US FDA Proposes Rule for Foreign Supplier Verification Program

On 29 July 2013 the United States Food and Drug Administration (US FDA) published the proposed rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals (1). This proposed rule is part of the Food Safety Modernization Act (FSMA). Comment period for this proposed rule ends 26 November 2013.

Foreign Supplier Verification Programs for Importers of Food for Human and Animals

This proposal requires the importer to perform a risk-based assessment of the food products imported into the US to verify that it has been produced at the same level of safety as required by those domestic producers. All importers must establish and follow a FSVP which includes the following:

1 - Compliance Status Review of the food and the foreign supplier
2 - Hazard Analysis of the food imported
3 - Verification Activities of the hazards indentified are being controlled
4 - Corrective Actions if foods are adulterated or misbranded
5 - Periodic reassessment of the FSVP at least every 3 years or when significant changes occur
6 - Importer Identification will be the Dun and Bradstreet Data Universal Number System (DUNS)
7 - Recordkeeping – all records for compliance of the FSVP must be maintained as per the FSMA record keeping requirements

Two Options for Food Hazards Controls

The US FDA created two options for controlling hazards. Which option that is used depends on whether there is a reasonable probability that exposure to the hazard will result in serious harm or death and whether the supplier or the importer is controlling the hazard. The control can be on-site audit which can be performed by an US FDA accredited third-party accredited auditor (SafeGuards 142/13 (http://newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-14213-us-fda-accreditation-of-third-party-auditors-a4-en-13.pdf)) or documentation audit depending on the hazard and the controlling entity.

There are modified requirements for dietary supplement and dietary supplement components, very small importers or the importation of food from a very small supplier and those suppliers from countries programs/agencies the US FDA deemed as equivalent to the them (New Zealand) and in compliance with that countries requirements.

Exceptions to the Foreign Supplier Verification Program

The following are exempt from this requirement as stated previously in FSMA: juice and seafood facilities in compliance with HACCP (Hazard Analysis Critical Control Point) regulations, food imported for research or evaluation, food imported for personal consumption, alcoholic beverages and food that is transshipped or imported for further processing and then exported.

Effective date will be 60 days after the final rule is published and compliance date will be 6 months after the compliance date of the Preventive control regulations.

More information on FSMA and how to comment on the proposed regulations is available on the website of the Food and Drug Administration (http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm)

Reference:

(1) “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
” – US Federal Register (https://www.federalregister.gov/articles/2013/07/29/2013-17993/foreign-supplier-verification-programs-for-importers-of-food-for-humans-and-animals)

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This release was published on openPR.