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Your guide to understanding the Foreign Supplier Verification Program for Importers Rule…

Through the implementation of FSMA, the FDA now requires all product imported into the country, to have been made in a facility that complies with the FSMA standard. This is known as the FSVP (Foreign Supplier Verification Program) and was published in November 2015.

FDA FSVP

The responsibility of the importer

It is now the responsibility of the importer of that food to verify that their suppliers have preventive controls in place.  The facility that manufactures the product has a responsibility to comply, but the overall responsibility sits squarely with the importer to ensure compliance for the food that they are importing. This means that the facility that processes the food must adhere to the Preventive Control Rule (HARPC), The Produce Safety Standards and Intentional Contamination Prevention Rule.

Compliance dates

For importers who are importing food from non US facilities, they must comply within 18 months of publication of the rule, which is about May 2017. The FDA have also stated, in addition to the above compliance date, that:

“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.”

When I first read this I found it really confusing.  How can a supplier of food, which is being imported be subjected to the preventive controls rule?  Wouldn’t that be like importing food made in the US (because they are subject to the rule) into the US (and therefore it’s not imported at all).  But having evaluated the statement, I think this may be where food businesses located in the US are importing food from other countries, either because their facility is located outside the US or because they contract manufacturer product in other countries. Therefore, these types of businesses would need to comply from May 2016.

Importer verification activities

Because the responsibility sits with the importer, they are responsible for ensuring that they verify that the food is processed in compliance with FSMA.

This means that the importer must have an approval and monitoring system for their suppliers.  Monitoring activities may include auditing of the facility, supplier questionnaires, review of records or product testing.

The first part of the program should be to carry out a hazard analysis exercise on the food for the potential risks involved.  Where there may be food safety risks associated with the food, then the importer must implement the approval and monitoring system for the suppliers of that food.

The FDA have stated, that where a food is deemed to not have any associated risks, then the supply approval and monitoring system would not need to be implemented for the supply of those goods.

They have provided examples of the types of foods that may not have any associated risks, which are:

  • Salt
  • Crackers
  • Cookies
  • Candy (such as hard candy, fudge, maple candy, taffy and toffee)
  • Bread
  • Dried pasta
  • Honey, molasses, sugar or syrup
  • Soft drinks
  • Jams, jellies or preserves

While I understand to some extent why they have listed these types of foods; as they all could have a low microbiological risk, I do not understand why they may not be subject to the other hazards defined in the Preventive Control rule – such as physical, chemical (including allergenic) and radiological risks.

When assessing adulteration for economic gain, some of the foods such as some types of honey may also need consideration.  Personally, I think it seems a bit misleading to provide such a list.

What foods are subject to this rule?

All imported foods must comply, with the exception of:

  • Those that are subject to the FDA HACCP regulations (for fish and fishery products, juice, low-acid canned foods (but only for the micro element))
  • Food that is imported into the country but will not be consumed there either because:
    • It will be further processed for export out of the US
    • It is being transhipped through the US to go onto another country
  • Food that is manufactured in the US, exported to another country and then returned without any processing
  • Food for research or evaluation purposes and therefore will not be widely consumed
  • Food for personal consumption
  • Alcoholic drinks and certain raw materials used in the processing of such drinks

They also state some meat, poultry and egg products are also exempt, following the regulations set out by the US Department of Agriculture.

FSMA accreditation

The FDA are going to create a third party certification program which meets the FSMA requirements.  Food facilities who are importing products in the US can prove that they meet the FSMA requirements, by being accredited to this scheme.  The FDA aim to agree certification bodies for this scheme within 2 years of enactment.

Certification for high risk foods

The FDA have the power to specify that high risk foods imported into the country must be accompanied by a third party certification.  It is not clear at this stage if this means they will enforce this and make it mandatory, or what type of certification will be acceptable.

Expedited review

The FDA will offer a voluntary program where food importers can apply for expedited review as a ‘qualified importer’.  The rules for application are not clear at this stage, but they have said it will include where facilities have accreditation.  This is due to be released 18 months from enactment.

Enforcement

The FDA can now refuse entry to imported products, if the food facility which produces them will not grant the FDA access for inspection, or if the country will not grant them access.

If you have any specific questions about the rule, please pop them in the comments section below.  If you’ve had any experience of this rule already, Your FSMA community would love to hear about it too!

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