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.
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
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.
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 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.”
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.
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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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.”
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