Tip of the Week: FSVP Impact on Importers

Are you an importer? How does the Foreign Supplier Verification Program (FSVP) affect you and your foreign supplier? Today's tip concerns the FSVP and its impact on both US importers and their foreign suppliers. Let's review the intent and scope of the rule and then consider an approach to enable compliance by May 2017. 

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The intent of the rule is two-fold: to prevent potentially adulterated food from being exported to the US; and to ensure imported food is produced under the same food safety requirements as domestic products.

In order to achieve this goal, the rule assigns food safety responsibilities to two parties: the importer of the food product in the US; and the foreign supplier. It is important to understand who will be regarded as importer and foreign supplier. The rule defines these as follows:

  • the importer, at the time of entry of the food into the US, is the owner of the food, or the consignee of the food, or the US agent or representative of the foreign owner or consignee
  • the foreign supplier is the establishment which manufactures/processes food, raises animals (including fish), or harvests food exported to the US without further manufacturing/processing by another establishment, except for the addition of labeling or any similar activity of a “de minimis” nature

The importer is the responsible party for verifying that the food produced by the foreign supplier was manufactured, raised, or harvested in accordance with relevant sections of the FD&C Act, depending on the type of food being imported.

The importer will be held accountable by the FDA for the food safety of all imported food products, including food contact substances. What activities will a food importer have to develop and implement to demonstrate these FSVP regulatory requirements are met? You may be surprised to learn that except for a few differences, the responsibilities of an importer are the same as for a US manufacturer who sources his raw materials and ingredients locally.

First, the importer will develop a hazard analysis for each type of food being imported to determine whether there are any hazards requiring a control. The hazard analysis must be written regardless of its outcome. 

Second, the foreign supplier’s compliance history with food safety regulations is reviewed. This is a long task list, including evaluating the supplier's procedures, processes, and practices related to the safety of the food; reviewing applicable FDA food safety regulations and information relevant to the 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; and the foreign supplier's food safety history, including available information about results from testing foods for hazards, audit results relating to food safety, and responsiveness of the foreign supplier in correcting problems.  

Next, the importer will have to assess applicability of other factors as appropriate and necessary, such as storage and transportation practices as they relate to food safety.

Then, based on the results of the hazard analysis and the evaluation of the supplier’s compliance history the importer must approve or disapprove the supplier.

Finally,  the importer will have to develop, implement, manage, and document certain verification activities designed to meet the two-fold intent of the rule as cited above. The written verification activities include but are not limited to:

  • Use of approved foreign suppliers. Establish and follow written procedures to ensure that foods are imported only from approved foreign suppliers. Unapproved foreign suppliers can be used on a temporary basis, however subject to certain verification activities carried out prior to importing the food.
  • Foreign supplier verification procedures. Must establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to the imported foods.
  • Requirement of supplier verification. The foreign supplier verification activities must provide assurance that the hazards requiring a control in the imported food have been significantly minimized or prevented.
  • Frequency of verification activities. The verification activities must be carried out with the appropriate frequency to assure timely evaluation of control measures, and effectiveness of corrections and corrective actions.
  • Appropriate verification activities. The following are appropriate supplier verification activities: on-site audits; initial and annual on-site audits are required for identified hazards needing a preventive control which can cause serious adverse health effects or death in humans and animals (SAHCODHA); sampling and testing of the food product, review of the foreign supplier's relevant food safety records; and other supplier verification activities that are appropriate based on foreign supplier performance and the risk associated with the food, such as storage and transportation activities essential for food safety, or temporal/seasonal changes that might affect food safety. 

The importer does not have to conduct an evaluation of a food and foreign supplier when the importer determines and documents that the type of food (e.g., raw agricultural commodities such as cocoa beans and coffee beans) could not be consumed without application of an appropriate control; and when the importer relies on his customer to significantly minimize or prevent the hazard and discloses in documents accompanying the food, in accordance with the practice of the trade, that the food is “not processed to control [identified hazard]”; and annually obtains from the customer written assurance that the customer has established and is following procedures that will significantly minimize or prevent the identified hazard.

The FSVP requires that the program be developed and audited by qualified individuals. For the development and management of the FSVP, the qualified individual must have the education, training, or experience (or a combination thereof) necessary to perform their assigned activities and must be able to read and understand the language of any records that must be reviewed in performing an activity. For the audits, a qualified auditor must have technical expertise obtained through education, training, or experience (or a combination thereof) necessary to perform the auditing function.

The importer can rely on external qualified individuals to undertake the product hazard analysis and supplier evaluation, as well as to develop and implement the verification activities to assure compliance. However, the importer must document his review of such external evaluations and verification activities, assess their conclusions, approve/disapprove and sign off.

Finally the FSVP has to be re-evaluated every three years or when failures occur that would affect the safety of the imported product, put in doubt the effectiveness of a given preventive control, the food safety performance of his foreign supplier, or the importer becomes aware of information that might affect the safety of the product.

These steps that can assist in developing and implementing an effective FSVP.

  • Contact all your foreign suppliers and make them aware of the FSVP and its compliance date. You should both study the rule to ensure proper understanding of intent and scope.
  • Set up a joint team to undertake the product hazard analysis and the foreign supplier compliance history evaluation. The team to undertake these evaluation activities can include the importer, foreign supplier (for the hazard analysis, not for performance evaluation), an independent qualified individual, or a combination of these.
  • Carry out evaluations to determine suppliers who will be approved or disapproved. If a given foreign supplier is not approved, corrective action needs to be taken to eliminate root causes before the compliance date of May 2017.
  • Determine appropriate verification activities and document how (written), when (frequency), and who (importer and/or independent qualified individual) will implement them.
  • Set up a schedule to allow you to complete these tasks, including the verification activities, by May 2017.
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