Foreign Supplier Verification Programs (FSVP) in the Food Industry

Foreign Supplier Verification Programs (FSVP) Food Industry Forum Cathy Groehnert, Consumer Safety Officer Office of Regulatory Affairs Division of Import Operations

Purpose of FSVP To provide adequate assurances that: Foreign suppliers produce food using processes and procedures providing the same level of public health protection as FSMA preventive controls or produce safety provisions Food is not adulterated or misbranded (as it relates to allergen labeling) FSVP creates a level of parity between U.S. food producers and foreign food producers 2

Which foods are covered by the FSVP Regulation? All imported foods regulated by FDA Includes Animal Foods Dietary Supplements 3

Which foods are exempt from FSVP? Juice products Fish and Fishery (Seafood) products Alcoholic beverages Food imported for research or evaluation Food imported for processing and export 4

Am I subject to the FSVP rule? The FSVP importer is the U.S. owner or consignee of the food offered for import (i.e., owns the food, has purchased it, or has agreed in writing to purchase it at the time of US. entry). If there is no U.S. owner or consignee at the time of entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee 5

Standard FSVP requirements Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers that are approved based on the importer s evaluation of the risk posed by the imported food and the supplier s performance Develop writtenFSVP Must be a qualified individual/auditor Conduct Hazard Analysis o Identify and evaluate hazards for each food Biological, chemical, and physical 6

Standard FSVP requirements Evaluate Food Risk and Foreign Supplier Performance for Approval o The hazard analysis o The foreign supplier s processes and procedures used to prevent the hazards o The foreign supplier s food safety history, can search foreign suppliers on FDA s Import Alert list 7

Standard FSVP requirements Supplier Verification o Importer must establish and follow written procedures to ensure it only imports from approved foreign suppliers and conduct appropriate supplier verification activities o Supplier verification options Annual on-site visits Sampling and testing Review suppliers relevant food safety records 8

Standard FSVP requirements Corrective Actions o Importers must promptly take appropriate corrective actions if they determine that a foreign supplier has not used processes and procedures that provide the same level of public health protection Identification of importer at the time of entry o Name, email address, and unique facility identifier (UFI) UFI is the importer s DUNS number 9

Standard FSVP requirements Maintenance of Records o Hazard Analysis o Reevaluation of the foreign supplier s performance and risks posed by the food o Procedures for importing food only from approved foreign suppliers o Performance of foreign supplier verification activities o Corrective actions taken o Investigations o FSVP modifications 10

Modified Requirements Certain importers may comply with the modified FSVP requirements Only certain verification activities must be conducted Applies to sections 1.507, 1.511, 1.512, and 1.513 1.507: foods intended for further manufacturing or processing and foods imported in their raw state, but cannot be consumed raw. e.g., coffee beans 1.511: dietary supplements and components 1.512: very small importer <$1 million dollars/ year for human food and <$2.5 million dollars/ year for animal food, or 1.513: Foods imported from a systems recognized country such as New Zealand and Canada 11

What to expect when youre inspected Pre-Inspection Contact An FDA investigator will contact you to confirm location verify you are the FSVP importer confirm records are in English or translated to English if original records are in another language are onsite 12

What to expect when youre inspected How to Prepare Gather your FSVP records Retrieve any records stored offsite Translate any records not in English 13

What to expect when youre inspected During the Inspection Generally conducted at FSVP importer s location, but we are conducting remote inspections due to the pandemic The Investigator will issue a Form FDA 482d, Request for FSVP Records The investigator will review the records and may ask for other documents or labels 14

What to expect when youre inspected During the Inspection If significant observations are noted, the Investigator will issue a Form FDA 483a, FSVP Observations We highly encourage you to submit a written response within 15 days; include your new/updated FSVP Records and evidence of corrections 15

FSVP Implementation FSVP inspections began in 2017 following an educate while we regulate approach Educate while we regulate will continue, but we ve moved forward with enforcement First FSVP Warning Letter issued on July 30, 2019 The importer s product caused a Salmonella outbreak and recall in May of 2019 The importer was in violation of the FSVP regulations The importer was placed on Import Alert 99-41 16

FSVP Implementation Initiating for cause FSVP inspections If a problem is identified at the time of entry or post entry, a for cause inspection of the importer may be initiated Re-inspections are being conducted To verify if corrective actions have been taken based on issues identified during the previous inspection The Agency will take enforcement action to protect the public health or to address egregious, continued non- compliance 17

Import Alert 99-41 Import Alert 99-41 was published on July 31, 2019. This is a firm alert and is specific to the importer, foreign supplier, and the food(s) they import As of March 11, 2021, there are 11 firms subject to detention without physical examination (DWPE) The basis of the Import Alert is non-compliance with FSVP The only way to gain removal from IA and begin importing foods again is through demonstration of compliance with FSVP 18

Compliant Importers Vast majority of importers want to comply The compliance history of these importers and foreign suppliers will be taken into account for our entry screening and targeting Importers will see benefits from having less risk with their products by avoiding issues that can lead to recalls, product withdrawals and liability. 19

Importers that are also manufacturers A manufacturer subject to the PC requirements that uses imported ingredients may also be an importer covered by FSVP. These manufacturers can be deemed in compliance with most FSVP requirements if 20

Importers that are also manufacturers They are in compliance with the Preventive Controls Rule (PC) supply-chain program requirements or Implement preventive controls for the hazards in the food in accordance with the requirements in the PC rules 21

Importers that are also manufacturers Must also evaluate the risk posed by the imported food and the supplier s performance at least every three years You will still need to provide FSVP identification information such as your DUNS number 22

Resources https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final- rule-foreign-supplier-verification-programs-fsvp-importers-food-humans- and-animals FDA.gov search for FSVP FSMA Final Rule on FSVP for Importers of Food for Humans and Animals Guidance for Industry FSVP Records FSMA Technical Assistance Network (TAN) 23

Questions? 24