only import food products from suppliers they have vetted and approved.

  • Most businesses which import food products for consumption inside the US must verify that the food is produced in alignment with FDA regulations. This is done through the implementation of a Foreign Supplier Verification Program (FSVP). When a certain type of food (i.e. seafood) is subject to specific regulation, a foreign supplier must also comply with those specific standards.

  • The verification process may include, among other methods: an assessment of the supplier's food safety records, a review of an audit report, or a site visit.

 

FSVP post photo.jpg

Applicability and Exemptions

Generally, foreign supplier verification is required for most importers, for most imported foods, and for most foreign suppliers. To better understand what types of businesses and products may not be regulated under Subpart L (Foreign Supplier Verification Program), see the exemptions below:

Very Small Importer Exemption

A "Very Small Importer" is a company that imports $<1mm year in product value for imported human food (or <$2.5mm year in value for imported animal food)

Modified requirements for "Very Small Importers"

  • A very small importer must document that they meet the qualification for this exemption (i.e. be able to prove they are doing less than $1 million in imports)

  • Receive a written assurance from each foreign suppliers, prior to importing any food. The written assurance must be obtained every 2 years and include the following

  1. A brief description of the preventive controls being applied to control hazards in the food. This must be provided for each food that is imported.

  2. A statement that the foreign supplier is compliant with FDA regulations or (when equivalent) the relevant laws of their own country

  • You must take corrective action (such as suspending your import of this food) if you determine that the supplier is not producing food consistent with their assurance.

  • You must keep signed and dated records of these activities for > 2 years.

Foreign Suppliers Requiring No Verification

An importer is not required to conduct verification activities for certain foreign suppliers, including

  • Qualified Facilities, or

  • farms that grow produce and are not covered under part 112, or

  • A shell egg producer that has fewer than 3,000 laying hens.

  • Suppliers operating in countries with an officially recognized or equivalent food safety system

If you are importing products from a foreign supplier that is exempt, the modified requirements are as follows:

  • You must obtain a written assurance of their exemption type (i.e. farm or qualified facility or small shell egg producer)

  • You must initially evaluate your foreign supplier's performance history as it relates to compliance with FDA regulations. You must re-evaluate this if you become aware of any relevant changes or information or ever 3 years at minimum.

  • You must take corrective action (such as suspending your import of this food) if you determine that the supplier is not producing food consistent with their assurance.

  • You must keep signed and dated records of all verification activities for > 2 years.

  • You must approve your foreign suppliers based on the activities described above.

  • You must establish written procedures to ensure that you are using only approved foreign suppliers. You may import from unapproved suppliers on a temporary basis, if you have other, adequate verification prior to import.

Source 21 CFR §1.512

 

Countries with Officially Recognized or Equivalent Food Safety Systems

If you are importing from a country with a recognized equivalent food system, you may be free from the following the majority of FSVP requirements (§1.504-§1.508). As of 2018, the only countries who have achieved this are: Australia, Canada, and New Zealand.

However, your program still must be developed by a qualified individual, your company must be identified upon food import, and you must maintain your FSVP records in compliance with §1.510.

Source 21 CFR §1.513   

Foods Subject to Special Foreign Supplier Verification Regulations:

Certain foods are exempt from Subpart L (the requirements for Foreign Supplier Verification Programs outlined in this article) and are subject to different requirements.

Imported Seafood Products (aka Fish / Fishery Products)

Since seafood products are subject to specific FDA regulations found in Part 123, importers of seafood products are required to verify that the overseas manufacturer is aligned with Part 123. You can read about the specific requirements for verifying a foreign seafood supplier here

Imported Juice Products

Juice products are subject to specific FDA regulations found in Part 120, importers of seafood products are required to verify that the overseas manufacturer is aligned with Part 120 (specifically, that they have and follow a HACCP plan).

Meat Products

The Foreign Supplier Verification Program does not apply to meat products that, at the time of import, are under USDA jurisdiction.

 

Food that cannot be consumed without the hazards being controlled

You aren’t required to conduct an evaluation or foreign supplier verification when:

  • The food can’t be consumed without controlling for the hazard

  • You rely on the customer (who must be subject to 117C) to control the hazards. In this case you must disclose this to the customer and obtain annual assurance that they are controlling for the hazard

  • You rely on a subsequent entity in the supply chain (further downstream from you and the customer) to control for the hazard.

Source 21 CFR §1.507


FSVP FAQ

How must the importer be identified at entry?

You must identify your firm as the importer and include your FDA identification (DUNS) number and email address when filing for entry. The foreign owner or consignee of the food oversees must designate a US representative as the importer as the food.

Source 21 CFR §1.509

What are some consequences of failing to comply with the requirements of this subpart?

  • The food may be inadmissible for import.

  • The importer may be found in violation of federal law.

Source 21 CFR §1.514

What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?

Source 21 CFR Section 1.511

Special Requirements for Imported Seafood

To learn more about foreign supplier verification and imported foods, see our guide

Importers of seafood products must verify that the foreign supplier is compliant with FDA regulations -- even though the food is processed outside the US.

Importers of seafood products must verify that the foreign supplier is compliant with FDA regulations -- even though the food is processed outside the US.

There are two ways to verify a supplier of imported fish / fishery (a.k.a. seafood) products from another country:

  1. The importer obtains the product from a country that has an active memorandum of understanding (MOU) with the FDA that documents the equivalency of their food safety systems, or

  2. The importer implements verification procedures for ensuring the fishery products being importer were processed in accordance with FDA seafood requirements.

Memorandum of Understanding:

An importer can check if there is a MOU with the exporting country looking it up on the FDA website, here. Note that MOUs are not particularly common.

Verification Requirements for Importing Fish / Fishery Products

If you are unable to obtain the fish / fishery products from a country that has an active MOU, then you must conduct your own verification to confirm that the product was produced in compliance with FDA regulations. This verification may be completed by a competent 3rd party.

The importer's verification process must be written and must include the following, at minimum:

  • Product specs for each imported product that ensure that product is not adulterated.

  • One or more of the following:

    • HACCP and sanitation monitoring records that relate to the specific lot of fish being imported.

    • A lot-by-lot or continuing certificate from a government authority or 3rd party certifying that the food was processed in accordance with FDA regulation on fish / fishery products (21 CFR §123)

    • Regularly inspecting the foreign processor's facilities to ensure that the imported product is being processed according to FDA regulation.

    • Maintaining on file a copy of the foreign processors HACCP plan and a written guarantee (English) that the imported product is being processed according to FDA regulation.

    • Periodically testing the imported products and maintaining on file a written guarantee (English) that the imported product is being processed according to FDA regulation.

    • Another equivalent method of verification.

All verification records must be kept on file by the importer.

What’s next:

Guide to Developing a Foreign Supplier Verification Program (FSVP)