Tag Archives: voluntary qualified importer program

FDA

COVID-19 Leads FDA to Extend VQIP Application Period to July 31

By Food Safety Tech Staff
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FDA

Last week FDA announced the extension of the application period for importers that want to participate in the Voluntary Qualified Importer Program for FY 2021. The COVID-19 pandemic has resulted in travel restrictions and advisories that have hampered efforts by accredited Certification Bodies (CBs) to both conduct the onsite regulatory audits and issue certifications to foreign entities, which are required by the VQIP application.

The application portal will stay open until July 31.

VQIP is a voluntary fee-based program that was established under FSMA. Approved applicants are granted an expedited review and import of human and animal foods into the United States if they prove they are achieving and maintaining a high level of control over their supply chains from a safety and security standpoint. Eligibility criteria includes ensuring facilities of foreign suppliers are certified by a CB that has been accredited via FDA’s Accredited Third-Party Certification Program.

FDA

ANSI Names First Certification Body Under FDA’s Accredited Third-Party Certification Program

By Food Safety Tech Staff
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FDA

The American National Standards Institute (ANSI) has accredited Perry Johnson Registrars Food Safety, Inc. under FDA’s Accredited Third-Party Certification Program. The firm is the first certification body (CB) to be accredited under the program for the scopes of Produce Safety, Preventive Controls for Human Food, Juice HACCP and Seafood HACCP. Under the voluntary program CBs can conduct food safety audits and issue certifications of foreign food facilities.

Once an accredited CB issues a certification through this program, importers can use it to establish eligibility to participate in the Voluntary Qualified Importer Program.

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FDA

FDA Recognizes ANAB as First Accreditation Body

By Food Safety Tech Staff
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FDA

In an effort to improve oversight of imported food, today FDA announced its recognition of the first accreditation body under FSMA’s voluntary accredited third body certification program. ANSI-ASQ National Accreditation Board (ANAB) has been recognized by FDA after meeting agency requirements, which were validated via an application review and on-site assessment.

“Accreditation bodies recognized by FDA will have the authority to accredit third-party certification bodies, also known as third-party auditors. These certification bodies, once accredited, can conduct food safety audits and issue certifications of foreign food facilities (including farms) and the foods – both human and animal – that they produce.” – FDA

Today FDA also launched the Voluntary Qualified Importer Program (VQIP), which provides expedited review and entry of human and animal food into the United States. Importers that want to participate in the program must meet certain requirements, including making sure that the facilities of their foreign suppliers are certified under the Accredited Third-Party Certification Program.

Participating in VQIP a Gold Star in FDA’s Eyes

By Maria Fontanazza
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Acceptance into the Voluntary Qualified Importer Program serves as proof that your company has a best-in-class food safety program.

As is evident in the name, the Voluntary Qualified Importer Program (VQIP), is just that—voluntary. However, participants in the program are showing that they are going above and beyond the requirements (i.e., FSMA’s Foreign Supplier Verification Program), which in the long run, is good for business and their marketing.

“VQIP is meant to be a step up—it’s almost a push for regulators to offer incentive programs for those suppliers and a way to reward good behavior,” said Melanie Neumann, executive vice president and chief financial officer of The Acheson Group. “VQIP is looking for a best-in-class supplier control program, and it’s meant to incentivize those companies who have it and can prove it.” During a recent FSMA Fridays session organized by SafetyChain, Neumann and David Acheson, MD, CEO and president of The Acheson Group, discussed the basics of VQIP and the benefits of participating in the program.

Under FSMA, FDA is required to develop a voluntary and fee-based program that enables expedited review of foods from importers that have achieved specific criteria related to supply chain safety and security.  The agency released the draft guidance in June. The annual fee to participate in the program is estimated to cost $16,400, and FDA has also requested comment as to whether this fee will pose a burden on smaller businesses. Applications are filed online.

To qualify for participation in the program, companies must meet several requirements. Businesses must:

  • Have a record of importing foods into the United States for at least three years
  • Have a Data Universal Numbering System (DUNS) number
  • Use a paperless filer/broker that has received a pass rating from its FDA filer evaluation
  • Have a quality assurance program and submit documentation of assurance program
  • Be compliant with FSVP

Businesses must not:

  • Have any imported food that is subject to either an import alert or Class I recall
  • Have any ongoing FDA administrative or judicial history of significant noncompliance
  • Be subject to any safety or security customs and border protection penalties and sanctions

One of the most important elements of the eligibility requirements is proof of a quality assurance program, according to Acheson. He highlighted several components that companies must have as part of their quality assurance program, including:

  • Corporate policy quality statements, relating to food safety and security explaining how a company is controlling risk in its supply chain
  • An organization chart (or a written explanation of management structure)
  • Policies and procedures that will be implemented to ensure a company’s system is producing safe food
  • Written description of the food defense system
  • Documentation of a company’s experience in employee training for those responsible for implementing the quality assurance program
  • Procedures for assuring the program is current and appropriately implemented
  • Written procedures for maintaining records relating to structures and process and procedures of the program
  • References to sources used to develop the quality assurance program

“The message here is that FDA is saying we really want to make sure you have a robust system,” said Acheson. He added that although businesses must apply each year, once the initial heavily lifting is done the first year (and assuming the company has maintained the required standards), reapplication should not be as onerous.

Once a company has been accepted into the program, it can expect expedited entry of imported foods into the United States and limited examination or sampling of VQUO foods (unless there is a “for cause” situation).
 
“If you have qualified for this program, you’ve really got the FDA gold star,” said Acheson. “That’s a marketable item. If you can say your product is VQIP approved, it’s a leverageable opportunity for the importer for their customers.”