Timeline of FSVP Compliance Dates for Importers of Human Food

Under the FSVP regulations, issued in final form in November (see 1511160014), food importers will have to verify their suppliers’ compliance with food safety requirements that are at least equivalent to U.S. regulations on preventive controls, produce safety, adulteration and misbranding. Modified requirements apply to very small importers and importers of food from small suppliers. In addition, importers may rely on written assurances that steps are being taken by their downstream costumers to address food safety risks. Filers will report FSVP requirements are being met via a data element in the Automated Commercial Environment (see 1512070014).

Some Foods Exempt From FSVP Entirely, Others Have Modified Requirements

FDA has posted a fact sheet detailing what foods are exempt from FSVP and what foods are subject to modified requirements (here). The following foods are exempt:

• Juice, fish, and fishery products already subject to FDA hazard analysis and critical control point (HACCP) regulations, supplements
• Food for research or evaluation
• Food for personal consumption
• Alcoholic beverages
• Food that is transshipped
• Food imported for processing and future export
• Food exported from and returned to the United States without manufacturing/processing in a foreign country,
• Certain meat, poultry, and egg products (i.e., other than shell eggs) regulated by the U.S. Department of Agriculture

Compliance Dates for Animal Food Still Unknown

Though importers will have to verify suppliers of both human and animal food, this timeline only includes deadlines for verification of human food. Animal food importers will have to implement FSVP six months after their suppliers are required to comply with FDA’s final rule on current good manufacturing practice (CGMP) requirements and preventive controls for animal food (see 1509100073). Some questions remains as to whether that six month period runs from the compliance date of animal food CGMP requirements or the compliance date of animal food preventive controls requirements. “We realize that there are questions regarding this issue, and we plan to issue a Federal Register notice that will address it,” said an FDA spokesman.

Staggered Implementation Begins 2017, Runs Until 2020 Depending on Food

The first compliance date for imports subject to FSVP comes in May 2017, when importers must have verification in place for suppliers that are not subject to FDA’s produce safety or preventive controls rules. FSVP must be in place for suppliers subject to preventive controls, which include “food facilities” required to register with FDA (other than farms) (see 1509100021), and subject to produce safety rules, which include farms that grow, harvest, pack and hold most fresh fruits and vegetables (see 1511170024), six months after the supplier must comply with the applicable rule.

The only exception is if the importer is a small business and a “receiving facility” that further processes food, and is therefore subject to supply-chain provisions of the human food preventive controls rule. These importers have a later first implementation date for certain suppliers.

Implementation dates for FSVP, based on the supplier and food being imported, are as follows:

May 30, 2017. Importers must verify suppliers not subject to preventive controls or produce safety regulations, including:

• Raw agricultural commodities that are not fruits and vegetables, such as grains.
• Raw agricultural commodities rarely consumed raw, such as beans, cranberries, sugar and potatoes.

FSVP must also be implemented by this date for importers from large suppliers with more than 500 employees that are subject to preventive controls for human food.

(NOTE: Except small business importers (less than 500 employees) that are “receiving facilities” subject to supply-chain provisions of preventive controls rule.)

July 26, 2017. Importers must verify suppliers of sprouts subject to the produce safety rule with $500,000 or more in average annual sales over three years.

(NOTE: Except small business importers (less than 500 employees) that are “receiving facilities” subject to supply-chain provisions of preventive controls rule.)

Sept. 18, 2017. Small business importers (with less than 500 employees) that are “receiving facilities” subject to supply-chain provisions of human food preventive controls (i.e., the importer further processes the food and the hazard isn’t controlled elsewhere) must verify suppliers that are not subject to preventive controls or produce safety, are large suppliers subject to preventive controls, or are large suppliers of sprouts subject to produce safety.

(NOTE: Importer "receiving facilities" have the same deadlines as other importers in all other circumstances, including if they are small businesses.)

March 19, 2018. Importers must verify small business suppliers (less than 500 employees) subject to preventive controls for human food.

July 26, 2018. Importers must verify suppliers subject to the produce safety rule (other than sprout suppliers) with annual sales $500,000 or more over the past three years. Also, importers must verify suppliers of sprouts subject to the produce safety rule with $250,000 to $499,999 or more in average annual sales over three years.

March 18, 2019. Importers must verify suppliers that are “qualified facilities” subject to human food preventive controls (with modified requirements). Also, importers must verify suppliers subject to the pasteurized milk ordinance.

July 29, 2019. Importers must verify suppliers subject to the produce safety rule (other than sprout suppliers) with annual sales $250,000 to $499,999 or more over the past three years (with modified requirements for suppliers with qualified exemptions). Also, Importers must verify suppliers of sprouts subject to the produce safety rule with less than $250,000 in average annual sales over the preceding three years.

July 27, 2020. Importers must verify suppliers subject to the produce safety rule (other than sprout suppliers) with annual sales of less than $250,000 over the past three years (but over $25,000), with modified requirements for suppliers with qualified exemptions.