Tag Archives: VQIP

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Beltway Beat

FDA Publishes New Guidance Document for Voluntary Qualified Importer Program

By Food Safety Tech Staff
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FSMA requires FDA to establish a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.  This control includes importation of food from facilities[1] that have been certified in accordance with FDA’s Accredited Third-Party Certification Program (also referred to as the Third-Party Program or TPP) (section 808 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 384d)) and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications regulation (also referred to as the TPP regulation) (see 21 CFR part 1, subpart M), as well as other measures that support a high level of confidence in the safety and security of the food they import.  Expedited entry incentivizes importers to adopt a robust system of supply chain management and further benefits public health by allowing FDA to focus its resources on food entries that pose a higher risk to public health.

The guidance document describes FDA’s policy regarding participation in FDA’s Voluntary Qualified Importer Program (VQIP) by importers of food for humans or animals.  This document provides guidance on:

  • The benefits VQIP importers can expect to receive;
  • The eligibility criteria for VQIP participation;
  • Instructions for completing a VQIP application;
  • Conditions that may result in revocation of participation in VQIP; and
  • Criteria for VQIP reinstatement following revocation.

This guidance document is presented in question and answer format.  This guidance document may be modified (in accordance with FDA’s good guidance practice regulation (21 CFR 10.115)) as VQIP is implemented and evaluated.  FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in Agency guidance means that something is suggested or recommended, but not required.  This guidance represents FDA’s current thinking regarding what will be considered for participation in VQIP and how VQIP will expedite entry of imports.

The pronouns “I,” “me,” “you,” and “your” are used in this guidance to refer to the importer who may want to participate in VQIP.  “Agency” and the pronouns “we” and “our” are used to refer to FDA.  The term “food” has the meaning given in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except that, for the purposes of VQIP, food does not include pesticides as defined in 7 U.S.C. 136(u).

Download the Guidance

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

By Food Safety Tech Staff
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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.

AFSAP, audits

AFSAP Second Annual Stakeholders Meeting to Be Held During Food Safety Supply Chain Conference

By Trish Wester
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AFSAP, audits

2018 Recap: As VQIP implementation began, confusion among the accreditation bodies (ABs) and certification bodies (CBs) was clearly evident, and options for explanations from FDA were limited. To facilitate information sharing, AFSAP hosted an open gathering of all interested parties to hear from FDA. The inaugural AFSAP Auditing Stakeholders meeting provided a unique opportunity for the auditing community at large to interact with FDA and expand their knowledge on the regulatory use of audits in FSMA. CB attendees gained valuable insight into their hybrid role as part Scheme Owner under the Third-Party Certification Program (TPP) and its operational challenges in the global community. After vigorous discussion, the development of a consensus program for FDA’s TPP audits emerged, although the definitive mechanism to achieve this objective was still to be determined. AFSAP established a membership category for CB’s, and has continued to pursue solutions to these and other audit related issues, but information sharing has been limited to members.

2019: Although progress has been made, there is still a need for information sharing among all interested parties. Once again, the 2nd Auditing Stakeholders Meeting will be co-located with the Food Safety Supply Chain Conference in Rockville, MD, May 29–30, 2019.

AFSAP extends a gracious thank you to them for supporting AFSAP’s mission and goals.

The 2019 Auditing Stakeholder meeting will build on the TPP knowledge base, incorporating other areas that overlap with auditing and auditor development in general. FDA has a new TPP management team participating this year, along with some familiar faces from 2018. Join AFSAP in welcoming them to our event!

We have an exciting agenda planned for this year that includes a members-only session, an at-large session, and updates from FDA’s new TPP team. Association announcements will be provided after the Association’s members meeting has concluded.

AFSAP Membership Meeting

  • Association updates; Accomplishments, Partnerships & Alliances, Plans and Activities
  • Committee Updates
    • The Auditor Development Committee/Chair introductions
  • AFSAP’s Voluntary Consensus Standard (VCS) for FDA’s 3rd Party Audit
  • VCS Board: Introductions and Nominations
    • The review and publication process for a VCS

Auditing Community Meeting Highlights

  • SGS’ Hank Karayan
    • The Accreditation Experience – Lessons Learned
  • Just the FAQ’s – Common questions and misconceptions
  • New! TPP Audit Templates and Auditor Trainings

Contact AFSAP for registration information: info@afsap.org

About AFSAP

The Association for Food Safety Auditing Professionals is a member driven association created to advance and support the professional development of food safety auditors globally. As a 501(c)(3) Trade Association, AFSAP provides a universal platform for individual auditors and the auditing community at large to harness their combined experience and knowledge into a powerful tool equal to the significant challenges that lie ahead. Working together, AFSAP members will have an unprecedented opportunity to engage regulatory agencies and external stakeholders with a unified voice, and collaborate on the development of creative solutions to the issues facing the food safety auditing industry.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.

2019 Food Safety Supply Chain Conference

FDA to Provide FSMA Update at 2019 Food Safety Supply Chain Conference

By Food Safety Tech Staff
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2019 Food Safety Supply Chain Conference

EDGARTOWN, MA, April 8, 2019 – Innovative Publishing Co., publisher of Food Safety Tech, has announced three speakers from FDA will kick off the 5th Annual Food Safety Supply Chain Conference on May 29–30. Priya Rathnam, Supervisory Consumer Safety Officer, CFSAN; Andrew J. Seaborn, Supervisory Consumer Safety Officer, Division of Import Operations, ORA; and Lisa L. Ross, Consumer Safety Officer, CFSAN (Office of Food Safety, Multi-Commodity Foods, Refrigerated and Frozen Foods Team) will provide the opening presentations on Wednesday, May 29. An interactive Town Hall with attendees will follow.

Lisa Ross, CFSAN, FDA
Lisa L. Ross, Consumer Safety Officer, CFSAN

Seaborn, Rathnam and Ross will provide FDA perspective on FSVP inspection updates, including outcomes and compliance, the voluntary qualified importer program (VQIP) and where the agency is headed with enforcement activities. They will also take a deeper dive into supply chain requirements as per subpart G of part 117.

“As FDA continues its ‘educate while regulate’ strategy, having FDA officials present to inform attendees of the agency’s latest activities, available resources for industry, and how industry can work together with FDA in achieving compliance provides a crucial benefit,” said Rick Biros, president of Innovative Publishing Co., Inc. and director of the Food Safety Supply Chain Conference. “Andrew and Priya added tremendous insights to the conference last year, and I am thrilled to welcome them back, along with the addition of Lisa this year.”

The Food Safety Supply Chain conference takes place May 29–30 in Rockville, MD. Registration is open with a virtual attendee option as well.

Rick Biros, Priya Rathnam, and Andrew Seaborn, 2018 Food Safety Supply Chain Conference
Priya Rathnam (middle) pictured with Rick Biros, president of Innovative Publishing (left) and Andrew J. Seaborn,Supervisory Consumer Safety Officer, Division of Import Operations, ORA, FDA at the 2018 Food Safety Supply Chain Conference

About Food Safety Tech

Food Safety Tech publishes news, technology, trends, regulations, and expert opinions on food safety, food quality, food business and food sustainability. We also offer educational, career advancement and networking opportunities to the global food industry. This information exchange is facilitated through ePublishing, digital and live events.

About the Food Safety Supply Chain Conference

A food company’s supply chain can be the weakest link in their food safety program. Food ingredient adulteration, fraud, and counterfeiting negatively impacts everyone in the food supply chain. FDA has recognized the risk in the food supply chain. Sanitary transportation and the Foreign Supplier Verification Program (FSVP) are major components of FSMA. The Food Safety Supply Chain Conference addresses best practices, and new tools and technologies that can help food companies, including manufacturers, retailers and food service companies protect their brands and customers from food safety threats in their supply chain while being compliant with regulators.

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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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.”