Ready for the foreign supplier verification final rule?

It is no secret in the food industry that the Food Safety Modernization Act (FSMA) represents the most sweeping change to our food safety laws in nearly 70 years and, for the first time, includes changes related to foreign supplier verification that will affect importers of foreign food. FSMA was signed into law in January of 2011 and required the FDA to write regulations that would update the food safety laws in the United States in an unprecedented way.

It has taken more than five years for the FDA to finalize six of the seven key rules to implement FSMA, and what was once a far off reform is quickly becoming a reality. So this begs the question: “What do I need to do to comply with FSMA as a private brand manufacturer or importer?”

There’s no doubt FSMA rules are complex, interrelated and overwhelming. Given the complexity and questions that are still outstanding, FDA has said that the agency intends to issue a number of guidance documents to help companies understand their obligations and provide clarity to many of the unresolved questions that exist. The Food Marketing Institute (FMI) continues to work diligently to provide resources to help food retailers and members of the FMI Private Brand Council to understand their obligations to help make implementation as seamless as possible across all FSMA rules. For example, FMI created a draft food safety plan that distribution centers and warehouses can use as a model to develop and implement individual food safety plans under the Preventive Controls Rule.

The first and most critical step is to understand which, if any, of the regulations will impact your business. While many of the FSMA rules exempt retail stores, retailers that have distribution centers, manufacturing facilities or a central kitchen, as well as retailers that import food into the United States, will have significant new responsibilities under the law. FSMA’s Foreign Supplier Verification Rule (FSVP) will greatly expand a private brand manufacturer’s and a retailer’s responsibility to verify that food produced or grown outside the United States was done in a way that provides the same level of public health protection as food produced domestically.

Who is responsible for developing an FSVP?

The FSVP rule brings a new player into the importation process — the FSVP importer. The FSVP importer is charged with verifying the safety of the food imported and ongoing monitoring of the compliance status and food safety performance of the supplier. There are key differences defining which party can be the FSVP importer and which can be the importer of record.

Retailers and wholesalers that do not meet the FDA definition of the “FSVP importer” are not responsible for compliance under the regulations. However, it is important to understand there could be situations where the importer of record, as currently understood, is not going to be the same person who is responsible for the FSVP rule. The FSVP rule defines the FSVP importer, in part, as the “U.S. owner or consignee as the person in the U.S. who, at the time of U.S. entry, either owns the food, has purchased the food, or has agreed in writing to purchase the food. If there is no U.S. owner or consignee, then the FSVP importer is the U.S. agent or representative of the foreign owner or consignee as properly designated.”

Given the wide range of commercial arrangements between foreign owners and the various types of contractual relationships, establishing the importer for purposes of FSVP compliance can be difficult. For example, there may be situations in which ownership of imported food has not transferred from the foreign owner at the time of entry to the United States, but a person in the United States has nevertheless purchased or agreed in writing to purchase the goods.

Therefore, it is imperative to ask the right questions upfront to ensure you understand whether you are the entity responsible for compliance, whether there are opportunities to shift the responsibility to a third party or whether you are merely purchasing from an FSVP importer once the product has entered the United States. For example:

• Am I listed as the importer of record or consignee on Customs documents?
• Do I work through a foreign broker or directly with the foreign supplier?
• Who is my foreign supplier or farm?
• Do I have criteria and a supplier program?

FSVP requirements: overview

Notably, all food retailers and wholesalers that are importing food will be required to develop, maintain and follow an FSVP for each food imported into the United States. Retailers and wholesalers that are considered importers under FSVP should maintain detailed records on the compliance status of their foreign suppliers, conduct a robust hazard analysis for each food, and import only from approved foreign suppliers.

Once the importer has conducted the hazard analysis, it will then have the flexibility to choose the appropriate verification activities based on the risk evaluation. Importers are also required to establish and implement procedures for periodically reassessing their FSVP, which includes comprehensive documentation of the reassessment and any resultant changes.

Foreign supplier verification activities

As noted above, the true crux of the final rule is that FSVP importers must ensure the food is not produced in a manner that will render it adulterated or misbranded with respect to allergen labeling.

Private brand owners can take steps now to start implementing verification activities, including:

• Establishing protocols for auditing suppliers or obtaining audits conducted within the past year.
• Determining the proper auditing standards.
• Determining whether or not they wish suppliers to be responsible for obtaining their own audits and/or conducting sampling and testing activities.
• Deciding whether or not they wish to use accredited third-party auditors such as SQFI.
• Deciding whether or not they wish to perform FSVP activities or outsource them.

Recordkeeping and documentation

The final rule imposes significant documentation and recordkeeping requirements on FSVP importers. For example, records must be kept documenting the hazard analysis, foreign supplier approval and verification and written procedures for such; determination of appropriate foreign supplier verification activities; performance of foreign supplier verification activities; corrective actions and more.

FMI has a number of recordkeeping best practices documents to assist your company in developing a robust record retention policy and to understand what is required.

When is compliance required?

The date of compliance depends on a number of factors, including the size of the importer, the foreign supplier and the farm. In general, the date by which importers must comply with the FSVP regulations is as early as 18 months after a facility or farm becomes subject to the produce safety or the preventive controls rule.

All food retailers and wholesalers that are importing food will be required to develop, maintain and follow an FSVP for each food imported into the United States.