Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals under FSMA (Food Safety Modernization Act) and Its Compliance Dates

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According to FDA, they will inspect FSVP importers to ensure they are  in compliance. The compliance dates must be noted below:

  • May 30, 2017
  • For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations
  • For an FSVP importer that is itself a manufacturer or processor subject to the supply -chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions.

http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM502160.pdf

What is the purpose of Foreign Supplier Verification Program (FSVP)?

In order to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food processors and produce farms, and is not adulterated or misbranded with respect to allergen labeling, importers will be required to perform risk-based activities.  This is an important purpose in the new import program. It requires importers to take responsibility for the safety of the food they import and will serve as an additional preventive measures on the system.

Who is subject to FSVP Rule?

First, you need to determine if you are a FSVP Importer:

(A) the United States owner or consignee of a food offered for import into the United States; or
(B) in the case when there is no United States owner or consignee at the time of U.S. entry, the importer is the U.S. agent or representative of a foreign owner or consignee of the food offered for import at the time of entry, as confirmed in a signed statement of consent.

Second, review the food products you are importing. Below are the list of food items not subject to FSVP Rule:

  • Fish and fishery products that are imported from a foreign supplier that is required to comply with, and is in compliance with, FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, as well as for certain raw materials or other ingredients for use in processing fish or fishery products in compliance with HACCP.
  • Juice products that are imported from a foreign supplier that is required to comply with, and is in compliance with, FDA’s HACCP regulation for those products, as well as for certain raw materials or other ingredients for use in processing juice in compliance with HACCP.
  • Food for research or evaluation
  • Food for personal consumption
  • Alcoholic beverages and certain raw materials and ingredients that are imported for use in alcoholic beverages
  • Food that is imported for processing and future export
  • Low-acid canned foods, such as canned vegetables, but only with respect to microbiological hazards
  • Certain meat, poultry and egg products
  • Food that is transshipped, meaning it stops in the U.S. en route to another country.
  • U.S. food that is exported and returned without further manufacturing or processing in a foreign country.

Third, if you are a receiving facility in compliance with requirements in the Preventive Controls for Human Food or Preventive Controls for Animal food rules related to implementation of preventive controls for the hazards in the food or supply-chain programs, or you are not required to implement a preventive control under those rules in certain specified circumstances, then you are deemed in compliance with most aspects of FSVP, except the requirement for importer identification at entry. (see 21 CFR 1.502(c)
 

Fourth, You are subject to modified  FSVP requirements for those dietary supplements subject to separate, pre-existing Current Good Manufacturing Practices (CGMPs) requirements for dietary supplements. 21 CFR part 111.

Fifth, you are subject to modified FSVP requirements if you are a very small importer. An example of modified requirements for certain importers is that they would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of  compliance.

Under 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 calendar year, in sales of human food combined with the U.S. market value of human food imported, manufactured, processed, packed, or held without sale (e.g., imported for a fee).

For animal food, an importer averaging less than $2.5 million per year during the 3-year period preceding the applicable 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).

Sixth, if you import food from certain small suppliers (i.e., qualified facilities under PCHF or PCAF, certain farms that are not covered farms under the produce safety regulation, and certain small egg
producers (See 21 CFR 1.512), then you are subject to modified FSVP requirements for food from those suppliers.

Seventh, if you import certain food from a country with an officially recognized or equivalent food safety system under 21 CFR 1.513, then you are subject to modified FSVP. This Includes determining that the supplier is in compliance with U.S. safety regulations or relevant laws in country deemed equivalent.

Source: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM472461.pdf

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm#FSVP_Rule

What’s the next step?

According to FDA, FSVP Activities must be developed by a qualified individual, depending on the circumstances, supplier verification activities could include audits, records review, sampling and testing, some combination of those, or other activities. When there is reason to believe that a hazard in a food that will be controlled by the foreign supplier is one for which there is a reasonable probability that it will cause serious adverse health consequences or deaths, a clear, rigorous verification standard is required in the form of annual on-site auditing of the supplier. However, importers have the flexibility to use a different approach if they can establish that it will be appropriate to provide adequate assurance that the foreign supplier is significantly minimizing or preventing the hazard.

Source: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM502160.pdf

 

Accredited Third Party Certification and Sanitary Transportation of Human and Animal Food

A system was established to recognize accreditation bodies that in turn accredit third-party certification bodies to perform food safety audits and issue certifications for foreign food facilities and the foods they produce. Such certifications will be required for participation in the Voluntary Qualified Importer Program (VQIP), which will allow for expedited review and entry of foods from importers in the program. In addition, to prevent potentially harmful food from reaching U.S. consumers, the FDA can require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.

A routinely report must be submitted by the third party to FDA for regulatory audits while a consultative audits will be for internal use.

**It is important to note that FDA can require in specific circumstances that a food offered for import be accompanied by a certification from an accredited third-party certification body.**

For  Complete Facts Sheets:

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm361903.htm

The  Sanitary Transportation Rule establishes requirements for vehicles and transportation equipment, transportation operations, training, and recordkeeping.

For list of examples you can go to:

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247559.htm#FSVP_Rule

For Facts Sheet:

http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm