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FDA Proposes New Rules under FSMA (July 2013)

The U.S. Food and Drug Administration (FDA) issued two new proposed rules under the Food Safety Modernization Act (FSMA) aimed at helping FDA create and integrate an import oversight system to efficiently improve food safety and protect human health. These proposed rules are an effort to prevent food safety problems rather than respond to problems after they have occurred.

One of the proposed rules would require U.S. importers to establish a Foreign Supplier Verification Program (FSVP) to verify that their foreign suppliers are implementing modern, prevention-oriented food safety practices that are comparable to domestic growers and processors. Importers would be responsible for formulating a plan to identify hazards associated with each food that are reasonably likely to occur, and implement quality assurance procedures to ensure that these hazards are being adequately controlled.

The other proposed rule would direct FDA to institute a program for the Accreditation of Third-Party Auditors for imported food. Accreditation bodies recognized by the FDA, which could be foreign government agencies or private companies, would be tasked with accrediting third-party auditors to audit and issue certifications for food and foreign food facilities, under certain circumstances. Importers would not generally be required to obtain certifications, but certifications may be used by FDA to determine whether to admit certain imported foods that pose a safety risk into the United States.


The public comment period for the FSVP and third-party accreditation proposed rules will remain open for the next 120 days.

For more information, please Contact TSG.

Summary of the FSVP Proposed Requirements

The proposed Foreign Supplier Verification Program (FSVP) rule is a risk-based approach to foreign supplier verification, focusing on foreseeable food safety risks identified through a hazard assessment process. Importers would be required to develop, maintain and implement an FSVP for each food it imports. FSVPs in general include several key components:

Compliance Status Review
Importers would be required to review compliance status of food and foreign supplier. Review would require FDA warning letters, import alerts and requirements for certification by FDA.

Hazard Analysis
Importers would need to conduct a hazard analysis on imported food to evaluate the severity of the illness or injury should a hazard occur.

Verification Analysis
Importers would be required to provide assurances that identified hazards are adequately controlled. Verification activities could include:

Onsite auditing of foreign suppliers;

Periodic or lot-by-lot sampling and testing of food; and

Period review of foreign supplier food safety records.

All FSVPs must include a list of foreign suppliers from which food is imported and establish written procedures for conducting verification activities.

Corrective Actions
Importers would be responsible for reviewing complaints against the foods they import, investigating misbranding or adulteration, and revising their FSVPs when identified as inadequate.

Periodic Reassessment of the FSVP
Importers would be required to reassess their FSVPs within three years of program establishment or the last assessment. If new information regarding potential food hazards is discovered, importers would need to reassess the FSVP at that time (e.g., changes to the source of raw materials or product formulation).

Importer Identification
Importers would be required to obtain a Dun and Bradstreet Universal Numbering System (DUNS) number for their company. Name and DUNS number must be provided electronically when filing for entry with Customs and Border Protection.

Recordkeeping
Importers are required to keep records, including compliance status reviews, hazard analyses , foreign supplier verification activities, FSVP reassessments, and investigations and corrective actions.

Modified Requirements and Exemptions
Under the proposed rule, modified FSVP requirements would apply in certain circumstances, including the following:

Importation of a dietary supplement or its component;

Importation of food from a very small foreign importer or supplier; and

Importation of food from a foreign supplier in good compliance standing with a food safety system that FDA has officially recognized as comparable or equivalent to that of the United States.

The proposed rule would exempt the importation of the following from FSVP requirements

Juice and seafood from facilities that comply with the Hazard Analysis & Critical Control Points (HACCP) regulations, which contain their own supplier verification provisions;

Food imported for research or evaluation purposes;

Food imported for personal consumption;

Alcoholic beverages; and

Food that is transshipped or imported for further processing and export.

More information about the Foreign Supplier Verification Program can be found here.

More information about the Accreditation of Third-Party Auditors can be found here.

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