Sharon Mayl FDA FSVP Compliance FSVP Regulations FSVP Deadlines

A Conversation with Sharon Mayl

Senior Advisor for Policy in the Office of Foods and Veterinary Medicine at FDA



The first major compliance date for importers covered by the Foreign Supplier Verification Programs (FSVP) rule arrives on May 30, 2017. FSVP is mandated by the FDA Food Safety Modernization Act (FSMA). A central tenet of that law is that the same preventive food safety standards apply to food consumed in the U.S., regardless of where the food is produced.


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.

Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine at FDA, explains what importers need to know when facing this May compliance date and what lies ahead for FSVP implementation.


Q: When are the compliance dates for the FSVP rule?

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 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.


Q: Who must be in compliance with FSVP by May 30, 2017?

U.S. importers subject to this first compliance date have foreign suppliers that fall into one of three categories: Foreign suppliers that will not be covered by the PC or produce safety rules; Foreign suppliers subject to the PC for Human Food rule and are not “small businesses,” “qualified facilities” (certain very small businesses) or subject to the Pasteurized Milk Ordinance; or Foreign suppliers subject to the current good manufacturing practices (CGMP) requirements in the PC for Animal Food rule, and are not “small businesses” or “qualified facilities”. For ease of viewing, we have a chart on fda.gov titled “Am I Subject to FSVP?” that importers can refer to if they are unsure if the rule applies to them.


Q: What do importers have to verify on May 30, 2017?

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.

The largest foreign suppliers subject to the PC for Human Food rule had to be in compliance in September 2016 with both the PC provisions and the CGMP requirements of that rule, but the largest suppliers subject to the PC for Animal Food rule only had to be in compliance with the CGMP requirements by that date. Therefore, importers of foods from those facilities will only need to consider those provisions of the PC rules that their suppliers have had to come in compliance with by May 30, as well as verify that the food is not adulterated or misbranded with respect to allergens.


And I want to clarify that importers have some flexibility with respect to the PC and produce safety rules. 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.


As noted above, importers will have additional time to develop and implement FSVPs 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.