1 AM I SUBJECT TO FSVP? Are you an importer as defined under Part 1 subpart L? (see 21 CFR 1.500) That is, are you the U.S. owner or consignee of an article of food that is FSVP does NOT NO being offered for import into the United apply to you. States? Or, if there is no U.S. owner or consignee of an article of food at the time of U.S. entry, are you the U.S. agent or representative of the foreign owner or consignee at the time of entry? YES Do you only import these foods? (see 21 CFR 1.501) • 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 • FSVP does NOT • Certain alcoholic beverages, or certain YES apply to these ingredients for use in alcoholic foods. 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 NO You do not need an FSVP with Do you import low acid canned food respect to microbiological in compliance with 21 CFR part 113? hazards for that food. (see 21 CFR 1.502(b)) Instead, you must verify and YES document that the food was produced in accordance with 21 CFR part 113. With respect to all matters that are not controlled by part 113, you must have an FSVP. NO Are you a receiving facility in compliance with requirements in the Preventive Controls for Human Food or Preventive You are deemed in Controls for Animal food rules related to compliance with most implementation of preventive controls for aspects of FSVP, except YES the hazards in the food or supply-chain the requirement for programs, or are you not required to importer identification implement a preventive control under at entry. those rules in certain specified circumstances? (see 21 CFR 1.502(c)) NO You are subject to modified Do you import dietary supplements FSVP requirements subject to certain dietary supplement for those dietary supplements subject current good manufacturing practice YES M to separate, pre-existing Current requirements in 21 CFR part 111? Good Manufacturing Practices (CGMPs) ( 0 21 CFR 1.511) requirements for dietary supplements. NO Are you a very small importer? (see 21 CFR 1.500 and 1.512) For human food, an importer averaging less than $1 million per year during the 3-year period preceding the applicable You are subject to modified calendar year, in sales of human food FSVP requirements. combined with the U.S. market value of human food imported, manufactured, An example of modified processed, packed, or held without sale requirements for certain importers YES (e.g., imported for a fee). M is that they would not have to conduct hazard analyses and For animal food, an importer averaging would be able to verify their foreign less than $2.5 million per year during the suppliers by obtaining written 3-year period preceding the applicable assurances of compliance. calendar year, in sales of animal food, combined with the U.S. market value of animal food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee). NO Do you import food from certain small suppliers (i.e., qualified facilities under PCHF or PCAF, certain farms that are not You are subject to modified FSVP covered farms under the produce safety YES requirements for food from those M regulation, and certain small egg suppliers. producers)? (See 21 CFR 1.512) NO You are subject to modified Do you import certain food from a country FSVP requirements for food with an officially recognized or equivalent from those countries. food safety system? YES Includes determining that the M (see 21 CFR 1.513) supplier is in compliance with U.S. safety regulations or relevant laws in country deemed equivalent. Created November 13, 2015 NO YOU ARE SUBJECT TO FSVP.