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TAG September 9, 2016 0 Comments

How prepared are you to comply with FSMA’s Foreign Supplier Verification Program (FSVP)? Will you register for the voluntary FDA’s Voluntary Qualified Importer Program (VQIP)? What can FDA do to help you? At three regional meetings FDA held earlier this summer to elicit response to these and similar questions, nearly 350 food producers, importers, and association representatives told FDA where they stood and what they thought about import safety and FSMA’s related rules. In a report released September 1, FDA summarized the general responses as being: Industry is working to move forward, but wants more clear, concise information from FDA on what is required under FSMA. Small food producers and importers less likely to be able to comply. When deciding whether to register for VQIP, importers are most likely to consider cost, ROI, and required effort. Because of the scope of the program, it will be critical for FDA to communicate with and educate foreign suppliers. In response to the questions cited at the beginning of this newsletter, following are summaries of meeting participant response and FDA analysis. Are you in agreement with these? How prepared is industry to comply with FSMA’s Foreign Supplier Verification Program (FSVP)? Currently, the greatest percentages of meeting participants stated that they have their own plan, using some form of industry-recognized processes or methods (e.g., HACCP, GFSI, etc.); they rely on assertions (import letters, letters of guarantee, etc.), COAs, and other forms of documentation provided directly by the suppliers; and/or the onsite supplier audits. Also cited were the use of ongoing risk reviews and assessments of the products, manufacturers, markets, and countries from which they import foods; testing, such as direct product testing, test data reviews, border inspections, and inspections upon arrival; and reviewing foreign supplier food safety plans or programs, generally as part of a supplier approval program. How prepared these current activities made them varied, with food producers and larger importers more prepared than smaller importers. But, overall, FDA noted that “Differences aside, participants who volunteered to respond to the self-assessment demonstrated a comparative lack of readiness in the same four areas, regardless the size of their business or whether they were a Food Producer or Importer.” Those areas are: Developing, maintaining and following an FSVP for each imported food for each foreign supplier of that food. Awareness of key exemptions and modified requirements of FSVP. Knowledge of how to respond appropriately. Ability to re-evaluate risk posed by the imported food and the supplier’s performance at least every three years or when new information comes to light about a potential hazard or the foreign supplier’s performance From this, participants saw their greatest compliance challenges as being understanding requirements and FDA expectations, the overall burden of compliance, implementation concerns and market complexity. To help industry overcome these, participants FDA and/or industry development of or assistance with cross program/systems analysis, product/commodity support, case studies/examples, foreign supplier support, and FDA clarification of expectations and service as an authoritative FSMA/FSVP body. Will industry register for the voluntary FDA’s Voluntary Qualified Importer Program (VQIP)? From participant response, it seems that industry is interested in VQIP and intends to at least consider it. Why the hesitation? Most cited were questions about the effort and cost it would take both initially and for ongoing maintenance of the program; what ROI would be gained (Will the benefits outweigh the risks?); any unforeseen challenges or risks of VQIP that have not yet been addressed or explained by the FDA; and potential consequences if the importer were to be unsuccessful in the application process. On the other hand, reasons that industry would be likely to participate were that they felt it would bring a boost in reputation and credibility in the eyes of their customers and the FDA; it increased efficiency and speed would give them a competitive edge; long-term reduction in import risk, cost, and disruption due to the reduction in FDA sampling and delays; and the potential to be part of a better food safety system, offering better service or experiences to customers. What can FDA do to help industry? FDA’s review and consolidation of responses from the three meetings found five key areas in which industry felt it could provide better assistance by increasing: Speed of information release, including quicker release of guidance, updates to and quicker response from its Technical Assistance Network (TAN), and development of compliance tools, templates, and training. Organization, clarity, and consolidation of information, e.g., by industry sector or commodity group, and in plain language with user-friendly, searchable information wherever possible. Direct access to FDA officials, such as to local officers, through contact lists with noted areas of expertise, and with live chat features. Outreach & education to help industry keep up with evolving FSMA requirements and benefit from joint training opportunities with industry associations. Foreign supplier focus, with the burden of educating foreign suppliers shared between FDA and the regulated industry, through such support as simplified education materials that could easily be translated into other languages, multilingual translations of FDA’s FSMA website, supporting documents (checklists, guidance, etc.), and education materials that importers can give to their suppliers To better reach industry and raise awareness, particularly those who are wholly uninvolved or unaware, it was also noted that FDA could use its facility registration database system and leverage its relationships with industry associations, embassy personnel, foreign representatives, state and local governments, and academia to identify opportunities to work together to expand outreach efforts through conference attendance, annual meetings, training development, etc. Our experience at TAG is very reflective of what the FDA found. Some companies are well on the way to figuring out FSVP– but others are struggling with the right approach. There continues to be confusion between FSVP and the supplier control component of the Preventive Control Rules. If you are reading this and you are are struggling with how to approach FSVP and the supplier components of FSMA give us a call. We have worked with many companies to simplify the approach and help design programs that build the foundation for FSMA compliance. How do you stack up against these responses? Let us know your thoughts … or give us a call to help! About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance.


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