FDA Foreign Supplier Verification Program (FSVP) Compliance Date Update
Background:
The Final Rule on Foreign Importer Verification Program was published on Novermber 17, 2015. It requires that an importer establishes an FSVP program for each food that they import from each supplier and that they must develop, maintain, and follow an FSVP in accordance with the requirements of hazard analysis, risk based preventive controls for human and animal food; standards for food safety and regulations. Importer must also ensure foreign supplier is producing food in accordance with adulteration and misbranding with respect to allergen labeling. A written verification procedures must be in place starting May 30, 2017.
FSVP does not apply to the following:
• Fish and Fishery Products (in compliance with part 123), or certain ingredients for use in fish and fishery products in compliance with part 123
• Juice (in compliance with part 120), or certain ingredients for use in juice products in compliance with part 123
• Food for research or evaluation
• Certain alcoholic beverages, or certain
ingredients for use in alcoholic beverages
• Certain meat, poultry, and egg products regulated by USDA
• Food imported for personal consumption
• Food that is transshipped
• Food that is imported for processing and export
• U.S. food that is exported and returned without further manufacturing/
processing in a foreign country
Reminder: Certain FSVP Exemptions FSX (For Further Compliance Dates) will end on Monday, March 19, 2018.
** If you are no longer covered by these exemptions, it is very important that you please contact Flegenheimer International with your FSVP insructions as FDA has been increasingly conducting FSVP inspections on the importers**
Below are the FSVP compliance dates posted on FDA website:
The compliance dates for importers subject to the Foreign Supplier Verification Programs (FSVP) rule differ according to a number of considerations, including:
- The size of the foreign supplier,
- The nature of the importer,
- and whether the foreign supplier must meet the requirements of the final rules for: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food,Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (collectively, “PC rules”), or Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (“produce safety rule”).
The following compliance dates are grouped according to the category of FSVP importer. This list does not include importers that are themselves a manufacturer or processor subject to the supply-chain program provisions in the Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (PC) rules. If importers are subject to the supply-chain program requirements in those rules, the compliance date for FSVP is the later of the applicable date in the below list or the date by which the importer is required to comply with the PC supply-chain program provisions.
FSVP importer whose foreign supplier is not subject to the PC or produce safety rules: May 30, 2017
FSVP importer whose foreign supplier is required to comply with the PC rule for human food. Compliance dates when foreign suppliers are in these categories:
-Small businesses as defined in 21 CFR 117.3: March 19, 2018
-Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 117.3: March 18, 2019
-Suppliers subject to the Pasteurized Milk Ordinance: March 18, 2019
-“All Other” Business Suppliers: May 30, 2017
FSVP importer of animal food whose foreign supplier is subject to the current good manufacturing practices (CGMP) requirements in subpart B of 21 CFR part 507 in the PC rule for animal food. Compliance dates when foreign suppliers are in these categories:
-Small Businesses as defined in 21 CFR 507.3: March 19, 2018
-Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3: March 18, 2019
-“All Other” Businesses: May 30, 2017
FSVP importer whose foreign supplier is required to comply with the animal food preventive controls requirements in subpart C of part 507 of the PC rule for animal food, but that is not required to comply with the CGMP requirements in subpart B of 21 CFR part 507. Compliance dates when foreign suppliers are in these categories:
-Small Businesses as defined in 21 CFR 507: March 18, 2019
-Qualified Facilities (including Very Small Businesses) as defined in 21 CFR 507.3: March 17, 2020
-“All Other” Businesses: March 19, 2018
FSVP importer whose foreign supplier is required to comply with the produce safety rule, except for the requirements applicable to sprouts in subpart M of 21 CFR part 112. Compliance dates when foreign suppliers are in these categories:
-Small Businesses as defined in 21 CFR 112.3: July 29, 2019
-Very Small Businesses as defined in as defined in 21 CFR 112.3: July 27, 2020
-“All Other” Businesses: July 26, 2018
FSVP importer whose foreign supplier is required to comply with the requirements in the produce safety rule applicable to sprouts in subpart M of 21 CFR part 112. Compliance dates when foreign suppliers are in these categories:
-Small Businesses as defined in 21 CFR 112.3: July 26, 2018
-Very Small Businesses as defined in 21 CFR 112.3: July 29, 2019
-“All Other” Businesses: July 26, 2017
FSVP importer whose foreign supplier is subject to the produce safety rule and eligible for a qualified exemption (other than when the foreign supplier is a farm producing sprouts). Compliance dates when foreign suppliers are in these categories:
-Small Businesses as defined in 21 CFR 112.3: July 29, 2019
-Very Small Businesses as defined in 21 CFR 112.3: July 27, 2020
FSVP importer whose foreign supplier is a farm producing sprouts that is eligible for a qualified exemption under the produce safety rule. Compliance dates when foreign suppliers are in these categories:
-Small Businesses as defined in 21 CFR 112.3: July 26, 2018
-Very Small Businesses as defined in 21 CFR 112.3: July 29, 2019
To read for further information:
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm503822.htm
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361902.htm