Understanding FDA's FSVP Rule

Many of you may have heard that FDA is starting to implement a new program called Foreign Supplier Verification Program (FSVP).

According to the FDA, 15 percent of the U.S. food supply is imported, including nearly 50 percent of fresh fruit and 20 percent of fresh vegetables, and 80 pecent of seafood. FSVP is being implemented to ensure that the same preventive food safety standards apply to food consumed in the U.S., whether the food is imported or not. It requires that importers perform varying levels of risk-based activities to verify that food imported into the U.S. has been handled in a manner that meets applicable U.S. safety standards.

Who will be affected?

All U.S. owner or consignee of food and dietary supplement offered for import will be affected. If there is no U.S. owner or consignee at time of entry, it will be the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent.

Are there any exemptions?

• Juice and seafood from foreign suppliers in compliance with HACCP

• Small quantities of food imported for research and evaluation purposes

• Small quantities of food imported for personal consumption

• LACF products are exempt with respect to microbiological hazards

• Certain alcoholic beverages

• American food returned

• Certain meat, poultry, and egg products

Who will subject to modified (more flexible) FSVP requirements?

• Dietary supplements that are subject to separate, pre-existing CGMPs

• Small business (importer and/or supplier)

• Importation from a foreign supplier in good compliance standing with a food safety System that FDA has officially recognized as comparable or equivalent to that of the United States

What shall I do to comply with FSVP?

Importers subject to modified requirements may need to perform the following activities:

• Annual written assurance from foreign suppliers that they minimize or prevent any identified hazards

• Identify the FSVP importer and appoint a qualified individual and a qualified auditor

• Maintain records for at least 2 years

Importers subject to standard FSVP requirements may need to perform the following activities:

• Use a qualified individual to develop an FSVP and to perform FSVP activities

• perform a hazard analysis that includes identifying known or reasonably foreseeable hazards associated for each type of food and determining whether they require a control

• Evaluate risks posed by the food and the performance of the foreign supplier

• Conduct appropriate supplier verification activities to provide assurance that the hazards requiring a control in the food you import have been significantly minimized or prevented.

• Take corrective actions (if necessary) and investigate the adequacy of the FSVP (when appropriate).

• Reevaluate the food and foreign supplier every three years or sooner if the FSVP importer becomes aware of new information about the hazards in the food or the foreign supplier’s performance

• Identify the FSVP Importer

It is important to note that FSVP importers can meet key FSVP obligations by relying on analyses, evaluations, and activities performed by other entities in certain circumstances, as long as the FSVP importer reviews and assesses corresponding documentation.

When will this become effective?

FSVP rule went into full effect on May 30, 2017, with some exceptions (see FDA Compliance Dates). The FDA understands that this new rule will be challenging for companies who do not have experience managing suppliers to the necessary detail required by law. Senior Advisor for Policy at the FDA for the Office of Foods and Veterinary Medicine, Sharon Mayl, stated recently:

We understand that this is new to a lot of importers, so our approach will be to educate while we regulate to create a culture of compliance. Importers can expect interactive FDA inspections with opportunities to explain how their programs meet our requirements and how they will take corrective actions if we observe deficiencies. Good communication is key. Our initial enforcement priorities will be, as they are now, on food safety problems that pose an imminent public health risk. But the FDA’s mandate is to protect public health and, when appropriate, the agency will act swiftly.

While the FDA is ramping up its enforcement priorities, it is very important to start setting up your FSVP and actively implementing and documenting FSVP policies and procedures as soon as possible.

If you have any questions about FSVP, please feel free to reach out to us at imports@accb.nyc.