WHAT IMPORTERS SHOULD KNOW ABOUT FSVP SERVICES

FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards.  More specifically, FSVP requires that importers verify that their suppliers are producing food using processes and procedures that offer the same level of public health protection as the preventive controls (PC) requirements in the preventive controls and current good manufacturing practices rules for human food and animal food and produce safety FSMA rules, and that the food is not adulterated and properly labeled with respect to allergens.

It is important to note the compliance dates for FSVP are not based on the size of the importer. Instead, the compliance dates are staggered based on the size of the foreign supplier and the regulations that apply to the foreign supplier.

The First Compliance For FSVP

Date is eighteen months after the FSVP final rule was published in the Federal Register. This date gives importers sufficient time to understand the rule and develop their FSVPs. After that, importers generally have to comply six months after their foreign supplier has to be in compliance with the PC or produce safety rules. We linked the FSVP compliance dates to the other FSMA rules because we wanted to minimize the likelihood that an importer would be required to comply with the FSVP regulation before its supplier is required to comply with other FSMA food safety regulations.

Importers covered by the FSVP rule will have to verify that their suppliers meet applicable FDA food safety requirements, including that the food is not adulterated or misbranded with respect to allergens. Importers will need to have a program that allows them to demonstrate that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the PC or produce rules. I also want to emphasize that we are investing significant resources in training FDA broker on how to conduct these inspections.

All Foods Regulated Through FSVP

By the FDA consulting  will see changes to the entry process as of May 30, 2017. When food is offered for entry into the United States, the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will require the filer to enter at least one additional code as part of the required data elements.

An FSVP importer subject to the May 30 compliance date should use the entity role code “FSV,” indicating the entry is subject to the FSVP regulation. This will then prompt the ACE system to ask for the importer’s name, email address, and unique facility identifier (UFI) recognized as acceptable by FDA. We recently issued guidance formally recognizing the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP.

As noted above, importers will have additional time to develop and implement FSVP agent services for foods from smaller suppliers that are considered qualified facilities or small businesses under the PC rules, as well for food subject to the produce safety rule.

Yes, we have done a lot of outreach already to help importers understand the regulations and what they have to do. However, 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.

 What Importers can expect By FSVP

An approach that is interactive, and by that I mean that our investigators will be asking questions about what they see and there will be the opportunity for a real dialogue. We encourage importers to keep the lines of communication open with FDA if problems are found. If a corrective action is needed, the importer should communicate clearly what actions will be taken and by what date the corrections will be completed.

If problems arise in meeting deadlines, the importer should let us know. If importers determine that an audit is the appropriate verification activity, they must make sure the audit meets the requirements in the rule, namely that the audit considers the FDA food safety requirements that apply, and that the auditor is qualified to perform the audit (e.g., education, training, experience). These requirements are designed to be flexible and there are a variety of audits currently being used within the industry that may meet our requirements.

That said, the agency would encourage all importers to ensure the scope of the audits they currently use consider all applicable FDA food safety regulations, including the PC and produce safety rules if they apply to their supplier. In addition, they should ensure that the auditors performing the audits are qualified auditors in accordance with the FSVP rule.

Conclusion

FSVP is a significant new tool in our import toolkit. We have many tools that help protect consumers from unsafe imported products. Some of those tools have been around for a while, like examinations and sampling at ports of entry and foreign inspections, but the volume of food imports and the logistics and cost of foreign inspections require something more to ensure the safety of imported food.

FSVP allows us to hold importers accountable for ensuring the products they bring into the United States are held to the same safety standards as domestically produced food. That’s a significant change to the way we currently do business, and complements our other import tools. FSVP provides us a way to get information about foreign suppliers to help ensure that they are meeting U.S. safety requirements and, thus, keeping food safe for U.S. consumers