With the Food Safety Modernization Act (FSMA) in place for more than a decade, the FDA has focused more heavily on regulation rather than education for FSMA rules. One rule in particular, which generated more than 550 Form 483s (issued when FDA inspectors observe violations) in 2020, is the Foreign Supplier Verification Programs (FSVP) Rule.
Here, we'll provide a refresher of the FSVP Rule and review some of the main reasons for receiving a 483 so that you maintain compliance and stay audit-ready.
What Is the FSVP Rule?
The FSVP Rule applies to importers of food for humans and animals. The overarching objective of FSMA is to prevent food hazards, address the safety of human and animal food throughout the supply chain, and provide the FDA with the tools needed to ensure safe food for U.S. consumers—regardless of where the food is produced. To that end, the FSVP Rule intends to ensure imported foods meet the same safety standards as those made in the U.S.
Importers are therefore responsible for verifying that their suppliers also meet these same requirements. Since imported foods account for 19% of the U.S. food supply, (52% of fresh fruits and 22% of fresh vegetables), this rule plays a significant role in keeping our food supply safe.
Key Principles of an FSVP
The FVSP Rule institutes shared responsibility between an importer and a foreign supplier in imported food safety. In other words, importers must have a program in place to verify that their foreign suppliers are producing safe food. The foods must not be adulterated, misbranded (especially with allergens), and meet other requirements.
FSVP requirements are risk-based. When evaluating risk, one should ask:
- What type of food is it?
- What types of hazards are there?
- How has the supplier performed in the past?
FSMA provides flexibility as to how these FSVP requirements can be met; there is no set format. Instead, the rule is a set of requirements that are specific to the circumstances of a particular food or supplier. What's most important is that everything pertaining to your FSVP is documented, and thorough records are kept—similar to the other components of FSMA.
For many importers, there's some confusion about how to implement an FSVP properly. Note that you only need one FSVP for similar products with similar risks. For instance, if you're importing ten different yogurt flavors from the same supplier with the same hazards, you'd only need one FSVP. However, if you had ten different items, each with unique hazards, each would need its own FSVP. Most importantly, an FSVP must be completed before any food enters the U.S.
What's Considered an Importer Under FSVP?
The FDA defines an importer as "the U.S. owner or consignee of an article of food that is being offered for import into the U.S." under 21 CFR Part 1. In some instances, there may be no U.S. owner or consignee, in which case you would need to designate an agent or representative to carry out FSVP responsibilities. Both parties must agree in writing what party in the U.S. is taking responsibility for the FSVP of the imported food before any items are imported. Communication and compliance among all parties are essential to ensure that all imports meet regulations without creating a bottleneck in the supply chain. If you appoint an FSVP Qualified Individual, the FDA will contact this person to review the program and any issues that may arise.
What Is an FSVP Qualified Individual?
As with the Preventive Controls Rule and other FSMA rules, the FSVP Rule requires a Qualified Individual. The FDA defines this as "a person who has the education, training, or experience (or a combination of these) necessary to perform an activity required under the FSVP regulation, and can read and understand the language of any records that the person must review in performing this activity."
Similar to other rules, you may designate different QIs to perform specific tasks. For example, some QIs may be better suited to conducting a hazard analysis, while others may excel in verification activities.
Do the FSVP Requirements Apply to You?
Most imported animal and human foods will require an FSVP, with some exemptions:
- Low-acid canned foods (for microbiological concerns only)
- Infant formula
- Acidified foods
- Shell eggs
- Bottled drinking water
Additional exempted foods include foods that fall under FDA HACCP Rules (seafood or juice); alcoholic beverages and their ingredients; not-for-sale food imported for research; certain meat, egg, and poultry products; and U.S.-produced foods that were exported then returned to the U.S. Another exemption category is foods produced in countries under systems with equivalent standards, such as Australia, Canada, and New Zealand. However, items from these countries will be required to have a “modified” FSVP.
What Are the FSVP Requirements?
Before moving on to discuss how to avoid 483s, let's briefly review the standard basic requirements for an FSVP:
- First, conduct a FSMA hazard analysis of the food, including hazard identification and risk evaluation, based on the severity and likelihood of an issue.
- Next, evaluate the foreign supplier's food safety performance and risk posed by the food. Consider how they're performing now, compared to the past, and if there have been any previous concerns, such as an import alert, or a recall.
- Based on #2, approve the foreign supplier.
- Establish written procedures to ensure the food is imported only from approved foreign suppliers.
- Determine and apply appropriate verification activities (assess results).
- Implement corrective actions, if needed.
- Re-evaluate the foreign supplier at least every three years and when there is reason to do so (such as after an import alert).
- Identify the FSVP importer at entry.
- Maintain thorough, updated records and documentation.
Remember, most importantly, the FSVP must be completed before any food enters the U.S.
What Are the Most Common FDA 483s?
For the fiscal year 2020, the top five FDA 483s included those pertaining to:
- FSVP Development
- Hazard Analysis
- Hygienic Design
- Supply Chain Controls
Of the 554 instances of 483s related to FSVP development in 2020, the top citations included failure to:
- Develop an FSVP (485)
- Document foreign supplier approval (53)
- Have a written hazard analysis (47)
- Conduct a document evaluation (44)
- Establish written procedures to ensure appropriate verification activities were conducted (39)
Other FSVP citations included failure to maintain or follow an FSVP, failure to provide an English translation of the FSVP, and missing dates or signatures, among others.
How to Avoid a 483 for Your FSVP
Through the coming months and years, the FDA will continue its transition from education to regulation. Following the COVID-19 pandemic, the FDA has heavily focused on FSVP because it does not require an FDA Investigator to be physically present. If you receive an FDA request, you are required to provide the information within 24 hours to ensure that you comply with that document review.
The FDA is also initiating more "for cause" FSVP inspections driven by instances of foodborne illnesses, as well as issues identified at the time of entry or post-entry. Failure to develop an FSVP continues to be the most common reason for a violation. With that in mind, here are the most effective ways to avoid a 483:
- Ensure you have a properly trained FSVP QI, as well as documented proof of their training.
- Make sure you have an FSVP for each article you import from each supplier's location.
- If the supplier verification documentation (such as a GFSI audit) is about to expire, ensure you re-evaluate and date the FSVP appropriately.
- Detail how you perform your foreign supplier approval and which documents are acceptable (such as SOPs).
- Do your basic homework and consider:
- Has the supplier been in any recall? Are they on any import alerts? Did they receive a 483 or warning letter? Did they have a poor audit?
- If the answer is yes, did they appropriately perform a corrective action?
- If not, what is your proper corrective action?
- Make sure the QI signs and dates the FSVP.
- Verify that the Hazard Analysis is complete. (Refer to Appendix 1: Potential Hazards for Foods and Processes.)
- Make sure records are in English and that you have retained them for two years after discontinuing use of the Foreign Supplier/food article or FSVP expiration.
Simply having an FSVP in place is one of the most manageable ways to avoid a 483. Beyond that, maintaining thorough records and performing your due diligence is critical to preventing violations. If you have questions or need assistance, give TAG a call.
Whether or not you're an importer, SafetyChain allows you to keep all of your FSMA program data and documentation in one convenient system, simplifying compliance and ensuring you're audit-ready at all times.